DETAILED ACTION
Primary Examiner acknowledges Claims 1-18 are pending in this application as originally filed on March 4, 2024.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Chua et al. (4,967,744).
As to Claim 1, Chua discloses a patient interface device (Figures 3-5) for a ventilator system (5, best seen Figure 2, “FIG. 2 diagrammatically illustrates a coaxial tube 30 connecting a ventilator 5 and humidifier 10 to a patient in the incubator 1.” Column 2, Lines 20-30) comprising: a therapy outlet (50, “On the patient end, the connection means includes a swivel patient connector 50. The swivel patient connector 50 is comprised of an end piece 54 and a connector ring 52 to which the inner tube 40 and the outer tubes 32 and 45 are attached. The end piece 54 is rotatably connected to the ring 52 so that by a swivel action, the orientation of the swivel patient connector 50 may be adjusted to accommodate varying positions of the patient without requiring twisting of the coaxial tube 30. Though not shown, the end piece 54 may be connected to a respiratory mouthpiece or the like.” Column 3, Lines 1-15) for delivering pressurized air to a patient (best seen Figure 2); a first port (52 via 32, “The swivel patient connector 50 is comprised of an end piece 54 and a connector ring 52 to which the inner tube 40 and the outer tubes 32 and 45 are attached. The end piece 54 is rotatably connected to the ring 52 so that by a swivel action, the orientation of the swivel patient connector 50 may be adjusted to accommodate varying positions of the patient without requiring twisting of the coaxial tube 30.” Column 3, Lines 1-15) for attachment to a first gas line (32, “As the patient exhales, the expiratory line 32 providing the exhalation passageway carries the exhaled air back to a breathing connector 60 and the gases return to the ventilator 5 through a return line 12.” Column 2, Lines 30-40) and in fluid communication with the therapy outlet (50); and a second port (52 via 40, “The swivel patient connector 50 is comprised of an end piece 54 and a connector ring 52 to which the inner tube 40 and the outer tubes 32 and 45 are attached. The end piece 54 is rotatably connected to the ring 52 so that by a swivel action, the orientation of the swivel patient connector 50 may be adjusted to accommodate varying positions of the patient without requiring twisting of the coaxial tube 30.” Column 3, Lines 1-15) for attachment to a second gas line (40, “The coaxial tube 30 has an inspiratory line 40 inside an outer tubing 32.” Column 2, Lines 20-30), wherein the second port (52 via 40) is in fluid communication with the therapy outlet (50), wherein each of the first port (52 via 32) and the second port (52 via 40) are fluidly connected to the therapy outlet (50) for delivering pressurized gas thereto and/or receiving exhaled gas therefrom and the second port (52 via 40) is positioned within (“The coaxial tube 30 has an inspiratory line 40 inside an outer tubing 32.” Column 2, Lines 20-30) the first port (52 via 32).
As to Claim 2, Chua discloses a third port (52 via 45, “The swivel patient connector 50 is comprised of an end piece 54 and a connector ring 52 to which the inner tube 40 and the outer tubes 32 and 45 are attached.” Column 3, Lines 1-15) for connection to a pressure monitor (via 45, “A proximal airway pressure line 45 is connected between the patient connector 50 and the ventilator 5 so the pressure at the patient may be monitored and adjusted if necessary.” Column 2, Lines 40-50) and in fluid communication with a pressure outlet (45 at 52, “The swivel patient connector 50 is comprised of an end piece 54 and a connector ring 52 to which the inner tube 40 and the outer tubes 32 and 45 are attached.” Column 3, Lines 1-15) adjacent the therapy outlet (50).
Claims 1, 7, and 8 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Lee (5,957,134).
As to Claim 1, Lee discloses a patient interface device (Figure 2) for a ventilator system comprising: a therapy outlet (13 and distal points beyond, “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39.” Column 4, Line 60 thru Column 5, Line 15) for delivering pressurized air to the patient; a first port (defined by the combination of 14 and 17 which engages with 19 of 13, wherein 14 – “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. As illustrated therein and in keeping with the invention, outer tubular element 14 is coupled to an exterior element (not shown) capable of receiving expelled gas from a patient and disposing of it in a manner well known in the prior art.” Column 3, Line 45 thru Column 4, Line 10; wherein 17 – “As illustrated in FIG. 2, inner tubular element 15 of coupling element 11 is of a diameter sufficient to be selectively hermetically coupled to inner tubular element 16 of filter element 12 while outer tubular element 17 of filter element 12 is of a diameter so as to be capable of being selectively hermetically coupled to outer tubular element 14 of coupling element 11.” Column 4, Lines 25-50; and wherein 19 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. … Similarly, outer tubular element 19 of elbow element 13 is of a diameter capable of being selectively hermetically coupled to outer tubular element 17 of filter element 12.” Column 4, Line 60 thru Column 5, Line 15) for attachment to a first gas line (14, “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. As illustrated therein and in keeping with the invention, outer tubular element 14 is coupled to an exterior element (not shown) capable of receiving expelled gas from a patient and disposing of it in a manner well known in the prior art.” Column 3, Line 45 thru Column 4, Line 10) and in fluid communication with the therapy outlet (13 and distal points beyond); and a second port (defined by the combination of 15 and 16 which engages with 18 of 13, wherein 15 – “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. … Inner tubular element 15 is coupled to an exterior source of gas (not shown) whose composition can be selectively mixed and regulated in a manner well known in the prior art. ” Column 3, Line 45 thru Column 4, Line 10; wherein 16 – “As illustrated in FIG. 2, inner tubular element 15 of coupling element 11 is of a diameter sufficient to be selectively hermetically coupled to inner tubular element 16 of filter element 12 while outer tubular element 17 of filter element 12 is of a diameter so as to be capable of being selectively hermetically coupled to outer tubular element 14 of coupling element 11.” Column 4, Lines 25-50; and wherein 18 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. … It should be further noted that inner tubular element 18 of elbow element 13 is of a diameter capable of being selectively hermetically coupled to inner tubular element 16 of filter element 12..” Column 4, Line 60 thru Column 5, Line 15) for attachment to a second gas line (15, “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. … Inner tubular element 15 is coupled to an exterior source of gas (not shown) whose composition can be selectively mixed and regulated in a manner well known in the prior art. ” Column 3, Line 45 thru Column 4, Line 10), wherein the second port (defined by the combination of 15 and 16 which engages with 18 of 13) is in fluid communication with the therapy outlet (13 and distal points beyond), wherein each of the first port (defined by the combination of 14 and 17 which engages with 19 of 13) and the second port (defined by the combination of 15 and 16 which engages with 18 of 13) are fluidly connected to the therapy outlet (13 and distal points beyond) for delivering pressurized gas thereto and/or receiving exhaled gas therefrom and the second port (defined by the combination of 15 and 16 which engages with 18 of 13) is positioned within the first port (defined by the combination of 14 and 17 which engages with 19 of 13).
