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
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN202310378868.4, filed on April 13, 2023.
Response to Arguments
Applicant's arguments filed April 16, 2026 have been fully considered but were found unpersuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “detachment prevention mechanism” and “detachment prevention mechanism” see page 9 of arguments) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, applicant’s argument on pages 11-13 that Bishop (2018) and Bishop (2020) do not teach or suggest ‘a proximal end of the suture is connected to a traction member and the traction member extends out of a body to connect with a ventricular implant; pulling the traction member to adjust the suture to an appropriate tension, wherein the traction member is connected to the ventricular implant before the adjustment, and the suture is connected to the ventricular implant after the adjustment’, is found unpersuasive in view of these new grounds of rejection.
The new ground of rejection expands the interpretation of retention element and invokes 112(f) interpretation as informed by applicant’s specification: “traction member 60 can also be a traction rope, such as a stainless steel wire rope, a tungsten wire rope or a nickel-titanium wire rope” or “a rod”, see pg 12 and Figure 7a of the instant application, and equivalents thereof. The Examiner is considering retention element to be the combination of 1912/1906/1904/1902, Fig 39, [0294-0296] (Bishop 2020). This new interpretation using a wire as claimed: ‘pulling the traction member to adjust the suture to an appropriate tension, wherein the traction member is connected to the ventricular implant before the adjustment, and the suture is connected to the ventricular implant after the adjustment’. In other words, the new interpretation teaches the invention as claimed and argued. This interpretation constitutes an obvious combination of Bishops (2020 and 2018), see rejection below for details.
Claim Objections
Claim 1 is objected to because of the following informalities: The word transvascular should be corrected to the grammatically correct adverb “transvascularly”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function.
Such claim limitation(s) is/are:
wherein a proximal end of the suture is connected to a traction member in claims 1 and 12. The traction member 60 can also be a traction rope, such as a stainless steel wire rope, a tungsten wire rope or a nickel-titanium wire rope” or “a rod” ...., see pg 12 and figure 7a of the instant application, and equivalents thereof.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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, 4-18, and 21-24 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 chordae tendineae repair (Fig. 42, trans catheter 100), comprising: transvascularly entering into an atrium of a heart (Fig 42, Abstract, 2-4); delivering the 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); and the suture is connected to the ventricular implant after the adjustment 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 38H, Bishop (2018).
But does not disclose teaches advancing a leaflet implant from one side of a leaflet of the heart, so as to fix the leaflet to a suture attached to the leaflet implant.
But Bishop (2020) teaches advancing a leaflet implant (Fig. 11, 340) from one side of a leaflet of the heart (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),
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 one side of a leaflet of the heart, so as to fix the leaflet to a suture attached to the leaflet implant, as taught and suggested by Bishop (2020) to securely anchor a suture to a leaflet (Bishop (2020) [0219]).
Bishops 2018/2020 do not explicitly disclose wherein a proximal end of the suture is connected to a traction member; and the traction member extends out of a body to connect with a ventricular implant, and pulling the traction member to adjust the suture to an appropriate tension, wherein the traction member is connected to the ventricular implant before the adjustment.
However, in another embodiment (See Figure 39) Bishop (2020) discloses a similar method for transcatheter chordae tendineae repair. Further, Bishop (2020) teaches wherein a proximal end of the suture is connected to a traction member (Fig. 39, retention element 1912/1906/1904/1902, [0294-0296]; Bishop 2020 teaches the retention element including more features as shown in Fig 43; this element is interpreted under 112(f) as a “the traction member 60 can be a traction wire, such as a stainless steel wire, a nickel-titanium wire or a tungsten wire. The traction member 60 can also be a traction rope, such as a stainless steel wire rope, a tungsten wire rope or a nickel-titanium wire rope” or “a rod” ...., see pg 12 and figure 7a of the instant application, and equivalents thereof); and the traction member extends out of a body to connect with a ventricular implant (Fig. 42, tissue anchor 110, ¶ 0142, 26-29), and pulling the traction member to adjust the suture (Bishop 2018, Fig 42, suture 138 ¶ 0285) to an appropriate tension ([0294-0295]); wherein the traction member is connected to the ventricular implant before the adjustment ([0294-0295]).
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 the steps wherein a proximal end of the suture is connected to a traction member; and the traction member extends out of a body to connect with a ventricular implant, and pulling the traction member to adjust the suture to an appropriate tension, wherein the traction member is connected to the ventricular implant before the adjustment, as taught and suggested by Bishop (2020), in order to allow better management of the surgical implantation [0288].
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].
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 1 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 1 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 1 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 1 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 10 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 chordae tendineae repair (Bishop 2018 Fig. 42, trans catheter 100), comprising: a delivery catheter (Fig. 1, transcatheter 100), wherein the delivery catheter is advanced into an atrium of a heart through a vasculature of a patient (Bishop 2018 Fig 42, Abstract, 2-4), so as to provide a pathway into the heart from outside a body (Bishop 2018 [0116]); a leaflet implant (Bishop 2018 Fig 42, pledget 136) to which a suture is attached (Bishop 2018 [0282]), wherein the leaflet implant (Bishop 2020 Fig 11, first tissue anchor 340) is configured to be advanced from one side of a leaflet (Bishop 2020 Figs. 3-6A, 7, and 11-12) to the other side through the delivery catheter (Bishop 2020 Fig. 11, delivery catheter 100 and ventricular anchor 302 [0202] [0162] and [0431]; example given is attaching atrial anchor then ventricular anchor), so as to fix the leaflet to the suture (Bishop 2020 [0202]); and a ventricular implant (Fig. 42, tissue anchor 110, ¶ 0142, 26-29), wherein a proximal end of the suture () is connected to a traction member (Fig. 39, retention element 1912/1906/1904/1902, [0294-0296]; Bishop 2020 teaches the retention element including more features as shown in Fig 43; this element is interpreted under 112(f) as a “the traction member 60 can be a traction wire, such as a stainless steel wire, a nickel-titanium wire or a tungsten wire. The traction member 60 can also be a traction rope, such as a stainless steel wire rope, a tungsten wire rope or a nickel-titanium wire rope” or “a rod” ...., see pg 12 and figure 7a of the instant application, and equivalents thereof), the traction member extends proximally through the delivery catheter to be connected with the ventricular implant outside the body (Bishop 2018[0156], Figures 26-34, Suture runs through the transcatheter to outside of the body), and the ventricular implant is configured to be advanced from the atrium to a corresponding ventricle through the delivery catheter (Bishop 2018, Fig 42, suture 138 ¶ 0285), so as to be anchored to ventricular tissue (Bishop 2020 [0294-0295]); when the suture being adjusted to an appropriate tension by pulling the traction member (Bishop 2020 [0294-0295]), actuating the ventricular implant to retain the suture at the ventricular implant, wherein the traction member is connected to the ventricular implant before the adjustment ([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) (Bishop 2018 [0275] “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), and the suture is connected to the ventricular implant after the adjustment (Bishop 2018Fig. 42).
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 (Bishop 2018 [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 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
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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