DETAILED ACTION
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller (U.S. Pat. Pub. No. 2011/0172699 A1).
Regarding claim 1, Miller discloses a flexible tubular elongate member (balloon catheter of Fig. 8A-8B – a variation on the balloon catheter 102/150 – see Fig. 1-2B, [0043-0046], [0056-0057], and [0086-0089]) having a tubular wall (see Fig. 8A-8B, wherein the tubular wall is the assembly of inner member 228, braided tubing 220, and outer layer 230) defining a lumen (in the same manner as working lumen 152 of prior variations – see Fig. 2A-2B, Fig. 8A-8B, [0056-0057], and [0086-0089]) through which a medical device (such as clot retrieval device 106) is deliverable to an anatomical site (a vascular lumen / blood vessel – see [0002], [0026-0028], and [0043-0046]), said flexible tubular elongate member comprising at least one hollow filament (braided tubing 220) extending within said tubular wall, from a first end of said flexible tubular elongate member to a second end of said flexible tubular elongate member (see Fig. 8A-8B, [0017-0023], and [0086-0089], wherein braided tubing 220 may extend from a plenum at a proximal end of said flexible tubular elongate member to a balloon/inflatable member 224 at the distal end of the said flexible tubular elongate member), and defining a medium-delivery channel therein through which a material may pass within the tubular wall from said first end of said flexible tubular elongate member to said second end of said flexible tubular elongate member (see Fig. 8A-8B, [0017-0023], and [0086-0089], wherein the braided tubing 220 are intended to function as fluid supply conduits for passing a fluid, such as may be used to inflate the balloon/inflatable member 224, from the plenum at a proximal end of said flexible tubular elongate member to the balloon/inflatable member 224 at the distal end of the said flexible tubular elongate member).
Regarding claim 2, Miller further discloses that said tubular wall is a multi- layer wall (see Fig. 8A-8B, [0075-0077], and [0088-0089]).
Regarding claim 3, Miller further discloses that said tubular wall comprises an outer layer (outer layer 230) and an inner layer (inner member 228), with said hollow filament extending therebetween longitudinally along said flexible tubular elongate member (see Fig. 8A-8B and [0086-0089]).
Regarding claim 4, Miller further discloses that said hollow filament is woven (braided) with a plurality of reinforcement filaments to form a reinforcing layer between said outer layer and said inner layer of said flexible tubular elongate member (see Fig. 8A-8B and [0088-0089]).
Regarding claim 5, Miller further discloses that more than one of said plurality of reinforcement filaments are hollow (see Fig. 8A-8B and [0088-0089]), extend from a first end of said flexible tubular elongate member to a second end of said flexible tubular elongate member (see Fig. 8A-8B and [0088-0089], wherein each filament/tube within braided tubing 220 may extend from a plenum at a proximal end of said flexible tubular elongate member to a balloon/inflatable member 224 at the distal end of the said flexible tubular elongate member), and define a medium-delivery channel therein through which a material may pass from said first end of said flexible tubular elongate member to said second end of said flexible tubular elongate member (see Fig. 8A-8B, [0017-0023], and [0086-0089], wherein each filament/tube within braided tubing 220 are intended to function as fluid supply conduits for passing a fluid, such as may be used to inflate the balloon/inflatable member 224, from the plenum at a proximal end of said flexible tubular elongate member to the balloon/inflatable member 224 at the distal end of the said flexible tubular elongate member).
Regarding claim 6, Miller further discloses that said hollow filament is embedded within the material of said tubular wall (see Fig. 8A-8B, [0017-0023], and [0086-0089], wherein each filament/tube within braided tubing 220 are at least partially embedded within the inner side of outer layer 230, and are completely embedded/enveloped by the assembly of outer layer 230 and inner layer 228).
Regarding claim 7, Miller further discloses that said hollow filament is one of a plurality of filaments extending longitudinally along said flexible tubular elongate member and within said tubular wall (see Fig. 8A-8B, [0017-0023], and [0086-0089], wherein at least two filaments/tubes within braided tubing 220 are woven together to form the braid).
Regarding claim 8, Miller further discloses that said plurality of filaments form a reinforcing layer within said tubular wall (see Fig. 8A-8B and [0017-0023], wherein braided tubing 220 may be metallic and are woven together to form a reinforcing braid structure).
Regarding claim 9, Miller further discloses that said hollow filament is one of the plurality of hollow filaments forming said reinforcing layer (see Fig. 8A-8B, [0017-0023], and [0086-0089], wherein each filament/tube within braided tubing 220 are hollow).
Claim(s) 17 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ishikawa (U.S. Pat. Pub. No. 2017/0239442 A1).
