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 .
Election/Restrictions
Claim 6-9 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/01/2025.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites “the leaflet body” but should recite “the leaflet bodies.”
Appropriate correction is required.
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) 1-3 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levi (US 20190046314 A1).
Regarding claim 1, Levi teaches a heart valve assembly (abstract), comprising a skirt body portion (element 38, fig 1) which is of a tubular structure (see fig 1), at least two leaflet bodies disposed on the inner wall of the skirt body portion (element 22, fig 1), and a plurality of integrated anchoring rings arranged on the exterior of the skirt body portion (element 44, fig 1, [0081]); one end of the integrated anchoring ring being fixedly arranged on the exterior of the skirt body portion (see fig 1, one side of loop is secured to skirt), and the other end of the integrated anchoring ring being a free end (see fig 1, one side of loop is extending free); and the skirt body portion, the leaflet bodies and the integrated anchoring rings forming an integral valve structure (figure 1).
Regarding claim 2, Levi further teaches wherein one end of the integrated anchoring ring is arranged at an edge of the skirt body portion (see loops at bottom edge in figure 1), or arranged at a random position on the exterior of the skirt body portion in the width direction thereof (see loops are in a width direction), or arranged in an interweaving region between the skirt body portion and one of the leaflet bodies (see fig 1, weft yarn is interwoven region, loops are between leaflets and bottom of skirt body portion).
Regarding claim 3, Levi further teaches wherein the skirt body portion, the integrated anchoring ring and the leaflet body are made of the same or different materials (the components are inherently made up of materials), which is a biocompatible polymer ([0081] and [0067]); preferably, the biocompatible polymer is one or more selected from ultrahigh molecular weight polyethylene, polyethylene terephthalate, polyether ether ketone, thermoplastic polyurethane elastomer rubber, polyglycolic acid, polylactic acid-glycolic acid copolymer, polylactic acid, poly-L-lactide, polydioxanone, polyhydroxyalkanoate, and poly-glycerol-sebacate polyurethane ([0081]); and more preferably, the skirt body portion, the integrated anchoring ring and the leaflet body are all made of ultrahigh molecular weight polyethylene ([0081]).
Regarding claim 10, Levi further teaches a stent mounted on the heart valve assembly (element 12, fig 1).
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) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi (US 20190046314 A1) in further view of Braido (US 20150209141 A1).
Regarding claim 4, Levi further teaches wherein the integrated anchoring ring has a length of 2 mm to 50 mm ([0113]). Levi does not specifically teach the length of the skirt. Braido teaches a heart valve (abstract) wherein a distance between the upper and lower sides of the skirt body portion is 1 mm to 50 mm ([0112]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Levi by applying the skirt length, as taught by Braido, in order to combine prior art elements according to known methods to yield predictable results of a reasonably sized skirt that will adequately fit and function within the human anatomy of a heart; (MPEP 2143).
Regarding claim 5, Levi does not specifically teach an auxiliary valve sealing ring. Braido teaches a heart valve (abstract) further comprising an auxiliary valve sealing ring (see additional ring 350a in fig 3b), wherein the skirt body portion, the leaflet bodies, the integrated anchoring rings and the auxiliary valve sealing ring form an integral valve structure (the combination would form an integral valve structure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Levi by applying the sealing ring, as taught by Braido, in order to combine prior art elements according to known methods to yield predictable results of a further sealing irregularities between the valve and human anatomy; (MPEP 2143).
Conclusion
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/H.L.P./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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