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 .
Response to Amendment
Claims 1-14, 16-18, and 20 are pending in the application. Claims 1-3, 11, 16, and 18 have been amended. Claims 1-14, 16-18, and 20 are rejected.
Drawings
The drawings were received on March 6, 2026. These drawings are acceptable.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 6, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Zhang (US PG Pub 2021/0038387) in view of previously cited Ek et al (US Pat. No. 6,086,608).
Regarding claim 1, Zhang teaches a system for edge-to-edge repair of a mitral valve (system for edge-to-edge repair of mitral valve, paragraph [0005]) comprising:
an integrated therapy catheter (see system 100 including suture implanting apparatus 1000 and suture locker 2000, Fig 3, paragraph[0053]) configured to1 engage a first leaflet and a second leaflet of a mitral valve (see how 1000 includes clamping assembly 1300 for clamping
leaflets of the mitral valve, Fig 7, 1000 includes clamping assembly 1300 for clamping the leaflet, paragraph[0054]) having:
a puncture device (see how 1000 includes puncturing assembly 1400, Fig 7, puncturing assembly 1400, paragraph(0054]) configured to:
puncture a first hole in the first leaflet (the puncturing assembly 1400 includes at least one puncturing needle 1410 to puncture the first leaflet, paragraph [0062]); and
puncture a second hole in the second leaflet (the puncturing assembly 1400 includes at least one puncturing needle 1410 to puncture the second leaflet, paragraph [0062]);
a delivery device (see how 1000 includes push rod 1330 with channel 1331 to deliver suture 3000, Fig 8, paragraph [0068]) configured to:
deliver a first leaflet anchor (3020) through the first hole (see paragraph [0071]), the first leaflet anchor having a first tether (suture 3000) (see a first suture portion 3000 passed through leaflet 600, Fig 43, leaflet 600, See paragraphs [0076] and [0135]) with distal end configured to engage the distal side2 of the first leaflet (see how anti-slip member 3020 engages a distal side of leaflet 600, Fig 43, anti-slip member is in contact with the upper surface of the leaflet, paragraph [0135]); and
deliver a second leaflet anchor (3020) through the second hole (the process is repeated for the other leaflet, paragraph [0137]), the second leaflet anchor having a second tether (see how the other anchor includes suture 3000, Fig 44) with distal end configured to engage the distal side3 of the second leaflet (see how anti-slip member 3020 engages a distal side of leaflet 600, Fig 43, anti-slip member in contact with the upper surface of the leaflet, paragraph[0135]); and
a "knot replacement" tool (see lock pin 21000 of suture locker 2000, Fig 21, the lock pin 21000 is used to fix the suture 3000, paragraph [0099]-[0100]) configured to tension the first and second tethers to bring the first and the second leaflet edges together and lock the first and
second tethers together (see how 21000 is delivered to bring the first and second leaflet edges together and lock the tethers 3000, Fig 48, the lock pin 21000 locks the sutures 3000 together to complete the repair, paragraph[0140]-[0141]).
Zhang does not explicitly teach the “knot replacement tool” includes a locking cap having a cavity with an open proximal end with an internal threaded portion and a closed distal end with first and second tether locking cap holes sized to receive the first and second tethers; a locking screw having an external threaded portion configured to rotatingly engage with the internal threaded portion of the locking cap, and first and second tether locking screw holes sized to receive the first and second tethers; and wherein the locking screw is configured to be screwed into the locking cap, with the first and second tether locking screw holes and the first and second tether locking cap holes being rotated in opposite directions.
Ek teaches an analogous knot replacement tool (collet 10) including a locking cap (ring 12) having a cavity (bore 16) with an open proximal end (See Figs. 2-6; Col. 3, lines 24-60) with an internal threaded portion (36) and a closed distal end (See Fig. 6A; Col. 3, lines 50-68 and Col. 4, lines 4-68 – note when the pin 14 is fully inserted, the distal end is closed except for the openings for the suture) with first and second tether locking cap holes (tunnels 24, 26) sized to receive the first and second tethers (suture 8 has two ends); a locking screw (14) having an external threaded portion (ridges 22) configured to4 rotatingly engage with the internal threaded portion of the locking cap, and first and second tether locking screw holes sized to receive the first and second tethers (See Figs. 1-3 and 6A); and wherein the locking screw is configured to be screwed into the locking cap, with the first and second tether locking screw holes and the first and second tether locking cap holes being rotated in opposite directions.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the knot replacement tool of Zhang such that it comprises a structure of a locking cap having first and second tether locking cap holes and a locking screw having first and second tether locking screw holes, wherein the locking screw is configured to be screwed into the locking cap, with the first and second tether locking screw holes and the first and second tether locking cap holes rotated in opposite directions so that the first tether and second tether are twisted around each other as taught by Ek in order to provide a simple, reliable mechanism to lock the suture in place when desired. Additionally, a wide variety of suture knot replacement mechanisms are known and used in the art. As stated in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B).
