DETAILED ACTION
Primary Examiner acknowledges Claims 21-40 are pending in this application, with Claims 21-40 having been newly added, and Claims 1-20 having been cancelled.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 33 is objected to because of the following informalities:
Claim 33, Line 3 appears to be grammatically incorrect having both a comma and semicolon adjacent to each other. Appropriate correction is required.
Claim 33, Line 15 includes a duplicate period. Pursuant to MPEP 608.01(m), “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).” (Emphasis Added). The duplicate period should be deleted. Appropriate correction is required.
Claim 33, Lines 14 and 15 recite “a ventilator side opening … a patient side opening”; however, the grammatical article should be “the” rather than “a” since the limitation of the “a ventilator side opening … a patient side opening” was originally introduced in Claim 21, Lines 9 and 10. 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 22, 28, and 33-40 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 22, Line 2 recites “a ventilator side portion of the tubular housing”; however, this limitation appears to lack antecedent basis in the claims. Formerly, in Claim 21, Line 9, Applicant has recited limitations of “a ventilator side opening of the tubular housing”. Primary Examiner is unsure if these terms are meant to be coextensive or separate and distinct. Appropriate correction and clarification is required.
Specifically, Claim 28 recites “a first portion of the tubular housing”; however, the breadth and scope of this limitation is unclear. Formerly, in Claim 21, Lines 9 and 10, Applicant has recited limitations of “a ventilator side opening of the tubular housing” and “a patient side opening of the tubular housing”. Yet, there does not appear to be any correlation between the former recitations of a ventilator side opening of the tubular housing” and “a patient side opening of the tubular housing” in Claim 21 and the newly recited “a first portion of the tubular housing” in Claim 28. Primary Examiner is unsure if this newly recited “a first portion of the tubular housing” is intended to be commensurate with the former recitations or alternatively is a separate and distinct limitation. Appropriate correction and clarification is required.
Specifically, Claim 33, Line 12 recites “a leakage path”; however, the breadth and scope of this limitation is unclear. Formerly in Claim 21, Line 4 “a leakage path” was originally introduced. Primary Examiner is unsure if the “leakage path” of Claim 33 is the same as the “leakage path” of Claim 21, or if these features are intended to be separate and distinct. Dependent claims 34-40 incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21, 22, 29, and 31-33 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by McAuley et al. (8,783,257).
As to Claim 21, McAuley discloses a breathing circuit (Figures 16 and 17) for directing fluid flow, comprising: a tubular housing (the combination of 90 and 91, “In this embodiment a body part 90 and a ball jointed connector 91 fit together as described above.” Column 7, Lines 35-45) configured to accommodate a bulk inspiration flow (defined by the passage of gas from 91 to 90) and a bulk expiration flow (defined by the passage of gas from 90 to 93, wherein 93 – “The body part 90 includes an expiratory vent shield 92 that extends down from the top wall 94 of the body part 90 and shields the outlet vent 93.” Column 7, Lines 35-45), the tubular housing (the combination of 90 and 91) comprising a plurality of leakage ports (array of openings at 93, best shown Figures 16 and 17, “The body part 90 includes an expiratory vent shield 92 that extends down from the top wall 94 of the body part 90 and shields the outlet vent 93.” Column 7, Lines 35-45) formed in the tubular housing (the combination of 90 and 91) and configured to create a leakage path (exit of gas via 93 to ambient atmosphere) for at least a portion of the bulk expiration flow (defined by the passage of gas from 90 to 93) out of the tubular housing (the combination of 90 and 91), at least one fluid diversion member (92, “The body part 90 includes an expiratory vent shield 92 that extends down from the top wall 94 of the body part 90 and shields the outlet vent 93.” Column 7, Lines 35-45) disposed adjacent to the plurality of leakage ports (array of openings at 93) and extends into the tubular housing (the combination of 90 and 91), wherein the at least one fluid diversion member (92) is configured to define a flow path for the bulk inspiration flow (defined by the passage of gas from 91 to 90) from the ventilator side opening (via 91) of the tubular housing (the combination of 90 and 91) to the patient side opening (via 90) of the tubular housing (the combination of 90 and 91) to guide the bulk inspiration flow (defined by the passage of gas from 91 to 90) to at least partially bypass the plurality of leakage ports (array of openings at 93) and guide the at least the portion of the bulk expiration flow (defined by the passage of gas from 90 to 93) toward the plurality of leakage ports (array of openings at 93).
