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 6/22/2026 have been fully considered but they are not persuasive. Applicant argues that the cited references fail to disclose the new requirement that the seal extends from the outer portion of the expandable member, and the blood inflow terminal end and along an inner surface of the expandable member, but the new claim requirements are disclosed by Bonyuet. It is noted that the particular manner in which the structure is achieved is not pertinent to the claimed structure, and a “continuous wrap around seal path” is not recited in the claims.
Bonyuet discloses that a seal may be mounted to a frame in a manner in which a terminal end of the expandable tubular member is encapsulated by the seal in order to prevent paravalvular leakage (col 6, lines 5-30). As shown in Figures 5A-C, the terminal end of the frame (52) is encapsulated by an inner layer (84), intermediate layer (56) and outer layer (86) that are fused together (col 6, lines 5-30; col 8, lines 30-40 and 55-60) or applied by electrospinning (col 8, lines 51-54).
Bonyuet teaches that the seal aids in mounting the valve leaflets to the frame, so it would have been further obvious to configure the seal such that it extends along the inner surface between the expandable tubular member and the leaflets.
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) 1-3, 8-13 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 8,945,209 (Bonyuet et al.), and further in view of USPAP 2014/0188221 (Chung et al.).
Regarding claim 1 and 11: Bonyuet discloses a seal for a prosthetic valve, having an expandable tubular member (stent frame 12), a plurality of leaflets (76) secured together along side edges (tabs 102) by sutures (106) at commissures 58 and the leaflets having a bottom edge secured adjacent to an inflow end of the expandable tubular member (52) (see suture line 108 in Figure 2; col 8, lines 52-65). The valve further comprises a tubular seal comprising a polymeric web (layers 84 and 86 formed of woven polyester or PTFE yarns meets the limitation “web”; col 6, lines 37-50), wherein the inflow portion of the seal has a woven fabric (skirt 56 formed of fabric such as Dacron) encapsulated by the polymer layers (col 6, lines 3-16; col 7, lines 30-50). The woven fabric (56) has a non-linear edge (the outflow end of the woven fabric skirt 56 has an undulating pattern) defining an interface between an inflow end region (having the woven fabric) and an outflow end region (does not contain woven fabric 56).
Bonyuet discloses the seal may be mounted to a frame in a manner in which a terminal end of the expandable tubular member is encapsulated by the seal in order to prevent paravalvular leakage (col 6, lines 5-30). As shown in Figures 5A-C, the terminal end of the frame (52) is encapsulated by an inner layer (84), intermediate layer (56) and outer layer (86) that are fused together (col 6, lines 5-30; col 8, lines 30-40 and 55-60) or applied by electrospinning (col 8, lines 51-54). Therefore, this meets the requirement that the seal extends from the outer portion of the expandable tubular member, around the blood inflow terminal end of the expandable tubular member, and along an inner surface of the expandable tubular member. Bonyuet describes the leaflets (76) attached to the seal after it is applied to the frame (52) (see col 8, line 42 of Bonyuet), so it is understood that the inner layer of the seal is positioned between the expandable tubular member and the leaflets. Additionally, the bottom edges (88) of the leaflets are secured to the web at suture line (108) (see Figure 2; col 8, lines 52-66).
Bonyuet fails to disclose a radiopaque marker, but Chung teaches that it is beneficial to include a radiopaque marker (73) on a prosthetic valve in order to aid in proper placement with the patient’s body (Fig. 2A; [0087]; [0158]). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to include a radiopaque marker on the Bonyuet prosthesis, as taught by Chung, in order to aid in visualization and proper placement of the device within the patient’s body.
Regarding claims 2, 3, 12 and 13, Bonyuet discloses the polymeric web may comprise an elastomeric material such as ePTFE, silicones, polyurethane, etc. (col 6, lines 37-53), the woven fabric is Dacron, which is known to be inelastic (skirt 56 formed of fabric such as Dacron), and the woven fabric (56) is encapsulated between the inner and outer layers (84 and 86) forming the polymeric web (col 6, lines 3-16; col 7, lines 30-50).
In regards to claims 8 and 18, the non-linear edge of the woven fabric (skirt 56) taught by Bonyuet can be described as sinusoidal, as it has an undulating pattern.
In regards to claims 9 and 19, one of ordinary skill in the art would ascertain that the outflow end of the seal disclosed by Bonyuet due to presence of the fabric skirt (56) at the inflow end.
Regarding claims 10 and 20, Bonyuet also discloses the outflow end comprises a plurality of grommets (see 58 in Figure 4).
Claim(s) 4-7 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bonyuet et al. and Chung, as applied to claim 3 above, and further in view of USPAP 2012/0277850 (Bertini).
Bonyuet fails to disclose the woven fabric (56) comprises fibers oriented in warp and weft directions that are angled with respect to the central axis of the seal. Bertini teaches a similar invention comprising an implantable graft 220 (Fig. 6) having a woven fabric ([0018] discloses a woven polypropylene graft) comprising fibers in a warp direction and fibers in a waft direction ([0018] discloses warp yarn 202 and weft yarns 204), wherein the fibers in both the warp direction and the waft direction are angled with respect to a central axis of the tubular graft ([0010 and 0018] disclose the yarns are not disposed parallel or perpendicular to the longitudinal axis but are disposed at an angle). In regards to claims 5 and 6, Bertini teaches the fibers in both the warp direction and the waft direction are arranged within the tubular member to form an angle of about 45 degrees with respect to the central axis of the tubular graft ([0010] discloses the angle is approximately 45 degrees), which meets the requirement of the fibers angled between 5 degrees and 70 degrees with respect to the central axis of the tubular graft. Bertini teaches that by orienting the fibers at an angle relative to the central axis of the prosthesis, the prosthesis exhibits enhanced flexibility, smaller packing profile and greater resistance to internal radial pressure. Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention was made to configure the woven fabric of the Bonyuet seal such that warp and weft fibers are angled about 45 degrees relative to the central axis of the tubular seal in order to achieve a predictable result of improving performance characteristics of the prosthesis (Bertini [0009]).
In regards to claims 7 and 17: The term “allow” is not considered to be a positive recitation of any particular features/characteristics, and therefore the prior art is not required to disclose these functions. The modified Bonyuet device having non-elastic fibers of the woven fabric arranged at an angle relative to the central axis, as taught by Bertini, provides the seal with the capability of stretching both axially and radially in response to sufficient forces applied to the seal in the corresponding directions.
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 SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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