Regarding claim 2, modified Zhang teaches the mitral valve repair system as required by claim 1 above and further teaches locking the first and second tethers with the “knot replacement” tool includes the first and second tethers (note two sutures 8) being inserted through he first and second locking cap holes (See Figs. 1-3 of Ek) the first and second tethers being inserted through the first and second locking screw holes (channels 24 and 26) and the locking screw is screwed into the locking cap (See Ek, Col. 9, lines 43-60) with the first and second tether locking screw holes and the first and second tether locking cap holes rotated5 in opposite directions so that the first tether and second tether are twisted around each other and locked in place.
Regarding claim 3, modified Zhang teaches the mitral valve repair system as required by claim 1 above and further teaches the “knot replacement” tool further includes a detachable delivery shaft (84) coupled to the locking screw (pin 14) (See Ek Figs. 7-8; Col. 5, lines 39-48).
Regarding claim 4, modified Zhang teaches the mitral valve repair system as required by claim 1 above and further teaches a cutter device configured to cut the first and second tethers (after using the lock pin 21000 the proximal end of suture 3000 is snipped hence a cutting device is configured to cut the two sutures 3000, paragraph [0141]).
Regarding claim 6, modified Zhang teaches the mitral valve repair system as required by claim 1 above and further teaches the integrated therapy catheter further includes a clamping device (1300) configured to clamp a leaflet (see Fig 7), the clamping device having a distal clamp portion (see distal clamp 1310, Fig 8, distal clamp 1310, paragraph [0065]) slidably coupled to a proximal body portion (see how 1310 is slidably coupled to proximal body 1320, Fig 8, distal clamp 1310 moves away and towards 1320, paragraph [0065]), wherein the distal clamp portion is configured to slide distally to position the leaflet between the distal clamp portion and the proximal body portion (1310 moves away from 1320 to form the open state to receive a leaflet, paragraph [0065]) and then the distal clamp portion is configured to slide proximally and the leaflet is clamped between the distal clamp portion and the proximal body portion (when the leaflet is received 1310 moves towards 1320 to form the closed state and clamp the leaflet, paragraph [0065]).
Regarding claim 10, modified Zhang teaches the mitral valve repair system as required by claim 1 above and further teaches the puncture device configured to puncture the first hole proximate a first leaflet edge (see how needle 1410 is configured to puncture a hole proximate a first leaflet edge 600, Fig 40, 1410 punctures the leaflet at S5, paragraph [0134]) and puncture a second hole proximate a second leaflet edge (S5 is repeated for the other leaflet hence needle 1410 is configured to puncture a second hole proximate a second leaflet edge, paragraph [0137]).
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US PG Pub 2021/0038387) in view of previously cited Ek et al (US Pat. No. 6,086,608) as applied to claim 4 above and further in view of applicant cited Findlay (US PG Pub 2007/0005081).
Regarding claim 5, modified Zhang teaches the mitral valve repair system as required by claim 4 above but is silent as to the specific arrangement of the cutter device.
