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 .
Priority
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Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claim(s) 1-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bishop et al. US 20180185153 A1, herein referred to as Bishop (2018), and in view of US Bishop et al. 20200297489 A1, herein referred to as Bishop (2020).
Regarding claims 1, Bishop (2018) discloses: A method for transcatheter (Fig. 42, trans catheter 100) chordae tendineae repair (Fig 42, Abstract, 1-2), comprising: transvascular entering into an atrium of a heart (Fig 42, Abstract, 2-4); delivering a ventricular implant (110) from the atrium to a corresponding ventricle (Fig. 42), and anchoring the ventricular implant (Fig. 42, tissue anchor 110) to ventricular tissue of the corresponding ventricle ([27] lines 5-7, Annotated Fig. 42 below); adjusting the suture (Fig 35H, suture 114) an appropriate tension (¶ 0010, 1-3, FIGS. 35A through 35O, to restore normal valve function); and actuating the ventricular implant (Fig. 42, tissue anchor 110) to retain the suture (Fig 35H, suture 114) at the ventricular implant under the appropriate tension ([275] “rotational deriver can extend proximally through the catheter 100. After anchoring the tissue anchor 108, the catheter 100 and/or anchor driver is proximally retracted to leave the anchor 110 secured to the wall, and attached to an anchor suture 114”; rotational movement of anchor holding suture satisfies actuation claimed).
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Annotated Figure 42, Bishop (2018).
But Bishop (2018) discloses advancing a leaflet implant (136) from a ventricular side to the atrial side so as to fix the leaflet to a suture (Figs. 35B-35H), thereby fails to disclose: advancing a leaflet implant from an atrial side of a leaflet of the heart to a corresponding ventricular side, so as to fix the leaflet to a suture attached to the leaflet implant, wherein a proximal end of the suture extends out of a body to connect with a ventricular implant.
Bishop (2020) discloses as similar method for transcatheter heart (100) repair (Abstract). Bishop (2020) teaches advancing a leaflet implant (Fig. 11, 340) from an atrial side of a leaflet of the heart to a corresponding ventricular side (Figs. 3-6A, 7, and 11-12), so as to fix the leaflet to a suture (Fig 11, suture 344) attached to the leaflet implant (Fig 11, pledget 340), wherein a proximal end of the suture extends out of a body to connect with a ventricular implant (Fig. 11).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the advancing step of Bishop (2018) to include advancing a leaflet implant from an atrial side of a leaflet of the heart to a corresponding ventricular side, so as to fix the leaflet to a suture attached to the leaflet implant, wherein a proximal end of the suture extends out of a body to connect with a ventricular implant, as taught and suggested by Bishop (2020) to be a known method of anchoring a suture to a leaflet ([0219]).
Re. claim 2, the combination of Bishop (2018) and Bishop (2020) as discussed above in claim 1 teaches: cutting the suture (Bishop 2018 Fig. 38G, suture 311) near the ventricular implant (Fig 42, tissue anchor 110, ¶ 0010, 3-6), so as to leave the suture (Fig. 38G, suture 311) between the leaflet implant (Fig. 42, pledget 136) and the ventricular implant (Fig. 42, tissue anchor 110) as an artificial chordae tendineae (Fig. 42, artificial tendon 138) (¶ 0010, 3-6).
Regarding claims 3, the combination of Bishop 2018 and 2020 discloses the invention substantially as discussed above with respect to claim 1, but fails to disclose discloses wherein a traction member is connected with the proximal end of the suture, and the traction member extends proximally out of the body to connect with the ventricular implant.
However, in another embodiment (See Figure 39) Bishop (2020) discloses a similar method for transcatheter chordae tendineae repair. Further, Bishop (2020) teaches: wherein a traction member (Fig. 39, retention element 1912, [0295]) is connected with the proximal end of the suture (Bishop 2018, Fig 42, suture 138 ¶ 0285), and the traction member extends proximally out of the body to connect with the ventricular implant (Fig. 42, tissue anchor 110, ¶ 0142, 26-29).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify combination of Bishop 2018 and 2020 to incorporate wherein a traction member is connected with the proximal end of the suture, and the traction member extends proximally out of the body to connect with the ventricular implant, as taught and suggested by Bishop (2020), in order to allow better management of the surgical implantation [288].
