DETAILED ACTION
This Office Action is in response to the request for continued examination, filed on June 26, 2026. Primary Examiner acknowledges Claims 1-8, 10-14, 47-51, and 53-61 are pending in this application, with Claims 1-4, 47, 48, 50, and 51 having been currently amended, and Claims 9, 15-46, and 52 having been cancelled.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 26, 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5, 6, 12, and 61 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.
Specifically, Claim 5, Line 2 recites “the single nasal axis”; however, this limitation lacks antecedent basis in the claims. By Applicant’s amendment, filed June 26, 2026, Applicant deleted the word “single” from the “single nasal axis” of the independent claim, Claim 1, Lines 22 and 29. Thus, by convention the remaining limitations within the claim listing must be amended in a commensurate manner. Appropriate correction is required.
Specifically, Claim 6, Line 1 recites “the nasal single axis”; however, this limitation lacks antecedent basis in the claims. By Applicant’s amendment, filed June 26, 2026, Applicant deleted the word “single” from the “single nasal axis” of the independent claim, Claim 1, Lines 22 and 29. Thus, by convention the remaining limitations within the claim listing must be amended in a commensurate manner. Appropriate correction is required.
Specifically, Claim 12, Line 2 recites the word “each”; which appears to be erroneous as there is only “one nasal hole”. The breadth and scope of this limitation appears unclear. Appropriate correction is required.
Specifically, Claim 61 Line 2 recites “the single nasal axis”; however, this limitation lacks antecedent basis in the claims. By Applicant’s amendment, filed June 26, 2026, Applicant deleted the word “single” from the “single nasal axis” of the independent claim, Claim 47, Line 23. Thus, by convention the remaining limitations within the claim listing must be amended in a commensurate manner. Appropriate correction is required.
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 1, 2, 5-8, 10-12, 14, 47-49, 53-56, 59, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Bornholdt et al. (2020/0016358) in view of Kidd (5,746,201), Kwok (2003/0079751), and Starr et al. (5,438,981).
As to Claim 1, Bornholdt discloses a patient interface (Figures 2A, 2B, and 9A-9C), comprising: a plenum chamber (130, Figures 9A-9C, “Pressurized gases supplied by the conduit 120 enters the breathing chamber 130 and are received by the user through the oro-nasal opening 134.” Para 0167) at least partially forming an interior space pressurizable to a therapeutic pressure above ambient pressure through a patient’s respiratory cycle in use (CPAP, “Respiratory interfaces are used to provide respiratory gas or gases, such as air in CPAP (or other positive pressure) therapy, to a user under positive pressure.” Para 0002; also see: “FIGS. 9A to 9C illustrate an alternative configuration for a cushion 444 for use with the CPAP system 10 of FIG. 1.” Para 0208); a seal forming structure (444, Figures 9A-9C, “FIGS. 9A to 9C illustrate an alternative configuration for a cushion 444 for use with the CPAP system 10 of FIG. 1.” Para 0208) at least partially formed with the plenum chamber (130) from a single homogenous silicone material (“silicone rubber 312”, “The impregnated region 234 is formed by impregnating the dual-layer textile material 314 of the locating region 242 with silicone rubber 312 during the overmolding process such that the locating region 242 and the sealing region 244 are integrally formed. Accordingly, the transition region 208 comprises a composite material of dual-layer textile material 314 and silicone rubber 312.” Para 0199; “Similar to the impregnation process previously described, the impregnated region 234 is formed by impregnating the dual-layer textile material 314 with silicone rubber 312 using the overmolding tool 320. … That is, the silicone rubber 312 may be allowed to permeate specific regions of the dual-layer textile material 314 to provide an impregnated region 234 with a shape that improves the seal with the user's face.” Para 0200), the seal forming structure (444) comprising a nasal portion (138, “The locating region 242 includes two openings including an oral opening 136 and a nasal opening 138. The oral opening 136 is configured to encircle the user's mouth and the nasal opening 138 is configured to encircle the user's nares.” Para 0205) and an oral portion (136, “The locating region 242 includes two openings including an oral opening 136 and a nasal opening 138. The oral opening 136 is configured to encircle the user's mouth and the nasal opening 138 is configured to encircle the user's nares.” Para 0205), the nasal portion (138) having at least one nasal hole (Figures 9A-9C) configured to deliver a flow of air at the therapeutic pressure (CPAP) to the patient’s nares in use, the oral portion (136) having an oral hole (Figures 9A-9C) configured to deliver the flow of air at the therapeutic pressure (CPAP) to the patient’s mouth in use, the seal forming structure (444) constructed and arranged to maintain the therapeutic pressure (CPAP) in the plenum chamber (130) throughout the patient’s respiratory cycle in use; a positioning and stabilizing structure (118, best seen Figures 2A and 2B, “The interface 110 also includes a headgear 118 for securing the mask 112 to the user.” Para 0162) comprising at least one tie and being configured to hold the seal forming structure (444) in a therapeutically effective position on the patient’s head in use; wherein the nasal portion (138) of the seal forming structure (444) includes a nasal textile laminate (314 proximate 138, “The locating region 242 is formed from a dual-layer textile material 314. The textile layers of the locating region 242 are configured to conform to the user's facial geometry and locate (i.e., visually, tactily, etc.) the cushion on the user's face. In some embodiments, the dual-layer textile