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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/24/2024 has been entered.
Response to Arguments
Applicant argues in the response filed 06/24/2024 that the prior art Davidson in view of Fanton and Bishop in view of Fanton do not disclose the tether extending from the suture anchor and utilizing the tether to actuate the suture lock. The rejections with respect to Davidson in view of Fanton and Bishop in view of Fanton have been withdrawn.
It is to be noted that Bishop does disclose other embodiments with the tether in figures 17-22; or figures 35k-m. A new rejection with respect to Bishop has been made below.
A new rejection with respect to Davidson in view of Reich has been made below.
Election/Restrictions
Newly submitted claims 20,21 are directed to a species that is distinct from the elected Species F, figures 7a-d in the response filed 09/06/2022. New claims 20,21 are directed to a spring lock which are supported by figures 8a-j. Figures 8a-j correspond to Species G, not the elected Species F.
Accordingly, claims 20, 21 are withdrawn from consideration as being directed to a non-elected invention/species. See 37 CFR 1.142(b) and MPEP § 821.03.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 10, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2018/0185153 to Bishop.
As to claim 1, Bishop discloses a method of repairing a heart valve in a beating heart of a patient (paragraph 113, the general repair can be on a beating heart, the heart may be halted to grasp a leaflet, but then after grasped, the heart is activated again during the repair, the repair is still for a heart valve in a beating heart), comprising: intravascularly accessing an interior of the heart (figures 17-22; or figures 35k-m, paragraph 110, 149/275, 282, 285, 286); inserting a first suture (60, the at least part of the suture 60 that extends from the leaflet to the anchor 32 and up to through the catheter, see annotated figure I below; or 138, figure 35k, paragraph 282, 287 ) into a heart valve leaflet (24, figure 17-18, paragraph 149, the suture 60 is attached to the leaflet; or as seen in figure 35k) of the heart; attaching the first sutures to a suture anchor (32, figure 17, paragraph 149; or 154/118/110 figure 35k, paragraph 275, 287) exterior to the heart (paragraph 112, the suture is threaded through the anchor outside of the heart); advancing the suture anchor into the heart and anchoring the suture anchor into a heart wall of the heart with an anchor delivery catheter (100, via the approach, paragraph 112, 116, 149, 275, 282, 285, 286) with a tether (the far left suture tail of 60, as seen in figure 17-22 where the lock extends along as seen in figure 22 and in the annotated figure below; or 114) extending from the suture anchor intravascularly to outside of the heart (figure 17-22; or 35k-m); adjusting a tension of the first suture to achieve proper heart valve function (paragraph 149; or paragraph 287); and utilizing the tether to actuate a suture lock (62; 154 and/or “suture lock” paragraph 287, the fulcrum and/or the suture lock of paragraph 287 can read on the suture lock) on the suture anchor to retain the first suture at the suture anchor at the tension that achieves proper heart valve function (paragraph 149; or paragraph 287). Bishop discloses two different embodiments, figure 17-22 or figure 35k-m, that can both read on the claims.
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As to claim 4, Bishop discloses delivering the suture lock to the suture anchor in the heart (paragraph 149 or 287).
As to claim 10, Bishop disclose unlocking the first suture on the suture anchor, readjusting the tension of the first suture and re-actuating the suture lock to retain the first sutures (paragraph 199, 263).
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.
Claims 1, 4, 5, 10, 21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S Patent Publication 2007/0118151 to Davidson in view of U.S. Patent Publication 2013/0096672 to Reich.
As to claim 1, Davidson discloses a method of repairing a heart valve in a beating heart of a patient (paragraph 19, 55, 154), comprising: intravascularly accessing an interior of the heart (figure 1, 2, paragraph 84, 86); inserting a first suture (180, figure 20-22) into a heart valve leaflet (6, figure 20-22, paragraph 110-112) of the heart; attaching the first suture to a suture anchor (150, figure 20-22, paragraph 111-114) exterior to the heart (paragraph 112, 97, 102, 103, 10, the permanent attached suture will be attached to the anchor exterior to the heart); advancing the suture anchor into the heart and anchoring the suture anchor into a heart wall of the heart with an anchor delivery catheter (5, figure 20, paragraph 112); adjusting a tension of the first sutures to achieve proper heart valve function (paragraph 113); and using a suture lock (156) on the suture anchor to retain the first suture at the tension that achieves proper heart valve function (paragraph 114), but is silent about a tether extending from the suture anchor intravascularly to outside the heart and utilizing the tether to actuate the suture lock.
