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 .
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.
Claim(s) 23, 26, 35-36, 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Carroll (2017/0273788A1) in view of Shaolian (2013/0226289A1).
In regard to claim 23, O’Carroll teaches an annuloplasty device comprising:
A first support ring 105 and a second support ring 106, said first and second support rings(105, 106) having a coiled configuration (fig 1a) in which the first and second support rings are arranged as a coil around a central axis (fig 1a) and wherein the first and second support rings 105, 106 are configured to be arranged on opposite sides of native heart valve leaflets of a heart valve [0001: position in the heart annulus]
wherein: the first support ring 105 is adapted to be arranged on an atrial side of said heart valve; [0001]
the second support ring 106 is adapted to be arranged on a ventricular side of the heart valve; [0001]
the first support ring 105 comprises a first posterior bow and the second support ring 106 comprises a second posterior bow (figure 5);
the first and second posterior bows are adapted to conform to a posterior aspect of said heart valve (fig 5);
the first support ring 105 and the second support ring 106 are formed from a material with circumferential walls 102 enclosing an interior channel 101
and wherein the material of the circumferential walls; (made of metal alloy [0034]; [0046] stainless steel, NiTinol)
the annuloplasty device further comprises a core 101 extending along the entire length of first support ring 105 and the second support ring 106 and the core 101 is a separate element from the interior channel (the channel is formed within 102, so 101 is a separate element) and is enclosed by the circumferential walls (enclosed by 102, fig 1b).
However, O’Carroll does not teach retention units as claimed.
Shaolin teaches the first support ring comprises first retention units 104;
the second support ring comprises second retention units 104;
the first and second retention units 104 extend from respective first and second support rings to produce a retention force, in use, at both of said opposite sides of said native heart valve leaflets [0054; will provide force an opposite sides when combined with the annuloplasty ring of O’Carroll]
the retention units 104 have an expanded position in which the retention units protrude from the outer surface of the first support ring and
the retention units 104 are integrated with the first support ring and the second support ring (integrated is interpreted as attached or linked; see fig 1B);
and wherein the retention units 104 are formed from the material of the circumferential walls [0060: Nitinol].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the retention units (including the openings through which the hooks fit) of Shaolin across both rings of annuloplasty device of O’Carroll in order to improve the implantation of the valve and decrease the need for suturing [0060].
In regard to claim 26, O’Carroll meets the claim limitations as discussed in the rejection of claim 25, and further teaches the circumferential walls 102 have a tubular shape enclosing said interior channel (fig 1B).
In regard to claim 35, O’Carroll meets the claim limitations as discussed in the rejection of claim 23, but does not teach the retention units.
Shaolin further teaches the retention units 104 comprise a shape-memory material [0060: Nitinol] and wherein activation of the shape-memory material causes the retention units to transfer from a retracted state to an expanded state. [0060: heat set to a deployed state, fig 1A-B]
In regard to claim 36, O’Carroll meets the claim limitations as discussed in the rejection of claim 23, and further teaches the first and second posterior bows are separated by an intermediate anterior portion (flat part of the D shape in figure 5) and the anterior portion comprises a smooth surface (at least a portion of the surface between the ridges is smooth, see fig 4).
In regard to claim 39, O’Carroll meets the claim limitations as discussed in the rejection of claim 23, and further teaches the first 105 and second support rings 106 have respective free ends (fig 1a);
wherein the free ends are displaced from each other with a peripheral off-set distance extending in a coil plane (fig 1a);
and wherein said coil plane is substantially parallel to an annular periphery of said coil and perpendicular to said central axis (coils are offset in the vertical direction from each other).
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Carroll (2017/0273788A1) in view of Shaolian (2013/0226289A1) and further in view of Roberts (2008/086203A1).
In regard to claims 27-28, O’Carroll meets the claim limitations as discussed in the rejection of claim 25, but does not teach the walls form an essentially rectangular shape.
Roberts teaches the circumferential walls comprise a plurality (defined as two or more) of sides forming a non-tubular shape enclosing said interior channel wherein the non- tubular shape is essentially rectangular (fig 3A).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the outer shape of Roberts in the outer ring of O’Carroll because the shape closely mimics the geometry of a mitral annulus [0022].
Response to Arguments
In regard to the drawing objections, the applicant’s arguments are found convincing and the rejection is withdrawn.
In regard to the 112a rejection of claims 32-34, cancellation of the claims renders the rejections moot.
In regard to the 112b rejection of claims 34, 38 and 42, cancellation of the claims renders the rejections moot.
In regard to the objection of claim 42, cancellation of the claim renders the rejection moot.
In regard to the 103(a) rejection of claims 23-26, 31 and 35-41 as unpatentable over Maimon (10039637B2) in view of Shaolian (2013/0226289A1), the applicant’s arguments have been fully considered but are moot in view of new grounds of rejection necessitated by the amendments.
In regard to the 103(a) rejection of claims 27-30 as unpatentable over Maimon (10039637B2) in view of Shaolian (2013/0226289A1) and further in view of Roberts (2008/0086203A1), the applicant’s arguments have been fully considered but are moot in view of new grounds of rejection necessitated by the amendments.
In regard to the 103(a) rejection of claims 40 and 42-43 as unpatentable over Maimon (10039637B2) in view of Starksen (20050055087A1), cancellation of the claims renders the rejections moot.
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 CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/ Primary Examiner, Art Unit 3774