As to Claim 7, Lee discloses the fitment of the second port (defined by the combination of 15 and 16 which engages with 18 of 13) having a conduit (16/18; wherein 16 – “As illustrated in FIG. 2, inner tubular element 15 of coupling element 11 is of a diameter sufficient to be selectively hermetically coupled to inner tubular element 16 of filter element 12 while outer tubular element 17 of filter element 12 is of a diameter so as to be capable of being selectively hermetically coupled to outer tubular element 14 of coupling element 11.” Column 4, Lines 25-50; and wherein 18 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. … It should be further noted that inner tubular element 18 of elbow element 13 is of a diameter capable of being selectively hermetically coupled to inner tubular element 16 of filter element 12..” Column 4, Line 60 thru Column 5, Line 15) is supported within the first port (defined by the combination of 14 and 17 which engages with 19 of 13) is retained by a strut (37/39, wherein 37 – “More particularly, filter element 12 comprises an outer tubular element 17 defining a hollow cylindrical chamber 36 which has passing therethrough in axial alignment inner tubular element 16, inner tubular element 16 being structurally centered within outer tubular element 17 by spatially positioned spoke members 37. It should be noted that nothing should be considered to limit the invention to the fact that inner tubular element 16 is structurally positioned in axial alignment with outer tubular element 17 by utilization of spoke members 37, since any well-known prior art means to so position inner tubular element 16 in axial alignment with outer tubular element 17 is within the scope of this invention.” Column 4, Lines 5-30; and wherein 39 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. It should be noted that nothing should be considered to limit the invention to the fact that inner tubular element 18 is structurally positioned in axial alignment with outer tubular element 19 by utilization of spoke members 39, since any well-known prior art means to so position inner tubular element 18 in axial alignment with outer tubular element 19 is within the scope of this invention.” Column 4, Line 60 thru Column 5, Line 15).
As to Claim 8, Lee discloses the configuration of the strut (37/39) being oriented as “spoke members”. The conventional orientation of a spoke includes a circular perimeter with solid cross hairs mounted within the circular perimeter, and space between the cross hairs which are free to permit the flow of gases. Returning to the claim language, the space between the cross hairs of the “spoke members” is effectively the claimed “two gaps” that are positioned on the sides of the strut so as to allow the gas flow around the strut.
Claims 1 and 7-9 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Leagre et al. (5,404,873).
As to Claim 1, Leagre discloses a patient interface device (Figure 1) for a ventilation system comprising: a therapy outlet (26, “The breathing circuit 10 also includes a second end 24 which can be attached to a face mask 26, or an endotracheal tube (not shown). Face mask 26 is typically placed over the face of a patient.” Column 5, Lines 50-60) for delivering pressurized air to a patient; a first port (34 engaging 54, “The snug fit is designed so that during normal use of the breathing circuit 10, the second end 34 of the expiratory tube 30 will not become dislodged from the radially outer surface 54 of the second end connector 50.” Column 6, Lines 10-30) for attachment to a first gas line (30, “expiratory tube 30” Column 6, Lines 10-30) and in fluid communication (via 50 to 78 to 26, “An elbow connector 78 (FIG. 1) is received interiorally in the distal portion 60 of the second end coupling member 50, and couples the second end coupling member 50 to the face mask 26.” Column 7, Lines 30-45) with the therapy outlet (26); and a second port (46 engaging 56, “The proximal end portion of the radially inner surface 56 of the second end connector 50 functions as a positioning member receiving portion for receiving a positioning member 68 coupled to the second end 46 of the inspiratory tube 40.” Column 6, Lines 25-55) for attachment to a second gas line (40, “inspiratory tube 40” Column 6, Lines 25-55), wherein the second port (46 engaging 56) is in fluid communication (via 50 to 78 to 26, “An elbow connector 78 (FIG. 1) is received interiorally in the distal portion 60 of the second end coupling member 50, and couples the second end coupling member 50 to the face mask 26.” Column 7, Lines 30-45) with the therapy outlet (26), wherein each of the first port (34 engaging 54) and the second port (46 engaging 56) are fluidly connected (via 50 to 78 to 26, “An elbow connector 78 (FIG. 1) is received interiorally in the distal portion 60 of the second end coupling member 50, and couples the second end coupling member 50 to the face mask 26.” Column 7, Lines 30-45) to the therapy outlet (26) for delivering pressurized gas thereto and/or receiving exhaled gases therefrom and the second port (46 engaging 56) is positioned within the first port (34 engaging 54).
