DETAILED ACTION
Primary Examiner acknowledges Claims 21-47 are pending in this application, with Claims 21-47 having been newly added, and Claims 1-20 having been cancelled by preliminary amendment on August 23, 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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Specifically, the abstract, filed on July 18, 2023, has greater than 150 words in length. Appropriate correction is required.
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.
Claims 21-47 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, Claim 21, Line 14 recites “rise surface”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure if this limitation should recite “riser surface” to be consistent with the “riser surface” as originally introduced in Claim 21, Line 11, or alternatively, if Applicant is attempting to recite a separate and distinct limitation of the claims. Consequently, the breadth and scope of the claims is unclear and thus deemed indefinite. Dependent claims, Claims 22-31, incorporate the indefinite subject matter from which they depend. Explicitly, Primary Examiner notes the term “rise surface” is noted in dependent claims, Claims 22, Line 1 and Claim 29, Line 1. Appropriate correction and clarification is required.
Specifically, Claim 32, Line 9 recites “the steps”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure if this limitation should recite “the plurality of steps” to be consistent with the “plurality of steps” as originally introduced in Claim 32, Line 9, or alternatively, if Applicant is attempting to recite a separate and distinct limitation of the claims. Consequently, the breadth and scope of the claims is unclear and thus deemed indefinite. Dependent claims, Claims 33-39, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 40, Lines 10 and 12 recite “the vent holes”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure if this limitation should recite “the plurality of vent holes” to be consistent with the “plurality of vent holes” as originally introduced in Claim 40, Line 8, or alternatively, if Applicant is attempting to recite a separate and distinct limitation of the claims. Consequently, the breadth and scope of the claims is unclear and thus deemed indefinite. Dependent claims, Claims 41-47, incorporate the indefinite subject matter from which they depend. Explicitly, Primary Examiner notes the term “the vent holes” is recited in Claim 42, Line 2, and the phase “plurality of rows of vent holes” is recited in Claim 43, Line 2. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21-27, 29, and 40-45 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over D. Jaffre et al. (2003/0005931, herein Jaffre) in view of Dantanarayana et al. (2004/0094157).
As to Claim 21, Jaffre discloses an elbow (Figures 3-9) configured to connect an air delivery conduit (52, best seen Figure 3, “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62.” Para 0047) to a patient interface (46, best seen Figure 3, “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62.” Para 0047) to deliver a flow of pressurized breathable gas (“breathing gas from a breathing gas source” via 32/32’, “supply of breathing gas from a breathing gas source, as indicated by arrow A, such as ambient atmosphere, and creates a flow of breathing gas at a pressure greater than ambient atmospheric pressure.” Para 0012 and “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62. Pressure generating system 32, 32' corresponds to any conventional pressure generating system, such as those discussed above with respect to FIGS. 1 and 2.” Para 0047) to the patient interface (46), the elbow (Figures 3-9) comprising: a first connection end (70, “The combination of vent member 64 and conduit coupling member 66 define a conduit having a first end 70 that is coupled to patient interface device 46 and a second end 72 that is coupled to patient circuit 52. In a preferred embodiment of the present invention, first end 70 is rotateably and permanently attached to patient interface device 46 using any conventional technique.” Para 0049, and “The combination of vent member 64 and conduit coupling member 66 define a conduit having a first end 70 that is coupled to patient interface device 46 and a second end 72 that is coupled to patient circuit 52. In a preferred embodiment of the present invention, first end 70 is rotateably and permanently attached to patient interface device 46 using any conventional technique.” Para 0053) configured to connect to the patient interface (46), a second connection end (72, “The combination of vent member 64 and conduit coupling member 66 define a conduit having a first end 70 that is coupled to patient interface device 46 and a second end 72 that is coupled to patient circuit 52. In a preferred embodiment of the present invention, first end 70 is rotateably and permanently attached to patient interface device 46 using any conventional technique. Second end 72 is preferably selectively attachable to patient circuit 52. However, the present invention alternatively contemplates permanently attaching second end 72 to patient circuit 52 so that the conduit formed by exhaust port assembly 62 essentially becomes part of the patient circuit.” Para 0049; “Furthermore, the present invention contemplates other techniques for providing a quick connect/release function for attaching second end 72 of exhaust port assembly 62 to patient circuit 52, including, but not limited to, a purely frictional attachment, a slot and key interconnection, or any other conventional technique for releaseably coupling two conduits to one another.” Para 0052; and “Exhaust port assembly 62 includes a venting structure, also referred to as a venting means, disposed between first end 70 and second end 72 of the conduit for venting a flow of exhaust gas from within the conduit to ambient atmosphere.” Para 0053) configured to connect to the air delivery conduit (46) or a connector for the air delivery conduit (46); a circumferential wall (84 via 64, “Furthermore, by providing the plurality of holes in a relative compact area, namely on a planar surface 84 of vent member 64, the area occupied by the venting structure on the conduit is minimized.” Para 0054; “As noted above, holes 82 are provided on planar surface 84 so that the exhaust gas flow F is dispersed in a direction generally away from the patient wearing patient interface device 46. Also, planar surface 84 provides a surface in which it is relatively easy to form holes 82.” Para 0059; also see: “Exhaust port assembly 62, as shown in greater detail in FIGS. 4-9, includes a vent member 64, a conduit coupling member 66, and a valve member 68.” Para 0048; “According to the embodiment illustrated in FIGS. 3-9, the venting structure includes a plurality of fixed diameter holes 82 defined directly through venting member 64 so that a continuous flow of exhaust gas can escape from within the exhaust port assembly to ambient atmosphere, as indicated by arrows F.” Para 0053) bounding an airflow path (G, best seen Figure 8, “If the gas pressure in an interior 92 of the conduit is greater than the ambient atmosphere, cantilever member 90 moves to the position shown in FIG. 8 to block opening 88, so that gas is able to flow between the patient and the pressure generating system, as indicated by arrow G.” Para 0062) that extends from the first connection end (70) to the second connection end (72); and a venting region (64, “Furthermore, by providing the plurality of holes in a relative compact area, namely on a planar surface 84 of vent member 64, the area occupied by the venting structure on the conduit is minimized.” Para 0054; “Exhaust port assembly 62, as shown in greater detail in FIGS. 4-9, includes a vent member 64, a conduit coupling member 66, and a valve member 68.” Para 0048; “According to the embodiment illustrated in FIGS. 3-9, the venting structure includes a plurality of fixed diameter holes 82 defined directly through venting member 64 so that a continuous flow of exhaust gas can escape from within the exhaust port assembly to ambient atmosphere, as indicated by arrows F.” Para 0053) located on the circumferential wall (84 via 64), the venting region (64) comprising a plurality of vent holes (82 and 88, wherein 82 operates in a fixed manner - “As noted above, holes 82 are provided on planar surface 84 so that the exhaust gas flow F is dispersed in a direction generally away from the patient wearing patient interface device 46. Also, planar surface 84 provides a surface in which it is relatively easy to form holes 82.” Para 0059; “According to the embodiment illustrated in FIGS. 3-9, the venting structure includes a plurality of fixed diameter holes 82 defined directly through venting member 64 so that a continuous flow of exhaust gas can escape from within the exhaust port assembly to ambient atmosphere, as indicated by arrows F.” Para 0053; and wherein 88 operates in a variable manner as a function of the movement of 90 – “To provide automatic access to the ambient atmosphere, exhaust port assembly 62 includes an auxiliary opening 88 defined in the conduit and having a relatively large diameter and valve member 68. During normal use, where the pressure support system is functioning properly, a cantilever member 90 of valve member 68 flexes, as shown to FIG. 8, to block auxiliary opening 88. If the gas pressure in an interior 92 of the conduit is greater than the ambient atmosphere, cantilever member 90 moves to the position shown in FIG. 8 to block opening 88, so that gas is able to flow between the patient and the pressure generating system, as indicated by arrow G.” Para 0062; “If, however, the pressure of the gas in interior 92 is not greater than ambient atmosphere, cantilever member 90 returns to its normal, undeflected position shown in FIG. 9 and unblocks auxiliary opening 88 so that the patient has access to the ambient atmosphere as indicated by arrow H. In this position, cantilever member 90 also blocks gas from flowing through the conduit toward the pressure support system. The spring force of cantilever member 90 tends to urge it toward the unflexed position shown in FIG. 9 to ensure that auxiliary opening 88 becomes unblocked if the pressure support system fails to provide an adequate supply of breathing gas.” Para 0063).
Yet, does not expressly disclose “wherein the circumferential wall has a stepped profile in the venting region, the stepped profile comprising at least one riser surface and at least one run surface, each adjacent riser surface and run surface extending perpendicular to each other, and wherein each of the vent holes extends through a corresponding one of the at least one rise surface.”
Dantanarayana teaches an elbow (Figures 14-18) configured to connect to an air delivery conduit (“FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118) to a patient interface (as best seen in Figure 24, “FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118) to deliver a flow of pressurized breathable gas to the patient interface (“a mask shell”), the elbow (Figures 14-18) comprising: a first connection end (via the vertically mounted end) configured to connect to the patient interface (“a mask shell”), a second connection end (via the horizontally mounted end) configured to connect to the air delivery conduit (“a gas flow conduit/tube”); a circumferential wall (170, “FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118) bounding an airflow path that extends from the first connection end (via the vertically mounted end) to the second connection end (via the horizontally mounted end); and a venting region (150, “FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118) located on the circumferential wall (170), the venting region comprising a plurality of holes (160 and 176, wherein 160 operates in a variable manner as a function of the movement of 152 – “The vent 150 includes a flap 152, a vent orifice 160 and a curved surface 161 as in the embodiment of FIG. 12 (see FIG. 26). In this embodiment, the vent orifice 160 is rectangular. However, this embodiment also includes a fixed bleed orifice 176 that remains open to provide a minimum vent flow even when the flap 152 completely covers the orifice 160 and the vent 150 is closed.” Para 0118, “This embodiment includes two parallel rectangular vent orifices 160 and a plurality of circular fixed bleed orifices 176.” Para 0119; and wherein 176 operates in a fixed manner –“The vent 150 includes a flap 152, a vent orifice 160 and a curved surface 161 as in the embodiment of FIG. 12 (see FIG. 26). In this embodiment, the vent orifice 160 is rectangular. However, this embodiment also includes a fixed bleed orifice 176 that remains open to provide a minimum vent flow even when the flap 152 completely covers the orifice 160 and the vent 150 is closed.” Para 0118, “This embodiment includes two parallel rectangular vent orifices 160 and a plurality of circular fixed bleed orifices 176.” Para 0119).
