DETAILED ACTION
Primary Examiner acknowledges Claims 31-50 are pending in this application, with Claims 31-50 having been newly added, and Claims 1-30 having been cancelled by preliminary amendment on January 20, 2023.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 50 is 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 50, Line 1 recites the preamble “the system of claim 39”; however, this limitation appears to lack antecedent basis in the claims. The preamble of claim 39 refers to “A positioning and stabilizing structure for a patient interface”. It appear perhaps the preamble of Claim 50 should depend from Claim 49, wherein the preamble of Claim 49 recites “A system for providing air to a patient …”. For purposes of this rejection, Primary Examiner will presume the dependency of Claim 50 should be to Claim 49. Appropriate correction and clarification 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 39 and 41-44 are rejected under 35 U.S.C. 103 as being unpatentable over Karpas et al. (2015/0157822) in view of Rudolph (5,538,000) and Ovizinsky et al. (2014/0102456).
As to Claim 39, Karpas discloses a positioning and stabilizing structure (best seen Figures 10A-10N for a nose only configuration and Figures 14A-14H for a nose and mouth configuration) for a patient interface (1000, “Illustrated in FIGS. 10A-10N is a first embodiment of a sleep apnea device including a face mask 1000 coinciding with the patient's nose, a headband 1010 for securing the mask to the face, and air ducts 1020 for channeling pressurized air from the CPAP machine to the mask.” Para 0098), the positioning and stabilizing structure (best seen Figures 10A-10N for a nose only configuration and Figures 14A-14H for a nose and mouth configuration) comprising a strap (1010, “a headband 1010 for securing the mask to the face” Para 0098) connectable to the patient interface (1000), wherein the strap (1010) is constructed of a material (“Like the mask, the inner face 1060 of the left and right portions of the headband 1010 may consist of a flexible material including silicone or other elastomeric material that is comfortable against the patient's skin.” Para 0101), wherein the material (“a flexible material including silicone or other elastomeric material”) is in contact with a conduit (1020, “air ducts 1020 for channeling pressurized air from the CPAP machine to the mask” Para 0098) wherein each conduit (one of 1020) comprises an interface connector (defined by the end point of 1020 engaging with the manifold 1002 of the face mask 1000, “The face mask may further include a pair of nasal tubes that channel air directly to nose, as well as one or more manifolds 1002 or connectors to couple the air ducts to the nasal tubes. The air ducts 1020 in the preferred embodiment are vinyl or polycarbonate tubes that run from the back of the head, along one or both sides of the face, and to face mask.” Para 0098) for connecting the conduit (1020), in use, to a respective inlet port (via 1002, “The face mask may further include a pair of nasal tubes that channel air directly to nose, as well as one or more manifolds 1002 or connectors to couple the air ducts to the nasal tubes. The air ducts 1020 in the preferred embodiment are vinyl or polycarbonate tubes that run from the back of the head, along one or both sides of the face, and to face mask.” Para 0098) of the patient interface (1000), the positioning and stabilizing structure (best seen Figures 10A-10N for a nose only configuration and Figures 14A-14H for a nose and mouth configuration) further including a connection port (1030, “The multi-tube coupling 1030 may be referred to herein as a "spider coupling" shown in more detail in FIGS. 17A-17D.” Para 0098) for connection, in use, to an air circuit (via “pressurized air from the CPAP machine to the mask” Para 0098), wherein the connection port (130) is in fluid communication with each conduit (1020).
Yet, Karpas does not expressly disclose the positioning and stabilizing structure having “at least four straps”, whereby the straps are constructed of “two or more layers arranged to define a channel”, wherein the conduit “is provided within each channel” of the strap.