Findlay teaches an analogous system featuring a suture cutting device (device for securing and cutting a suture via catheter, paragraph [0008]) comprising:
an outer body (12) with an outer body side opening (38) (see Fig 2b, paragraph [0043]); and
an inner body (26) with an inner body side opening (34) (see Fig 2a, paragraph [0043]) slidably positioned within the outer body (longitudinally slidable inner body 26 within main body 12, paragraph [0042]), the inner body side opening and the outer body side opening are positioned to provide an opening to a center lumen (see how openings 34 and 38 are aligned to provide an opening to a center lumen for suture 50, Fig 5a),
wherein the first and second tethers enter a distal end of the center lumen and exit out through the inner body side opening and outer body side opening (see how suture strands 50a and 50b enter a right end of the center lumen and exit out the side openings 34 and 38, Fig 5b), and axial movement of the inner body in relation to the outer body side opening closes the opening to the center lumen and scissor cuts the first and second tethers (see how axial movement of inner body 26 closes the opening to cut the suture strands 50a and 50b, Fig 5c, as inner body 26 is retracted the suture leads 50a, 50b are cut, paragraph [0053]) in order to provide the mechanism to cut the suture (to provide a device capable of cutting suture, paragraph [0008]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to further modify the mitral valve repair system as taught by modified Zhang so as to include a cutter device with the recited sliding inner and outer bodies with a side opening for cutting sutures, as taught by Findlay, in order to provide a reliable and low profile mechanism for cutting the first and second tethers as desired during the procedure.
Claims 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US PG Pub 2021/0038387) in view of previously cited Ek et al (US Pat. No. 6,086,608) as applied to claim 6 above and further in view of Coremedic GMBH (WO 2020/187944).
Regarding claim 7, modified Zhang teaches the mitral valve repair system as required by claim 6 above but does not expressly teach the puncture device includes an cannulated needle as claimed.
Coremedic teaches an analogous mitral valve repaid system featuring an integrated catheter for edge-to-edge mitral valve repair (catheter instrument for repairing heart valves, page 16, ln 13-21;) comprising a clamping device (grabbing device 3) (See Fig 1; grabbing structure to grasp and hold a leaflet, page 26, ln 1-8) comprising a distal clamp (5) (See Fig 1) and proximal body (7) (see Fig 1), wherein a cannulated needle (8) (See Fig 3) is positioned within the proximal body (cannulated needle 8 advanced from a proximal end of the grabbing structure, page 26, ln 8-9) and is configured to extend distally to puncture a hole in the leaflet (when the needle is advanced it is able to puncture the grabbed leaflet, page 26, ln 11-12).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to further modify the puncture device of modified Zhang to further comprise a cannulated needle positioned within the proximal body configured to extend distally to puncture a hole in the leaflet as taught by Coremedic in order to use the needle to both puncture the leaflet and deliver an implant distally of the leaflet. As stated in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B).
Regarding claim 8, modified Zhang teaches the mitral valve repair system of claim 7 as set forth above, and further teaches wherein delivery device is configured to6 deliver a leaflet anchor through the cannulated needle (within the needle an implant is arranged so that the distal implant part can be implanted distally of the leaflet, page 26, ln 11-14).
Claims 9, 11, 12, 16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US PG Pub 2021/0038387) in view of previously cited Ek et al (US Pat. No. 6,086,608) and further in view of applicant cited Wilson et al (US PG Pub 2019/0000624).
Regarding claim 9, modified Zhang teaches the mitral valve repair system as required by claim 1 above but does not explicitly teach distal ends of the first and second tethers are self-expanding and configured to expand larger than the first and second holes.
Wilson teaches an analogous mitral valve repair system featuring a distal anchor for mitral valve repair (distal anchor for minimally invasive cardiac valve procedure, paragraph [0013] and [0002]) comprising a tether (742) wherein the distal end (740) of the tether is self-expanding (see Fig. 17A-B, note as the distal anchor 740 is moved distally to exit the delivery device it is allowed to expand, paragraph [0104]; anchor 740 is a shape-memory material to self-expand, paragraph [0105]) and configured to expand larger than the first and second holes. (See Figs. 17A-B). Wilson teaches the self-expanding distal ends are better for anchoring the implant to the heart valve leaflet (the distal end is radially expandable to anchor to the heart valve leaflet, paragraph [0013]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the puncture device of Zhang to include the self-expanding distal ends of the tethers so they expand larger than the first and second holes as taught by Wilson in order to allow the distal ends to expand and better anchor the implant to the heart valve leaflet and reduce the risk of the suture slipping through the leaflet puncture.
