DETAILED ACTION
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 .
Prosecution Reopened
In view of the Appeal Brief filed on 11/07/2025, PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781
Status of Claims
Claims 1-6, 8, and 10-18 are currently pending. Claims 7 and 9 were previously cancelled. No new subject matter is added.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 8, and 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over Cook et al. (US 5470324 A), hereinafter referred to as “Cook”, and as evidence by (“Guide to the Uses and Applications of Polyisoprene in Industrial Settings”, published on October 28, 2022 on https://www.kentelastomer.com/guide-to-the-uses-and-applications-of-polyisoprene-in-industrial-settings/) and in view of Choksi (WO 9624791 A1).
Regarding claim 1, Cook teaches a collection device for receiving secretions suctioned out of a patient (see Figures 1-8, see Abstract), the collection device comprising:
a collecting unit (canister 48) comprising a closure (lid 62) and a bag (flexible liner 60), the collecting unit enclosing a collecting unit interior space (interior of canister 48), the closure defining an inner closure surface (inner surface of the lid 62), the bag defining an inner bag surface (inner surface of liner 60) and the inner closure surface and the inner bag surface delimiting the collecting unit interior space (flexible liner 60 fixedly and fluidly sealed within a circular groove formed in the bottom of the lid 62 so that the lid and the liner form a complete and closed container, see Figure 2), the collecting unit being configured to receive secretions in the collecting unit interior space (the liner with an unexpanded but expandable section preferably forms the standard volume for receiving fluid, for a given canister size, see Col.6 ln47-49);
a patient-side port (46), the patient side port defining a patient-side fluid connection interface (the patient port is slightly tapered to a narrower opening for accepting the collection tube 44,see Figure 1 and 5); and
a backflow barrier (flapper valve 84) for the patient-side port, wherein the backflow barrier comprises a blocking body (valve element 88) and a restoring force generator (flapper valve 84 is preferably a unitary polyisoprene material, see Col. 35-36); as evidence by kentelastomer.com, Polyisoprene is a resilient polymer with high tensile strength and good elasticity; therefore would have a natural restoring force) and is configured to be transferred into a passing state and into a blocking state (flapper valve is a one-way valve in the port for the fluid coming into the canister so as to allow fluid into the canister but to prevent fluid from exiting the canister through the port, see Col. 3 ln 25-33), wherein the patient-side fluid connection interface of the patient-side port (narrow opening of patient port 46) is configured to enable a patient-side fluid connection between a patient-side coupling unit (collecting tube 44) located outside the collecting unit and the collecting unit interior space (collecting tube 44 located outside of the collecting unit 48, see Figure 1), wherein the blocking body (88) is fastened to the inner closure surface of the closure (patient port 46 is located on lid 62 with the valve element 88 fastened to the inner surface of lid 62, see Figure 5), which inner closure surface of the closure faces the collecting unit interior space (inner surface of the lid 62 faces the interior of space of the canister 48, see Figures 1-5), wherein the backflow barrier (84), in the blocking state, at least partially closes the patient-side port at the inner closure surface and inhibits or at least reduces a flow of secretions out of the collecting unit interior space into the patient-side port (flapper valve prevents reflux of fluid from the interior of the liner along the passageway of the collection tube 44 and the flapper valve inhibits fluid flow through the collection tube when the valve is closed, such as after the vacuum has been removed, see Col. 8 ln 53-57), wherein the restoring force generator exerts a restoring force on the blocking body which acts for transferring the backflow barrier into the blocking state and for keeping the backflow barrier in the blocking state (as evidence by kentelastomer.com, the polyisoprene would have an natural elastic property that enact a restoring force of the material to return to its original state when deformed, i.e. flexed open for fluid flow), and wherein the backflow barrier is arranged such that a flow of secretions through the patient-side port into the collecting unit interior space brings about a transfer of the backflow barrier (the valve element 88 can extend to permit fluid flow through the flapper valve and into the interior of the liner, see Col. 8 ln 45-47), against the restoring force (against the natural elasticity of the polyisoprene), into the passing state in which passing state secretions can flow through the patient-side port into the collecting unit interior space (the flapper valve retainer 82 is preferably cup-shaped with a circular opening 92 through which the valve element 88 can extend to permit fluid flow through the flapper valve and into the interior of the liner, see Col. 8 ln 44-47).
