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 87 objected to because of the following informalities:
Claim 87, line 7: “3-5mm” should read --3-5 mm--,
Claim 87, line 10: “3-5mm” should read --3-5 mm--.
Appropriate correction is required.
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 9, 11-12, 35, 62, 64 & 80-83, 87 & 92-95 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.
Regarding claim 9, the claim recites “tissue” in line 3 and it is unclear if this is the same tissue or a different tissue from that recited in line 2. For examination purposes, these are the same tissue and the limitation will be interpreted as “the tissue”.
Claims 11-12 are also rejected by virtue of their dependency on claim 9.
Regarding claim 35, the claim recites “tissue” in line 14 and it is unclear if this is the same tissue or a different tissue from that recited in line 9. For examination purposes, these are the same tissue and the limitation will be interpreted as “the tissue”.
Regarding claim 62, the claim recites “tissue” in line 6 and it is unclear if this is the same tissue or a different tissue from that recited in line 4. For examination purposes, these are the same tissue and the limitation will be interpreted as “the tissue”.
Claims 64 & 80-83 are also rejected by virtue of their dependency on claim 62.
Regarding claim 87, the claim recites “tissue” in line 11 and it is unclear if this is the same tissue or a different tissue from that recited in line 8. For examination purposes, these are the same tissue and the limitation will be interpreted as “the tissue”.
Regarding claim 92, the claim recites “a tissue wall” in line 10 and it is unclear if this is the same tissue wall or a different tissue wall as that recited in line 2. For examination purposes, these are the same tissue walls and the limitation will be interpreted as “the tissue wall”.
Claims 93-95 are also rejected by virtue of their dependency on claim 92.
Claim 93 recites the limitation “the tissue wall needle” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 93 recites the limitation “the second delivery tube of the anchor catheter” in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-2, 9, 11-12, 35, 62, 64, 80-84, 87, 92, 95 & 101 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Rammohan et al. (U.S. Pub. No. 20210038228), herein referred to as “Rammohan”.
Regarding claim 1, Rammohan teaches a system for repairing a tissue defect (Abstract: A system for forming and closing an aperture in tissue for atrial transseptal access), the system comprising:
a locating member configured to extend into the tissue defect and to locate one or more components of the system relative to the tissue defect ([0045]: a separate balloon catheter B may be advanced over the guidewire and disposed in the septal puncture as shown in FIG. 4R. Inflation of the balloon then further dilates the septal puncture to allow a diagnostic or interventional device to be delivered transseptally into the left atrium; wherein the device being configured for placement within the septum is seen as locating one or more components of the system relative to the tissue defect), wherein the locating member defines a non-circular outside shape (see Fig. 4R where the cross section shown is non-circular).
Regarding claim 2, Rammohan teaches wherein the locating member comprises a non-circular balloon ([0045]: a separate balloon catheter B may be advanced over the guidewire and disposed in the septal puncture as shown in FIG. 4R; see Fig. 4R where the cross section shown is non-circular).
Regarding claim 9, Rammohan teaches further comprising a first tissue anchor (anchor 236, two shown in Fig. 4A) configured to be implanted into tissue at a first location ([0036]: Both sliders 250, 244 are advanced distally to move the assembly of the needle 222, pusher 228, and the fastener 234 (here a suture) with actuatable anchor 236, all move distally together toward the right side of the atrial septal wall S), and a second tissue anchor (anchor 236, two shown in Fig. 4A) configured to be implanted into tissue at a second location ([0036]: Both sliders 250, 244 are advanced distally to move the assembly of the needle 222, pusher 228, and the fastener 234 (here a suture) with actuatable anchor 236, all move distally together toward the right side of the atrial septal wall S).
Regarding claim 11, Rammohan teaches wherein the non-circular outside shape of the locating member defines a major axis ([0045]: a separate balloon catheter B may be advanced over the guidewire and disposed in the septal puncture as shown in FIG. 4R. Inflation of the balloon then further dilates the septal puncture to allow a diagnostic or interventional device to be delivered transseptally into the left atrium; see Fig. 4R where the cross section shown is non-circular & the dashed line shows the axis), and wherein the first tissue anchor and the second tissue anchor (anchor 236, two shown in Fig. 4A) are equally spaced on opposite sides of the major axis (see Fig. 4R where the anchors 236 are equally spaced on opposite sides of the major axis).
