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 Arguments
Applicant’s arguments filed 1/20/2026 have been fully considered but they are not persuasive.
Applicant has amended claim 23 to recite the suture contacts “and restrains” the valve leaflet and an adjacent leaflet during systole “to prevent the valve leaflet from prolapsing.” Applicant argues that Khairkhahan lacks a suture which contacts the valve leaflet and an adjacent leaflet as claimed.
In response, Examiner has reversed the order of the presented references, using Davidson as the base reference and incorporating Khairkhahan as the teaching reference. Davidson utilizes the suture to prevent leaflet prolapse, and thus includes a suture which contacts the leaflet and adjacent valve leaflet as claimed. The Davidson suture contacts and restrains the valve leaflet and an adjacent leaflet during systole
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 23, 25, 27-35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 has been amended to state “such that the suture contacts and restrains the valve leaflet and an adjacent leaflet during systole to prevent the valve leaflet from prolapsing.” This limitation is indefinite as it implies the suture restrains the adjacent leaflet. Applicant’s specification indicates the suture restrains one leaflet (e.g., para. 35, fig. 5A-B).
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.
Claims 23, 25, 27-35 are rejected under 35 U.S.C. 103 as being unpatentable over Davidson (Pub. No.: US 2007/0118151) in view of Khairkhahan et al. (Pub. No.: US 2012/0197388).
Davidson discloses a method of repairing a heart valve in a beating heart of a patient (e.g., para. 19), comprising:
intravascularly accessing an interior of a beating heart of a patient (e.g., fig. 20),
attaching a suture 180 to a valve leaflet of a mitral valve of the heart (e.g., fig. 20) at a location on an atrial side of the mitral valve (e.g., fig. 10) including inserting an atrial anchor attached to the suture on the atrial side of the mitral valve (not disclosed),
attaching a ventricular anchor 150 to the suture (e.g., para. 112-113);
inserting the ventricular anchor into heart tissue in a left ventricle of the heart (e.g., fig. 20) such that the suture extends from the [location] atrial anchor (not disclosed) on the atrial side of the mitral valve around the valve leaflet and through a coaptation zone of the mitral valve to the ventricular anchor (e.g., fig. 10),
adjusting a tension on the suture to promote coaptation of the valve leaflet such that the suture contacts and restrains the valve leaflet (e.g., fig. 10, 19) and an adjacent leaflet during systole to prevent the valve leaflet from prolapsing (e.g., abstract); and
securing the suture at the tension (e.g., para. 113).
As provided in italicized text above, Davidson lacks inserting an atrial anchor attached to the suture on the atrial side of the mitral valve in combination with a suture that extends from the atrial anchor around the valve leaflet and through a coaptation zone of the mitral valve. In the embodiments in which Davidson utilizes an atrial anchor, the leaflet is pierced and the suture extends through the leaflet to the papillary muscle, thus bypassing the coaptation zone (see fig. 53-56). In figure 10, Davidson’s suture extends into the coaptation zone, however, there is no atrial anchor as claimed.
Khairkhahan et al. (hereinafter, Khairkhahan teaches a method of repairing a heart valve (e.g., abstract) in a beating heart of a patient (e.g., para. 18), including attaching a suture 905 (e.g., para. 105) to a valve leaflet (not specifically disclosed) of a mitral valve of the heart at a location on an atrial side of the mitral valve (e.g., fig. 12A, 12B) including inserting an atrial anchor 906 attached to the suture 905 on the atrial side of the mitral valve (e.g., fig. 12A). Khairkhahan teaches extending the suture from the atrial anchor around the valve leaflet and through a coaptation zone of the mitral valve to the ventricular anchor (e.g., fig. 12A, 13A). It would have been obvious to have provided the Davidson method with an atrial anchor as taught by Khairkhahan and Davidson’s figures 53-56 embodiments as an obvious alternate means to anchor to a heart valve leaflet.
As provided in italicized text above, Khairkhahan does not specify attaching the suture to a valve leaflet of a mitral valve. Instead, Khairkhahan discloses the atrial anchor as attached “to or adjacent the annulus.” As the annulus is adjacent the leaflets, one of ordinary skill in the art would contemplate attaching the suture to a valve leaflet of the native valve. Davidson teaches artificial chordae anchored to the leaflet with various anchors (e.g., fig. 53-56), demonstrating that the leaflet surface is a suitable location for chordae anchoring.
For claim 25, Davidson discloses the method of claim 29, wherein inserting the ventricular anchor into heart tissue includes rotating the anchor to embed the anchor coil in the heart tissue (e.g., fig. 13).
For claim 27, Davidson discloses the method of claim 23, wherein adjusting a tension on the suture includes sliding the suture through the anchor head (e.g., fig. 24, para. 114).
For claim 28, Davidson discloses the method of claim 23, wherein inserting the ventricular anchor into heart tissue in the left ventricle of the heart includes inserting the ventricular anchor into a papillary muscle 2 in the left ventricle (e.g., fig. 21).
For claim 29, Davidson discloses the method of claim 23, wherein the anchor includes an anchor coil 152 and an anchor head 156 (e.g., fig. 24).
For claim 30, Davidson discloses the method of claim 29, wherein attaching the ventricular anchor to the suture includes attaching the suture to the anchor head (e.g., fig. 24).
For claim 31, Davidson discloses the method of claim 23, further comprising attaching a second suture to the valve leaflet of the mitral valve at a second location on the atrial side of the mitral valve (para. 112).
For claim 32, Davidson discloses the method of claim 31, further comprising connecting the suture and the second suture (para. 112, sutures are connected when a single fastener 150 is used).
For claim 33, Davidson discloses the method of claim 32, wherein the suture and the second suture are connected at a location on a ventricular side of the mitral valve (para. 112).
For claim 34, Davidson discloses the method of claim 35, wherein the atrial anchor comprises a plurality of barbs (e.g., fig. 56)
For claim 35, Davidson discloses the method of claim 23, wherein attaching the suture to the valve leaflet includes inserting an atrial anchor 2115 attached to the suture into the valve leaflet (e.g., fig. 75B).
Conclusion
THIS ACTION IS MADE FINAL. 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 SUBA GANESAN whose telephone number is (571)272-3243. The examiner can normally be reached Monday-Friday, 8 AM - 5 PM MT.
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
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