As to Claim 7, Leagre discloses the second port (46 engaging 56) comprises a conduit (68, “a positioning member 68” Column 6, Lines 25-55), the conduit (68) supported within the first port (34 engaging 54) by a strut (64, best seen Figures 2A and 2B, “It includes a series of four axially extending ramps 64 which are formed thereon. The axially extending ramps 64 extend radially inwardly from the radially inner surface 56, such that the effective inner diameter of the interior of the proximal end portion 58 of the second end connector 50 is decreased because of the presence of the ramps 64. The axially extending ramps 64 include radially inwardly facing ramping surfaces 66 which are provided for receiving a positioning member 68. … The distal end of the positioning member 68 is received by the ramping surfaces 66 of the ramps 64, so that the positioning member 68, and (hence the second end 46 of the inspiratory tube 40) is positioned generally in the center of the interior of the proximal end portion 58 of the second end connector 50.” Column 6, Lines 25-55).
As to Claim 8, Leagre discloses the use of a strut (64, best seen Figures 2A and 2B) in the formation of a circular perimeter with solid cross hairs mounted within the circular perimeter, and space between the cross hairs which are free to permit the flow of gases. Returning to the claim language, the space between the cross hairs of the struct (64) is effectively the claimed “two gaps” that are positioned on the sides of the strut so as to allow the gas flow around the strut.
As to Claim 9, Leagre discloses an auxiliary exhaust port (72, “The second end coupling member 50 also includes a radially extending monitoring port 72 through which internal gases can be monitored. The radially extending monitoring port 72 is covered by a selectively engageable cap 74.” Column 7, Lines 30-45) having a removable closure (74, “a selectively engageable cap 74.” Column 7, Lines 30-45), the auxiliary exhaust port (72) providing an alternative outlet for exhaled air.
Claims 1, 10, and 14 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Varga (2012/0247480).
As to Claim 1, Varga discloses a patient interface device (200, Figure 2, “FIG. 2 depicts an embodiment of nCPAP device 200 for use in a nCPAP system.” Para 0020) for a ventilator system comprising: a therapy outlet (130/131, “For example, nasal prongs are physically and fluidly associated with ports 130 and 131.” Para 0026; also see: “For example, if the nare corresponding to port 130 requires half the gas supply than the nare corresponding to port 131 (due to anatomy and/or flow demands), then flow splitter 140 proportionally splits jet flow 160 such that channel flow 162 provides half as much gas flow through channel 132 than channel flow 161 flowing through channel 134.” Para 0013) for delivering pressurized air to the patient; a first port (120, “During an exhalation phase, the patient exhalation flow, along with the fresh gas flow, are exhausted together out exhaust port 120.” Para 0018) for attachment to a first gas line (via 120) and in fluid communication (via 120 to 130/131) with the therapy outlet (130/131); and a second port (215, “The pressure measurement ports are fluidly connected to pressure monitoring port 215, where a pressure line can be connected and routed to a pressure monitor.” Para 0021) for attachment to a second gas line (via 215) in fluid communication (via 215 via 210s within 130/131; wherein 210s – “In particular, device 200 includes pressure measurement port 210 associated with port 130 and another pressure measurement port (not shown) associated with port 131.” Para 0021) with the therapy outlet (130/131), wherein each of the first port (120) and the second port (215) are fluidly connected to the therapy outlet (130/131) for receiving exhaled gas therefrom and the second port (215) is positioned within the first port (120).
As to Claim 10, Varga discloses a nasal prong device (“nasal prongs”, “For example, nasal prongs are physically and fluidly associated with ports 130 and 131.” Para 0026) attached to the therapy outlet (130/131) for engaging the nares of the patient to deliver nCPAP (“FLOW SPLITTING NCPAP DEVICE” Title) therapy.
As to Claim 14, Varga discloses the therapy outlet (130/131) comprises a first therapy outlet (one of 130 and 131) and a second therapy outlet (other of 130 and 131), each of the first therapy outlet (one of 130 and 131) and the second therapy outlet (other of 130 and 131) connected to each of the first port (120) and the second port (215).
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 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Chua et al. (4,967,744).
As to Claim 3, Chua discloses third port (52 via 45) connected with the first port (52 via 32) - “The swivel patient connector 50 is comprised of an end piece 54 and a connector ring 52 to which the inner tube 40 and the outer tubes 32 and 45 are attached.” (Column 3, Lines 1-15); yet, does not expressly disclose the orientation of “the third port is positioned within the first port”.
In light of the relationship of the third port (52 via 45) to be interconnected with each of the first port (52 via 32) and the second port (52 via 40) in order to provide a unitary connection to the therapy outlet (50), the configuration of the third port to be located within the first port is obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to provide a unitary connection to the therapy outlet (50) so that each of inhaled air, exhaled air, and pressure monitoring at the patient end is permissible.
Applicant has not asserted the specific orientation of the third port (52 via 45) positioned within the first port (52 via 32) provides a particular advantage, solves a stated problem, or serves a particular purpose; thus, the use of the specific orientation of the third port located within the first port lacks criticality in its design.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with Chua, as the unitary connection of each of the first port (52 via 32), second port (52 via 40) and the third port (52 via 45) would yield the predictable results of permitting each of inhaled air, exhaled air, and pressure monitoring at the patient end.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the orientation of the third port of Chua to be positioned within the first port, a known result effective variable in order to provide each of inhaled air, exhaled air, and pressure monitoring at the patient end.
As to Claim 4, the modified Chua, specifically Chua discloses third port (52 via 45), the second port (52 via 40) and the first port (52 via 32) each connected to the therapy outlet (50); yet, does not expressly disclose the orientation whereby “the second and third ports are radially offset from the center of the first port”.
In light of the relationship of the third port (52 via 45) to be interconnected with each of the first port (52 via 32) and the second port (52 via 40) in order to provide a unitary connection to the therapy outlet (50), the configuration of the third port and second port to be radially offset from the center of the first port is obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to provide a unitary connection to the therapy outlet (50) so that each of inhaled air, exhaled air, and pressure monitoring at the patient end is permissible.