However, Cook does not explicitly disclose wherein the blocking body is configured as a rigid flap, and the restoring force generator, is mechanically connected to the closure and to the flap, wherein the flap is movable back and forth between a passing position, which brings about the passing state, and a blocked blocking position, which brings about a blocking state in relation to the closure, and wherein the restoring force generator acts to move the flap into the blocked blocking position and to hold the flap in the blocked blocking position.
Choksi teaches a collection device for receiving secretions suctioned out of a patient (blood is drained from a patient's wound site or urine drained from a patient's bladder into a fluid drainage or collection bag via a drainage line, see Col. 1 ln 12-15), the collection device comprising: a blocking body (valve member 54), wherein the blocking body is configured as a rigid body (disc portion 60), and the restoring force generator (connecting arm portions 66), is mechanically connected to the closure and to the body, wherein the body is movable back and forth between a passing position, which brings about the passing state (an open position wherein the disc portion 60 is separated from the orifice 20 and fluid flows from the orifice 20 into the interior chamber 52 and orifice 36 via the side openings 68 of the valve member 54, see Col. 9 ln 21-24), and a blocked blocking position, which brings about a blocking state in relation to the closure (when in the closed position, the connecting arm portions 66 are flexed slightly toward the second housing half 16, with the inner surface 62 of the disc portion 66 being abutted against the annular shoulder 24 of the first housing half 14, thus covering and sealing the orifice 20, see Col. 9 ln 28-33), and wherein the restoring force generator acts to move the flap into the blocked blocking position and to hold the flap in the blocked blocking position (the resiliency of the connecting arm portions 66 causes the disc portion 60 to quickly return to its sealed engagement with the shoulder 24 when flow in the direction NF is discontinued, see Col. 11 ln 9-13).
Cook and Choksi are analogous art because both disclose a unidirectional flow valve in medical fluid handling applications.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the flapper valve of Cook and further include wherein the blocking body is rigid, and the restoring force generator, is mechanically connected to the closure and to the flap, wherein the flap is movable back and forth between a passing position, which brings about the passing state, and a blocked blocking position, which brings about a blocking state in relation to the closure, and wherein the restoring force generator acts to move the flap into the blocked blocking position and to hold the flap in the blocked blocking position, as taught by Choksi. Choksi teaches it beneficial for the device to allow for unidirectional flow valve which is adapted to open under low pressure and provide a high flow rate with no retrograde leakage (see Col. 1 ln 4-7).
Regarding claim 3, Cook and Choksi teaches all of the limitations, as discussed above in claim 2 and Cook further wherein when the backflow barrier is in the blocking state (flapper valve 84 is closed), the blocking body extends in a plane (see Figure 5), which is at right angles or is arranged obliquely to a flow direction of secretions through the patient-side port (see Figure 5) and with the backflow barrier in the passing state, the blocking body protrudes into the collecting unit interior space (circular wall 80 surrounds the patient port and extends downwardly from the underside of the lid to the interior of the liner for accepting, on the outside thereof, a flapper valve retainer 82 and for accepting, within the interior thereof, a flapper valve 84, see Col. 8 ln 31-36; see Figure 5) (therefore when the flapper valve is an open position extends into the interior of the canister 48).
Regarding claim 4, Cook and Choksi teaches all of the limitations, as discussed above in claim 1 and Cook further teaches wherein an opening (92) is formed in the closure through which the patient-side port is in a fluid connection with the collecting unit interior space (see Figures 5 and 8),
wherein the blocking body is fastened to a surface of the closure at a spaced location from the opening (see Figure 5).
