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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR
1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/16/2026 has been entered.
Status of Claims
Claims 1, 5, and 22 are currently amended.
Claims 4, 8-13, 20-21, and 23 are cancelled.
Response to Arguments
Applicant’s arguments, see pages 6-10, filed 2/16/2026, with respect to the rejection(s) of
claim(s) 1-3, 5-7, 14-19, 22, and 24-29 under 35 U.S.C. 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Davidson.
35 U.S.C. 102 and 103:
Regarding claim 1, applicant argue that Cioanta, alone or in combination with the prior art, does
not teach “a fluid circulator that is in fluid communication with a fluid inflow line, a fluid outflow line and the balloon interior to define a fluid recirculation loop, the fluid circulator being configured to selectively circulate the catheter fluid out of the balloon interior via the fluid outflow line and back into the balloon interior via the fluid inflow line during use of the catheter system.” After further search and consideration, the examiner argues that Davidson teaches this limitation (fig. 2; paragraph 19). The fluid in this closed loop system is continuously circulated by a pump 26 which is coupled to the two fluid conduits 22 and 24.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 6, and 25 are rejected under 35 U.S.C. 103 as being unpatentable by Cioanta et al. US Pub.: US 2011/0034832 A1, hereinafter Cioanta in view of Davidson et al. US Pub.: US 20150045670 A1, hereinafter Davidson.
Regarding claim 1, Cioanta teaches a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve, the catheter system comprising (paragraph 141):
a balloon including a balloon wall that defines a balloon interior, the balloon being configured to selectively retain a catheter fluid within the balloon interior (figs. 54A-B and 55A-C; paragraph 539-544); It is disclosed that the balloon interior may be filled with degassed water or saline solution or saline solution/contrast mixture.
a laser that generates energy (figs. 54A-B and 55A-C; paragraph 539-544); A laser is discharged 557 into the catheter.
an optical fiber that is configured to guide the energy into the balloon interior to generate a plasma within the catheter fluid that is retained within the balloon interior (figs. 54A-B and 55A-C; paragraph 539-544); It is disclosed that “Laser fiber 555 for laser discharge 557 runs within catheter 340.” Furthermore, “the laser will create a plasma bubble that during its growth and collapse will be able to generate a radial wave 474.”
and a fluid circulator with a fluid inflow line, a fluid outflow line and the balloon interior (fig. 54A-B; paragraph 435 and 539). It is disclosed that an IN lumen 365 and OUT lumen 366 is in fluid communication with a fluid circulator pump, which bring and extract fluid from within the balloon enclosure 541.
However, Cioanta does not explicitly teach a fluid circulator that is in fluid communication with a fluid inflow line, a fluid outflow line and the balloon interior to define a fluid recirculation loop, the fluid circulator being configured to selectively circulate the catheter fluid out of the balloon interior via the fluid outflow line and back into the balloon interior via the fluid inflow line during use of the catheter system.
Davidson, in the same field of endeavor, teaches a fluid circulator (26) that is in fluid communication with a fluid inflow line (22), a fluid outflow line (24) and the balloon interior to define a fluid recirculation loop, the fluid circulator (26) being configured to selectively circulate the catheter fluid out of the balloon interior via the fluid outflow line (24) and back into the balloon interior via the fluid inflow line (22) during use of the catheter system (fig. 2; paragraph 19). The fluid in this closed loop system is continuously circulated by a pump 26 which is coupled to the two fluid conduits 22 and 24.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid circulator of Cioanta to have a closed loop circulation pathway as taught by Davidson for the benefit of providing continuous circulation, which would reduce the risk of occlusion and associated complications.
Regarding claim 6, Cioanta in view of Davidson teaches the claimed invention and Cioanta
further teaches a fluid pump that is configured to pump the catheter fluid into the balloon interior to expand the balloon from a collapsed configuration so that the balloon is configured to be moved relative to the vessel wall, to an expanded configuration suitable for anchoring the balloon in position relative to the vessel wall (fig. 54A-B; paragraph 435 and 539). It is disclosed that an IN lumen 365 and OUT lumen 366 is in fluid communication with a fluid circulator, pump, which bring and extract fluid from within the balloon enclosure 541.