Applicant has not asserted the specific orientation of the third port (52 via 45) and second port (52 via 40) positioned radially offset from the center of the first port (52 via 32) provides a particular advantage, solves a stated problem, or serves a particular purpose; thus, the use of the specific orientation of the third port located within the first port lacks criticality in its design.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with Chua, as the unitary connection of each of the first port (52 via 32), second port (52 via 40) and the third port (52 via 45) would yield the predictable results of permitting each of inhaled air, exhaled air, and pressure monitoring at the patient end.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the orientation of the third port and second port of Chua to be radially offset from the center of the first port, a known result effective variable in order to provide each of inhaled air, exhaled air, and pressure monitoring at the patient end.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Chua et al. (4,967,744) in view of Lee (5,957,134).
As to Claim 5, the modified Chua, specifically Chua discloses the third port (52 via 45), the second port (52 via 40) and the first port (52 via 32) each connected to the therapy outlet (50); yet, does not expressly disclose the “the second and third ports comprise respective conduits supported within the first port by a strut”.
Lee teaches a patient interface (Figure 2) having a therapy outlet (13 and distal points beyond, “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39.” Column 4, Line 60 thru Column 5, Line 15) for delivering pressurized air to the patient; a first port (defined by the combination of 14 and 17 which engages with 19 of 13, wherein 14 – “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. As illustrated therein and in keeping with the invention, outer tubular element 14 is coupled to an exterior element (not shown) capable of receiving expelled gas from a patient and disposing of it in a manner well known in the prior art.” Column 3, Line 45 thru Column 4, Line 10; wherein 17 – “As illustrated in FIG. 2, inner tubular element 15 of coupling element 11 is of a diameter sufficient to be selectively hermetically coupled to inner tubular element 16 of filter element 12 while outer tubular element 17 of filter element 12 is of a diameter so as to be capable of being selectively hermetically coupled to outer tubular element 14 of coupling element 11.” Column 4, Lines 25-50; and wherein 19 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. … Similarly, outer tubular element 19 of elbow element 13 is of a diameter capable of being selectively hermetically coupled to outer tubular element 17 of filter element 12.” Column 4, Line 60 thru Column 5, Line 15) for attachment to a first gas line (14, “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. As illustrated therein and in keeping with the invention, outer tubular element 14 is coupled to an exterior element (not shown) capable of receiving expelled gas from a patient and disposing of it in a manner well known in the prior art.” Column 3, Line 45 thru Column 4, Line 10) and in fluid communication with the therapy outlet (13 and distal points beyond); and a second port (defined by the combination of 15 and 16 which engages with 18 of 13, wherein 15 – “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. … Inner tubular element 15 is coupled to an exterior source of gas (not shown) whose composition can be selectively mixed and regulated in a manner well known in the prior art. ” Column 3, Line 45 thru Column 4, Line 10; wherein 16 – “As illustrated in FIG. 2, inner tubular element 15 of coupling element 11 is of a diameter sufficient to be selectively hermetically coupled to inner tubular element 16 of filter element 12 while outer tubular element 17 of filter element 12 is of a diameter so as to be capable of being selectively hermetically coupled to outer tubular element 14 of coupling element 11.” Column 4, Lines 25-50; and wherein 18 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. … It should be further noted that inner tubular element 18 of elbow element 13 is of a diameter capable of being selectively hermetically coupled to inner tubular element 16 of filter element 12..” Column 4, Line 60 thru Column 5, Line 15) for attachment to a second gas line (15, “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. … Inner tubular element 15 is coupled to an exterior source of gas (not shown) whose composition can be selectively mixed and regulated in a manner well known in the prior art. ” Column 3, Line 45 thru Column 4, Line 10), wherein the second port (defined by the combination of 15 and 16 which engages with 18 of 13) is in fluid communication with the therapy outlet (13 and distal points beyond), wherein each of the first port (defined by the combination of 14 and 17 which engages with 19 of 13) and the second port (defined by the combination of 15 and 16 which engages with 18 of 13) are fluidly connected to the therapy outlet (13 and distal points beyond) for delivering pressurized gas thereto and/or receiving exhaled gas therefrom and the second port (defined by the combination of 15 and 16 which engages with 18 of 13) is positioned within the first port (defined by the combination of 14 and 17 which engages with 19 of 13).
Regarding the remaining limitations, Lee teaches the fitment of the second port (defined by the combination of 15 and 16 which engages with 18 of 13) within the first port (defined by the combination of 14 and 17 which engages with 19 of 13) is retained by a strut (37/39, wherein 37 – “More particularly, filter element 12 comprises an outer tubular element 17 defining a hollow cylindrical chamber 36 which has passing therethrough in axial alignment inner tubular element 16, inner tubular element 16 being structurally centered within outer tubular element 17 by spatially positioned spoke members 37. It should be noted that nothing should be considered to limit the invention to the fact that inner tubular element 16 is structurally positioned in axial alignment with outer tubular element 17 by utilization of spoke members 37, since any well-known prior art means to so position inner tubular element 16 in axial alignment with outer tubular element 17 is within the scope of this invention.” Column 4, Lines 5-30; and wherein 39 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. It should be noted that nothing should be considered to limit the invention to the fact that inner tubular element 18 is structurally positioned in axial alignment with outer tubular element 19 by utilization of spoke members 39, since any well-known prior art means to so position inner tubular element 18 in axial alignment with outer tubular element 19 is within the scope of this invention.” Column 4, Line 60 thru Column 5, Line 15).
In light of the teachings of Lee, the use of a strut (37/39) to retain the placement of the second port within the first port was a known manner of providing axial alignment of the second port (defined by the combination of 15 and 16 which engages with 18 of 13) within the first port (defined by the combination of 14 and 17 which engages with 19 of 13).
