DETAILED ACTION
Primary Examiner acknowledge Claims 81-96 are pending in this application, with Claims 81-96 having been newly added, and Claims 1-80 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 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 81-96 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 81, Line 14 recites “via the first valve port”; however, this limitation appears to lack antecedent basis in the claims. It appears the limitation should read “via the at least a first valve port” to be consistent with the former recitation of the “at least a first valve port” in Claim 81, Line 8. Dependent claims, Claims 82-96, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 84, Line 2 recites the limitation “preferably”; however, the use of this claim renders the claim indefinite as Primary Examiner is unsure if the limitation after the word “preferably” are required to meet the limitations of the claims. Dependent claim, Claim 85, incorporates the indefinite subject matter from which it depend. Appropriate correction and clarification is required.
Specifically, Claim 86, Line 3 recites the limitation “preferably”; however, the use of this claim renders the claim indefinite as Primary Examiner is unsure if the limitation after the word “preferably” are required to meet the limitations of the claims. Dependent claims, Claims 87 and 88, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 87, Line 2, recites the phrase “for example”. This phrase renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Primary Examiner is unsure if the limitation after the phrase “for example” are required to meet the limitations of the claims. Dependent claim, Claim 88, incorporates the indefinite subject matter from which it depend. Appropriate correction and clarification is required.
Specifically, Claim 88, Line 2 recites the phrase “for example”. This phrase renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Primary Examiner is unsure if the limitation after the phrase “for example” are required to meet the limitations of the claims. Appropriate correction and clarification is required.
Specifically, Claim 89, Line 3 recites the limitation “preferably”; however, the use of this claim renders the claim indefinite as Primary Examiner is unsure if the limitation after the word “preferably” are required to meet the limitations of the claims. Appropriate correction and clarification is required.
Specifically, Claim 92, Line 2 recites the limitation “preferably”; however, the use of this claim renders the claim indefinite as Primary Examiner is unsure if the limitation after the word “preferably” are required to meet the limitations of the claims. Appropriate correction and clarification is required.
Specifically, Claim 93, Line 3 recites the limitation “preferably”; however, the use of this claim renders the claim indefinite as Primary Examiner is unsure if the limitation after the word “preferably” are required to meet the limitations of the claims. Appropriate correction and clarification is required.
Specifically, Claim 94, Line 2 recites the limitation “preferably”; however, the use of this claim renders the claim indefinite as Primary Examiner is unsure if the limitation after the word “preferably” are required to meet the limitations of the claims. 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 81, 89, 91-93, 95, and 96 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Bugamelli et al. (2016/0184549).
As to Claim 81, Bugamelli discloses a conduit connector assembly (Figures 1 and 14) for a respiratory therapy apparatus and configured to connect to a patient interface (8, best seen Figure 1, “System 2 includes a pressure generating device 4, a delivery conduit 6, and a patient interface device 8 including an elbow connector 10 fluidly coupled to delivery conduit 6.” Para 0026) to a gas delivery conduit (6, best seen Figure 1, “System 2 includes a pressure generating device 4, a delivery conduit 6, and a patient interface device 8 including an elbow connector 10 fluidly coupled to delivery conduit 6.” Para 0026), the conduit connector assembly (Figures 1 and 14) comprising: a conduit (10E, “Elbow connector 10E is similar to elbow connector 10. However, rather than having posts 15 formed on valve member 14 as in elbow connector 10, elbow connector 10E includes a post 15E formed on the interior surface of housing 11.” Para 0047) comprising: a first flow port (11 proximate 8, wherein 11 – “Elbow connector 10E is similar to elbow connector 10. However, rather than having posts 15 formed on valve member 14 as in elbow connector 10, elbow connector 10E includes a post 15E formed on the interior surface of housing 11.” Para 0047 and wherein 8 – “a patient interface device 8” Para 0026) configured to be connected to the patient interface (8), a second flow port (11 proximate 6, wherein 11 – “Elbow connector 10E is similar to elbow connector 10. However, rather than having posts 15 formed on valve member 14 as in elbow connector 10, elbow connector 10E includes a post 15E formed on the interior surface of housing 11.” Para 0047 and wherein 6 – “a delivery conduit 6” Para 0026) configured to be connected to the gas delivery conduit (6), a supplemental flow port (13 when permitting the introduction of ambient air, “Exhalation holes 12 and an