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 .
Claim Objections
Claims 1-3, 11, 14-17, 19, 21-23, 29, 34, and 51 are objected to because of the following informalities:
-Claim 1, line 4: please correct “pressurised” to “pressurized”
-Claim 2, line 2: please correct “a flow” to “the flow”
-Claim 3, lines 2-3: please correct “the source” to “the pressurized source”
-Claim 3, line 3: please correct “a flow” to “the flow”
-Claim 3, line 4: please correct “the tube” to “the flexible tube”
-Claim 11, line 2: please correct “a source” to “the pressurized source”
-Claim 14, line 1: please correct “the positive displacement pump” to “the user actuatable positive displacement pump”
-Claim 15, lines 1-2: please correct “the positive displacement pump” to “the user actuatable positive displacement pump”
-Claim 15, line 2: please correct “flushing liquid” to “the flushing liquid”
-Claim 16, lines 1-2: please correct “the positive displacement pump” to “the user actuatable positive displacement pump”
-Claim 16, line 2: please correct “flushing liquid” to “the flushing liquid”
-Claim 16, line 3: please correct “the positive displacement pump” to “the user actuatable positive displacement pump”
-Claim 17, lines 1-2: please correct “the positive displacement pump” to “the user actuatable positive displacement pump”
-Claim 17, line 4: please correct “flushing liquid fluid source” to “the flushing liquid”
-Claim 19, lines 1-2: please correct “the first and second fluid deliver devices” to “the first fluid delivery device and the second fluid delivery device”
-Claim 21, lines 5-6: please correct “the respective sources of the first and the second flushing liquids” to “the source of the flushing liquid and the source of the second flushing liquid”
-Claim 22, line 2: please correct “pressurised” to “pressurized”
-Claim 23, line 3: please correct “pressurised” to “pressurized”
-Claim 23, line 4: please correct “flushing gas” to “the flushing gas”
-Claim 23, line 4: please correct “flushing liquid” to “a flushing liquid”
-Claim 29, line 2: please add a period after “adjusted”
-Claim 34, line 2: please correct “flushing fluid” to “the flushing gas”
-Claim 51, line 2: please correct “flushing fluid” to “the flushing liquid”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 11-17, and 21 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.
Regarding claim 9, the recitation "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the Examiner interprets the claim with “preferably” being deleted.
Regarding claim 11, the recitation "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the Examiner interprets the claim with “preferably” being deleted.
Regarding claim 12, the recitation "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the Examiner interprets the claim with “preferably” being deleted.
Claims 13-17 are rejected by virtue of their dependency on rejected claim 12.
Regarding claim 21, the recitation "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the Examiner interprets the claim with “preferably” being deleted.
Claim Rejections - 35 USC § 102
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 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.
Claims 23 and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by LaHaye (US 2009/0277478 A1).
Regarding claim 23, LaHaye discloses 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] and [0009]-[0010]), comprising:
flushing the lumen with a pulsed supply of a flushing gas from a pressurized source of flushing gas via a first fluid delivery device (gas pump, see par. [0010] and [0019]) (see par. [0009]-[0010] and [0019]), and with a supply of flushing liquid from a source of the flushing liquid via a second fluid delivery device (liquid pump, see par. [0010] and [0016]) (see par. [0009]-[0010] and [0016]), and
actuating a flow restrictor to restrict the flow of the flushing gas of the first fluid delivery device (gas pump, see par. [0010] and [0019]) (see abstract, par. [0009]-[0010] and [0019]; the gas pump has structures which restrict the gas flow to a pulsating output).
Regarding claim 34, LaHaye discloses the method of claim 23, wherein flushing the lumen comprises coupling the lumen to the pulsed supply of the flushing gas (see par. [0013] and [0019]).
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, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over LaHaye (US 2009/0277478 A1) in view of Travis et al. (US 2013/0138074 A1).
Regarding claim 1, LaHaye discloses a system for flushing a lumen of a medical device to remove air (see par. [0003] and [0009]-[0010]), comprising:
a first fluid delivery device (gas pump, see par. [0010] and [0019]) adapted to provide a pulsatile flow of a flushing gas from a pressurised source of the flushing gas (see par. [0009]-[0010] and [0019]);
a second fluid delivery device (liquid pump, see par. [0010] and [0016]) adapted to provide a flow of a flushing liquid from a source of the flushing liquid (see par. [0009]-[0010] and [0016]); and,
wherein the first fluid delivery device (gas pump, see par. [0010] and [0019]) comprises a flow restrictor that is actuatable to restrict a flow of the flushing gas to thereby pulse the flow of the flushing gas (see abstract, par. [0009]-[0010] and [0019]; the gas pump has structures which restrict the gas flow to a pulsating output).
