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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 18, 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on December 18, 2025. As directed by the amendment: claims 1-2, 4-9, 17-25, 30 and 32-36 have been amended, claims 3, 10-15, 26 and 31 have been cancelled, and no claims have been added. Thus, claims 1-2, 4-9, 16-25, 27-30 and 32-36 are presently pending in this application.
Drawings
The drawings were received on 18 December 2025. These drawings are acceptable.
Response to Arguments
Applicant’s arguments, see Remarks, filed December 18, 2025, with respect to the rejection of newly amended independent claims 1 and 23 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Eidenschink et al. (Eidenschink) US 6,113,579 for claim 1 and Smith US 5,087,246 for claim 23.
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 23-25 and 27-28 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.
Claim 23 recites the limitation "the fluid flow channels" in line 21. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, line 21 is interpreted as “…and radially projecting landing areas having sufficient area to form fluid flow channels with the inner surface of the vessel and channel fluid along a length of the occlusion balloon, the fluid flow channels…”, Claims 24-25 and 27-28 are rejected at least because they depend from claim 23.
Claim 27 recites the limitation "the proximal catheter section" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the inflation catheter section”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 5, 29-30 and 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Eidenschink et al. (Eidenschink) US 6,113,579 in view of Blix US 2008/0171977 A1.
Regarding claim 1, Eidenschink discloses an occlusion catheter system for at least partial occlusion of a patient's aorta to obstruct blood flow downstream and increase blood flow upstream to vital organs (MPEP 2111.02(II) recites that statements in the preamble reciting intended use must be evaluated to determine whether or not the intended use results in a structural difference between the claimed invention and the prior art, and here the preamble does not result in a structural difference between the claimed invention and the prior art because the size of a patient’s aorta is variable and is not specified in the claim), the occlusion catheter (catheter 20, c 6 ln 22-45 and shown in Fig. 1, with the tip 116 of Fig. 8, c 8 ln 61 to c 9 ln 10 and c 10 ln 4-17) comprising: a proximal hub (hub, see annotated Fig. 1 below) having an inflation connection port and an inflation pathway (inflation connection port and inflation pathway, see annotated Fig. 1 below); an inflation catheter section (shaft assembly 22, c 6 ln 25) fluidly connected to the proximal hub, the inflation catheter section having an inflation lumen (inflation lumen 37, c 6 ln 45) and a first port (first port, see annotated Fig. 1 below) in fluid communication with the inflation pathway; a distal catheter section (distal catheter section, see annotated Fig. 8 below) having an atraumatic tip (tip 116, c 10 ln 4-17) positioned distally on the distal catheter section, the inflation catheter section and the distal catheter section positioned in longitudinal spaced apart relationship along a longitudinal axis (Figs. 1 and 8), the atraumatic tip having a relaxed configuration wherein the atraumatic tip curves away from the longitudinal axis and an introduction configuration wherein the atraumatic tip is relatively straight (the tip of Fig. 8 can be configured to optimize crossing and thus minimize trauma by having two configurations, one being a straight tip when the guidewire is extended therethrough for crossing a narrowed lumen, and one with a bent configuration as depicted in Fig. 8 for crossing a stent), the distal catheter section closed at a distal end (Fig. 8); and an intervening occlusion balloon (balloon 112 of Fig. 8, c 10 ln 9) attached to the inflation catheter section and the distal catheter section (Figs. 1 and 8), the first port being fluidly connected with an internal space of the occlusion balloon (Fig. 1).
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Eidenschink does not teach wherein the occlusion balloon is configured to define both radially projecting members and intervening radially projecting landing areas upon inflation of the occlusion balloon into a partially inflated state, the radially projecting members having a sufficient area to seat in apposition with an inner surface of the vessel and the radially projecting landing areas having sufficient area to form fluid flow channels with the inner surface of the vessel and channel fluid along a length of the occlusion balloon from a distal side of the occlusion balloon to a proximal side of the occlusion balloon, and wherein the fluid flow channels extend along the length of the occlusion balloon, and wherein further inflation of the occlusion balloon beyond the partially inflated state is configured to eliminate perceptible fluid flow through the fluid flow channels.