As to Claim 22, McAuley discloses the at least one fluid diversion member (92) is circumferentially disposed (best seen Figures 16 and 17) around at least a portion of the circumference of the ventilator side opening (via 91) of the tubular housing (the combination of 90 and 91).
As to Claim 29, McAuley discloses a ball joint (91 as inserted within 92/90) separating the tubular housing (the combination of 90 and 91) into a first tubular housing portion (one of 91 or 90) and a second tubular housing portion (other of 91 or 90), the ball joint (91 as inserted within 92/90) configured to direct the bulk expiration flow (defined by the passage of gas from 90 to 93) around a bend (defined by the curvature of 92) at the ball joint (91 as inserted within 92/90) between the first tubular housing portion (one of 91 or 90) and the second tubular housing portion (other of 91 or 90).
As to Claim 31, McAuley discloses the plurality of leakage ports (array of openings at 93) are disposed along (best seen Figures 16 and 17) a circumference of the tubular housing (the combination of 90 and 91).
As to Claim 32, McAuley discloses the plurality of leakage ports (array of openings at 93) comprise a first set of leakage ports (one of the 6 rows as best seen Figure 16) and a second set of leakage ports (another of the one of the 6 rows as best seen in Figure 16), the second set of leakage ports (another of the one of the 6 rows as best seen in Figure 16) angularly spaced (laterally parallel, best seen Figures 16 and 17) apart from the first set of leakage ports (one of the 6 rows as best seen Figure 16).
As to Claim 33, McAuley discloses the tubular housing (the combination of 90 and 91) comprises a first tubular housing portion (91) defining a first flow path (defined by the passage of gas from 91 to 90) between the first end portion (91 proximate the ventilator) and a second end portion (91 proximate connection to 90); a ball joint surface (defined by the rounded shape at 91 as inserted within 92/90) adjacent to the second end portion (91 proximate connection to 90) and defined along an outer surface of the first tubular housing portion (91); a second tubular housing portion (90) defining a second flow path (defined by the passage of gas from 90 to 93) between the third end portion (90 proximate the patient interface) and a fourth end portion (90 proximate connection to 91), wherein the second tubular housing portion (90) is coupled to the first tubular housing portion (91) to permit fluid communication between the first flow path (defined by the passage of gas from 91 to 90) to the second flow path (defined by the passage of gas from 90 to 93), and; a mating socket (defined by the open C shape at 90 proximate connection to 91 and receives 91) within an inner surface of the fourth end portion (90 proximate connection to 91) wherein the mating socket (defined by the open C shape at 90 proximate connection to 91 and receives 91) is configured to movably couple with the ball joint surface (defined by the rounded shape at 91 as inserted within 92/90); and the leakage path (exit of gas via 93 to ambient atmosphere) defined between the second end portion (91 proximate connection to 90) and the fourth end portion (90 proximate connection to 91), wherein the leakage path (exit of gas via 93 to ambient atmosphere) is in communication with the first flow path (defined by the passage of gas from 91 to 90), wherein the first end portion (91 proximate the ventilator) defines a ventilator side opening (via 91) and the third end portion (90 proximate the patient interface) defines a patient side opening (via 90).
Claims 21, 22, 28, 31, and 32 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Glidden (2,684,066).
