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 Amendment
The amendment filed April 30, 2026 has been entered. Applicant’s amendments to the Specification, specifically the Abstract of the Disclosure, has overcome each and every objection previously set forth in the Non-Final Office Action
mailed 03/25/2026.
Response to Arguments
Applicant's arguments filed 04/30/2026 have been fully considered but they are not persuasive.
Applicant’s argument on pages 6-7, regarding Levi 897’ [0053] was found to be persuasive. The ascertain of this passage was a typographical error.
However, applicant’s argument page 8, is found unpersuasive. They argued a “specific bulge mechanism” that is not claimed. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “specific dimensional relationship is what causes the outer sealing member to outwardly bulge when the frame transitions to the expanded configuration, because the frame shortens axially upon expansion, the outer sealing member (which was sized to match the longer compressed state length) has excess material that bulges outward”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, using broadest reasonable interpretation (BRI), “the first length” as recited is not specific enough that the prior art does not read on the claim. In claims 1 and 18, the claim language only confines the length to be between the proximal and distal ends of the claimed implantable prosthetic valve while in the compressed configuration; many lengths are confined between the proximal and distal ends of said prosthesis. Therefore, applicant is further implying a constraint onto the claimed limitation. In [0057] of Levi 387’: “Alternatively, the outer skirt 18 can be configured to form a snug fit with the frame 12 such that it lies against the outer surface of the frame 12 when the prosthetic valve 10 is in the radially expanded configuration”. If the skirt lies snuggly in the expanded configuration as recited, it would bulge outward matching the expansion, such as the instant case in the presented claim.
On page 7, applicant alleges the Office Action is using the relations of the loops that cover a dimension of the prosthesis in [0068] of Levi 314.’ However, Examiner was mapping Levi 314’ to illustrate the coverage of the skirt of the BRI of skirt coverage, for which the Levi 314’ still reads over the claimed invention.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, applicant’s argument pages 7-8 regarding teaching away alleged the “dimensional bulge mechanism” were found unpersuasive. Applicant argues that Levi ‘314 does not teach ‘This limitation requires that the outer sealing member's length matches the length of the first portion of the frame in the radially compressed configuration.” However, the claim is not constructed in this way. Claim 1 recites:
“wherein the outer sealing member has a length substantially identical to the first length of the first portion; and wherein the outer sealing member is configured to outwardly bulge when the annular frame is in the radially expanded configuration, thereby forming a seal against surrounding tissue when the prosthetic valve is implanted.”
Applicant uses qualifying language to define the claimed dimensional relationship of the invention in the instant application. Specifically, applicant uses the term ‘substantially identical to the first length of the first portion’. Therefore, applicant’ arguments do not fully consider the scope of the claim language originally submitted. While the MPEP allows applicant to use the word substantially in claim language ultimately finding the term definite, it is explicit regarding the broadest reasonable interpretation given to relative terms such as ‘substantially’. Please refer to MPEP 2173.05(b) for further guidance.
For at least these reasons, Examiner maintains ground of rejection filed 04/30/2026.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-8, 10, & 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi et al. US 20190053897 A1, herein referred to as Levi 1, in view of Levi et al US 20190046314 A1, herein referred to as Levi 2.
RE. Claim 1, Levi discloses an implantable prosthetic valve (Fig 2, prosthetic valve 10) comprising: a) an annular frame (Fig 2, bare frame 12) having an inner surface (Annotated Fig 2 below) and an outer surface (Annotated Fig 2 below), an wherein the annular frame is compressible and expandable between a radially compressed configuration ([0048]) and a radially expanded configuration ([0048]); and b) an outer sealing member (Fig 2, outer skirt 18) having a proximal end (Annotated Fig 2 below) and a distal end (Annotated Fig 2 below) and is mounted circumferentially around a first portion (Annotated Fig 2 below) of the outer surface of the annular frame (Annotated Fig 2 below), wherein the first portion of the outer surface has a proximal end (Annotated Fig 4 below) and a distal end (Annotated Fig 4 below), and wherein the first portion has a first length extending between the proximal end and the distal end in the radially compressed configuration of the annular frame (Fig 4, row III; [0054]) and a second length extending between the proximal end and the distal end in the radially expanded configuration of the annular frame (Fig 4, row IV; [0054]); and wherein the outer sealing member is configured to outwardly bulge when the annular frame is in the radially expanded configuration (, thereby forming a seal against surrounding tissue when the prosthetic valve is implanted ([0056], bulging then seals implant).
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But does not disclose an inflow end, and an outflow end; wherein the proximal end of the first portion is at the inflow end of the annular frame; wherein the outer sealing member has a length substantially identical to the first length of the first portion.