Regarding claim 5, Cook and Choksi teaches all of the limitations, as discussed above in claim 1 and Cook further teaches wherein with the backflow barrier being in the passing state (flapper valve is open), the blocking body engages with a stream of secretions (it is to be understood when the flapper valve is an open position it comes into contact with medical waste), which stream flow into the collecting unit interior space, and changes a direction of the stream of secretions (it is understood that the flow path of medical secretions can change directions when comping into contact with flapper valve 84).
Regarding claim 6, Cook and Choksi teaches all of the limitations, as discussed above in claim 1 and Cook further teaches wherein the blocking body is configured as a reversibly deformable closing element (flapper valve 84 is preferably a unitary polyisoprene material, see Col. 35-36); as evidence by kentelastomer.com, Polyisoprene is a resilient polymer with high tensile strength and good elasticity; therefore would have a natural restoring force),
wherein the closing element in a non-deformed state is in a blocking position (see Figure 5), which brings about the blocking state (flapper valve 84 closed), and in a deformed state is in a passing position (the polyisoprene flapper valve is open), which brings about the passing state,
wherein the closing element in the blocking position is in contact with the closure (flapper valve 84 is contact with lid 62 when closed, see Figure 5) and
wherein the closing element in case of a deformation exerts a restoring force (as evidence by kentelastomer.com, the polyisoprene would have natural elastic property that enacts a restoring force of the material to return to its original state when deformed, i.e. flexed open for fluid flow), acting against the deformation and thereby acting to bring the closing element into the blocking position (natural elastic force to close the polyisoprene flapper valve, as discussed above).
Regarding claim 8, Cook and Choksi teaches all of the limitations, as discussed above in claim 1 and Cook further teaches wherein the bag is expandable (the liner 60 preferably includes an enlargeable or expandable wall portion 64, see Figure 19),
wherein an expansion of the bag brings about a bag restoring force (natural restoring force of a flexible bag when filled), which acts to reduce the volume of the bag (it is to be understood that the expansion of a flexible bag will have a natural elastic restoring force to return to its initial unexpanded state),
wherein the collection device (40) is configured such that the bag restoring force, which is brought about by an expansion of the bag, brings about secretions in the collecting unit interior space being pushed against the blocking body (the natural elastic restoring force of the flexible liner 60 will exert a force on the fluids within and cause it to enter an area with less force, in this case, upwards towards the opening of the patient port towards the flapper valve 84) and transferring the backflow barrier into the blocking state and keeping the backflow barrier in the blocking state (flapper valve 84, when not fully in a closed state can be force onto a closed state by the fluid force acting up it).
Regarding claim 10, Cook teaches A system comprising: a collection device for medical use (see Figures 1-8, see Abstract) comprising:
a collecting unit (see Figure 2) comprising a closure (lid 62) and a bag (flexible liner 60), the collecting unit enclosing a collecting unit interior space (interior of canister 48), the collecting unit being configured to receive secretions in the collecting unit interior space (the liner with an unexpanded but expandable section preferably forms the standard volume for receiving fluid, for a given canister size, see Col.6 ln 47-49) and the closure defining an inner closure surface (inner surface of the lid 62), the bag defining an inner bag surface (inner surface of liner 60) and the inner closure surface and the inner bag surface delimiting the collecting unit interior space (flexible liner 60 fixedly and fluidly sealed within a circular groove formed in the bottom of the lid 62 so that the lid and the liner form a complete and closed container, see Figure 2);
a patient-side port (46) configured to establish a patient-side fluid connection between a patient-side coupling unit located outside the collecting unit and the collecting unit interior space (the patient port is slightly tapered to a narrower opening for accepting the collection tube 44, see Figure 1 and 5), the patient side port defining a patient-side fluid connection interface (narrow opening of patient port 46); and a backflow barrier for the patient-side port (flapper valve 84), the backflow barrier comprising a blocking body (88) and a restoring force generator (flapper valve 84 is preferably a unitary polyisoprene material, see Col. 35-36); as evidence by kentelastomer.com, Polyisoprene is a resilient polymer with high tensile strength and good elasticity; therefore would have a natural restoring force) and being configured to be transferred into a passing state and into a blocking state (flapper valve is a one-way valve in the port for the fluid coming into the canister so as to allow fluid into the canister but to prevent fluid