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 .
DETAILED ACTION
Status of Claims
This office action is in response to the amendment and remarks filed on 12/03/2025. In making the below rejections, the examiner has considered and addressed each of the applicants arguments. Claims 1-6 have been canceled, Claims 21-26 have been newly added and Claims 7-26 are currently pending and being examined.
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 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.
Claim Objections
Claim 16 is objected to because of the following informalities: Claim 16 recites
“-6the” examiner believes it should be “the”. Examiner is taking this to be a simple mistake and it is examined as such. However, appropriate correction is required.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 7 and 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Perkins (USPAP 2009/0248142) in view of Wilson (USPAP 2012/0289987).
In reference to independent claim 7, Perkins discloses a catheter (11, fig 3A-3G) capable of a method of treating chronic venous insufficiency by remodeling a venous valve disposed within a vein within a patient's leg (fig 1, para 0007 discloses “The present invention provides a method and system for improving the competency of a venous valve wherein a compressor (e.g., a space occupying material or implantable device) is delivered at one or more location(s) adjacent to the venous valve to cause one or both leaflets of the valve to move toward the other, thereby improving closure or coaptation of the valve leaflets.”), the method comprising:
advancing a catheter (11) through the vein to a position proximate the venous valve (shown in fig 2A-2F), the catheter (11) including a hollow needle (85) extendable out a first side wall of the catheter (bottom of 11 fig 3B)
then advancing the hollow needle (85) at least partially into the vessel wall (fig 2A-2F discloses the needle piercing the wall); and
then injecting a bulking agent near the venous valve in order to remodel the venous valve (para 0047 discloses “A penetrator 85 is advanced from the catheter 11 into tissue adjacent to the venous valve V V. A compressor 10 is then delivered over or through the penetrator 85 such that the compressor 10 becomes implanted or forms a mass at a location outside of and adjacent to the venous valve V V, thereby causing compression of the valve V V in a manner that causes at least one of the valve leaflets L to move toward the other leaflet L.”), however
Perkins does not teach an inflatable balloon located on a second, opposing, side wall of the catheter to the needle; then inflating the inflatable balloon in order to urge the catheter towards a vessel wall opposite that of the inflatable balloon.
Wilson, a similar catheter for improving vasculature, teaches an inflatable balloon (5706 the “support device”, fig 57A-B) located on a second, opposing, side wall of the catheter to the needle (fig 57 clearly shows the balloon on one side and the needle on the other); then inflating the inflatable balloon (5706) in order to urge the catheter towards a vessel wall opposite that of the inflatable balloon (seen in fig 57A and 57B also para 0290 discloses “The support device includes in this embodiment a single expansion mechanism 5706 to create the necessary wall straightness, taughtness, and apposition along and near the side port 5703 of the support structure 5704.”),
furthermore in para 0290 Wilson discloses “The geometry of the support structure is such that, upon expansion of an expansion mechanism 5706 (here a balloon) into one side of the vessel wall 5707, the vessel wall on the opposite side 5708 is forced to take an offset around the support structure 5704, which allows the puncture element 5700 and probe 5702 to approach the wall 5708 at an angle to permit entry, and allows the puncture element 5700 and probe 5702 to enter the vessel wall 5708 sufficiently parallel to it and within a plane 5709 somewhere between the inner most layer 5710 and the outer most layer 5711. The stiffness of the support mechanism is such that, upon expansion of the balloon 5706, the distal portion of the support structure 5705 does not bend significantly along any axis. FIG. 57A depicts the system after wall apposition has been accomplished, and the puncture element 5700 has been advanced distally through the distal end 5701 of the stationary probe 5702 (which helps to hold the correct orientation of the puncture element 5700), until it punctures the vessel wall 5708”) this cite clearly shows inflating the balloon to hold the vessel and then insert the needle.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the balloon and lumen as taught by Wilson into the catheter of Perkins “to create the necessary wall straightness, taughtness, and apposition along and near the side port 5703 of the support structure 5704” para 0290; Wilson. To be clear, the modification is done by adding the balloon and the step of inflating the balloon, in the appropriate order, directly before advancing the needle into the needle wall in order to create “necessary wall straightness, taughtness, and apposition” so the needle can more accurately pierce the vessel wall.