Regarding claim 25, Cioanta in view of Davidson teaches the claimed invention and Cioanta
further teaches wherein the fluid circulator is coupled in fluid communication to both the inflow line and the outflow line via a pump outlet and a pump inlet (fig. 54A-B; paragraph 435 and 539). It is disclosed that an IN lumen 365 and OUT lumen 366 is in fluid communication with a fluid circulator, pump, which bring and extract fluid from within the balloon enclosure 541.
Regarding claim 26, Cioanta in view of Davidson teaches the claimed invention and Cioanta
further teaches further comprising an inflation conduit that is coupled in fluid communication with the inflow line (fig. 54A-B; paragraph 435 and 539). It is disclosed that an IN lumen 365 and OUT lumen 366 is in fluid communication with a fluid circulator, pump, which bring and extract fluid from within the balloon enclosure 541.
Claims 2, 14-16, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Cioanta in
view of Davidson in view of BEYAR et al. US Pub.: US 2012/0071715 A1, hereinafter Beyar.
Regarding claim 2, Cioanta in view of Davidson teaches the claimed invention and Cioanta
further teaches the modified claimed invention and Nguyen further teaches a fluid circulator (fig. 54A-B; paragraph 435 and 539). It is disclosed that an IN lumen 365 and OUT lumen 366 is in fluid communication with a fluid circulator, pump, which bring and extract fluid from within the balloon enclosure 541.
However, Cioanta in view of Davidson does not teach wherein the fluid circulator is configured so that a temperature of the catheter fluid within the balloon interior is maintained within a predetermined temperature range.
Beyar further teaches wherein the fluid circulator is configured so that a temperature of the catheter fluid within the balloon interior is maintained within a predetermined temperature range (paragraph 181). It is disclosed that “a temperature sensor in the balloon is coupled with fluid circulation through the balloon is used.” It is further disclosed that “when a temperature of the balloon increases above a desired amount, a safety is used to warn a user and/or prevent additional energy provision.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid circulator of Cioanta in view of Davidson to add a temperature sensor from Beyer for the benefit of increasing the safety of the device by warning the user when the temperature of the balloon exceed above a desired amount.
Regarding claim 14, Cioanta in view of Davidson does not teach further comprising a fluid
temperature sensor that is configured to sense a temperature of the catheter fluid within the balloon interior, the fluid temperature sensor being configured to generate a signal to activate the fluid circulator.
Beyer further teaches further comprising a fluid temperature sensor that is configured to sense a temperature of the catheter fluid within the balloon interior, the fluid temperature sensor being configured to generate a signal to activate the fluid circulator (paragraph 181). It is disclosed that “a temperature sensor in the balloon is coupled with fluid circulation through the balloon is used.” It is further disclosed that “when a temperature of the balloon increases above a desired amount, a safety is used to warn a user and/or prevent additional energy provision.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid circulator of Cioanta in view of Davidson to add a temperature sensor from Beyer for the benefit of increasing the safety of the device by warning the user when the temperature of the balloon exceed above a desired amount.
Regarding claim 15, Cioanta in view of Davidson does not teach further comprising a fluid
temperature controller that controls a temperature of the catheter fluid as the catheter fluid is being circulated by the fluid circulator.
Beyer further teaches further comprising a fluid temperature controller that controls a temperature of the catheter fluid as the catheter fluid is being circulated by the fluid circulator (paragraph 181). It is disclosed that “A fluid return line 112 with an inlet near the distal end of the device 100 draws in the conductive fluid from the interior volume, while a fluid pump (not shown) pumps in additional conductive fluid via a fluid inlet (shown in FIG. 5) at a proximal end of the device 100.” The device is configured to pump fluid in and out of the balloon interior. Therefore, a temperature controller is present because pumping fluid in and out of the catheter will decrease and increase the temperature, respectively.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid circulator of Cioanta in view of Davidson to add the temperature controller of Beyer for the benefit of increasing the safety of the device by warning the user when the temperature of the balloon exceed above a desired amount.