However, Blix teaches an angioplasty balloon (P0020, and shown in Figs. 3 and 8a-b) configured to define both radially projecting members (tip portions 24, P0057) and intervening radially projecting landing areas (collapsed portions 22, P0057) upon inflation of the occlusion balloon into a partially inflated state (partial inflation shown in Fig. 8a, and described in P0057), the radially projecting members having a sufficient area to seat in apposition with an inner surface of the vessel (sufficient area of radially projecting members shown in annotated Fig. 8a below, fully capable of seating in apposition with an inner surface of the vessel) and the radially projecting landing areas having sufficient area (sufficient area, see annotated Fig .8a below) to form fluid flow channels with the inner surface of the vessel and channel fluid along a length of the occlusion balloon from a distal side of the occlusion balloon to a proximal side of the occlusion balloon (the collapsed portions have sufficient area to be fully capable of forming fluid flow channels with the inner surface of the vessel and channeling fluid along a length of the occlusion balloon from a distal side of the occlusion balloon to a proximal side of the occlusion balloon), and wherein the fluid flow channels extend along the length of the occlusion balloon, and wherein further inflation of the occlusion balloon beyond the partially inflated state is configured to eliminate perceptible fluid flow through the fluid flow channels (balloon has a circular working portion 16 when in the inflated state, P0050 and P0057 and see Fig. 3, which is fully capable of eliminating perceptible fluid flow through the fluid flow channels).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Eidenschink with the balloon of Blix for the purpose of facilitating folding of the balloon in a uniform manner upon deflation of the balloon after use P0004, to reduce withdrawal force P0012.
Regarding claim 5, Eidenschink in view of Blix teaches the occlusion catheter system of claim 1, wherein the radially projecting members are integrally formed with the occlusion balloon (Blix, Fig. 8a).
Regarding claim 29, Eidenschink in view of Blix teaches the occlusion catheter system of claim 1, wherein the fluid flow channels extend in a substantially curvilinear manner along the length of the occlusion balloon (Blix, the fluid flow channels are bounded by curved lines, and therefore extend in a curvilinear manner, see annotated Fig. 8a above and dictionary.com definition of the previous action).
Regarding claim 30, Eidenschink in view of Blix teaches the occlusion catheter system of claim 1, wherein the atraumatic tip is coupled to the distal catheter section along the longitudinal axis and projects distally from the distal catheter section (Eidenschink, annotated Fig. 8 above).
Regarding claim 32, Eidenschink in view of Blix teaches the occlusion catheter system of claim 1, wherein the inflation catheter section is fixed at a proximal end to the proximal hub (Eidenschink, the proximal end of the shaft assembly extends into manifold 26 adhesively bonded to the shaft assembly, c 6 ln 30-32), the inflation catheter section including a first catheter member (Eidenschink, inner tube 28/110, c 6 ln 36 and c 10 ln 7) and a second catheter member (Eidenschink, outer tube 34, c 6 ln 35), the first catheter member fixed at a distal end to a proximal end of the distal catheter section (Eidenschink, the area just distal of the distal waist bond is backfilled with adhesive 43 to provide a smooth transition and for improved adhesion between dissimilar substrates, c 8 ln 26-29), the first catheter member extending along the longitudinal axis from the inflation catheter section into the proximal end of the distal catheter section, the inflation lumen defined at least partially between the first catheter member and the second catheter member.
Regarding claim 33, Eidenschink in view of Blix teaches the occlusion catheter system of claim 1, wherein the inflation catheter section is fixed at a proximal end to the proximal hub (Eidenschink, the distal balloon waist is attached to the distal tip through a urethane adhesive bond, c 8 ln 24-26), the inflation catheter section including a stiffener member (Eidenschink, inner tube 28/110, c 6 ln 36 and c 10 ln 7, increases stiffness because it provides additional structure within the catheter) and an inflation catheter member (Eidenschink, outer tube 34, c 6 ln 35), the stiffener member fixed at a distal end to a proximal end of the distal catheter section (Eidenschink, Fig. 8), the stiffener member extending along the longitudinal axis from the inflation catheter section into the proximal end of the distal catheter section, the inflation lumen defined at least partially between the stiffener member and the inflation catheter member.