In reference to independent claim 21, Perkins discloses a structure capable of the method of treating chronic venous insufficiency by remodeling a venous valve disposed within a vein within a patient's leg (fig 1, para 0007 discloses “The present invention provides a method and system for improving the competency of a venous valve wherein a compressor (e.g., a space occupying material or implantable device) is delivered at one or more location(s) adjacent to the venous valve to cause one or both leaflets of the valve to move toward the other, thereby improving closure or coaptation of the valve leaflets.”), the method comprising: positioning a catheter (11) within the vein proximate the venous valve (shown in fig 2A-2F), the catheter (11) having a hollow needle (85); using the controlled positioning to advance the hollow needle into the target vessel wall at a predetermined angle and depth (fig 2A-2F discloses the needle piercing the wall); and delivering a bulking agent through the hollow needle to remodel valve function (para 0047 discloses “A penetrator 85 is advanced from the catheter 11 into tissue adjacent to the venous valve V V. A compressor 10 is then delivered over or through the penetrator 85 such that the compressor 10 becomes implanted or forms a mass at a location outside of and adjacent to the venous valve V V, thereby causing compression of the valve V V in a manner that causes at least one of the valve leaflets L to move toward the other leaflet L.”), however
Perkins does not teach an inflatable balloon on opposing side walls; inflating the inflatable balloon to create controlled positioning of the catheter against a target vessel wall.
Wilson, a similar catheter for improving vasculature, teaches an inflatable balloon (5706 the “support device”, fig 57A-B) on opposing side walls (fig 57 clearly shows the balloon on one side and the needle on the other); inflating the inflatable balloon (5706) to create controlled positioning of the catheter against a target vessel wall (seen in fig 57A and 57B also para 0290 discloses “The support device includes in this embodiment a single expansion mechanism 5706 to create the necessary wall straightness, taughtness, and apposition along and near the side port 5703 of the support structure 5704.”), furthermore in para 0290 Wilson discloses “The geometry of the support structure is such that, upon expansion of an expansion mechanism 5706 (here a balloon) into one side of the vessel wall 5707, the vessel wall on the opposite side 5708 is forced to take an offset around the support structure 5704, which allows the puncture element 5700 and probe 5702 to approach the wall 5708 at an angle to permit entry, and allows the puncture element 5700 and probe 5702 to enter the vessel wall 5708 sufficiently parallel to it and within a plane 5709 somewhere between the inner most layer 5710 and the outer most layer 5711. The stiffness of the support mechanism is such that, upon expansion of the balloon 5706, the distal portion of the support structure 5705 does not bend significantly along any axis. FIG. 57A depicts the system after wall apposition has been accomplished, and the puncture element 5700 has been advanced distally through the distal end 5701 of the stationary probe 5702 (which helps to hold the correct orientation of the puncture element 5700), until it punctures the vessel wall 5708”) this cite clearly shows inflating the balloon to hold the vessel and then insert the needle.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the balloon and lumen as taught by Wilson into the catheter of Perkins “to create the necessary wall straightness, taughtness, and apposition along and near the side port 5703 of the support structure 5704” para 0290; Wilson. To be clear, the modification is done by adding the balloon and the step of inflating the balloon in the appropriate order directly before advancing the needle into the needle wall in order to create “necessary wall straightness, taughtness, and apposition” so the needle can more accurately pierce the vessel wall.
In reference to dependent claim 22, Perkins in view of Willson discloses a structure capable of the method of claim 21, Perkins further discloses a catheter wherein the bulking agent comprises medical grade silicone (para 0050 discloses “Such injectable space occupying material will form a depot or mass at the intended location(s) adjacent to the venous valve V V. The amount of such material(s) injected will be sufficient to exert pressure on the valve V V to cause the desired shift in the position of at least one valve leaflet L and resulting in improved coaptation of the valve leaflets L during closure of the valve. Examples of injectable materials that may be used for this purpose include but are not necessarily limited to; bulking agents, fat,-- silicones (e.g., high-viscosity liquid silicone such as Adatosil-5000.TM. and Silikon-1000.TM., Dow Corning, Midland Mich.),), however
Perkins is silent to a silicon that specifically has a viscosity between about 50,000 and about 200,000 cP when delivered through the hollow needle.