Hence, as Lee as modifying Chua considers the usage of a strut for the engagement of the second port (defined by the combination of 15 and 16 which engages with 18 of 13) within the first port (defined by the combination of 14 and 17 which engages with 19 of 13), the similar construction of a third port also located within the first port utilizing a strut would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to axially align the third port within the first port.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Chua, as the construction of a strut for axial alignment would yield the predictable results of providing for the retainment of each of the second port and the third port within the first port.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the first port of the modified Chua, to include a strut internally mounted therein, as taught by Lee, to support the axial retainment of each of the second port within the first port and the third port within the first port.
As to Claim 6, the modified Chua, specifically Lee teaches the configuration of the strut (37/39) being oriented as “spoke members”. The conventional orientation of a spoke includes a circular perimeter with solid cross hairs mounted within the circular perimeter, and space between the cross hairs which are free to permit the flow of gases. Returning to the claim language, the space between the cross hairs of the “spoke members” is effectively the claimed “two gaps” that are positioned on the sides of the strut so as to allow the gas flow around the strut.
As to Claim 7, Chua discloses the second port (52 via 40) within the first port (52 via 32) each connected to the therapy outlet (50); yet, does not expressly disclose the “the second port comprising a conduit, the conduit supported within the first port by a strut”.
Lee teaches a patient interface (Figure 2) having a therapy outlet (13 and distal points beyond, “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39.” Column 4, Line 60 thru Column 5, Line 15) for delivering pressurized air to the patient; a first port (defined by the combination of 14 and 17 which engages with 19 of 13, wherein 14 – “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. As illustrated therein and in keeping with the invention, outer tubular element 14 is coupled to an exterior element (not shown) capable of receiving expelled gas from a patient and disposing of it in a manner well known in the prior art.” Column 3, Line 45 thru Column 4, Line 10; wherein 17 – “As illustrated in FIG. 2, inner tubular element 15 of coupling element 11 is of a diameter sufficient to be selectively hermetically coupled to inner tubular element 16 of filter element 12 while outer tubular element 17 of filter element 12 is of a diameter so as to be capable of being selectively hermetically coupled to outer tubular element 14 of coupling element 11.” Column 4, Lines 25-50; and wherein 19 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. … Similarly, outer tubular element 19 of elbow element 13 is of a diameter capable of being selectively hermetically coupled to outer tubular element 17 of filter element 12.” Column 4, Line 60 thru Column 5, Line 15) for attachment to a first gas line (14, “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. As illustrated therein and in keeping with the invention, outer tubular element 14 is coupled to an exterior element (not shown) capable of receiving expelled gas from a patient and disposing of it in a manner well known in the prior art.” Column 3, Line 45 thru Column 4, Line 10) and in fluid communication with the therapy outlet (13 and distal points beyond); and a second port (defined by the combination of 15 and 16 which engages with 18 of 13, wherein 15 – “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. … Inner tubular element 15 is coupled to an exterior source of gas (not shown) whose composition can be selectively mixed and regulated in a manner well known in the prior art. ” Column 3, Line 45 thru Column 4, Line 10; wherein 16 – “As illustrated in FIG. 2, inner tubular element 15 of coupling element 11 is of a diameter sufficient to be selectively hermetically coupled to inner tubular element 16 of filter element 12 while outer tubular element 17 of filter element 12 is of a diameter so as to be capable of being selectively hermetically coupled to outer tubular element 14 of coupling element 11.” Column 4, Lines 25-50; and wherein 18 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. … It should be further noted that inner tubular element 18 of elbow element 13 is of a diameter capable of being selectively hermetically coupled to inner tubular element 16 of filter element 12..” Column 4, Line 60 thru Column 5, Line 15) for attachment to a second gas line (15, “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. … Inner tubular element 15 is coupled to an exterior source of gas (not shown) whose composition can be selectively mixed and regulated in a manner well known in the prior art. ” Column 3, Line 45 thru Column 4, Line 10), wherein the second port (defined by the combination of 15 and 16 which engages with 18 of 13) is in fluid communication with the therapy outlet (13 and distal points beyond), wherein each of the first port (defined by the combination of 14 and 17 which engages with 19 of 13) and the second port (defined by the combination of 15 and 16 which engages with 18 of 13) are fluidly connected to the therapy outlet (13 and distal points beyond) for delivering pressurized gas thereto and/or receiving exhaled gas therefrom and the second port (defined by the combination of 15 and 16 which engages with 18 of 13) is positioned within the first port (defined by the combination of 14 and 17 which engages with 19 of 13).
Regarding the remaining limitations, Lee teaches the fitment of the second port (defined by the combination of 15 and 16 which engages with 18 of 13) having a conduit (16/18; wherein 16 – “As illustrated in FIG. 2, inner tubular element 15 of coupling element 11 is of a diameter sufficient to be selectively hermetically coupled to inner tubular element 16 of filter element 12 while outer tubular element 17 of filter element 12 is of a diameter so as to be capable of being selectively hermetically coupled to outer tubular element 14 of coupling element 11.” Column 4, Lines 25-50; and wherein 18 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. … It should be further noted that inner tubular element 18 of elbow element 13 is of a diameter capable of being selectively hermetically coupled to inner tubular element 16 of filter element 12..” Column 4, Line 60 thru Column 5, Line 15) is supported within the first port (defined by the combination of 14 and 17 which engages with 19 of 13) is retained by a strut (37/39, wherein 37 – “More particularly, filter element 12 comprises an outer tubular element 17 defining a hollow cylindrical chamber 36 which has passing therethrough in axial alignment inner tubular element 16, inner tubular element 16 being structurally centered within outer tubular element 17 by spatially positioned spoke members 37. It should be noted that nothing should be considered to limit the invention to the fact that inner tubular element 16 is structurally positioned in axial alignment with outer tubular element 17 by utilization of spoke members 37, since any well-known prior art means to so position inner tubular element 16 in axial alignment with outer tubular element 17 is within the scope of this invention.” Column 4, Lines 5-30; and wherein 39 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. It should be noted that nothing should be considered to limit the invention to the fact that inner tubular element 18 is structurally positioned in axial alignment with outer tubular element 19 by utilization of spoke members 39, since any well-known prior art means to so position inner tubular element 18 in axial alignment with outer tubular element 19 is within the scope of this invention.” Column 4, Line 60 thru Column 5, Line 15).