Regarding claim 34, Eidenschink in view of Blix teaches the occlusion catheter system of claim 1, wherein the distal catheter section includes a cylindrical member (Eidenschink, cylindrical member, see annotated Fig. 8 below, wherein the area just distal of the distal waist bond is backfilled with adhesive 43 to provide a smooth transition and for improved adhesion between dissimilar substrates, c 8 ln 26-29) spacing the atraumatic tip from a distal balloon end.
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Regarding claim 35, Eidenschink in view of Blix teaches the occlusion catheter system of claim 1, further comprising: a first catheter member (Eidenschink, inner tube 28/110, c 6 ln 36 and c 10 ln 7) fixed at a proximal end to the proximal hub (Eidenschink, the proximal end of the shaft assembly extends into manifold 26 adhesively bonded to the shaft assembly, c 6 ln 30-32) and at a distal end to a proximal end of the distal catheter section (Eidenschink, the proximal end of the shaft assembly extends into manifold 26 adhesively bonded to the shaft assembly, c 6 ln 30-32), the distal catheter section comprised of a third catheter member (third catheter member, see annotated Fig. 8 below) with a third lumen (third lumen is the lumen of the third catheter member), the distal end of the first catheter member fixed in a proximal end of the third lumen.
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Regarding claim 36, Eidenschink in view of Blix teaches the occlusion catheter system of claim 1, wherein the distal catheter section is comprised of a third catheter member (third catheter member, see annotated Fig. 8 below), the atraumatic tip integrally formed at a distal end of the third catheter member.
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Claims 2, 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Eidenschink in view of Blix as applied to claim 1 above, and further in view of Gianotti et al. (Gianotti) US 2013/0253467 A1.
Regarding claim 2, Eidenschink in view of Blix teaches the occlusion catheter of claim 1.
Eidenschink does not teach wherein a greatest outer diameter of the occlusion balloon, the inflation catheter section and the distal catheter section, in an uninflated condition, is 8 Fr or less.
However, Gianotti teaches a balloon catheter for performing angioplasty wherein a greatest outer diameter of the occlusion balloon, the inflation catheter section and the distal catheter section, in an uninflated condition, is 8 Fr or less (the adjustable balloon catheter is compatible with a 4 French introducer sheath, P0141, for performing angioplasty P0056).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Eidenschink to be 8 Fr or less as taught by Gianotti for the purpose of accessing the vasculature to treat vascular occlusions.
Regarding claim 4, Eidenschink in view of Blix teaches the occlusion catheter of claim 1.
Blix does not teach wherein the radially projecting members are constructed of a material having a higher durometer than other portions of the occlusion balloon.
However, Gianotti teaches a balloon catheter wherein the balloon can be multilayered P0148, wherein the outer layer is of a higher durometer than one or more inner layers, P0150-0157.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the balloon of Blix as taught by Gianotti to be multilayered for the purpose of having a balloon that is low compliance (P0145) and relatively high rupture pressure when compared to a balloon of otherwise similar construction but formed solely of the highest durometer material used to make the multilayered balloon, P0153).
Regarding claim 6, Eidenschink in view of Blix teaches the occlusion catheter of claim 1.
Blix does not teach wherein the occlusion balloon is constructed of a semi-compliant or substantially non-compliant material.
However, Gianotti teaches a balloon catheter wherein the occlusion balloon is constructed of a semi-compliant or substantially non-compliant material (non-compliant polymeric material P0157).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the balloon of Blix with a non-compliant material as taught by Gianotti for the purpose of having a balloon that remains substantially at a pre-selected diameter as the internal balloon pressure increases beyond that required to fully inflate the balloon, Gianotti P0053.
Claims 7-8, 16-17 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Eidenschink in view of Blix as applied to claim 1 above, and further in view of Levin et al. (Levin) US 2006/0100639 A1.
Regarding claim 7, Eidenschink in view of Blix teaches the occlusion catheter of claim 1.
Eidenschink teaches dilatation balloons.
Eidenschink does not teach the catheter in combination with a controller operatively coupled therewith, the controller configured to monitor and increase or decrease pressure within the occlusion balloon.
However, Levin teaches balloon catheter in combination with a controller (Levin, controller 601, P0056) operatively coupled therewith, the controller configured to monitor and increase or decrease pressure within the occlusion balloon (Levin, P0056).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the catheter of Eidenschink in view of Blix with the controller of Levin for the purpose of reducing reperfusion injury subsequent to an angioplasty, Levin P0011 and P0021.