Regarding claim 16, Cioanta in view of Davidson does not teach further comprising a fluid
pressure sensor that is positioned within the balloon interior, the fluid pressure sensor being configured to sense a pressure of the catheter fluid within the balloon interior, the fluid pressure sensor being configured to generate a signal when the pressure of the catheter fluid within the balloon interior falls outside of a desired inflation pressure range; the signal indicating when to selectively activate the fluid circulator to adjust at least one of (i) a first rate at which the circulation fluid is being pumped out of the balloon interior by the fluid circulator, and (ii) a second rate at which the circulation fluid is being pumped back into the balloon interior by the fluid circulator.
Beyer, in the same field of endeavor, teaches further comprising a fluid pressure sensor that is positioned within the balloon interior, the fluid pressure sensor being configured to sense a pressure of the catheter fluid within the balloon interior, the fluid pressure sensor being configured to generate a signal when the pressure of the catheter fluid within the balloon interior falls outside of a desired inflation pressure range (paragraph 97 and 222); It is disclosed that “the balloon includes a pressure sensor, used to measure the response of the wall of the vessel to applied pressure and thus assess the effect of the treatment.” The pressure sensor is configured to measure a desired pressure.
the signal indicating when to selectively activate the fluid circulator to adjust at least one of (i) a first rate at which the circulation fluid is being pumped out of the balloon interior by the fluid circulator, and (ii) a second rate at which the circulation fluid is being pumped back into the balloon interior by the fluid circulator (paragraph 97 and 222). It is disclosed in [97] that “a fill mechanism adapted to introduce an amount of therapeutic agent into said inner cavity at a desired pressure and a release mechanism adapted to transform said nascent holes into actual holes.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid circulator of Cioanta in view of Davidson the fluid pressure sensor and fill mechanism from Beyer for the benefit of increasing the safety of the device by warning the user when the pressure of the balloon exceed above a desired amount.
Regarding claim 22, Cioanta teaches a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve, the catheter system comprising (paragraph 141):
a balloon including a balloon wall that defines a balloon interior, the balloon being configured to selectively retain a catheter fluid within the balloon interior (figs. 54A-B and 55A-C; paragraph 539-544); It is disclosed that the balloon interior may be filled with degassed water or saline solution or saline solution/contrast mixture.
an energy guide that is configured to guide energy into the balloon interior to generate a plasma within the catheter fluid that is retained within the balloon interior (figs. 54A-B and 55A-C; paragraph 539-544); It is disclosed that “Laser fiber 555 for laser discharge 557 runs within catheter 340.” Furthermore, “the laser will create a plasma bubble that during its growth and collapse will be able to generate a radial wave 474.”
a fluid circulator with a fluid inflow line, a fluid outflow line and the balloon interior (fig. 54A-B; paragraph 435 and 539). It is disclosed that an IN lumen 365 and OUT lumen 366 is in fluid communication with a fluid circulator, pump, which bring and extract fluid from within the balloon enclosure 541.
and an energy source that directs the energy along the energy guide into the balloon interior (figs. 54A-B and 55A-C; paragraph 539-544); A laser is discharged 557 into the catheter via a laser source.
However, Cioanta does not teach the energy source providing sub-millisecond pulses of light energy to the energy guides, the sub-millisecond pulses of light energy being guided along the energy guide and into the balloon interior to generate the plasma within the catheter fluid retained within the balloon interior; a fluid circulator that is in fluid communication with a fluid inflow line, a fluid outflow line and the balloon interior to define a fluid recirculation loop, the fluid circulator being configured to selectively circulate the catheter fluid out of the balloon interior via the fluid outflow line and back into the balloon interior via the fluid inflow line during use of the catheter system.
