DETAILED ACTION
This Office Action is in response to the request for continued examination, filed on January 22, 2026. Primary Examiner acknowledges Claims 11-28, 30, and 34-36 are pending in this application, with Claims 11 and 30 having been currently amended, Claims 34-36 having been newly added, Claims 22-28 and 36 (formerly 33 now cancelled) having been indicated as objected to but would be allowable if rewritten in independent form including all the limitations of the base claims and any intervening claims, and Claims 1-10, 29, and 31-33 having been cancelled.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 22, 2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 11-13, 16, 17, 19, 30, and 34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rollins (3,799,164) in view of Duncan (2005/0139221).
As to Claim 11, Rollins discloses a mask assembly (Figures 1 and 2) for delivering breathable gas (via 10, “Referring first to FIG. 1, an analgesic system is shown having a metered source 10 of analgesic gas, such as nitrous oxide, connected to a conventional inhalator or nose piece 12 by a preferred form of gas delivery apparatus 14 of the present invention.” Column 2, Lines 45-55) at pressure to a patient, comprising: an interfacing structure (12, “Referring first to FIG. 1, an analgesic system is shown having a metered source 10 of analgesic gas, such as nitrous oxide, connected to a conventional inhalator or nose piece 12 by a preferred form of gas delivery apparatus 14 of the present invention.” Column 2, Lines 45-55) configured to sealingly engage a patient’s face in use (“To further stabilize the nose piece 12 on the patient's head and also to help provide an effective seal between the nose piece and the face of the patient to prevent peripheral leakage of the analgesic gas, connecting strap means 44, which can be passed behind the patient's head, are attached to the hose-linkage device 14.” Column 3, Line 55 thru Column 4, Line 15); an air delivery and stabilizing system (14, “The gas delivery apparatus 14 takes the form of a hose-linkage device which includes a pair of gas supply conduits leading into opposite sides of the inhalator and consist of identical flexible rubber lateral extension hoses 24 and 26, a pair of identical hollow elbow joints or fittings 28 and 30, a pair of identical rearward extension gas supply hoses 32 and 34, and a hose clip 36 for holding the gas supply hoses together at a location adjacent the top of a patient's head.” Column 2, Line 60 thru Column 3, Line 5) configured to deliver the breathable gas (via 10) to the interfacing structure (12) and support the interfacing structure (12) on the patient’s face during use, and an adjustment mechanism (36, “a hose clip 36 for holding the gas supply hoses together at a location adjacent the top of a patient's head.” Column 2, Line 60 thru Column 3, Line 5; also see: “The hose clip 36 of the hose-linkage device is comprised of a flat bar having two adjacent apertures therethrough and, as stated before, serves to hold the two gas supply hoses 32 and 34 together at a location adjacent the patient's head. The diameter of each of the apertures in the flat bar is substantially equivalent to the outside diameter of each of the gas supply hoses so that the clip 36 can be manually slid along the length of the hoses and will retain its longitudinal position on the hoses when released. It will be apparent that the clip 36 when positioned adjacent the top of a patient's head and the elbow joints 28 and 30 define corners of a triangle whose respective sides are comprised of a portion of the supply hose 32, a portion of the supply hose 34, and the inhalator 12 along with the tubular connectors 20 and 22 and the extension hoses 24 and 26. This triangular arrangement provides a three-point stabilizing system for the inhalator 12 to prevent it from being easily dislocated since the elbow joints 28 and 30 rest on the cheeks of the patient on either side of the nose, and the hose clip 36 rests near the top of the patient's head at a location approximately equispaced from the two elbow joints.” Column 3, Lines 30-55) configured to be positioned on top of the patient’s head (“the clip 36 when positioned adjacent the top of a patient's head … the hose clip 36 rests near the top of the patient's head” Column 3, Lines 30-55) at or near the crown of the patient’s head during use; the air delivery and stabilizing system (14), the adjustment mechanism (36), and the interfacing structure (12) together form a ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1), the air delivery and stabilizing system (14) including two tubes (“a pair of gas supply conduits leading into opposite sides of the inhalator and consist of identical flexible rubber lateral extension hoses 24 and 26, a pair of identical hollow elbow joints or fittings 28 and 30, a pair of identical rearward extension gas supply hoses 32 and 34” Column 2, Line 60 thru Column 3, Line 5) that form respective sections of the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1), wherein the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1) is formed by only the interfacing structure (12), the two tubes (“a pair of gas supply conduits” Column 2, Line 60 thru Column 3, Line 5) and the adjustment mechanism (36), wherein the adjustment mechanism (36) is configured to allow lengthwise adjustment (“the clip 36 can be manually slid along the length of the hoses and will retain its longitudinal position on the hoses when released” Column 3, Lines 30-55) of the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1), wherein each tube (“a pair of gas supply conduits” Column 2, Line 60 thru Column 3, Line 5) is configured to, in use, pass along a respective side of the patient’s face between the patient’s eyes and the patient’s ear (via 32/34 as best seen Figure 1), and wherein each tube (“a pair of gas supply conduits” Column 2, Line 60 thru Column 3, Line 5) includes a cheek portion (defined by the combination of 24/26 and 28/30 – wherein “flexible rubber lateral extension hoses 24 and 26, a pair of identical hollow elbow joints or fittings 28 and 30” Column 2, Line 60 thru Column 3, Line 5) configured to, in use, extend along a respective cheek region of the patient (via 24/26 and 28/30 as best seen in Figure 1), the adjustment mechanism (36) being configured to, in use, adjust the distance between the cheek portions (defined by the combination of 24/26 and 28/30 – wherein “flexible rubber lateral extension hoses 24 and 26, a pair of identical hollow elbow joints or fittings 28 and 30” Column 2, Line 60 thru Column 3, Line 5) that extend along the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1) across the top of the patient’s head (“the clip 36 when positioned adjacent the top of a patient's head … the hose clip 36 rests near the top of the patient's head” Column 3, Lines 30-55) so as to provide lengthwise adjustment (“the clip 36 can be manually slid along the length of the hoses and will retain its longitudinal position on the hoses when released” Column 3, Lines 30-55) of the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1).
