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 Amendment
This action is entered in response to Applicant's amendment and reply of 12/5/25. The claims 30-35, 37, and 38 are pending. The claims 30, 31, 33, 34, and 35 are amended. Claim 22-29, and 36 has been cancelled. Claims 37 and 38 are new.
Response to Arguments
Applicant’s arguments with respect to the objection to the drawings has been considered but is not persuasive. Applicant states the specification describes the closure device “may be delivered initially as two physically separate pads 1502A, 1502B that may be drawn together via one of the earlier described devices or techniques, and locked, prior to final release”. Thus, the other embodiments are satisfactory for the embodiment claimed. Examiner disagrees, as stated in the MPEP 608.02(d) section 6.36 “The drawings must show every feature of the invention specified in the claims”. However, the amendment overcomes the objection.
Applicant’s amendment has overcome the 35 U.S.C. 112(b) rejection.
Applicant’s arguments, filed 12/5/25 with respect to the rejections of claims 22-24, 28-33, 35, and 36 under 35 U.S.C. 102(a)(1) as being anticipated by Keidar (US2017/0304050) have been fully considered and the amendment overcomes the previous rejection. However, upon further consideration, a new grounds of rejection has been made under a different interpretation of Keidar (US2017/0304050).
Claim Objections
Claim 30 is objected to because of the following informalities:
Claim 30 recites “the first side of the first leaflet opposite” should be changed to read “the first side of the first leaflet”.
Appropriate correction is required.
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 of this title, 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 30-33, 35, 37, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Keidar (US2017/0304050).
Regarding claim 30, Keider discloses a method comprising:
delivering a catheter (needle 501, where the needle is interpreted as a catheter by being a hollow tube navigated to the heart valve, [0058]) through the vasculature of a patient to a site of a native heart valve adjacent a first side of a first leaflet ([0074]);
puncturing through the first side of the first leaflet ([0074]),
advancing the catheter through the first leaflet and a second leaflet such that a portion of the catheter is on the second side of the second leaflet ([0074]);
deploying a first pad (1702) of a closure device (1701/1702/1710) on the second side of the second leaflet (see annotated Fig. 18, [0074]);
retracting the catheter through the second leaflet ([0074]), a second pad (1701) of the closure device is on one side of the first leaflet ([0074]); and
wherein the first pad and the second pad are coupled together to hold the first leaflet and the second leaflet together ([0074]).
Keidar does not explicitly disclose puncturing through the first side of the first leaflet, through a second side of the first leaflet, across a gap between the first leaflet and a second leaflet, through a first side of the second leaflet facing the second side of the first leaflet, and through a second side of the second leaflet opposite the first side of the second leaflet; retracting the catheter through the second leaflet, across the gap between the first leaflet and the second leaflet, and through the first leaflet such that a second pad of the closure device is on the first side of the first leaflet opposite, deploying the second pad on the first side of the first leaflet. Keidar according to the embodiment of Fig. 20-23 teaches a needle (catheter) is advanced through the wall of the heart 2303 and then through a leaflet 2302 ([0084]). Where the wall of the heart (interpreted as the first leaflet) has a first side and a second side and the leaflet (interpreted as the second leaflet) has a first side and a second side and there is a gap between the heart structures (see annotated Fig. 23). After piercing, the needle is retracted and the chord 2301 is secured to the leaflet 2302 and a second end is anchored outside the ventricular wall 2303 (see Fig. 23, [0084]). Where the anchors can be a pledget and are shown on the first side of the ventricular wall and second side of the leaflet ([0084]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the method of anchoring the ventricular wall and the leaflet as in the embodiment of Fig. 23 for the method of anchoring two leaflets together as in the embodiment of Fig. 18, since the substitution would have the same predictable result of anchoring structures of the heart to restore proper function of the heart valve, while also providing the added benefit of a single movement through the leaflets.
