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 .
Response to Amendment
The amendment filed on 5/11/2026 has been entered. Claims 1-23, 26, 28-34, and 51-52 are pending in the application. Claim 52 is new. Claims 24-25, 27, and 35-50 are cancelled. The amendments to the claims overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed on 1/12/2026.
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.
Claims 1, 10, 12-14, 19-20, 22-23, 26, 30-32, 34, and 51-52 are rejected under 35 U.S.C. 103 as being unpatentable over Kolbel (WO 2017/072592 A1) in view of LaHaye (US 2009/0277478 A1).
Regarding claim 1, Kolbel discloses a system for flushing a lumen of a medical device (introducing assembly 8) to remove air (see Figs. 1-3, page 7 lines 17-28), comprising:
a first fluid delivery device (syringe, pump, or container of CO2 or bio-inert gas, see page 12 lines 4-10, page 13 lines 3-14) adapted to provide a flow of a flushing gas from a pressurized source (chamber of syringe, pump, or container which holds the CO2 or bio-inert gas, see page 12 lines 4-10, page 13 lines 3-14) of the flushing gas (see Fig. 3, page 12 lines 4-10, page 13 lines 3-14);
a second fluid delivery device (syringe, pump, or container of PFC or saline solution, see page 12 lines 4-10, page 13 lines 15-20) adapted to provide a flow of a flushing liquid from a source (chamber of syringe, pump, or container which holds the PFC or saline solution, see page 12 lines 4-10, page 13 lines 15-20) of the flushing liquid (see Fig. 3, page 12 lines 4-10, page 13 lines 15-20); and,
at least one fluid coupling (first port 90a) for connecting the first fluid delivery device (syringe, pump, or container of CO2 or bio-inert gas, see page 12 lines 4-10, page 13 lines 3-14) and the second fluid delivery device (syringe, pump, or container of PFC or saline solution, see page 12 lines 4-10, page 13 lines 15-20) to the lumen of the medical device (introducing assembly 8) (see Figs. 1-3, page 13 lines 4-27).
However, Kolbel fails to state the first fluid delivery device adapted to provide a pulsatile flow of the flushing gas, wherein the first fluid delivery device comprises a flow restrictor that is actuatable to restrict a flow of the flushing gas to thereby pulse the flow of the flushing gas.
LaHaye teaches a system for flushing a lumen of a medical device to remove air (see par. [0003], [0009]-[0010]) comprising a first fluid delivery device (diaphragm pump and electric motor, see par. [0010], [0019]) adapted to provide a pulsatile flow of the flushing gas (see par. [0009]-[0010], [0019]), wherein the first fluid delivery device (diaphragm pump and electric motor, see par. [0010], [0019]) comprises a flow restrictor (diaphragm pump, see par. [0019]) that is actuatable to restrict a flow of the flushing gas to thereby pulse the flow of the flushing gas (see par. [0019]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kolbel to include the first fluid delivery device adapted to provide a pulsatile flow of the flushing gas, wherein the first fluid delivery device comprises a flow restrictor that is actuatable to restrict a flow of the flushing gas to thereby pulse the flow of the flushing gas, as taught by LaHaye, in order to allow for the flow of the flushing gas to be electrically controlled (see LaHaye par. [0019]) and because pulsating flow is superior for cleaning systems (see LaHaye par. [0007]).
Regarding claim 10, modified Kolbel teaches the system of claim 1 substantially as claimed. Modified Kolbel further teaches wherein the first fluid delivery device (Kolbel, syringe, pump, or container of CO2 or bio-inert gas, see page 12 lines 4-10, page 13 lines 3-14) comprises a user actuatable gas control mechanism for providing the pulsatile flow of the flushing gas (see previous modifications in rejection of claim 1 above, see LaHaye par. [0010], [0019], [0022], the user actuates a switch to initiate the pulsed flow of the gas).