But Levi 2 discloses a similar implant heart valve. Levi 2 teaches inflow end (Fig 1, inflow 16 [0064]), and an outflow end (Fig 1, outflow 18 [0064]); wherein the proximal end of the first portion is at the inflow end of the annular frame (Fig 1 [0068]); wherein the outer sealing member (Fig 1, Skirt 30) has a length substantially identical to the first length of the first portion [0068]
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Levi 1 to incorporate an inflow end, and an outflow end; wherein the proximal end of the first portion is at the inflow end of the annular frame; wherein the outer sealing member has a length substantially identical to the first length of the first portion, as taught and suggested by Levi 2 in order to mimic a tricuspid arrangement similar to the aortic valve [0064].
RE. Claim 2, the combination of Levi 1 and 2 discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the outer surface (Levi 1 Annotated Fig 2 above) of the annular frame has a second portion that is free of the outer sealing member (Levi 1Annotated Fig 2 above) and wherein the second portion extends between the outflow end of the annular frame and the distal end of the first portion (Levi 1Annotated Fig 2 above).
RE. Claim 3, the combination of Levi 1 and 2 discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the outer sealing member (Levi 1 Fig 2, outer skirt 18 and Fig 5 inner skirt 12) comprises a mesh layer (Levi 1 [0015] Fig 5, layer 84, electrospun layer is equivalent to mesh) and a pile layer (Levi 1 Fig 5, reinforcing layer 88), wherein the pile layer comprises a plurality of pile yarns (Levi 1 [0063]) extending outwardly from at least a portion of an outer surface of the mesh layer (Levi 1 [0073]), wherein an inner surface of the mesh layer is substantially free of the pile yarns (Levi 1 [0061], window openings allow space of free yarns) and wherein at least a portion of the inner surface of the mesh layer is in substantial contact with at least a portion of the outer surface of the annular frame (Levi 1 [0061], window openings allow space of free yarns).
RE. Claim 4, the combination of Levi 1 and Levi 2 discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the mesh layer (Levi 1 Fig 5, layer 84) has a first height extending axially along the frame (Levi 1 [0079]), and the pile layer has a second height extending axially along the frame (Levi 1 [0079], wherein the first height is greater than the second height (Levi 1 [0079], Levi 1 teaches the first height may also be greater).
RE. Claim 5, the combination of Levi 1 and Levi 2 discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the mesh layer (Levi 1 [0015] Fig 5, layer 84) comprises a plurality of warp and weft yarns (Levi 1 Fig 1, multiple warp and weft visible on skirt) and comprises a plurality of wales extending axially across the length of the outer sealing layer and a plurality of courses extending circumferentially along a width of the outer sealing layer (Levi 1 Fig 1, extends entire surface), wherein the width of the outer layer is substantially identical to a circumference of the annular frame in the expanded configuration (Levi 1 [0058]).
RE. Claim 6, the combination of Levi 1 and Levi 2 discloses the invention substantially as claimed and as discussed above with respect to claim 5 teaches
wherein the mesh layer has a wales density from about 10 to about 50 wales per inch (Levi 2 [0060], Levi 2 teaches approximately 13.33 gsm derived from:
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Derived range is approximately 1.29-16.67 gsm, as calculated using denier yarn sizes cited paragraph 115 of the instant application) and/or a course density from about 25 to about 85 courses per inch.
RE. Claim 7, the combination of Levi 1 and Levi 2 discloses the invention substantially as claimed and as discussed above with respect to claim 5 teaches wherein the plurality of wales comprises a warp yarn (Levi 1 Fig 1), wherein the warp yarn is fully-drawn, or spin-drawn or low or not twisted (Levi 1 [0015]).
RE. Claim 8, the combination of Levi 1 and Levi 2 discloses the invention substantially as claimed and as discussed above with respect to claim 5 teaches wherein the warp yarn has a size from about 10 denier to about 40 denier and a filament count from about 6 to about 56 (Levi 2 [0119-0120] “1-200 denier” and “1-600 count” While Levi 2 does not teach the specific range, the claimed ranges are with the ranges taught by Levi) and/or wherein the warp yarn has a tenacity from about 30 to about 400 cN/tex.
RE. Claim 10, the combination of Levi 1 and Levi 2 discloses the invention substantially as claimed and as discussed above with respect to claim 5 teaches wherein the plurality of courses are formed with a weft yarn (Levi 1Fig 1), wherein the weft yarn is a monofilament yarn (Levi 1 [0072]).