Perkins does teach a wide range of bulking agents (para 0050), including Restylane dermal filler which has a viscosity of 119,180 cP.
The MPEP specifically states “PRIOR ART WHICH TEACHES A RANGE OVERLAPPING, APPROACHING, OR TOUCHING THE CLAIMED RANGE ANTICIPATES IF THE PRIOR ART RANGE DISCLOSES THE CLAIMED RANGE WITH "SUFFICIENT SPECIFICITY"” MPEP 2131.03, II
"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated' if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Examiner takes the position that since Perkins teaches medical grade silicones as a bulking agent and a bulking agent with a viscosity within the range of applicant’s range, the prior art teaches a medical grade silicone with viscosity in the claimed range.
In reference to dependent claim 23, Perkins in view of Willson discloses a structure capable of the method of claim 21, Perkins further discloses a catheter further comprising using external ultrasound evaluation during the delivering step to monitor remodeling progress in real time (para 0049 discloses “any suitable technique, such as contrast radiography and/or imaging (e.g., ultrasound imaging) of the valve leaflets L, may be used to determine when the leaflets L have been sufficiently repositioned to once again render the valve V V competent”).
In reference to dependent claim 24, Perkins in view of Willson discloses a structure capable of the method of claim 21, Perkins discloses a catheter further comprising: deflating the inflatable balloon; circumferentially repositioning the catheter to a different angular position around the venous valve (described in para 0048 below); reinflating the inflatable balloon (Perkins is silent to a balloon however Wilson, combined above, does disclose in para 0233 “The balloon 260 is then deflated, retracted slightly, and then re-inflated”); and delivering additional bulking agent at the different angular position to create multiple areas of valve remodeling (para 0048 discloses “the compressor 10 is positioned at a discrete location on just one side of the venous valve V V, a single compressor 10 may move the leaflets L together adequately to restore substantial coaptation of the leaflets L, as seen in FIG. 2C. However, in other cases, it may be desirable to deliver one or more additional compressor(s) to other location(s) adjacent to the venous valve V V. Accordingly, FIGS. 2D through 2F show optional additional steps that may be performed to deliver additional compressor(s) 10 to additional location(s) adjacent to the venous valve V V. As shown in FIG. 2D, the tissue penetrating catheter 11 remains positioned within (or if previously removed, has been reinserted into) the lumen of the vein V and the longitudinal position and/or rotational orientation of the catheter 11 has been adjusted as needed to aim the penetrator 85 toward an intended site that, in this example, is diametrically opposite the location at which the first compressor 10 had been implanted (e.g., next to the base of the other leaflet, approximately 90 degrees from the valve commissure or plane of separation between the leaflets and approximately 180 degrees from the previously implanted compressor). After the penetrator 85 has been advanced to this desired location, a second compressor 10 is delivered to the second location as shown in FIG. 2E. This exerts compressive force inwardly on the venous valve V V in a direction opposite the compressive force exerted by the first compressor 10 (delivered in FIG. 2B) and causes the leaflets L to move further together as seen in FIG. 2F.”).
In reference to dependent claim 25, Perkins in view of Willson discloses a structure capable of the method of claim 21, Perkins further discloses a catheter wherein positioning the catheter comprises advancing the catheter through the vein from a position below the venous valve (see fig 2A-F, fig 8A shows advancing a catheter from below the valve),however
Perkins is silent to wherein the controlled positioning orients the hollow needle substantially parallel to the target vessel wall (fig 57A shows the needle substantially parallel to the target vessel wall).
Wilson, a similar catheter for improving vasculature, teaches the controlled positioning orients the hollow needle substantially parallel to the target vessel wall.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the balloon and lumen as taught by Wilson into the catheter of Perkins in view of Wilson “to create the necessary wall straightness, taughtness, and apposition along and near the side port 5703 of the support structure 5704” para 0290; Wilson.