Regarding claim 12, modified Kolbel teaches the system of claim 1 substantially as claimed. However, modified Kolbel fails to state wherein the second fluid delivery device comprises a user actuatable liquid delivery mechanism for providing a pulsatile flow of the flushing liquid, wherein the user actuatable liquid delivery mechanism is a trigger.
LaHaye further teaches wherein the second fluid delivery device (liquid pump, see par. [0010] and [0016]) comprises a user actuatable liquid delivery mechanism for providing a pulsatile flow of the flushing liquid (see par. [0010], [0016], [0021], the user actuates a switch to initiate the pulsed flow of the liquid), wherein the user actuatable liquid delivery mechanism is a trigger (see par. [0010], [0016], [0021], the user actuates a switch to initiate the pulsed flow of the liquid).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel to include wherein the second fluid delivery device comprises a user actuatable liquid delivery mechanism for providing a pulsatile flow of the flushing liquid, wherein the user actuatable liquid delivery mechanism is a trigger, as taught by LaHaye, because pulsating flow is superior for cleaning systems (see LaHaye par. [0007]).
Regarding claim 13, modified Kolbel teaches the system of claim 12 substantially as claimed. Modified Kolbel further teaches wherein the second fluid delivery device (LaHaye, liquid pump, see par. [0010] and [0016], see previous modifications in rejection of claim 12 above) comprises a user actuatable positive displacement pump (see LaHaye par. [0016] and [0021], peristaltic pumps are positive displacement pumps and the user actuates a switch to operate the pump, see previous modifications in rejection of claim 12 above).
Regarding claim 14, modified Kolbel teaches the system of claim 13 substantially as claimed. Modified Kolbel further teaches wherein the user actuatable positive displacement pump (LaHaye, see par. [0016] and [0021], peristaltic pumps are positive displacement pumps) comprises a compression chamber (LaHaye, see par. [0013] and [0016], peristaltic pumps are roller/compression-type pumps and the tubing is threaded through a channel of the pump such that the channel of the pump forms the compression chamber, see previous modifications in rejection of claim 12 above).
Regarding claim 19, modified Kolbel teaches the system of claim 1 substantially as claimed. Kolbel further teaches wherein the first fluid delivery device (syringe, pump, or container of CO2 or bio-inert gas, see page 12 lines 4-10, page 13 lines 3-14) and the second fluid delivery device (syringe, pump, or container of PFC or saline solution, see page 12 lines 4-10, page 13 lines 15-20) are comprised in a single device (see Kolbel Fig. 3, page 12 lines 4-10, page 13 lines 15-20, the entire system operates as a single device).
Regarding claim 20, modified Kolbel teaches the system of claim 1 substantially as claimed. Kolbel further teaches wherein the first fluid delivery device (syringe, pump, or container of CO2 or bio-inert gas, see page 12 lines 4-10, page 13 lines 3-14) is couplable to the at least one fluid coupling (first port 90a) via the second fluid delivery device (syringe, pump, or container of PFC or saline solution, see page 12 lines 4-10, page 13 lines 15-20) (see Figs. 1-3, page 13 lines 4-27).
Regarding claim 22, modified Kolbel teaches the system of claim 1 substantially as claimed. However, modified Kolbel fails to state a sterile filter positionable in-line between the first fluid delivery device and the pressurized source of the flushing gas.
LaHaye further teaches a sterile filter positionable in-line between the first fluid delivery device (gas pump, see par. [0010] and [0019]) and the pressurized source of the flushing gas (see par. [0019]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel to include a sterile filter positionable in-line between the first fluid delivery device and the pressurized source of the flushing gas, as taught by LaHaye, in order to remove particulate matter such that the medical device is sterile or nearly sterile (see LaHaye par. [0019]).