atmospheric port 13 are formed in housing 11.” Para 0026); and at least a first valve port (defined by the opening within 11 at 15E to receive/abut 14E, “However, rather than having posts 15 formed on valve member 14 as in elbow connector 10, elbow connector 10E includes a post 15E formed on the interior surface of housing 11. Post 15E is structured to prevent valve member 14E from moving to the folded down position. Post 15E is formed on the interior surface of housing 11 opposite of the hinged end of valve member 14E. Post 15E prevents valve member 14E from moving to the folded down position while blocking a minimal area of the airflow path through elbow connector 10E.” Para 0047) configured to be closed or opened by a valve flap (14E, “valve member 14E” Para 0047), the conduit (10E) and the valve flap (14E) being configured to selectively provide two flow paths through the conduit (10E), being: an inspiratory flow path from the second flow port (11 proximate 6) to the first flow port (11 proximate 8) of an elbow (“Elbow connector 10E” Para 0047); an expiratory flow path from the first flow port (11 proximate 8) of the conduit (10E) to the supplementary flow port (13 when permitting the introduction of ambient air, “an atmospheric port 13”) via the at least first valve port (defined by the opening within 11 at 15E to receive/abut 14E), wherein a supplementary gas flow path (12, “Exhalation holes 12 and an atmospheric port 13 are formed in housing 11.” Para 0026) is provided between the first flow port (11 proximate 8) and the second flow port (11 proximate 6) and the supplementary flow port (13 when permitting the introduction of ambient air) via a supplementary valve port (defined by the abutment of 14E at 13 to block the introduction of ambient air) defined by or comprising part of the valve flap (14E).
It should be noted Applicant has recited each of “a supplementary flow port”, “a supplementary gas flow path” and “a supplementary valve port”; yet, the claim listing only requires the “supplementary flow port” and the “supplementary valve port” to be directly related to each other. By Primary Examiner’s interpretation, the supplementary flow port is defined by the ability of 13 to permit the introduction of ambient air into the conduit/elbow, whereby the valve flap (14E) is closed against 15E; whilst, the supplementary valve port is defined by the ability of 13 to prevent the introduction of ambient air by the orientation of the valve flap 14E to block 13.
In operation of Bugamelli, when the patient is inhaling with pressurized gas flow from the gas delivery conduit (8), gas will be provided from the second flow port (11 proximate 6) to the first flow port (11 proximate 8) without limitation as the “first valve port” (15E) of the valve flap (14E) is opened and positioned towards the supplemental valve port (defined by the abutment of 14E at 13 to block the introduction of ambient air) to prevent the introduction of ambient air through the supplemental flow port (13); when the patient is inhaling in the absence of pressurized gas flow from the gas delivery conduit (8), ambient air (via 12 and 13) will be permitted to be introduced to the patient through the supplemental flow port (13) to the first flow port (11 proximate 8) whilst the “first valve port” (15E) of the valve flap (14E) is closing/closed; and when the patient is exhaling from the first flow port (11 proximate 8) to the supplementary flow port (13) the “first valve port” (15E) of the valve flap (14E) is closed, leaving the only exhaustion path of gas through either the supplemental valve port (defined by the abutment of 14E at 13 to block the introduction of ambient air) when the valve flap (14E) is positioned in the closed position at the “first valve port” (15E) and/or through the supplementary gas flow path (12) which remains open regardless of the orientation of the valve flap (14E).
Thus, the claimed expiratory flow path involves the passage of air from the first flow port (11 proximate 8) to the supplementary flow port (13) via the closure of the “first valve port” (15E) with the valve flap (14E), and the operation of the supplementary flow port (13) via the supplemental valve port (defined by the abutment of 14E at 13 to block the introduction of ambient air) is defined by the orientation of the valve flap (14E) to abut/receive the supplementary flow port (13).
Hence, the limitations of Claim 81 are met by the disclosure of Bugamelli.
As to Claim 89, Bugamelli discloses the valve flap (14E) comprises a hinge or pivot (defined by the bulbous region of 14E proximate 13 in Figure 14 – “Post 15E is formed on the interior surface of housing 11 opposite of the hinged end of valve member 14E.” Para 0047) about which the valve flap (14E) rotates in use, the supplementary valve port (defined by the abutment of 14E at 13 to block the introduction of ambient air) being provided at a position distal from the hinge or pivot (defined by the bulbous region of 14E proximate 13 in Figure 14), a distal position comprising an arcuate part of a perimeter of the valve flap (14E). As seen in Figure 14, the movement of the valve flap (14E) permits for the arcuate engagement of the valve flap (14E) to the supplementary valve port (defined by the abutment of 14E at 13 to block the introduction of ambient air).