Regarding the limitations of “wherein the circumferential wall has a stepped profile in the venting region, the stepped profile comprising at least one riser surface and at least one run surface, and wherein each of the vent holes extends through a corresponding one of the at least one rise surface”, as best seen in Figures 17 and 18, Dantanarayana teaches the circumferential wall (170) has a stepped profile (best seen Figures 17 and 18) in the venting region (150), the stepped profile (best seen Figures 17 and 18) comprising at least one riser surface (defined by the variation in vertical height from 176 to 160) and at least one run surface (defined by the variation in horizonal length from 176 to 160) and wherein each of the vent holes (176) extends through a corresponding one of the at least one rise surface (defined by the variation in vertical height from 176 to 160).
In this configuration as shown in Figures 17 and 18, Dantanarayana teaches the “two parallel rectangular vent orifices 160 and a plurality of circular fixed bleed orifices 176” (Para 0119) in an offset location whereby the operation of one set of vent holes (160) operates in a variable manner as a function of the movement of 152, wherein 152 -- “The vent 150 includes a flap 152, a vent orifice 160 and a curved surface 161 as in the embodiment of FIG. 12 (see FIG. 26). In this embodiment, the vent orifice 160 is rectangular. However, this embodiment also includes a fixed bleed orifice 176 that remains open to provide a minimum vent flow even when the flap 152 completely covers the orifice 160 and the vent 150 is closed.” Para 0118, “This embodiment includes two parallel rectangular vent orifices 160 and a plurality of circular fixed bleed orifices 176.” Para 0119; and a second set of vent holes (176) operates in a fixed manner. The resultant effect of the plurality of vent holes (160 and 176) is the ability to provide controlled operational of the venting of gases from the patient interface to the ambient environment (“One or more of these tuning mechanisms can be used in conjunction with each other to readily and effectively provide an unlimited ability to precisely tune the gas flow characteristics of the flow regulation vent 150 at any point within an anticipated operating pressure range.” Para 0114).
With respect to remaining limitation of “each adjacent riser surface and run surface extending perpendicular to each other”, although Dantanarayana teaches a single riser surface and a single run surface forming a singular step of a stepped profile, the orientation of a series of adjacent riser surface and run surface extending perpendicular to each other forming a plurality steps in a stepped profile would be obvious to try choosing from a finite number of identified and predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to provide controlled operational of the venting of gases from the patient interface to the ambient environment.
In light of the relationship of the stepped profile to permit the controlled operational of the venting of gases from the patient interface to the ambient environment, it would have been obvious to one having ordinary skill in the art to select the number of steps with respect to the desired venting operational control, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
As applicant has not asserted the specific stepped profile configuration having a plurality of steps would provide a particular advantage, solve a stated problem, or serve a particular purpose different from that of permitting the controlled operational of the venting of gases from the patient interface to the ambient environment, the use of the specific stepped profile configuration having a plurality of steps lacks criticality in its design.
Furthermore, Applicant is advised the specific stepped profile having a plurality of steps appears to be an aesthetic design change, which is ornamental only and has no mechanical function. As such, a person having ordinary skill in art may choose vary the number of steps and even the dimensions of the steps whereby there is no unexpected result and the predictability of these variations are known to provide controlled operational of the venting of gases from the patient interface to the ambient environment.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the invention of Jaffre as modified by Dantanarayana, as the construction of an stepped profile offsetting the vent holes would yield the predictable results of providing controlled operational of the venting of gases from the patient interface to the ambient environment.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the plurality of vent holes of Jaffre to include an stepped profile offsetting the vent holes, as taught by Dantanarayana, wherein the stepped profile includes a plurality of steps, a known result effective variable in order to yield controlled operational of the venting of gases from the patient interface to the ambient environment.
For purposes of this rejection, Primary Examiner will refer to the plurality of vent holes as primarily (176) having the riser surface of defined by the variation in vertical height from 176 to 160, but will also include a discussion of the plurality of vent holes (160) where applicable to meet aspects of the claim language, as the orientation of the riser surface and the run surface can be identified in the alternative.
As to Claim 22, the modified Jaffre, specifically Dantanarayana teaches the one riser surface (defined by the variation in vertical height from 176 to 160) including more than one of the plurality of vent holes (176). As best seen in Figure 17, the plurality of vent holes (176) includes an array of five openings. Additionally, is noted in the alternative the vent holes (160) include the riser surface (defined by the variation in vertical height from 160 to 176) including an array of two openings.
As to Claim 23, the modified Jaffre, specifically Dantanarayana teaches more than one of the plurality of vent holes (160 and 176) is arranged in a row. As best seen in Figure 17, the vent holes (176) are oriented in a row of five openings. Additionally, is noted in the alternative the vent holes (160) are oriented in a row of two openings.
As to Claim 24, the modified Jaffre, specifically Dantanarayana teaches the plurality of the vent holes (176) are oriented so that the central longitudinal axis of each vent hole (176) is substantially parallel (as best seen in Figure 18) to the central longitudinal axis of the first connection end (via the vertically mounted end). It should be noted, as the vent holes (176) are circular and furthermore the first connection end (via the vertically mounted end) is circular in shape the longitudinal axis is the same as the latitudinal axis and the planes are parallel. Additionally, it is noted in the alternative the plurality of vent holes (160) are oriented so that the central longitudinal axis of the each vent holes (160) is substantially parallel (as best seen in Figure 18) to the central longitudinal axis of the first connection end (via the vertically mounted end). In this configuration, the vent holes (160) are coplanar.
As to Claim 25, the modified Jaffre, specifically Dantanarayana teaches for each vent hole (176) a run surface (defined by the variation in horizonal length from 176 to 160) on one side of the vent hole (176) extends beyond the vent hole (176) and a run surface (defined by the variation in horizonal length from 176 to 160) on the opposite side of the vent hole (176) extends to the vent hole (176). Additionally, it is noted in the alternative for each vent hole (160) a run surface (defined by the variation in horizonal length from 176 to 160) on one side of the vent hole (160) extends beyond the vent hole (160) and a run surface (defined by the variation in horizonal length from 176 to 160) on the opposite side of the vent hole (160) extends to the vent hole (160).
As to Claim 26, the modified Jaffre, specifically Dantanarayana teaches the plurality of vent holes (176) have the same diameter (best seen Figure 17). Additionally, is noted in the alternative the plurality of vent holes (160) have the same diameter (best seen Figure 17).
As to Claim 27, the modified Jaffre, specifically Dantanarayana teaches a bend (defined by the arcuate curvature of Figure 18) between the first connection end (via the vertically mounted end) and the second connection end (via the horizontally mounted end) and the venting portion (150) is between the bend (defined by the arcuate curvature of Figure 18) and the second connection end (via the horizontally mounted end).
As to Claim 29, the modified Jaffre, specifically Dantanarayana teaches the one riser surface (defined by the variation in vertical height from 176 to 160) including more than one of the plurality of vent holes (176). As best seen in Figure 17, the plurality of vent holes (176) includes an array of five openings. Additionally, is noted in the alternative the vent holes (160) include the riser surface (defined by the variation in vertical height from 160 to 176) including an array of two openings; the modified Jaffre, specifically Dantanarayana teaches more than one of the plurality of vent holes (160 and 176) is arranged in a row. As best seen in Figure 17, the vent holes (176) are oriented in a row of five openings. Additionally, is noted in the alternative the vent holes (160) are oriented in a row of two openings; the plurality of the vent holes (176) are oriented so that the central longitudinal axis of each vent hole (176) is substantially parallel (as best seen in Figure 18) to the central longitudinal axis of the first connection end (via the vertically mounted end). It should be noted, as the vent holes (176) are circular and furthermore the first connection end (via the vertically mounted end) is circular in shape the longitudinal axis is the same as the latitudinal axis and the planes are parallel. Additionally, it is noted in the alternative the plurality of vent holes (160) are oriented so that the central longitudinal axis of the each vent holes (160) is substantially parallel (as best seen in Figure 18) to the central longitudinal axis of the first connection end (via the vertically mounted end). In this configuration, the vent holes (160) are coplanar; for each vent hole (176) a run surface (defined by the variation in horizonal length from 176 to 160) on one side of the vent hole (176) extends beyond the vent hole (176) and a run surface (defined by the variation in horizonal length from 176 to 160) on the opposite side of the vent hole (176) extends to the vent hole (176). Additionally, it is noted in the alternative for each vent hole (160) a run surface (defined by the variation in horizonal length from 176 to 160) on one side of the vent hole (160) extends beyond the vent hole (160) and a run surface (defined by the variation in horizonal length from 176 to 160) on the opposite side of the vent hole (160) extends to the vent hole (160); the plurality of vent holes (176) have the same diameter (best seen Figure 17). Additionally, is noted in the alternative the plurality of vent holes (160) have the same diameter (best seen Figure 17); and a bend (defined by the arcuate curvature of Figure 18) between the first connection end (via the vertically mounted end) and the second connection end (via the horizontally mounted end) and the venting portion (150) is between the bend (defined by the arcuate curvature of Figure 18) and the second connection end (via the horizontally mounted end).