Regarding claim 23, Kolbel discloses a method for flushing a lumen of a medical device (introducing assembly 8) to remove air prior to introducing the medical device (introducing assembly 8) within a body (see Figs. 1-3, page 7 lines 17-28), comprising:
flushing the lumen (lumen of introducing assembly 8) with a supply of a flushing gas from a pressurized source (chamber of syringe, pump, or container which holds the CO2 or bio-inert gas, see page 12 lines 4-10, page 13 lines 3-14) of the flushing gas via a first fluid delivery device (syringe, pump, or container of CO2 or bio-inert gas, see page 12 lines 4-10, page 13 lines 3-14) (see Fig. 3, page 12 lines 4-10, page 13 lines 3-14), and with a supply of a flushing liquid from a source (chamber of syringe, pump, or container which holds the PFC or saline solution, see page 12 lines 4-10, page 13 lines 15-20) of the flushing liquid via a second fluid delivery device (syringe, pump, or container of PFC or saline solution, see page 12 lines 4-10, page 13 lines 15-20) (see Fig. 3, page 12 lines 4-10, page 13 lines 15-20).
However, Kolbel fails to state flushing the lumen with a pulsed supply of the flushing gas, and actuating a flow restrictor to restrict a flow of the flushing gas of the first fluid delivery device.
LaHaye teaches a method for flushing a lumen of a medical device to remove air prior to introducing the medical device within a body (see par. [0003], [0009]-[0010]) comprising flushing the lumen with a pulsed supply of the flushing gas (see par. [0009]-[0010], [0019]), and actuating a flow restrictor (diaphragm pump, see par. [0019]) to restrict a flow of the flushing gas of the first fluid delivery device (diaphragm pump and electric motor, see par. [0010], [0019]) (see par. [0019]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kolbel to include flushing the lumen with a pulsed supply of the flushing gas, and actuating a flow restrictor to restrict a flow of the flushing gas of the first fluid delivery device, as taught by LaHaye, in order to allow for the flow of the flushing gas to be electrically controlled (see LaHaye par. [0019]) and because pulsating flow is superior for cleaning systems (see LaHaye par. [0007]).
Regarding claim 26, modified Kolbel teaches the system of claim 23 substantially as claimed. Kolbel further teaches wherein the flushing gas is carbon dioxide (see page 12 lines 4-10, page 13 lines 3-14).
Regarding claim 30, modified Kolbel teaches the system of claim 23 substantially as claimed. Kolbel further teaches wherein the flushing liquid is saline (see page 12 lines 4-10, page 13 lines 15-20).
Regarding claim 31, modified Kolbel teaches the system of claim 23 substantially as claimed. Kolbel further teaches wherein the flushing liquid is degassed (see page 12 lines 4-10, page 13 lines 15-20, page 4 lines 23-30).
Regarding claim 32, modified Kolbel teaches the system of claim 23 substantially as claimed. Kolbel further teaches wherein the flushing liquid is a perfluorocarbon solution (see page 12 lines 4-10, page 13 lines 15-20).
Regarding claim 34, modified Kolbel teaches the system of claim 23 substantially as claimed. Modified Kolbel further teaches wherein flushing the lumen comprises coupling the lumen to the pulsed supply of the flushing gas (see Kolbel page 12 lines 4-10, page 13 lines 3-20, see LaHaye par. [0019], see previous modifications in rejection of claim 23 above).
Regarding claim 51, modified Kolbel teaches the system of claim 1 substantially as claimed. However, modified Kolbel fails to state wherein the second fluid delivery device is adapted to provide a pulsatile flow of the flushing liquid.
LaHaye further teaches wherein the second fluid delivery device (liquid pump, see par. [0010] and [0016]) is adapted to provide a pulsatile flow of the flushing liquid (see par. [0010], [0016], [0021]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel to include wherein the second fluid delivery device is adapted to provide a pulsatile flow of the flushing liquid, as taught by LaHaye, because pulsating flow is superior for cleaning systems (see LaHaye par. [0007]).