As to Claim 21, Glidden discloses a breathing circuit (Figures 1-3) for directing fluid flow, comprising: a tubular housing (the combination of 15 and 22, wherein “In the illustration given, the face portion 11 of the gas mask is integrally formed with an exhaust conduit extension 15 providing interiorly an exhaust passage 16. … In the illustration given, this member consists of a ring member 25s integrally connected by means of webs 21 to a tubular intake conduit 22, as seen more clearly in Fig. 3.” Column 3, Lines 45-70) configured to accommodate a bulk inspiration flow (from 22 to 26/36 and into 11) and a bulk expiration flow (from 11 to 16/15 to 23 leading to the ambient atmosphere), the tubular housing (the combination of 15 and 22) comprising a plurality of leakage ports (23, “Web connections 21 are spaced apart to provide a plurality of passages 23 therethrough, as seen best in Fig. 2.” Column 3, Lines 45-75) formed in the tubular housing (the combination of 15 and 22) and configured to create a leakage path (passage of fluid from 11 to 16/15 to 23 leading to the ambient atmosphere) for at least a portion of the bulk expiration flow (from 11 to 16/15 to 23 leading to the ambient atmosphere) out of the tubular housing (the combination of 15 and 22), at least one fluid diversion member (33 via 34/35, “In the illustration given, the inner end of conduit 22 is received within an integral intake conduit extension 33 dividing to form outlet extensions 34 and 35, as seen more clearly in Fig. 2. Thus, interiorly member 33 provides an extension of intake passage 26 leading upwardly through the interior of the forked extensions 34 and 35 to inlet openings 36 and 31 adjacent windows 13.” Column 4, Lines 10-20), disposed adjacent to the plurality of leakage ports (23) and extends into the tubular housing (the combination of 15 and 22), wherein the at least one fluid diversion member (33 via 34/35) is configured to define a flow path for the bulk inspiration flow (from 22 to 26/36 and into 11) from the ventilator side opening (via 22) of the tubular housing (the combination of 15 and 22) to a patient side opening (via 15 within 11) of the tubular housing (the combination of 15 and 22) to guide the bulk inspiration flow (from 22 to 26/36 and into 11) to at least partially bypass the plurality of leakage ports (23) and guide the at least the portion of the bulk expiration flow (from 11 to 16/15 to 23 leading to the ambient atmosphere) toward the plurality of leakage ports (23).
As to Claim 22, Glidden discloses the at least one fluid diversion member (33 via 34/35) is circumferentially disposed (best seen Figures 2 and 3) around at least a portion of the circumference of the ventilator side opening (via 22) of the tubular housing (the combination of 15 and 22).
As to Claim 28, Glidden discloses a plurality of vanes (44, left and right as shown in Figure 2) configured to swirl the portion of the bulk expiration flow (from 11 to 16/15 to 23 leading to the ambient atmosphere) within a first portion (via 22) of the tubular housing (the combination of 15 and 22). By construction during exhalation the vane (44) is closed which prevents the passage of fluid flow back through the first portion (via 22) of the tubular housing (the combination of 15 and 22), this closure results in turbulent flow which swirls the fluid flow and requires the redirection of gas toward the plurality of leakage ports (23).
As to Claim 31, Glidden discloses the plurality of leakage ports (23) are disposed along a circumference (best seen Figures 2, 3, and 5) of the tubular housing (the combination of 15 and 22).
As to Claim 32, Glidden discloses the plurality of leakage ports (23) comprise a first set of leakage ports (one of 23, whereby Figure 5 shows an array of 4 openings) and the second set of leakage ports (another of 23, whereby Figure 5 shows an array of 4 openings), the second set of leakage ports (another of 23, whereby Figure 5 shows an array of 4 openings) angularly spaced (best seen Figure 5) from the first set of leakage ports (one of 23, whereby Figure 5 shows an array of 4 openings).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over McAuley et al. (8,783,257).