Beyar, in the same field of endeavor, teaches the energy source providing sub-millisecond pulses of light energy to the energy guides, the sub-millisecond pulses of light energy being guided along the energy guide and into the balloon interior to generate the plasma within the catheter fluid retained within the balloon interior (paragraph 253). It is disclosed energy pulses delivered by distal tip of fiber 230 last about 200-300 microseconds.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the laser pulse of Cioanta with the sub-millisecond pulses of Beyar for the benefit of producing quick laser pulses within the balloon causing plasma generation, expansion and steady contact with patient’s tissue.
Davidson, in the same field of endeavor, teaches a fluid circulator (26) that is in fluid communication with a fluid inflow line (22), a fluid outflow line (24) and the balloon interior to define a fluid recirculation loop, the fluid circulator (26) being configured to selectively circulate the catheter fluid out of the balloon interior via the fluid outflow line (24) and back into the balloon interior via the fluid inflow line (22) during use of the catheter system (fig. 2; paragraph 19). The fluid in this closed loop system is continuously circulated by a pump 26 which is coupled to the two fluid conduits 22 and 24.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid circulator of Cioanta to have a closed loop circulation pathway as taught by Davidson for the benefit of providing continuous circulation, which would reduce the risk of occlusion and associated complications.
Claims 3, 5, 7, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Cioanta in view of Davidson in view of Nguyen et al. US Pub.: US 2018/0360482 A1, hereinafter Nguyen.
Regarding claim 3, Cioanta in view of Davidson teaches the claimed invention and Cioanta
further teaches a fluid circulator (fig. 54A-B; paragraph 435 and 539). It is disclosed that an IN lumen 365 and OUT lumen 366 is in fluid communication with a fluid circulator, pump, which bring and extract fluid from within the balloon enclosure 541.
Nguyen, in the same field of endeavor, teaches wherein the fluid circulator is configured so that a pressure of the catheter fluid within the balloon interior is maintained within a predetermined pressure range (paragraph 30). It is disclosed that “a pressure relief valve is used to maintain the fluid pressure within the interior volume of the device while the conductive fluid is circulated.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid circulator of Cioanta in view of Davidson to add the pressure relief valve of Nguyen for the benefit of maintaining the fluid pressure within the interior volume of the device while the conductive fluid is circulated.
Regarding claim 5, Cioanta in view of Davidson in view of Nguyen teaches the claimed invention
and Cioanta further teaches wherein the fluid outflow line includes an inlet port that is positioned in the balloon interior so that the catheter fluid flows out of the balloon interior into the fluid outflow line via the inlet port, the fluid inflow line including an outlet port that is positioned within the balloon interior so that the catheter fluid flows through the fluid inflow line and back into the balloon interior via the outlet port (fig. 54A-B; paragraph 435 and 539). It is disclosed that an IN lumen 365 and OUT lumen 366 is in fluid communication with a fluid circulator, pump, which bring and extract fluid from within the balloon enclosure 541. OUT hole 547 provides a conduit to OUT lumen 366.
Regarding claim 7, Cioanta in view of Davidson in view of Nguyen teaches the claimed invention
and Nguyen further teaches wherein when the balloon is in the expanded configuration, the catheter fluid generates a balloon pressure within a desired inflation pressure range within the balloon interior (paragraph 30). It is disclosed that “the fluid pump may fill the interior volume with fluid to a certain pressure with the use of the relief valve.”
Regarding claim 17, Cioanta in view of Davidson in view of Nguyen teaches the claimed
invention and Nguyen further teaches further comprising a fluid pressure controller that controls a pressure of the catheter fluid as the catheter fluid is being circulated by the fluid circulator (paragraph 30). It is disclosed that “a pressure relief valve is used to maintain the fluid pressure within the interior volume of the device while the conductive fluid is circulated.” The pressure valve equates to the fluid pressure controller.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cioanta in view of Davidson in view of Angel et al. US Pub.: US 2013/0190803 A1, hereinafter Angel.