material 314 may comprise first and second layers that have different properties. For example, the dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight, so as to increase the sealing region 244 that contacts the user's face and improve the seal achieved. The dual-layer textile material 314 may also comprise at least one comfort layer, so as to increase the softness, cushioning, texture, breathability, etc. of the locating region 242.” Para 0197) comprising a first textile layer (“first and second layers that have different properties … dual-layer textile material 314 may also comprise at least one comfort layer” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185) and a first elastomeric material layer (“first and second layers that have different properties … dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185), the nasal textile laminate (314 proximate 138) forming the at least one nasal hole (Figures 9A-9C) and being configured to contact the patient’s nose in use, and at least a portion of the nasal textile laminate (314 proximate 138) being positively curved around a nasal axis (the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136, in which the curvature of the nasal axis at the nasal opening 138 has a different curvature than the curvature of the oral axis at the oral opening 136) before the patient interface (Figures 2A, 2B, and 9A-9C) is worn; wherein the oral portion (136) of the seal forming structure (444) includes an oral textile laminate (314 proximate 136, “The locating region 242 is formed from a dual-layer textile material 314. The textile layers of the locating region 242 are configured to conform to the user's facial geometry and locate (i.e., visually, tactily, etc.) the cushion on the user's face. In some embodiments, the dual-layer textile material 314 may comprise first and second layers that have different properties. For example, the dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight, so as to increase the sealing region 244 that contacts the user's face and improve the seal achieved. The dual-layer textile material 314 may also comprise at least one comfort layer, so as to increase the softness, cushioning, texture, breathability, etc. of the locating region 242.” Para 0197) that is separate (via 140, “The oral and nasal openings 136, 138 form a sub-nasal sling 140 that is a strip of textile material that extends laterally across the face contacting portion 202.” Para 0205) from the nasal textile laminate (314 proximate 138), the oral textile laminate (314 proximate 136) comprising a second textile layer (“first and second layers that have different properties … dual-layer textile material 314 may also comprise at least one comfort layer” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185) and a second elastomeric material layer (“first and second layers that have different properties … dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185), the oral textile laminate (314 proximate 136) forming the oral hole (Figures 9A-9C) and being configured to contact the patient’s face proximate to the patient’s mouth in use, and at least a portion of the oral textile laminate (314 proximate 136) being positively curved around an oral axis (the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136, in which the curvature of the nasal axis at the nasal opening 138 has a different curvature than the curvature of the oral axis at the oral opening 136) that is oriented differently from the nasal axis (the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136, in which the curvature of the nasal axis at the nasal opening 138 has a different curvature than the curvature of the oral axis at the oral opening 136) before the patient interface (Figures 2A, 2B, and 9A-9C) is worn; wherein the silicone material (“silicone rubber 312”) of the seal forming structure (444) is overmolded (“The impregnated region 234 is formed by impregnating the dual-layer textile material 314 of the locating region 242 with silicone rubber 312 during the overmolding process such that the locating region 242 and the sealing region 244 are integrally formed. Accordingly, the transition region 208 comprises a composite material of dual-layer textile material 314 and silicone rubber 312.” Para 0199; “Similar to the impregnation process previously described, the impregnated region 234 is formed by impregnating the dual-layer textile material 314 with silicone rubber 312 using the overmolding tool 320. … That is, the silicone rubber 312 may be allowed to permeate specific regions of the dual-layer textile material 314 to provide an impregnated region 234 with a shape that improves the seal with the user's face.” Para 0200) onto both the nasal textile laminate (314 proximate 138) and the oral textile laminate (314 proximate 136) such that the silicone material (“silicone rubber 312”) of the nasal portion (138) and the oral portion (136) of the seal forming structure (444) is a continuous material.
Yet, Bornholdt does not expressly disclose the specific therapeutic pressure “of at least 6 cm of water”; “a vent comprising a plurality of holes configured to allow a continuous vent flow from the interior space of the plenum chamber to ambient throughout the patient's respiratory cycle while the therapeutic pressure within the plenum chamber is positive with respect to ambient;” nor “wherein the patient interface is configured to allow the patient to breath from ambient in the absence of the flow of air at the therapeutic pressure.”
Regarding the specific therapeutic pressure “of at least 6 cm of water”, Kidd teaches a patient interface for CPAP therapy providing a therapeutic pressure of “10 cm of water” (Column 3, Lines 40-60) to treat a patient suffering the effects of sleep apnea.
In light of the teachings of Kidd, the modification of Bornholdt which also operates a CPAP therapy to the specific therapeutic pressure “of at least 6 cm of water” is a known operational pressure suitable for imparting CPAP therapy to a patient.