Regarding claims 4, the combination of Bishop 2018 and 2020 as discussed above in claim 3 teaches: wherein a step of the adjusting the suture (Bishop 2018, Fig 42, 138 artificial tendon) to an appropriate tension comprises (¶ 0144,5-6): pulling proximally the traction member (Fig. 39, retention element 1912, [0295]) to bring at least partially of the proximal end of the suture (Fig 42, 138 artificial tendon) to the ventricular implant (Fig. 42, tissue anchor 110) for connecting (¶ 0160, 1-2).
Regarding claims 5, the combination of Bishop 2018 and 2020 as discussed above in claim 4 fails to teach: wherein the ventricular implant comprises a suture locking portion, and a step of adjusting the suture to an appropriate tension further comprises: bringing the proximal end of the suture to pass through the suture locking portion from a distal end of the suture locking portion to a proximal end of the suture locking portion, so as to retain the proximal end of the suture beside the proximal end of the suture locking portion.
However, in another embodiment (see Figure 38H) Bishop (2018) teaches wherein the ventricular implant (Fig 38H, suture anchor 302) comprises a suture locking portion (Fig. 41A, suture lock 376; [0307] “the expanded diameter of the guard 303 may provide sufficient space for rotation of the helical anchor 302 without contacting an inner surface of the guard 303” shows anchor is capable of being actuated as claimed), and a step of adjusting the suture (Fig 38H, sutures 311 and 344) to an appropriate tension further comprises (¶ 0320): bringing the proximal end of the suture to pass through the suture locking portion (Annotated Fig 38H below, suture lock 376) from a distal end (Annotated Fig 38H below) of the suture locking portion to a proximal end (Annotated Fig 38H below) of the suture locking portion (¶ 0112, 5-8), so as to retain the proximal end of the suture (Annotated Fig 38H below) beside the proximal end of the suture locking portion (Annotated Fig 38H , ¶ 0112, 8-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claim invention to modify the combination of Bishop 2018 and 2020 to incorporate wherein the ventricular implant comprises a suture locking portion, and a step of adjusting the suture to an appropriate tension further comprises: bringing the proximal end of the suture to pass through the suture locking portion from a distal end of the suture locking portion to a proximal end of the suture locking portion, so as to retain the proximal end of the suture beside the proximal end of the suture locking portion, as taught and suggested by Bishop (2018) in another embodiment in order to improve anchor adhesion [0004].
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Annotated Figure 38H, Bishop (2018).
Regarding claims 6, the combination of Bishop 2018 and 2022 as discussed above in claim 5 teaches: wherein a step of the actuating the ventricular implant comprises: actuating the suture locking portion (Fig 38H, suture lock 376) to lock the suture in the suture locking portion (¶ 0160, 1-2).
Regarding claims 7, the combination of Bishop 2018 and 2020 as discussed above in claim 3 teaches: further comprising: connecting the traction member (Fig. 39, retention element 1912, [0295]) to the proximal end of the suture (Fig 38H, sutures 344) outside the body (¶ 0142, 26-29).
Regarding claims 8, the combination of Bishop 2018 and 2020 as discussed above in claim 3 but teaches to leave the suture (Bishop 2018, Fig 42, suture 138) as an artificial chordae tendineae (Bishop (2018) Fig 42, chorda tendon 138).
But fails to teach: withdrawing the traction member after chorda placement.
However, in another embodiment (See Figure 39) Bishop (2020) discloses a similar method for transcatheter chordae tendineae repair. Further, Bishop (2020) teaches further comprising: withdrawing the traction member (Bishop (2020), Fig. 39, retention element 1912, [0295]),
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filling date of the claimed invention to modify the combination of Bishop 2018 and 2020 to incorporate a withdrawal-able traction member that is withdrawn after the artificial chorda is placed, as taught and suggested by Bishop (2020) in another embodiment in order to provide rapid use (Bishop 2020 [0294])
Regarding claims 9, the combination of Bishop 2018 and 2020 as discussed above in claim 8 teaches: cutting the suture (Bishop (2018) Fig 42, suture 138) at the proximal end of the suture (¶ 0320, 5-8), and withdrawing the traction member Bishop (2020), Fig. 39, retention element 1912, [0295]).