RE. Claim 15, the combination of Levi 1 and Levi 2 discloses the invention substantially as claimed and as discussed above with respect to claim 7 teaches herein the warp yarn comprises a polyester (Levi 1 [0063]), co-polyester (Levi 2 [0133] nylon), polyamide (Levi 1 [0063]), polyolefin, polyaryletherketones, aromatic polymers (Levi 2 [0133], PET), polyurethane (Levi 1 [0098]), or any combination thereof (Levi 1 [0063]).
RE. Claim 16, the combination of Levi 1 and Levi 2 discloses the invention substantially as claimed and as discussed above with respect to claim 7 teaches herein the weft yarn comprises a polyester (Levi 1 [0063]), co-polyester (Levi 2 [0133]), polyamide (Levi 1 [0063]), polyolefin, polyaryletherketones, aromatic polymers (Levi 2 [0133], PET, polyurethane (Levi 1 [0098] polyurethane), or any combination thereof (Levi 1 [0063]).
RE. Claim 17, the combination of Levi 1 and Levi 2 discloses the invention substantially as claimed and as discussed above with respect to claim 3 teaches wherein the mesh layer comprises a knit or woven fabric (Levi 2 [0056] Fig 12, 16).
RE. Claim 18, Levi discloses wherein the knit fabric is crochet knit and/or warp-knit fabric (Levi 2 Fig 24, shows a v-stitch, a crochet knit).
Claim(s) 9, 11-14, & 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi 1 in view of Levi 2, and further in view of Van Hulle et al. US 20180202082 A1, herein referred to as Van Hulle.
RE. Claim 9, the combination of Levi 1 and Levi 2 discloses the invention substantially as claimed and as discussed above with respect to claim 5 teaches wherein the plurality of courses are formed with a weft yarn (Levi 1 Fig 1).
But does not explicitly disclose wherein the weft yarn comprises a multifilament configuration comprising a twisted yarn, a flat yarn, a textured yarn, or any combination thereof (Levi 1 [0073]).
But Van Hulle teaches a similar woven implant. Van Hulle teaches wherein the weft yarn comprises a multifilament configuration comprising a twisted yarn, a flat yarn, a textured yarn, or any combination thereof (Van Hull [0043]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Levi 1 and Levi 2 to incorporate wherein the weft yarn comprises a multifilament configuration comprising a twisted yarn, a flat yarn, a textured yarn, or any combination thereof as taught and suggested by Van Hulle in order to allow the addition of pockets/openings to the woven element [Van Hulle 0032].
RE. Claim 11, the combination of Levi 1, Levi 2, and Van Hulle discloses the invention substantially as claimed and as discussed above with respect to claim 9 teaches wherein the weft (Levi 2 [0021]) yarn is a combination of the twisted yarn or the flat yarn with the textured yarn (Van Hulle Fig 14A-E, [0026] & [0099], loops function as twisted yarn).
RE. Claim 12, the combination of Levi 1, Levi 2, and Van Hulle discloses the invention substantially as claimed and as discussed above with respect to claim 9 teaches wherein the twisted yarn and/or flat yarn have a size of about 10 denier to about 40 denier (Van Hulle [0046], While Van Hulle does not teach the specific range, the claimed ranges are with the ranges taught by Van Hulle), and wherein the textured yarn has a size of about 20 denier to about 160 denier (Van Hulle [0043] While Van Hulle does not teach the specific range, the claimed ranges are with the ranges taught by Van Hulle).
RE. Claim 13, the combination of Levi 1, Levi 2, and Van Hulle discloses the invention substantially as claimed and as discussed above with respect to claim 12 teaches wherein the twisted yarn and/or flat yarn have a size of about 10 denier to about 40 denier (Van Hulle [0046], While Van Hulle does not teach the specific range, the claimed ranges are with the ranges taught by Van Hulle), and wherein the textured yarn has a size of about 20 denier to about 160 denier (Van Hulle [0043] While Van Hulle does not teach the specific range, the claimed ranges are with the ranges taught by Van Hulle)
RE. Claim 14, the combination of Levi and Van Hulle discloses the invention substantially as claimed and as discussed above with respect to claim 9 teaches wherein the textured yarn is configured to fill gaps in the mesh layer (Levi 1 [0080] “two layers are fused”, filling gaps).
RE. Claim 19, the combination of Levi 1, Levi 2, and Van Hulle discloses the invention substantially as claimed and as discussed above with respect to claim teaches 9 wherein the knit fabric is crochet knit and/or warp-knit fabric (Levi 2 Fig 24, shows a v-stitch, a crochet knit).
RE. Claim 20, the combination of Levi 1, Levi 2, and Van Hulle discloses the invention substantially as claimed and as discussed above with respect to claim teaches 9 wherein the pile yarn comprises a flat or textured yarn (Levi 1[0080] layers are fused).
Conclusion
THIS ACTION IS MADE FINAL. 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 Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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