As to Claim 40, Jaffre discloses an elbow (Figures 3-9) configured to connect an air delivery conduit (52, best seen Figure 3, “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62.” Para 0047) to a patient interface (46, best seen Figure 3, “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62.” Para 0047) to deliver a flow of pressurized breathable gas (“breathing gas from a breathing gas source” via 32/32’, “supply of breathing gas from a breathing gas source, as indicated by arrow A, such as ambient atmosphere, and creates a flow of breathing gas at a pressure greater than ambient atmospheric pressure.” Para 0012 and “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62. Pressure generating system 32, 32' corresponds to any conventional pressure generating system, such as those discussed above with respect to FIGS. 1 and 2.” Para 0047) to the patient interface (46), the elbow (Figures 3-9) comprising: a first connection end (70, “The combination of vent member 64 and conduit coupling member 66 define a conduit having a first end 70 that is coupled to patient interface device 46 and a second end 72 that is coupled to patient circuit 52. In a preferred embodiment of the present invention, first end 70 is rotateably and permanently attached to patient interface device 46 using any conventional technique.” Para 0049, and “The combination of vent member 64 and conduit coupling member 66 define a conduit having a first end 70 that is coupled to patient interface device 46 and a second end 72 that is coupled to patient circuit 52. In a preferred embodiment of the present invention, first end 70 is rotateably and permanently attached to patient interface device 46 using any conventional technique.” Para 0053) configured to connect to the patient interface (46), a second connection end (72, “The combination of vent member 64 and conduit coupling member 66 define a conduit having a first end 70 that is coupled to patient interface device 46 and a second end 72 that is coupled to patient circuit 52. In a preferred embodiment of the present invention, first end 70 is rotateably and permanently attached to patient interface device 46 using any conventional technique. Second end 72 is preferably selectively attachable to patient circuit 52. However, the present invention alternatively contemplates permanently attaching second end 72 to patient circuit 52 so that the conduit formed by exhaust port assembly 62 essentially becomes part of the patient circuit.” Para 0049; “Furthermore, the present invention contemplates other techniques for providing a quick connect/release function for attaching second end 72 of exhaust port assembly 62 to patient circuit 52, including, but not limited to, a purely frictional attachment, a slot and key interconnection, or any other conventional technique for releaseably coupling two conduits to one another.” Para 0052; and “Exhaust port assembly 62 includes a venting structure, also referred to as a venting means, disposed between first end 70 and second end 72 of the conduit for venting a flow of exhaust gas from within the conduit to ambient atmosphere.” Para 0053) configured to connect to the air delivery conduit (46) or a connector for the air delivery conduit (46); a circumferential wall (84 via 64, “Furthermore, by providing the plurality of holes in a relative compact area, namely on a planar surface 84 of vent member 64, the area occupied by the venting structure on the conduit is minimized.” Para 0054; “As noted above, holes 82 are provided on planar surface 84 so that the exhaust gas flow F is dispersed in a direction generally away from the patient wearing patient interface device 46. Also, planar surface 84 provides a surface in which it is relatively easy to form holes 82.” Para 0059; also see: “Exhaust port assembly 62, as shown in greater detail in FIGS. 4-9, includes a vent member 64, a conduit coupling member 66, and a valve member 68.” Para 0048; “According to the embodiment illustrated in FIGS. 3-9, the venting structure includes a plurality of fixed diameter holes 82 defined directly through venting member 64 so that a continuous flow of exhaust gas can escape from within the exhaust port assembly to ambient atmosphere, as indicated by arrows F.” Para 0053) bounding an airflow path (G, best seen Figure 8, “If the gas pressure in an interior 92 of the conduit is greater than the ambient atmosphere, cantilever member 90 moves to the position shown in FIG. 8 to block opening 88, so that gas is able to flow between the patient and the pressure generating system, as indicated by arrow G.” Para 0062) that extends from the first connection end (70) to the second connection end (72); and a venting region (64, “Furthermore, by providing the plurality of holes in a relative compact area, namely on a planar surface 84 of vent member 64, the area occupied by the venting structure on the conduit is minimized.” Para 0054; “Exhaust port assembly 62, as shown in greater detail in FIGS. 4-9, includes a vent member 64, a conduit coupling member 66, and a valve member 68.” Para 0048; “According to the embodiment illustrated in FIGS. 3-9, the venting structure includes a plurality of fixed diameter holes 82 defined directly through venting member 64 so that a continuous flow of exhaust gas can escape from within the exhaust port assembly to ambient atmosphere, as indicated by arrows F.” Para 0053) located on the circumferential wall (84 via 64), the venting region (64) comprising a plurality of vent holes (82 and 88, wherein 82 operates in a fixed manner - “As noted above, holes 82 are provided on planar surface 84 so that the exhaust gas flow F is dispersed in a direction generally away from the patient wearing patient interface device 46. Also, planar surface 84 provides a surface in which it is relatively easy to form holes 82.” Para 0059; “According to the embodiment illustrated in FIGS. 3-9, the venting structure includes a plurality of fixed diameter holes 82 defined directly through venting member 64 so that a continuous flow of exhaust gas can escape from within the exhaust port assembly to ambient atmosphere, as indicated by arrows F.” Para 0053; and wherein 88 operates in a variable manner as a function of the movement of 90 – “To provide automatic access to the ambient atmosphere, exhaust port assembly 62 includes an auxiliary opening 88 defined in the conduit and having a relatively large diameter and valve member 68. During normal use, where the pressure support system is functioning properly, a cantilever member 90 of valve member 68 flexes, as shown to FIG. 8, to block auxiliary opening 88. If the gas pressure in an interior 92 of the conduit is greater than the ambient atmosphere, cantilever member 90 moves to the position shown in FIG. 8 to block opening 88, so that gas is able to flow between the patient and the pressure generating system, as indicated by arrow G.” Para 0062; “If, however, the pressure of the gas in interior 92 is not greater than ambient atmosphere, cantilever member 90 returns to its normal, undeflected position shown in FIG. 9 and unblocks auxiliary opening 88 so that the patient has access to the ambient atmosphere as indicated by arrow H. In this position, cantilever member 90 also blocks gas from flowing through the conduit toward the pressure support system. The spring force of cantilever member 90 tends to urge it toward the unflexed position shown in FIG. 9 to ensure that auxiliary opening 88 becomes unblocked if the pressure support system fails to provide an adequate supply of breathing gas.” Para 0063).
Yet, does not expressly disclose “a venting region comprising a plurality of vent holes oriented in the same direction so that the central longitudinal axes of the plurality of vent holes are parallel to each other, wherein the vent holes are arranged in a plurality of rows with each row being progressively offset from an adjacent row in a direction parallel to the central longitudinal axes of the vent holes.”
Dantanarayana teaches an elbow (Figures 14-18) configured to connect to an air delivery conduit (“FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118) to a patient interface (as best seen in Figure 24, “FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118) to deliver a flow of pressurized breathable gas to the patient interface (“a mask shell”), the elbow (Figures 14-18) comprising: a first connection end (via the vertically mounted end) configured to connect to the patient interface (“a mask shell”), a second connection end (via the horizontally mounted end) configured to connect to the air delivery conduit (“a gas flow conduit/tube”); a circumferential wall (170, “FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118) bounding an airflow path that extends from the first connection end (via the vertically mounted end) to the second connection end (via the horizontally mounted end); and a venting region (150, “FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118) located on the circumferential wall (170), the venting region comprising a plurality of holes (160 and 176, wherein 160 operates in a variable manner as a function of the movement of 152 – “The vent 150 includes a flap 152, a vent orifice 160 and a curved surface 161 as in the embodiment of FIG. 12 (see FIG. 26). In this embodiment, the vent orifice 160 is rectangular. However, this embodiment also includes a fixed bleed orifice 176 that remains open to provide a minimum vent flow even when the flap 152 completely covers the orifice 160 and the vent 150 is closed.” Para 0118, “This embodiment includes two parallel rectangular vent orifices 160 and a plurality of circular fixed bleed orifices 176.” Para 0119; and wherein 176 operates in a fixed manner –“The vent 150 includes a flap 152, a vent orifice 160 and a curved surface 161 as in the embodiment of FIG. 12 (see FIG. 26). In this embodiment, the vent orifice 160 is rectangular. However, this embodiment also includes a fixed bleed orifice 176 that remains open to provide a minimum vent flow even when the flap 152 completely covers the orifice 160 and the vent 150 is closed.” Para 0118, “This embodiment includes two parallel rectangular vent orifices 160 and a plurality of circular fixed bleed orifices 176.” Para 0119).
Regarding the limitations of “a venting region comprising a plurality of vent holes oriented in the same direction so that the central longitudinal axes of the plurality of vent holes are parallel to each other”, as best seen in Figures 17 and 18, Dantanarayana teaches a vented region (150) comprising a plurality of vent holes (176, as shown in Figure 17) oriented in the same direction so that the central longitudinal axes of the plurality of vent holes (176) are parallel to each other and arranged in a singular row (best seen Figure 17).
In this configuration as shown in Figures 17 and 18, Dantanarayana teaches the “two parallel rectangular vent orifices 160 and a plurality of circular fixed bleed orifices 176” (Para 0119) in an offset location whereby the operation of one set of vent holes (160) operates in a variable manner as a function of the movement of 152, wherein 152 -- “The vent 150 includes a flap 152, a vent orifice 160 and a curved surface 161 as in the embodiment of FIG. 12 (see FIG. 26). In this embodiment, the vent orifice 160 is rectangular. However, this embodiment also includes a fixed bleed orifice 176 that remains open to provide a minimum vent flow even when the flap 152 completely covers the orifice 160 and the vent 150 is closed.” Para 0118, “This embodiment includes two parallel rectangular vent orifices 160 and a plurality of circular fixed bleed orifices 176.” Para 0119; and a second set of vent holes (176) operates in a fixed manner. The offset location is a function of the stepped profile (best seen Figures 17 and 18) comprising at least one riser surface (defined by the variation in vertical height from 176 to 160) and at least one run surface (defined by the variation in horizonal length from 176 to 160) and wherein each of the vent holes (176) extends through a corresponding one of the at least one rise surface (defined by the variation in vertical height from 176 to 160).