Regarding claim 18, Cioanta in view of Davidson does not teach further comprising a filtration
system that removes microparticles from the catheter fluid as the catheter fluid is being circulated by the fluid circulator.
Angel, in the same field of endeavor, teaches further comprising a filtration system that removes microparticles from the catheter fluid as the catheter fluid is being circulated by the fluid circulator (paragraph 63). It is disclosed that “Bioactive agents, flushing fluids for flushing or under elevated pressures for mechanical thrombolysis of thrombus in the filter member 16.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid circulation system of Cioanta in view of Davidson with the filtration system of Angel for the benefit of cleaning the catheter fluid for recirculation.
Regarding claim 19, Cioanta in view of Davidson does not teach wherein the catheter fluid is
circulated out of the balloon interior and to the fluid circulator along a fluid outflow line, the filtration system being positioned along the fluid outflow line.
Angel, in the same field of endeavor, teaches wherein the catheter fluid is circulated out of the balloon interior and to the fluid circulator along a fluid outflow line, the filtration system being positioned along the fluid outflow line (paragraph 63). It is disclosed that “Bioactive agents, flushing fluids for flushing or under elevated pressures for mechanical thrombolysis of thrombus in the filter member 16, contrast agents or other fluids may be infused through the infusion lumens 40 and out of the at least one infusion port 36 to pass into the patient's venous system for either local or systemic effect.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outflow line of fluid circulation system of Cioanta in view of Davidson to include the filtration system of Angel for the benefit of cleaning the catheter fluid for recirculation.
Claims 24 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Cioanta in
view of Davidson in view Beyer in further view of Nguyen.
Regarding claim 24, Cioanta in view of Davidson in view of Beyar teaches the claimed invention
but does not teach wherein the inflation conduit is in fluid communication with the inflow line via a fluid valve.
Nguyen, in the same field of endeavor, teaches wherein the inflation conduit is in fluid communication with the inflow line via a fluid valve (paragraph 30). It is disclosed that “a pressure relief valve is used to maintain the fluid pressure within the interior volume of the device while the conductive fluid is circulated.” The pressure valve equates to the fluid pressure controller. Relief of the valve equate to an open to the inflow line, a non-relief valve equate to the second position where there is no opening.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid circulator of Cioanta in view of Davidson in view of Beyer to add the pressure relief valve of Nguyen for the benefit of maintaining the fluid pressure within the interior volume of the device while the conductive fluid is circulated.
Regarding claim 27, Nguyen in view of Davidson in view of Beyar in view of Nguyen teaches the
claimed invention and Nguyen further teaches wherein the inflation conduit is in fluid communication with the inflow line via a fluid valve (paragraph 30). It is disclosed that “a pressure relief valve is used to maintain the fluid pressure within the interior volume of the device while the conductive fluid is circulated.” The pressure valve equates to the fluid pressure controller. Relief of the valve equate to an open to the inflow line, a non-relief valve equate to the second position where there is no opening.
Regarding claim 28, Nguyen in view of Davidson in view of Beyar claimed invention and Nguyen
further teaches wherein the fluid valve is movable between (i) a first position where the inflation conduit is open to the inflow line, and (ii) a second position where the inflation conduit is no longer open to the inflow line (paragraph 30). It is disclosed that “a pressure relief valve is used to maintain the fluid pressure within the interior volume of the device while the conductive fluid is circulated.” The pressure valve equates to the fluid pressure controller. Relief of the valve equate to an open to the inflow line, a non-relief valve equate to the second position where there is no opening.
Regarding claim 29, Cioanta in view of Davidson in view of Nguyen in view of Beyar teaches the
modified claimed invention and Beyar further teaches wherein the energy source provides sub-millisecond pulses of light energy to the optical fiber (paragraph 253). It is disclosed energy pulses delivered by distal tip of fiber 230 last about 200-300 microseconds.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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/T.J.T./Examiner, Art Unit 3792
/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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