from exiting the canister through the port, see Col. 3 ln 25-33), wherein the patient-side fluid connection interface of the patient-side port (narrow opening of patient port 46) is configured to enable a patient-side fluid connection between a patient-side coupling unit (collecting tube 44) located outside the collecting unit and the collecting unit interior space (collecting tube 44 located outside of the collecting unit 48, see Figure 1), the blocking body (88) being fastened to the inner closure surface of the closure (patient port 46 is located on lid 62 with the valve element 88 fastened to the inner surface of lid 62, see Figure 5), which inner closure surface of the closure is directed towards the collecting unit interior space (inner surface of the lid 62 faces the interior of space of the canister 48, see Figures 1-5), in the blocking state, the blocking body (88) at least partially closing the patient-side port at the inner closure surface to inhibit or at least reduce a flow of secretions out of the collecting unit interior space into the patient-side port (flapper valve prevents reflux of fluid from the interior of the liner along the passageway of the collection tube 44 and the flapper valve inhibits fluid flow through the collection tube when the valve is closed, such as after the vacuum has been removed, see Col. 8 ln 53-57), the restoring force generator exerting a restoring force on the blocking body which acts for transferring the backflow barrier into the blocking state and for keeping the backflow barrier in the blocking state (as evidence by kentelastomer.com, the polyisoprene would be have natural elastic property that enact a restoring force of the material to return to its original state when deformed, i.e. flexed open for fluid flow), and wherein the backflow barrier is arranged such that a flow of secretions through the patient-side port into the collecting unit interior space brings about a transfer of the backflow barrier (the valve element 88 can extend to permit fluid flow through the flapper valve and into the interior of the liner, see Col. 8 ln 45-47), against the restoring force (against the natural elasticity of the polyisoprene, as taught above), into the passing state in which passing state secretions can flow through the patient-side port into the collecting unit interior space (the flapper valve retainer 82 is preferably cup-shaped with a circular opening 92 through which the valve element 88 can extend to permit fluid flow through the flapper valve and into the interior of the liner, see Col. 8 ln 44-47);
a container (canister 48); and
a device-side port (vacuum port 54), wherein the container accommodates and carries the collecting unit (canister 48 holds the liner 60, see Figure 2) and wherein the device-side port is configured to enable a vacuum fluid connection to be established between the collecting unit interior space and a vacuum source outside the container (The vacuum pump 42 is coupled to vacuum ports 54 on the first canister 48 for providing the required pressure differential, as is known to those skilled in the art, see Figure 1; Col. 6 ln 24-38).
However, Cook does not explicitly disclose wherein the blocking body is configured as a rigid body, and the restoring force generator, is mechanically connected to the closure and to the flap, wherein the flap is movable back and forth between a passing position, which brings about the passing state, and a blocked blocking position, which brings about a blocking state in relation to the closure, and wherein the restoring force generator acts to move the flap into the blocked blocking position and to hold the body in the blocked blocking position.
Choksi teaches a collection device for receiving secretions suctioned out of a patient (blood is drained from a patient's wound site or urine drained from a patient's bladder into a fluid drainage or collection bag via a drainage line, see Col. 1 ln 12-15), the collection device comprising: a blocking body (valve member 54), wherein the blocking body is configured as a rigid body (disc portion 60), and the restoring force generator (connecting arm portions 66), is mechanically connected to the closure and to the body, wherein the body is movable back and forth between a passing position, which brings about the passing state (an open position wherein the disc portion 60 is separated from the orifice 20 and fluid flows from the orifice 20 into the interior chamber 52 and orifice 36 via the side openings 68 of the valve member 54, see Col. 9 ln 21-24), and a blocked blocking position, which brings about a blocking state in relation to the closure (when in the closed position, the connecting arm portions 66 are flexed slightly toward the second housing half 16, with the inner surface 62 of the disc portion 66 being abutted against the annular shoulder 24 of the first housing half 14, thus covering and sealing the orifice 20, see Col. 9 ln 28-33), and wherein the restoring force generator acts to move the flap into the blocked blocking position and to hold the flap in the blocked blocking position (the resiliency of the connecting arm portions 66 causes the disc portion 60 to quickly return to its sealed engagement with the shoulder 24 when flow in the direction NF is discontinued, see Col. 11 ln 9-13).