Regarding claim 12, Rammohan teaches wherein the non- circular outside shape of the locating member defines a minor axis (see Fig. 4R where the atrial septum S forms a minor axis perpendicular to the major axis (the dashed line)), and wherein the first tissue anchor and the second tissue anchor are located on the minor axis (see Fig. 4R where the anchors 236 are along the minor axis).
Regarding claim 35, Rammohan teaches a system for repairing an atrial septal defect (Abstract: A system for forming and closing an aperture in tissue for atrial transseptal access), the system comprising:
a catheter ([0019]: an outer sheath may cover the sheaths 202, hub 206, and tip 212 to provide protection);
a centering member slidably supported within the catheter or beyond a distal end of the catheter ([0045]: a separate balloon catheter B may be advanced over the guidewire and disposed in the septal puncture as shown in FIG. 4R … The balloon may be integral with the transseptal access and closure device), wherein the centering member is configured to extend from the catheter into the atrial septal defect (see Fig. 4R);
a first delivery tube (sheath 202, two shown in Fig. 4A) slidably supported within the catheter;
a first tissue anchor (anchor 236, two shown in Fig. 4A) disposed within a distal end of the first delivery tube, wherein the first delivery tube is configured to be advanced from the catheter to allow implantation of the first tissue anchor into tissue at a first location adjacent a first side of the atrial septal defect ([0026]: a sheath 202 concentrically disposed over a needle 222 which is concentrically disposed over pusher 228 which is concentrically disposed over fastener 234 with expandable anchor 236; [0036]: Both sliders 250, 244 are advanced distally to move the assembly of the needle 222, pusher 228, and the fastener 234 (here a suture) with actuatable anchor 236, all move distally together toward the right side of the atrial septal wall S);
a second delivery tube (sheath 202, two shown in Fig. 4A) slidably supported within the catheter; and
a second tissue anchor (anchor 236, two shown in Fig. 4A) disposed within a distal end of the second delivery tube, wherein the second delivery tube is configured to be advanced from the catheter to allow implantation of the second tissue anchor into tissue at a second location adjacent a second side of the atrial septal defect ([0026]: a sheath 202 concentrically disposed over a needle 222 which is concentrically disposed over pusher 228 which is concentrically disposed over fastener 234 with expandable anchor 236; [0036]: Both sliders 250, 244 are advanced distally to move the assembly of the needle 222, pusher 228, and the fastener 234 (here a suture) with actuatable anchor 236, all move distally together toward the right side of the atrial septal wall S).
Regarding claim 62, Rammohan teaches a system for repairing an atrial septal defect (Abstract: A system for forming and closing an aperture in tissue for atrial transseptal access), the system comprising:
a centering member configured to extend into the atrial septal defect ([0045]: a separate balloon catheter B may be advanced over the guidewire and disposed in the septal puncture as shown in FIG. 4R … The balloon may be integral with the transseptal access and closure device), wherein the centering member defines a non-circular outside shape (see Fig. 4R where the cross section shown is non-circular);
a first tissue anchor (anchor 236, two shown in Fig. 4A) configured to be implanted into tissue at a first location adjacent a first side of the atrial septal defect ([0036]: Both sliders 250, 244 are advanced distally to move the assembly of the needle 222, pusher 228, and the fastener 234 (here a suture) with actuatable anchor 236, all move distally together toward the right side of the atrial septal wall S); and
a second tissue anchor (anchor 236, two shown in Fig. 4A) configured to be implanted into tissue at a second location adjacent a second side of the atrial septal defect ([0036]: Both sliders 250, 244 are advanced distally to move the assembly of the needle 222, pusher 228, and the fastener 234 (here a suture) with actuatable anchor 236, all move distally together toward the right side of the atrial septal wall S).