Yet, although Rollins discloses the administration of a composition of “analgesic gas” to the patient (Abstract); Rollins does not expressly disclose the suitability of breathable gas to be supplied at “positive pressure…for treatment of sleep disordered breathing”.
Duncan teaches the use of a mask assembly (Figure 2) for the delivery of breathable gas (“air” via 12, “According to one embodiment, the flow generator 12 is configured to create an air flow that is provided through the delivery component 14 to the reservoir 16 and then the mask 18 via the tubes 20, 22, 24.” Para 0029) to a patient, wherein the mask assembly (Figure 2) includes an interfacing structure (18, “FIG. 2 depicts a CPAP machine 10 according to an alternative embodiment of the present invention. The machine 10 has a flow generator 12, a delivery component 14, a reservoir 16, and a mask 18. The delivery component 14 has an inlet port 26 and a metering component 28. A tube 20 connects the flow generator 12 to the delivery component 14, while a tube 22 connects the delivery component 14 to the reservoir 16, and a tube 24 connects the reservoir 16 to the mask 18.” Para 0028) to engage the patient’s face, and an air delivery and stabilizing system (defined by the series of 20/22/24, “A tube 20 connects the flow generator 12 to the delivery component 14, while a tube 22 connects the delivery component 14 to the reservoir 16, and a tube 24 connects the reservoir 16 to the mask 18.” Para 0028) to deliver the breathable gas (“air” via 12) to the interfacing structure (18), wherein the composition of the breathable gas (“air” via 12).
Explicitly, Duncan teaches the composition of the breathable gas (“air” via 12) can include an additional therapeutic additive (via 14, “The delivery component 14, according to one embodiment, is configured to receive an additive and deliver the additive to the reservoir 16.” Para 0030) admixed with the breathable gas (“The additive is then mixed with the air flow and delivered to the reservoir 16 through the tube 22.” Para 0030) for administration to the patient, wherein additive can include various medications including analgesics (“ Non-limiting exemplary additives for pain relief, including some prescription medications, include certain products sold under brand names such as Tylenol.RTM., Motrin.RTM., Advil.RTM., Excedrin.RTM., Aleve.RTM., Celebrex.RTM., Vioxx.RTM., Flextra-DS.RTM., Fioricet.RTM., and Tramadol.RTM..” Para 0025).
Regarding the remaining limitations of the claims, Duncan teaches the administration of the breathable gas (“air” via 12) at continuous positive airway pressure (CPAP) (“The present invention is a method and apparatus for delivering an additive with a continuous positive airway pressure ("CPAP") machine.” Abstract) was known, wherein CPAP operational parameters are known to treat sleep disordered breathing (“The present invention relates to treatments for Sleep Apnea. More specifically, the present invention relates to an improved CPAP machine and methods of using a CPAP machine to provide an aromatic or therapeutic additive in the air flow provided to the patient.” Para 0002; “One treatment for Sleep Apnea is a continuous positive airway pressure ("CPAP") machine, which provides a continuous flow of air through the nostrils via a mask. The flow of air works to maintain an open airway. Sleep Apnea sufferers must wear the mask for the entire night.” Para 0004).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the mask assembly of Rollins to operate with a CPAP machine for the treatment of sleep disordered breathing, as taught by Duncan to in order to provide a composition of gas that treats the sleep disordered breathing and alleviates the pain of the patient.
As to Claim 12, the modified Rollins, specifically Rollins discloses the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1) is configured to move relative to the top of the patient’s head for lengthwise adjustment (“the clip 36 can be manually slid along the length of the hoses and will retain its longitudinal position on the hoses when released” Column 3, Lines 30-55) of the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1) defined by the bounding of the patient’s eyes and forehead as seen in Figure 1).
As to Claim 13, the modified Rollins, specifically Rollins discloses the adjustment mechanism (36) is configured to, in use, adjust a distance between two points (36 relative to each of 32/34) along the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1), the two points (36 relative to each of 32/34) configured to be positioned on top of the patient’s head during use (“the clip 36 when positioned adjacent the top of a patient's head … the hose clip 36 rests near the top of the patient's head” Column 3, Lines 30-55).
As to Claim 16, the modified Rollins, specifically Rollins discloses the adjustment mechanism (36) allows lengthwise adjustment (“the clip 36 can be manually slid along the length of the hoses and will retain its longitudinal position on the hoses when released” Column 3, Lines 30-55) of the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1) by moving points of the air delivery and stabilizing system (36 relative to each of 32/34) closer together or farther apart.
As to Claims 17 and 34, the modified Rollins, specifically Rollins discloses the two tubes (“a pair of gas supply conduits” Column 2, Line 60 thru Column 3, Line 5) are connected respectively, to opposing sides (via 20/22, “The nose piece has an adjustable valve 15 to regulate the amount of air mixed with the analgesic gas administered to the patient, and suitable gas inlet means including two protruding hollow arms 16 and 18 extending from opposite sides of the inhalator which have rigid tubular hose connectors 20 and 22, respectively, hermetically sealed in their ends.” Column 2, Lines 50-65) of the interfacing structure (12) to deliver breathable gas to the interfacing structure (12).