Regarding claims 10, the combination of Bishop 2018 and 2020 discloses the invention substantially as claimed and discussed in claims 9 teaches wherein a step of the anchoring the ventricular implant (Bishop (2018) Fig. 42, tissue anchor 110) to ventricular tissue comprises: rotating the ventricular implant into the ventricular tissue (¶ 0126).
Therefore, it would have been obvious to one of ordinary skill in the art before the effect filling date of the claimed invention to modify the combination of Bishop 2018 and 2020 to incorporate wherein a step of the anchoring the ventricular implant to ventricular tissue comprises: rotating the ventricular implant into the ventricular tissue, as suggested and taught by Bishop (2018), in order to further improve implant adhesion [0004].
Regarding claims 11, the combination of Bishop 2018 and 2020 discloses the invention substantially as claimed and discussed in claims 9 teaches disclose wherein a step of the anchoring the ventricular implant (Bishop (2018) Fig. 42, tissue anchor 110) to ventricular tissue further comprises: inserting a locator [0114] into the ventricular tissue before rotating the ventricular implant.
Regarding claims 12, Bishop (2018) discloses: A system for transcatheter (Fig. 42, transcatheter 100) chordae tendineae repair (Figs. 42, Abstract, 1-2), comprising: a delivery catheter (Fig. 1, transcatheter 100), wherein the delivery catheter is advanced into an atrium of a heart (Fig 42, Abstract, 2-4) through a vasculature of a patient (Annotated Fig 42 above, Abstract, 2-4, [0116]), so as to provide a pathway into the heart from outside a body ([0116]); a leaflet implant (Fig 42, pledget 136) to which a suture (Fig 35H, suture 114) is attached, so as to fix the leaflet to the suture ([0282]); and a ventricular implant (Fig. 42, tissue anchor 110), wherein the suture extends proximally through the delivery catheter to be connected with the ventricular implant outside the body ([0156], Figures 26-34, Suture runs through the transcatheter to outside of the body), so as to be anchored to ventricular tissue (Fig. 42, tissue anchor 110, [0275]); when the suture (Fig 35H, suture 114) being adjusted to an appropriate tension, actuating the ventricular implant (Fig. 42, tissue anchor 110) to retain the suture (Fig 35H, suture 114) at the ventricular implant ([275] “rotational deriver can extend proximally through the catheter 100. After anchoring the tissue anchor 108, the catheter 100 and/or anchor driver is proximally retracted to leave the anchor 110 secured to the wall, and attached to an anchor suture 114”; rotational movement of anchor holding suture satisfies actuation claimed).
But fails to teach wherein the leaflet implant is configured to be advanced from an atrial side of a leaflet to a corresponding ventricular side through the delivery catheter, so as to fix the leaflet to the suture; and a ventricular implant.
However, Bishop (2020) discloses a similar transcatheter for chordae tendineae repair. Bishop teaches wherein the leaflet implant (Fig 11, first tissue anchor 340) is configured to be advanced from an atrial side of a leaflet (Figs. 3-6A, 7, and 11-12) to a corresponding ventricular side through the delivery catheter (Fig. 11, delivery catheter 100 and ventricular anchor 302 [0202] [0162] and [0431]; example given is attaching atrial anchor then ventricular anchor).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Bishop 2018 to include a wherein the leaflet implant is configured to be advanced from an atrial side of a leaflet to a corresponding ventricular side through the delivery catheter, as taught and suggest by Bishop (2020) to be a known method of anchoring a suture to a leaflet ([0219] & [0431]).
Regarding claims 13, the combination of Bishop 2018 and 2020 as discussed above in claim 12, but fails to disclose a puncture assembly, wherein the leaflet implant is preloaded in the puncture assembly, the suture extends proximally through the puncture assembly, and the puncture assembly is delivered into the atrium through the delivery catheter to puncture the leaflet, so as to release the leaflet implant to the ventricular side from the puncture assembly.