As to Claim 91, Bugamelli discloses the valve flap (14E) comprises a sealing face (where 14E abuts 13), the supplementary valve port (defined by the abutment of 14E at 13 to block the introduction of ambient air) extending through the sealing face (where 14E abuts 13). As seen in Figure 14, the movement of the valve flap (14E) permits for the sealing of the supplementary valve port (defined by the abutment of 14E at 13 to block the introduction of ambient air).
As to Claim 92, Bugamelli discloses the sealing face (where 14E abuts 13) is provided about the perimeter of the valve flap (14E).
As to Claim 93, Bugamelli discloses a flow restricting formation (15E) configured to prevent or restrict the flow of gas across or along at least part of the valve flap (14E). In operation, the flow restricting formation (15E) prevents the movement of valve flap (14E) to be “folded down” (Para 0047 – “Post 15E prevents valve member 14E from moving to the folded down position while blocking a minimal area of the airflow path through elbow connector 10E.”). This flow restricting formation (15E) make the valve flap (14E) a one-way valve and restriction the flow of gas to a single direction – towards the first flow port (11 proximate 8) oriented proximate the patient interface (8).
As to Claim 95, Bugamelli discloses the conduit connector assembly (Figure 14) of the conduit (10E) is an elbow conduit connector assembly (“Elbow connector 10E” Para 0047).
As to Claim 96, Bugamelli discloses the conduit connector assembly (Figure 14) being utilized as a respiratory therapy system (2, Figure 1, “A system 2 adapted to provide a regimen of respiratory therapy to a patient according to one exemplary embodiment of the disclosed concept is generally shown in FIG. 1. System 2 includes a pressure generating device 4, a delivery conduit 6, and a patient interface device 8 including an elbow connector 10 fluidly coupled to delivery conduit 6.” Para 0026).
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 90 is rejected under 35 U.S.C. 103 as being unpatentable over Bugamelli et al. (2016/0184549) in view of Doshi et al. (2007/0277832).
As to Claim 90, Bugamelli discloses a valve flap (14E); yet, does not expressly disclose the valve flap to have “one or more reinforced portions”.
Doshi teaches a valve flap (42A/42B, “Moveable elements 42a and/or 42b (flaps) are attached to one another or are constructed from a single piece. Moveable elements 42a and 42b are attached to the inner surface of the passageway (shown as a rim 30) at attachment points 44a and 44b, and these attachment points may allow the valve to pivot around a hinge 43 in response to direction and amplitude of airflow.” Para 0150) for the controlled delivery of gas within a medical device.
Regarding the use of “one or more reinforced portions”, Doshi teaches the use of one or more reinforcement portions (60A/60B, “In FIG. 14, the movable elements further comprise a flap reinforcement 60a and 60b that is located partially or completely covering the moveable elements 42a and 42b.” Para 0156) oriented with the valve flap (42A/42B) for the purpose of providing “additional structure and/or stiffness to these moveable elements”; promoting “a more reliable seal and may standardize the movements of moveable elements 42a and 42b while reducing the likelihood that moveable elements will invert, buckle in the direction of airflow, or otherwise fail”; and to dampen “any whistling or other sounds during inspiration or expiration” (Para 0156).
Therefore, in light of the teachings of Doshi, it would have been obvious to one having ordinary skill in the art to modify the construction of the valve flap of Bugamelli to include the use of “one or more reinforced portions” as taught by Doshi to be a known feature suitable to provide “additional structure and/or stiffness”; promote “a more reliable seal and may standardize the movements”; and to dampen “any whistling or other sounds during inspiration or expiration”.
Claims 82, 83, 86-88 and 94 are rejected under 35 U.S.C. 103 as being unpatentable over Bugamelli et al. (2016/0184549) in view of Mittelstadt et al. (2002/0195108).
As to Claim 82, Bugamelli discloses a supplementary valve port (defined by the abutment of 14E at 13 to block the introduction of ambient air) defined by the valve flap (14E); yet, does not expressly disclose “a flow slot provided on or comprising part of the valve flap”.
