4DETAILED 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 Arguments
Applicant argues in the response filed 06/15/2026 that the claim amendments and new claims are supported by paragraph 46. The examiner agrees the amendments to claim 1 are supported by the elected species figure 7a-c, paragraph 46 but not the new claims 25, 26. Paragraph 46 only states that the tether extends from the anchor body, is used to advance a suture cover, and can be severed and withdrawn. The paragraph 46 does not support the tether extends into the anchor body and/or the suture anchor is rotated with the tether. The examiner suggests a new application to be filed with respect to the other species embodiments.
With respect to the prior art Bishop rejections, the applicant argues Bishop doesn’t disclose the first suture and the tether. However, there isn’t any limitations with respect to the differences between the first suture and the tether. Therefore, the different portions as highlighted in the annotated figure can still read on the first suture and the tether. The applicant further argues Bishop does not disclose the suture anchor is actuated by rotating the suture lock. A new rejection with alternative interpretations and further prior art teachings have been made below with respect to Bishop in view of Johnson/Zollinger.
With respect to the prior art to Davidson in view of Reich rejections, the applicant argues Davidson and Reich does not read on actuating the suture lock includes rotating the suture lock. It is to be noted the specific structure of the suture lock which is rotated, what axis the suture lock is rotated, and/or how the suture lock is rotated, is not further claimed. Reich does teach mechanisms that is associated with a suture lock which is rotated. Therefore Reich can teach actuating the suture lock by rotating the suture. Alternatively, a new rejection with alternative interpretations and further prior art teachings have been made below with respect to Davidson in view of Reich and Zollinger, where prior art Zollinger can further teach a rotating suture lock.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 25, 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 25 is directed to the tether is extends into and is connected to the suture anchor within the anchor body of the suture anchor. However, the elected species figure 7a-d, paragraph 46 only supports that the tether is left extending from the anchor body, a suture cover is advanced over of the tether, and the tether is severed and withdrawn. The elected species as supported by the specification as originally filed does not state that the tether extends into the suture anchor and it would not be inherent. There can be other mechanisms of how the tether extends from the anchor, such as wrapping around the external proximal surface of the anchor. Since the elected species does not support how the tether is connected to the anchor body, the limitation is considered new matter.
Claim 26 is directed to the suture anchor is anchored into the heart wall by rotating the suture anchor with the tether. However, the elected species figure 7a-d, paragraph 46 only supports that the tether is left extending from the anchor body, a suture cover is advanced over of the tether, and the tether is severed and withdrawn. The elected species as supported by the specification as originally filed does not state the tether aspects when the suture anchor is inserted into the heart wall. It would be unclear the specific positioning and/or function of the tether when the suture anchor is inserted by the elected species. Therefore, the limitation is considered new matter.
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, 24, 25 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2018/0185153 to Bishop in view of U.S. Patent Publication 2004/0024451 to Johnson or U.S. Patent Publication 2007/0213582 to Zollinger.
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) the suture anchor including an anchor body (73, figure 25; or 154, figure 35k ) with an anchor coil (coil of 32, figure 17, 25 ;or 110, figure 35k) extending distally therefrom; advancing the suture anchor into the heart and anchoring the anchor coil of 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 actuating a suture lock (62; “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. However, Bishop is silent about actuating the suture lock includes rotating the suture lock to clamp the suture in the anchor body of the suture anchor in either of the two embodiments.
Bishop discloses in another embodiment where a suture lock is actuated by rotating the suture lock (paragraph 325). Johnson teaches a similar device in a method (tension locking, abstract) comprising a suture lock actuated by rotating the suture lock (paragraph 53, 62, 87, figure 15-17). Zollinger teaches a similar device in a method (tension locking, abstract) comprising a lock which is actuated by rotating the suture lock (abstract). It is known that a suture lock can be actuated by rotating the suture lock in order to lock the suture lock. It would have been obvious to one of ordinary skill in the art before the effective filing date to actuate the suture lock in the embodiments of figure 17-22 or 35k-m of Bishop includes rotating the suture lock to clamp the suture in the anchor body of the suture anchor in order to be able to actuate the suture lock.