As to Claim 19, the modified Rollins, specifically Rollins discloses the two tubes (“a pair of gas supply conduits” Column 2, Line 60 thru Column 3, Line 5) are configured to directly engage the patient’s skin in use. It should be noted term “skin” is broad and would also include a hairless or bald region of a patient’s head.
As to Claim 30, Rollins discloses a mask assembly (Figures 1 and 2) for delivering breathable gas (via 10, “Referring first to FIG. 1, an analgesic system is shown having a metered source 10 of analgesic gas, such as nitrous oxide, connected to a conventional inhalator or nose piece 12 by a preferred form of gas delivery apparatus 14 of the present invention.” Column 2, Lines 45-55) at pressure to a patient, comprising: an interfacing structure (12, “Referring first to FIG. 1, an analgesic system is shown having a metered source 10 of analgesic gas, such as nitrous oxide, connected to a conventional inhalator or nose piece 12 by a preferred form of gas delivery apparatus 14 of the present invention.” Column 2, Lines 45-55) configured to sealingly engage a patient’s face in use (“To further stabilize the nose piece 12 on the patient's head and also to help provide an effective seal between the nose piece and the face of the patient to prevent peripheral leakage of the analgesic gas, connecting strap means 44, which can be passed behind the patient's head, are attached to the hose-linkage device 14.” Column 3, Line 55 thru Column 4, Line 15); an air delivery and stabilizing system (14, “The gas delivery apparatus 14 takes the form of a hose-linkage device which includes a pair of gas supply conduits leading into opposite sides of the inhalator and consist of identical flexible rubber lateral extension hoses 24 and 26, a pair of identical hollow elbow joints or fittings 28 and 30, a pair of identical rearward extension gas supply hoses 32 and 34, and a hose clip 36 for holding the gas supply hoses together at a location adjacent the top of a patient's head.” Column 2, Line 60 thru Column 3, Line 5) configured to deliver the breathable gas (via 10) to the interfacing structure (12) and support the interfacing structure (12) on the patient’s face during use, and an adjustment mechanism (36, “a hose clip 36 for holding the gas supply hoses together at a location adjacent the top of a patient's head.” Column 2, Line 60 thru Column 3, Line 5; also see: “The hose clip 36 of the hose-linkage device is comprised of a flat bar having two adjacent apertures therethrough and, as stated before, serves to hold the two gas supply hoses 32 and 34 together at a location adjacent the patient's head. The diameter of each of the apertures in the flat bar is substantially equivalent to the outside diameter of each of the gas supply hoses so that the clip 36 can be manually slid along the length of the hoses and will retain its longitudinal position on the hoses when released. It will be apparent that the clip 36 when positioned adjacent the top of a patient's head and the elbow joints 28 and 30 define corners of a triangle whose respective sides are comprised of a portion of the supply hose 32, a portion of the supply hose 34, and the inhalator 12 along with the tubular connectors 20 and 22 and the extension hoses 24 and 26. This triangular arrangement provides a three-point stabilizing system for the inhalator 12 to prevent it from being easily dislocated since the elbow joints 28 and 30 rest on the cheeks of the patient on either side of the nose, and the hose clip 36 rests near the top of the patient's head at a location approximately equispaced from the two elbow joints.” Column 3, Lines 30-55) configured to be positioned on top of the patient’s head (“the clip 36 when positioned adjacent the top of a patient's head … the hose clip 36 rests near the top of the patient's head” Column 3, Lines 30-55) during use; the air delivery and stabilizing system (14), the adjustment mechanism (36), and the interfacing structure (12) together form a ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1), the air delivery and stabilizing system (14) including two tubes (“a pair of gas supply conduits leading into opposite sides of the inhalator and consist of identical flexible rubber lateral extension hoses 24 and 26, a pair of identical hollow elbow joints or fittings 28 and 30, a pair of identical rearward extension gas supply hoses 32 and 34” Column 2, Line 60 thru Column 3, Line 5) that form respective sections of the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1), wherein the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1) is formed by only the interfacing structure (12), the two tubes (“a pair of gas supply conduits” Column 2, Line 60 thru Column 3, Line 5) and the adjustment mechanism (36), wherein the adjustment mechanism (36) is configured to allow lengthwise adjustment (“the clip 36 can be manually slid along the length of the hoses and will retain its longitudinal position on the hoses when released” Column 3, Lines 30-55) of the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1), wherein each tube (“a pair of gas supply conduits” Column 2, Line 60 thru Column 3, Line 5) is configured to, in use, pass along a respective side of the patient’s face between the patient’s eyes and the patient’s ear (via 32/34 as best seen Figure 1), and wherein each tube (“a pair of gas supply conduits” Column 2, Line 60 thru Column 3, Line 5) has a terminal end (36 as engaging 32/34) formed as part of the respective section of the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1), the adjustment mechanism (36) being configured to adjust a distance between the terminal ends (36 as engaging 32/34) that extend along the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1) across the top of the patient’s head (“the clip 36 when positioned adjacent the top of a patient's head … the hose clip 36 rests near the top of the patient's head” Column 3, Lines 30-55) so as to provide lengthwise adjustment (“the clip 36 can be manually slid along the length of the hoses and will retain its longitudinal position on the hoses when released” Column 3, Lines 30-55) of the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1).