Mittelstadt teaches a valve flap (70x, “Additionally referring to FIGS. 3 and 4, one embodiment of valve diaphragm 56 is shown, where diaphragm 56 includes a flap portion 70 having a top surface 72, a bottom surface 74, a first end 76, and a second end 77.” Para 0024) for controlling the directionality of gas flow within a medical device.
Regarding the construction of the valve flap, Mittelstadt the use of a flow slot (defined by the space between 90 as best seen in Figure 5 OR ALTERNATIVELY the sinusoidal undulations of 72b in Figure 6B, wherein 90 – “Referring now to FIG. 5, one aspect of diaphragm 56 includes multiple ribs 90 extending from the top surface 72 of flap portion 70 for at least part of the distance from the first end 76 to second end 77. In this embodiment, the base part of flap portion 70 has a uniform thickness. The ribs 90 provide additional stiffness to the diaphragm 56, which can be useful in providing the desired seal between the flap portion 70 and the valve seat 54 while minimizing the mass added to the flap portion 70. … The length, width, and thickness of each rib 90 can be chosen to achieve the desired level of stiffness for the flap portion 70. A single rib 90 or multiple ribs 90 may be used, where the design of each rib 90 may be the same or different than other ribs 90 on the same flap portion 70. Each rib 90 may also vary from one end of the rib to the other end of the rib. For example, each rib 90 may be wider or thicker at one end of that rib than at the other end of that rib. The rib or ribs may also extend for only part of the distance between the first end 76 of flap portion 70 to second end 77. In any case, the number, size, and shape of ribs used should provide a desired level of stiffness to the valve diaphragm while allowing enough flexibility so that the valve diaphragm can open under normal pressure changes.” Para 0030 and 0031; OR ALTERNATIVELY wherein 72b – “Another example of varying the thickness of a flap portion is illustrated in FIG. 6b. As shown, the top surface 72b of the flap portion 70b varies in a sinusoidal pattern from the first side 78b to second side 79b, thereby providing portions of flap portion 70b with different thicknesses. It is understood that any number of thickness variations, both regular and irregular, across the surface of a particular flap portion are possible and are considered to be within the scope of the present invention. In one aspect of the invention, however, a difference in the thickness at any point between the first side 78 and the second side 79 of greater than about 10% is desirable. Like the addition of ribs to a flap portion, these thickness variations can also provide an increased stiffness to mass ratio for a flap portion as compared to a flap portion with uniform thickness from side to side.” Para 0033) provided on the valve flap (70x).
In operation, the flow slot (defined by the space between 90 as best seen in Figure 5; OR ALTERNATIVELY the sinusoidal undulations of 72b in Figure 6B) defines channels extending from the hinged end (76/78x, “first end 76” Para 0030; OR ALTERNATIVELY “first side 78b to second side 79b” Para 0033) to the free end (77/78x, “second end 77” Para 0030; OR ALTERNATIVELY “first side 78b to second side 79b” Para 0033) upon which gas may flow along the planar surface (72x) of the valve flap (70x). The resultant effect of the flow slot (defined by the space between 90 as best seen in Figure 5; OR ALTERNATIVELY the sinusoidal undulations of 72b in Figure 6B) as variations to the planar shape of the valve flap (70x) results in changes to the flexibility and opening pressure (Para 0031 – “allowing enough flexibility so that the valve diaphragm can open under normal pressure changes” and Para 0033 – “Like the addition of ribs to a flap portion, these thickness variations can also provide an increased stiffness to mass ratio for a flap portion as compared to a flap portion with uniform thickness from side to side.”) of the valve flap (70x). Hence, the resultant effect of the use of the flow slot is to control the desired functionality of the valve flap (70x) to open and flex as desired.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the valve flap (14E) of Bugamelli to include the use of a flow slot as taught by Mittelstadt to be a known method of controlling the flexibility and opening pressure of the valve flap.
As to Claim 83, the modified Bugamelli, specifically Mittelstadt teaches the construction of a flow slot (defined by the space between 90 as best seen in Figure 5; OR ALTERNATIVELY the sinusoidal undulations of 72b in Figure 6B) extending the entire length of the valve flap (70x) and thus meeting the claimed orientation of “from a position radially inward of a perimeter… to a position at the perimeter of the valve flap”.