Regarding claim 64, Rammohan teaches wherein the centering member is configured to extend into the atrial septal defect while in a collapsed introduction configuration and expand into an expanded deployed configuration after being positioned within the atrial septal defect ([0045]: After the fasteners have been secured to the atrial septum, a separate balloon catheter B may be advanced over the guidewire and disposed in the septal puncture as shown in FIG. 4R. Inflation of the balloon then further dilates the septal puncture to allow a diagnostic or interventional device to be delivered transseptally into the left atrium).
Regarding claim 80, Rammohan teaches a suture coupled to at least one of the first tissue anchor and the second tissue anchor ([0036]: Both sliders 250, 244 are advanced distally to move the assembly of the needle 222, pusher 228, and the fastener 234 (here a suture) with actuatable anchor 236, all move distally together toward the right side of the atrial septal wall S).
Regarding claim 81, Rammohan teaches a suture coupled to each of the first tissue anchor and the second tissue anchor ([0036]: Both sliders 250, 244 are advanced distally to move the assembly of the needle 222, pusher 228, and the fastener 234 (here a suture) with actuatable anchor 236, all move distally together toward the right side of the atrial septal wall S).
Regarding claim 82, Rammohan teaches further comprising a suture lock (knot 288) configured to secure a length of a tensioned portion of the suture between the first tissue anchor and the second tissue anchor ([0050] FIG. 4W the knot 280 is advanced further distally until it is adjacent the piercing in the septal wall S, thereby tensioning the fasteners 234 which will close the aperture pierced in the septal wall).
Regarding claim 83, Rammohan teaches further comprising a suture cutter (fastener cutter instrument 288).
Regarding claim 84, Rammohan teaches a system for repairing an elongated atrial septal defect (Abstract: A system for forming and closing an aperture in tissue for atrial transseptal access), the system comprising:
a centering member configured to extend into the elongated atrial septal defect ([0045]: a separate balloon catheter B may be advanced over the guidewire and disposed in the septal puncture as shown in FIG. 4R … The balloon may be integral with the transseptal access and closure device), wherein the centering member is configured to conform to a shape of the elongated atrial septal defect and to orient one or more components of the system with a lengthwise direction of the elongated atrial septal defect ([0045]: After the fasteners have been secured to the atrial septum, a separate balloon catheter B may be advanced over the guidewire and disposed in the septal puncture as shown in FIG. 4R. Inflation of the balloon then further dilates the septal puncture to allow a diagnostic or interventional device to be delivered transseptally into the left atrium).
Regarding claim 87, Rammohan teaches a system for repairing an atrial septal defect (Abstract: A system for forming and closing an aperture in tissue for atrial transseptal access), the system comprising:
a catheter ([0019]: an outer sheath may cover the sheaths 202, hub 206, and tip 212 to provide protection);
a centering member slidably supported within the catheter or beyond a distal end of the catheter ([0045]: a separate balloon catheter B may be advanced over the guidewire and disposed in the septal puncture as shown in FIG. 4R … The balloon may be integral with the transseptal access and closure device), wherein the centering member is configured to extend from the catheter into the atrial septal defect ([0045]: Inflation of the balloon then further dilates the septal puncture to allow a diagnostic or interventional device to be delivered transseptally into the left atrium);
a first tissue anchor (anchor 236, two shown in Fig. 4A) carried by the catheter and configured to be advanced from the catheter to a first location within 3-5mm of a first side of the atrial septal defect for implantation into tissue ([0036]: Both sliders 250, 244 are advanced distally to move the assembly of the needle 222, pusher 228, and the fastener 234 (here a suture) with actuatable anchor 236, all move distally together toward the right side of the atrial septal wall S; wherein this describes a structure capable of being advanced from the catheter to a first location within 3-5mm of a first side of the atrial septal defect for implantation into tissue);
a second tissue anchor (anchor 236, two shown in Fig. 4A) carried by the catheter and configured to be advanced from the catheter to a second location within 3-5mm of a second side of the atrial septal defect for implantation into tissue ([0036]: Both sliders 250, 244 are advanced distally to move the assembly of the needle 222, pusher 228, and the fastener 234 (here a suture) with actuatable anchor 236, all move distally together toward the right side of the atrial septal wall S; wherein this describes a structure capable of being advanced from the catheter to a second location within 3-5mm of a second side of the atrial septal defect for implantation into tissue).
