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 with respect to claims 1-3, 5-15 have been considered but are moot in view of the new grounds for rejection.
New claims 21-26 are addressed below.
Allowable Subject Matter
Claims 12-13, 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to fairly teach or suggest a valve component/peripheral member which comprises a first and second layer contacting opposite leaflet surfaces and attached to the leaflet with suturing that extends through the leaflet and the first and second layers of the valve component/peripheral member, wherein loop portions are wrapped around the strut in opposite directions, are formed of second sutures inserted through openings defined in the woven fabric valve component, or are arranged in pairs with a strut located therebetween.
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 1-3, 5, 7-11, 14, 21-22, 24-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benichou (Pub. No.: US 2009/0157175).
Benichou discloses a prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration (para. 4), the prosthetic valve comprising:
an annular frame 104 including a plurality of angled strut members 206 (e.g., fig. 5);
a plurality of leaflets 106 disposed within the frame and secured to the frame (e.g., fig. 1);
a valve component 304 sutured to a leaflet of the plurality of leaflets and extending along an edge portion of the leaflet adjacent at least one strut member of the plurality of strut members (e.g., fig. 5-7), wherein the valve component comprises a first layer 304 contacting a first surface of the leaflet (fig. 6) and a second layer 304 contacting a second surface of the leaflet opposite the first surface (fig. 6), wherein the first and the second layers of the valve component are secured to the leaflet via suturing comprising stitches 330 that extend through the leaflet and the first and the second layers of the valve component (fig. 6-8) and
a suture 320, 316 threaded around portions of the valve component and extending generally in a direction along a longitudinal axis of the at least one strut member to secure the valve component and the leaflet to the at least one strut member (fig. 1, 5-6).
For claim 2, Benichou discloses the prosthetic valve of claim 1, wherein the valve component 304 is disposed between the leaflet 106 and the at least one strut member 206 (fig. 6).
For claim 3, Benichou discloses the prosthetic valve of claim 1, wherein the valve component 304 is tied to the at least one strut member 206 by the suture 320.
For claim 5, Benichou discloses the prosthetic valve of claim 1, wherein the valve component 304 is in contact with the at least one strut member 206 (fig. 6).
For claim 7, Benichou discloses the prosthetic valve of claim 1, wherein the valve component 304 is laced to the at least one strut member 206 with the suture 320, 316.
For claim 8, Benichou discloses the prosthetic valve of claim 1, wherein the suture 320 forms a series of loops around portions of the valve component in the direction along the axis of the at least one strut member (fig. 1, 6, 7, noting that stitching inherently forms a series of loops, and that stitching 320 is parallel to stitching 330, seen in figure 7).
For claim 9, Benichou discloses the prosthetic valve of claim 1, wherein the suture is radially outward of the at least one strut member (e.g., fig. 6).
For claim 10, Benichou discloses the prosthetic valve of claim 1, wherein the valve component 304 comprises a woven fabric (para. 52).
For claim 11, Benichou discloses the prosthetic valve of claim 10, wherein the woven fabric valve component comprises first and second longitudinal edge portions, and a plurality of loop portions are located on the first and second longitudinal edge portions (see fig. 1, free edges are stitched to the frame).
For claim 14, Benichou discloses the prosthetic valve of claim 11, wherein the loop portions are spaced apart from one another in the direction along the longitudinal axis of the at least one strut member (see fig. 1, 6, free edges are stitched to the frame)
For claim 21, Benichou discloses the prosthetic valve of claim 1, wherein the valve component comprises an elongate peripheral member that extends along the edge portion over a lower portion and opposing side portions of the leaflet (fig. 7, 8).
For claim 22, Benichou discloses a prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration (para. 4), the prosthetic valve comprising:
an annular frame 104 including a plurality of angled strut members 206 (e.g., fig. 5);
a plurality of leaflets 106 disposed within and secured to the frame (e.g., fig. 1), each leaflet having a main body comprising a lower portion and first and second side portions on opposing sides of the lower portion (fig. 7);
an elongate peripheral member 304 secured to a leaflet of the plurality of leaflets, wherein the elongate peripheral member extends along a peripheral edge portion of the lower portion and the first and the second side portions of the leaflet (fig. 7), the peripheral edge portion being adjacent at least one strut member 206 of the plurality of strut members (fig. 5-6), wherein the peripheral member 304 comprises a first layer 340 contacting a first surface of the leaflet (fig. 6) and a second layer 304 contacting a second surface of the leaflet opposite the first surface (fig. 6), wherein the first and the second layers of the peripheral member are secured to the leaflet via suturing comprising a plurality of stitches 330 that extend through the leaflet and the first and the second layers (fig. 6-8); and
a suture 320, 316 forming a series of loops around portions of the peripheral member (fig. 6), the series of loops extending in a direction along a longitudinal axis of the at least one strut member to secure the peripheral member and the leaflet to the at least one strut member (fig. 1, 6).
For claim 24, Benichou discloses the prosthetic valve of claim 22, wherein the plurality of stitches are a plurality of in-and-out stitches that extend through the leaflet and the first and the second layers (fig. 7).
For claim 25, Benichou discloses the prosthetic valve of claim 22, wherein the peripheral edge portion of the leaflet is sandwiched between the first and the second layers of the peripheral member (fig. 6, 8).
For 26, Benichou discloses the prosthetic valve of claim 22, wherein the peripheral member is a peripheral member assembly (fig. 7, para. 53) and the first layer and the second layer are separate pieces of material (para. 53).
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 6, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Benichou (Pub. No.: US 2009/0157175) in view of Grundeman et al. (Pub. No.: US 2017/0065408).
For claims 6 and 23, Benichou discloses the valve component/peripheral member is a polymeric material (para. 52), however, Benichou fails to specify the valve component/peripheral member comprises ultra-high molecular weight polyethylene (UHMWPE). Grundeman teaches providing leaflets and skirt of UHMWPE material as an obvious suitable material for prosthetic valve components (para. 55), therefore it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the Benichou heart valve with UHMWPE material as taught by Grudeman as an obvious selection of a known material suitable for use in a prosthetic valve as skirt material. This modification would have occurred using known methods and would have yielded predictable results to one of ordinary skill in the art at the time the invention was filed.
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.
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
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