Cook and Choksi are analogous art because both disclose a unidirectional flow valve in medical fluid handling applications.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the flapper valve of Cook and further include wherein the blocking body is rigid, and the restoring force generator, is mechanically connected to the closure and to the flap, wherein the flap is movable back and forth between a passing position, which brings about the passing state, and a blocked blocking position, which brings about a blocking state in relation to the closure, and wherein the restoring force generator acts to move the flap into the blocked blocking position and to hold the flap in the blocked blocking position, as taught by Choksi. Choksi teaches it is beneficial for the device to allow for a unidirectional flow valve which is adapted to open under low pressure and provide a high flow rate with no retrograde leakage (see Col. 1 ln 4-7).
Regarding claim 11, Cook and Choksi teaches all of the limitations, as discussed above in claim 10 and Cook further teaches the vacuum source (24); and
the patient-side coupling unit (narrow opening of patient port 46), wherein the patient-side coupling unit is fluid-tight connected to the patient side port (the narrow portion of port 46 configured to couple to collection tube 44 to collect fluid, see Col. 6 ln 20-23), wherein the vacuum source is fluid tightly connected to the device-side port (vacuum source 42 is configured to couple to vacuum port 54 to provide appropriate negative pressure, see Col. 24-30), wherein the patient-side fluid connection is established or establishable between the patient-side coupling unit (port 46 connected to tubing 44, see Figure 1) and the collecting unit interior space (patient port 46 has an opening to the interior of see Figure 5) and leads through the patient-side port (the vacuum system pulls fluid into the interior of the liner through the patient port 46) and into the volume defined by the liner, see Figures 2-4) and wherein the vacuum fluid connection is established or establishable between the vacuum source and the collecting unit interior space and wherein the vacuum fluid connection leads through the device side port (vacuum source 42 is configured to couple to vacuum port 54 to provide appropriate negative pressure within the interior of canister 48, see Figure 1; Col. 7 ln 25-44).
Regarding claim 12, Cook teaches a process for receiving secretions suctioned out of a patient (see Figures 1-8, see Abstract), the process comprising the steps of:
providing a collection device (see Figures 1-8), which collection device comprises a collecting unit (canister 48), a patient-side port (46), the patient side port defining a patient-side fluid connection interface (the patient port is slightly tapered to a narrower opening for accepting the collection tube 44,see Figure 1 and 5), and a backflow barrier (flapper valve 84) for the patient-side port (see Figure 5), wherein the collecting unit comprises a closure (lid 62), and a bag (flexible liner 60) and encloses a collecting unit interior space (interior space of canister 48), the closure defining an inner closure surface (inner surface of lid 62), the bag defining an inner bag surface (inner surface of flexible liner 60) and the inner closure surface and the inner bag surface delimiting the collecting unit interior space (flexible liner 60 fixedly and fluidly sealed within a circular groove formed in the bottom of the lid 62 so that the lid and the liner form a complete and closed container, see Figure 2), wherein the backflow barrier comprises a blocking body (88) and a restoring force generator (flapper valve 84 is preferably a unitary polyisoprene material, see Col. 35-36)(as evidence by kentelastomer.com, Polyisoprene is a resilient polymer with high tensile strength and good elasticity; therefore would have a natural restoring force) and is configured to be transferred into a passing state and into a blocking state (flapper valve is a one-way valve in the port for the fluid coming into the canister so as to allow fluid into the canister but to prevent fluid from exiting the canister through the port, see Col. 3 ln 25-33), wherein the blocking body is fastened to the inner closure surface of the closure (patient port 46 is located on lid 62 with the valve element 88 fastened to the inner surface of lid 62, see Figure 5), which inner closure surface of the closure faces the collecting unit interior space at the inner closure surface (inner surface of the lid 62 faces the interior of space of the canister 48, see Figures 1-5), and in the blocking state, the blocking body at least partially closing the patient-side port at the inner closure surface to inhibit or at least reduce a flow of secretions out of the collecting unit interior space into the patient-side port (flapper valve prevents reflux of fluid from the interior of the liner along the passageway of the collection tube 44 and the flapper valve inhibits fluid flow through the collection tube when the valve is closed, such as after the vacuum has been removed, see Col. 8 ln 53-57);
