DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 4 is objected to because of the following informalities: line 1 discloses “catheter 20” which should be changed to “catheter”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: line 1 discloses “port 38” which should be changed to “port”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: line 7 discloses “end 34 of the balloon, the first catheter 20 having a port 36” should be changed to “end of the balloon, the first catheter having a port”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 7, 8, 9, 10, 14, 15 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murphy US 2016/0220793.
Regarding claim 1, Murphy discloses a retrograde blood flow occlusion flushing device 1 (for example, figures 1, 9), comprising: a first catheter 18 having a proximal end, a distal end, and a lumen extending through the first catheter from the proximal end to the distal end (figures 1, 9, sleeve 18, for example, see annotated figure 9 below); a second catheter 5 disposed within the lumen of the first catheter (figures 1, 9, shaft 5, for example, see annotated figure 9 below), the second catheter having a proximal end, a distal end, and a lumen extending through the second catheter from the proximal end to the distal end (see annotated figure 9 below), the second catheter being axially movable with respect to the first catheter (paragraph 0030, sleeve 18 is slidable along surface of shaft 5) , the second catheter having an inflatable balloon 2 connected to an outer circumferential surface of the second catheter at the distal end of the second catheter (inflatable balloon, paragraph 0029, figures 1, 9), the balloon being movable between a collapsed state and an inflated state (paragraph 0029, in unexpanded state when being delivered, expanded when infused with an inflation medium), the balloon being fixedly connected to the outer circumferential surface of the second catheter at a proximal end of the balloon and at a distal end of the balloon (figures 1, 9; fixed an proximal and distal end of the balloon while the center is expanded during inflation), the second catheter having a port 11 in the sidewall between the proximal end of the balloon and the distal end of the balloon (see annotated figure 9 below), the balloon having at least one port 51 proximate the proximal end of the balloon (see annotated figure 9 below); wherein the balloon is movable between the collapsed state and the inflated state by a fluid deliverable through the lumen of the second catheter via the proximal end and exiting the port in the sidewall of the second catheter to selectively move the balloon between the collapsed state and the inflated state (paragraphs 0005, 0007; 0004; figure 9, introducing a medium to cause the expandable structure or balloon to expand; one or more holes are provided on the proximal side 50 of balloon to deliver the medium through ports 51); in the inflated state, the fluid being deliverable through the lumen of the second catheter through the port in the sidewall of the second catheter to inflate the balloon (paragraph 0005, inflation medium flows through the inner lumen of the second catheter 5 through one or more holes to cause the expandable structure to expand) and at least some of the fluid exiting the inflated balloon in the proximal direction through the at least one port in the balloon (figure 9, through openings 51, paragraph 0040).
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Regarding claim 2, Murphy discloses wherein the distal end of the second catheter is sealed such that the only openings in the second catheter are at the proximal end and at the port in the sidewall of the second catheter (paragraph 0003, 0032, elongate member 20 having a seal unit distal end 22, for example, shown in figure 2B, allows for flow into the inflation balloon through ports 11 but blocks flow through the lumen of catheter 5).