The resultant effect of the use of a strut (37/39) is the ability to axially align the orientation of the second port within the first port.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the first port of the modified Chua, to include a strut internally mounted therein, as taught by Lee, to support the axial retainment of each of the second port within the first port and the third port within the first port.
As to Claim 8, the modified Chua, specifically Lee teaches the configuration of the strut (37/39) being oriented as “spoke members”. The conventional orientation of a spoke includes a circular perimeter with solid cross hairs mounted within the circular perimeter, and space between the cross hairs which are free to permit the flow of gases. Returning to the claim language, the space between the cross hairs of the “spoke members” is effectively the claimed “two gaps” that are positioned on the sides of the strut so as to allow the gas flow around the strut.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Varga (2012/0247480) in view of Lee (5,957,134).
As to Claim 7, Varga discloses a second port (215) comprises a conduit (defined by the pathway from 215 to 210); the conduit (defined by the pathway from 215 to 210) within the first port (120); yet, does not expressly disclose the “the second port comprising a conduit, the conduit supported within the first port by a strut”.
Lee teaches a patient interface (Figure 2) having a therapy outlet (13 and distal points beyond, “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39.” Column 4, Line 60 thru Column 5, Line 15) for delivering pressurized air to the patient; a first port (defined by the combination of 14 and 17 which engages with 19 of 13, wherein 14 – “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. As illustrated therein and in keeping with the invention, outer tubular element 14 is coupled to an exterior element (not shown) capable of receiving expelled gas from a patient and disposing of it in a manner well known in the prior art.” Column 3, Line 45 thru Column 4, Line 10; wherein 17 – “As illustrated in FIG. 2, inner tubular element 15 of coupling element 11 is of a diameter sufficient to be selectively hermetically coupled to inner tubular element 16 of filter element 12 while outer tubular element 17 of filter element 12 is of a diameter so as to be capable of being selectively hermetically coupled to outer tubular element 14 of coupling element 11.” Column 4, Lines 25-50; and wherein 19 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. … Similarly, outer tubular element 19 of elbow element 13 is of a diameter capable of being selectively hermetically coupled to outer tubular element 17 of filter element 12.” Column 4, Line 60 thru Column 5, Line 15) for attachment to a first gas line (14, “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. As illustrated therein and in keeping with the invention, outer tubular element 14 is coupled to an exterior element (not shown) capable of receiving expelled gas from a patient and disposing of it in a manner well known in the prior art.” Column 3, Line 45 thru Column 4, Line 10) and in fluid communication with the therapy outlet (13 and distal points beyond); and a second port (defined by the combination of 15 and 16 which engages with 18 of 13, wherein 15 – “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. … Inner tubular element 15 is coupled to an exterior source of gas (not shown) whose composition can be selectively mixed and regulated in a manner well known in the prior art. ” Column 3, Line 45 thru Column 4, Line 10; wherein 16 – “As illustrated in FIG. 2, inner tubular element 15 of coupling element 11 is of a diameter sufficient to be selectively hermetically coupled to inner tubular element 16 of filter element 12 while outer tubular element 17 of filter element 12 is of a diameter so as to be capable of being selectively hermetically coupled to outer tubular element 14 of coupling element 11.” Column 4, Lines 25-50; and wherein 18 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. … It should be further noted that inner tubular element 18 of elbow element 13 is of a diameter capable of being selectively hermetically coupled to inner tubular element 16 of filter element 12..” Column 4, Line 60 thru Column 5, Line 15) for attachment to a second gas line (15, “More particularly, and as illustrated in FIG. 2, coupling element 11 comprises outer tubular element 14 and inner tubular element 15. … Inner tubular element 15 is coupled to an exterior source of gas (not shown) whose composition can be selectively mixed and regulated in a manner well known in the prior art. ” Column 3, Line 45 thru Column 4, Line 10), wherein the second port (defined by the combination of 15 and 16 which engages with 18 of 13) is in fluid communication with the therapy outlet (13 and distal points beyond), wherein each of the first port (defined by the combination of 14 and 17 which engages with 19 of 13) and the second port (defined by the combination of 15 and 16 which engages with 18 of 13) are fluidly connected to the therapy outlet (13 and distal points beyond) for delivering pressurized gas thereto and/or receiving exhaled gas therefrom and the second port (defined by the combination of 15 and 16 which engages with 18 of 13) is positioned within the first port (defined by the combination of 14 and 17 which engages with 19 of 13).
Regarding the remaining limitations, Lee teaches the fitment of the second port (defined by the combination of 15 and 16 which engages with 18 of 13) having a conduit (16/18; wherein 16 – “As illustrated in FIG. 2, inner tubular element 15 of coupling element 11 is of a diameter sufficient to be selectively hermetically coupled to inner tubular element 16 of filter element 12 while outer tubular element 17 of filter element 12 is of a diameter so as to be capable of being selectively hermetically coupled to outer tubular element 14 of coupling element 11.” Column 4, Lines 25-50; and wherein 18 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. … It should be further noted that inner tubular element 18 of elbow element 13 is of a diameter capable of being selectively hermetically coupled to inner tubular element 16 of filter element 12..” Column 4, Line 60 thru Column 5, Line 15) is supported within the first port (defined by the combination of 14 and 17 which engages with 19 of 13) is retained by a strut (37/39, wherein 37 – “More particularly, filter element 12 comprises an outer tubular element 17 defining a hollow cylindrical chamber 36 which has passing therethrough in axial alignment inner tubular element 16, inner tubular element 16 being structurally centered within outer tubular element 17 by spatially positioned spoke members 37. It should be noted that nothing should be considered to limit the invention to the fact that inner tubular element 16 is structurally positioned in axial alignment with outer tubular element 17 by utilization of spoke members 37, since any well-known prior art means to so position inner tubular element 16 in axial alignment with outer tubular element 17 is within the scope of this invention.” Column 4, Lines 5-30; and wherein 39 – “As further illustrated in FIG. 2, elbow element 13 comprises two concentric tubular elements, inner tubular element 18 and outer tubular element 19, inner tubular element 18 being structurally centered within outer tubular element 19 by spatially positioned spoke members 39. It should be noted that nothing should be considered to limit the invention to the fact that inner tubular element 18 is structurally positioned in axial alignment with outer tubular element 19 by utilization of spoke members 39, since any well-known prior art means to so position inner tubular element 18 in axial alignment with outer tubular element 19 is within the scope of this invention.” Column 4, Line 60 thru Column 5, Line 15).