exerting, with the restoring force generator a restoring force, which keeps the backflow barrier in the blocking state (as evidence by kentelastomer.com, the polyisoprene would be have natural elastic properties that enact a restoring force of the material to return to its original state when deformed, i.e. flexed open for fluid flow);
connecting the patient-side port to a patient-side coupling (the narrow portion of port 46 configured to couple to collection tube 44 to collect fluid, see Col. 6 ln 20-23), so that with the patient-side fluid connection interface, a patient-side fluid connection is established (fluid connection is established at port 46) between a patient-side coupling unit (tubing 44) located outside the collecting unit and the collecting unit interior space (see Figure 1), wherein the patient-side fluid connection leads through the patient-side port (see Figure 1-5);
bringing about a flow of secretions through the patient-side fluid connection into the collecting unit (vacuum system pulls fluid into the interior of the liner through the patient port 46 and into the volume defined by the liner, see Figure 2-4)
with the backflow barrier being transferred against the restoring force into the passing state by the brought-about flow of secretions through the patient-side port into the collecting unit interior space (the valve element 88 can extend to permit fluid flow through the flapper valve and into the interior of the liner, see Col. 8 ln 45-47);
terminating the flow of secretions into the collecting unit (fluid flow into the interior of canister 48);
with the restoring force again transferring again the backflow barrier into the blocking state (as evidence by kentelastomer.com, the polyisoprene would have natural elastic properties that enact a restoring force of the material to return to its original state when deformed, i.e. closed in its original state); and
with the backflow barrier in the blocking state completely or at least partially closing the patient-side port and as a result, inhibiting or at least reducing, compared with the passing state, a flow of secretions out of the collecting unit interior space through the patient-side port (flapper valve prevents reflux of fluid from the interior of the liner along the passageway of the collection tube 44 and the flapper valve inhibits fluid flow through the collection tube when the valve is closed, such as after the vacuum has been removed, see Col. 8 ln 53-57).
However, Cook does not explicitly disclose wherein the blocking body is configured as a rigid body, and the restoring force generator, is mechanically connected to the closure and to the flap, wherein the flap is movable back and forth between a passing position, which brings about the passing state, and a blocked blocking position, which brings about a blocking state in relation to the closure, and wherein the restoring force generator acts to move the flap into the blocked blocking position and to hold the body in the blocked blocking position.
Choksi teaches a collection device for receiving secretions suctioned out of a patient (blood is drained from a patient's wound site or urine drained from a patient's bladder into a fluid drainage or collection bag via a drainage line, see Col. 1 ln 12-15), the collection device comprising: a blocking body (valve member 54), wherein the blocking body is configured as a rigid body (disc portion 60), and the restoring force generator (connecting arm portions 66), is mechanically connected to the closure and to the body, wherein the body is movable back and forth between a passing position, which brings about the passing state (an open position wherein the disc portion 60 is separated from the orifice 20 and fluid flows from the orifice 20 into the interior chamber 52 and orifice 36 via the side openings 68 of the valve member 54, see Col. 9 ln 21-24), and a blocked blocking position, which brings about a blocking state in relation to the closure (when in the closed position, the connecting arm portions 66 are flexed slightly toward the second housing half 16, with the inner surface 62 of the disc portion 66 being abutted against the annular shoulder 24 of the first housing half 14, thus covering and sealing the orifice 20, see Col. 9 ln 28-33), and wherein the restoring force generator acts to move the flap into the blocked blocking position and to hold the flap in the blocked blocking position (the resiliency of the connecting arm portions 66 causes the disc portion 60 to quickly return to its sealed engagement with the shoulder 24 when flow in the direction NF is discontinued, see Col. 11 ln 9-13).