The resultant effect of the plurality of vent holes (160 and 176) is the ability to provide controlled operational of the venting of gases from the patient interface to the ambient environment (“One or more of these tuning mechanisms can be used in conjunction with each other to readily and effectively provide an unlimited ability to precisely tune the gas flow characteristics of the flow regulation vent 150 at any point within an anticipated operating pressure range.” Para 0114).
With respect to remaining limitation of “wherein the vent holes are arranged in a plurality of rows with each row being progressively offset from an adjacent row in a direction parallel to the central longitudinal axes of the vent holes”, although Dantanarayana teaches a single riser surface and a single run surface forming a singular step of a stepped profile along a single row, the orientation of a series of adjacent riser surface and run surface extending perpendicular to each other forming a plurality steps in a stepped profile along a plurality of rows and being progressively offset would be obvious to try choosing from a finite number of identified and predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to provide controlled operational of the venting of gases from the patient interface to the ambient environment.
In light of the relationship of the stepped profile along a singular row to permit the controlled operational of the venting of gases from the patient interface to the ambient environment, it would have been obvious to one having ordinary skill in the art to select the number of steps and rows with respect to the desired venting operational control, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
As applicant has not asserted the specific stepped profile configuration having a plurality of steps along a plurality of rows would provide a particular advantage, solve a stated problem, or serve a particular purpose different from that of permitting the controlled operational of the venting of gases from the patient interface to the ambient environment, the use of the specific stepped profile configuration having a plurality of steps along a plurality of rows lacks criticality in its design.
Furthermore, Applicant is advised the specific stepped profile having a plurality of steps along a plurality of rows appears to be an aesthetic design change, which is ornamental only and has no mechanical function. As such, a person having ordinary skill in art may choose vary the number of steps, rows, and even the dimensions of the steps whereby there is no unexpected result and the predictability of these variations are known to provide controlled operational of the venting of gases from the patient interface to the ambient environment.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the invention of Jaffre as modified by Dantanarayana, as the construction of an stepped profile progressively offsetting the vent holes along a plurality of steps and rows would yield the predictable results of providing controlled operational of the venting of gases from the patient interface to the ambient environment.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the plurality of vent holes of Jaffre to include an stepped profile offsetting progressively offsetting the vent holes along a plurality of steps and row, as taught by Dantanarayana, wherein the stepped profile includes a plurality of steps along a plurality of rows, a known result effective variable in order to yield controlled operational of the venting of gases from the patient interface to the ambient environment.
For purposes of this rejection, Primary Examiner will refer to the plurality of vent holes as primarily (176) having the riser surface of defined by the variation in vertical height from 176 to 160, but will also include a discussion of the plurality of vent holes (160) where applicable to meet aspects of the claim language, as the orientation of the riser surface and the run surface can be identified in the alternative.
As to Claim 41, the modified Jaffre, specifically Dantanarayana teaches the plurality of the vent holes (176) are oriented so that the central longitudinal axis of each vent hole (176) is substantially parallel (as best seen in Figure 18) to the central longitudinal axis of the first connection end (via the vertically mounted end). It should be noted, as the vent holes (176) are circular and furthermore the first connection end (via the vertically mounted end) is circular in shape the longitudinal axis is the same as the latitudinal axis and the planes are parallel. Additionally, it is noted in the alternative the plurality of vent holes (160) are oriented so that the central longitudinal axis of the each vent holes (160) is substantially parallel (as best seen in Figure 18) to the central longitudinal axis of the first connection end (via the vertically mounted end). In this configuration, the vent holes (160) are coplanar.
As to Claim 42, the modified Jaffre, specifically Dantanarayana teaches a stepped profile (best seen Figures 17 and 18) comprising at least one riser surface (defined by the variation in vertical height from 176 to 160) and at least one run surface (defined by the variation in horizonal length from 176 to 160), wherein each of the vent holes (176) extends through a corresponding one of the at least one rise surface (defined by the variation in vertical height from 176 to 160), and the plurality of the vent holes (176) are located only on the riser surface (defined by the variation in vertical height from 176 to 160).
As to Claim 43, the modified Jaffre, specifically Dantanarayana teaches the one riser surface (defined by the variation in vertical height from 176 to 160) including more than one of the plurality of vent holes (176). As best seen in Figure 17, the plurality of vent holes (176) includes an array of five openings. Additionally, is noted in the alternative the vent holes (160) include the riser surface (defined by the variation in vertical height from 160 to 176) including an array of two openings.
As to Claim 44, the modified Jaffre, specifically Dantanarayana teaches the plurality of vent holes (176) have the same diameter (best seen Figure 17). Additionally, is noted in the alternative the plurality of vent holes (160) have the same diameter (best seen Figure 17).
As to Claim 45, the modified Jaffre, specifically Dantanarayana teaches a bend (defined by the arcuate curvature of Figure 18) between the first connection end (via the vertically mounted end) and the second connection end (via the horizontally mounted end) and the venting portion (150) is between the bend (defined by the arcuate curvature of Figure 18) and the second connection end (via the horizontally mounted end).
Claims 28, 30, 31, 46, and 47 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over D. Jaffre et al. (2003/0005931, herein Jaffre) in view of Dantanarayana et al. (2004/0094157), as applied to Claim 21, and further in view of Ho et al. (2005/0076913).
As to Claim 28, the modified Jaffre, specifically Dantanarayana teaches a plurality of vent holes (160 and 176); yet, does not expressly disclose the orientation whereby “for each vent hole, an air inlet diameter is greater than an air outlet diameter.”
Ho teaches an additional elbow (best seen Figures 1-4 and 6-8) configured to connect to an air delivery conduit (16, “The system for delivering a breathing gas to a patient according to the present invention comprises a pressure or gas flow generating device 14 that produces a flow of gas, a conduit 16, which is also referred to as a patient circuit, having a first end portion 18 operatively coupled to the gas flow generating device and a second end portion 20. Conduit 16 carries the flow of gas from pressure generating device 14 during operation of the system to patient interface device 12 coupled to second end portion 20 of conduit 16.” Para 0042) to a patient interface (12, “Conduit 16 carries the flow of gas from pressure generating device 14 during operation of the system to patient interface device 12 coupled to second end portion 20 of conduit 16.” Para 0042) to deliver a flow of pressurized breathable gas (via 14, “a pressure or gas flow generating device 14 that produces a flow of gas” Para 0042) to the patient interface (12), the elbow (best seen Figures 1-4 and 6-8) comprising: a first connection end (60, “Cradle 58 is substantially curved having an oval shaped opening 60 that connects to oval shaped opening 32 of nasal cushion 28.” Para 0053) configured to connect to the patient interface (12, via 28, “Patient interface device 12 is generally a nasal interface having a nasal cushion 28 and a pair of laterally spaced nares elements 30 at its distal end for insertion into the nostrils of the patient. See FIGS. 3-4.” Para 0044, “Cradle 58 is substantially curved having an oval shaped opening 60 that connects to oval shaped opening 32 of nasal cushion 28.” Para 0053), a second connection end (66, “In the illustrated exemplary embodiment, cradle 58 has a double wall construction 62 and forming a hollow chamber 64. An opposite end 66 of the cradle is substantially circular. See FIGS. 3-4.” Para 0053) configured to connect to a connector (via 76, 78, 164, 24 – as best seen in Figure 1– “Referring again to FIGS. 1, 2, and 14-16, the upper end of tubular section 80 of length adjustment assembly 76 is connected to an air hose 164. Cross strap 136 further includes mounting bracket 166 for mounting a crown swivel 168 for attaching air hose 164 to conduit 16.” Para 0074) for the air delivery conduit (16); a circumferential wall (70, “As shown in FIGS. 4 and 6-8, an outer curved surface 70 of cradle 58 includes an exhaust diffusion plate 72 having diffusion holes 74 for exhausting exhaled gas from the pressurized system to the atmosphere.” Para 0055) bounding an airflow path that extends from the first connection end (60) to the second connection end (66); and a venting region (72, “As shown in FIGS. 4 and 6-8, an outer curved surface 70 of cradle 58 includes an exhaust diffusion plate 72 having diffusion holes 74 for exhausting exhaled gas from the pressurized system to the atmosphere.” Para 0055) located on the circumferential wall (70), the venting region (72) comprises a plurality of vent holes (74, “As shown in FIGS. 4 and 6-8, an outer curved surface 70 of cradle 58 includes an exhaust diffusion plate 72 having diffusion holes 74 for exhausting exhaled gas from the pressurized system to the atmosphere.” Para 0055).
Regarding the remaining limitation of the claims “for each vent hole, an air inlet diameter is greater than an air outlet diameter”, Ho teaches the construction of the plurality of vent holes (74) having an air inlet diameter (via the interior curvature as seen in Figure 8) greater than an air outlet diameter (via the exterior curvature as seen in Figure 8). Explicitly, Ho states “Preferably, exhaust diffusion plate 72 includes diffusion holes 74 having a tapered diameter and arranged in a fan pattern.” (Para 0055). The resultant effect of this configuration of the vent hole provides for the exhausting of exhaled gases from the pressurized system to the atmosphere under diffusion (Para 0055).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the size diameters of the vent holes of the modified Jaffre to include the orientation of the air inlet diameter being greater than an air outlet diameter as taught by Ho, for the purpose of providing the exhausting of exhaled gases from the pressurized system to the atmosphere under diffusion.
As to Claim 30, the modified Jaffre, specifically Dantanarayana teaches a patient interface assembly comprising a patient interface (as best seen in Figure 24, “FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118); the elbow (Figures 14-18); an air delivery conduit (“FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118), the elbow (Figures 14-18) being configured to connect the air delivery conduit (“a gas flow conduit/tube” Para 0118) to the patient interface (“a mask shell” Para 0118).
Yet, does not expressly disclose the configuration of a patient interface assembly having the patient interface being “configured to sealingly engage a patient’s face” nor “headgear configured to support the patient interface on the patient's head”.