While LaHaye teaches that the first fluid delivery device (gas pump, see par. [0010] and [0019]) and the second fluid delivery device (liquid pump, see par. [0010] and [0016]) are connected to the lumen of the medical device (see par. [0020]-[0022]), LaHaye fails to describe the specific mechanism for providing the connection. Specifically, LaHaye fails to state at least one fluid coupling for connecting the first fluid delivery device and the second fluid delivery device to the lumen of the medical device.
Travis teaches a system (see Figs. 1-2) comprising at least one fluid coupling (connector 22) for connecting the fluid delivery device (pump 38) to the lumen of the medical device (needle or complementary connection of other medical device, see par. [0037]) (see Figs. 1-2, par. [0037] and [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 LaHaye such that the first and second fluid delivery devices are connected to the lumen of the medical device through at least one fluid coupling, as suggested by Travis, in order to provide the mechanism for connecting the first and second fluid delivery devices to the lumen of the medical device (see LaHaye par. [0020]-[0022] and Travis par. [0037] and [0045]).
Regarding claim 10, modified LaHaye teaches the system of claim 1 substantially as claimed. LaHaye further teaches wherein the first fluid delivery device (gas pump, see par. [0010] and [0019]) comprises a user actuatable gas control mechanism for providing the pulsatile flow of the flushing gas (see par. [0010], [0019], [0022], the user actuates a switch to initiate the pulsed flow of the gas).
Regarding claim 12, modified LaHaye teaches the system of claim 1 substantially as claimed. 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).
Regarding claim 13, modified LaHaye teaches the system of claim 12 substantially as claimed. LaHaye further teaches wherein the second fluid delivery device (liquid pump, see par. [0010] and [0016]) comprises a user actuatable positive displacement pump (see par. [0016] and [0021], peristaltic pumps are positive displacement pumps and the user actuates a switch to operate the pump).
Regarding claim 14, modified LaHaye teaches the system of claim 13 substantially as claimed. LaHaye further teaches wherein the positive displacement pump (see par. [0016] and [0021], peristaltic pumps are positive displacement pumps) comprises a compression chamber (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).
Regarding claim 19, modified LaHaye teaches the system of claim 1 substantially as claimed. LaHaye further teaches wherein the first (gas pump, see par. [0010] and [0019]) and second (liquid pump, see par. [0010] and [0016]) fluid delivery devices are comprised in a single device (see par. [0010], the two pumps operate in a particular manner as a single system/device).
Regarding claim 20, modified LaHaye teaches the system of claim 1 substantially as claimed. Modified LaHaye further teaches wherein the first fluid delivery device (gas pump of LaHaye, see LaHaye par. [0010] and [0019]) is couplable to the at least one fluid coupling (connector 22 of Travis) via the second fluid delivery device (liquid pump of LaHaye, see LaHaye par. [0010] and [0016]) (see previous modifications in rejection of claim 1 above to incorporate the at least one fluid coupling of Travis into the system of LaHaye to connect the first and second fluid delivery devices to the lumen of the medical device; since the at least one fluid coupling connects the first and second fluid delivery devices to the lumen of the medical device and thus each of these three structures are fluidly connected to each other, the first fluid delivery device would be considered couplable to the at least one fluid coupling via the second fluid delivery device).
Regarding claim 22, modified LaHaye teaches the system of claim 1 substantially as claimed. 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]).
Regarding claim 51, modified LaHaye teaches the system of claim 1 substantially as claimed. 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 fluid (see par. [0010] and [0016]).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over LaHaye (US 2009/0277478 A1) in view of Travis et al. (US 2013/0138074 A1), as applied to claim 1 above, further in view of Richardson et al. (US 2005/0256447 A1).
