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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/24/2025 has been entered.
Response to Arguments
In view of the amendments filed on 11/24/2025, the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ) first paragraph rejections, cited in the office action of 7/22/2025, are moot.
In view of the amendments filed on 11/24/2025, the nonstatutory double patenting rejections over U.S. Patent No. 11,622,852 are moot.
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.
Claim(s) 1, 2, and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braido et al. (Pub. No. US 2019/0247184; hereinafter “Braido”).
Braido discloses the following regarding claim 1: a replacement heart valve implant, comprising: a tubular anchor member (30) actuatable between a delivery configuration and a deployed configuration (para. 0055), the tubular anchor member including an inflow end (lower end), an outflow end (upper end), and a plurality of anchor member intersection points (connecting areas between cells of element 30), and defining a longitudinal axis (central longitudinal axis) extending from the inflow end of the tubular anchor member to the outflow end of the tubular anchor member (Figs. 15-16); a plurality of valve leaflets (70) fixed to the tubular anchor member (Figs. 15-16; para. 0056), each valve leaflet having a first surface (interior-facing surfaces of element 70) facing the tubular member and a second surface (exterior-facing surfaces of element 70) opposite the first surface (Figs. 15-16); and a seal member (80, 90) secured to the tubular anchor member at the inflow end of the tubular anchor member (Figs. 15-16); wherein each valve leaflet and the seal member extend upstream of the inflow end of the tubular anchor member (Figs. 15-16); wherein a portion of the second surface of each valve leaflet extends alongside and overlies a portion of the seal member at a position upstream of the inflow end of the tubular anchor member (Figs. 15-16).
Braido discloses the following regarding claim 2: the replacement heart valve implant of claim 1, wherein the portion of the second surface of each of the plurality of valve leaflets overlaps an inner-facing surface of the seal member at the position upstream of the inflow end of the tubular anchor member (Figs. 15-16).
Braido discloses the following regarding claim 4: the replacement heart valve implant of claim 1, further comprising: a plurality of lashings (interpreted as the bindings with the sutures) securing the seal member to the tubular anchor member at some of the anchor member intersection points (para. 0058).
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) 3, 5-12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Braido in view of Schraut et al. (Pub. No.: US 2014/0277417; hereinafter “Schraut”).
Regarding claims 3, 5, and 14, Braido discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the valve leaflet being secured directly to the seal member by a suture. Schraut teaches that it is well known that prosthetic heart valves comprise valve leaflets that are secured directly to a seal member by a suture, and that a plurality of stitches secure a plurality of valve leaflets to the seal member (paras. 0057-0061, 0074-0079, 0093), for the purpose of securely attaching the leaflets to the device while maintaining the desired flexibility and mechanical characteristics. Schraut further teaches that each of the plurality of valve leaflets can be directly attached to the seal member at multiple locations by a single suture element (as seen in Figure 4A, W2 attaches the valve leaflet to the seal member at multiple locations as described in para. 0061). It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the device of Braido to have the leaflets directly secured to the seal member by a suture, as taught by Schraut, in order to securely attach the leaflets to the device while maintaining the desired flexibility and mechanical characteristics. Such a modification would be made with a reasonable expectation of success.
Regarding claims 6-9, Braido discloses the limitations of the claimed invention, as described above. It further teaches a fabric strip element (260, 262) (para. 0058) that is attached to the rest of the seal member. However, it does not explicitly recite the seal member including a fabric strip fixedly attached to a polymeric seal element. Schraut teaches that it is well known that a prosthetic heart valves comprises a seal member (450) including a fabric strip fixedly attached to a polymeric seal element suture (paras. 0051, 0071), for the purpose of providing additional structural support to the seal member. Schraut further teaches that the fabric strip is at least partially embedded in the polymeric seal element (Fig. 6A); and a free end (Fig. 7F) of the fabric strip folds back on itself adjacent the inflow end of the tubular anchor member to form a radially inner layer and a radially outer layer, and the radially inner layer including the free end (Fig. 7F; para. 0079). It would have been obvious to one having ordinary skill in the art to modify the seal member of Braido to have the fabric strip and polymeric material, as taught by Schraut, in order to provide additional structural support to the seal member. Such a modification would be made with a reasonable expectation of success.
Braido teaches the following regarding claim 8: the replacement heart valve implant of claim 6, wherein the polymeric seal element is disposed radially outward of an outside surface of the tubular anchor member (Figs. 15-16).
Braido teaches the following regarding claim 9: the replacement heart valve implant of claim 6, wherein a free end (262) of the fabric strip (para. 0058) folds back on itself adjacent the inflow end of the tubular anchor member to form a radially inner layer and a radially outer layer (Figs. 15-16).
Braido teaches the following regarding claim 10: the replacement heart valve implant of claim 9, wherein a plurality of lashings (bindings formed by suture) secure the seal member to the tubular anchor member at some of the anchor member intersection points (para. 0058), each of the plurality of lashings including a securing element (suture) disposed between the radially inner layer and the radially outer layer (para. 0058).
Regarding claim 11, it is well-known in the art for a suture to be secured via a knot of the suture. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to tie a knot in the ends of the suture of Braido and Schraut when used as a securing element in order to prevent the elements being secured from becoming unsecured.
Regarding claim 12, Braido discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the securing element being an adhesive. Schraut teaches that it is well known that prosthetic heart valves comprise a plurality of lashings (S1 and S2) (Fig. 3C) to secure the seal member (300) to the tubular anchor member (102) at some of the anchor member intersection points, each of the plurality of lashings including an adhesive securing element disposed between the radially inner layer and the radially outer layer (para. 0056), for the purpose of securely attaching the components of the device together at the desired configuration. It would have been obvious to one having ordinary skill in the art to modify the securing element of Braido to be an adhesive, as taught by Schraut, in order to securely attach the components of the device together at the desired configuration. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case replacing one type of securing element for another, is generally considered to be within the level of ordinary skill in the art.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Braido in view of Schraut, further in view of Babrowicz (Pub. No.: US 2013/0074454 A1).
Braido, as modified by Schraut, teaches the limitations of the claimed invention, as described above. However, they do not specify that the securing element is a portion of the lashing melted to itself to form a co-mingled bead of material. In the similar art of securing medical elements, Babrowicz teaches sealing elements together via a melted bead formed by heating (para. 0053), for the purpose of securely attaching the components of the device together at the desired configuration. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to utilize the melt-bead sealing method as taught by Babrowicz as a suitable means for securing the elements of Braido and Schraut, in order to securely attach the components of the device together at the desired configuration. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case replacing one type of securing element for another, is generally considered to be within the level of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
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/ANN HU/Primary Examiner, Art Unit 3774