Regarding claim 52, Kolbel discloses a system for flushing a lumen of a medical device (introducing assembly 8) to remove air (see Figs. 1-3, page 7 lines 17-28), comprising:
a gas container (chamber of syringe, pump, or container which holds the CO2 or bio-inert gas, see page 12 lines 4-10, page 13 lines 3-14) storing a flushing gas in a compressed state (see page 12 lines 4-10, page 13 lines 3-14);
a first fluid delivery device (syringe, pump, or container of CO2 or bio-inert gas, see page 12 lines 4-10, page 13 lines 3-14) adapted to provide a flow of a flushing gas from the gas container (chamber of syringe, pump, or container which holds the CO2 or bio-inert gas, see page 12 lines 4-10, page 13 lines 3-14) (see Fig. 3, page 12 lines 4-10, page 13 lines 3-14);
a second fluid delivery device (syringe, pump, or container of PFC or saline solution, see page 12 lines 4-10, page 13 lines 15-20) adapted to provide a flow of a flushing liquid from a source (chamber of syringe, pump, or container which holds the PFC or saline solution, see page 12 lines 4-10, page 13 lines 15-20) of the flushing liquid (see Fig. 3, page 12 lines 4-10, page 13 lines 15-20); and,
a fluid coupling (first port 90a) for connecting the first fluid delivery device (syringe, pump, or container of CO2 or bio-inert gas, see page 12 lines 4-10, page 13 lines 3-14) and the second fluid delivery device (syringe, pump, or container of PFC or saline solution, see page 12 lines 4-10, page 13 lines 15-20) to the lumen of the medical device (introducing assembly 8) (see Figs. 1-3, page 13 lines 4-27).
However, Kolbel fails to state the first fluid delivery device adapted to provide a pulsatile flow of the flushing gas, wherein the first fluid delivery device comprises a flow restrictor that is actuatable to restrict a flow of the flushing gas to thereby pulse the flow of the flushing gas, wherein the flow restrictor is positioned between the gas container and the fluid coupling.
LaHaye teaches a system for flushing a lumen of a medical device to remove air (see par. [0003], [0009]-[0010]) comprising a first fluid delivery device (diaphragm pump and electric motor, see par. [0010], [0019]) adapted to provide a pulsatile flow of the flushing gas (see par. [0009]-[0010], [0019]), wherein the first fluid delivery device (diaphragm pump and electric motor, see par. [0010], [0019]) comprises a flow restrictor (diaphragm pump, see par. [0019]) that is actuatable to restrict a flow of the flushing gas to thereby pulse the flow of the flushing gas (see par. [0019]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kolbel to include the first fluid delivery device adapted to provide a pulsatile flow of the flushing gas, wherein the first fluid delivery device comprises a flow restrictor that is actuatable to restrict a flow of the flushing gas to thereby pulse the flow of the flushing gas, as taught by LaHaye, in order to allow for the flow of the flushing gas to be electrically controlled (see LaHaye par. [0019]) and because pulsating flow is superior for cleaning systems (see LaHaye par. [0007]). Such a modification would further teach that the flow restrictor (LaHaye, diaphragm pump, see par. [0019]) is positioned between the gas container (Kolbel, chamber of syringe, pump, or container which holds the CO2 or bio-inert gas, see page 12 lines 4-10, page 13 lines 3-14) and the fluid coupling (Kolbel, first port 90a) in order to properly direct the flow from the source of gas into the fluid coupling where the medical device is to be flushed (see Kolbel Figs. 3-5, page 12 lines 4-10, page 13 lines 3-14).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Kolbel (WO 2017/072592 A1) in view of LaHaye (US 2009/0277478 A1), as applied to claim 1 above, further in view of Richardson et al. (US 2005/0256447 A1).
Regarding claim 2, modified Kolbel teaches the system of claim 1 substantially as claimed. However, modified Kolbel fails to state wherein the restrictor is actuatable between an open position and a closed position to thereby pulse the flow of the flushing gas.