As to Claim 23, McAuley discloses the at least one fluid diversion member (92) as best seen in Figure 16, whereby the area of the bulk inspiration flow (defined by the passage of gas from 91 to 90) proximate the at least one fluid diversion member (92) is approximately twice as large as the area of the bulk expiration flow (defined by the passage of gas from 90 to 93) proximate the at least one fluid diversion member (92). In this configuration, the passage of gas along the bulk inspiration flow (defined by the passage of gas from 91 to 90) proximate the at least one fluid diversion member (92) to achieve leakage must undergo a turbulent flow U-turn in the fluid dynamics to permit the exhaustion of the bulk inspiration flow (defined by the passage of gas from 91 to 90) to exit the plurality of leakage ports (array of openings at 93); whilst, the passage of gas along the bulk expiration flow (defined by the passage of gas from 90 to 93) proximate the at least one fluid diversion member (92) to achieve leakage is a laminar flow to permit the exhaustion of the bulk expiration flow (defined by the passage of gas from 90 to 93) to exit the plurality of leakage ports (array of openings at 93). Based upon fluid dynamics, the leakage rate of the breathing circuit in the direction of the exhalation whereby gas passes along the bulk expiration flow (defined by the passage of gas from 90 to 93) to exit the plurality of leakage ports (array of openings at 93) in laminar flow would be greater than the leakage rate of the breathing circuit in the direction of inhalation whereby gas passes along the bulk inspiration flow (defined by the passage of gas from 91 to 90) to exit the plurality of leakage ports (array of openings at 93) requires a turbulent flow U-turn.
Yet, McAuley does not expressly disclose the specific numerical valuation of “at least 20% increase” of leakage rate.
In light of the relationship between the dimensional features of the area of the bulk inspiration flow (defined by the passage of gas from 91 to 90) proximate the at least one fluid diversion member (92) being approximately twice as large as the area of the bulk expiration flow (defined by the passage of gas from 90 to 93) proximate the at least one fluid diversion member (92) and furthermore the distinction of the inhalation direction as compared to the exhalation direction in fluid dynamics required to achieve leakage from the plurality of leakage ports (array of openings at 93), the specific numerical valuation of “at least 20% increase” of leakage rate would be obvious to try choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, whereby success would defined by the ability to permit greater leakage during exhalation flow than during inhalation flow within the tubular housing. The resultant effect of this configuration would be the reduction of fresh gas being wasted through being leaked to the ambient atmosphere, and the increase of spent gas to be removed from the patient to increase washout of carbon dioxide and prevent hypoxia.
Applicant has not asserted the specific numerical valuation of “at least 20% increase” of leakage rate provides a particular advantage, solves a stated problem, or serves particular purpose; thus, the use of the specific numerical valuation of “at least 20% increase” of leakage rate lacks criticality in its design. One of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the McAuley as the construction would permit the reduction of fresh gas being wasted through being leaked to the ambient atmosphere, and the increase of spent gas to be removed from the patient to increase washout of carbon dioxide and prevent hypoxia.
Thus, it would have been obvious to one having ordinary skill in the art to modify the construction of the fluid diversion member of McAuley, to permit an “at least 20% increase” of leakage rate, a known result effective variable, in order to reduce fresh gas being wasted through being leaked to the ambient atmosphere, and the increase of spent gas to be removed from the patient to increase washout of carbon dioxide and prevent hypoxia.
Claims 24-27, and 34-40 are rejected under 35 U.S.C. 103 as being unpatentable over McAuley et al. (8,783,257) in view of Fu et al. (7,934,501).
As to Claim 24, McAuley discloses the at least one fluid diversion member (92) as best seen in Figure 16; yet, does not expressly disclose “a plurality of fluid diversion members, wherein each fluid diversion member enshrouds a respective leakage port of the plurality of leakage ports.”