Regarding claim 8, Eidenschink in view of Blix in view of Levin teaches the occlusion catheter of claim 7, further comprising at least one sensor (Levin, blood pressure sensor, P0054) connected to the occlusion catheter and to the controller (Levin, sensor mounted on the tip of the catheter, P0054).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the catheter of Eidenschink in view of Blix with the sensor of Levin for the purpose of maintaining CS pressure within desired physiologic limits, Levin P0054.
Regarding claim 16, Eidenschink in view of Blix in view of Levin teaches the occlusion catheter of claim 8, wherein the at least one sensor includes a pressure sensor (Levin, blood pressure sensor, P0054).
Regarding claim 17, Eidenschink in view of Blix in view of Levin teaches the occlusion catheter of claim 16, wherein the pressure sensor is mounted to the distal catheter section (Levin, mounted on the tip, P0054).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Eidenschink in view of Blix in view of Levin with the sensor mounted distally of the balloon to the distal catheter section for the purpose of monitoring downstream physiological conditions relevant to reducing reperfusion injury.
Regarding claim 19, Eidenschink in view of Blix in view of Levin teaches the occlusion catheter of claim 8, wherein the at least one sensor is positioned to detect at least one physiological parameter (Levin, blood pressure) distal to the occlusion balloon (Levin, sensor mounted on the tip of the catheter, P0054).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Eidenschink in view of Blix in view of Levin with the sensor mounted distally to the balloon for the purpose of monitoring downstream physiological conditions relevant to reducing reperfusion injury.
Regarding claim 20, Eidenschink in view of Blix in view of Levin teaches the occlusion catheter of claim 16, wherein the controller is configured to automatically adjust inflation of the occlusion balloon in response to the at least one physiological parameter detected by the at least one sensor (Levin, automatic control of the balloon inflation to maintain CS pressure within a desired range, P0060).
Regarding claim 21, Eidenschink in view of Blix teaches the occlusion catheter of claim 1.
Eidenschink in view of Blix do not teach the catheter in combination with a manually controlled pressure source in fluid communication with the proximal hub, for manually increasing or decreasing pressure within the occlusion balloon (Levin, the operator, based on the readings of physiologic sensors, can make corrections manually to the balloon size, P0062).
However, Levin teaches a balloon catheter in combination with a manually controlled pressure source in fluid communication with the proximal hub, for manually increasing or decreasing pressure within the occlusion balloon (Levin, the operator, based on the readings of physiologic sensors, can make corrections manually to the balloon size, P0062).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the catheter of Eidenschink in view of Blix with a manually controlled pressure source as taught by Levin for the purpose of addressing circumstances for which the automation of the controller may not be programmed to address.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Eidenschink in view of Blix in view of Levin as applied to claim 8 above, and further in view of Mohl US 2010/0130810 A1.
Regarding claim 9, Eidenschink in view of Blix in view of Levin teaches the occlusion catheter of claim 8.
Eidenschink in view of Blix in view of Levin does not teach wherein the at least one sensor is selected from the group consisting of a heart rate sensor.
However, Mohl teaches a device for intermittently occluding the coronary sinus wherein the at least one sensor includes a heart rate sensor (electrocardiogram of ECG sensor, P0031).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the catheter of Eidenschink in view of Blix in view of Levin with the ECG sensors of Mohl for the purpose of monitoring heart function.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Eidenschink in view of Blix in view of Levin as applied to claim 16 above, and further in view of Mohl (Mohl 302’) US 2011/0295302 A1.
Regarding claim 18, Eidenschink in view of Blix in view of Levin teaches the occlusion catheter sensor of claim 16.
Eidenschink in view of Blix in view of Levin does not teach the catheter wherein the pressure sensor is positioned externally to the inflation catheter section and the distal catheter section, and is in fluid communication with the occlusion balloon via the inflation catheter section.