Richardson teaches a system (see Figs. 1-3 and 6) comprising a flow restrictor (catheter control apparatus within housing 10) actuatable between an open position and a closed position to thereby pulse a flow of the flushing fluid (see Figs. 1-3 and 6, par. [0073]-[0074], [0076], [0088], [0091], [0095]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel such that the flow restrictor is actuatable between an open position and a closed position to thereby pulse the flow of the flushing gas, as taught by Richardson, in order to provide the mechanism for creating the pulsatile flow through the system which can be electronically controlled based on sensed flow conditions of the system (see Richardson par. [0088]).
Regarding claim 3, modified Kolbel teaches the system of claim 1 substantially as claimed. However, modified Kolbel fails to state wherein the first fluid delivery device comprises a compression element configured to compress a flexible tube coupled to the pressurized source of the flushing gas at predetermined time intervals to thereby restrict the flow of the flushing gas through the flexible tube.
Richardson teaches a system (see Figs. 1-3 and 6) wherein the first fluid delivery device (catheter control apparatus within housing 10) comprises a compression element (valve actuators 7, see Fig. 1, par. [0073]-[0074]) configured to compress a flexible tube (resilient tube 1) coupled to the pressurized source of the fluid at predetermined time intervals to thereby restrict the flow of the fluid through the flexible tube (see Fig. 1, par. [0073]-[0074], [0093]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel to include wherein the first fluid delivery device comprises a compression element configured to compress a flexible tube coupled to the pressurized source of the flushing gas at predetermined time intervals to thereby restrict the flow of the flushing gas through the flexible tube, as taught by Richardson, in order to provide the mechanism for creating the pulsatile flow through the system which can be electronically controlled based on sensed flow conditions of the system (see Richardson par. [0088]).
Regarding claim 4, modified Kolbel teaches the system of claim 3 substantially as claimed. Modified Kolbel further teaches wherein the compression element (valve actuators 7 of Richardson, see Richardson Fig. 1, par. [0073]-[0074]) is reciprocally movable (see previous modifications in rejection of claim 3 above to incorporate the structure of the flow restrictor of Richardson into the flow restrictor of the first fluid delivery device of Kolbel, see Richardson Fig. 1, Richardson par. [0073]-[0074], valve actuators 7 open and close in the direction of the arrows in Fig. 1 which is a reciprocal back/forth movement).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kolbel (WO 2017/072592 A1) in view of LaHaye (US 2009/0277478 A1) and further in view of Richardson et al. (US 2005/0256447 A1), as applied to claim 4 above, and further in view of Naples et al. (US 2023/0218883 A1).
Regarding claim 5, modified Kolbel teaches the system of claim 4 substantially as claimed. However, modified Kolbel fails to expressly describe the structure for driving the compression element. Specifically, modified Kolbel fails to state wherein the compression element comprises a solenoid motor.
Naples teaches a system (see Figs. 1-8) comprising a compression element (pinch valve 300) comprising a solenoid motor (see par. [0156]-[0157]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel such that the compression element comprises a solenoid motor, as taught by Naples, because a solenoid motor is a type of conventional electromechanical motor which would provide the structure for driving the compression element (see Naples par. [0157]).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kolbel (WO 2017/072592 A1) in view of LaHaye (US 2009/0277478 A1) and further in view of Richardson et al. (US 2005/0256447 A1), as applied to claim 3 above, and further in view of Newell et al. (US 2017/0304605 A1).
Regarding claim 6, modified Kolbel teaches the system of claim 3 substantially as claimed. However, modified Kolbel fails to expressly describe the structure for driving the compression element. Specifically, modified Kolbel fails to state wherein the compression element comprises a rotatable cam.
Newell teaches a system (see Figs. 10-18) comprising a compression element (pinch clamp 200) comprising a rotatable cam (cam pin 235) (see par. [0046] and [0050]-[0052]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel such that the compression element comprises a rotatable cam, as taught by Newell, because a rotatable cam would provide the structure for driving the compression element (see Newell par. [0050]-[0052]).
Regarding claim 7, modified Kolbel teaches the system of claim 6 substantially as claimed. However, modified Kolbel fails to state wherein the rotatable cam is coupled to a torsion spring adapted to drive the rotatable cam.