Regarding claim 2, modified LaHaye teaches the system of claim 1 substantially as claimed. While LaHaye teaches that the first fluid delivery device (gas pump, see par. [0010] and [0019]) comprises a flow restrictor that is actuatable to restrict a flow of the flushing gas to thereby pulse the flow of the flushing gas (see abstract, par. [0009]-[0010] and [0019]; the gas pump has structures which restrict the gas flow to a pulsating output), LaHaye fails to describe the specific structure/mechanism of the restrictor. Specifically, modified LaHaye fails to state wherein the restrictor is actuatable between an open position and a closed position to thereby pulse a 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 LaHaye such that the flow restrictor of the first fluid delivery device of LaHaye includes the structure of the flow restrictor of 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 LaHaye teaches the system of claim 1 substantially as claimed. While LaHaye teaches that the first fluid delivery device (gas pump, see par. [0010] and [0019]) comprises a flow restrictor that is actuatable to restrict a flow of the flushing gas to thereby pulse the flow of the flushing gas (see abstract, par. [0009]-[0010] and [0019]; the gas pump has structures which restrict the gas flow to a pulsating output), LaHaye fails to describe the specific structure/mechanism of the restrictor. Specifically, modified LaHaye fails to state wherein the first fluid delivery device comprises a compression element configured to compress a flexible tube coupled to the source of the flushing gas at predetermined time intervals to thereby restrict a flow of the flushing gas through the 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 source of the fluid at predetermined time intervals to thereby restrict a flow of the fluid through the 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 LaHaye such that the first fluid delivery device of LaHaye includes the structure of the flow restrictor of Richardson which comprises a compression element 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 LaHaye teaches the system of claim 3 substantially as claimed. Modified LaHaye 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 LaHaye, 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 LaHaye (US 2009/0277478 A1) in view of Travis et al. (US 2013/0138074 A1), 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 LaHaye teaches the system of claim 4 substantially as claimed. However, modified LaHaye fails to expressly describe the structure for driving the compression element. Specifically, modified LaHaye 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 LaHaye 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 LaHaye (US 2009/0277478 A1) in view of Travis et al. (US 2013/0138074 A1), 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 LaHaye teaches the system of claim 3 substantially as claimed. However, modified LaHaye fails to expressly describe the structure for driving the compression element. Specifically, modified LaHaye 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 LaHaye 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 LaHaye teaches the system of claim 6 substantially as claimed. However, modified LaHaye 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 LaHaye 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 LaHaye teaches the system of claim 3 substantially as claimed. However, modified LaHaye fails to expressly describe the structure for driving the compression element. Specifically, modified LaHaye 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 LaHaye 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]).
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over LaHaye (US 2009/0277478 A1) in view of Travis et al. (US 2013/0138074 A1), further in view of Richardson et al. (US 2005/0256447 A1), as applied to claims 1 and 3 above, and further in view of Irish et al. (US 2021/0033204 A1).
Regarding claim 9, modified LaHaye teaches the system of claim 3 substantially as claimed. However, modified LaHaye fails to expressly describe the structure for driving the compression element. Specifically, modified LaHaye 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 LaHaye 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]).
Regarding claim 11, modified LaHaye teaches the system of claim 1 substantially as claimed. However, modified LaHaye fails to state a stand adapted to retain a 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 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 LaHaye to include a stand adapted to retain a 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 LaHaye (US 2009/0277478 A1) in view of Travis et al. (US 2013/0138074 A1), as applied to claims 13-14 above, further in view of Ambrosina et al. (US 2014/0148757 A1).
Regarding claim 15, modified LaHaye teaches the system of claim 14 substantially as claimed. However, modified LaHaye fails to expressly state wherein the positive displacement pump comprises a one-way valve configured to allow a one-way flow of 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 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 LaHaye to include wherein the positive displacement pump comprises a one-way valve configured to allow a one-way flow of 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 LaHaye teaches the system of claim 13 substantially as claimed. However, modified LaHaye fails to expressly state wherein the positive displacement pump comprises a one-way valve configured to allow a one-way flow of flushing liquid from the source of the flushing liquid 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 flushing liquid from the source of the flushing liquid 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 LaHaye to include wherein the positive displacement pump comprises a one-way valve configured to allow a one-way flow of flushing liquid from the source of the flushing liquid 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 LaHaye (US 2009/0277478 A1) in view of Travis et al. (US 2013/0138074 A1), as applied to claim 13 above, further in view of Piehl et al. (US 10,016,564 B2).