Regarding claim 7, Murphy discloses a blood flow occlusion flushing device, comprising: a first catheter 18 having a proximal end, a distal end, and a lumen extending through the first catheter from the proximal end to the distal end (figures 1, 9, sleeve 18, for example, see annotated figure 9 below); a second catheter 5 disposed within the lumen of the first catheter (figures 1, 9, shaft 5, for example, see annotated figure 9 below), the second catheter having a proximal end, a distal end, and a lumen extending through the second catheter from the proximal end to the distal end (see annotated figure 9 below), the second catheter being axially movable with respect to the first catheter (paragraph 0030, sleeve 18 is slidable along surface of shaft 5), the second catheter having a port 11 in the sidewall proximate the distal end of the second catheter (see annotated figure 9 below); a guidewire 20 disposed within the lumen of the second catheter (shown for example, figure 2A), the guidewire being axially movable with respect to the second catheter (paragraph 0032, wire 20 moves within shaft 5 to seal or unseal ports), the guidewire having a proximal end and a distal end (figure 2A, proximal end expending at the proximal end of shaft 5 at portion 21, distal end at the distal end of the guidewire 20, adjacent enlarged portion 22), the guidewire having a first diameter that is less than an inner diameter of the second catheter (guidewire 20 is slidably placed within second catheter 5, therefore, less than the inner diameter of the second catheter, for example, figure 2A) , the guidewire having a radially outwardly projecting bump 22 proximate the distal end of the guidewire (figure 2A), the radially outwardly projecting bump having an outer diameter that is approximately equal to an inner diameter of the second catheter at the distal end of the second catheter such that when the radially outwardly projecting bump is aligned with the distal end of the second catheter (figure 2A, portion 22 seals against shaft 5), the radially outwardly projecting bump being in sealing contact with the inner diameter of the second catheter at the distal end of the second catheter such that a fluid deliverable through the lumen of the second catheter via the proximal end and exiting the port in the sidewall of the second catheter (projecting bump moves distally to expose ports 11 to allow fluid flow into the balloon 2, figure 2B, while sealing the distal end).
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Regarding claim 8, Murphy further discloses an inflatable balloon 2 connected to an outer circumferential surface of the second catheter at the distal end of the second catheter (inflatable balloon, paragraph 0029, figures 1, 9), the balloon being movable between a collapsed state and an inflated state (paragraph 0029, in unexpanded state when being delivered, expanded when infused with an inflation medium), the inflatable balloon being fixedly connected to the outer circumferential surface of the second catheter at a proximal end of the balloon and at a distal end of the balloon (figures 1, 9; fixed an proximal and distal end of the balloon while the center is expanded during inflation).
Regarding claims 9 and 10, Murphy discloses wherein the balloon having at least one port 51 between the proximal end of the balloon and the distal end of the balloon (figure 9 below), wherein the at least one port 51 in the balloon being disposed at the proximal end of the balloon (figure 9, ports 51 disposed and facing the proximal end of the catheter).
Regarding claim 14, Murphy discloses wherein the radially outwardly projecting bump 22 is a radiopaque marker (radiopaque markers on seal member 22, paragraph 0037).
Regarding claim 15, Murphy discloses wherein a retrograde blood flow occlusion flushing device (for example, figures 1, 9), comprising: a first catheter 5 having a proximal end, a distal end, and a lumen 10 extending through the first catheter from the proximal end to the distal end (figures 1, 9, proximal and distal end of shaft 5, for example, see annotated figure 9 below), the first catheter having an inflatable balloon 2 connected to an outer circumferential surface of the first catheter at the distal end of the first catheter inflatable balloon (paragraph 0029, figures 1, 9), the balloon being movable between a collapsed state and an inflated state (paragraph 0029, in unexpanded state when being delivered, expanded when infused with an inflation medium), the balloon being fixedly connected to the outer circumferential surface of the first catheter at a proximal end of the balloon and at a distal end of the balloon (figures 1, 9; fixed an proximal and distal end of the balloon while the center is expanded during inflation), the first catheter having a port 11 in the sidewall between the proximal end of the balloon and the distal end of the balloon, the balloon having at least one port proximate the proximal end of the balloon (see annotated figure 9 below); wherein the balloon is movable between the collapsed state and the inflated state by a fluid deliverable through the lumen of the first catheter via the proximal end and exiting the port in the sidewall of the first catheter to selectively move the balloon between the collapsed state and the inflated state (paragraph 0005, inflation medium flows through the inner lumen of the second catheter 5 through one or more holes to cause the expandable structure to expand); in the inflated state, the fluid being deliverable through the lumen of the first catheter, through the port in the sidewall of the first catheter to inflate the balloon and at least some of the fluid exiting the inflated balloon in the proximal direction through the at least one port 51 in the balloon (paragraphs 0005, 0007; 0004; figure 9, introducing a medium to cause the expandable structure or balloon to expand; one or more holes are provided on the proximal side 50 of balloon to deliver the medium through ports 51).