In reference to dependent claim 26, Perkins in view of Willson discloses a structure capable of the method of claim 24, Perkins further discloses a catheter wherein the circumferential repositioning creates a first area of bulking agent and a second area of bulking agent positioned to provide improved valve leaflet coaptation (para 0007 specifically discloses “improving closure or coaptation of the valve leaflets”) during valve closure (para 0048 discloses “the compressor 10 is positioned at a discrete location on just one side of the venous valve V V, a single compressor 10 may move the leaflets L together adequately to restore substantial coaptation of the leaflets L, as seen in FIG. 2C. However, in other cases, it may be desirable to deliver one or more additional compressor(s) to other location(s) adjacent to the venous valve V V. Accordingly, FIGS. 2D through 2F show optional additional steps that may be performed to deliver additional compressor(s) 10 to additional location(s) adjacent to the venous valve V V. As shown in FIG. 2D, the tissue penetrating catheter 11 remains positioned within (or if previously removed, has been reinserted into) the lumen of the vein V and the longitudinal position and/or rotational orientation of the catheter 11 has been adjusted as needed to aim the penetrator 85 toward an intended site that, in this example, is diametrically opposite the location at which the first compressor 10 had been implanted (e.g., next to the base of the other leaflet, approximately 90 degrees from the valve commissure or plane of separation between the leaflets and approximately 180 degrees from the previously implanted compressor). After the penetrator 85 has been advanced to this desired location, a second compressor 10 is delivered to the second location as shown in FIG. 2E. This exerts compressive force inwardly on the venous valve V V in a direction opposite the compressive force exerted by the first compressor 10 (delivered in FIG. 2B) and causes the leaflets L to move further together as seen in FIG. 2F.”).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Perkins (USPAP 2009/0248142) in view of Wilson (USPAP 2012/0289987) as applied to claim 7 above, and further in view of Kugler (USPAP 2019/0269434).
In reference to dependent claim 8, Perkins in view of Wilson discloses the catheter capable of the method of claim 7, however
Perkins and Wilson are silent to wherein advancing the hollow needle at least partially into the vessel wall comprises advancing the hollow needle through an endothelium of the vessel wall and into a subintimal space within the vessel wall.
Kugler, a similar catheter for improving vasculature, teaches advancing the hollow needle (304, fig 4) at least partially into the vessel wall (200) comprises advancing the hollow needle through an endothelium of the vessel wall and into a subintimal space within the vessel wall (para 0026 discloses “Subintimal device lumen 303 is positioned adjacent to the intimal layer 200 and subintimal device 304 has been advanced as to perforate the subintimal layer. A fluid source (i.e. syringe) 305 is in fluid communication with subintimal device lumen 303 through infusion lumen 306. Fluid may flow from the fluid source 305 through the subintimal device lumen 303 under a controlled pressure or a controlled volume.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the needle placement method of Kugler in the method of Perkins in view of Wilson to better shape the vasculature and improve circulation para 0005-0009, Kugler.
In reference to dependent claim 9, Perkins in view of Wilson and Kugler discloses the catheter capable of the method of claim 8, Perkin further discloses injecting the bulking agent (10) near the venous valve (fig 2A-2F shows the needle going completely thru the vein wall and injecting the bulking agent near the valve), comprises injecting into the subintimal space within the vessel wall (Perkins and Wilson are silent to specifically where within the wall to inject however, Kugler, combined above, discloses specifically manipulating the subintimal layer to improve the vasculature).
Claims 10-15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Perkins (USPAP 2009/0248142) in view of Wilson (USPAP 2012/0289987) as applied to claim 7 above, and further in view of Gross (USPAP 2007/0050013).
In reference to dependent claim 10, Perkins in view of Wilson discloses the catheter capable of the method of claim 7, Perkins further discloses a catheter (11) wherein advancing the hollow needle (85) at least partially into the vessel wall comprises advancing the hollow needle through the vessel wall and into a space exterior to the vessel wall (para 0047 discloses “A penetrator 85 is advanced from the catheter 11 into tissue adjacent to the venous valve V V. A compressor 10 is then delivered over or through the penetrator 85 such that the compressor 10 becomes implanted or forms a mass at a location outside of and adjacent to the venous valve V V, thereby causing compression of the valve V V in a manner that causes at least one of the valve leaflets L to move toward the other leaflet L.” examiner takes the position that Perkins renders obvious every position outside but adjacent to the wall).