Rudolph teaches an alternative positioning and stabilizing structure (best seen Figures 1-4) including a plurality of straps (10/11/12, “The airflow distributor 6, conduits 7, 8 and 9, straps 10, 11 and 12 and nasal mask 13 are collectively referred to as a headgear 16.” Column 3, Lines 40-65) having a plurality of conduits (7/8/9, “The airflow distributor 6, conduits 7, 8 and 9, straps 10, 11 and 12 and nasal mask 13 are collectively referred to as a headgear 16.” Column 3, Lines 40-65), whereby the number of straps is the same as the number of conduits, and whereby the conduits (7/8/9) are used to convey the delivery of air from an air circuit (20, “The primary conduit 5 is preferably formed of flexible plastic or rubber tubing and includes a first end (not shown) connected to a source of pressurized air 20 shown schematically in FIG. 3.” Column 3, Line 60 thru Column 4, Line 5) to a connection port (6, “airflow distributor 6” Column 3, Lines 40-65) and further along the conduit-strap configuration (defined by the engagement of 7/8/9 with 10/11/12, respectively) to a patient interface (13, “nasal mask 13” Column 3, Lines 40-65).
Regarding the claimed “at least four strap”, Rudolph teaches the conduit-strap configuration (defined by the engagement of 7/8/9 with 10/11/12, respectively) whereby the number of conduits motivates the number of straps in the positioning and stabilizing device. In light of the four conduits of Karpas, the decision to use a complementary number of straps is taught by Rudolph to provide a positioning and stabilizing structure suitable for both securing the patient interface to the face of the user and conveying the gas from the connection port to the user.
Regarding the concept of straps forming a channel and the channel receiving a conduit, Rudolph expressly states although Figures 1-4 show the conduit-strap configuration (defined by the engagement of 7/8/9 with 10/11/12, respectively) in an overlying configuration, an alternative configuration includes the use of a sleeve (“Further the straps 10, 11 and 12 may include a sleeve through which respective secondary conduits 7, 8 and 9 might extend and be secured.” Column 5, Lines 40-55) to receive the conduit-strap configuration (defined by the engagement of 7/8/9 with 10/11/12, respectively). In this configuration, clearly the sleeve provides a channel upon which the conduit is inserted therewith to provide a positioning and stabilizing structure suitable for both securing the patient interface to the face of the user and conveying the gas from the connection port to the user.
Regarding the remaining limitations of the claims, although the modification of Karpas with Rudolph does not expressly disclose the manner of formation of the sleeve of the strap for receiving the conduit, the construction of a sleeve for receiving a conduit was known as taught by Ovizinsky.
Ovizinsky teaches the formation of a sleeve for encompassing a conduit (best seen Figures 8-14) whereby the sleeve is constructed of at least two layers of material (655, “an outer layer of a textile or fabric 655 that forms an exterior surface of the conduit. … The film laminate 650 is applied to the fabric 655 (FIG. 11), and then the fabric and laminate are both thermoformed to create symmetrical complementary shapes (FIG. 12), i.e., conduit portions 621, 622. During the thermoforming process, the laminate adheres to the fabric giving it air impermeable properties. The two conduit portions 621 and 622 can then be seam welded as shown in FIG. 13 (e.g., RF weld to couple the conduit portions) and then ultrasonically die cut as shown in FIG. 14 (e.g., to remove seam edges) to create an air tight textile conduit.” Para 0188 and 0189) which are thermoformed and seam welded together to create a textile sleeve that encompasses a conduit to convey the delivery of gas to the user.
In light of the teachings of Ovizinsky, the formation of a sleeve which is constructed to encompass a conduit was known to include the use of at least two layers of material thermoformed and seam welded together.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the four conduits of Karpas to each have an individual strap encompassing each conduit in a sleeve formation as taught by Randolph to provide a positioning and stabilizing structure suitable for both securing the patient interface to the face of the user and conveying the gas from the connection port to the user, whereby the sleeve formation includes the construction of at least two layers of material bonded together, as shown in Ovizinsky to be a known construction methodology suitable to provide a textile sleeve that encompasses a conduit to convey the delivery of gas to the user.
As to Claim 41, the modified Karpas, specifically Ovizinsky teaches the formation of the sleeve of the strap including a joint (best seen Figures 10-14, by the abutment of the upper half oval to the lower half oval on either the left or right side) along one edge of the strap.
Should Applicant allege specificity of “one edge”, Applicant is advised the construction of a channel through the use of a single sheet of material overlayed over each other, results in two layers, whereby the edges of the sheets are bound at one edge is a well-known, routine, and conventional practice in manufacturing including sewing for the formation of headbands, scrunchies – fabric covered hair ties with elastic therebetween (e.g. Scunci ®), curtain pockets for receiving curtain rods, and drawstring waist bands for gym shorts and sweat pants. Thus the use of “one edge” does not overcome this rejection as it is an obvious manufacturing process to form a channel.