Regarding claim 11, Zhang teaches a system for edge-to-edge repair of a mitral valve (system for edge-to-edge repair of mitral valve, paragraph [0005]) comprising:
an integrated therapy catheter (see system 100 including suture implanting apparatus 1000 and suture locker 2000, Fig 3, paragraph[0053]) configured to7 engage a first leaflet and a second leaflet of a mitral valve (see how 1000 includes clamping assembly 1300 for clamping
leaflets of the mitral valve, Fig 7, 1000 includes clamping assembly 1300 for clamping the leaflet, paragraph[0054]) having:
a puncture device (see how 1000 includes puncturing assembly 1400, Fig 7, puncturing assembly 1400, paragraph(0054]) configured to:
puncture a first hole in the first leaflet (the puncturing assembly 1400 includes at least one puncturing needle 1410 to puncture the first leaflet, paragraph [0062]); and
puncture a second hole in the second leaflet (the puncturing assembly 1400 includes at least one puncturing needle 1410 to puncture the second leaflet, paragraph [0062]);
a delivery device (see how 1000 includes push rod 1330 with channel 1331 to deliver suture 3000, Fig 8, paragraph [0068]) configured to:
deliver a first leaflet anchor (3020) through the first hole (see paragraph [0071]), the first leaflet anchor having a first tether (suture 3000) (see a first suture portion 3000 passed through leaflet 600, Fig 43, leaflet 600, See paragraphs [0076] and [0135]) with distal end configured to engage the distal side8 of the first leaflet (see how anti-slip member 3020 engages a distal side of leaflet 600, Fig 43, anti-slip member is in contact with the upper surface of the leaflet, paragraph [0135]); and
deliver a second leaflet anchor (3020) through the second hole (the process is repeated for the other leaflet, paragraph [0137]), the second leaflet anchor having a second tether (see how the other anchor includes suture 3000, Fig 44) with distal end configured to engage the distal side9 of the second leaflet (see how anti-slip member 3020 engages a distal side of leaflet 600, Fig 43, anti-slip member in contact with the upper surface of the leaflet, paragraph[0135]); and
a "knot replacement" tool (see lock pin 21000 of suture locker 2000, Fig 21, the lock pin 21000 is used to fix the suture 3000, paragraph [0099]-[0100]) configured to tension the first and second tethers to bring the first and the second leaflet edges together and lock the first and
second tethers together (see how 21000 is delivered to bring the first and second leaflet edges together and lock the tethers 3000, Fig 48, the lock pin 21000 locks the sutures 3000 together to complete the repair, paragraph[0140]-[0141]).
Zhang does not explicitly teach the “knot replacement tool” includes a locking cap having a cavity with an open proximal end with an internal threaded portion and a closed distal end with first and second tether locking cap holes sized to receive the first and second tethers; a locking screw having an external threaded portion configured to rotatingly engage with the internal threaded portion of the locking cap, and first and second tether locking screw holes sized to receive the first and second tethers; and wherein the locking screw is configured to be screwed into the locking cap, with the first and second tether locking screw holes and the first and second tether locking cap holes being rotated in opposite directions.
Ek teaches an analogous knot replacement tool (collet 10) including a locking cap (ring 12) having a cavity (bore 16) with an open proximal end (See Figs. 2-6; Col. 3, lines 24-60) with an internal threaded portion (36) and a closed distal end (See Fig. 6A; Col. 3, lines 50-68 and Col. 4, lines 4-68 – note when the pin 14 is fully inserted, the distal end is closed except for the openings for the suture) with first and second tether locking cap holes (tunnels 24, 26) sized to receive the first and second tethers (suture 8 has two ends); a locking screw (14) having an external threaded portion (ridges 22) configured to10 rotatingly engage with the internal threaded portion of the locking cap, and first and second tether locking screw holes sized to receive the first and second tethers (See Figs. 1-3 and 6A); and wherein the locking screw is configured to be screwed into the locking cap, with the first and second tether locking screw holes and the first and second tether locking cap holes being rotated in opposite directions.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the knot replacement tool of Zhang such that it comprises a structure of a locking cap having first and second tether locking cap holes and a locking screw having first and second tether locking screw holes, wherein the locking screw is configured to be screwed into the locking cap, with the first and second tether locking screw holes and the first and second tether locking cap holes rotated in opposite directions so that the first tether and second tether are twisted around each other as taught by Ek in order to provide a simple, reliable mechanism to lock the suture in place when desired. Additionally, a wide variety of suture knot replacement mechanisms are known and used in the art. As stated in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B).