But Bishop (2018) in another embodiment describes a similar system for transcatheter chordae tendineae repair including a puncture assembly. Further, Bishop (2018) also teaches a puncture assembly (Bishop 2018, FIG. 35O, hub 150), wherein the leaflet implant (Fig 42, leaflet anchor suture 138) is preloaded in the puncture assembly ([0282] loading suture into puncture catheter described), the suture extends proximally through the puncture assembly (Fig 35H, [0070]), and the puncture assembly is delivered into the atrium through the delivery catheter to puncture the leaflet (Fig. 35B, ¶ 0066), so as to release the leaflet implant to the ventricular side from the puncture assembly (¶ 0155).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed to modify the combination of Bishop 2018 and 2020 to include a puncture assembly, wherein the leaflet implant is preloaded in the puncture assembly, the suture extends proximally through the puncture assembly, and the puncture assembly is delivered into the atrium through the delivery catheter to puncture the leaflet, so as to release the leaflet implant to the ventricular side from the puncture assembly, as taught and suggested by Bishop (2018) in order to improve anchor adhesion [0004]
Regarding claims 14, the combination of Bishop 2018 and 2020 but fails to disclose a capture assembly, wherein the capture assembly is delivered via the delivery catheter, until a distal end of the capture assembly is beyond a distal end of the delivery catheter.
However, Bishop (2018) in another embodiment describes a similar system1 for repairing a chordae tendinae. Further, Bishop (2018) also teaches further comprising: a capture assembly (Fig. 35B, capture catheter 120, ¶ 0155), wherein the capture assembly is delivered via the delivery catheter (catheter 100, ¶ 0155), until a distal end of the capture assembly is beyond a distal end of the delivery catheter (Fig. 35O, capture catheter 120).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed to modify the combination of Bishop 2018 and 2020 to include a capture assembly, wherein the capture assembly is delivered via the delivery catheter, until a distal end of the capture assembly is beyond a distal end of the delivery catheter, as taught and suggested by Bishop (2018) in order to improve anchor adhesion [0004]
Regarding claims 15, the combination of Bishop 2018 and 2020 as discussed above in claim 14 teaches: wherein the puncture assembly (FIG. 35O, hub 150) is loaded in the capture assembly (Fig. 35B, capture catheter 120) (¶ 0309).
Regarding claims 16, the combination of Bishop 2018 and 202 as discussed above in claim 12 substantially discloses the claim invention, but fails to disclose
wherein the ventricular implant comprises a suture locking portion, and a proximal end of the suture is brought to pass through the suture locking portion from a distal end of the suture locking portion to a proximal end of the suture locking portion, so as to retain the proximal end of the suture beside the proximal end of the suture locking portion.
However, Bishop (2018) in another embodiment discloses a similar system for implanting artificial chorda tendinae. Further, Bishop (2018) teaches: wherein the ventricular implant (Fig 38H, suture anchor 302) comprises a suture locking portion (Fig. 41A, suture lock 376, [135-136]), and a proximal end of the suture (Fig 38H, suture 344) is brought to pass through the suture locking portion from a distal end of the suture locking portion to a proximal end of the suture locking portion (Annotated Fig 38H below, suture lock 376), so as to retain the proximal end of the suture beside the proximal end of the suture locking portion (¶ 0149, 1-3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claim invention to modify the combination of Bishop 2018 and 2020 to incorporate wherein the ventricular implant comprises a suture locking portion, and a proximal end of the suture is brought to pass through the suture locking portion from a distal end of the suture locking portion to a proximal end of the suture locking portion, so as to retain the proximal end of the suture beside the proximal end of the suture locking portion, as taught and suggested by Bishop (2018) in another embodiment in order to improve anchor adhesion [0004].
Regarding claims 17, the combination of Bishop 2018 and 2020 as discussed above in claim 16 teaches: wherein the suture locking portion (Annotated Fig 38H below, suture lock 376) is capable of being actuated to lock the suture (Fig 38H, suture 344) in the suture locking portion (¶ 0160, 1-2).
Regarding claims 18, the combination of Bishop 2018 and 2020 as discussed above in claim 17 teaches Bishop but does not disclose: a locking actuator, wherein the locking actuator is pushed along the suture and is delivered to the ventricle via the delivery catheter, so as to actuate the suture locking portion to lock the suture.