As to Claim 42, the modified Karpas, specifically Ovizinsky teaches the formation of the sleeve of the strap including a first point (one of left or right side of the abutment of the upper half oval to the lower half oval as seen in Figures 10-14) along one edge of the strap and a second joint (other of left or right side of the abutment of the upper half oval to the lower half oval as seen in Figures 10-14) along an opposite edge of the strap.
As to Claim 43, the modified Karpas, specifically Rudolph discloses the configuration whereby each conduit (7/8/9) is completely encased with the respective strap (10/11/12).
As to Claim 44, the modified Karpas, specifically Rudolph discloses the conduits (7/8/9) are decoupled from the straps (10/11/12), via the cutting away of the sleeve and/or removal of the sleeve from the conduit, such that, in use, the conduits (7/8/9) do not contribute to an interfacing vector.
The concept of interfacing vector is related to the tension/force applied by the strap to retain the placement of the patient interface about the head of the user, when the strap is removed either by cutting away of the sleeve and/or the removal of the sleeve from the conduit, there is less tension/force applied to retain the placement of the patient interface on the face of the user, thus, the conduit does not contribute to the interfacing vector.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Karpas et al. (2015/0157822) in view of Rudolph (5,538,000) and Ovizinsky et al. (2014/0102456), as applied to Claim 39, and further in view of Landis (5,269,296).
As to Claim 40, the modified Karpas, specifically Karpas discloses the use of conduits (1020) for the conveyance of air from the air circuit (via “pressurized air from the CPAP machine to the mask” Para 0098) to the patient interface (1000).
Yet, does not expressly disclose the specific dimensions of the conduit to be 5 mm or less.
Landis teaches an alternative positioning and stabilizing structure (best seen Figure 7 – in situ) including formations (best seen Figures 1 and 6) constructed of a plurality of pathways (60/62/66/72/74/76/78/90) to both provide a conduit-strap configuration to retain the placement of the patient interface (20) on the face of the user, whereby the conduit-strap configuration receives air from the an air circuit (70).
Regarding the remaining limitations of the claims, Landis teaches the specific dimensions of the conduits can be 5 mm or less was a known size dimension suitable for the conveyance of gas to a patient for treatment. Explicitly Landis teaches “Referring now to FIGS. 2 and 3, each cannula is configured and dimensioned to be inserted into a naris of a patient, and typically has an outer cannula diameter about 2 millimeters (mm) to about 10 mm, and preferably about 5 mm.” Column 5, Lines 20-65).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the dimensions of the conduits of the modified Karpas to be 5 mm or less, as taught by Landis to be a known size dimension suitable for the conveyance of gas to the patient for treatment.
Claims 31, 36-38, and 45-50 are rejected under 35 U.S.C. 103 as being unpatentable over Karpas et al. (2015/0157822) in view of Sher et al. (8,397,724), Rudolph (5,538,000), and Huby et al. (2011/0162647)
As to Claim 31, Karpas discloses a patient interface (1000, “Illustrated in FIGS. 10A-10N is a first embodiment of a sleep apnea device including a face mask 1000 coinciding with the patient's nose, a headband 1010 for securing the mask to the face, and air ducts 1020 for channeling pressurized air from the CPAP machine to the mask.” Para 0098), comprising: a plenum chamber (defined by the interior of 1000 upon which gas exits 1050, whereby 1050 - “Referring to FIG. 10D, the mask includes nasal tubes 1050 that are configured to extend a short distance into the patient's nose.” Para 0102) pressurizable to a therapeutic pressure (“CPAP” Abstract) above ambient pressure; at least three plenum inlet ports (1004 via 1002, “Each manifold is a substantially enclosed cavity or compartment including (1) a plurality of input holes 1004 configured to receive one end of each polycarbonate tube 1020, and (2) an output hole 1006 that channels air into one of the nasal tubes. Each manifold in configured to snap into and friction fit onto the base plate.” Para 0100; also see: “The face mask may further include a pair of nasal tubes that channel air directly to nose, as well as one or more manifolds 1002 or connectors to couple the air ducts to the nasal tubes.” Para 0098) sized and structure to receive respective flows