Newell teaches a system (see Figs. 10-18) wherein the rotatable cam (cam pin 235) is coupled to a torsion spring (spring 250) adapted to drive the rotatable cam (cam pin 235) (see par. [0046] and [0050]-[0052]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel such that the rotatable cam is coupled to a torsion spring adapted to drive the rotatable cam, as taught by Newell, in order to generate a moment that forces the cam to rotate to drive the compression element (see Newell par. [0050]-[0052]).
Regarding claim 8, modified Kolbel teaches the system of claim 3 substantially as claimed. However, modified Kolbel fails to expressly describe the structure for driving the compression element. Specifically, modified Kolbel fails to state wherein the compression element is coupled to an electric motor configured to drive the compression element.
Newell teaches a system (see Figs. 10-18) comprising a compression element (pinch clamp 200) which is coupled to an electric motor (motor/drive unit 220) configured to drive the compression element (pinch clamp 200) (see par. [0046]-[0056]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel such that the compression element is coupled to an electric motor configured to drive the compression element, as taught by Newell, because an electric motor would provide the structure for driving the compression element (see Newell par. [0046]-[0056]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kolbel (WO 2017/072592 A1) in view of LaHaye (US 2009/0277478 A1) and further in view of Richardson et al. (US 2005/0256447 A1), as applied to claim 3 above, and further in view of Irish et al. (US 2021/0033204 A1).
Regarding claim 9, modified Kolbel teaches the system of claim 3 substantially as claimed. However, modified Kolbel fails to expressly describe the structure for driving the compression element. Specifically, modified Kolbel fails to state wherein the compression element is pneumatically drivable, wherein the compression element is pneumatically drivable by the flushing gas.
Irish teaches a system (see Figs. 4-6) comprising a compression element (compressor 2) which is pneumatically drivable (see par. [0039] and [0042]-[0045]), wherein the compression element (compressor 2) is pneumatically drivable by the flushing gas (see par. [0039] and [0042]-[0045]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel to include wherein the compression element is pneumatically drivable by the flushing gas, as taught by Irish, because a pneumatic system would provide the structure for driving the compression element (see Irish par. [0042]-[0045]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kolbel (WO 2017/072592 A1) in view of LaHaye (US 2009/0277478 A1), as applied to claim 1 above, further in view of Irish et al. (US 2021/0033204 A1).
Regarding claim 11, modified Kolbel teaches the system of claim 1 substantially as claimed. However, modified Kolbel fails to state a stand adapted to retain a pressurized source of the flushing gas in an upright position, wherein the stand comprises the first fluid delivery device.
Irish teaches a system (see Figs. 4-6) comprising a stand (triclamp 9) adapted to retain a pressurized source of the flushing gas in an upright position (see Figs. 4-6, par. [0036], [0039], [0045]), wherein the stand (triclamp 9) comprises the first fluid delivery device (housing 1) (see Figs. 4-6, par. [0036], [0039], [0045]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel to include a stand adapted to retain a pressurized source of the flushing gas in an upright position, wherein the stand comprises the first fluid delivery device, as taught by Irish, in order to hold the source of the flushing gas and the first fluid delivery device together (see Irish par. [0036]).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kolbel (WO 2017/072592 A1) in view of LaHaye (US 2009/0277478 A1), as applied to claims 13-14 above, further in view of Ambrosina et al. (US 2014/0148757 A1).
Regarding claim 15, modified Kolbel teaches the system of claim 14 substantially as claimed. However, modified Kolbel fails to expressly state wherein the user actuatable positive displacement pump comprises a one-way valve configured to allow a one-way flow of the flushing liquid from the source of the flushing liquid into the compression chamber.