Yet, although Rollins discloses the administration of a composition of “analgesic gas” to the patient (Abstract); Rollins does not expressly disclose the suitability of breathable gas to be supplied at “positive pressure…for treatment of sleep disordered breathing”.
Duncan teaches the use of a mask assembly (Figure 2) for the delivery of breathable gas (“air” via 12, “According to one embodiment, the flow generator 12 is configured to create an air flow that is provided through the delivery component 14 to the reservoir 16 and then the mask 18 via the tubes 20, 22, 24.” Para 0029) to a patient, wherein the mask assembly (Figure 2) includes an interfacing structure (18, “FIG. 2 depicts a CPAP machine 10 according to an alternative embodiment of the present invention. The machine 10 has a flow generator 12, a delivery component 14, a reservoir 16, and a mask 18. The delivery component 14 has an inlet port 26 and a metering component 28. A tube 20 connects the flow generator 12 to the delivery component 14, while a tube 22 connects the delivery component 14 to the reservoir 16, and a tube 24 connects the reservoir 16 to the mask 18.” Para 0028) to engage the patient’s face, and an air delivery and stabilizing system (defined by the series of 20/22/24, “A tube 20 connects the flow generator 12 to the delivery component 14, while a tube 22 connects the delivery component 14 to the reservoir 16, and a tube 24 connects the reservoir 16 to the mask 18.” Para 0028) to deliver the breathable gas (“air” via 12) to the interfacing structure (18), wherein the composition of the breathable gas (“air” via 12).
Explicitly, Duncan teaches the composition of the breathable gas (“air” via 12) can include an additional therapeutic additive (via 14, “The delivery component 14, according to one embodiment, is configured to receive an additive and deliver the additive to the reservoir 16.” Para 0030) admixed with the breathable gas (“The additive is then mixed with the air flow and delivered to the reservoir 16 through the tube 22.” Para 0030) for administration to the patient, wherein additive can include various medications including analgesics (“ Non-limiting exemplary additives for pain relief, including some prescription medications, include certain products sold under brand names such as Tylenol.RTM., Motrin.RTM., Advil.RTM., Excedrin.RTM., Aleve.RTM., Celebrex.RTM., Vioxx.RTM., Flextra-DS.RTM., Fioricet.RTM., and Tramadol.RTM..” Para 0025).
Regarding the remaining limitations of the claims, Duncan teaches the administration of the breathable gas (“air” via 12) at continuous positive airway pressure (CPAP) (“The present invention is a method and apparatus for delivering an additive with a continuous positive airway pressure ("CPAP") machine.” Abstract) was known, wherein CPAP operational parameters are known to treat sleep disordered breathing (“The present invention relates to treatments for Sleep Apnea. More specifically, the present invention relates to an improved CPAP machine and methods of using a CPAP machine to provide an aromatic or therapeutic additive in the air flow provided to the patient.” Para 0002; “One treatment for Sleep Apnea is a continuous positive airway pressure ("CPAP") machine, which provides a continuous flow of air through the nostrils via a mask. The flow of air works to maintain an open airway. Sleep Apnea sufferers must wear the mask for the entire night.” Para 0004).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the mask assembly of Rollins to operate with a CPAP machine for the treatment of sleep disordered breathing, as taught by Duncan to in order to provide a composition of gas that treats the sleep disordered breathing and alleviates the pain of the patient.
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rollins (3,799,164) in view of Duncan (2005/0139221), as applied to Claim 11, and further in view of McGilvary (4,878,491).
As to Claim 18, the modified Rollins, specifically Rollins discloses the two tubes (“a pair of gas supply conduits” Column 2, Line 60 thru Column 3, Line 5) suitable for imparting the delivery of breathing gas to the patient.
Yet, the modified Rollins does not expressly disclose the cross-sectional shape of the tubes.
McGilvary teaches an additional mask assembly suitable for imparting breathing gas to a patient, whereby the tubes can be constructed of various cross sections, including but not limited to a D shaped cross section (best seen Figure 6) in order to convey the breathing gas from its source, to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the cross section of the tubes of the modified Rollins to include the use of a D-shaped cross section, as taught by McGilvary to be a known cross sectional shape suitable for conveying breathing gas from its source to the patient.
Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rollins (3,799,164) in view of Duncan (2005/0139221), as applied to Claim 11, and further in view of Fink (2,376,871).
As to Claim 20, the modified Rollins, specifically Rollins discloses the interfacing structure (12) constructed of rubber (“a flexible rubber cup adapted to fit down over the nose of a patient P and seat on the patient's face, as shown in FIG. 1.” Column 2, Lines 50-65).
Yet, the modified Rollins does not expressly disclose the interfacing structure comprises a textile configured to sealing engage the patient’s face.
Fink teaches an additional mask assembly (Figures 1 and 2) having an interfacing structure (1, “As there is shown, 1 indicates generally the face portion of the mask. This portion is formed of resilient material such as rubber or rubberized fabric and is shaped to fit the average configuration of the human face around the nose, cheeks, and chin, an air-tight seal being formed either by a thin tapered edge of the material or a rolled edge such as that used in bathing caps.” Page 1, Column 2, Lines 1-15) configured to sealing engage the patient’s face, whereby the material composition of the interfacing structure (1) can include a textile (“rubberized fabric” Page 1, Column 2, Lines 1-15).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the “rubber” interfacing structure of the modified Rollins to be constructed of a textile such as “rubberized fabric” as taught by Fink to be a functionally equivalent alternative construction suitable for the formation of a face sealing mask to administer oxygen to a patient.