Ho teaches an additional elbow (best seen Figures 1-4 and 6-8) configured to connect to an air delivery conduit (16, “The system for delivering a breathing gas to a patient according to the present invention comprises a pressure or gas flow generating device 14 that produces a flow of gas, a conduit 16, which is also referred to as a patient circuit, having a first end portion 18 operatively coupled to the gas flow generating device and a second end portion 20. Conduit 16 carries the flow of gas from pressure generating device 14 during operation of the system to patient interface device 12 coupled to second end portion 20 of conduit 16.” Para 0042) to a patient interface (12, “Conduit 16 carries the flow of gas from pressure generating device 14 during operation of the system to patient interface device 12 coupled to second end portion 20 of conduit 16.” Para 0042) to deliver a flow of pressurized breathable gas (via 14, “a pressure or gas flow generating device 14 that produces a flow of gas” Para 0042) to the patient interface (12), the elbow (best seen Figures 1-4 and 6-8) comprising: a first connection end (60, “Cradle 58 is substantially curved having an oval shaped opening 60 that connects to oval shaped opening 32 of nasal cushion 28.” Para 0053) configured to connect to the patient interface (12, via 28, “Patient interface device 12 is generally a nasal interface having a nasal cushion 28 and a pair of laterally spaced nares elements 30 at its distal end for insertion into the nostrils of the patient. See FIGS. 3-4.” Para 0044, “Cradle 58 is substantially curved having an oval shaped opening 60 that connects to oval shaped opening 32 of nasal cushion 28.” Para 0053), a second connection end (66, “In the illustrated exemplary embodiment, cradle 58 has a double wall construction 62 and forming a hollow chamber 64. An opposite end 66 of the cradle is substantially circular. See FIGS. 3-4.” Para 0053) configured to connect to a connector (via 76, 78, 164, 24 – as best seen in Figure 1– “Referring again to FIGS. 1, 2, and 14-16, the upper end of tubular section 80 of length adjustment assembly 76 is connected to an air hose 164. Cross strap 136 further includes mounting bracket 166 for mounting a crown swivel 168 for attaching air hose 164 to conduit 16.” Para 0074) for the air delivery conduit (16); a circumferential wall (70, “As shown in FIGS. 4 and 6-8, an outer curved surface 70 of cradle 58 includes an exhaust diffusion plate 72 having diffusion holes 74 for exhausting exhaled gas from the pressurized system to the atmosphere.” Para 0055) bounding an airflow path that extends from the first connection end (60) to the second connection end (66); and a venting region (72, “As shown in FIGS. 4 and 6-8, an outer curved surface 70 of cradle 58 includes an exhaust diffusion plate 72 having diffusion holes 74 for exhausting exhaled gas from the pressurized system to the atmosphere.” Para 0055) located on the circumferential wall (70), the venting region (72) comprises a plurality of vent holes (74, “As shown in FIGS. 4 and 6-8, an outer curved surface 70 of cradle 58 includes an exhaust diffusion plate 72 having diffusion holes 74 for exhausting exhaled gas from the pressurized system to the atmosphere.” Para 0055).
Regarding the remaining limitation of the claims, Ho teaches the patient interface (12, via 28, “Patient interface device 12 is generally a nasal interface having a nasal cushion 28 and a pair of laterally spaced nares elements 30 at its distal end for insertion into the nostrils of the patient. See FIGS. 3-4.” Para 0044) is configured to sealingly engage a patient’s face (“The present invention contemplates varying a property of the walls forming nasal cushion 28, outlet legs 34, and nares elements 30, such as the thickness and/or elasticity, to provide performance improvements in the patient interface, such as increased comfort, better mask/patient seal, and/or greater customization capability.” Para 0051) and the use of headgear (22 including 26, “A headgear 22 according to the principles of the present invention, includes a mounting assembly 24 that couples patient interface device 12 to conduit 16, and an adjustable harness assembly 26.” Para 0042) configured to support the patient interface (12) on the patient’s head (“As shown in FIGS. 1, 2, and 14-16, harness assembly 26 of headgear 22 is adapted to be worn on the head of a patient and includes a cross strap 136 extending over the top of the patient's head and a forehead strap 138 extending over the forehead and temples of the patient.” Para 0066). The resultant effect of each of the sealing engagement of the patient interface (12) and the headgear (22 including 26) to position the patient interface (12) onto the head of the patient provides for the direct delivery of the breathable gas to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface of the modified Jaffre to sealing engage the patient’s face and further to include headgear for securing the patient interface to the head of the patient, as taught by Ho to provide for a patient interface assembly suitable for the direct delivery of the breathable gas to the patient.
As to Claim 31, the modified Jaffre, specifically Ho teaches the patient interface assembly having the patient interface (12), the elbow, the air delivery conduit (16), and the headgear (22 including 26) suitable for the direct delivery of the breathable gas to the patient.
Yet, does not expressly disclose the features of “a blower or flow generator configured to pressurize a flow of breathable gas…[whereby] the patient interface assembly being configured to fluidly connect to the blower or flow generator to deliver the pressuized breathable gas to the patient's airways.”
Regarding the remaining limitation of the claims, modified Jaffre, specifically Jaffre discloses a respiratory therapy system configured to deliver pressurizable breathable gas (“breathing gas from a breathing gas source” via 32/32’, “supply of breathing gas from a breathing gas source, as indicated by arrow A, such as ambient atmosphere, and creates a flow of breathing gas at a pressure greater than ambient atmospheric pressure.” Para 0012 and “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62. Pressure generating system 32, 32' corresponds to any conventional pressure generating system, such as those discussed above with respect to FIGS. 1 and 2.” Para 0047) to the patient’s airways, the respiratory therapy system comprising: a blower (34 via 32/32’, “Pressure support systems 30 and 30' include a pressure generating system, generally indicated at 32 and 32', that receives a supply of breathing gas from a breathing gas source, as indicated by arrow A, such as ambient atmosphere, and creates a flow of breathing gas at a pressure greater than ambient atmospheric pressure. The flow of breathing gas from pressure generator is indicated by arrow B. A pressure generator 34, such as a blower, impeller, drag compressor, fan, piston, or bellows, or other device that achieves this result, creates the flow of breathing gas at a pressure greater than the ambient atmospheric pressure.” Para 0012 and “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62. Pressure generating system 32, 32' corresponds to any conventional pressure generating system, such as those discussed above with respect to FIGS. 1 and 2.” Para 0047) configured to pressurize a flow of breathable gas (“breathing gas from a breathing gas source” via 32/32’); whereby the patient interface (46) is configured to fluidly connect to the blower (34) to deliver the breathable gas to the patient’s airways.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface assembly of the modified Jaffre to include the blower or flow generator of a respiratory therapy system, as disclosed by Jaffre to provide pressurized breathing gas to the patient’s airways.
As to Claim 46, the modified Jaffre, specifically Dantanarayana teaches a patient interface assembly comprising a patient interface (as best seen in Figure 24, “FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118); the elbow (Figures 14-18); an air delivery conduit (“FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118), the elbow (Figures 14-18) being configured to connect the air delivery conduit (“a gas flow conduit/tube” Para 0118) to the patient interface (“a mask shell” Para 0118).
Yet, does not expressly disclose the configuration of a patient interface assembly having the patient interface being “configured to sealingly engage a patient’s face” nor “headgear configured to support the patient interface on the patient's head”.
Ho teaches an additional elbow (best seen Figures 1-4 and 6-8) configured to connect to an air delivery conduit (16, “The system for delivering a breathing gas to a patient according to the present invention comprises a pressure or gas flow generating device 14 that produces a flow of gas, a conduit 16, which is also referred to as a patient circuit, having a first end portion 18 operatively coupled to the gas flow generating device and a second end portion 20. Conduit 16 carries the flow of gas from pressure generating device 14 during operation of the system to patient interface device 12 coupled to second end portion 20 of conduit 16.” Para 0042) to a patient interface (12, “Conduit 16 carries the flow of gas from pressure generating device 14 during operation of the system to patient interface device 12 coupled to second end portion 20 of conduit 16.” Para 0042) to deliver a flow of pressurized breathable gas (via 14, “a pressure or gas flow generating device 14 that produces a flow of gas” Para 0042) to the patient interface (12), the elbow (best seen Figures 1-4 and 6-8) comprising: a first connection end (60, “Cradle 58 is substantially curved having an oval shaped opening 60 that connects to oval shaped opening 32 of nasal cushion 28.” Para 0053) configured to connect to the patient interface (12, via 28, “Patient interface device 12 is generally a nasal interface having a nasal cushion 28 and a pair of laterally spaced nares elements 30 at its distal end for insertion into the nostrils of the patient. See FIGS. 3-4.” Para 0044, “Cradle 58 is substantially curved having an oval shaped opening 60 that connects to oval shaped opening 32 of nasal cushion 28.” Para 0053), a second connection end (66, “In the illustrated exemplary embodiment, cradle 58 has a double wall construction 62 and forming a hollow chamber 64. An opposite end 66 of the cradle is substantially circular. See FIGS. 3-4.” Para 0053) configured to connect to a connector (via 76, 78, 164, 24 – as best seen in Figure 1– “Referring again to FIGS. 1, 2, and 14-16, the upper end of tubular section 80 of length adjustment assembly 76 is connected to an air hose 164. Cross strap 136 further includes mounting bracket 166 for mounting a crown swivel 168 for attaching air hose 164 to conduit 16.” Para 0074) for the air delivery conduit (16); a circumferential wall (70, “As shown in FIGS. 4 and 6-8, an outer curved surface 70 of cradle 58 includes an exhaust diffusion plate 72 having diffusion holes 74 for exhausting exhaled gas from the pressurized system to the atmosphere.” Para 0055) bounding an airflow path that extends from the first connection end (60) to the second connection end (66); and a venting region (72, “As shown in FIGS. 4 and 6-8, an outer curved surface 70 of cradle 58 includes an exhaust diffusion plate 72 having diffusion holes 74 for exhausting exhaled gas from the pressurized system to the atmosphere.” Para 0055) located on the circumferential wall (70), the venting region (72) comprises a plurality of vent holes (74, “As shown in FIGS. 4 and 6-8, an outer curved surface 70 of cradle 58 includes an exhaust diffusion plate 72 having diffusion holes 74 for exhausting exhaled gas from the pressurized system to the atmosphere.” Para 0055).