Additionally, modified Zhang does not explicitly teach distal ends of the first and second tethers are self-expanding and configured to expand larger than the first and second holes.
Wilson teaches an analogous mitral valve repair system featuring a distal anchor for mitral valve repair (distal anchor for minimally invasive cardiac valve procedure, paragraph [0013] and [0002]) comprising a tether (742) wherein the distal end (740) of the tether is self-expanding (see Fig. 17A-B, note as the distal anchor 740 is moved distally to exit the delivery device it is allowed to expand, paragraph [0104]; anchor 740 is a shape-memory material to self-expand, paragraph [0105]) and configured to expand larger than the first and second holes. (See Figs. 17A-B). Wilson teaches the self-expanding distal ends are better for anchoring the implant to the heart valve leaflet (the distal end is radially expandable to anchor to the heart valve leaflet, paragraph [0013]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to further modify the puncture device of modified Zhang to include the self-expanding distal ends of the tethers so they expand larger than the first and second holes, as taught by Wilson, in order to allow the distal ends to expand and better anchor the implant to the heart valve leaflet and reduce the risk of the suture slipping through the leaflet puncture.
Regarding claim 12, modified Zhang teaches the mitral valve repair system as required by claim 11 above and further teaches the integrated therapy catheter further includes a clamping device (1300) configured to clamp a leaflet (see Fig 7), the clamping device having a distal clamp portion (see distal clamp 1310, Fig 8, distal clamp 1310, paragraph [0065]) slidably coupled to a proximal body portion (see how 1310 is slidably coupled to proximal body 1320, Fig 8, distal clamp 1310 moves away and towards 1320, paragraph [0065]), wherein the distal clamp portion is configured to slide distally to position the leaflet between the distal clamp portion and the proximal body portion (1310 moves away from 1320 to form the open state to receive a leaflet, paragraph [0065]) and then the distal clamp portion is configured to slide proximally and the leaflet is clamped between the distal clamp portion and the proximal body portion (when the leaflet is received 1310 moves towards 1320 to form the closed state and clamp the leaflet, paragraph [0065]).
Regarding claim 16, modified Zhang teaches the mitral valve repair system as required by claim 11 above and further teaches the “knot replacement” tool further includes a detachable delivery shaft (84) coupled to the locking screw (pin 14) (See Ek Figs. 7-8; Col. 5, lines 39-48).
Regarding claim 18, Zhang teaches a system for edge-to-edge repair of a mitral valve (system for edge-to-edge repair of mitral valve, paragraph [0005]) comprising:
an integrated therapy catheter (see system 100 including suture implanting apparatus 1000 and suture locker 2000, Fig 3, paragraph[0053]) configured to11 engage a first leaflet and a second leaflet of a mitral valve (see how 1000 includes clamping assembly 1300 for clamping
leaflets of the mitral valve, Fig 7, 1000 includes clamping assembly 1300 for clamping the leaflet, paragraph[0054]) having:
a puncture device (see how 1000 includes puncturing assembly 1400, Fig 7, puncturing assembly 1400, paragraph(0054]) configured to:
puncture a first hole in the first leaflet (the puncturing assembly 1400 includes at least one puncturing needle 1410 to puncture the first leaflet, paragraph [0062]); and
puncture a second hole in the second leaflet (the puncturing assembly 1400 includes at least one puncturing needle 1410 to puncture the second leaflet, paragraph [0062]);
a delivery device (see how 1000 includes push rod 1330 with channel 1331 to deliver suture 3000, Fig 8, paragraph [0068]) configured to:
deliver a first leaflet anchor (3020) through the first hole (see paragraph [0071]), the first leaflet anchor having a first tether (suture 3000) (see a first suture portion 3000 passed through leaflet 600, Fig 43, leaflet 600, See paragraphs [0076] and [0135]) with distal end configured to engage the distal side12 of the first leaflet (see how anti-slip member 3020 engages a distal side of leaflet 600, Fig 43, anti-slip member is in contact with the upper surface of the leaflet, paragraph [0135]); and
deliver a second leaflet anchor (3020) through the second hole (the process is repeated for the other leaflet, paragraph [0137]), the second leaflet anchor having a second tether (see how the other anchor includes suture 3000, Fig 44) with distal end configured to engage the distal side13 of the second leaflet (see how anti-slip member 3020 engages a distal side of leaflet 600, Fig 43, anti-slip member in contact with the upper surface of the leaflet, paragraph[0135]); and
a "knot replacement" tool (see lock pin 21000 of suture locker 2000, Fig 21, the lock pin 21000 is used to fix the suture 3000, paragraph [0099]-[0100]) configured to tension the first and second tethers to bring the first and the second leaflet edges together and lock the first and
second tethers together (see how 21000 is delivered to bring the first and second leaflet edges together and lock the tethers 3000, Fig 48, the lock pin 21000 locks the sutures 3000 together to complete the repair, paragraph[0140]-[0141]); and
a cutter device configured to cut the first and second tethers (after using the lock pin 21000 the proximal end of suture 3000 is snipped hence a cutting device is configured to cut the two sutures 3000, paragraph [0141]).