Fu teaches a breathing circuit (Figures 5-7) for directing fluid flow, comprising: a tubular housing (130, “A swivel elbow 130 in accordance with an embodiment of the invention has a main body that is generally L-shaped.” Column 4, Lines 15-30) configured to accommodate a bulk inspiration flow (via 175, “Within the swivel elbow 130 two fluid pathways are defined by baffle 160. A conduit pathway 175 allows flow between the air delivery conduit and the mask cavity. A vent pathway 170 allows flow between the mask cavity and atmosphere.” Column 4, Lines 25-55) and a bulk expiration flow (via 170, “Within the swivel elbow 130 two fluid pathways are defined by baffle 160. A conduit pathway 175 allows flow between the air delivery conduit and the mask cavity. A vent pathway 170 allows flow between the mask cavity and atmosphere.” Column 4, Lines 25-55), the tubular housing (130) comprising a plurality of leakage ports (170 as shown in Figure 7 having an array of 3 openings) formed in the tubular housing (130) and configured to create a leakage path (defined by the passage of gas from the patient to the ambient atmosphere) for at least a portion of the bulk expiration flow (via 170) out of the tubular housing (130), at least one fluid diversion member (160 and 165, “Within the swivel elbow 130 two fluid pathways are defined by baffle 160. … In a preferred form, the baffle 160 is spaced from generally cylindrical portion 180 by four spacers 165 and vent pathway 170. In other forms, fewer or more spacers may be used. By increasing the angle which the baffle 160 subtends, it is possible to decrease the height of the spacers 165. ” Column 4, Lines 25-55), disposed adjacent to the plurality of leakage ports (170 as shown in Figure 7 having an array of 3 openings) and extends into the tubular housing (130), wherein the at least one fluid diversion member (160 and 165) is configured to define a flow path for the bulk inspiration flow (via 175) from a ventilator side opening (155, “The base portion 150 includes a generally cylindrical section 155 over which in use an end of an air delivery conduit (not shown) may be friction fit (or otherwise engaged).” Column 4, Lines 15-30) of the tubular housing (130) to a patient side (135, “The frame engaging portion 135 includes a series of slots 137 adapted to engage with a frame (not shown).” Column 4, Lines 15-30) of the tubular housing (130) to guide the bulk inspiration flow (via 175) to at least partially bypass the plurality of leakage ports (170 as shown in Figure 7 having an array of 3 openings) and guide the at least the portion of the bulk expiration flow (via 170) toward the plurality of leakage ports (170 as shown in Figure 7 having an array of 3 openings).
Regarding the “a plurality of fluid diversion members, wherein each fluid diversion member enshrouds a respective leakage port of the plurality of leakage ports,” Fu teaches a plurality of fluid diversion members (165, “Within the swivel elbow 130 two fluid pathways are defined by baffle 160. … In a preferred form, the baffle 160 is spaced from generally cylindrical portion 180 by four spacers 165 and vent pathway 170. In other forms, fewer or more spacers may be used. By increasing the angle which the baffle 160 subtends, it is possible to decrease the height of the spacers 165. ” Column 4, Lines 25-55), wherein each fluid diversion member (one of 165) enshrouds a respective leakage port (one of 170) of the plurality of leakage ports (170 as shown in Figure 7 having an array of 3 openings).
The resultant effect of this configuration is separate and distinct leakage ports (170 as shown in Figure 7 having an array of 3 openings) adding duplicity should one of the leakage ports become clogged the others will remain open and still allow the washing out of carbon dioxide gas and reductions in noise (“Extending the baffle reduces noise and improves CO.sub.2 washout.” Column 4, Line 60 thru Column 5, Line 5; also see: “The extended baffle causes the airstreams to remain separate until the inlet air has slowed down and the two airstreams have diverged. Hence there will be much less interference between the streams and the resultant turbulence and increase in noise is avoided.” Column 5, Lines 10-25).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the at least one fluid diversion member of the modified McAuley to include a plurality of fluid diversion members as taught by Fu to add duplicity should one of the leakage ports become clogged the others will remain open and still allow the washing out of carbon dioxide gas and reductions in noise.
As to Claim 25, the modified McAuley, specifically Fu teaches each fluid diversion member (one of 165) enshrouds a respective leakage port (one of 170) of the plurality of leakage ports (170 as shown in Figure 7 having an array of 3 openings) and defines a fluid diversion cavity (defined by the length of the passageway from 165/170 proximate the patient side of the tubular housing as shown in Figure 6 to the ambient atmospheric opening of 170 as shown in Figure 7) between the respective leakage port (one of 170) and the respective fluid diversion member (one of 165).
Yet, does not expressly disclose “each of the plurality of fluid diversion members has a generally semi-spherical shape or igloo shape”.