Reich teaches a similar method (tissue adjustment, abstract) having a tether (40, paragraph 216) extending from a suture anchor (150) intravascularly to outside the heart (figure 1,2), and the method step of actuating utilizing the tether to actuate a suture lock (56, paragraph 243) to retain a first suture (74a,b) at the suture anchor at a tension (paraphrase 243, 248, 251) for the purpose of allowing the tension to be adjusted (paragraph 154,155). The manipulator 32 uses the tether 40 to be able to advance towards the suture anchor/lock in order to engage the suture lock. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the tether and substitute the suture lock of Reich in the method Davidson in order for providing an alternative mechanism for allowing the user to lock allowing the tension to be adjusted.
As to claim 4, with the method of Davidson and Reich, Davidson discloses delivering the suture lock to the suture anchor in the heart (figure 20).
As to claim 5, with the method of Davidson and Reich, Davidson discloses the first suture is inserted into the heart valve leaflet before the suture anchor is anchored into the heart wall (paragraph 110-113).
As to claim 10, with the method of Davidson and Reich, Davidson further teaches unlocking the first suture on the suture anchor, readjusting the tension of the first suture and re-actuating the suture lock to retain the first sutures at the adjusted tension (paragraph 18, 255, 256).
As to claim 21, with the method of Davidson and Reich above, Davidson discloses inserting a second suture (“multiple sutures”, paragraph 112) in the valve leaflet, attaching the second suture to the suture anchor, adjusting a tension of the second suture to achieve proper heart valve function and actuating the suture lock to retain the second suture at the suture anchor at the tension that achieves proper heart valve function (paragraph 112-114).
Claim 5 is rejected under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2018/0185153 to Bishop.
As to claim 5, Bishop discloses the method above but is silent about discloses the first suture is inserted into the heart valve leaflet before the suture anchor is anchored into the heart wall in the embodiments of figures 17-22; or figures 35k-m. However Bishop does disclose first suture is inserted into the heart valve leaflet before the suture anchor is anchored into the heart wall in paragraph 310 and embodiment similar to figures 35k-m. The order of inserting the first suture or the suture anchor first can either be the first suture first or the suture anchor first. In the embodiment of figures 35k-m, the order would not matter since after both are inserted, tension can then be adjusted. Having the first suture be inserted prior to the suture anchor in the embodiment of figures 35k-m will still allow the device to perform the function of repairing a heart valve. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the first suture inserted prior the suture anchor of the embodiment of figure 35k-m of Bishop in order for selecting the order of steps from a known possibility which will allow the heart valve to be repaired.
Claim 21 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2018/0185153 to Bishop in view of U.S Patent Publication 2007/0118151 to Davidson.
As to claim 21, Bishop discloses the method above including inserting a second suture (“or more sutures”, paragraph 148; “sutures”, paragraph 210; “or more sutures”, paragraph 258, “additional sutures” paragraph 322) in the valve leaflet, attaching the second suture to the suture anchor, adjusting a tension of the second suture to achieve proper heart valve function and actuating the suture lock to retain the second suture at the suture anchor at the tension that achieves proper heart valve function (paragraph 148, 210, 258, 322, 323).
If, however, it would not be known that Bishop would read or render obvious the second suture, Davidson teaches a similar method (surgical heart valve repair, abstract) including inserting a second suture (“multiple sutures”, paragraph 112) in the valve leaflet, attaching the second suture to the suture anchor, adjusting a tension of the second suture to achieve proper heart valve function and actuating the suture lock to retain the second suture at the suture anchor at the tension that achieves proper heart valve function (paragraph112-114) for the purpose of achieving the desired clinical effect depending on the anatomic situation. It would have been obvious to use a second suture as taught by Davidson in the method of Bishop in order for achieving the desired clinical effect depending on the anatomic situation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Publication 2011/0011917 to Loulmet (as cited in the IDS filed 01/23/2023), U.S. Patent Publication 2010/0161041 to Maisano (as cited reference H in the 892 filed 09/21/2022) both disclose similar devices and methods capable of rendering obvious and/or providing evidence on the claims of record specifically the tether.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771