of air (via 1020, “air ducts 1020” Para 0098) at the therapeutic pressure (“CPAP” Abstract) for breathing by a patient; a seal forming structure (1050, “nasal tubes 1050” Para 0102) constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways, the seal forming structure (1050) having a hole therein (best seen Figure 10K) such that the flow of air at the therapeutic pressure (“CPAP” Abstract) is delivered to at least an entrance to the patient’s nares, the seal forming structure (1050) constructed and arranged to maintain the therapeutic pressure (“CPAP” Abstract) in the plenum chamber (defined by the interior of 1000 upon which gas exits 1050) through the patient’s respiratory cycle in use; a positioning and stabilizing structure (best seen Figures 10A-10N for a nose only configuration and Figures 14A-14H for a nose and mouth configuration) for a patient interface (1000, “Illustrated in FIGS. 10A-10N is a first embodiment of a sleep apnea device including a face mask 1000 coinciding with the patient's nose, a headband 1010 for securing the mask to the face, and air ducts 1020 for channeling pressurized air from the CPAP machine to the mask.” Para 0098), the positioning and stabilizing structure (best seen Figures 10A-10N for a nose only configuration and Figures 14A-14H for a nose and mouth configuration) comprising a strap (1010, “a headband 1010 for securing the mask to the face” Para 0098) connectable to the patient interface (1000), wherein the strap (1010) is constructed of a material (“Like the mask, the inner face 1060 of the left and right portions of the headband 1010 may consist of a flexible material including silicone or other elastomeric material that is comfortable against the patient's skin.” Para 0101), wherein the material (“a flexible material including silicone or other elastomeric material”) is in contact with a conduit (1020, “air ducts 1020 for channeling pressurized air from the CPAP machine to the mask” Para 0098) wherein each conduit (one of 1020) comprises an interface connector (defined by the end point of 1020 engaging with the manifold 1002 of the face mask 1000, “The face mask may further include a pair of nasal tubes that channel air directly to nose, as well as one or more manifolds 1002 or connectors to couple the air ducts to the nasal tubes. The air ducts 1020 in the preferred embodiment are vinyl or polycarbonate tubes that run from the back of the head, along one or both sides of the face, and to face mask.” Para 0098) for connecting the conduit (1020), in use, to a respective inlet port (via 1002, “The face mask may further include a pair of nasal tubes that channel air directly to nose, as well as one or more manifolds 1002 or connectors to couple the air ducts to the nasal tubes. The air ducts 1020 in the preferred embodiment are vinyl or polycarbonate tubes that run from the back of the head, along one or both sides of the face, and to face mask.” Para 0098) of the patient interface (1000), the positioning and stabilizing structure (best seen Figures 10A-10N for a nose only configuration and Figures 14A-14H for a nose and mouth configuration) further including a connection port (1030, “The multi-tube coupling 1030 may be referred to herein as a "spider coupling" shown in more detail in FIGS. 17A-17D.” Para 0098) for connection, in use, to an air circuit (via “pressurized air from the CPAP machine to the mask” Para 0098), wherein the connection port (130) is in fluid communication with each conduit (1020).
Yet, Karpas does not expressly disclose the patient interface having a therapeutic pressure of “at least 6 cm of water”, the positioning and stabilizing structure having “at least four straps”, whereby the straps “define a channel”, wherein the conduit “is provided within each channel” of the strap, nor “the plenum chamber is provided with at least one pressure measurement port”.
Regarding the therapeutic pressure value, Sher teaches a patient interface operable provide a therapeutic pressure in the form of CPAP to a patient interface (100). Explicitly, Sher teaches known valuations of CPAP pressure - “Typical CPAP airflow generators can deliver air to patients at pressures between 4 and 20 cm H.sub.2O. More specialized units can delivery pressures up to 25 or even 30 cm H.sub.2O. Most patients typically require air delivered at pressures between 6 and 14 cm H.sub.2O.” (Column 2, Lines 5-15). Thus, the therapeutic pressure value as claimed of “at least 6 cm of water” is a well-known, routine, and conventional pressure valuation utilized to treat patients in need of CPAP therapy.