Applicant has not asserted the specific shape of the fluid diversion members to have “a generally semi-spherical shape or igloo shape” provides a particular advantage, solves a stated problem, or serves a particular purpose. Hence, the shape of “a generally semi-spherical shape or igloo shape” would be obvious to try choosing from a finite number of identified predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability of the shape and dimensions of the fluid diversion members to “reduces noise and improves CO.sub.2 washout.” (Column 4, Line 60 thru Column 5, Line 5).
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified McAuley, as the construction of the shape of the fluid diversion members would yield the predictable results of reducing noise and improving gas washout.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the fluid diversion member of the modified McAuley, a known result effective variable, in order to reducing noise and improving gas washout.
As to Claim 26, the modified McAuley, specifically Fu teaches each fluid diversion member (one of 165) enshrouds a respective leakage port (one of 170) of the plurality of leakage ports (170 as shown in Figure 7 having an array of 3 openings).
Yet, does not expressly disclose “each of the plurality of fluid diversion members has generally U-shaped walls with a closed first end portion and an open second end portion, wherein the open second end portion is between the respective leakage port and a patient-side opening of the tubular housing”.
Applicant has not asserted the specific shape of the fluid diversion members to have “generally U-shaped walls” provides a particular advantage, solves a stated problem, or serves a particular purpose. Hence, the shape of “generally U-shaped walls” would be obvious to try choosing from a finite number of identified predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability of the shape and dimensions of the fluid diversion members to “reduces noise and improves CO.sub.2 washout.” (Column 4, Line 60 thru Column 5, Line 5).
Furthermore it should be noted the modified McAuley, specifically McAuley discloses a singular fluid diversion member (92) having a “generally U-shaped wall” with a closed first end portion (proximate the ball joint at the connection of 90/91) and an open second end portion (proximate the patient side opening 90), wherein the open second end portion (proximate the patient side opening 90) is between the leakage port (93) and the patient side opening (90).
In this configuration, the resultant effect of the modified McAuley would yield the predictable results of permitting the washout of carbon dioxide in the expiration flow path. Thus, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified McAuley.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the fluid diversion member of the modified McAuley, a known result effective variable, in order to permit gas washout.
As to Claim 27, the modified McAuley, specifically Fu teaches each fluid diversion member (one of 165) enshrouds a respective leakage port (one of 170) of the plurality of leakage ports (170 as shown in Figure 7 having an array of 3 openings), whereby the shape of the fluid diversion member (one of 165) appears to taper from a wider portion (as shown in Figure 6) to a narrower portion (as shown in Figure 7), wherein the wider portion (as shown in Figure 6) is disposed toward a patient side opening (via 90).
Yet, does not expressly disclose “wherein each of the plurality of fluid diversion members has a generally trapezoidal shape”.
Applicant has not asserted the specific shape of the fluid diversion members to have “a generally trapezoidal shape” provides a particular advantage, solves a stated problem, or serves a particular purpose. Hence, the shape of “a generally trapezoidal shape” would be obvious to try choosing from a finite number of identified predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability of the shape and dimensions of the fluid diversion members to “reduces noise and improves CO.sub.2 washout.” (Column 4, Line 60 thru Column 5, Line 5).
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified McAuley, as the construction of the shape of the fluid diversion members would yield the predictable results of reducing noise and improving gas washout.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the fluid diversion member of the modified McAuley, a known result effective variable, in order to reducing noise and improving gas washout.
As to Claim 34, McAuley discloses the at least one fluid diversion member (92),as best seen in Figure 16, associated with the ball joint surface (defined by the rounded shape at 91 as inserted within 92/90) to direct a fluid flow from the leakage path (93) away from the mating socket (defined by the open C shape at 90 proximate connection to 91 and receives 91).
Yet, does not expressly disclose “a plurality of fluid diversion channels to direct a fluid flow from the leakage path away from the mating socket”.