Claims 11-13, 16, 17, 19-21, 30, and 34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Agdanowski et al. (4,648,398) in view of Sheridan (2,931,358) and Starr et al. (2005/0121033).
As to Claim 11, Agdanowski discloses a mask assembly (Figures 1 and 2) for delivering breathable gas (“oxygen” via 12, “Referring now to the drawing and particularly to FIG. 1, a nasal harness assembly indicated generally at 10 is shown connected to a source of gas such as an oxygen source 12. The assembly 10 includes a nasal harness 14 including a nasal cannula 16 connected by gas supply tubes 18 and 20 to a connector 22. Connector 22 is sealingly connected to one end of a main gas supply tube 24 to connect the supply tubes 18 and 20 and nasal cannula 16 with the oxygen source 12.” Column 2, Lines 25-45) at a pressure to a patient, comprising: an interfacing structure (16, “The nasal cannula 16 is shown for illustration as including a bridge member 28 carrying a pair of gas outlets or nasal tips 30 and 32 in spaced relation for insertion in the nostrils of a patient.” Column 2, Lines 40-50) configured to sealingly engage (via 34/36, “The nasal tips 30 and 32, respectively, include soft, compressible, resilient, foam or sponge-like seals 34 and 36 having passages 38 and 40, respectively, which extend through the seals.” Column 2, Lines 45-60) the patient’s face in use; an air delivery and stabilizing system (defined by the combination of 18 and 20, “gas supply tubes 18 and 20” Column 2, Lines 25-45) configured to deliver the breathable gas (“oxygen” via 12) to the interfacing structure (16) and support the interfacing structure (16) on the patient’s face during use; and an adjustment mechanism (26, “A conventional slip ring 26 encircles the two supply tubes 18 and 20 so that these tubes may be adjusted for proper fitting after the harness 14 is applied to a patient.” Column 2, Lines 25-45); the air delivery and stabilizing system (defined by the combination of 18 and 20), the adjustment mechanism (26), and the interfacing structure (16) together forming a ring shape (best seen Figure 1), the delivery and stabilizing structure (defined by the combination of 18 and 20) including two tubes (18/20, “gas supply tubes 18 and 20” Column 2, Lines 25-45) that form respective sections of the ring shape (best seen Figure 1), wherein the ring shape (best seen Figure 1) is formed by only the interfacing structure (16), the two tubes (18/20) and the adjustment mechanism (26), wherein the adjustment mechanism (26) is configured to allow lengthwise adjustment (defined by the movement of 26 along 18/20) of the ring shape (best seen Figure 1).
Yet, Agdanowski does not expressly disclose the relationship of the mask assembly as oriented on the face of the user wherein “an adjustment mechanism configured to be positioned on top of the patient's head at or near the crown of the patient's head during use … wherein each tube is configured to, in use, pass along a respective side of the patient's face between the patient's eye and the patient's ear, and wherein each tube includes a cheek portion configured to, in use, extend along a respective cheek region of the patient, the adjustment mechanism being configured to, in use, adjust a distance between the cheek portions that extends along the ring shape across the top of the patient's head so as to provide lengthwise adjustment of the ring shape” nor the suitability of breathable gas to be supplied at “positive pressure…for treatment of sleep disordered breathing”.
Regarding the orientation of the mask assembly on the face of the user, Sheridan teaches an alternative mask assembly (Figures 1 and 2) for delivering breathable gas (via 14, “The gas conveying tube 12 has an outwardly tapering section 14 on its inlet end which enables this tube to be easily connected to a ribbed, male- end connector of a gas supply source.” Column 2, Line 70 thru Column 3, Line 5) having an interfacing structure (28/28, “a pair of adjustable length gas-delivery members” Column 3, Lines 25-35) to engage the face of the patient; an air delivery and stabilizing system (4/4, “The narine tubes 4 are provided with extensions 30 so that the distance from the outlet ends 8 to the inlet ends 32 are at least about a foot long for each of the separate tubes, i.e., long enough to permit the tubes to extend around from the front to the back of the head of a patient, as shown in Fig. 1.” Column 3, Lines 30-45) configured to deliver breathable gas to the interfacing structure (28/28) on the patient’s face in use, and an adjustment mechanism (64, “A small ring 64 of gum rubber or plastic is slidably fitted around the pair of narie tubes, and this can be moved up on the tubing extensions 30 to hold the cannula rather tightly onto the head of the patient. There is enough frictional engagement between the retaining ring 64 and the tube extensions 30 so that it will remain on the tubes at whatever position it is placed.” Column 5, Lines 35-50), whereby the air delivery and stabilizing system (4/4), the adjustment mechanism (64), and the interfacing structure (28/28) together form a ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1).
With respect to the orientation, as best seen in Figure 1 of Sheridan, the adjustment mechanism (64) is configured to be positioned on top of the patient's head at or near the crown of the patient's head during use, while each tube (4/4) is configured to, in use, pass along a respective side of the patient's face between the patient's eye and the patient's ear, and wherein each tube (4/4) includes a cheek portion (30/30) configured to, in use, extend along a respective cheek region of the patient, the adjustment mechanism (64) being configured to, in use, adjust a distance between the cheek portions (30/30) that extends along the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1), across the top of the patient's head so as to provide lengthwise adjustment (via movement of 64 along 30/30) of the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1). Thus, the manner of wear of the mask assembly as claimed is taught by Sheridan.