Regarding claim 92, Rammohan teaches a method of repairing a tissue defect (Title: SYSTEMS AND METHODS FOR ATRIAL TRANSSEPTAL ACCESS AND CLOSURE), the method comprising:
positioning an introducer sheath adjacent a defect of a tissue wall on a first side of the tissue wall (see Fig. 4C; [0019]: Optionally, an outer sheath may cover the sheaths 202, hub 206, and tip 212 to provide protection);
positioning a guidewire through the defect of the tissue wall ([0030]: FIG. 4C shows that after the atrial septum has been pierced and a guide wire advanced across the septum);
inserting a proximal end of the guidewire into a centering balloon lumen (see Fig. 4C);
advancing an anchor catheter over the guidewire and within the introducer sheath ([0030]: the transseptal access and closure system 200 may be loaded over the guidewire GW and advanced distally);
advancing a balloon member through the anchor catheter to position the balloon member partially through the defect ([0045]: After the fasteners have been secured to the atrial septum, a separate balloon catheter B may be advanced over the guidewire and disposed in the septal puncture as shown in FIG. 4R);
inflating the balloon member ([0045]: Inflation of the balloon then further dilates the septal puncture to allow a diagnostic or interventional device to be delivered transseptally into the left atrium);
advancing a first needle (needle 222) of the anchor catheter through a tissue wall at a first location of the tissue wall, wherein the first location is adjacent to the defect ([0037]: FIG. 4J shows further actuation of sliders 250, 244 extend the needle 222, pusher 228, and the fastener 234 with actuatable anchor 236 distally until the needle pierces through the septal wall S and the actuatable anchor 236 is disposed on the left side of the heart in the left atrium while still disposed in the needle);
deploying a first delivery tube (pusher 228) of the anchor catheter through a first hole created by the first needle ([0037]: FIG. 4J shows further actuation of sliders 250, 244 extend the needle 222, pusher 228, and the fastener 234 with actuatable anchor 236 distally until the needle pierces through the septal wall S and the actuatable anchor 236 is disposed on the left side of the heart in the left atrium while still disposed in the needle; wherein this step also deploys pusher 228); and
deploying a first tissue anchor from the first delivery tube to a second side of the tissue wall ([0042]: FIG. 4O shows proximal retraction of slider 250 which proximally retracts the pusher 228 back into sheath 202 which is disposed in the open channel 208 of hub 206. The fastener, here a suture 234 is now anchored with anchor 236 to the left side of the heart).
Regarding claim 95, Rammohan teaches wherein advancing the first needle of the anchor catheter through the tissue wall at the first location comprises advancing each of the first delivery tube and the first tissue anchor through the tissue wall with the first needle, wherein distal ends of the first needle, the first delivery tube, and the first tissue anchor form a chamfered edge ([0037]: FIG. 4J shows further actuation of sliders 250, 244 extend the needle 222, pusher 228, and the fastener 234 with actuatable anchor 236 distally until the needle pierces through the septal wall S and the actuatable anchor 236 is disposed on the left side of the heart in the left atrium while still disposed in the needle; see chamfered edge of needle 222 in Fig. 4J).
Regarding claim 101, Rammohan teaches system for repairing a tissue defect (Abstract: A system for forming and closing an aperture in tissue for atrial transseptal access), the system comprising:
a locating member configured to extend into the tissue defect and to locate one or more components of the system relative to the tissue defect ([0033]: FIG. 4F shows the tapered tip 212 being advanced distally over the guidewire GW so that the apertures 214 are disposed on the left side of the heart in the left atrium; wherein the locating member being disposed within the septum is seen as locating one or more components of the system relative to the tissue defect), wherein the locating member defines a circular outside shape (see circular shape in Fig. 4F).
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rammohan as applied to claim 1 above, and further in view of Davis et al. (U.S. Pub. No. 20080033421), herein referred to as “Davis”.
Regarding claim 6, Rammohan fails to disclose wherein the locating member comprises an expandable body, such as a cage or trusswork.