The modification of Bugamelli with the valve flap (70x) of Mittelstadt results in the orientation of the supplementary gas flow path (12) of Bugamelli to extend through the perimeter of the valve flap (14E). In operation, during inhalation, the introduction of gas from the ambient to the first flow port (11 proximate 8) along the supplementary gas flow path (12) would permit the flow of gas along the valve flap (14E) along the perimeter of the valve flap (14E). In the operation, during exhalation, the removal of gas from the first flow port (11 proximate 8) to the supplementary flow port (12) would yield the passage of gas along the supplementary gas flow path (12) such that gas would flow along the valve flap (14E) along the perimeter of the valve flap (14E) before being excised from the conduit (10E) at the supplementary gas flow path (12) and/or supplementary valve port (13) to the ambient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the specific orientation of the flow slot of the modified Bugamelli to include the flow of gas along the supplementary gas flow path of the modified Bugamelli, as taught by Mittelstadt control the flexibility and opening pressure of the valve flap.
As to Claim 94, the modified Bugamelli, specifically Mittelstadt teaches the construction of a flow slot (defined by the space between 90 as best seen in Figure 5; OR ALTERNATIVELY the sinusoidal undulations of 72b in Figure 6B) being tapered. Explicitly, Mittelstadt teaches “The thickness of flap portion 70 may taper gradually from first side 78 to second side 79 or the thickness can vary less gradually, such as in a type of "step" arrangement, or in any other regular or irregular variation from one side to the other.”. The resultant effect of the construction of the tapered flow slot permits for changes to the flexibility and opening pressure (Para 0031 – “allowing enough flexibility so that the valve diaphragm can open under normal pressure changes” and Para 0033 – “Like the addition of ribs to a flap portion, these thickness variations can also provide an increased stiffness to mass ratio for a flap portion as compared to a flap portion with uniform thickness from side to side.”) of the valve flap (70x).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the valve flap of the modified Bugamelli to include a tapered structure as taught by Mittelstadt to control the flexibility and opening pressure of the valve flap.
As to Claim 86, Bugamelli discloses a supplementary valve port (defined by the abutment of 14E at 13 to block the introduction of ambient air) defined by the valve flap (14E); yet, does not expressly disclose “the valve flap comprises a planar face, and wherein each flow slot is defined between two upstanding portions of the valve flap that project away from the planar face, and preferably wherein the supplementary gas flow path extends substantially parallel with the planar face.”
Mittelstadt teaches a valve flap (70x, “Additionally referring to FIGS. 3 and 4, one embodiment of valve diaphragm 56 is shown, where diaphragm 56 includes a flap portion 70 having a top surface 72, a bottom surface 74, a first end 76, and a second end 77.” Para 0024) for controlling the directionality of gas flow within a medical device, wherein the valve flap (70x) includes a planar surface (72x, “a top surface 72” Para 0024; “the top surface 72b of the flap portion 70b” Para 0033).
Regarding the construction of the flow slot, Mittelstadt the use of a flow slot (defined by the space between 90 as best seen in Figure 5 OR ALTERNATIVELY the sinusoidal undulations of 72b in Figure 6B, wherein 90 – “Referring now to FIG. 5, one aspect of diaphragm 56 includes multiple ribs 90 extending from the top surface 72 of flap portion 70 for at least part of the distance from the first end 76 to second end 77. In this embodiment, the base part of flap portion 70 has a uniform thickness. The ribs 90 provide additional stiffness to the diaphragm 56, which can be useful in providing the desired seal between the flap portion 70 and the valve seat 54 while minimizing the mass added to the flap portion 70. … The length, width, and thickness of each rib 90 can be chosen to achieve the desired level of stiffness for the flap portion 70. A single rib 90 or multiple ribs 90 may be used, where the design of each rib 90 may be the same or different than other ribs 90 on the same flap portion 70. Each rib 90 may also vary from one end of the rib to the other end of the rib. For example, each rib 90 may be wider or thicker at one end of that rib than at the other end of that rib. The rib or ribs may also extend for only part of the distance between the first end 76 of flap portion 70 to second end 77. In any case, the number, size, and shape of ribs used should provide a desired level of stiffness to the valve diaphragm while allowing enough flexibility so that the valve diaphragm can open under normal pressure changes.” Para 0030 and 0031; OR ALTERNATIVELY wherein 72b – “Another example of varying the thickness of a flap portion is illustrated in FIG. 6b. As shown, the top surface 72b of the flap portion 70b varies in a sinusoidal pattern from the first side 78b to second side 79b, thereby providing portions of flap portion 70b with different thicknesses. It is understood that any number of thickness variations, both regular and irregular, across the surface of a particular flap portion are possible and are considered to be within the scope of the present invention. In one aspect of the invention, however, a difference in the thickness at any point between the first side 78 and the second side 79 of greater than about 10% is desirable. Like the addition of ribs to a flap portion, these thickness variations can also provide an increased stiffness to mass ratio for a flap portion as compared to a flap portion with uniform thickness from side to side.” Para 0033) provided on the valve flap (70x), wherein each flow slot (defined by the space between 90 as best seen in Figure 5; OR ALTERNATIVELY the sinusoidal undulations of 72b in Figure 6B) is defined between two upstanding portions of the valve flap (70x) that project away from the planar surface (72x).