Regarding claim 17, Ishikawa discloses a method of delivering a material to a distal end of a reinforced flexible tubular elongate member (catheter shaft 40 of catheter 110), said method comprising delivering a material (contrast medium) through a medium-delivery channel (one of outer lumens 43) defined longitudinally along a hollow reinforcement filament (corresponding one of tube bodies 41a-41j) extending within the wall of the reinforced flexible tubular elongate member between a proximal end and a distal end of the reinforced flexible tubular elongate member (see Fig. 1A-1B and 6-7, [0008-0012] and [0040-0042], wherein the contrast medium is introduced into the hollow reinforcement filaments at a proximal end of the catheter shaft 40 of catheter 110 in the vicinity of opening 9, and is passed through outer lumens 43 to be delivered via holes 45 at the distal end of the catheter shaft 40).
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) 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Decker (U.S. Pat. Pub. No. 2019/0059876 A1) in view of Ishikawa (U.S. Pat. Pub. No. 2017/0239442 A1).
Regarding claim 10, Decker discloses a delivery and/or deployment system for delivering and/or deploying a medical device to an anatomical site, said delivery/deployment system comprising: at least one flexible tubular elongate member (anchoring catheter 20) having a wall defining a lumen (see Fig. 1A-1C and [0047]); and a device (assembly of tissue anchor 24 with pressure regulating assembly 50) delivered at said distal end of said flexible tubular elongate member (see Fig. 1A-3D, [0047]-[0048], ln 3, and [0056-0064]). Decker fails to teach that the flexible tubular elongate member comprises a medium- delivery channel defined within said wall and extending longitudinally along said flexible tubular elongate member between a proximal end thereof and a distal end thereof.
Ishikawa exhibits a flexible tubular elongate member (catheter shaft 40 of catheter 110) configured to deliver a device at a distal end thereof (see Fig. 1A-1B, 6-7, and [0003], ln 5-7), similar to that exhibited in Decker, the flexible tubular elongate member comprising a wall (tubular wall of catheter shaft 40) defining a central lumen (see Fig. 6-7). Ishikawa teaches that such a flexible tubular elongate member may further comprise a medium-delivery channel (one of outer lumens 43) defined within said wall and extending longitudinally along said flexible tubular elongate member between a proximal end thereof and a distal end thereof (see Fig. 1A-1B and 6-7, [0008-0012] and [0040-0042], wherein outer lumens 43 are configured to deliver a contrast medium introduced into at a proximal end of the catheter shaft 40 in the vicinity of opening 9 to holes 45 at the distal end of the catheter shaft 40), said medium-delivery channel being formed within a hollow reinforcement filament (corresponding one of tube bodies 41a-41j) extending within the wall of said flexible tubular elongate member between said proximal end and said distal end of said flexible tubular elongate member (see Fig. 1A-1B and 6-7, [0008-0012] and [0040-0042], wherein the contrast medium is introduced into the hollow reinforcement filaments at a proximal end of the catheter shaft 40 of catheter 110 in the vicinity of opening 9, and is passed through outer lumens 43 to be delivered via holes 45 at the distal end of the catheter shaft 40). Ishikawa teaches that such a configuration allows the user to deliver a material, such as a contrast medium, through the medium-delivery channel within said wall of said flexible tubular elongate member and into the tissue surrounding the distal end of the flexible tubular elongate member ([0008-0012] and [0040-0042]), thereby providing a means to the user of locating the distal end of the flexible tubular elongate member within the patient relative to surrounding tissue using a visualization method which can detect the contrast medium, as is well known in the art (see Decker, [0051]).
While Decker contemplates the use of radiopaque markers for locating the distal end of the flexible tubular elongate member within the patient ([0049], ln 12-15), such means do not allow the user to visualize the surrounding tissue in the vicinity of the distal end of the flexible tubular elongate member. To do this, Decker teaches that a contrast medium may be introduced into the tissue region wherein the device is to be delivered by a separate catheter ([0051]). Yet, the configuration taught by Ishikawa allows the user to deliver a contrast medium that illuminates the distal end and surrounding tissue from the same flexible tubular elongate member that delivers the device. Because such a configuration would greatly simplify the procedure of delivering a device taught by Decker, thereby reducing the time demands of such a procedure as well as reducing the potential for complications (e.g. irritation of the patient, exposure to infectious microbes, etc.) arising from using multiple catheters/ flexible tubular elongate members, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the flexible tubular elongate member of Decker to comprise a medium- delivery channel defined within said wall and extending longitudinally along said flexible tubular elongate member between a proximal end thereof and a distal end thereof, said medium-delivery channel being formed within a hollow reinforcement filament extending within the wall of said flexible tubular elongate member between said proximal end and said distal end of said flexible tubular elongate member, as taught by Ishikawa, to thereby enable the user to delivery a contrast medium to the distal end of the flexible tubular elongate member for illuminating the distal end and the tissue surrounding it for visualization by the user using a visualization method which can detect the contrast medium, as is well known in the art (see Decker, [0051-0053] and [0061]).