Perkins and Wilson are silent to injecting the bulking agent into the advential space.
Gross, a similar method of improving venous vasculature, teaches placing a valve improving device (in this case a prosthetic) in the advential space (para 0045 discloses “A seal 106 is made between the nozzle and the tissue, for example by using a tie wrap or O-ring placed over the advential (i.e. outer) surface of the vein at the inflow and outflow, respectively which seat in a groove 105.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the bulking agent in the advential space as taught in Gross in the method of Perkins in view of Wilson “ to maintain a proper blood flow rate through the valve” para 0002, Gross.
In reference to dependent claim 11, Perkins in view of Wilson and Gross discloses the catheter capable of the method of claim 10, Perkins further discloses a catheter (11) wherein injecting the bulking agent (10) near the venous valve comprises injecting the bulking agent into the advential space (Perkins is silent to the advential space however, Gross, combined above does disclose manipulating the area to positively impact vasculature) exterior to the vessel wall (para 0047 discloses “A penetrator 85 is advanced from the catheter 11 into tissue adjacent to the venous valve V V. A compressor 10 is then delivered over or through the penetrator 85 such that the compressor 10 becomes implanted or forms a mass at a location outside of and adjacent to the venous valve V V, thereby causing compression of the valve V V in a manner that causes at least one of the valve leaflets L to move toward the other leaflet L.” examiner takes the position that Perkins renders obvious every position outside but adjacent to the wall).
In reference to dependent claim 12, Perkins in view of Wilson and Gross discloses the catheter capable of the method of claim 10, Perkins further discloses a catheter (11) further comprising using external ultrasound to evaluate progress towards remodeling the venous valve (para 0049 discloses “any suitable technique, such as contrast radiography and/or imaging (e.g., ultrasound imaging) of the valve leaflets L, may be used to determine when the leaflets L have been sufficiently repositioned to once again render the valve V V competent”).
In reference to dependent claim 13, Perkins in view of Wilson and Gross discloses the catheter capable of the method of claim 10, Perkins discloses a catheter further comprising: subsequently withdrawing the hollow needle back into the catheter (para 0010 discloses “the penetrator may be retracted into the catheter and the catheter may be removed”); then moving the catheter to a different position (described in para 0048 below); then advancing the hollow needle at least partially into the vessel wall (shown in fig 2D); and then injecting a bulking agent near the venous valve (para 0048 discloses “the compressor 10 is positioned at a discrete location on just one side of the venous valve V V, a single compressor 10 may move the leaflets L together adequately to restore substantial coaptation of the leaflets L, as seen in FIG. 2C. However, in other cases, it may be desirable to deliver one or more additional compressor(s) to other location(s) adjacent to the venous valve V V. Accordingly, FIGS. 2D through 2F show optional additional steps that may be performed to deliver additional compressor(s) 10 to additional location(s) adjacent to the venous valve V V. As shown in FIG. 2D, the tissue penetrating catheter 11 remains positioned within (or if previously removed, has been reinserted into) the lumen of the vein V and the longitudinal position and/or rotational orientation of the catheter 11 has been adjusted as needed to aim the penetrator 85 toward an intended site that, in this example, is diametrically opposite the location at which the first compressor 10 had been implanted (e.g., next to the base of the other leaflet, approximately 90 degrees from the valve commissure or plane of separation between the leaflets and approximately 180 degrees from the previously implanted compressor). After the penetrator 85 has been advanced to this desired location, a second compressor 10 is delivered to the second location as shown in FIG. 2E. This exerts compressive force inwardly on the venous valve V V in a direction opposite the compressive force exerted by the first compressor 10 (delivered in FIG. 2B) and causes the leaflets L to move further together as seen in FIG. 2F.”).