In operation, the flow slot (defined by the space between 90 as best seen in Figure 5; OR ALTERNATIVELY the sinusoidal undulations of 72b in Figure 6B) defines channels extending from the hinged end (76/78x, “first end 76” Para 0030; OR ALTERNATIVELY “first side 78b to second side 79b” Para 0033) to the free end (77/78x, “second end 77” Para 0030; OR ALTERNATIVELY “first side 78b to second side 79b” Para 0033) upon which gas may flow along the planar surface (72x) of the valve flap (70x). The resultant effect of the flow slot (defined by the space between 90 as best seen in Figure 5; OR ALTERNATIVELY the sinusoidal undulations of 72b in Figure 6B) as variations to the planar shape of the valve flap (70x) results in changes to the flexibility and opening pressure (Para 0031 – “allowing enough flexibility so that the valve diaphragm can open under normal pressure changes” and Para 0033 – “Like the addition of ribs to a flap portion, these thickness variations can also provide an increased stiffness to mass ratio for a flap portion as compared to a flap portion with uniform thickness from side to side.”) of the valve flap (70x). Hence, the resultant effect of the use of the flow slot is to control the desired functionality of the valve flap (70x) to open and flex as desired.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the planar surface of the valve flap (14E) of Bugamelli to include the use of a flow slot as taught by Mittelstadt to be a known method of controlling the flexibility and opening pressure of the valve flap.
As to Claim 87, the modified Bugamelli, specifically Mittelstadt teaches the construction of a flow slot (defined by the space between 90 as best seen in Figure 5; OR ALTERNATIVELY the sinusoidal undulations of 72b in Figure 6B) on a planar face (72x) of the valve flap (70x) whereby there are recessed portions (dipped space between 90 as best seen in Figure 5; OR ALTERNATIVELY dips in sinusoidal undulations of 72b of Figure 6B) in fluid communication with each flow slot (defined by the space between 90 as best seen in Figure 5; OR ALTERNATIVELY the sinusoidal undulations of 72b in Figure 6B), whereby the recessed portions (dipped space between 90 as best seen in Figure 5; OR ALTERNATIVELY dips in sinusoidal undulations of 72b of Figure 6B) run laterally through the thickness of the valve flap (70x) along the planar surface (72x).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the specific orientation of the flow slot of the modified Bugamelli to include recessed portions as taught by Mittelstadt control the flexibility and opening pressure of the valve flap.
As to Claim 88, the modified Bugamelli, specifically Mittelstadt teaches the construction of a flow slot (defined by the space between 90 as best seen in Figure 5; OR ALTERNATIVELY the sinusoidal undulations of 72b in Figure 6B) on a planar face (72x) of the valve flap (70x) with the recessed portions (dipped space between 90 as best seen in Figure 5; OR ALTERNATIVELY dips in sinusoidal undulations of 72b of Figure 6B) as an array/series over the planar surface (72x) of the valve flap (70x).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the specific orientation of the plurality of flow slot of the modified Bugamelli to include the plurality of recessed portions as taught by Mittelstadt control the flexibility and opening pressure of the valve flap.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 81, 95, and 96 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 18, and 19 of U.S. Patent No. 12,005,193.