Regarding the features of the positioning and stabilizing structure, Rudolph teaches an alternative positioning and stabilizing structure (best seen Figures 1-4) including a plurality of straps (10/11/12, “The airflow distributor 6, conduits 7, 8 and 9, straps 10, 11 and 12 and nasal mask 13 are collectively referred to as a headgear 16.” Column 3, Lines 40-65) having a plurality of conduits (7/8/9, “The airflow distributor 6, conduits 7, 8 and 9, straps 10, 11 and 12 and nasal mask 13 are collectively referred to as a headgear 16.” Column 3, Lines 40-65), whereby the number of straps is the same as the number of conduits, and whereby the conduits (7/8/9) are used to convey the delivery of air from an air circuit (20, “The primary conduit 5 is preferably formed of flexible plastic or rubber tubing and includes a first end (not shown) connected to a source of pressurized air 20 shown schematically in FIG. 3.” Column 3, Line 60 thru Column 4, Line 5) to a connection port (6, “airflow distributor 6” Column 3, Lines 40-65) and further along the conduit-strap configuration (defined by the engagement of 7/8/9 with 10/11/12, respectively) to a patient interface (13, “nasal mask 13” Column 3, Lines 40-65).
Regarding the claimed “at least four strap”, Rudolph teaches the conduit-strap configuration (defined by the engagement of 7/8/9 with 10/11/12, respectively) whereby the number of conduits motivates the number of straps in the positioning and stabilizing device. In light of the four conduits of Karpas, the decision to use a complementary number of straps is taught by Rudolph to provide a positioning and stabilizing structure suitable for both securing the patient interface to the face of the user and conveying the gas from the connection port to the user.
Regarding the concept of straps forming a channel and the channel receiving a conduit, Rudolph expressly states although Figures 1-4 show the conduit-strap configuration (defined by the engagement of 7/8/9 with 10/11/12, respectively) in an overlying configuration, an alternative configuration includes the use of a sleeve (“Further the straps 10, 11 and 12 may include a sleeve through which respective secondary conduits 7, 8 and 9 might extend and be secured.” Column 5, Lines 40-55) to receive the conduit-strap configuration (defined by the engagement of 7/8/9 with 10/11/12, respectively). In this configuration, clearly the sleeve provides a channel upon which the conduit is inserted therewith to provide a positioning and stabilizing structure suitable for both securing the patient interface to the face of the user and conveying the gas from the connection port to the user.
Thus, the claimed features of the positioning and stabilizing structure are a known consideration to provide a positioning and stabilizing structure suitable for both securing the patient interface to the face of the user and conveying the gas from the connection port to the user.
Regarding the plenum chamber features, Huby teaches a system (102, best seen Figure 2, “The respiratory treatment device 102 will also typically include a patient interface such as a flow delivery conduit 106 and nasal prongs or nasal cannula 108 to carry the flow of air or breathable gas to the upper airway of a user of the device or patient.” Para 0030) for providing air to a patient at a therapeutic pressure (“CPAP” Para 0003, 0049, 0084) above ambient pressure, including a patient interface (108, “nasal prongs or nasal cannula 108” Para 0030), an air circuit (via 104, “The blower 104 can be coupled with the air delivery conduit 106 and the nasal cannula 108 so as to provide the breathable gas from the blower 104.” Para 0030) and an intermediary conduit (106, “a flow delivery conduit 106” Para 0030) therebetween to convey the delivery of gas from the air circuit (via 104) to the patient interface (108), wherein the patient interface (108) includes at least one pressure port (via 131, “The respiratory treatment device may also optionally include one or more pressure sensors 114, 131 such as a pressure transducer. … An additional or alternative pressure sensor 131 may be located downstream of the blower such as in the patient interface.” Para 0031) within the plenum chamber (defined as the interior of the patient interface -108) to determine the pressure at the patient interface (108). Thus, providing a pressure measurement of the pressure as delivered to the patient at the patient interface.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the therapeutic pressure in CPAP of Karpas to be at least 6 cm of water as taught by Sher to be a well-known, routine, and conventional pressure valuation utilized to treat patients in need of CPAP therapy; to modify the positioning and stabilizing structure of Karpas having four conduits to include each conduit having an individual strap encompassing each conduit in a sleeve formation as taught by Randolph to provide a positioning and stabilizing structure suitable for both securing the patient interface to the face of the user and conveying the gas from the connection port to the user; and to modify the patient interface of Karpas to include a pressure sensor at the plenum chamber, as taught by Huby to assure the explicit pressure being delivered to the patient at the patient interface.