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Regarding claim 31, Keidar makes obvious method of claim 30, wherein the first pad and the second pad are coupled together via a tether (chord 2301, [0084]), extending from the second pad, through the second leaflet, across the gap between the first leaflet and the second leaflet, through the first leaflet, and to the first pad (where the chord as shown in annotated Fig. 23 would extend across the first and second leaflet and through the gap in the manner as claimed).
Regarding claim 32, Keidar makes obvious the method of claim 31, further comprising: releasing the closure device from the catheter; and withdrawing the catheter from the vasculature of the patient ([0074], [0084]).
Regarding claim 33, Keidar makes obvious the method of claim 32, wherein the native heart valve is a mitral valve, the first leaflet is an anterior leaflet, the second leaflet is a posterior leaflet, the first side of the first leaflet is an anterior side of the first leaflet, the second side of the first leaflet is a posterior side of the first leaflet, the first side of the second leaflet is an anterior side of the second leaflet, and the second side of the second leaflet is a posterior side of the second leaflet (see annotated Fig. 18 from the rejection of claim 30).
Regarding claim 35, Keidar makes obvious a closure device for clamping leaflets of a native heart valve comprising: a first pad (1701) configured to be deployed on a first side of a first leaflet opposite a second leaflet (see annotated Fig. 18 from the rejection of claim 30); a second pad (1702) (see annotated Fig. 18 from the rejection of claim 30); and a tether (line 1710) coupling the first pad and the second pad ([0074]), the tether configured to extend through the first leaflet and the second leaflet (see Fig. 18).
Keidar does not explicitly disclose the second pad configured to be deployed on a second side of the second leaflet opposite the first leaflet, the tether configured to extend from the first pad, through the first leaflet, across a gap between the first leaflet and the second leaflet, and through the second leaflet to the second pad. Keidar according to the embodiment of Fig. 20-23 teaches a needle is advanced through the wall of the heart 2303 and then through a leaflet 2302 ([0084]). Where the wall of the heart (interpreted as the first leaflet) has a first side and a second side and the leaflet (interpreted as the second leaflet) has a first side and a second side and there is a gap between the heart structures (see annotated Fig. 23 from the rejection of claim 30). After piercing the chord 2301 is secured to the leaflet 2302 and a second end is anchored outside the ventricular wall 2303 (see Fig. 23, [0084]). Where the anchors can be a pledget and are shown on the first side of the ventricular wall and second side of the leaflet (see annotated Fig. 23 from the rejection of claim 30, [0084]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the method of anchoring the ventricular wall and the leaflet as in the embodiment of Fig. 23 for the method of anchoring two leaflets together as in the embodiment of Fig. 18, since the substitution would have the same predictable result of anchoring structures of the heart to restore proper function of the heart valve, while also providing the added benefit of a single movement through the leaflets.
Regarding claim 37, Keidar makes obvious the method of claim 30, wherein delivering the catheter through the vasculature of a patient to the site of the native heart valve comprises delivering the catheter to a native mitral valve of the patient ([0074], [0082]).
Regarding claim 38, Keidar makes obvious the method of claim 37, wherein delivering the catheter to the native mitral valve comprises a transseptal approach to the native mitral valve ([0082]).
Claims 34 is rejected under 35 U.S.C. 103 as being unpatentable over Keidar (US2017/0304050) in view of Weber (WO2012/040865).
Regarding claim 34, Keidar discloses the method of claim 37; yet, is does not explicitly disclose wherein delivering the catheter to the site of the mitral valve comprises delivering the catheter through an aorta of the patient and into a left ventricle of the patient. Weber teaches methods for treating valve insufficiency in the heart by repairing the chordae tendineae (see Page 1, lines 6-10). Where a catheter is delivered to the heart by the retrograde approach via the aorta, aortic valve and left ventricle to deliver a treatment device (Page 3, lines 15-21). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the catheter accessing the mitral valve by the retrograde approach (via the aorta to the left ventricle) of Weber for the method of access of the catheter of Keidar, since the substitution would have yielded the same predictable result of having a catheter access the left ventricle for treatment of a deficient mitral valve.
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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached on (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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