Fu teaches a breathing circuit (Figures 5-7) for directing fluid flow, comprising: a tubular housing (130, “A swivel elbow 130 in accordance with an embodiment of the invention has a main body that is generally L-shaped.” Column 4, Lines 15-30) configured to accommodate a bulk inspiration flow (via 175, “Within the swivel elbow 130 two fluid pathways are defined by baffle 160. A conduit pathway 175 allows flow between the air delivery conduit and the mask cavity. A vent pathway 170 allows flow between the mask cavity and atmosphere.” Column 4, Lines 25-55) and a bulk expiration flow (via 170, “Within the swivel elbow 130 two fluid pathways are defined by baffle 160. A conduit pathway 175 allows flow between the air delivery conduit and the mask cavity. A vent pathway 170 allows flow between the mask cavity and atmosphere.” Column 4, Lines 25-55), the tubular housing (130) comprising a plurality of leakage ports (170 as shown in Figure 7 having an array of 3 openings) formed in the tubular housing (130) and configured to create a leakage path (defined by the passage of gas from the patient to the ambient atmosphere) for at least a portion of the bulk expiration flow (via 170) out of the tubular housing (130), at least one fluid diversion member (160 and 165, “Within the swivel elbow 130 two fluid pathways are defined by baffle 160. … In a preferred form, the baffle 160 is spaced from generally cylindrical portion 180 by four spacers 165 and vent pathway 170. In other forms, fewer or more spacers may be used. By increasing the angle which the baffle 160 subtends, it is possible to decrease the height of the spacers 165. ” Column 4, Lines 25-55), disposed adjacent to the plurality of leakage ports (170 as shown in Figure 7 having an array of 3 openings) and extends into the tubular housing (130), wherein the at least one fluid diversion member (160 and 165) is configured to define a flow path for the bulk inspiration flow (via 175) from a ventilator side opening (155, “The base portion 150 includes a generally cylindrical section 155 over which in use an end of an air delivery conduit (not shown) may be friction fit (or otherwise engaged).” Column 4, Lines 15-30) of the tubular housing (130) to a patient side (135, “The frame engaging portion 135 includes a series of slots 137 adapted to engage with a frame (not shown).” Column 4, Lines 15-30) of the tubular housing (130) to guide the bulk inspiration flow (via 175) to at least partially bypass the plurality of leakage ports (170 as shown in Figure 7 having an array of 3 openings) and guide the at least the portion of the bulk expiration flow (via 170) toward the plurality of leakage ports (170 as shown in Figure 7 having an array of 3 openings).
Regarding the “a plurality of fluid diversion channels,” Fu teaches a plurality of fluid diversion members (165, “Within the swivel elbow 130 two fluid pathways are defined by baffle 160. … In a preferred form, the baffle 160 is spaced from generally cylindrical portion 180 by four spacers 165 and vent pathway 170. In other forms, fewer or more spacers may be used. By increasing the angle which the baffle 160 subtends, it is possible to decrease the height of the spacers 165. ” Column 4, Lines 25-55), wherein each fluid diversion member (one of 165) enshrouds a respective leakage port (one of 170) of the plurality of leakage ports (170 as shown in Figure 7 having an array of 3 openings), whereby each fluid diversion member (one of 165) provides a plurality of fluid diversion channels (defined by the length of the passageway from 165/170 proximate the patient side of the tubular housing as shown in Figure 6 to the ambient atmospheric opening of 170 as shown in Figure 7).
The resultant effect of this configuration is separate and distinct leakage ports (170 as shown in Figure 7 having an array of 3 openings) adding duplicity should one of the leakage ports become clogged the others will remain open and still allow the washing out of carbon dioxide gas and reductions in noise (“Extending the baffle reduces noise and improves CO.sub.2 washout.” Column 4, Line 60 thru Column 5, Line 5; also see: “The extended baffle causes the airstreams to remain separate until the inlet air has slowed down and the two airstreams have diverged. Hence there will be much less interference between the streams and the resultant turbulence and increase in noise is avoided.” Column 5, Lines 10-25).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the at least one fluid diversion member of the modified McAuley to include a plurality of fluid diversion members as taught by Fu to add duplicity should one of the leakage ports become clogged the others will remain open and still allow the washing out of carbon dioxide gas and reductions in noise.