As to Claim 36, the modified Karpas, specifically Rudolph discloses the configuration whereby each conduit (7/8/9) is completely encased with the respective strap (10/11/12).
As to Claims 37 and 38, the modified Karpas, specifically Rudolph discloses the conduits (7/8/9) are decoupled from the straps (10/11/12), via the cutting away of the sleeve and/or removal of the sleeve from the conduit, such that, in use, the conduits (7/8/9) do not contribute to an interfacing vector.
The concept of interfacing vector is related to the tension/force applied by the strap to retain the placement of the patient interface about the head of the user, when the strap is removed either by cutting away of the sleeve and/or the removal of the sleeve from the conduit, there is less tension/force applied to retain the placement of the patient interface on the face of the user, thus, the conduit does not contribute to the interfacing vector.
As to Claims 45 and 48, the modified Karpas, specifically Karpas discloses the positioning and stabilizing structure (best seen Figures 10A-10N for a nose only configuration and Figures 14A-14H for a nose and mouth configuration) whereby gas is delivered via the conduits (1020 - Figures 10A-10N; 5020 - Figures 14A-14H) to the patient interface (1000/5000), such that there is a nasal inlet port (1050/5050) and an oral inlet port (best seen Figure 14G near 5060, “In a fifth embodiment illustrated in FIG. 14A through 14H, the sleep apnea mask 5000 is substantially similar to the fourth embodiment with the inclusion of an enclosure that covers both the nose and mouth. In this embodiment, the internal chamber 5052 connects the air ducts 5020 with both nasal tubes 5050 as well as an opening to the mouth, thereby better distributing the pressure from the CPAP machine to the patient's respiratory system.” Para 0111).
Regarding the features of proximity of conduits to either the nose or the mouth, Sher teaches an additional patient interface (100) having separate channels (132/134 – “Gas supply divider 130 can split the gas supply tube 106 into nasal channel 132 and oral channel 134 for delivering breathable gas to nasal breathing chamber 124 and oral breathing chamber 126, respectively.” Column 4, Lines 45-65) to service each of the nose (via 132) and mouth (via 134) of the patient interface (100), respectively. In this configuration, the nose channel (132) is proximate the nasal ports (118/120), whilst, the mouth channel (134) is proximate the mouth port (108) to direct the flow of gases separately to each of the nose and mouth of the patient. Because of this separation in the nose and oral pathways, Sher expressly teaches each passageway of the nose and mouth may have separate pressurizations to meet the needs of the patient during therapy to ensure effective treatment and patient comfort. (“Separate channels 132, 134 under the control of one or more valves or like mechanisms can allow a doctor to prescribe different pressures or ranges of pressures of breathable gas to be received nasally and orally by a patient. The patient or doctor can adjust the pressure of the breathable gas coming to the patient's nose or mouth by selecting or adjusting the corresponding valve. This may allow the doctor and patient to form a consensus on an effective treatment that may be comfortable to the patient. For example, a doctor prescribing pressurized gas or a patient prescribed pressurized gas can adjust the nasal flow to 8 cm H.sub.2O and the oral flow to 2 cm H.sub.2O. Likewise, the doctor or patient can adjust the nasal flow to 4 cm H.sub.2O and the oral flow to 6 cm H.sub.2O and so on.” Column 5, Lines 45-70).
Thus, the claimed orientation of the nasal inlets being proximate the nasal ports and the oral inlet proximate the oral port was considered by the modified Karpas to ensure effective treatment and patient comfort.
As to Claim 46, please see the rejection of Claim 45, the modified Karpas, specifically Sher considers modifying the impedance to gas flow of the nasal channel (132) to be different from that of the oral channel (134) to meet the needs of the patient during therapy to ensure effective treatment and patient comfort through the operation of valves. (Column 5, Lines 45-70).