Regarding the “a vent comprising a plurality of holes configured to allow a continuous vent flow from the interior space of the plenum chamber to ambient throughout the patient's respiratory cycle while the therapeutic pressure within the plenum chamber is positive with respect to ambient”, Kwok teaches a patient interface (Figures) having a vent (20, “The mask (10) includes a mask shell (12) which is, in use, in fluid communication with a gas supply conduit and a gas washout vent assembly (20). The gas washout vent assembly (20) includes at least one gas washout orifice (22) extending from a first side of the vent assembly (20) positioned, in use, adjacent the human or animal's face and a second side positioned, in use, adjacent the atmosphere.” Abstract) comprising a plurality of holes (22, “at least one gas washout orifice (22)”Abstract) configured to allow continuous vent flow from the interior space of the plenum chamber (via 12, “The mask shell 12 also includes a flexible sealing membrane 16 which is used to provide a gas tight seal between the face of the wearer and the interior of the shell 12.” Para 0034) to the ambient throughout the patient’s respiratory cycle while the therapeutic pressure within the plenum chamber (via 12) is positive with respect to ambient.
In light of the teachings of Kwok, the modification of Bornholdt’s plenum chamber to include the vent as taught by Kwok permits the washing out of carbon dioxide and other gases from the plenum chamber on a continuous basis to prevent a hypoxic environment within the plenum chamber.
Regarding the configuration wherein the patient interface is configured to allow the patient to breath from ambient in the absence of the flow of air at the therapeutic pressure”, Starr teaches a patient interface (Figures 1-5) having an elbow attached thereto to convey the positive pressure from the source to the plenum chamber through the operation of a valve (36, “closure member 36” Column 6, Lines 35-50). In operation, Starr teaches “Should the pressurized respiratory gas flow then be cut off for any reason, the user's next inhalation following such gas flow cessation would exert a negative pressure force on the underside of the closure member 36, thereby causing the valve element 32 to pivot downwardly and cover the primary inlet 14. With the valve element so disposed, the user would have complete access to ambient air through secondary inlet 16. This situation would continue until such time that the pressurized gas flow is restored, whereupon the positive pressure produced by the pressurized gas would again compel the valve element 32 to pivot upwardly whereby closure portion 36 would cover secondary inlet 16 and assisted ventilation would proceed.” Column 6, Lines 35-50).
In light of the teachings of Starr, the modification of Bornholdt’s patient interface to include an elbow attached thereto provides an anti-asphyxia valve in the absence of positive pressure to permit the patient to breath ambient air.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface of Bornholdt to operate at a therapeutic pressure of “at least 6 cm of water”, as taught by Kidd to be a known operational pressure for CPAP therapy, to modify the plenum chamber of Bornholdt to include a vent for continuous venting, as taught by Kwok to permit the washing out of carbon dioxide and other gases to prevent a hypoxic environment, and to modify the patient interface of Bornholdt to include an elbow attached thereto, as taught by Starr to provide an anti-asphyxia valve in the absence of positive pressure so that the patient may breath ambient air.
As to Claims 2 and 48, the modified Bornholdt, specifically Bornholdt discloses a first textile segment of the nasal textile laminate (314 proximate 138) and/or the oral textile laminate (314 proximate 136) extends radially inwardly beyond the silicone material (“silicone rubber 312”) in a cantilever manner (as seen at 232 and 248, best seen Figures 9B and 9C, wherein “As such, the seam 232 has an increased thickness that extends from an interior surface of the transition region towards the interior of the cushion 444. The raised bead 236 extends around the seam 232 along the perimeter of the locating region 242. The raised bead 236 extends onto an internal or interior-facing surface 248 of the dual-layer textile material 314.” Para 0209).
As to Claim 5, the modified Bornholdt, specifically Bornholdt discloses the seal forming structure (444) is configured such that the single nasal axis (the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136, in which the curvature of the nasal axis at the nasal opening 138 has a different curvature than the curvature of the oral axis at the oral opening 136) that is oriented differently from the nasal axis (the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136, in which the curvature of the nasal axis at the nasal opening 138 has a different curvature than the curvature of the oral axis at the oral opening 136) and the oral axis (the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136, in which the curvature of the nasal axis at the nasal opening 138 has a different curvature than the curvature of the oral axis at the oral opening 136) that is oriented differently from the nasal axis (the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136, in which the curvature of the nasal axis at the nasal opening 138 has a different curvature than the curvature of the oral axis at the oral opening 136) are located in the patient’s sagittal plane in use.
As to Claim 6, the modified Bornholdt, specifically Bornholdt discloses the nasal axis (the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136, in which the curvature of the nasal axis at the nasal opening 138 has a different curvature than the curvature of the oral axis at the oral opening 136) and the oral axis (the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136, in which the curvature of the nasal axis at the nasal opening 138 has a different curvature than the curvature of the oral axis at the oral opening 136) are oriented relative to one another at an angle greater than 90 degrees (best seen Figure 2A and 2B).