Cook and Choksi are analogous art because both disclose a unidirectional flow valve in medical fluid handling applications.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the flapper valve of Cook and further include wherein the blocking body is rigid, and the restoring force generator, is mechanically connected to the closure and to the flap, wherein the flap is movable back and forth between a passing position, which brings about the passing state, and a blocked blocking position, which brings about a blocking state in relation to the closure, and wherein the restoring force generator acts to move the flap into the blocked blocking position and to hold the flap in the blocked blocking position, as taught by Choksi. Choksi teaches it is beneficial for the device to allow for a unidirectional flow valve which is adapted to open under low pressure and provide a high flow rate with no retrograde leakage (see Col. 1 ln 4-7).
Regarding claim 13, Cook and Choksi teaches all of the limitations, as discussed above in claim 1 and Cook further teaches wherein the inner closure surface (inner surface of lid 62) comprises an opening to the interior space (see below) as an opening of the inner bag surface (circle wall 80 extends into the liner, see Col. 8 ln 32-36; therefore the opening of flapper valve 84 creates an opening for the liner 60) and the inner closure surface (see below); and wherein the backflow barrier is in contact with the inner closure surface and covers and blocks the opening to the interior space in the blocking state (see Figure 5).
Regarding claim 14, Cook and Choksi teaches all of the limitations, as discussed above in claim 13 and Cook further teaches wherein the patient-side port is a hollow structure fixed to the cover (patient port 46 is a hollow solid structure fixed to cover 62, see Figure 5); and wherein the hollow structure defines a fluid tight passage between the inner closure surface and the patient-side fluid connection interface (vacuum system pulls fluid into the interior of the liner through the patient port 46, see Col. 7 ln 33-34; therefore would need to fluid tight to provide suction).
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Regarding claim 15, Cook and Choksi teaches all of the limitations, as discussed above in claim 10 and Cook further teaches wherein the inner closure surface (inner surface of lid 62) comprises an opening to the interior space (see above) as an opening of the inner bag surface (circle wall 80 extends into the liner, see Col. 8 ln 32-36; therefore the opening of flapper valve 84 creates an opening for the liner 60) and the inner closure surface (see above); and wherein the backflow barrier is in contact with the inner closure surface and covers and blocks the opening to the interior space in the blocking state (see Figure 5).
Regarding claim 16, Cook and Choksi teaches all of the limitations, as discussed above in claim 15 and Cook further teaches wherein the patient-side port is a hollow structure fixed to the cover (patient port 46 is a hollow solid structure fixed to cover 62, see Figure 5); and wherein the hollow structure defines a fluid tight passage between the inner closure surface and the patient-side fluid connection interface (vacuum system pulls fluid into the interior of the liner through the patient port 46, see Col. 7 ln 33-34; therefore would need to fluid tight to provide suction).
Regarding claim 17, Cook and Choksi teaches all of the limitations, as discussed above in claim 12 and Cook further teaches wherein the inner closure surface (inner surface of lid 62) comprises an opening to the interior space (see above) as an opening of the inner bag surface (circle wall 80 extends into the liner, see Col. 8 ln 32-36; therefore the opening of flapper valve 84 creates an opening for the liner 60) and the inner closure surface (see above); and wherein the backflow barrier is in contact with the inner closure surface and covers and blocks the opening to the interior space in the blocking state (see Figure 5).
Regarding claim 18, Cook and Choksi teaches all of the limitations, as discussed above in claim 17 and Cook further teaches wherein the patient-side port is a hollow structure fixed to the cover (patient port 46 is a hollow solid structure fixed to cover 62, see Figure 5); and wherein the hollow structure defines a fluid tight passage between the inner closure surface and the patient-side fluid connection interface (vacuum system pulls fluid into the interior of the liner through the patient port 46, see Col. 7 ln 33-34; therefore would need to fluid tight to provide suction).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERIC RASSAVONG/ (5/19/2026)Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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