As to Claim 47, please see the rejection of Claim 46, the modified Karpas, specifically Sher teaches the operation of the valves to adjust the impedance to gas flow along each of the nasal channel (132) and the oral channel (134). (Column 5, Lines 45-70).
As to Claims 49 and 50, please see the rejection of Claim 31, wherein the modified Karpas, specifically Karpas discloses an air circuit (via “pressurized air from the CPAP machine to the mask” Para 0098) oriented between the RPT device (“CPAP machine” Para 0098) and the patient interface (“mask” Para 0098), and the modified Karpas teaches the features of the patient interface suitable for operations at a therapeutic pressure of at least 6 cm of water.
Yet, does not expressly disclose “an RPT device; and an air circuit connecting the RPT device and the patient interface, wherein the RPT device is configured to vary a flow rate through the air circuit and/or a flow rate through one of the inlet ports in response to variations in pressure measured at the at least one pressure measurement port” (Claim 49), and further “the RPT device comprises at least one pressure sensor port, wherein each pressure measurement port of the patient interface is fluidly connected to a respective pressure sensor port of the RPT device by a respective pressure signal conduit” (Claim 50).
The modified Karpas, specifically Huby teaches at least one pressure port (via 131, “The respiratory treatment device may also optionally include one or more pressure sensors 114, 131 such as a pressure transducer. … An additional or alternative pressure sensor 131 may be located downstream of the blower such as in the patient interface.” Para 0031) within the plenum chamber (defined as the interior of the patient interface -108) to determine the pressure at the patient interface (108); and additionally, a subsequent at least one pressure port (114, “The respiratory treatment device may also optionally include one or more pressure sensors 114, 131 such as a pressure transducer. The pressure sensor 114 can be configured to measure the pressure generated by the blower 104 and/or supplied at the nasal cannula or patient airway. In the illustrated embodiment, the pressure sensor 114 is proximate to the blower 104.” Para 0031) located proximate the air circuit/RPT device to measure the pressure at the blower.
The resultant effect of the usage of two pressure sensors is the ability to monitor the differential pressure between the pressure supplied at the blower as compared to the pressure as supplied at the patient interface to access the efficacy of the treatment protocol and determine if there is any leakage or blockage which may hinder the effectiveness of the treatment protocol. In this determination, the signals from each pressure sensor (131 and 114) undergo feedback processing within a controller (120) to determine modifications, if necessary to the system (“At 1126, these may also include stored processor control instructions for automated methodologies for respiratory treatment control such as feedback processing and pressure or flow control adjustment according to the power related conditions and power-wise methodologies, etc. Finally, they may also include stored data at 1128 for the methodologies such as flow data, detected respiratory characteristics, stored parameters, power data, charge data, time data, battery usage and maintenance data, power failure data, energy consumption data, treatment change data, historic data, reports, graphs, etc.” Para 0088).
Thus, meeting the claimed configuration of feedback control of the system to assure proper ventilation along the pathway of gas from the air circuit/RPT device to the patient interface at the plenum chamber.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Karpas et al. (2015/0157822) in view of Sher et al. (8,397,724), Rudolph (5,538,000), and Huby et al. (2011/0162647), as applied to Claim 31, and further in view of Landis (5,269,296).
As to Claim 32, the modified Karpas, specifically Karpas discloses the use of conduits (1020) for the conveyance of air from the air circuit (via “pressurized air from the CPAP machine to the mask” Para 0098) to the patient interface (1000).
Yet, does not expressly disclose the specific dimensions of the conduit to be 5 mm or less.
Landis teaches an alternative positioning and stabilizing structure (best seen Figure 7 – in situ) including formations (best seen Figures 1 and 6) constructed of a plurality of pathways (60/62/66/72/74/76/78/90) to both provide a conduit-strap configuration to retain the placement of the patient interface (20) on the face of the user, whereby the conduit-strap configuration receives air from the an air circuit (70).
Regarding the remaining limitations of the claims, Landis teaches the specific dimensions of the conduits can be 5 mm or less was a known size dimension suitable for the conveyance of gas to a patient for treatment. Explicitly Landis teaches “Referring now to FIGS. 2 and 3, each cannula is configured and dimensioned to be inserted into a naris of a patient, and typically has an outer cannula diameter about 2 millimeters (mm) to about 10 mm, and preferably about 5 mm.” Column 5, Lines 20-65).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the dimensions of the conduits of the modified Karpas to be 5 mm or less, as taught by Landis to be a known size dimension suitable for the conveyance of gas to the patient for treatment.