As to Claim 7, the modified Bornholdt, specifically Bornholdt discloses the radius of curvature of the nasal textile laminate (314 proximate 138) is less than the radius of curvature of the oral textile laminate (314 proximate 136). As best seen in Figures 9A-9C, the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136. In light of this fact and the general anatomical feature of the nose being smaller than that of the mouth, the nasal portion has a smaller radius of curvature to accommodate the nose than the oral portion having a larger radius of curvature to accommodate the mouth.
As to Claims 8 and 55, the modified Bornholdt, specifically Bornholdt discloses each of the nasal textile laminate (314 proximate 138) and the oral textile laminate (314 proximate 136) is air-impermeable (“the dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight, so as to increase the sealing region 244 that contacts the user's face and improve the seal achieved.” Para 0197).
As to Claims 10 and 53, the modified Bornholdt, specifically Bornholdt discloses the first textile layer (“first and second layers that have different properties … dual-layer textile material 314 may also comprise at least one comfort layer” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185) and the second textile layer (“first and second layers that have different properties … dual-layer textile material 314 may also comprise at least one comfort layer” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185) have the same properties.
As to Claims 11 and 54, the modified Bornholdt, specifically Bornholdt discloses the first textile layer (“first and second layers that have different properties … dual-layer textile material 314 may also comprise at least one comfort layer” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185) and the second textile layer (“first and second layers that have different properties … dual-layer textile material 314 may also comprise at least one comfort layer” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185) have at least one property that is different (“different properties”).
As to Claims 12 and 56, the modified Bornholdt, specifically Bornholdt discloses the nasal textile laminate (314 proximate 138) consists of one nasal hole (Figures 9A-9C) configured to direct the flow of air into both nares during use.
As to Claim 14, the modified Bornholdt, specifically Bornholdt discloses the nasal textile laminate (314 proximate 138) is configured to be positioned adjacent the patient’s columella in use (via proximity to 140).
As to Claim 47, Bornholdt discloses a patient interface (Figures 2A, 2B, and 9A-9C), comprising: a plenum chamber (130, Figures 9A-9C, “Pressurized gases supplied by the conduit 120 enters the breathing chamber 130 and are received by the user through the oro-nasal opening 134.” Para 0167) at least partially forming an interior space pressurizable to a therapeutic pressure above ambient pressure through a patient’s respiratory cycle in use (CPAP, “Respiratory interfaces are used to provide respiratory gas or gases, such as air in CPAP (or other positive pressure) therapy, to a user under positive pressure.” Para 0002; also see: “FIGS. 9A to 9C illustrate an alternative configuration for a cushion 444 for use with the CPAP system 10 of FIG. 1.” Para 0208); a seal forming structure (444, Figures 9A-9C, “FIGS. 9A to 9C illustrate an alternative configuration for a cushion 444 for use with the CPAP system 10 of FIG. 1.” Para 0208) at least partially formed with the plenum chamber (130) from a single homogenous silicone material (“silicone rubber 312”, “The impregnated region 234 is formed by impregnating the dual-layer textile material 314 of the locating region 242 with silicone rubber 312 during the overmolding process such that the locating region 242 and the sealing region 244 are integrally formed. Accordingly, the transition region 208 comprises a composite material of dual-layer textile material 314 and silicone rubber 312.” Para 0199; “Similar to the impregnation process previously described, the impregnated region 234 is formed by impregnating the dual-layer textile material 314 with silicone rubber 312 using the overmolding tool 320. … That is, the silicone rubber 312 may be allowed to permeate specific regions of the dual-layer textile material 314 to provide an impregnated region 234 with a shape that improves the seal with the user's face.” Para 0200), the seal forming structure (444) comprising a nasal portion (138, “The locating region 242 includes two openings including an oral opening 136 and a nasal opening 138. The oral opening 136 is configured to encircle the user's mouth and the nasal opening 138 is configured to encircle the user's nares.” Para 0205) and an oral portion (136, “The locating region 242 includes two openings including an oral opening 136 and a nasal opening 138. The oral opening 136 is configured to encircle the user's mouth and the nasal opening 138 is configured to encircle the user's nares.” Para 0205), the nasal portion (138) having at least one nasal hole (Figures 9A-9C) configured to deliver a flow of air at the therapeutic pressure (CPAP) to the patient’s nares in use, the oral portion (136) having an oral hole (Figures 9A-9C) configured to deliver the flow of air at the therapeutic pressure (CPAP) to the patient’s mouth in use, the seal forming structure (444) constructed and arranged to maintain the therapeutic pressure (CPAP) in the plenum chamber (130) throughout the patient’s respiratory cycle in use; a positioning and stabilizing structure (118, best seen Figures 2A and 2B, “The interface 110 also includes a headgear 118 for securing the mask 112 to the user.” Para 0162) comprising at least one tie and being configured to hold the seal forming structure (444) in a therapeutically effective position on the patient’s head in use; and a textile laminate (314, “The locating region 242 is formed from a dual-layer textile material 314. The textile layers of the locating region 242 are configured to conform to the user's facial geometry and locate (i.e., visually, tactily, etc.) the cushion on the user's face. In some embodiments, the dual-layer textile material 314 may comprise first and second layers that have different properties. For example, the dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight, so as to increase the sealing region 244 that contacts the user's face and improve the seal achieved. The dual-layer textile material 314 may also comprise at least one comfort layer, so as to increase the softness, cushioning, texture, breathability, etc. of the locating region 242.” Para 0197) comprising: a nasal textile laminate (314 proximate 138, “The locating region 242 is formed from a dual-layer textile material 314. The textile layers of the locating region 242 are configured to conform to the user's facial geometry and locate (i.e., visually, tactily, etc.) the cushion on the user's face. In some embodiments, the dual-layer textile material 314 may comprise first and second layers that have different properties. For example, the dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight, so as to increase the sealing region 244 that contacts the user's face and improve the seal achieved. The dual-layer textile material 314 may also comprise at least one comfort layer, so as to increase the softness, cushioning, texture, breathability, etc. of the locating region 242.” Para 0197) that at least partially forms the at least one nasal hole (Figures 9A-9C) and is positioned on the nasal portion (138) of the seal forming structure (444) to contact the patient’s nose in use, the nasal textile laminate (314 proximate 138) comprising a first textile layer (“first and second layers that have different properties … dual-layer textile material 314 may also comprise at least one comfort layer” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185) and a first elastomeric material layer (“first and second layers that have different properties … dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185), at least a portion of the nasal textile laminate (314 proximate 138) being positively curved around a nasal axis (the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136, in which the curvature of the nasal axis at the nasal opening 138 has a different curvature than the curvature of the oral axis at the oral opening 136) before the patient interface (Figures 2A, 2B, and 9A-9C) is worn; an oral textile laminate (314 proximate 136, “The locating region 242 is formed from a dual-layer textile material 314. The textile layers of the locating region 242 are configured to conform to the user's facial geometry and locate (i.e., visually, tactily, etc.) the cushion on the user's face. In some embodiments, the dual-layer textile material 314 may comprise first and second layers that have different properties. For example, the dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight, so as to increase the sealing region 244 that contacts the user's face and improve the seal achieved. The dual-layer textile material 314 may also comprise at least one comfort layer, so as to increase the softness, cushioning, texture, breathability, etc. of the locating region 242.” Para 0197) that at least partially forms an oral hole (Figures 9A-9C) and is positioned in the oral portion (136) of the seal forming structure (444) to contact the patient’s face proximal to the patient’s mouth in use, the oral textile laminate (314 proximate 136) comprising a second textile layer (“first and second layers that have different properties … dual-layer textile material 314 may also comprise at least one comfort layer” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185) and a second elastomeric material layer (“first and second layers that have different properties … dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185); and a gap (140, “The oral and nasal openings 136, 138 form a sub-nasal sling 140 that is a strip of textile material that extends laterally across the face contacting portion 202.” Para 0205) in the textile laminate between the at least one nasal hole (Figures 9A-9C) and the oral hole (Figures 9A-9C); wherein the silicone material (“silicone rubber 312”) of the seal forming structure (444) is overmolded (“The impregnated region 234 is formed by impregnating the dual-layer textile material 314 of the locating region 242 with silicone rubber 312 during the overmolding process such that the locating region 242 and the sealing region 244 are integrally formed. Accordingly, the transition region 208 comprises a composite material of dual-layer textile material 314 and silicone rubber 312.” Para 0199; “Similar to the impregnation process previously described, the impregnated region 234 is formed by impregnating the dual-layer textile material 314 with silicone rubber 312 using the overmolding tool 320. … That is, the silicone rubber 312 may be allowed to permeate specific regions of the dual-layer textile material 314 to provide an impregnated region 234 with a shape that improves the seal with the user's face.” Para 0200) onto both the nasal textile laminate (314 proximate 138) and the oral textile laminate (314 proximate 136) such that the silicone material (“silicone rubber 312”) of the nasal portion (138) and the oral portion (136) of the seal forming structure (444) is a continuous material.
Yet, Bornholdt does not expressly disclose the specific therapeutic pressure “of at least 6 cm of water”; “a vent comprising a plurality of holes configured to allow a continuous vent flow from the interior space of the plenum chamber to ambient throughout the patient's respiratory cycle while the therapeutic pressure within the plenum chamber is positive with respect to ambient;” nor “wherein the patient interface is configured to allow the patient to breath from ambient in the absence of the flow of air at the therapeutic pressure.”
Regarding the specific therapeutic pressure “of at least 6 cm of water”, Kidd teaches a patient interface for CPAP therapy providing a therapeutic pressure of “10 cm of water” (Column 3, Lines 40-60) to treat a patient suffering the effects of sleep apnea.