Ambrosina teaches a system (see Figs. 1a and 5a-b) wherein the pump comprises a one-way valve (one-way or check valves 29) configured to allow a one-way flow of the flushing liquid from the source of the flushing liquid into the compression chamber (pumping chambers 19) (see Fig. 5b, par. [0051] and [0054]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel to include wherein the user actuatable positive displacement pump comprises a one-way valve configured to allow a one-way flow of the flushing liquid from the source of the flushing liquid into the compression chamber, as suggested by Ambrosina, in order to ensure that the flushing liquid flows only from the source of the flushing liquid in a single direction through the pump toward the patient (see Ambrosina par. [0051] and [0054]).
Regarding claim 16, modified Kolbel teaches the system of claim 13 substantially as claimed. However, modified Kolbel fails to expressly state wherein the user actuatable positive displacement pump comprises a one-way valve configured to allow a one-way flow of the flushing liquid from the user actuatable positive displacement pump towards the at least one fluid coupling.
Ambrosina teaches a system (see Figs. 1a and 5a-b) wherein the pump comprises a one-way valve (one-way or check valves 29) configured to allow a one-way flow of the flushing liquid from the pump towards the at least one fluid coupling (connector at distal/outlet end of tubing 8 toward patient) (see Figs. 1a and 5b, par. [0051] and [0054]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel to include wherein the user actuatable positive displacement pump comprises a one-way valve configured to allow a one-way flow of the flushing liquid from the user actuatable positive displacement pump towards the at least one fluid coupling, as suggested by Ambrosina, in order to ensure that the flushing liquid flows only from the source of the flushing liquid in a single direction through the pump toward the patient (see Ambrosina par. [0051] and [0054]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kolbel (WO 2017/072592 A1) in view of LaHaye (US 2009/0277478 A1), as applied to claim 13 above, further in view of Piehl et al. (US 10,016,564 B2).
Regarding claim 17, modified Kolbel teaches the system of claim 13 substantially as claimed. However, modified Kolbel fails to state wherein the user actuatable positive displacement pump comprises one or more resilient compression members arranged to reset the user actuatable liquid delivery mechanism to an initial position and/or draw the flushing liquid from the source of the flushing liquid.
Piehl teaches a system (see Fig. 1) wherein the user actuatable positive displacement pump (infusion device 10) comprises one or more resilient compression members (spring 55) arranged to reset the user actuatable liquid delivery mechanism (trigger 37) to an initial position and/or draw the flushing liquid from the source of the flushing liquid (syringe 48) (see Fig. 1, col. 15 lines 24-62).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel to include wherein the user actuatable positive displacement pump comprises one or more resilient compression members arranged to reset the user actuatable liquid delivery mechanism to an initial position and/or draw the flushing liquid from the source of the flushing liquid, as taught by Piehl, in order to return the user actuatable liquid delivery mechanism to the initial position when firing is complete after the user actuates the user actuatable liquid delivery mechanism (see Piehl col. 15 lines 24-62).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kolbel (WO 2017/072592 A1) in view of LaHaye (US 2009/0277478 A1), as applied to claim 1 above, further in view of Gillespie, Jr. et al. (US 2014/0046125 A1).
Regarding claim 18, modified Kolbel teaches the system of claim 1 substantially as claimed. However, modified Kolbel fails to state wherein the at least one fluid coupling is a three-way valve.
Gillespie, Jr. teaches a system (see Figs. 1-2c) comprising at least one fluid coupling (three-way stopcock valve 287) which is a three-way valve (see par. [0238]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel to include wherein the at least one fluid coupling is a three-way valve, as taught by Gillespie, Jr., in order to couple three fluid paths together and selectively allow fluid communication between two of the three fluid paths (see Gillespie, Jr. par. [0238]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Kolbel (WO 2017/072592 A1) in view of LaHaye (US 2009/0277478 A1), as applied to claim 1 above, further in view of Elia et al. (US 2020/0060943 A1).
Regarding claim 21, modified Kolbel teaches the system of claim 1 substantially as claimed. However, modified Kolbel fails to state wherein the flushing liquid is a first flushing liquid, and wherein the second fluid delivery device is further adapted to provide a pulsatile flow of a second flushing liquid from a source of the second flushing liquid, wherein the second fluid delivery device comprises control means for selectively coupling the second fluid delivery device to the source of the flushing liquid and the source of the second flushing liquid.