In reference to dependent claim 14, Perkins in view of Wilson and Gross discloses the catheter capable of the method of claim 13, Perkins further discloses the catheter (11) wherein moving the catheter to a different position comprises:
deflating the inflatable balloon prior to moving the catheter to a different position (Perkins is silent to a balloon however Wilson, combined above, does disclose in para 0233 “The balloon 260 is then deflated, retracted slightly, and then re-inflated”); then moving the catheter to a different position (shown in fig 2A-2D wherein the catheter is rotated to provide a “compressor” on either side of the vein); and then inflating the inflatable balloon prior to advancing the hollow needle at least partially into the vessel wall ((Perkins is silent to a balloon however Wilson, combined above, does discloses in para 0290 “upon expansion of an expansion mechanism 5706 (here a balloon) into one side of the vessel wall 5707, the vessel wall on the opposite side 5708 is forced to take an offset around the support structure 5704, which allows the puncture element 5700 and probe 5702 to approach the wall 5708 at an angle to permit entry,” the cite discloses inserting the needle after the balloon is inflated).
In reference to dependent claim 15, Perkins in view of Wilson discloses the catheter capable of the method of claim 14, Perkins further discloses the catheter (11) wherein moving the catheter to a different position comprises translating the catheter and/or rotating the catheter (para 0048 discloses “As shown in FIG. 2D, the tissue penetrating catheter 11 remains positioned within (or if previously removed, has been reinserted into) the lumen of the vein V and the longitudinal position and/or rotational orientation of the catheter 11 has been adjusted as needed to aim the penetrator 85 toward an intended site that, in this example, is diametrically opposite the location at which the first compressor 10 had been implanted (e.g., next to the base of the other leaflet, approximately 90 degrees from the valve commissure or plane of separation between the leaflets and approximately 180 degrees from the previously implanted compressor). After the penetrator 85 has been advanced to this desired location, a second compressor 10 is delivered to the second location as shown in FIG. 2E. This exerts compressive force inwardly on the venous valve V V in a direction opposite the compressive force exerted by the first compressor 10 (delivered in FIG. 2B) and causes the leaflets L to move further together as seen in FIG. 2F.”).
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Perkins (USPAP 2009/0248142) in view of Wilson (USPAP 2012/0289987) further in view of Gross (USPAP 2007/0050013).
In reference to independent claim 16, Perkins discloses a catheter (11, fig 3A-3G) capable of a method of treating chronic venous insufficiency by remodeling a venous valve disposed within a vein within a patient's leg (fig 1, para 0007 discloses “The present invention provides a method and system for improving the competency of a venous valve wherein a compressor (e.g., a space occupying material or implantable device) is delivered at one or more location(s) adjacent to the venous valve to cause one or both leaflets of the valve to move toward the other, thereby improving closure or coaptation of the valve leaflets.”), the method comprising:
advancing a catheter (11) through the vein to a position proximate the venous valve (shown in fig 2A-2F), the catheter (11) including a hollow needle (85) extendable out a first side wall of the catheter (bottom of 11 fig 3B) and the hollow needle (85) advancing through the vessel wall (V) and into an space outside the vessel wall (shown in fig 2A-2F the needle is capable of injecting the bulking agent to any area within the area outside of the wall); and
subsequently injecting a bulking agent (10) into the space outside the vessel wall (para 0047 discloses “A penetrator 85 is advanced from the catheter 11 into tissue adjacent to the venous valve V V. A compressor 10 is then delivered over or through the penetrator 85 such that the compressor 10 becomes implanted or forms a mass at a location outside of and adjacent to the venous valve V V, thereby causing compression of the valve V V in a manner that causes at least one of the valve leaflets L to move toward the other leaflet L.”).
Perkins does not teach an inflatable balloon located on a second, opposing, side wall of the catheter; subsequently inflating the inflatable balloon in order to urge the catheter towards a vessel wall opposite that of the inflatable balloon; subsequently advancing the hollow needle into the vessel wall opposite that of the inflatable balloon and
is silent to injecting the bulking agent into the advential space.