However, Mohl ‘302 teaches a system for intermittently occluding the coronary sinus wherein the pressure sensor is positioned externally to the inflation catheter section and the distal catheter section (pressure sensor arranged within the control system, P0035), and is in fluid communication with the occlusion balloon via the inflation catheter section (balloon sensor line in fluid communication with the interior of the inflatable balloon device is connected to a corresponding port 144 of the control system 140, and balloon pressure lumen extends through the coronary sinus occlusion catheter 120 and to the inflatable balloon device 122, P0035).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the catheter of Eidenschink in view of Blix in view of Levin with the pressure sensor of Mohl ‘302 for the purpose of monitoring balloon pressure as part of a safety feature that is employed to protect the vessel from an overly pressurized balloon, as taught by Mohl ‘302 P0035.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Eidenschink in view of Blix as applied to claim 1 above, and further in view of Mohl 302’.
Regarding claim 22, Eidenschink in view of Blix teaches the occlusion catheter of claim 1.
Eidenschink in view of Blix does not teach the catheter further comprising: a fluid column extending through the inflation catheter section and the occlusion balloon and into the distal catheter section; and the distal catheter section including a distal port through a wall thereof providing fluid communication between an interior of the distal catheter section and an environment external to the distal catheter section, wherein the fluid column fluidly communicates the distal port with the proximal hub, the proximal hub being connected to a pressure sensor configured to measure pressure of the external environment via the distal port and the fluid column.
However, Mohl ‘302 teaches a system for intermittently occluding the coronary sinus further comprising a fluid column (sinus pressure lumen 125 may operate as a fluid filled path that transfers blood pressure in the coronary sinus to pressure sensor device 136, P0036) extending through the inflation catheter section and the occlusion balloon and into the distal catheter section (sinus pressure lumen 125 extending through the coronary sinus occlusion catheter 120 and to the distal ports 129 that are forward of the balloon device 122, P0036 and see annotated Fig. 7 below); and the distal catheter section including a distal port (distal port 129, P0036) through a wall thereof (Fig. 7) providing fluid communication between an interior of the distal catheter section and an environment external to the distal catheter section (P0036), wherein the fluid column fluidly communicates the distal port with the proximal hub (the proximal hub joins third line 135 with the coronary sinus pressure lumen 125, P0036, and the coronary sinus pressure lumen 125 and at least a portion of the third line 135 may operate as a fluid filled path, P0036), the proximal hub being connected to a pressure sensor (pressure sensor device 136, P0036) configured to measure pressure of the external environment via the distal port and the fluid column (P0036).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Eidenschink in view of Blix with the pressure sensor of Mohl ‘302 for the purpose of monitoring blood pressure during use to prevent reperfusion injury, Mohl ‘302 P0080.
Claims 23, 25 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Anderson US 2012/0209176 A1.
Regarding claim 23, Smith discloses an occlusion catheter system for at least partial occlusion of a patient's aorta to obstruct blood flow downstream and increase blood flow upstream to vital organs (MPEP 2111.02(II) recites that statements in the preamble reciting intended use must be evaluated to determine whether or not the intended use results in a structural difference between the claimed invention and the prior art, and here the preamble does not result in a structural difference between the claimed invention and the prior art because the size of a patient’s aorta is variable and is not specified in the claim), the occlusion catheter (catheter 14, c 3 ln 56 and shown in Figs. 1 and 3-6A) comprising: a proximal hub (luer fitting 24, c 4 ln 3) having an inflation connection port (inflation connection port, see annotated Fig. 3 below) and an inflation pathway (lumen of luer fitting, see annotated Fig. 3 below); an inflation catheter section (section of the catheter of Fig. 3 between the luer fitting 24 and the balloon 20) fluidly connected to the proximal hub, the inflation catheter section having an inflation lumen (lumen 22, c 3 ln 66) and a first port (first port, see annotated Fig. 3 below); a distal catheter section (distal catheter section, see annotated Fig. 3 below) including a solid atraumatic tip (atraumatic tip 38, c 4 ln 22-28, solid atraumatic tip shown in Fig. 3) positioned distally on the distal catheter section; an intervening occlusion balloon (balloon 20, c 3 ln 65) attached to the inflation catheter section and the distal catheter section (Fig. 3), the first port being fluidly connected