However, Davis discloses wherein the locating member comprises an expandable body, such as a cage ([0083]: FIG. 7A illustrates one embodiment of a medical device 700a having a left electrode 702a linked to a right electrode 704a; see the cage in Fig. 7A) or trusswork. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the locating member of Rammohan to be an expandable body, such as a cage, as taught by Davis, for the purpose of providing anatomical conformance by including the ability of the right and left anchor/electrodes to freely pivot and/or flex relative to their delivery shafts, catheters, or tubes. Flexure can enable the anchor/electrodes to be positioned against the atrial wall in an optimal manner, which, in general, may not be perpendicular to the axis of the delivery shaft (Davis: [0092]).
Claim 93 is rejected under 35 U.S.C. 103 as being unpatentable over Rammohan as applied to claim 9 above, and further in view of Alexander et al. (U.S. Pub. No. 20190247036, cited in IDS), herein referred to as “Alexander”.
Regarding claim 93, Rammohan discloses wherein prior to advancing the first needle through the tissue wall needle at the first location, the method comprises deploying the first delivery tube of the anchor catheter and the second delivery tube of the anchor catheter adjacent to the first location of the tissue wall on the first side of the tissue wall ([0036]: In FIG. 4I, slider 244 is operatively coupled to needle 222, and slider 250 is operatively coupled to pusher 228. Both sliders 250, 244 are advanced distally to move the assembly of the needle 222, pusher 228, and the fastener 234 (here a suture) with actuatable anchor 236, all move distally together toward the right side of the atrial septal wall S. Advancement of the pusher advances the fastener 234 because the pusher pushes against the actuatable anchor 236 which is coupled to the fastener 234. The sheath 202 remains in position; see progression of Figs. 4I to 4J where 4I occurs prior to 4J such that the needles 222 and pushers 228 are positioned adjacent the first location of the tissue wall on the first side of the tissue wall),
But Rammohan fails to disclose wherein the first delivery tube and the second delivery tube are each configured to curve radially outward from the delivery catheter.
However, Alexander discloses wherein the first delivery tube and the second delivery tube are each configured to curve radially outward from the delivery catheter (wire delivery lumens 116, 126; [0075]: As illustrated in FIGS. 5a-5b, in one embodiment of the present teachings, a distal portion (118, 128) of each delivery catheter for tissue piercing wire (110, 120) attaches to a portion of the bow wire (30, 40) and the rest portion of the tissue piercing catheter (110, 120) connects to a portion of the bow catheter (70). These attachments allow the distal portion (118, 128) of each delivery catheter for tissue piercing wire (110, 120) to move along with the movement of each of the bow wires (30, 40)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the first delivery tube and second delivery tubes of Rammohan to be configured to curve radially outward from the delivery catheter, as taught by Alexander, for the purpose of the distal end portion of the delivery catheter for tissue piercing wire directs further radially outward at a pre-defined angle and distance so that the distal ends of the delivery catheter for tissue piercing wire can be positioned precisely at the most desired treatment location (Alexander: [0076]).
Claim 94 is rejected under 35 U.S.C. 103 as being unpatentable over Rammohan as applied to claim 9 above, and further in view of Kuroda et al. (U.S. Pub. No. 20090069810), herein referred to as “Kuroda”.
Regarding claim 94, Rammohan fails to disclose further comprising energizing the first needle prior to advancing the first needle through the tissue wall.
However, Kuroda discloses further comprising energizing the first needle prior to advancing the first needle through the tissue wall ([0134]: When the PFO closing device according to this embodiment is used, the foramen ovale valve M2 is held by the positioning hold mechanism 60 from the left atrium side and thereafter, the needle members 121a, 121a are moved forward (distally) to protrude distally from the catheter 30. Next, owing to the electric energy supply unit 20, electric energy is supplied between the stick portion 121 and the sandwich member 1, the stick portion 121 is heated to the shape-recovery temperature, and the needle members 121a, 121a of the stick portion 121 are expanded. Next, the lever 76b for the needle members 121a, 121a is moved forward and the needle members 121a, 121a are stuck into the aimed position of the foramen ovale valve M2; wherein the stick portion 121 is seen as a needle member). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Rammohan to include the steps of Kuroda for the purpose of heating the stick portion to the shape-recovery temperature, the needle members are expanded and enabling the needle members to be stuck into the aimed position of the foramen ovale valve (Kuroda: [0134]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794