Regarding the remaining limitation of the claims, Ho teaches the patient interface (12, via 28, “Patient interface device 12 is generally a nasal interface having a nasal cushion 28 and a pair of laterally spaced nares elements 30 at its distal end for insertion into the nostrils of the patient. See FIGS. 3-4.” Para 0044) is configured to sealingly engage a patient’s face (“The present invention contemplates varying a property of the walls forming nasal cushion 28, outlet legs 34, and nares elements 30, such as the thickness and/or elasticity, to provide performance improvements in the patient interface, such as increased comfort, better mask/patient seal, and/or greater customization capability.” Para 0051) and the use of headgear (22 including 26, “A headgear 22 according to the principles of the present invention, includes a mounting assembly 24 that couples patient interface device 12 to conduit 16, and an adjustable harness assembly 26.” Para 0042) configured to support the patient interface (12) on the patient’s head (“As shown in FIGS. 1, 2, and 14-16, harness assembly 26 of headgear 22 is adapted to be worn on the head of a patient and includes a cross strap 136 extending over the top of the patient's head and a forehead strap 138 extending over the forehead and temples of the patient.” Para 0066). The resultant effect of each of the sealing engagement of the patient interface (12) and the headgear (22 including 26) to position the patient interface (12) onto the head of the patient provides for the direct delivery of the breathable gas to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface of the modified Jaffre to sealing engage the patient’s face and further to include headgear for securing the patient interface to the head of the patient, as taught by Ho to provide for a patient interface assembly suitable for the direct delivery of the breathable gas to the patient.
As to Claim 47, the modified Jaffre, specifically Ho teaches the patient interface assembly having the patient interface (12), the elbow, the air delivery conduit (16), and the headgear (22 including 26) suitable for the direct delivery of the breathable gas to the patient.
Yet, does not expressly disclose the features of “a blower or flow generator configured to pressurize a flow of breathable gas…[whereby] the patient interface assembly being configured to fluidly connect to the blower or flow generator to deliver the pressuized breathable gas to the patient's airways.”
Regarding the remaining limitation of the claims, modified Jaffre, specifically Jaffre discloses a respiratory therapy system configured to deliver pressurizable breathable gas (“breathing gas from a breathing gas source” via 32/32’, “supply of breathing gas from a breathing gas source, as indicated by arrow A, such as ambient atmosphere, and creates a flow of breathing gas at a pressure greater than ambient atmospheric pressure.” Para 0012 and “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62. Pressure generating system 32, 32' corresponds to any conventional pressure generating system, such as those discussed above with respect to FIGS. 1 and 2.” Para 0047) to the patient’s airways, the respiratory therapy system comprising: a blower (34 via 32/32’, “Pressure support systems 30 and 30' include a pressure generating system, generally indicated at 32 and 32', that receives a supply of breathing gas from a breathing gas source, as indicated by arrow A, such as ambient atmosphere, and creates a flow of breathing gas at a pressure greater than ambient atmospheric pressure. The flow of breathing gas from pressure generator is indicated by arrow B. A pressure generator 34, such as a blower, impeller, drag compressor, fan, piston, or bellows, or other device that achieves this result, creates the flow of breathing gas at a pressure greater than the ambient atmospheric pressure.” Para 0012 and “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62. Pressure generating system 32, 32' corresponds to any conventional pressure generating system, such as those discussed above with respect to FIGS. 1 and 2.” Para 0047) configured to pressurize a flow of breathable gas (“breathing gas from a breathing gas source” via 32/32’); whereby the patient interface (46) is configured to fluidly connect to the blower (34) to deliver the breathable gas to the patient’s airways.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface assembly of the modified Jaffre to include the blower or flow generator of a respiratory therapy system, as disclosed by Jaffre to provide pressurized breathing gas to the patient’s airways.
Claims 32, 33, 38, and 39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over D. Jaffre et al. (2003/0005931, herein Jaffre) in view of Ho et al. (2005/0076913).
As to Claim 32, Jaffre discloses an elbow (Figures 3-9) configured to connect an air delivery conduit (52, best seen Figure 3, “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62.” Para 0047) to a patient interface (46, best seen Figure 3, “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62.” Para 0047) to deliver a flow of pressurized breathable gas (“breathing gas from a breathing gas source” via 32/32’, “supply of breathing gas from a breathing gas source, as indicated by arrow A, such as ambient atmosphere, and creates a flow of breathing gas at a pressure greater than ambient atmospheric pressure.” Para 0012 and “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62. Pressure generating system 32, 32' corresponds to any conventional pressure generating system, such as those discussed above with respect to FIGS. 1 and 2.” Para 0047) to the patient interface (46), the elbow (Figures 3-9) comprising: a first connection end (70, “The combination of vent member 64 and conduit coupling member 66 define a conduit having a first end 70 that is coupled to patient interface device 46 and a second end 72 that is coupled to patient circuit 52. In a preferred embodiment of the present invention, first end 70 is rotateably and permanently attached to patient interface device 46 using any conventional technique.” Para 0049, and “The combination of vent member 64 and conduit coupling member 66 define a conduit having a first end 70 that is coupled to patient interface device 46 and a second end 72 that is coupled to patient circuit 52. In a preferred embodiment of the present invention, first end 70 is rotateably and permanently attached to patient interface device 46 using any conventional technique.” Para 0053) configured to connect to the patient interface (46), a second connection end (72, “The combination of vent member 64 and conduit coupling member 66 define a conduit having a first end 70 that is coupled to patient interface device 46 and a second end 72 that is coupled to patient circuit 52. In a preferred embodiment of the present invention, first end 70 is rotateably and permanently attached to patient interface device 46 using any conventional technique. Second end 72 is preferably selectively attachable to patient circuit 52. However, the present invention alternatively contemplates permanently attaching second end 72 to patient circuit 52 so that the conduit formed by exhaust port assembly 62 essentially becomes part of the patient circuit.” Para 0049; “Furthermore, the present invention contemplates other techniques for providing a quick connect/release function for attaching second end 72 of exhaust port assembly 62 to patient circuit 52, including, but not limited to, a purely frictional attachment, a slot and key interconnection, or any other conventional technique for releaseably coupling two conduits to one another.” Para 0052; and “Exhaust port assembly 62 includes a venting structure, also referred to as a venting means, disposed between first end 70 and second end 72 of the conduit for venting a flow of exhaust gas from within the conduit to ambient atmosphere.” Para 0053) configured to connect to the air delivery conduit (46) or a connector for the air delivery conduit (46); a circumferential wall (84 via 64, “Furthermore, by providing the plurality of holes in a relative compact area, namely on a planar surface 84 of vent member 64, the area occupied by the venting structure on the conduit is minimized.” Para 0054; “As noted above, holes 82 are provided on planar surface 84 so that the exhaust gas flow F is dispersed in a direction generally away from the patient wearing patient interface device 46. Also, planar surface 84 provides a surface in which it is relatively easy to form holes 82.” Para 0059; also see: “Exhaust port assembly 62, as shown in greater detail in FIGS. 4-9, includes a vent member 64, a conduit coupling member 66, and a valve member 68.” Para 0048; “According to the embodiment illustrated in FIGS. 3-9, the venting structure includes a plurality of fixed diameter holes 82 defined directly through venting member 64 so that a continuous flow of exhaust gas can escape from within the exhaust port assembly to ambient atmosphere, as indicated by arrows F.” Para 0053) bounding an airflow path (G, best seen Figure 8, “If the gas pressure in an interior 92 of the conduit is greater than the ambient atmosphere, cantilever member 90 moves to the position shown in FIG. 8 to block opening 88, so that gas is able to flow between the patient and the pressure generating system, as indicated by arrow G.” Para 0062) that extends from the first connection end (70) to the second connection end (72); and a venting region (64, “Furthermore, by providing the plurality of holes in a relative compact area, namely on a planar surface 84 of vent member 64, the area occupied by the venting structure on the conduit is minimized.” Para 0054; “Exhaust port assembly 62, as shown in greater detail in FIGS. 4-9, includes a vent member 64, a conduit coupling member 66, and a valve member 68.” Para 0048; “According to the embodiment illustrated in FIGS. 3-9, the venting structure includes a plurality of fixed diameter holes 82 defined directly through venting member 64 so that a continuous flow of exhaust gas can escape from within the exhaust port assembly to ambient atmosphere, as indicated by arrows F.” Para 0053) located on the circumferential wall (84 via 64), the venting region (64) comprising a plurality of vent holes (82 and 88, wherein 82 operates in a fixed manner - “As noted above, holes 82 are provided on planar surface 84 so that the exhaust gas flow F is dispersed in a direction generally away from the patient wearing patient interface device 46. Also, planar surface 84 provides a surface in which it is relatively easy to form holes 82.” Para 0059; “According to the embodiment illustrated in FIGS. 3-9, the venting structure includes a plurality of fixed diameter holes 82 defined directly through venting member 64 so that a continuous flow of exhaust gas can escape from within the exhaust port assembly to ambient atmosphere, as indicated by arrows F.” Para 0053; and wherein 88 operates in a variable manner as a function of the movement of 90 – “To provide automatic access to the ambient atmosphere, exhaust port assembly 62 includes an auxiliary opening 88 defined in the conduit and having a relatively large diameter and valve member 68. During normal use, where the pressure support system is functioning properly, a cantilever member 90 of valve member 68 flexes, as shown to FIG. 8, to block auxiliary opening 88. If the gas pressure in an interior 92 of the conduit is greater than the ambient atmosphere, cantilever member 90 moves to the position shown in FIG. 8 to block opening 88, so that gas is able to flow between the patient and the pressure generating system, as indicated by arrow G.” Para 0062; “If, however, the pressure of the gas in interior 92 is not greater than ambient atmosphere, cantilever member 90 returns to its normal, undeflected position shown in FIG. 9 and unblocks auxiliary opening 88 so that the patient has access to the ambient atmosphere as indicated by arrow H. In this position, cantilever member 90 also blocks gas from flowing through the conduit toward the pressure support system. The spring force of cantilever member 90 tends to urge it toward the unflexed position shown in FIG. 9 to ensure that auxiliary opening 88 becomes unblocked if the pressure support system fails to provide an adequate supply of breathing gas.” Para 0063).