with an internal space of the occlusion balloon (internal space of the occlusion balloon, see annotated Fig. 3 below); and a stiffener member (wire 34, c 4 ln 18) fixedly coupled to the proximal hub (the proximal end of the wire 34 is encapsulated within the proximal fitting 24, c 4 ln 19-21) and extending through the inflation catheter section, the occlusion balloon and into the distal catheter section (Fig. 3), the stiffener member positioned in a spaced apart relationship from the inflation catheter section to define the inflation lumen and terminating in the proximal hub (Fig. 3), the stiffener member including a stiffener distal end fixedly coupled within the distal catheter section distally relative to a distal balloon end of the occlusion balloon (distal balloon end, see annotated Fig. 3), the occlusion balloon configured to define both radially projecting members (wings 46, c 5 ln 16-17, and shown in Fig. 5) and intervening radially projecting landing areas (flutes 44, c 4 ln 16, and shown in Fig. 5) upon inflation of the occlusion balloon into a partially inflated state (partially inflated state shown in Fig. 5, and described as relaxed, which in contrast to fully inflated shown in Figs. 3-4 and collapsed as shown in Figs. 6-6A, see c 5 ln 5-37), the radially projecting members having a sufficient area to seat in apposition with an inner surface of the vessel (sufficient area of radially projecting members, see annotated Fig. 3 below, fully capable of seating in apposition with an inner surface of the vessel) and the radially projecting landing areas (sufficient area of the radially projecting landing areas, see annotated Fig. 3 below, fully capable of forming fluid flow channels with the inner surface of the vessel), the fluid flow channels configured to facilitate at least partial flow of fluid through the fluid flow channels along a length of the occlusion balloon from a distal side of the occlusion balloon to a proximal side of the occlusion balloon (the flutes extend into the end cones 28 of the balloon as well as along the midportion of the balloon, c 5 ln 35-37).
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Smith does not explicitly teach the stiffener member defining a central longitudinal axis.
However, Anderson teaches a balloon catheter having a stiffener member (core wire 16) defining a central longitudinal axis (core wire).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the positioning of the wire 34 of Smith to define a central longitudinal axis for the purpose of transmitting torque distally, Anderson P0028.
Regarding claim 25, Smith in view of Anderson teaches the occlusion catheter system of claim 23, wherein the stiffener member is comprised of a solid wire (Smith, elongate wire 34, wherein a wire lacks a lumen).
Regarding claim 28, Smith in view of Anderson teaches the occlusion catheter system of claim 23, wherein a shaft of the atraumatic tip (Smith, proximal portion of distal tip 38) is positioned within a distal lumen of the distal catheter section (Smith, distal lumen of collar 32) and is configured to project distally from the distal catheter section (Fig. 3).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Anderson as applied to claim 23 above, and further in view of Wolvek et al. (Wolvek) US 4,276,874.
Regarding claim 24, Smith in view of Anderson teaches the occlusion catheter system of claim 23, wherein the stiffener member is configured to lend columnar strength to the occlusion catheter (Smith, the segment of the wire 34 extending between the metal ring 40 and the distal tip 38 serves to impart a slight longitudinal tension to the balloon when the balloon is deflated, thereby to assure that the balloon will be tensioned in a fluted configuration, c 4 ln 36-43).
Smith does not teach wherein the proximal end of the stiffener member bonded to the proximal hub.
However, Wolvek teaches a balloon catheter wherein the proximal end 48 of the stiffener member 46 is bonded to the proximal hub 26b, c 6 ln 48-50.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further secure the wire 34 of Smith to the luer fitting 24 of Smith with adhesive as taught by Wolvek for the purpose of permanent securement, Wolvek c 6 ln 48-50.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Anderson as applied to claim 23 above, and further in view of Valley et al. (Valley) US 2005/0148997 A1.
Regarding claim 27, Smith in view of Anderson teaches the occlusion catheter system of claim 23.
Smith does not explicitly teach wherein the proximal end of the proximal catheter section is adhesively bonded within the proximal hub.
However, Valley teaches an occluding member wherein the proximal end of the proximal catheter section (tube 104, P0107 and shown in Fig. 5A) is adhesively bonded (adhesive bonding, P0107) within the proximal hub (proximal hub 108, P0107).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the connection between the luer fitting 24 and shaft 18 of Smith with adhesive bonding as taught by Valley for the purpose of forming a sealed connection for the balloon inflation lumen, Valley P0107.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783