Regarding the suitability of breathable gas to be supplied at “positive pressure…for treatment of sleep disordered breathing”, Starr teaches a mask assembly (Figures 1 and 2) for delivering breathable gas (“oxygen” via 110, “A connector 108 is provided at the proximal end of the conduit to connect the conduit to a supply of gas 110, such as a tank of oxygen with a pressure regulator or an oxygen concentrator.” Para 0034) at pressure to a patient, comprising: an interfacing structure (114, “In the embodiment illustrated in FIG. 1, the patient interface device is a pair of nasal prongs 114, each of which includes a port for delivering a flow of gas to both nares of a patient. The prongs at the distal end of the conduit do not seal the patient's nostril, so that some gas is permitted to flow from the patient's nose to the ambient atmosphere around the prongs.” Para 0035) to engage the patient’s face in use, and an air delivery and stabilizing system (103, “Monitoring and therapy delivery system 100 includes a conduit or cannula 102 having a proximal end 104 and a distal end 106. The terms "conduit" and "cannula" are used interchangeably. A connector 108 is provided at the proximal end of the conduit to connect the conduit to a supply of gas 110, such as a tank of oxygen with a pressure regulator or an oxygen concentrator.” Para 0034) configured to deliver the breathable gas (“oxygen” via 110) to the interfacing structure (114).
With respect to the operation parameters of the breathable gas, Starr teaches the administration of breathable gas (“oxygen” via 110) at various PAP levels (“Measurement of the pressure level allows pressure related respiratory variables, such as the inspiratory positive airway pressure (IPAP), expiratory positive airway pressure (EPAP), positive end expiratory pressure (PEEP), and continuous positive airway pressure (CPAP) to be determined. Of course, measuring IPAP, EPAP, and CPAP are only possible when the appropriate pressure support therapy is being provided to the patient in addition the gas flow through conduit 102.” Para 0054) was known, wherein these PAP levels are known to be suitable for treating sleep disordered breathing (“ During the administration of oxygen, whether via nasal cannula or mask, it is often desirable to monitor the patient's respiratory status. For example, it is desirable to monitor timing related parameters, such as the patient's breath rate, inspiratory and expiratory times, pressure related parameters, such as the end expiratory pressure, and volume related parameters, such as inspiratory and expiratory tidal volume. Additionally, it is desirable to recognize abnormal breathing patterns, such as Cheyne-Stokes breathing, cessation of breathing (apnea), a reduction in the flow during breathing (hypopnea) or disconnection of the patient from the supplemental oxygen, while the patient is receiving supplemental oxygen.” Para 0007, and “Breathing pattern analysis includes the identification of abnormal forms of breathing, such as, but not limited to, Cheyne-Stokes breathing, Kussmaul breathing, apnea, hypopnea, and snoring. Breathing pattern analysis may be performed using the respiratory timing variables derived according to the present invention. Cheynes-Stokes breathing is seen with some central nervous system disorders, uremia, and some sleep patterns and is characterized by repeating cycles of waxing and waning in the depth of breathing including a period of apnea. Kussmaul breathing is seen in coma or diabetic ketoacidosis and is characterized by a deep, rapid respiratory pattern. Any conventional technique for determining these breathing patterns can be used in the present invention.” Para 0064). Thus, the operational parameters of CPAP for the treatment of sleep disordered breathing is taught by Starr.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the manner of wearing the mask assembly of Agdanowski to be oriented as claimed, as taught by Sheridan to be a known method of wearing the mask assembly and further to modify the operational parameters of the breathable gas of Agdanowski to operate at PAP levels as taught by Starr to enable identification and treatment of sleep disordered breathing.
As to Claim 12, the modified Agdanowski, specifically Sheridan teaches the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1) is configured to move relative to the top of the patient’s head for lengthwise adjustment (via the movement of the adjustment mechanism along the length of the two tubes) of the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1).
As to Claim 13, the modified Agdanowski, specifically Sheridan teaches the adjustment mechanism is configured to, in use, adjust a distance (defined by the space between the two tubes) between two points (the tube relative to the adjustment mechanism) along the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1), the two points (the tube relative to the adjustment mechanism) to be positioned on top of the patient’s head during use.
As to Claim 16, the modified Agdanowski, specifically Agdanowski discloses the adjustment mechanism (26) allows lengthwise adjustment (defined by the movement of 26 along 18/20) of the ring shape (best seen Figure 1) by moving points (the tube relative to the adjustment mechanism) of the air delivery and stabilizing system (18/20) closer together or father apart.
As to Claims 17 and 34, the modified Agdanowski, specifically Agdanowski discloses the two tubes (18/20) are connected respectively, to opposing sides (via 50/52, “Bridge 28, also shown in FIG. 2, is illustrated in the form of an unitary or single-piece, molded plastic sheet member which when folded upon itself provides a pair of channels 50 and 52 through which the distal end portions of the supply tubes 18 and 20 pass.” Column 2, Line 60-70) of the interfacing structure (16) to deliver the breathable gas to the interfacing structure (16).
As to Claim 19, the modified Agdanowski, specifically Sheridan teaches the two tubes (4/4) are configured to directly engage the patient’s skin in use. It should be noted term “skin” is broad and would also include a hairless or bald region of a patient’s head. Furthermore, it should be noted there is no structure oriented on the tubes (4/4) that would preclude or prevent the ability of at least a portion of the tubes directly engage the patient’s face.
As to Claim 20, the modified Agdanowski, specifically Agdanowski discloses interfacing structure (16) comprises textile (34/36, “The nasal tips 30 and 32, respectively, include soft, compressible, resilient, foam or sponge-like seals 34 and 36 having passages 38 and 40, respectively, which extend through the seals.” Column 2, Lines 45-60) configured to sealingly engage the patient’s face.