Yet, does not expressly disclose “a recessed vent region that is a recessed portion of the circumferential wall, the recessed vent region comprising a plurality of steps and a plurality of vent holes arranged on the steps.”
Ho teaches an additional elbow (best seen Figures 1-4 and 6-8) configured to connect to an air delivery conduit (16, “The system for delivering a breathing gas to a patient according to the present invention comprises a pressure or gas flow generating device 14 that produces a flow of gas, a conduit 16, which is also referred to as a patient circuit, having a first end portion 18 operatively coupled to the gas flow generating device and a second end portion 20. Conduit 16 carries the flow of gas from pressure generating device 14 during operation of the system to patient interface device 12 coupled to second end portion 20 of conduit 16.” Para 0042) to a patient interface (12, “Conduit 16 carries the flow of gas from pressure generating device 14 during operation of the system to patient interface device 12 coupled to second end portion 20 of conduit 16.” Para 0042) to deliver a flow of pressurized breathable gas (via 14, “a pressure or gas flow generating device 14 that produces a flow of gas” Para 0042) to the patient interface (12), the elbow (best seen Figures 1-4 and 6-8) comprising: a first connection end (60, “Cradle 58 is substantially curved having an oval shaped opening 60 that connects to oval shaped opening 32 of nasal cushion 28.” Para 0053) configured to connect to the patient interface (12, via 28, “Patient interface device 12 is generally a nasal interface having a nasal cushion 28 and a pair of laterally spaced nares elements 30 at its distal end for insertion into the nostrils of the patient. See FIGS. 3-4.” Para 0044, “Cradle 58 is substantially curved having an oval shaped opening 60 that connects to oval shaped opening 32 of nasal cushion 28.” Para 0053), a second connection end (66, “In the illustrated exemplary embodiment, cradle 58 has a double wall construction 62 and forming a hollow chamber 64. An opposite end 66 of the cradle is substantially circular. See FIGS. 3-4.” Para 0053) configured to connect to a connector (via 76, 78, 164, 24 – as best seen in Figure 1– “Referring again to FIGS. 1, 2, and 14-16, the upper end of tubular section 80 of length adjustment assembly 76 is connected to an air hose 164. Cross strap 136 further includes mounting bracket 166 for mounting a crown swivel 168 for attaching air hose 164 to conduit 16.” Para 0074) for the air delivery conduit (16); a circumferential wall (70, “As shown in FIGS. 4 and 6-8, an outer curved surface 70 of cradle 58 includes an exhaust diffusion plate 72 having diffusion holes 74 for exhausting exhaled gas from the pressurized system to the atmosphere.” Para 0055) bounding an airflow path that extends from the first connection end (60) to the second connection end (66).
Regarding the remaining limitation of the claims, Ho teaches a recessed vent region (72, as seen in Figure 6 to be inserted into 70, “As shown in FIGS. 4 and 6-8, an outer curved surface 70 of cradle 58 includes an exhaust diffusion plate 72 having diffusion holes 74 for exhausting exhaled gas from the pressurized system to the atmosphere.” Para 0055) that is a recessed portion of the circumferential wall (70), the recessed vent region (72) comprises a plurality of steps (defined by the vertical space between laterally extending bars of Figure 7) and a plurality of vent holes (74, “As shown in FIGS. 4 and 6-8, an outer curved surface 70 of cradle 58 includes an exhaust diffusion plate 72 having diffusion holes 74 for exhausting exhaled gas from the pressurized system to the atmosphere.” Para 0055) oriented on the plurality of steps (defined by the vertical space between laterally extending bars of Figure 7). The resultant effect of this configuration of the vent hole provides for the exhausting of exhaled gases from the pressurized system to the atmosphere under diffusion (Para 0055).
Therefore, it would have been obvious to one having ordinary skill in the art to modify vent region of Jaffre to a recessed vent region as taught by Ho, for the purpose of providing the exhausting of exhaled gases from the pressurized system to the atmosphere under diffusion.
As to Claim 33, the modified Jaffre, specifically Ho teaches the depth of the recessed vent region (72) along the vent holes (74) increases towards the second connection end (66). Explicitly, as best seen in Figure 8, and stated by Ho “Preferably, exhaust diffusion plate 72 includes diffusion holes 74 having a tapered diameter and arranged in a fan pattern.” (Para 0055).
As to Claim 38, the modified Jaffre, specifically Ho teaches the elbow (best seen Figures 1-4 and 6-8).
Yet, does not expressly disclose the configuration of a patient interface assembly having the patient interface being “configured to sealingly engage a patient’s face” nor “headgear configured to support the patient interface on the patient's head”.
Regarding the remaining limitation of the claims, Ho teaches the patient interface (12, via 28, “Patient interface device 12 is generally a nasal interface having a nasal cushion 28 and a pair of laterally spaced nares elements 30 at its distal end for insertion into the nostrils of the patient. See FIGS. 3-4.” Para 0044) is configured to sealingly engage a patient’s face (“The present invention contemplates varying a property of the walls forming nasal cushion 28, outlet legs 34, and nares elements 30, such as the thickness and/or elasticity, to provide performance improvements in the patient interface, such as increased comfort, better mask/patient seal, and/or greater customization capability.” Para 0051) and the use of headgear (22 including 26, “A headgear 22 according to the principles of the present invention, includes a mounting assembly 24 that couples patient interface device 12 to conduit 16, and an adjustable harness assembly 26.” Para 0042) configured to support the patient interface (12) on the patient’s head (“As shown in FIGS. 1, 2, and 14-16, harness assembly 26 of headgear 22 is adapted to be worn on the head of a patient and includes a cross strap 136 extending over the top of the patient's head and a forehead strap 138 extending over the forehead and temples of the patient.” Para 0066). The resultant effect of each of the sealing engagement of the patient interface (12) and the headgear (22 including 26) to position the patient interface (12) onto the head of the patient provides for the direct delivery of the breathable gas to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface of the modified Jaffre to sealing engage the patient’s face and further to include headgear for securing the patient interface to the head of the patient, as taught by Ho to provide for a patient interface assembly suitable for the direct delivery of the breathable gas to the patient.
As to Claim 39, the modified Jaffre, specifically Ho teaches patient interface assembly.
Yet, does not expressly disclose the features of “a blower or flow generator configured to pressurize a flow of breathable gas…[whereby] the patient interface assembly being configured to fluidly connect to the blower or flow generator to deliver the pressuized breathable gas to the patient's airways.”
Regarding the remaining limitation of the claims, modified Jaffre, specifically Jaffre discloses a respiratory therapy system configured to deliver pressurizable breathable gas (“breathing gas from a breathing gas source” via 32/32’, “supply of breathing gas from a breathing gas source, as indicated by arrow A, such as ambient atmosphere, and creates a flow of breathing gas at a pressure greater than ambient atmospheric pressure.” Para 0012 and “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62. Pressure generating system 32, 32' corresponds to any conventional pressure generating system, such as those discussed above with respect to FIGS. 1 and 2.” Para 0047) to the patient’s airways, the respiratory therapy system comprising: a blower (34 via 32/32’, “Pressure support systems 30 and 30' include a pressure generating system, generally indicated at 32 and 32', that receives a supply of breathing gas from a breathing gas source, as indicated by arrow A, such as ambient atmosphere, and creates a flow of breathing gas at a pressure greater than ambient atmospheric pressure. The flow of breathing gas from pressure generator is indicated by arrow B. A pressure generator 34, such as a blower, impeller, drag compressor, fan, piston, or bellows, or other device that achieves this result, creates the flow of breathing gas at a pressure greater than the ambient atmospheric pressure.” Para 0012 and “Pressure support system 60 includes a pressure generating system 32, 32', a patient interface device 46, a patient circuit 52, and an exhaust port assembly 62. Pressure generating system 32, 32' corresponds to any conventional pressure generating system, such as those discussed above with respect to FIGS. 1 and 2.” Para 0047) configured to pressurize a flow of breathable gas (“breathing gas from a breathing gas source” via 32/32’); whereby the patient interface (46) is configured to fluidly connect to the blower (34) to deliver the breathable gas to the patient’s airways.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface assembly of the modified Jaffre to include the blower or flow generator of a respiratory therapy system, as disclosed by Jaffree to provide pressurized breathing gas to the patient’s airways.
Claims 34-37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over D. Jaffre et al. (2003/0005931, herein Jaffre) in view of Ho et al. (2005/0076913), as applied to Claim 32, and further in view of Dantanarayana et al. (2004/0094157).
As to Claim 34, the modified Jaffre, specifically Ho teaches a plurality of steps (defined by the vertical space between laterally extending bars of Figure 7) and a plurality of vent holes (74, “As shown in FIGS. 4 and 6-8, an outer curved surface 70 of cradle 58 includes an exhaust diffusion plate 72 having diffusion holes 74 for exhausting exhaled gas from the pressurized system to the atmosphere.” Para 0055) oriented on the plurality of steps (defined by the vertical space between laterally extending bars of Figure 7).
Yet, does not expressly disclose “each step comprises a riser surface and a run surface and each of the riser surfaces comprises at least one of the plurality of vent holes.”