Elia teaches a system (see Figs. 3A-4B) wherein the flushing liquid is a first flushing liquid (see Figs. 3A-4B, par. [0088]-[0089], a first flushing liquid is delivered from fluid bag 41), and wherein the second fluid delivery device is further adapted to provide a pulsatile flow of a second flushing liquid from a source of the second flushing liquid (fluid bag 42) (see Figs. 3A-4B, par. [0088]-[0089], a second flushing liquid is delivered from fluid bag 42), wherein the second fluid delivery device comprises control means (intake pinch valve 26) for selectively coupling the second fluid delivery device to the source of the flushing liquid and the source of the second flushing liquid (fluid bags 41 and 42) (see Figs. 3A-4B, par. [0088]-[0089], first and second flushing liquids are deliverable from fluid bags 41 and 42 and intake pinch valve 26 is operable to select which fluid is being delivered).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Kolbel to include wherein the flushing liquid is a first flushing liquid, and wherein the second fluid delivery device is further adapted to provide a pulsatile flow of a second flushing liquid from a source of the second flushing liquid, wherein the second fluid delivery device comprises control means for selectively coupling the second fluid delivery device to the source of the flushing liquid and the source of the second flushing liquid, as taught by Elia, in order to allow an additional flushing liquid to be delivered from the second fluid delivery device and allow the user to select which fluid is being delivered (see Elia par. [0088]-[0089]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Kolbel (WO 2017/072592 A1) in view of LaHaye (US 2009/0277478 A1), as applied to claim 23 above, further in view of Hogard et al. (US 2022/0040389 A1).
Regarding claim 28, modified Kolbel teaches the method of claim 23 substantially as claimed. However, modified Kolbel fails to state wherein the flushing liquid is a buffer solution.
Hogard teaches a method for flushing a lumen (see par. [0073]) wherein the
flushing liquid is a buffer solution (see par. [0073]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Kolbel to include wherein the flushing liquid is a buffer solution, as taught by Hogard, because Hogard teaches that buffer solutions closely mimic the composition of saline for flushing a lumen (see Hogard par. [0073]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Kolbel (WO 2017/072592 A1) in view of LaHaye (US 2009/0277478 A1), as applied to claim 23 above, further in view of Anderson (US 10,099,009 B1).
Regarding claim 29, modified Kolbel teaches the method of claim 23 substantially as claimed. However, modified Kolbel fails to state wherein the flushing liquid is pH adjusted.
Anderson teaches a method for flushing a lumen (see col. 4 lines 45-65) wherein the flushing liquid is pH adjusted (see col. 4 lines 45-65).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Kolbel to include wherein the flushing liquid is pH adjusted, as taught by Anderson, because Anderson teaches that pH adjusted solutions can dissolve obstructions or precipitates in the lumen of the medical device (see Anderson col. 4 lines 45-65).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Kolbel (WO 2017/072592 A1) in view of LaHaye (US 2009/0277478 A1), as applied to claim 23 above, further in view of Fischer (US 2016/0129179 A1).
Regarding claim 33, modified Kolbel teaches the method of claim 23 substantially as claimed. However, modified Kolbel fails to state wherein flushing the lumen comprises flushing at a pressure above 101.325 kPa.
Fischer teaches a method for flushing a lumen (see par. [0108]) wherein flushing the lumen comprises flushing at a pressure above 101.325 kPa (see par. [0108]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Kolbel to include wherein flushing the lumen comprises flushing at a pressure above 101.325 kPa, as taught by Fischer, because Fischer teaches that this pressure is possible for flushing the medical device with a similar pumping system (see Fischer par. [0108]).
Response to Arguments
Applicant’s arguments with respect to the rejection of claim(s) 1 and 23 under 35 U.S.C. 103 and 35 U.S.C. 102, respectively, have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103.
Conclusion
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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