Wilson, a similar catheter for improving vasculature, teaches an inflatable balloon (5706 the “support device”, fig 57A-B) located on a second, opposing, side wall of the catheter (fig 57A and 57B clearly shows the balloon on one side and the needle on the opposite side); inflating the inflatable balloon (5706) in order to urge the catheter towards a vessel wall opposite that of the inflatable balloon (seen in fig 57A and 57B also para 0290 discloses “The support device includes in this embodiment a single expansion mechanism 5706 to create the necessary wall straightness, taughtness, and apposition along and near the side port 5703 of the support structure 5704.”); advancing the needle (5700) into the vessel wall (508) opposite that of the inflatable balloon (fig 57A and 57B clearly shows the balloon on one side and the needle on the opposite side) furthermore in para 0290 Wilson discloses “The geometry of the support structure is such that, upon expansion of an expansion mechanism 5706 (here a balloon) into one side of the vessel wall 5707, the vessel wall on the opposite side 5708 is forced to take an offset around the support structure 5704, which allows the puncture element 5700 and probe 5702 to approach the wall 5708 at an angle to permit entry, and allows the puncture element 5700 and probe 5702 to enter the vessel wall 5708 sufficiently parallel to it and within a plane 5709 somewhere between the inner most layer 5710 and the outer most layer 5711. The stiffness of the support mechanism is such that, upon expansion of the balloon 5706, the distal portion of the support structure 5705 does not bend significantly along any axis. FIG. 57A depicts the system after wall apposition has been accomplished, and the puncture element 5700 has been advanced distally through the distal end 5701 of the stationary probe 5702 (which helps to hold the correct orientation of the puncture element 5700), until it punctures the vessel wall 5708”) this cite clearly shows inflating the balloon to hold the vessel and then insert the needle.
21It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the balloon and lumen as taught by Wilson into the catheter of Perkins “to create the necessary wall straightness, taughtness, and apposition along and near the side port 5703 of the support structure 5704” para 0290; Wilson.
Wilson is silent to injecting the bulking agent into the advential space.
Gross, a similar method of improving venous vasculature, teaches placing a valve improving device (in this case a prosthetic) in the advential space (para 0045 discloses “A seal 106 is made between the nozzle and the tissue, for example by using a tie wrap or O-ring placed over the advential (i.e. outer) surface of the vein at the inflow and outflow, respectively which seat in a groove 105.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the bulking agent in the advential space as taught in Gross in the method of Perkins in view of Wilson “ to maintain a proper blood flow rate through the valve” para 0002, Gross. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the balloon and lumen as taught by Wilson into the catheter of Perkins “to create the necessary wall straightness, taughtness, and apposition along and near the side port 5703 of the support structure 5704” para 0290; Wilson. To be clear, the modification is done by adding the balloon and the step of inflating the balloon, in the appropriate order, directly before advancing the needle into the needle wall in order to create “necessary wall straightness, taughtness, and apposition” so the needle can more accurately pierce the vessel wall.
In reference to dependent claim 17, Perkins in view of Wilson and Gross discloses the catheter capable of the method of claim 16, Perkins further discloses the catheter (11) wherein advancing the catheter through the vein comprises advancing the catheter through the vein from a position below the venous valve (fig 2A-2F shows the catheter moving to a position below the valve portions L).
In reference to dependent claim 18, Perkins in view of Wilson and Gross discloses the catheter capable of the method of claim 16, Perkins discloses the catheter (11) further comprising: withdrawing the hollow needle back into the catheter (para 0010 discloses “the penetrator may be retracted into the catheter and the catheter may be removed”); subsequently moving the catheter to a different position (from fig 2A to fig 2D); subsequently advancing the hollow needle into and through the vessel wall (shown in fig 2D); and subsequently injecting a bulking agent (10) into the advential space (Perkins is silent to the advential space however, Gross, combined above does disclose manipulating the area to positively impact vasculature) outside the vessel wall (para 0047 discloses “A penetrator 85 is advanced from the catheter 11 into tissue adjacent to the venous valve V V. A compressor 10 is then delivered over or through the penetrator 85 such that the compressor 10 becomes implanted or forms a mass at a location outside of and adjacent to the venous valve V V, thereby causing compression of the valve V V in a manner that causes at least one of the valve leaflets L to move toward the other leaflet L.” examiner takes the position that Perkins renders obvious every position outside but adjacent to the wall).