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Regarding claim 16, Murphy discloses wherein the distal end of the first catheter is sealed such that the only openings in the first catheter are at the proximal end and at the port in the sidewall of the first catheter (paragraph 0003, 0032, elongate member 20 having a seal unit distal end 22, for example, shown in figure 2B, allows for flow into the inflation balloon through ports 11 but blocks flow through the lumen of catheter 5).
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.
Claim(s) 3-5, 11, 12 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murphy US 2016/0220793 in view of Ogle US 11,229,445.
Regarding claim 3-5, 11 and 12, Murphy discloses various components of the treatment catheter may include radiopaque markers to assist in visualizing the position of the various components, wherein the second catheter has a second radiopaque marker proximal to and distal to the balloon (paragraph 0037, radiopaque markers 26 may be on each the proximal and distal side of the balloon on the catheter shaft or along sleeve 18 or on seal member 22 at the sealed distal end, for example, figure 4), but fails to explicitly disclose the second catheter having a first radiopaque marker proximal to and proximal the balloon, wherein the second catheter has a second radiopaque marker proximal to and distal to the balloon. Examiner notes the radiopaque member is placed proximal to the balloon, but appears to be placed on the first catheter 18, not the second catheter 5.
However, Ogle teaches a catheter comprising a balloon and profusion ports, the catheter may comprise one or more marker bands or other imageable components to position the balloon and ports relative the target location. Ogle teaches there is generally significant design flexibility for placement of the radiopaque elements and a person of ordinary skill can manage such placement as necessary to achieve convenience for the corresponding procedures (column 17, lines 19-28).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Murphy with radiopaque markers on the second catheter, proximal or distal to the balloon or at the sealed distal end, as taught by Ogle, that it is known in the art to adjust the placement of the radiopaque markers as necessary for achieving the desired mechanical performance for a corresponding procedure.
Regarding claim 17-19, Murphy discloses various components of the treatment catheter may include radiopaque markers to assist in visualizing the position of the various components, wherein the catheter has a radiopaque marker proximal to and distal to the balloon (paragraph 0037, radiopaque markers 26 may be on each the proximal and distal side of the balloon on the catheter shaft or along sleeve 18 or on seal member 22 at the sealed distal end, for example, figure 4), but fails to explicitly disclose the first catheter having a first radiopaque marker proximal to and proximal the balloon, wherein the first catheter has a second radiopaque marker proximal to and distal to the balloon. Examiner notes the radiopaque member is placed proximal to the balloon, but appears to be placed on the outer catheter sleeve 18, not the first catheter 5.
However, Ogle teaches a catheter comprising a balloon and profusion ports, the catheter may comprise one or more marker bands or other imageable components to position the balloon and ports relative the target location. Ogle teaches there is generally significant design flexibility for placement of the radiopaque elements and a person of ordinary skill can manage such placement as necessary to achieve convenience for the corresponding procedures (column 17, lines 19-28).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Murphy with radiopaque markers on the second catheter, proximal or distal to the balloon or at the sealed distal end, as taught by Ogle, that it is known in the art to adjust the placement of the radiopaque markers as necessary for achieving the desired mechanical performance for a corresponding procedure.
Claim(s) 6 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murphy US 2016/0220793 in view of Wainwright et al. US 2024/0198039.
Regarding claims 6 and 13, Murphy discloses the device essentially as claimed as discussed above, but fails to disclose wherein the distal end of the first catheter has a radially outwardly flared opening.
Wainwright et al. teaches a catheter that may be designed to flare outward to a slightly larger diameter at the distal end, various infusion catheters designs being contemplated, the can provide backflow (paragraph 0039), the widening of the distal end of a catheter may provide easier entrance of a clot (paragraph 0055) or place delivery devices within the lumen to place tools distal to the catheter (paragraph 0087).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Murphy with a radially outwardly flared opening, as taught by Wainwright et al. and known in the art to provide a catheter design that can allow for easier entrance of clots or placement of devices within the lumen or vessel distal to the catheter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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