As to Claim 21, the modified Agdanowski, specifically Agdanowski discloses the interfacing structure (16) is an under-the-nose interface (best seen Figure 2) configured to sealingly engage an underside of the patient’s nose in use.
As to Claim 30, Agdanowski discloses a mask assembly (Figures 1 and 2) for delivering breathable gas (“oxygen” via 12, “Referring now to the drawing and particularly to FIG. 1, a nasal harness assembly indicated generally at 10 is shown connected to a source of gas such as an oxygen source 12. The assembly 10 includes a nasal harness 14 including a nasal cannula 16 connected by gas supply tubes 18 and 20 to a connector 22. Connector 22 is sealingly connected to one end of a main gas supply tube 24 to connect the supply tubes 18 and 20 and nasal cannula 16 with the oxygen source 12.” Column 2, Lines 25-45) at a pressure to a patient, comprising: an interfacing structure (16, “The nasal cannula 16 is shown for illustration as including a bridge member 28 carrying a pair of gas outlets or nasal tips 30 and 32 in spaced relation for insertion in the nostrils of a patient.” Column 2, Lines 40-50) configured to sealingly engage (via 34/36, “The nasal tips 30 and 32, respectively, include soft, compressible, resilient, foam or sponge-like seals 34 and 36 having passages 38 and 40, respectively, which extend through the seals.” Column 2, Lines 45-60) the patient’s face in use; an air delivery and stabilizing system (defined by the combination of 18 and 20, “gas supply tubes 18 and 20” Column 2, Lines 25-45) configured to deliver the breathable gas (“oxygen” via 12) to the interfacing structure (16) and support the interfacing structure (16) on the patient’s face during use; and an adjustment mechanism (26, “A conventional slip ring 26 encircles the two supply tubes 18 and 20 so that these tubes may be adjusted for proper fitting after the harness 14 is applied to a patient.” Column 2, Lines 25-45); the air delivery and stabilizing system (defined by the combination of 18 and 20), the adjustment mechanism (26), and the interfacing structure (16) together forming a ring shape (best seen Figure 1), the delivery and stabilizing structure (defined by the combination of 18 and 20) including two tubes (18/20, “gas supply tubes 18 and 20” Column 2, Lines 25-45) that form respective sections of the ring shape (best seen Figure 1), wherein the ring shape (best seen Figure 1) is formed by only the interfacing structure (16), the two tubes (18/20) and the adjustment mechanism (26), wherein the adjustment mechanism (26) is configured to allow lengthwise adjustment (defined by the movement of 26 along 18/20) of the ring shape (best seen Figure 1).
Yet, Agdanowski does not expressly disclose the relationship of the mask assembly as oriented on the face of the user wherein “an adjustment mechanism configured to be positioned on top of the patient's head … wherein each tube is configured to, in use, pass along a respective side of the patient's face between the patient's eye and the patient's ear, and wherein each tube portion has a terminal end formed as part of the respective section of the ring shape, the adjustment mechanism being configured to adjust a distance between the terminal ends that extends along the ring shape across the top of the patient's head so as to provide lengthwise adjustment of the ring shape” nor the suitability of breathable gas to be supplied at “positive pressure…for treatment of sleep disordered breathing”.
Regarding the orientation of the mask assembly on the face of the user, Sheridan teaches an alternative mask assembly (Figures 1 and 2) for delivering breathable gas (via 14, “The gas conveying tube 12 has an outwardly tapering section 14 on its inlet end which enables this tube to be easily connected to a ribbed, male- end connector of a gas supply source.” Column 2, Line 70 thru Column 3, Line 5) having an interfacing structure (28/28, “a pair of adjustable length gas-delivery members” Column 3, Lines 25-35) to engage the face of the patient; an air delivery and stabilizing system (4/4, “The narine tubes 4 are provided with extensions 30 so that the distance from the outlet ends 8 to the inlet ends 32 are at least about a foot long for each of the separate tubes, i.e., long enough to permit the tubes to extend around from the front to the back of the head of a patient, as shown in Fig. 1.” Column 3, Lines 30-45) configured to deliver breathable gas to the interfacing structure (28/28) on the patient’s face in use, and an adjustment mechanism (64, “A small ring 64 of gum rubber or plastic is slidably fitted around the pair of narie tubes, and this can be moved up on the tubing extensions 30 to hold the cannula rather tightly onto the head of the patient. There is enough frictional engagement between the retaining ring 64 and the tube extensions 30 so that it will remain on the tubes at whatever position it is placed.” Column 5, Lines 35-50), whereby the air delivery and stabilizing system (4/4), the adjustment mechanism (64), and the interfacing structure (28/28) together form a ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1).
With respect to the orientation, as best seen in Figure 1 of Sheridan, the adjustment mechanism (64) is configured to be positioned on top of the patient's head at or near the crown of the patient's head during use, while each tube portion (4/4) is configured to, in use, pass along a respective side of the patient's face between the patient's eye and the patient's ear, and wherein each tube portion (4/4) has a terminal end (64 as engaging 30/30) formed as part of the respective section of the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1), the adjustment mechanism (64) being configured to adjust a distance (defined by the space between the two tubes) between the terminal ends (64 as engaging 30/30) that extends along the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1) across the top of the patient's head so as to provide lengthwise adjustment (via movement of 64 along 30/30) of the ring shape (defined by the bounding of the patient’s eyes and forehead as seen in Figure 1). Thus, the manner of wear of the mask assembly as claimed is taught by Sheridan.