In light of the teachings of Kidd, the modification of Bornholdt which also operates a CPAP therapy to the specific therapeutic pressure “of at least 6 cm of water” is a known operational pressure suitable for imparting CPAP therapy to a patient.
Regarding the “a vent comprising a plurality of holes configured to allow a continuous vent flow from the interior space of the plenum chamber to ambient throughout the patient's respiratory cycle while the therapeutic pressure within the plenum chamber is positive with respect to ambient”, Kwok teaches a patient interface (Figures) having a vent (20, “The mask (10) includes a mask shell (12) which is, in use, in fluid communication with a gas supply conduit and a gas washout vent assembly (20). The gas washout vent assembly (20) includes at least one gas washout orifice (22) extending from a first side of the vent assembly (20) positioned, in use, adjacent the human or animal's face and a second side positioned, in use, adjacent the atmosphere.” Abstract) comprising a plurality of holes (22, “at least one gas washout orifice (22)”Abstract) configured to allow continuous vent flow from the interior space of the plenum chamber (via 12, “The mask shell 12 also includes a flexible sealing membrane 16 which is used to provide a gas tight seal between the face of the wearer and the interior of the shell 12.” Para 0034) to the ambient throughout the patient’s respiratory cycle while the therapeutic pressure within the plenum chamber (via 12) is positive with respect to ambient.
In light of the teachings of Kwok, the modification of Bornholdt’s plenum chamber to include the vent as taught by Kwok permits the washing out of carbon dioxide and other gases from the plenum chamber on a continuous basis to prevent a hypoxic environment within the plenum chamber.
Regarding the configuration wherein the patient interface is configured to allow the patient to breath from ambient in the absence of the flow of air at the therapeutic pressure”, Starr teaches a patient interface (Figures 1-5) having an elbow attached thereto to convey the positive pressure from the source to the plenum chamber through the operation of a valve (36, “closure member 36” Column 6, Lines 35-50). In operation, Starr teaches “Should the pressurized respiratory gas flow then be cut off for any reason, the user's next inhalation following such gas flow cessation would exert a negative pressure force on the underside of the closure member 36, thereby causing the valve element 32 to pivot downwardly and cover the primary inlet 14. With the valve element so disposed, the user would have complete access to ambient air through secondary inlet 16. This situation would continue until such time that the pressurized gas flow is restored, whereupon the positive pressure produced by the pressurized gas would again compel the valve element 32 to pivot upwardly whereby closure portion 36 would cover secondary inlet 16 and assisted ventilation would proceed.” Column 6, Lines 35-50).
In light of the teachings of Starr, the modification of Bornholdt’s patient interface to include an elbow attached thereto provides an anti-asphyxia valve in the absence of positive pressure to permit the patient to breath ambient air.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface of Bornholdt to operate at a therapeutic pressure of “at least 6 cm of water”, as taught by Kidd to be a known operational pressure for CPAP therapy, to modify the plenum chamber of Bornholdt to include a vent for continuous venting, as taught by Kwok to permit the washing out of carbon dioxide and other gases to prevent a hypoxic environment, and to modify the patient interface of Bornholdt to include an elbow attached thereto, as taught by Starr to provide an anti-asphyxia valve in the absence of positive pressure so that the patient may breath ambient air.
As to Claim 49, the modified Bornholdt, specifically Bornholdt discloses textile laminate (314) is unitary (best seen Figures 9A-9C).
As to Claims 59 and 61, the modified Bornholdt, specifically Bornholdt discloses oral textile laminate (314 proximate 136) is positively curved around only the oral axis (the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136, in which the curvature of the nasal axis at the nasal opening 138 has a different curvature than the curvature of the oral axis at the oral opening 136) that is oriented different from the nasal axis (the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136, in which the curvature of the nasal axis at the nasal opening 138 has a different curvature than the curvature of the oral axis at the oral opening 136). As best seen in Figures 9A-9C, the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136. In light of this fact and the general anatomical feature of the nose being smaller than that of the mouth, the nasal portion has a smaller radius of curvature to accommodate the nose than the oral portion having a larger radius of curvature to accommodate the mouth. Thus the oral axis is distinct for the coverage of the oral region of the patient’s face and the nasal axis is distinct for the coverage of the nasal region of the patient’s face.
Claims 13 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Bornholdt et al. (2020/0016358) in view of Kidd (5,746,201), Kwok (2003/0079751), and Starr et al. (5,438,981), as applied to Claims 1 and 47, and further in view of Baecke et al. (8,985,115).
As to Claims 13 and 57, the modified Bornholdt, specifically Bornholdt discloses the nasal textile laminate (314 proximate 138) consists of one nasal hole (Figures 9A-9C) configured to direct the flow of air into both nares during use; yet, does not disclose the configuration of the nasal textile laminate consists of two nasal holes configured to direct the flow of air into a corresponding one of the nares during use.