Claims 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Karpas et al. (2015/0157822) in view of Sher et al. (8,397,724), Rudolph (5,538,000), and Huby et al. (2011/0162647), as applied to Claim 31, and further in view of Ovizinsky et al. (2014/0102456).
As to Claim 33, the modified Karpas, specifically Rudolph teaches the configuration of a sleeve as a channel to receive and encompass a conduit in a conduit-strap configuration (defined by the engagement of 7/8/9 with 10/11/12, respectively).
Yet, does not expressly disclose the manner of formation of the sleeve of the strap for receiving the conduit, including the use of two layers of material, whereby the channel is provided between the layers.
Ovizinsky teaches the formation of a sleeve for encompassing a conduit (best seen Figures 8-14) whereby the sleeve is constructed of at least two layers of material (655, “an outer layer of a textile or fabric 655 that forms an exterior surface of the conduit. … The film laminate 650 is applied to the fabric 655 (FIG. 11), and then the fabric and laminate are both thermoformed to create symmetrical complementary shapes (FIG. 12), i.e., conduit portions 621, 622. During the thermoforming process, the laminate adheres to the fabric giving it air impermeable properties. The two conduit portions 621 and 622 can then be seam welded as shown in FIG. 13 (e.g., RF weld to couple the conduit portions) and then ultrasonically die cut as shown in FIG. 14 (e.g., to remove seam edges) to create an air tight textile conduit.” Para 0188 and 0189) which are thermoformed and seam welded together to create a textile sleeve that encompasses a conduit to convey the delivery of gas to the user.
In light of the teachings of Ovizinsky, the formation of a sleeve which is constructed to encompass a conduit was known to include the use of at least two layers of material thermoformed and seam welded together.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the a sleeve formation as taught by the modified Karpas, to include the construction of at least two layers of material bonded together, as taught in Ovizinsky to be a known construction methodology suitable to provide a textile sleeve that encompasses a conduit to convey the delivery of gas to the user.
As to Claim 34, the modified Karpas, specifically Ovizinsky teaches the formation of the sleeve of the strap including a joint (best seen Figures 10-14, by the abutment of the upper half oval to the lower half oval on either the left or right side) along one edge of the strap.
Should Applicant allege specificity of “one edge”, Applicant is advised the construction of a channel through the use of a single sheet of material overlayed over each other, results in two layers, whereby the edges of the sheets are bound at one edge is a well-known, routine, and conventional practice in manufacturing including sewing for the formation of headbands, scrunchies – fabric covered hair ties with elastic therebetween (e.g. Scunci ®), curtain pockets for receiving curtain rods, and drawstring waist bands for gym shorts and sweat pants. Thus the use of “one edge” does not overcome this rejection as it is an obvious manufacturing process to form a channel.
As to Claim 35, the modified Karpas, specifically Ovizinsky teaches the formation of the sleeve of the strap including a first point (one of left or right side of the abutment of the upper half oval to the lower half oval as seen in Figures 10-14) along one edge of the strap and a second joint (other of left or right side of the abutment of the upper half oval to the lower half oval as seen in Figures 10-14) along an opposite edge of the strap.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kulilk et al. (2006/0102184) discloses an additional four conduit CPAP device with bilateral channels (8”) and an additional channel (12) both oriented within the strap (9).
Smith (2012/0325219) discloses an additional patient interface having two conduits (14) extending lateral to the patient’s head, respectively, and including a sleeve (46A/46B) receiving each lateral conduit (Para 0028).
Aulgur et al. (4,915,106) discloses a patient interface having an inflatable conduit (20, Column 3, Lines 30-40) with a fabric outer covering (Column 4, Line 65 thru Column 5, Line 15) for encompassing the conduit (20).
Kooij et al. (11,040,165) shares a common assignee/inventor with the instant application and discloses a patient interface having two lateral conduits (3350) and including a sleeve (3340) constructed of elastic (Column 53, Line 10 thru Column 54, Line 20) for covering the conduits (3350).
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785