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As to claim 4, with the method of Bishop and Johnson/Zollinger above, Bishop discloses delivering the suture lock to the suture anchor in the heart (paragraph 149 or 287).
As to claim 5, with the method of Bishop and Johnson/Zollinger above, 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.
As to claim 10, with the method of Bishop and Johnson/Zollinger above, 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).
AS to claim 24, with the method of Bishop and Johnson/Zollinger above, Bishop discloses cutting the tether adjacent the suture anchor and withdrawing the tether from the heat (paragraph 10, 126, figure 35n). If it wouldn’t be known that Bishop would disclose cutting the tether adjacent the anchor and withdrawing the tether form the heart, it would have been obvious in order leaving the system in place to function as a chordae.
As to claim 25, with the method of Bishop and Johnson/Zollinger above, Bishop discloses the tether extends into and is connected to the suture anchor within the anchor body of the suture anchor (figure 17, 35k).
Claims 1, 4, 5, 10, 21, 25, 26 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2007/0118151 to Davidson, U.S. Patent Publication 2013/0096672 to Reich and U.S. Patent Publication 2007/0213582 to Zollinger.
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), the suture anchor including an anchor coil (figure 20-22); advancing the suture anchor into the heart and anchoring the anchor coil of 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 actuating 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 the suture anchor including an anchor body, a tether extending from the suture anchor intravascularly to outside the heart, and actuating the suture lock includes rotating the suture lock to clamp the suture in the anchor body of the suture anchor.
Reich teaches a similar method (tissue adjustment, abstract) having a suture anchor (350) with an anchor body (322, 56a,b,c, figure 14-15) and an anchor coil (50) extending distally thereof, a tether (40b) extending from the suture anchor intravascularly to outside the heart (paragraph 257, 263, figure 1, 2, 14, 15) for the purpose of having docking stations on the anchor to attach multiple sutures. Davidson does disclose the use of multiple sutures (paragraph 112). It would have been obvious to one of ordinary skill in the art before the effective filing date to use the anchor of Reich in the method of Davidson, where the suture anchor has an anchor body and a tether extending therefrom in order for having docking stations on the anchor to attach multiple sutures.
Zollinger teaches a similar device in a method (tension locking, abstract) comprising a lock which is actuated by rotating the suture lock (abstract). Reich also teaches a suture locking mechanism can have a rotatable structure that is rotated to actuated a suture lock (paragraph 58, 61, 78, figure 6, 7). It is known that a suture lock can be actuated by rotating the suture lock in order to lock the suture lock. It would have been obvious to one of ordinary skill in the art before the effective filing date to actuate the suture lock includes rotating the suture lock to clamp the suture in the anchor body of the suture anchor in order to be able to actuate the suture lock.
As to claim 4, with the method of Davidson, Reich, and Zollinger above, Davidson discloses delivering the suture lock to the suture anchor in the heart (figure 20).
As to claim 5, with the method of Davidson, Reich, and Zollinger above, 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, Reich, and Zollinger above, 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, Reich, and Zollinger 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).
As to claim 25, with the method of Davidson, Reich, and Zollinger above, Reich further teaches the tether extends into and is connected with the suture anchor within the anchor body of the suture anchor (figure 14).
As to claim 26, with the method of Davidson, Reich, and Zollinger above, Reich further teaches the suture anchor is anchored into the heart wall by rotating the suture anchor with the tether (paragraph 218). The anchor is rotated and anchored into the heart with the tether extending from the suture anchor.
Claim 21, 26 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2018/0185153 to Bishop in view of U.S. Patent Publication 2004/0024451 to Johnson or U.S. Patent Publication 2007/0213582 to Zollinger as applied to claims 1, 4, 5, 10, 24, 25 above, and further in view of U.S Patent Publication 2007/0118151 to Davidson.
As to claim 21, Bishop as modified by Johnson/Zollinger 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 (paragraph 112-114) 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 and Johnson/Zollinger in order for achieving the desired clinical effect depending on the anatomic situation.
As to claim 26, with the method of Bishop, Johnson/Zollinger, and Davidson above, Bishop discloses the suture anchor is anchored into the heart wall by rotating the suture anchor with the tether (figure 17, 35k). The anchor is rotated and anchored into the heart with the tether extending from the suture anchor.
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 ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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