Regarding claim 17, modified LaHaye teaches the system of claim 13 substantially as claimed. However, modified LaHaye fails to state wherein the 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 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 LaHaye to include wherein the 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 LaHaye (US 2009/0277478 A1) in view of Travis et al. (US 2013/0138074 A1), as applied to claim 1 above, further in view of Gillespie, Jr. et al. (US 2014/0046125 A1).
Regarding claim 18, modified LaHaye teaches the system of claim 1 substantially as claimed. However, modified LaHaye 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 LaHaye 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 LaHaye (US 2009/0277478 A1) in view of Travis et al. (US 2013/0138074 A1), as applied to claim 1 above, further in view of Elia et al. (US 2020/0060943 A1).
Regarding claim 21, modified LaHaye teaches the system of claim 1 substantially as claimed. However, modified LaHaye 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, preferably wherein the second fluid delivery device comprises control means for selectively coupling the second fluid delivery device to the respective sources of the first and the second flushing liquids.
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), preferably wherein the second fluid delivery device comprises control means (intake pinch valve 26) for selectively coupling the second fluid delivery device to the respective sources of the first and the second flushing liquids (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 LaHaye 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, preferably wherein the second fluid delivery device comprises control means for selectively coupling the second fluid delivery device to the respective sources of the first and the second flushing liquids, 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]).
Claims 26 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over LaHaye (US 2009/0277478 A1), as applied to claim 23 above, in view of Kolbel (US 2017/0367861 A1).
Regarding claim 26, LaHaye discloses the method of claim 23. However, LaHaye fails to state wherein the flushing gas is carbon dioxide.
Kolbel teaches a method for flushing a lumen (see par. [0040]) wherein the flushing gas is carbon dioxide (see par. [0040]).
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 LaHaye to include wherein the flushing gas is carbon dioxide, as taught by Kolbel, because Kolbel teaches that carbon dioxide is appropriate for high-pressure flushing of medical devices (see Kolbel par. [0040]).
Regarding claim 31, LaHaye discloses the method of claim 23. However, LaHaye fails to state wherein the flushing liquid is degassed.
Kolbel teaches a method for flushing a lumen (see par. [0039]) wherein the flushing liquid is degassed (see par. [0039]).
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 LaHaye to include wherein the flushing liquid is degassed, as taught by Kolbel, because Kolbel teaches that degassed liquids are appropriate for flushing of medical devices (see Kolbel par. [0039]).
Regarding claim 32, LaHaye discloses the method of claim 23. However, LaHaye fails to state wherein the flushing liquid is a perfluorocarbon solution.
Kolbel teaches a method for flushing a lumen (see par. [0036]-[0039]) wherein the flushing liquid is a perfluorocarbon solution (see par. [0036]-[0039]).
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 LaHaye to include wherein the flushing liquid is a perfluorocarbon solution, as taught by Kolbel, because Kolbel teaches that perfluorocarbon solutions are appropriate for flushing of medical devices to absorb air prior to introducing the medical device into the patient (see Kolbel par. [0036]-[0039]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over LaHaye (US 2009/0277478 A1), as applied to claim 23 above, in view of Hogard et al. (US 2022/0040389 A1).
Regarding claim 28, LaHaye discloses the method of claim 23. However, LaHaye 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 LaHaye 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 LaHaye (US 2009/0277478 A1), as applied to claim 23 above, in view of Anderson (US 10,099,009 B1).
Regarding claim 29, LaHaye discloses the method of claim 23. However, LaHaye 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 LaHaye 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 30 is rejected under 35 U.S.C. 103 as being unpatentable over LaHaye (US 2009/0277478 A1), as applied to claim 23 above, in view of Kim (US 2020/0338260 A1).
Regarding claim 30, LaHaye discloses the method of claim 23. However, LaHaye fails to state wherein the flushing liquid comprises saline.
Kim teaches a method for flushing a lumen (see par. [0046]) wherein the flushing liquid comprises saline (see par. [0046]).
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 LaHaye to include wherein the flushing liquid comprises saline, as taught by Kim, because Kim teaches that saline can function as a flushing liquid which is harmless to the human body (see Kim par. [0046]).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over LaHaye (US 2009/0277478 A1), as applied to claim 23 above, in view of Fischer (US 2016/0129179 A1).
Regarding claim 33, LaHaye discloses the method of claim 23. However, LaHaye 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 LaHaye 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]).
Conclusion
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/AVERY SMALE/Examiner, Art Unit 3783 /Lauren P Farrar/Primary Examiner, Art Unit 3783