Dantanarayana teaches an elbow (Figures 14-18) configured to connect to an air delivery conduit (“FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118) to a patient interface (as best seen in Figure 24, “FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118) to deliver a flow of pressurized breathable gas to the patient interface (“a mask shell”), the elbow (Figures 14-18) comprising: a first connection end (via the vertically mounted end) configured to connect to the patient interface (“a mask shell”), a second connection end (via the horizontally mounted end) configured to connect to the air delivery conduit (“a gas flow conduit/tube”); a circumferential wall (170, “FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118) bounding an airflow path that extends from the first connection end (via the vertically mounted end) to the second connection end (via the horizontally mounted end); and a venting region (150, “FIGS. 14-16 disclose an alternative embodiment of the vent 150 mounted to a swivel elbow joint 170 for connecting a gas flow conduit/tube to a mask shell.” Para 0118) located on the circumferential wall (170), the venting region comprising a plurality of holes (160 and 176, wherein 160 operates in a variable manner as a function of the movement of 152 – “The vent 150 includes a flap 152, a vent orifice 160 and a curved surface 161 as in the embodiment of FIG. 12 (see FIG. 26). In this embodiment, the vent orifice 160 is rectangular. However, this embodiment also includes a fixed bleed orifice 176 that remains open to provide a minimum vent flow even when the flap 152 completely covers the orifice 160 and the vent 150 is closed.” Para 0118, “This embodiment includes two parallel rectangular vent orifices 160 and a plurality of circular fixed bleed orifices 176.” Para 0119; and wherein 176 operates in a fixed manner –“The vent 150 includes a flap 152, a vent orifice 160 and a curved surface 161 as in the embodiment of FIG. 12 (see FIG. 26). In this embodiment, the vent orifice 160 is rectangular. However, this embodiment also includes a fixed bleed orifice 176 that remains open to provide a minimum vent flow even when the flap 152 completely covers the orifice 160 and the vent 150 is closed.” Para 0118, “This embodiment includes two parallel rectangular vent orifices 160 and a plurality of circular fixed bleed orifices 176.” Para 0119).
Regarding the limitations of “each step comprises a riser surface and a run surface and each of the riser surfaces comprises at least one of the plurality of vent holes”, as best seen in Figures 17 and 18, Dantanarayana teaches the circumferential wall (170) has a stepped profile (best seen Figures 17 and 18) in the venting region (150), the stepped profile (best seen Figures 17 and 18) comprising at least one riser surface (defined by the variation in vertical height from 176 to 160) and at least one run surface (defined by the variation in horizonal length from 176 to 160) and wherein each of the vent holes (176) extends through a corresponding one of the at least one rise surface (defined by the variation in vertical height from 176 to 160).
In this configuration as shown in Figures 17 and 18, Dantanarayana teaches the “two parallel rectangular vent orifices 160 and a plurality of circular fixed bleed orifices 176” (Para 0119) in an offset location whereby the operation of one set of vent holes (160) operates in a variable manner as a function of the movement of 152, wherein 152 -- “The vent 150 includes a flap 152, a vent orifice 160 and a curved surface 161 as in the embodiment of FIG. 12 (see FIG. 26). In this embodiment, the vent orifice 160 is rectangular. However, this embodiment also includes a fixed bleed orifice 176 that remains open to provide a minimum vent flow even when the flap 152 completely covers the orifice 160 and the vent 150 is closed.” Para 0118, “This embodiment includes two parallel rectangular vent orifices 160 and a plurality of circular fixed bleed orifices 176.” Para 0119; and a second set of vent holes (176) operates in a fixed manner, such that the one riser surface (defined by the variation in vertical height from 176 to 160) including more than one of the plurality of vent holes (176). As best seen in Figure 17, the plurality of vent holes (176) includes an array of five openings. Additionally, is noted in the alternative the vent holes (160) include the riser surface (defined by the variation in vertical height from 160 to 176) including an array of two openings.
The resultant effect of the plurality of vent holes (160 and 176) is the ability to provide controlled operational of the venting of gases from the patient interface to the ambient environment (“One or more of these tuning mechanisms can be used in conjunction with each other to readily and effectively provide an unlimited ability to precisely tune the gas flow characteristics of the flow regulation vent 150 at any point within an anticipated operating pressure range.” Para 0114).
Although Dantanarayana teaches a single riser surface and a single run surface forming a singular step of a stepped profile, the orientation of a series of adjacent riser surface and run surface extending perpendicular to each other forming a plurality steps in a stepped profile would be obvious to try choosing from a finite number of identified and predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to provide controlled operational of the venting of gases from the patient interface to the ambient environment.
In light of the relationship of the stepped profile to permit the controlled operational of the venting of gases from the patient interface to the ambient environment, it would have been obvious to one having ordinary skill in the art to select the number of steps with respect to the desired venting operational control, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
As applicant has not asserted the specific stepped profile configuration having a plurality of steps would provide a particular advantage, solve a stated problem, or serve a particular purpose different from that of permitting the controlled operational of the venting of gases from the patient interface to the ambient environment, the use of the specific stepped profile configuration having a plurality of steps lacks criticality in its design.
Furthermore, Applicant is advised the specific stepped profile having a plurality of steps appears to be an aesthetic design change, which is ornamental only and has no mechanical function. As such, a person having ordinary skill in art may choose vary the number of steps and even the dimensions of the steps whereby there is no unexpected result and the predictability of these variations are known to provide controlled operational of the venting of gases from the patient interface to the ambient environment.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the invention of Jaffre as modified by Dantanarayana, as the construction of an stepped profile offsetting the vent holes would yield the predictable results of providing controlled operational of the venting of gases from the patient interface to the ambient environment.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the plurality of vent holes of Jaffre to include an stepped profile offsetting the vent holes, as taught by Dantanarayana, wherein the stepped profile includes a plurality of steps, a known result effective variable in order to yield controlled operational of the venting of gases from the patient interface to the ambient environment.
For purposes of this rejection, Primary Examiner will refer to the plurality of vent holes as primarily (176) having the riser surface of defined by the variation in vertical height from 176 to 160, but will also include a discussion of the plurality of vent holes (160) where applicable to meet aspects of the claim language, as the orientation of the riser surface and the run surface can be identified in the alternative.
As to Claim 35, the modified Jaffre, specifically Ho discloses the vent holes (74) are located only on the riser surface (defined by the variation in vertical height along each step). Additionally, it is noted the modified Jaffre, specifically Dantanarayana teaches the plurality of the vent holes (176) are located only on the riser surface (defined by the variation in vertical height from 176 to 160).
As to Claim 36, the modified Jaffre, specifically Dantanarayana teaches more than one of the plurality of vent holes (160 and 176) is arranged in a row. As best seen in Figure 17, the vent holes (176) are oriented in a row of five openings. Additionally, is noted in the alternative the vent holes (160) are oriented in a row of two openings.
As to Claim 37, the modified Jaffre, specifically Dantanarayana teaches a bend (defined by the arcuate curvature of Figure 18) between the first connection end (via the vertically mounted end) and the second connection end (via the horizontally mounted end) and the venting portion (150) is between the bend (defined by the arcuate curvature of Figure 18) and the second connection end (via the horizontally mounted end).
The resultant effect of the orientation of the bend is the ability to provide controlled operational of the venting of gases from the patient interface to the ambient environment (“One or more of these tuning mechanisms can be used in conjunction with each other to readily and effectively provide an unlimited ability to precisely tune the gas flow characteristics of the flow regulation vent 150 at any point within an anticipated operating pressure range.” Para 0114).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rummery et al. (8,573,201) shares a common assignee/inventor with this instant application; however, at this time, there does not appear to be a double patenting rejection applicable at this time. Primary Examiner notes the instant independent claim, Claim 21, appears to have similar subject matter to patent claim, Claim 22. However, patent claim, Claim 22, does not positively recite the features of the “circumferential wall bounding an airflow path that extends from the first connection end to the second connection end; and a venting region located on the circumferential wall, the venting region comprising a plurality of vent holes, wherein the circumferential wall has a stepped profile in the venting region” nor the orientation by which “each of the vent holes extends through a corresponding one of the at least one rise surface”. Additionally, Primary Examiner notes the instant independent claim, Claim 32, appears to have similar subject matter to patent claim, Claim 35. However, patent claim, Claim 35, does not positively recite the features of the “a circumferential wall bounding an airflow path that extends from the first connection end to the second connection end; and a recessed vent region that is a recessed portion of the circumferential wall, the recessed vent region comprising a plurality of steps and a plurality of vent holes arranged on the steps.” Finally, Primary Examiner notes the instant independent claim, Claim 40, appears to have similar subject matter to patent claims, Claims 22 and 35. However, patent claims, Claims 22 and 35, does not positively recite the features of the “a circumferential wall bounding an airflow path that extends from the first connection end to the second connection end; and a venting region comprising a plurality of vent holes oriented in the same direction so that the central longitudinal axes of the plurality of vent holes are parallel to each other, wherein the vent holes are arranged in a plurality of rows with each row being progressively offset from an adjacent row in a direction parallel to the central longitudinal axes of the vent holes.” In light of these deficiencies not being recited in the patent claims, there does not appear to be a double patenting rejection applicable at this time.
Guney et al. (2009/0044808) appears to share a common assignee/inventor with this instant application and appears to disclose an elbow with a vented region (Figures 18-8-10 thru 18-8-17); yet, does not appear to disclose, teach or fairly suggest the features of “the stepped profile comprising at least one riser surface and at least one run surface, each adjacent riser surface and run surface extending perpendicular to each other” of instant independent Claim 21; the features of “a recessed vent region that is a recessed portion of the circumferential wall, the recessed vent region comprising a plurality of steps and a plurality of vent holes arranged on the steps” of instant independent Claim 32; nor the features of “wherein the vent holes are arranged in a plurality of rows with each row being progressively offset from an adjacent row in a direction parallel to the central longitudinal axes of the vent holes” of the instant independent Claim 40.
Lovell (6,631,718), Ho et al. (2011/0240030), and Gradon et al. (2003/0154978) each disclose additional elbow assemblies with venting regions and a plurality of vent holes in various orientations - Lovell discloses a stacked orientation of at least two vent holes best seen Figures 1, 2A, 2B, 3, 7-11); Ho discloses an array of at least eight vent holes best seen Figures 1-8; and Gradon at least two vent holes in Figures 12 and 13; one vent hole in Figure 14, and at least six vent holes in Figures 15 and 16.
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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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785