The resultant effect of the use of a strut (37/39) is the ability to axially align the orientation of the second port within the first port.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the first port of Varga, to include a strut internally mounted therein, as taught by Lee, to support the axial retainment of each of the second port within the first port and the third port within the first port.
As to Claim 8, the modified Varga, specifically Lee teaches the configuration of the strut (37/39) being oriented as “spoke members”. The conventional orientation of a spoke includes a circular perimeter with solid cross hairs mounted within the circular perimeter, and space between the cross hairs which are free to permit the flow of gases. Returning to the claim language, the space between the cross hairs of the “spoke members” is effectively the claimed “two gaps” that are positioned on the sides of the strut so as to allow the gas flow around the strut.
Claims 11-13 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Varga (2012/0247480) in view of Moa et al. (5,193,532).
As to Claim 11, Varga discloses the second port (215) is in fluid communication with the therapy outlet (130/131); yet, does not expressly disclose “a channel having a diameter sized such that gas entering the channel from the second port forms a jet having an increased fluid pressure”.
Moa teaches a patient interface device (Figure 6) for a ventilator system comprising: a therapy outlet (11/11, best seen Figures 1-4, “FIG. 1 shows diagrammatically a breathing-channel 10 which is angled and thereby divided into a first branch-channel 11, which can be attached to the patient's nose and/or mouth and a second branch-channel 12 which opens to the free atmosphere.” Column 2, Lines 40-50) for delivering pressurized air to a patient; a first port (10, “a breathing-channel 10” Column 2, Lines 40-50) for attachment to a first gas line (via 10, “a breathing-channel 10” Column 2, Lines 40-50) and in fluid communication with the therapy outlet (11/11); and a second port (20, “The inlet channel 13 branches out from a supply channel 20.” Column 3, Lines 10-20) for attachment to a second gas line (via 20, “The inlet channel 13 branches out from a supply channel 20.” Column 3, Lines 10-20), wherein the second port (20) is in fluid communication with the therapy outlet (11/11), wherein each of the first port (10) and the second port (20) are fluidly connected to the therapy outlet (11/11) for delivering pressurized gas thereto and/or receiving exhaled gas therefrom.
Regarding the remaining limitations of the claims, Moa teaches the second port (20) is in fluid communication with the therapy outlet (11/11) via a channel (13, “The inlet channel 13 branches out from a supply channel 20.” Column 3, Lines 10-20) having a diameter sized such that gas entering the channel (13) from the second port (20) forms a jet having an increased fluid pressure (“By means of the angled arrangement of the breathing-channel and the special attachment of the inlet channel and the relation between the cross-sectional areas of the inlet channel and the branch-channel, a desired jet entrainment is attained in a simple manner. The atmospheric air and/or excess fresh-gas indicated by arrow 14 can thus be sucked into channel 11 during the inspiration phase so that the pressure in the airway of the patient tends to be maintained, even if the inspiratory flow exceeds the fresh-gas flow. Arrows 15 indicate the flow to the lungs and arrows 16 indicate the outflow from the inlet channel 13. At a maximum inspiratory flow the ejection flow 16 will consequently bring gas from channel 12 with it, thereby counteracting a lowering of pressure in the airway of the patient. During the expiratory phase according to FIG. 2, the expired gas according to arrows 17 together with the excess gas flow are directed out through branch channel 12 as indicated by arrows 18. Since branch channel 12 has a relatively large flow capacity, a rise over the desired value in elevated pressure in the airway of the patient is counteracted.” Column 2, Line 50 thru Column 3, Line 10). The resultant effect is the ability to control the flow profile of the gas delivered to and removed from the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the second port of Varga to include a channel forming a jet, as taught by Moa to control the flow profile of the gas delivered to and removed from the patient.
As to Claim 12, the modified Varga, specifically Moa teaches the diameter of the channel (13) is 1.3 mm (“Channel 11 had a diameter of 3.5 mm, channel 12 had a diameter of 4.0 mm and channel 13 had a diameter of 1.3 mm.” Column 3, Lines 15-25). Returning to the claim language, this diameter meets the claimed limitation of between 0.1 mm and 3 mm.
As to Claim 13, the modified Varga, specifically Moa teaches the diameter of the channel (13) is 1.3 mm (“Channel 11 had a diameter of 3.5 mm, channel 12 had a diameter of 4.0 mm and channel 13 had a diameter of 1.3 mm.” Column 3, Lines 15-25). Returning to the claim language, this diameter is slightly larger than the claimed limitation between 0.3 mm and 1 mm.
Nevertheless, it has been held where the general conditions of a claim are disclosed the in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. As Applicant has not asserted the specific dimensions of between 0.3 mm and 1 mm provides a particular advantage, solves a stated problem, or serves a particular purpose, the use of the specific dimensions between 0.3 mm and 1 mm appears to lack criticality in its design.