As to Claim 35, the modified McAuley, specifically Fu teaches plurality of fluid diversion channels (defined by the length of the passageway from 165/170 proximate the patient side of the tubular housing as shown in Figure 6 to the ambient atmospheric opening of 170 as shown in Figure 7) are axial flow channels (best seen Figures 6 and 7).
As to Claim 36, the modified McAuley, specifically Fu teaches plurality of fluid diversion channels (defined by the length of the passageway from 165/170 proximate the patient side of the tubular housing as shown in Figure 6 to the ambient atmospheric opening of 170 as shown in Figure 7) a plurality of channel walls (defined by the perimeter of 165 encompassing 170).
As to Claim 37, the modified McAuley, specifically Fu teaches the plurality of channel walls (defined by the perimeter of 165 encompassing 170) are arranged parallel to one another (best seen Figures 6 and 7).
As to Claim 38, the modified McAuley, specifically Fu teaches the plurality of channel walls (defined by the perimeter of 165 encompassing 170) are arranged radially (best seen Figures 6 and 7).
As to Claim 39, the modified McAuley, specifically Fu teaches the plurality of channel walls (defined by the perimeter of 165 encompassing 170) form an overall arcuate, spherical, or rounded profile (best seen Figures 6 and 7) to engage with the mating socket (defined by the open C shape at 90 proximate connection to 91 and receives 91) of the modified McAuley.
As to Claim 40, the modified McAuley, specifically McAuley discloses the ball joint surface (defined by the rounded shape at 91 as inserted within 92/90) defines a circumferential flow control rib (via the extension of 92 from 91 into 90) to control the fluid flow from the leakage path (93).
Allowable Subject Matter
Claim 30 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art made of record does not appear to disclose, teach, or fairly suggest the construction of a breathing circuit as claimed in Claim 30, including its parent lineage, whereby “the portion of bulk expiration flow to the plurality of leakage ports” is controlled based upon the bending of the ball joint.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Holley et al. (10,589,042) discloses an additional breathing circuit (Figures 28-31) having a tubular housing (2609) with a plurality of leakage ports (2611), at least one fluid diversion member (2607) suitable to direct the bulk of inspiration flow (via IS) from a ventilator side opening of the tubular housing (2609) to bypass the plurality of leakage ports (2611) and guide the bulk of expiration flow (via EF/ES) from the patient side opening of the tubular housing (2609) toward the plurality of leakage ports (2611). Applicant is strongly advised to consider this prior art reference to expedite advancement of prosecution.
Wood (6,478,026) discloses an additional breathing circuit (Figures 7 and 10) having a tubular housing (32) with a plurality of leakage ports (54), at least one fluid diversion member (the combination of 58/66) suitable to direct the bulk of inspiration flow (57) from the ventilator side opening of the tubular housing (32) to bypass the plurality of leakage ports (54) and guide the bulk of expiration flow (59) from the patient side opening of the tubular housing (32) toward the plurality of leakage ports (54).
Lambert (5,398,673); Starr et al. (5,438,981); D. Jaffre et al. (2003/005931); and Drew et al. (2004/0112385) each disclose additional breathing circuit having tubular housings with a plurality of leakage ports, at least one fluid diversion member suitable to direct the bulk of inspiration flow from the ventilator side opening of the tubular housing to bypass the plurality of leakage ports and guide the bulk of expiration flow from the patient side opening of the tubular housing toward the plurality of leakage ports.
Varga et al. (11,906,097) shares a common assignee/inventor with the instant application; however, at this time there does not appear to be an applicable double patenting rejection. Although patent claim, Claim 2, of Varga appears to recite the features of a tubular housing, a plurality of leakage ports, and a fluid diversion member – the concepts of “bulk inspiration flow”, “bulk expiration flow”, “ventilator side opening”, “patient side opening”, nor the relative degree of the “bulk inspiration flow to at least partially bypass the plurality of leakage ports and guide the at least the portion of the bulk expiration flow toward the plurality of leakage ports” of the instant claim listing do not appear to be disclosed, taught, or fairly suggest in the patent claim, Claim 2.
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
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