Regarding claim 11, Decker further discloses that said device comprises a delivery device (pressure regulating assembly 50) having an interior within which a deployable device (tissue anchor 24) is positioned (see Fig. 2A-3D and [0056-0057]).
Regarding claim 12, Decker further discloses that the lumen defined by said flexible tubular elongate member wall is in fluid communication with the interior of said delivery device (see Fig. 3A-3D and [0056], and Fig. 1A-1B and [0047]-{0048], ln 3, wherein tissue anchor 24 and associated rail 26 are passed through the inner lumen of the anchoring catheter 20).
Regarding claim 13, Decker further discloses that said deployable device is a tissue anchor (24, see Fig. 1A-3D, [0047]-[0048], ln 3, and [0056-0064]).
Regarding claim 14, Decker further discloses that said tissue anchor is biased to shift from a deployment configuration (barbs in retracted position 30) to a deployed configuration (barbs in curled position 30’) upon exiting an open distal end of said delivery device (see Fig. 1C and 2A, [0049], and [0056]).
Claim(s) 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Decker as modified by Ishikawa according to claim 14, and in further view of Haverkost (U.S. Pat. Pub. No. 2015/0217085 A1).
Regarding claim 15, Decker as modified by Ishikawa according to claim 14 exhibits the delivery/deployment system of claim 14, wherein a medium is deliverable through the medium-delivery channel within said wall of said flexible tubular elongate member (see in re claim 10). Here, a medium-delivery channel of the type taught by Ishikawa was incorporated into the flexible tubular elongate member of Decker, such that a contrast medium may be delivered to the distal end region of the flexible tubular elongate member (see in re claim 10). While Decker teaches that the lumen defined by the flexible tubular elongate member wall is in fluid communication with the interior of said delivery device (see in re claim 12), neither Decker nor Ishikawa teach that a medium-delivery channel of the type taught by Ishikawa may also be in fluid communication with the interior of said delivery device, for example by comprising an outlet at the distal end tip of the flexible tubular elongate member for allowing a contrast medium to be delivered out of the open distal end of the delivery device. Such a configuration would, however, be suggested by the goal of Decker, which seeks to assist the user in visualizing the position of the medical device (including the deployable device) provided at the distal end of the flexible tubular elongate member (see Decker, [0051-0053] and [0061]). Further, such a configuration is known within the art. Haverkost, for example, exhibits a flexible tubular elongate member (intravascular guide catheter 100/600) for delivering a device within the tissue of a patient ([0036-0037], [0039], and [0043]), similar to that of Decker, and teaches that such a flexible tubular elongate member may comprise a medium-delivery channel (microtube channels 620) which may extend to the distal end thereof (distal end face 615 - see Fig. 6A and 6C and [0055]), and which may comprise an outlet at the distal end tip of the flexible tubular elongate member for allowing a contrast medium to be delivered out of the open distal end of the flexible tubular elongate member (see Fig. 6A and 6C, and [0055-0057]). As such, based on the example of Haverkost and the aspirations of Decker, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flexible tubular elongate member of Decker such that the medium-delivery channel may further comprise an outlet at the distal end tip of the flexible tubular elongate member, thereby fluidly communicating with the interior of the delivery device in the same manner as the lumen, in order to thereby allow a contrast medium to be delivered through the medium-delivery channel, into the interior of the delivery device, and out of the open distal end of the delivery device. By allowing the contrast medium to be delivered out of the open distal end of the delivery device, such a configuration would allow the user to more accurately locate the implantable device provided at the distal end of the flexible tubular elongate member, thus improving the accuracy of the delivery of the device to its appropriate location within the patient.
Regarding claim 16, the proposed combination of Decker as modified by Ishikawa and Haverkost according to claim 15 exhibits that said medium-delivery channel is formed within a hollow reinforcement filament extending within the wall of said flexible tubular elongate member between said proximal end and said distal end of said flexible tubular elongate member (see in re claim 10).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa in view of Miller.