Zhang does not explicitly teach the “knot replacement tool” includes a locking cap having a cavity with an open proximal end with an internal threaded portion and a closed distal end with first and second tether locking cap holes sized to receive the first and second tethers; a locking screw having an external threaded portion configured to rotatingly engage with the internal threaded portion of the locking cap, and first and second tether locking screw holes sized to receive the first and second tethers; and wherein the locking screw is configured to be screwed into the locking cap, with the first and second tether locking screw holes and the first and second tether locking cap holes being rotated in opposite directions.
Ek teaches an analogous knot replacement tool (collet 10) including a locking cap (ring 12) having a cavity (bore 16) with an open proximal end (See Figs. 2-6; Col. 3, lines 24-60) with an internal threaded portion (36) and a closed distal end (See Fig. 6A; Col. 3, lines 50-68 and Col. 4, lines 4-68 – note when the pin 14 is fully inserted, the distal end is closed except for the openings for the suture) with first and second tether locking cap holes (tunnels 24, 26) sized to receive the first and second tethers (suture 8 has two ends); a locking screw (14) having an external threaded portion (ridges 22) configured to14 rotatingly engage with the internal threaded portion of the locking cap, and first and second tether locking screw holes sized to receive the first and second tethers (See Figs. 1-3 and 6A); and wherein the locking screw is configured to be screwed into the locking cap, with the first and second tether locking screw holes and the first and second tether locking cap holes being rotated in opposite directions.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the knot replacement tool of Zhang such that it comprises a structure of a locking cap having first and second tether locking cap holes and a locking screw having first and second tether locking screw holes, wherein the locking screw is configured to be screwed into the locking cap, with the first and second tether locking screw holes and the first and second tether locking cap holes rotated in opposite directions so that the first tether and second tether are twisted around each other as taught by Ek in order to provide a simple, reliable mechanism to lock the suture in place when desired. Additionally, a wide variety of suture knot replacement mechanisms are known and used in the art. As stated in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B).
Additionally, modified Zhang does not explicitly teach distal ends of the first and second tethers are self-expanding and configured to expand larger than the first and second holes.
Wilson teaches an analogous mitral valve repair system featuring a distal anchor for mitral valve repair (distal anchor for minimally invasive cardiac valve procedure, paragraph [0013] and [0002]) comprising a tether (742) wherein the distal end (740) of the tether is self-expanding (see Fig. 17A-B, note as the distal anchor 740 is moved distally to exit the delivery device it is allowed to expand, paragraph [0104]; anchor 740 is a shape-memory material to self-expand, paragraph [0105]) and configured to expand larger than the first and second holes. (See Figs. 17A-B). Wilson teaches the self-expanding distal ends are better for anchoring the implant to the heart valve leaflet (the distal end is radially expandable to anchor to the heart valve leaflet, paragraph [0013]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to further modify the puncture device of modified Zhang to include the self-expanding distal ends of the tethers so they expand larger than the first and second holes as taught by Wilson in order to allow the distal ends to expand and better anchor the implant to the heart valve leaflet and reduce the risk of the suture slipping through the leaflet puncture.
Claims 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US PG Pub 2021/0038387) in view of previously cited Ek et al (US Pat. No. 6,086,608) and applicant cited Wilson et al (US PG Pub 2019/0000624), as applied to claim 12 above, and further in view of Coremedic GMBH (WO 2020/187944).