However, Bishop (2018) in another embodiment discloses a similar system of transcatheter artificial chordae tendinae repair. Further, Bishop teaches a locking actuator (Fig. 40B, 352 actuation knob 352), wherein the locking actuator is pushed along the suture (Fig 38H, suture 344, ¶0312, 6-8, delivery of anchor subsystem includes sutures for securing anchors of tendinae) and is delivered to the ventricle via the delivery catheter (Fig 100, [0319] describe subsystem movement from delivery catheter), so as to actuate the suture locking portion to lock the suture (¶ 0312).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claim invention the combination of Bishop 2018 and 2020 to include a locking actuator, wherein the locking actuator is pushed along the suture and is delivered to the ventricle via the delivery catheter, so as to actuate the suture locking portion to lock the suture, as taught and suggested by Bishop (2018) to facilitate chorda placement [0004]
Regarding claims 19, the combination of Bishop 2018 and 2020 discloses the invention substantially as claimed and discussed in claim 16, teaches a suture cutter (Fig. 41A, cutter head 375), wherein the suture cutter is configured to cut the suture (Fig 42, suture 138) near the ventricular implant (¶ 0039, 1-3, Fig 42 tissue anchor 302), so as to leave the suture between the leaflet implant and the ventricular implant (Fig. 42 ,tissue anchor 302)as an artificial chordae tendineae (Fig. 42, artificial chordae tendineae138, ¶ 0010, 3-6).
Therefore, it would have been obvious to one of ordinary skill before the effective filling date of the claimed invention to modify the combination of Bishop 2018 and 2020 to include suture cutter, wherein the suture cutter is configured to cut the suture near the ventricular implant, so as to leave the suture between the leaflet implant and the ventricular implant as an artificial chordae tendineae, as taught and suggested by Bishop (2018) to provide strain relief to the suture while implant [0143]
Regarding claims 20, the combination of Bishop 2018 and 2020 discloses the invention substantially as discussed above with respect to claim 1, but fails to disclose discloses
a traction member, wherein a proximal end of the suture is connected with the traction member, and the traction member extends proximally out of the body through the delivery catheter to connect with the ventricular implant outside of the body.
However, in another embodiment (See Figure 39) Bishop (2020) discloses a similar method for transcatheter chordae tendineae repair. Further, Bishop (2020) teaches:
a traction member (Bishop (2020), (Fig. 39, retention element 1912, [0295]), wherein a proximal end of the suture (Fig 42, suture 138) is connected with the traction member (¶ 0329, 2-3), and the traction member extends proximally out of the body through the delivery catheter to connect with the ventricular implant (Fig 42, tissue anchor 302) outside of the body (¶ 0302, 5-8, ¶ 0142, 26-29).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claim invention to modify the combination of Bishop 2018 and 2020 to incorporate a traction member, wherein a proximal end of the suture is connected with the traction member, and the traction member extends proximally out of the body through the delivery catheter to connect with the ventricular implant outside of the body, as taught and suggested by Bishop (2020) in another embodiment in order to improve anchor adhesion [XXX].
Regarding claims 21 the combination of Bishop 2018 and 2020 as discussed in claim 20 teaches: wherein the traction member (Bishop (2020), (Fig. 39, retention element 1912, [0295]) pulls the suture (Fig 42, suture 138), so as to bring at least partially of the proximal end of the suture to the ventricular implant (Fig 42, tissue anchor 302) for connecting.
Regarding claims 22, the combination of Bishop 2018 and 2020 as discussed in claim 21 teaches: wherein the suture (Bishop (2018), Fig 42, suture 138) is being left as an artificial chordae tendineae (Fig. 42, artificial chordae138) after the traction member (Fig. 39, retention element 1912, [0295]) is withdrawn (¶ 0064, 1-2).
Regarding claims 23, the combination of Bishop 2018 and 2020 as discussed in claim 22 teaches: a suture cutter (375), wherein the suture cutter is configured to cut the suture at the proximal end of the suture (¶ 0323, 8-14), so as to leave the suture between the leaflet implant and the ventricular implant as the artificial chordae tendineae (138) (¶ 0064, 1-2).
Regarding claims 24, the combination of Bishop 2018 and 2020 as discussed in claim 23 teaches: further comprising: a locator, wherein the locator is configured to be inserted into the ventricular tissue before the ventricular implant is anchored through the delivery catheter (¶ 0114, art describes including a radio marker to tissue implant).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799