Although the claims at issue are not identical, they are not patentably distinct from each other because instant independent claim, Claim 81, is merely broader than patent claims 11 and 19. It is clear all of the elements of the instant claims are found in the patent claims, the difference lies in the fact that the patent claims include many more elements and is thus much more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant claims. It has been held that the “generic” invention is “anticipated” by the ”species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Instant Application – 18/651,348
Patent - 12,005,193
Differences Underlined
81. (New) A conduit connector assembly for a respiratory therapy apparatus and configured to connect a patient interface to a gas delivery conduit, the conduit connector assembly comprising: a conduit comprising:
a first flow port configured to be connected to the patient interface,
a second flow port configured to be connected to the gas delivery conduit,
a supplementary flow port; and
at least a first valve port configured to be closed or opened by a valve flap,
the conduit and the valve flap being configured to selectively provide two flow paths through the conduit, being:
an inspiratory flow path from the second flow port of the conduit to the first flow port of an elbow;
an expiratory flow path from the first flow port of the conduit to the supplementary flow port via the first valve port,
wherein: a supplementary gas flow path is provided between the first flow port and/or the second flow port and the supplementary flow port via a supplementary valve port
defined by or comprising part of the valve flap.
AND
81. (New) A conduit connector assembly for a respiratory therapy apparatus and configured to connect a patient interface to a gas delivery conduit, the conduit connector assembly comprising:
a conduit comprising: a first flow port configured to be connected to the patient interface,
a second flow port configured to be connected to the gas delivery conduit,
a supplementary flow port; and
at least a first valve port configured to be closed or opened by a valve flap,
the conduit and the valve flap being configured to selectively provide two flow paths through the conduit, being:
an inspiratory flow path from the second flow port of the conduit to the first flow port of an elbow;
an expiratory flow path from the first flow port of the conduit to the supplementary flow port via the first valve port,
wherein: a supplementary gas flow path is provided between the first flow port and/or the second flow port and the supplementary flow port via a supplementary valve port
defined by or comprising part of the valve flap
1. A conduit connector assembly for a respiratory therapy apparatus and configured to connect a patient interface to a gas delivery conduit, the conduit connector assembly comprising: a conduit comprising
a first flow port configured to be connected to the patient interface, and
a second flow port configured to be connected to the gas delivery conduit, and
a supplementary flow port configured to be in fluid communication with an ambient environment; and a hollow valve body configured to be mounted on or in the conduit and comprising
at least a first valve port positioned on the hollow valve body configured to be closed or opened by a valve flap, wherein the valve flap is configured to move between a first position and a second position relative to the hollow valve body;
the conduit, valve body and the valve flap being configured to selectively provide three flow paths through an elbow, being:
an therapy flow path provided between the second flow port of the conduit and the first flow port of the conduit;
an anti-asphyxiation flow path provided between the first flow port of the conduit and the supplementary flow port via the first valve port of the valve body, and
wherein: a supplementary gas flow path is provided between the first flow port and/or the second flow port and the supplementary flow port via a supplementary valve port of the valve body, and wherein the valve body and/or conduit is configured such that the supplementary gas flow path is permanently open.
11. The conduit connector assembly of claim 1 wherein the supplementary valve port is formed on the valve body.
AND
18. A conduit connector assembly for a respiratory therapy apparatus and configured to connect a patient interface to a gas delivery conduit, the conduit connector assembly comprising:
a conduit comprising a first flow port configured to be connected to the patient interface, and
a second flow port configured to be connected to the gas delivery conduit, and
a supplementary flow port configured to be in fluid communication with an ambient environment; and
a first valve port configured to be closed or opened by a valve flap, wherein the valve flap is configured to move between a first position and a second position relative to the first valve port,
the conduit and the valve flap being configured to selectively provide three flow paths through the conduit, being:
a therapy flow path between the second flow port of the conduit and the first flow port of the conduit;
an anti-asphyxiation flow path between the first flow port of the conduit and the supplementary flow port via the first valve port, and
wherein: a supplementary gas flow path is provided between the first flow port and/or the second flow port and the supplementary flow port via a supplementary valve port, and wherein the supplementary gas flow path is permanently open.
19. The conduit connector assembly of claim 18, wherein the supplementary valve port is provided on, or comprises part of: the valve flap; or a hollow valve body configured to be mounted on or in the conduit.
95. (New) The conduit connector assembly of claim 81 being an elbow conduit connector assembly, the conduit comprising an elbow conduit.
Excerpt from Claim 1:
“….the conduit, valve body and the valve flap being configured to selectively provide three flow paths through an elbow, being:…“
96. (New) A respiratory therapy system comprising the conduit connector assembly of claim 81.
Excerpt from Claims 1 and 18:
“… A conduit connector assembly for a respiratory therapy apparatus and configured to connect a patient interface to a gas delivery conduit, …”
Allowable Subject Matter
Claims 84 and 85 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, AND upon overcoming the rejection of the claims under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra D Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
Prosecution Insights