Regarding claim 13, Zhang teaches the mitral valve repair system as required by claim 12 above but does not expressly teach the puncture device includes a cannulated needle as claimed.
Coremedic teaches an analogous mitral valve repaid system featuring an integrated catheter for edge-to-edge mitral valve repair (catheter instrument for repairing heart valves, page 16, ln 13-21;) comprising a clamping device (grabbing device 3) (See Fig 1; grabbing structure to grasp and hold a leaflet, page 26, ln 1-8) comprising a distal clamp (5) (See Fig 1) and proximal body (7) (see Fig 1), wherein a cannulated needle (8) (See Fig 3) is positioned within the proximal body (cannulated needle 8 advanced from a proximal end of the grabbing structure, page 26, ln 8-9) and is configured to extend distally to puncture a hole in the leaflet (when the needle is advanced it is able to puncture the grabbed leaflet, page 26, ln 11-12).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to further modify the puncture device of Zhang to further comprise a cannulated needle positioned within the proximal body configured to extend distally to puncture a hole in the leaflet as taught by Coremedic in order to use the needle to both puncture the leaflet and deliver an implant distally of the leaflet. As stated in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B).
Regarding claim 14, modified Zhang teaches the mitral valve repair system of claim 13 as set forth above, and further teaches wherein delivery device is configured to15 deliver a leaflet anchor through the cannulated needle (within the needle an implant is arranged so that the distal implant part can be implanted distally of the leaflet, page 26, ln 11-14).
Claims 17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US PG Pub 2021/0038387) in view of previously cited Ek et al (US Pat. No. 6,086,608) and applicant cited Wilson et al (US PG Pub 2019/0000624) as applied to claims 11 and 18 respectively above and further in view of applicant cited Findlay (US PG Pub 2007/0005081).
Regarding claim 17, modified Zhang teaches the mitral valve repair system as required by claim 11 above but is silent as to the specific arrangement of the cutter device.
Findlay teaches an analogous system featuring a suture cutting device (device for securing and cutting a suture via catheter, paragraph [0008]) comprising:
an outer body (12) with an outer body side opening (38) (see Fig 2b, paragraph [0043]); and
an inner body (26) with an inner body side opening (34) (see Fig 2a, paragraph [0043]) slidably positioned within the outer body (longitudinally slidable inner body 26 within main body 12, paragraph [0042]), the inner body side opening and the outer body side opening are positioned to provide an opening to a center lumen (see how openings 34 and 38 are aligned to provide an opening to a center lumen for suture 50, Fig 5a),
wherein the first and second tethers enter a distal end of the center lumen and exit out through the inner body side opening and outer body side opening (see how suture strands 50a and 50b enter a right end of the center lumen and exit out the side openings 34 and 38, Fig 5b), and axial movement of the inner body in relation to the outer body side opening closes the opening to the center lumen and scissor cuts the first and second tethers (see how axial movement of inner body 26 closes the opening to cut the suture strands 50a and 50b, Fig 5c, as inner body 26 is retracted the suture leads 50a, 50b are cut, paragraph [0053]) in order to provide the mechanism to cut the suture (to provide a device capable of cutting suture, paragraph [0008]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to further modify the mitral valve repair system as taught by modified Zhang so as to include a cutter device with the recited sliding inner and outer bodies with a side opening for cutting sutures as taught by Findlay in order to provide a reliable and low profile mechanism for cutting the first and second tethers as desired during the procedure.
Regarding claim 20, modified Zhang teaches the mitral valve repair system as required by claim 18 above but is silent as to the specific arrangement of the cutter device.