Regarding the suitability of breathable gas to be supplied at “positive pressure…for treatment of sleep disordered breathing”, Starr teaches a mask assembly (Figures 1 and 2) for delivering breathable gas (“oxygen” via 110, “A connector 108 is provided at the proximal end of the conduit to connect the conduit to a supply of gas 110, such as a tank of oxygen with a pressure regulator or an oxygen concentrator.” Para 0034) at pressure to a patient, comprising: an interfacing structure (114, “In the embodiment illustrated in FIG. 1, the patient interface device is a pair of nasal prongs 114, each of which includes a port for delivering a flow of gas to both nares of a patient. The prongs at the distal end of the conduit do not seal the patient's nostril, so that some gas is permitted to flow from the patient's nose to the ambient atmosphere around the prongs.” Para 0035) to engage the patient’s face in use, and an air delivery and stabilizing system (103, “Monitoring and therapy delivery system 100 includes a conduit or cannula 102 having a proximal end 104 and a distal end 106. The terms "conduit" and "cannula" are used interchangeably. A connector 108 is provided at the proximal end of the conduit to connect the conduit to a supply of gas 110, such as a tank of oxygen with a pressure regulator or an oxygen concentrator.” Para 0034) configured to deliver the breathable gas (“oxygen” via 110) to the interfacing structure (114).
With respect to the operation parameters of the breathable gas, Starr teaches the administration of breathable gas (“oxygen” via 110) at various PAP levels (“Measurement of the pressure level allows pressure related respiratory variables, such as the inspiratory positive airway pressure (IPAP), expiratory positive airway pressure (EPAP), positive end expiratory pressure (PEEP), and continuous positive airway pressure (CPAP) to be determined. Of course, measuring IPAP, EPAP, and CPAP are only possible when the appropriate pressure support therapy is being provided to the patient in addition the gas flow through conduit 102.” Para 0054) was known, wherein these PAP levels are known to be suitable for treating sleep disordered breathing (“ During the administration of oxygen, whether via nasal cannula or mask, it is often desirable to monitor the patient's respiratory status. For example, it is desirable to monitor timing related parameters, such as the patient's breath rate, inspiratory and expiratory times, pressure related parameters, such as the end expiratory pressure, and volume related parameters, such as inspiratory and expiratory tidal volume. Additionally, it is desirable to recognize abnormal breathing patterns, such as Cheyne-Stokes breathing, cessation of breathing (apnea), a reduction in the flow during breathing (hypopnea) or disconnection of the patient from the supplemental oxygen, while the patient is receiving supplemental oxygen.” Para 0007, and “Breathing pattern analysis includes the identification of abnormal forms of breathing, such as, but not limited to, Cheyne-Stokes breathing, Kussmaul breathing, apnea, hypopnea, and snoring. Breathing pattern analysis may be performed using the respiratory timing variables derived according to the present invention. Cheynes-Stokes breathing is seen with some central nervous system disorders, uremia, and some sleep patterns and is characterized by repeating cycles of waxing and waning in the depth of breathing including a period of apnea. Kussmaul breathing is seen in coma or diabetic ketoacidosis and is characterized by a deep, rapid respiratory pattern. Any conventional technique for determining these breathing patterns can be used in the present invention.” Para 0064). Thus, the operational parameters of CPAP for the treatment of sleep disordered breathing is taught by Starr.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the manner of wearing the mask assembly of Agdanowski to be oriented as claimed, as taught by Sheridan to be a known method of wearing the mask assembly and further to modify the operational parameters of the breathable gas of Agdanowski to operate at PAP levels as taught by Starr to enable identification and treatment of sleep disordered breathing.
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Agdanowski et al. (4,648,398) in view of Sheridan (2,931,358) and Starr et al. (2005/0121033), as applied to Claim 11, and further in view of McGilvary (4,878,491).
As to Claim 18, the modified Agdanowski, specifically Agdanowski discloses the two tubes (18/20) suitable for imparting the delivery of breathing gas to the patient.
Yet, the modified Agdanowski does not expressly disclose the cross-sectional shape of the tubes.
McGilvary teaches an additional mask assembly suitable for imparting breathing gas to a patient, whereby the tubes can be constructed of various cross sections, including but not limited to a D shaped cross section (best seen Figure 6) in order to convey the breathing gas from its source, to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the cross section of the tubes of the modified Agdanowski to include the use of a D-shaped cross section, as taught by McGilvary to be a known cross sectional shape suitable for conveying breathing gas from its source to the patient.
Allowable Subject Matter
Claims 14, 15, 22-28, 35, and 36 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection.
Applicant is reinvited to incorporate the allowable subject matter into independent form including all of the limitations of the base claim and any intervening claims to permit this application to proceed to issue.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ellman (2,763,263) and Farr (3,802,431) disclose additional mask assemblies for delivering breathable gas having an interfacing structure, an air delivery and stabilizing structure including two tubes, and an adjustment mechanism positioned on top of the patient’s head.
The following IS NOT prior art made of record BUT is considered pertinent to applicant's disclosure.
Jablons (2010/0224196) discloses an additional mask assembly suitable for the delivery of breathable gas at CPAP pressures having an interfacing structure, an air delivery and stabilizing structure including two tubes, and an adjustment mechanism.
Smith (2012/0325219) discloses an additional mask assembly suitable for the delivery of breathable gas at CPAP pressures having an interfacing structure, an air delivery and stabilizing structure including two tubes, and an adjustment mechanism in the form of corrugated bellows (18/18) positioned near the top of the patient’s head.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra D Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785