In reference to dependent claim 19, Perkins in view of Wilson and Gross discloses the catheter capable of the method of claim 18, Perkins further discloses the catheter (11) wherein moving the catheter to a different position comprises:
deflating the inflatable balloon prior to moving the catheter to a different position (Perkins is silent to a balloon however Wilson, combined above, does disclose in para 0233 “The balloon 260 is then deflated, retracted slightly, and then re-inflated”); subsequently moving the catheter to a different position (shown in fig 2A-2D wherein the catheter is rotated to provide a “compressor” on either side of the vein); and subsequently inflating the inflatable balloon prior to advancing the hollow needle into and through the vessel wall ((Perkins is silent to a balloon however Wilson, combined above, does discloses in para 0290 “upon expansion of an expansion mechanism 5706 (here a balloon) into one side of the vessel wall 5707, the vessel wall on the opposite side 5708 is forced to take an offset around the support structure 5704, which allows the puncture element 5700 and probe 5702 to approach the wall 5708 at an angle to permit entry,” the cite discloses inserting the needle after the balloon is inflated).
In reference to dependent claim 20, Perkins in view of Wilson and Gross discloses the catheter capable of the method of claim 19, Perkins further discloses a catheter wherein moving the catheter to a different position comprises translating the catheter and/or rotating the catheter (para 0048 discloses “As shown in FIG. 2D, the tissue penetrating catheter 11 remains positioned within (or if previously removed, has been reinserted into) the lumen of the vein V and the longitudinal position and/or rotational orientation of the catheter 11 has been adjusted as needed to aim the penetrator 85 toward an intended site that, in this example, is diametrically opposite the location at which the first compressor 10 had been implanted (e.g., next to the base of the other leaflet, approximately 90 degrees from the valve commissure or plane of separation between the leaflets and approximately 180 degrees from the previously implanted compressor). After the penetrator 85 has been advanced to this desired location, a second compressor 10 is delivered to the second location as shown in FIG. 2E. This exerts compressive force inwardly on the venous valve V V in a direction opposite the compressive force exerted by the first compressor 10 (delivered in FIG. 2B) and causes the leaflets L to move further together as seen in FIG. 2F.”).
Response to Arguments
In response to applicant’s argument that “Cobbling together an apparatus that may be capable of performing the claimed method step does not teach or suggest the claimed method. The Examiner has failed to properly examine the method claims because the rejections are based on the legally insufficient "capable of' reasoning rather than actual method step analysis. Method claims require analysis of whether the prior art actually teaches the method steps, not merely whether apparatus exists that could theoretically perform individual functions.” Examiner respectfully disagrees. The entire purpose of the balloon is to make the vessel wall rigid to accept the needle, in para 0290 Wilson discloses “The geometry of the support structure is such that, upon expansion of an expansion mechanism 5706 (here a balloon) into one side of the vessel wall 5707, the vessel wall on the opposite side 5708 is forced to take an offset around the support structure 5704, which allows the puncture element 5700 and probe 5702 to approach the wall 5708 at an angle to permit entry, and allows the puncture element 5700 and probe 5702 to enter the vessel wall 5708 sufficiently parallel to it and within a plane 5709 somewhere between the inner most layer 5710 and the outer most layer 5711. The stiffness of the support mechanism is such that, upon expansion of the balloon 5706, the distal portion of the support structure 5705 does not bend significantly along any axis. FIG. 57A depicts the system after wall apposition has been accomplished, and the puncture element 5700 has been advanced distally through the distal end 5701 of the stationary probe 5702 (which helps to hold the correct orientation of the puncture element 5700), until it punctures the vessel wall 5708”) this cite clearly shows inflating the balloon to hold the vessel and then insert the needle.
In response to applicant’s argument that “claim 7 requires a coordinated procedural sequence that is simply not taught by either of the cited references. The catheter is advanced through the vein. After that, the inflatable balloon is inflated. After that, the hollow needle is advanced. After that, a bulking agent is injected. This coordinated procedural sequence is simply not taught by two references that are relied upon to assemble hardware that is believed "capable of' practicing the claimed method, particularly when the two references do not actually teach or suggest each of the claimed method steps, in the order outlined. It is axiomatic that obviousness requires at least a suggestion of each and every element in a claim.” Examiner respectfully disagrees Wilson clearly discloses using the balloon to secure the vessel wall for the insertion of the hollow needle as evidenced be para 0290 above. Furthermore, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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/C.W.N/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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