Baecke teaches an additional patient interface having the construction of a nasal region having two holes (35 and 40) to direct the flow of air into a corresponding one of the nares during use. Baecke teaches this particular two hole configuration has the benefit of aiding in the positioning of the nasal interface with respect to the patient’s nostrils (Column 2, Lines 20-45).
Therefore, it would have been obvious to modify the construction of the singular opening of the nare hole of the modified Bornholdt to include the two hole configuration for each nare, as taught by Baecke to be a known construction suitable for imparting breathing gas to the patient and further aiding in positioning the nasal interface with respect to the patient’s nostrils.
Claims 58 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Bornholdt et al. (2020/0016358) in view of Kidd (5,746,201), Kwok (2003/0079751), and Starr et al. (5,438,981), as applied to Claims 1 and 47, and further in view of Asvadi et al. (2014/0109911).
As to Claims 58 and 60, the modified Bornholdt, specifically Bornholdt discloses each of the first and second elastomeric material layers (“first and second layers that have different properties … dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185) may include the use of “foam”; yet, does not expressly disclose the material composition of the first and second elastomeric material layers to be “silicone”.
Asvadi teaches an additional patient interface having a multi layered construction of a seal forming structure (Figures 10 and 14). As clearly shown in Figure 10 of Asvadi, Asvadi teaches the seal forming structure comprises a polymer layer (44, Para 0066) that is attached to a fabric layer (42, Para 0065) such that the "third layer 44 can be coated or laminated on [the] second layer 42" (Para 0066). In this teaching of Asvadi, Asvadi affirms the manner of manufacturing of a fabric and polymer combination in a seal forming structure to include the features of lamination of a fabric layer to a polymer layer was a known method of manufacturing to yield a seal forming structure for a patient interface. Still further, as shown in Figure 14 of Asvadi, Asvadi teaches an additional alternative configuration of another seal forming structure of a patient interface having a polymer layer (66, Para 0074 - ref back to 44) is layered upon a textile layer (64, Para 0078) to form the claimed lamination of a fabric layer upon a polymer layer was a known method of manufacturing to yield a seal forming structure for a patient interface.
Regarding the material composition, Asvadi teaches “foam” and “silicone” are functionally equivalent alternative material compositions suitable for usage in a seal forming structure – “In another particular exemplary embodiment (referred to as "Embodiment 42B"), second layer 42 is made of a foam (e.g., without limitation, a silicone or polyurethane foam) or a gel (e.g., without limitation, silicone gel or polyurethane gel) spacer material.” (Para 0059); and “In the exemplary embodiment, second layer 42 is made of a spacer fabric (as described herein), a nonwoven textile, a foam material or a gel material, such as silicone gel or polyurethane gel, that mainly serves to distribute load and/or transport air or water to keep the skin optimally dry and cool on the one hand and avoid pressure spots on the other.” (Para 0057).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the material composition of the first and second elastomeric material layers of the modified Bornholdt from “foam” to silicone, as taught by Asvadi to be known functionality equivalent alternative material suitable for imparting seal forming structure properties.
Allowable Subject Matter
Claims 3, 4, 50, and 51 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The modified Bornholdt does not appear to disclose, teach, or fairly suggest the construction of “the silicone material exposed between the nasal textile laminate and the oral textile laminate” (Claims 3 and 4), nor the construction of “the silicone material of the seal forming structure is exposed at the gap” (Claims 50 and 51). Rather, the modified Bornholdt expressly discloses “an outer perimeter of the dual-layer textile material 314 is overmolded to the sealing region 244” (Para 0198), and “The impregnated region 234 is formed by impregnating the dual-layer textile material 314 of the locating region 242 with silicone rubber 312 during the overmolding process such that the locating region 242 and the sealing region 244 are integrally formed.” (Para 0199). In this configuration, there is no “silicone material exposed between the nasal textile laminate and the oral textile laminate” (Claims 3 and 4)”, nor is there any “silicone material … exposed at the gap” (Claim 50 and 51), wherein the gap is defined as “the textile laminate between the at least one nasal hole and the oral hole” (parent INDP Claim 47). Thus, it appears the incorporation of these features into the independent claims, would yield allowable subject matter as there would be motivation beyond hindsight incorporation to modify the construction of the overmolded silicone material to be oriented in an exposed region between the “the nasal textile laminate and the oral textile laminate” (Claims 3 and 4)”, nor “the gap” (Claim 50 and 51). Applicant is encouraged to consider and accept this indication of allowable subject matter.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Newly located reference, Bornholdt et al. (2020/0016358) in combination, appears to expressly disclose the newly added features of the claims including but not limited to:
the configuration of the seal forming structure (444, Figures 9A-9C, “FIGS. 9A to 9C illustrate an alternative configuration for a cushion 444 for use with the CPAP system 10 of FIG. 1.” Para 0208) at least partially formed with the plenum chamber (130) from a single homogenous silicone material (“silicone rubber 312”, “The impregnated region 234 is formed by impregnating the dual-layer textile material 314 of the locating region 242 with silicone rubber 312 during the overmolding process such that the locating region 242 and the sealing region 244 are integrally formed. Accordingly, the transition region 208 comprises a composite material of dual-layer textile material 314 and silicone rubber 312.” Para 0199; “Similar to the impregnation process previously described, the impregnated region 234 is formed by impregnating the dual-layer textile material 314 with silicone rubber 312 using the overmolding tool 320. … That is, the silicone rubber 312 may be allowed to permeate specific regions of the dual-layer textile material 314 to provide an impregnated region 234 with a shape that improves the seal with the user's face.” Para 0200),
the material composition of the nasal portion and oral portion having the nasal textile laminate (314 proximate 138) comprising a first textile layer (“first and second layers that have different properties … dual-layer textile material 314 may also comprise at least one comfort layer” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185) and a first elastomeric material layer (“first and second layers that have different properties … dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185), at least a portion of the nasal textile laminate (314 proximate 138) being positively curved around a nasal axis (the curvature of the axis is a function of the size of the nasal opening 138 and the size of the oral opening 136, in which the curvature of the nasal axis at the nasal opening 138 has a different curvature than the curvature of the oral axis at the oral opening 136) before the patient interface (Figures 2A, 2B, and 9A-9C) is worn; an oral textile laminate (314 proximate 136, “The locating region 242 is formed from a dual-layer textile material 314. The textile layers of the locating region 242 are configured to conform to the user's facial geometry and locate (i.e., visually, tactily, etc.) the cushion on the user's face. In some embodiments, the dual-layer textile material 314 may comprise first and second layers that have different properties. For example, the dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight, so as to increase the sealing region 244 that contacts the user's face and improve the seal achieved. The dual-layer textile material 314 may also comprise at least one comfort layer, so as to increase the softness, cushioning, texture, breathability, etc. of the locating region 242.” Para 0197) that at least partially forms an oral hole (Figures 9A-9C) and is positioned in the oral portion (136) of the seal forming structure (444) to contact the patient’s face proximal to the patient’s mouth in use, the oral textile laminate (314 proximate 136) comprising a second textile layer (“first and second layers that have different properties … dual-layer textile material 314 may also comprise at least one comfort layer” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185) and a second elastomeric material layer (“first and second layers that have different properties … dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight” Para 0197; also see: “In some configurations, the nasal region 144 may be formed from a textile material, a laminate material and/or a foam and fabric laminate material.” Para 0185); and
the orientation of the silicone material (“silicone rubber 312”) of the seal forming structure (444) is overmolded (“The impregnated region 234 is formed by impregnating the dual-layer textile material 314 of the locating region 242 with silicone rubber 312 during the overmolding process such that the locating region 242 and the sealing region 244 are integrally formed. Accordingly, the transition region 208 comprises a composite material of dual-layer textile material 314 and silicone rubber 312.” Para 0199; “Similar to the impregnation process previously described, the impregnated region 234 is formed by impregnating the dual-layer textile material 314 with silicone rubber 312 using the overmolding tool 320. … That is, the silicone rubber 312 may be allowed to permeate specific regions of the dual-layer textile material 314 to provide an impregnated region 234 with a shape that improves the seal with the user's face.” Para 0200) onto both the nasal textile laminate (314 proximate 138) and the oral textile laminate (314 proximate 136) such that the silicone material (“silicone rubber 312”) of the nasal portion (138) and the oral portion (136) of the seal forming structure (444) is a continuous material.
Yet, the modified Bornholdt does not appear to disclose, teach, or fairly suggest the construction of “the silicone material exposed between the nasal textile laminate and the oral textile laminate” (Claims 3 and 4), nor the construction of “the silicone material of the seal forming structure is exposed at the gap” (Claims 50 and 51). Rather, the modified Bornholdt expressly discloses “an outer perimeter of the dual-layer textile material 314 is overmolded to the sealing region 244” (Para 0198), and “The impregnated region 234 is formed by impregnating the dual-layer textile material 314 of the locating region 242 with silicone rubber 312 during the overmolding process such that the locating region 242 and the sealing region 244 are integrally formed.” (Para 0199). In this configuration, there is no “silicone material exposed between the nasal textile laminate and the oral textile laminate” (Claims 3 and 4)”, nor is there any “silicone material … exposed at the gap” (Claim 50 and 51), wherein the gap is defined as “the textile laminate between the at least one nasal hole and the oral hole” (parent INDP Claim 47). Thus, it appears the incorporation of these features into the independent claims, would yield allowable subject matter as there would be motivation beyond hindsight incorporation to modify the construction of the overmolded silicone material to be oriented in an exposed region between the “the nasal textile laminate and the oral textile laminate” (Claims 3 and 4)”, nor “the gap” (Claim 50 and 51). Applicant is encouraged to consider and accept this indication of allowable subject matter.
In light of the aforementioned reasoning, the rejection of the claims has been maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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