Regarding claim 18, Ishikawa discloses the method of claim 17 (see in re claim 17), further comprising delivering a material through a plurality of hollow reinforcement filaments forming a reinforcing layer within the wall of the reinforced flexible tubular elongate member (see Fig. 1A-1B and 6-7, [0008-0012] and [0040-0042], wherein a contrast medium is introduced into the hollow reinforcement filaments – tube bodies 41a-41j – at a proximal end of the catheter shaft 40 of catheter 110 in the vicinity of opening 9, and is passed through outer lumens 43 to be delivered via holes 45 at the distal end of the catheter shaft 40). Ishikawa fails to teach that the plurality of hollow reinforcement filaments are braided, however braided configurations for reinforcement filaments, including hollow filaments, are well known within the art. For example, Miller exhibits that hollow filaments of the type taught by Ishikawa may be configured in a braided configuration (hollow braided tubing 220 – see Fig. 8A-8B, [0017-0023], and [0086-0089]) as a known alternative configuration to a helical coil configuration (spirally embedded/coiled fluid supply filaments – see Fig. 9, [0016-0017], and [0090-0091]) for providing suitable structural integrity and flexibility to a reinforced flexible tubular elongate member ([0017-0023]). It would thus have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the layout/configuration of the hollow filaments of Ishikawa such that the plurality of hollow reinforcement filaments are braided as a matter of simple substitution of one known hollow filament layout/configuration (braided, as taught by Miller) for another (straight or helically twisted, as taught by Ishikawa – see Fig. 3-8), thereby obtaining predictable results (both configurations being known to be suitable for the intended purpose). See MPEP 2143(I)(B).
Claim(s) 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa in view of Decker.
Regarding claim 19, Ishikawa discloses the method of claim 17 (see in re claim 17), further comprising delivering a contrast agent to the distal end of the reinforced flexible tubular elongate member through the hollow reinforcement filament (see Fig. 1A-1B and 6-7, [0008-0012] and [0040-0042], wherein a contrast medium is introduced into the hollow reinforcement filaments – tube bodies 41a-41j – at a proximal end of the catheter shaft 40 of catheter 110 in the vicinity of opening 9, and is passed through outer lumens 43 to be delivered via holes 45 at the distal end of the catheter shaft 40). While not explicitly taught by Ishikawa, Decker further teaches that such may be done in order to allow the user to determine the position of the reinforced flexible tubular elongate member with respect to surrounding tissue (see Decker, [0051-0053] and [0061]) during a process to implant an implantable device from the distal end of the reinforced flexible tubular elongate member into the tissue (see Decker, Fig. 1A-3D, [0047-0053], and [0056-0064]). Since such an implantation process is contemplated by Ishikawa ([0003], ln 5-7), and since the capability of visualizing the location of the distal end of the reinforced flexible tubular elongate member with respect to surrounding tissue has the clear advantage of aiding the user in proper placement of the implantable device with respect to surrounding tissue (see Decker, [0051-0053] and [0061]), it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to perform the delivery process for delivering a contrast agent taught by Ishikawa as part of a method of implanting an implantable device from the distal end of the reinforced flexible tubular elongate member into surrounding tissue, as suggested by Ishikawa ([0003]), wherein the delivery of contrast agent at the distal end of the reinforced flexible tubular elongate member allows the user to determine the position of the reinforced flexible tubular elongate member with respect to surrounding tissue during the implantation process, as taught by Decker (see Decker, [0051-0053] and [0061]), thereby improving the ease and accuracy of implantation, thus benefiting the health of the patient.
Regarding claim 20, Decker teaches that the delivery of contrast agent at the distal end of the reinforced flexible tubular elongate member allows the user to determine the position of the reinforced flexible tubular elongate member with respect to surrounding tissue during the implantation process (see in re claim 19). Decker further teaches other means by which the position of the distal end may be confirmed, such as by providing radiopaque markers on and around the deployment device at the distal end of the reinforced flexible tubular elongate member – see [0049], ln 12-15) which may be observed by imaging sensors to confirm the position of the distal end prior to implanting the implantable device delivered at the distal end of the reinforced flexible tubular elongate member into the tissue ([0051-0053] and [0061]), Decker also teaching the implantation process (Fig. 1A-3D, [0047-0053], and [0056-0064]). Because these techniques further improve the accuracy of implantation of the implantable device at the correct position, it would further have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to carry out the method of implanting an implantable device exhibited by Ishikawa as modified by Decker (see above rejection in re claim 19) as further comprising confirming the position of the distal end of the reinforced flexible tubular elongate member with respect to tissue at an anatomical site, and implanting an implantable device delivered at the distal end of the reinforced flexible tubular elongate member into the tissue, as taught by Decker (Fig. 1A-3D, [0047-0053], and [0056-0064]) and suggested by Ishikawa ([0003], ln 5-7).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783