Hence, the dimensions of 1.3 mm being nominally close to 1 mm would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability of the channel diameter to control the flow profile of the gas delivered to and removed from the patient.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Varga as the specific diameter would yield the predictable results of controlling flow profile of the gas delivered to and removed from the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the dimensions of the channel of the modified Varga a known result effective variable in order to provide control of the flow profile of the gas delivered to and removed from the patient.
As to Claim 11, Varga discloses the second port (215) is in fluid communication with the therapy outlet (130/131); yet, does not expressly disclose “a chamber fluidly connected to the second port, the chamber comprising two holes forming respective channels, each of the channels having a respective diameter sized such that gas entering the channel from the chamber forms a jet having an increased fluid pressure”.
Moa teaches a patient interface device (Figure 6) for a ventilator system comprising: a therapy outlet (11/11, best seen Figures 1-4, “FIG. 1 shows diagrammatically a breathing-channel 10 which is angled and thereby divided into a first branch-channel 11, which can be attached to the patient's nose and/or mouth and a second branch-channel 12 which opens to the free atmosphere.” Column 2, Lines 40-50) for delivering pressurized air to a patient; a first port (10, “a breathing-channel 10” Column 2, Lines 40-50) for attachment to a first gas line (via 10, “a breathing-channel 10” Column 2, Lines 40-50) and in fluid communication with the therapy outlet (11/11); and a second port (20, “The inlet channel 13 branches out from a supply channel 20.” Column 3, Lines 10-20) for attachment to a second gas line (via 20, “The inlet channel 13 branches out from a supply channel 20.” Column 3, Lines 10-20), wherein the second port (20) is in fluid communication with the therapy outlet (11/11), wherein each of the first port (10) and the second port (20) are fluidly connected to the therapy outlet (11/11) for delivering pressurized gas thereto and/or receiving exhaled gas therefrom.
Regarding the remaining limitations of the claims, Moa teaches the a chamber (19A, “FIG. 4 shows an embodiment in which the plastic body 19A has two parallel systems of channels 11, 12 and 13 as in FIG. 3.” Column 3, Lines 25-35) fluidly connected to the second port (20), the chamber (19A) having two holes (via 13/13) forming respective channels (13/13, “two parallel systems of channels 11, 12 and 13 as in FIG. 3.” Column 3, Lines 25-35), each of the channels (one of 13, “The inlet channel 13 branches out from a supply channel 20.” Column 3, Lines 10-20) having a diameter sized such that gas entering the channel (13) from the second port (20) forms a jet having an increased fluid pressure (“By means of the angled arrangement of the breathing-channel and the special attachment of the inlet channel and the relation between the cross-sectional areas of the inlet channel and the branch-channel, a desired jet entrainment is attained in a simple manner. The atmospheric air and/or excess fresh-gas indicated by arrow 14 can thus be sucked into channel 11 during the inspiration phase so that the pressure in the airway of the patient tends to be maintained, even if the inspiratory flow exceeds the fresh-gas flow. Arrows 15 indicate the flow to the lungs and arrows 16 indicate the outflow from the inlet channel 13. At a maximum inspiratory flow the ejection flow 16 will consequently bring gas from channel 12 with it, thereby counteracting a lowering of pressure in the airway of the patient. During the expiratory phase according to FIG. 2, the expired gas according to arrows 17 together with the excess gas flow are directed out through branch channel 12 as indicated by arrows 18. Since branch channel 12 has a relatively large flow capacity, a rise over the desired value in elevated pressure in the airway of the patient is counteracted.” Column 2, Line 50 thru Column 3, Line 10). The resultant effect is the ability to control the flow profile of the gas delivered to and removed from the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the second port of Varga to include two holes forming respective channels forming a jet, as taught by Moa to control the flow profile of the gas delivered to and removed from the patient.
As to Claim 16, the modified Varga, specifically Moa teaches each hole (via 13) comprises an axis substantially aligned with an axis of one of the first therapy outlet (one of 11) and the second therapy outlet (other of 11).
As to Claim 17, the modified Varga, specifically Moa teaches the diameter of the channel (13) is 1.3 mm (“Channel 11 had a diameter of 3.5 mm, channel 12 had a diameter of 4.0 mm and channel 13 had a diameter of 1.3 mm.” Column 3, Lines 15-25). Returning to the claim language, this diameter meets the claimed limitation of between 0.1 mm and 3 mm.
As to Claim 18, the modified Varga, specifically Moa teaches the diameter of the channel (13) is 1.3 mm (“Channel 11 had a diameter of 3.5 mm, channel 12 had a diameter of 4.0 mm and channel 13 had a diameter of 1.3 mm.” Column 3, Lines 15-25). Returning to the claim language, this diameter is slightly larger than the claimed limitation between 0.3 mm and 1 mm.
Nevertheless, it has been held where the general conditions of a claim are disclosed the in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. As Applicant has not asserted the specific dimensions of between 0.3 mm and 1 mm provides a particular advantage, solves a stated problem, or serves a particular purpose, the use of the specific dimensions between 0.3 mm and 1 mm appears to lack criticality in its design.
Hence, the dimensions of 1.3 mm being nominally close to 1 mm would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability of the channel diameter to control the flow profile of the gas delivered to and removed from the patient.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Varga as the specific diameter would yield the predictable results of controlling flow profile of the gas delivered to and removed from the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the dimensions of the channel of the modified Varga a known result effective variable in order to provide control of the flow profile of the gas delivered to and removed from the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dryden et al. (4,838,258) and Hoenig (2002/0148464) each disclose the construction of a tube within a tube for connection to a therapy outlet of a patient interface device.
Hofstetter al. (5,975,077), Olsen et al. (2003/0047185), Stenzler et al. (2003/0200970), Duquette et al. (2007/0074724) and Pierro et al. (2007/0125379) each disclose additional nCPAP patient interface devices.
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.
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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.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
Prosecution Insights