Findlay teaches an analogous system featuring a suture cutting device (device for securing and cutting a suture via catheter, paragraph [0008]) comprising:
an outer body (12) with an outer body side opening (38) (see Fig 2b, paragraph [0043]); and
an inner body (26) with an inner body side opening (34) (see Fig 2a, paragraph [0043]) slidably positioned within the outer body (longitudinally slidable inner body 26 within main body 12, paragraph [0042]), the inner body side opening and the outer body side opening are positioned to provide an opening to a center lumen (see how openings 34 and 38 are aligned to provide an opening to a center lumen for suture 50, Fig 5a),
wherein the first and second tethers enter a distal end of the center lumen and exit out through the inner body side opening and outer body side opening (see how suture strands 50a and 50b enter a right end of the center lumen and exit out the side openings 34 and 38, Fig 5b), and axial movement of the inner body in relation to the outer body side opening closes the opening to the center lumen and scissor cuts the first and second tethers (see how axial movement of inner body 26 closes the opening to cut the suture strands 50a and 50b, Fig 5c, as inner body 26 is retracted the suture leads 50a, 50b are cut, paragraph [0053]) in order to provide the mechanism to cut the suture (to provide a device capable of cutting suture, paragraph [0008]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to further modify the mitral valve repair system as taught by modified Zhang so as to include a cutter device with the recited sliding inner and outer bodies with a side opening for cutting sutures as taught by Findlay in order to provide a reliable and low profile mechanism for cutting the first and second tethers as desired during the procedure.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-14, 16-18, and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The entirety of applicant’s arguments are directed to how Zhang (US PG Pub 2021/0038387) and Foerster (US PG Pub 2004/0098050) fail to teach the recited claim limitations, particularly the claimed features of the knot replacement tool having a locking cap and locking screw as recited in the amended claims. These arguments are moot as Foerster is no longer being applied. The previously cited Ek reference (US Pat. No. 6,086,608) is relied upon for the teachings of the specific knot replacement tool as presently required by the claims.
The remainder of applicant’s arguments amount to an allegation of patentability based on the alleged deficiencies of the primary reference. For the reasons set forth above, this is unpersuasive.
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.
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/R.S.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
1 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, the puncturing device as taught by Zhang is capable of puncturing a hole in both leaflets. See Fig. 49
2 It is noted that “proximal” and “distal” are relative terms. It is further noted that while "distal" is often used to describe the portion of a device farthest from the operator, it is also used in the medical art to describe the portion closest to the operator. Further, “proximal” and “distal” are defined by Merriam-Webster in relation to the center of the body. It is further noted that the system as taught by Zhang would be capable of delivering the anchors (3020) to either side of the leaflet.
3 See footnote 2 above
4 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). As long as the prior art meets the structural requirements and is capable of performing the functions, the prior art meets the limitations. In the instant case, the device of Ek meets all the structural requirements and is capable of performing the intended function, rotating. (See also Col. 9, lines 43-60).
5 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). As long as the prior art meets the structural requirements and is capable of performing the functions, the prior art meets the limitations. In the instant case, the device of Ek meets all the structural requirements and is capable of performing the intended function, namely having the pin 14 be rotated into the threads 36 of the collar ring 12. (See also Col. 9, lines 43-60).
6 See footnote 2 above
7 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, the puncturing device as taught by Zhang is capable of puncturing a hole in both leaflets. See Fig. 49
8 It is noted that “proximal” and “distal” are relative terms. It is further noted that while "distal" is often used to describe the portion of a device farthest from the operator, it is also used in the medical art to describe the portion closest to the operator. Further, “proximal” and “distal” are defined by Merriam-Webster in relation to the center of the body. It is further noted that the system as taught by Zhang would be capable of delivering the anchors (3020) to either side of the leaflet.
9 See footnote 2 above
10 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). As long as the prior art meets the structural requirements and is capable of performing the functions, the prior art meets the limitations. In the instant case, the device of Ek meets all the structural requirements and is capable of performing the intended function, rotating. (See also Col. 9, lines 43-60).
11 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, the puncturing device as taught by Zhang is capable of puncturing a hole in both leaflets. See Fig. 49
12 It is noted that “proximal” and “distal” are relative terms. It is further noted that while "distal" is often used to describe the portion of a device farthest from the operator, it is also used in the medical art to describe the portion closest to the operator. Further, “proximal” and “distal” are defined by Merriam-Webster in relation to the center of the body. It is further noted that the system as taught by Zhang would be capable of delivering the anchors (3020) to either side of the leaflet.
13 See footnote 2 above
14 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). As long as the prior art meets the structural requirements and is capable of performing the functions, the prior art meets the limitations. In the instant case, the device of Ek meets all the structural requirements and is capable of performing the intended function, rotating. (See also Col. 9, lines 43-60).
15 See footnote 2 above