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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 24 February 2026 has been entered.
Claim Status
Applicant’s Remarks and Amendments filed 22 December 2025 have been entered. Claims 1-20 are pending.
Response to Arguments
Applicant’s arguments, see pgs. 6-7 of remarks, filed 22 December 2025, with respect to the drawings have been fully considered and are persuasive. The objection to the drawings has been withdrawn.
Applicant’s arguments, see pgs. 7-8 of remarks, filed 22 December 2025, with respect to the 112(a) rejection have been fully considered and are persuasive. The 112(a) rejection to claims 1, 3-6, 9-11, 13-15, and 18-20 has been withdrawn.
Applicant’s arguments with respect to claims 1, 11, and 20 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 22 December 2026 regarding claim 11 have been fully considered but they are not persuasive. Regarding Applicant’s argument that a “PHOSITA would understand from the instant disclosure that the outer skirt shifts between an unexpanded configuration and an expanded configuration relative to the expandable framework – that is, the outer skirt shifts between the unexpanded configuration and the expanded configuration without any change in the configuration of the expandable framework (e.g., while the expandable framework is in its expanded configuration)” (pg. 9 of remarks), Examiner respectfully disagrees. Applicant’s intended meaning of this amendment appears to be understood, that the outer skirt may expand or shrink regardless of the expanded state of the framework, however, the amended claim language of “relative to the expandable framework” does not translate this intended meaning. Merriam-Webster defines relative as “not absolute or independent”, however it appears that Applicant’s use of “relative” means the opposite: that the outer skirt does expand/contract independently of the expansion state of the expandable framework. If this meaning is correctly understood by Examiner, it is recommended that the claims be amended to reflect this meaning.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hayes et al. (US 2020/0352708 A1), “Hayes” in view of Suri et al. (US Pat. No. 10966823 B2), “Suri”.
Regarding claim 1, Hayes teaches a heart valve (Fig. 2, medical implant 16), comprising: an expandable framework configured to shift from a closed configuration to an expanded configuration (Fig. 2, expandable anchor member 70 expands via self-expanding or mechanical means [0058]), the expandable framework (Fig. 2, expandable anchor member 70) having an inflow end (Fig. 2, inflow end 24), an outflow end (Fig. 2, outflow end 26) and a lumen extending therein (Fig. 2, expandable anchor member 70 forms a tubular structure defining a lumen extending through [0058]); a plurality of valve leaflets coupled to the expandable framework (Fig. 2, valve leaflets 68 are secured to expandable anchor member 70 [0058]), each of the plurality of valve leaflets (Fig. 2, valve leaflets 68) including a root edge (Fig. 2, valve leaflets 68 secured to inflow end 24 [0061]), and a free edge (Fig. 2, valve leaflets 68 topmost portion); and an outer skirt coupled to the plurality of valve leaflets (Fig. 3, seal member 30 consists of porous material 36 [0071] and is one with reinforcing band 32 which is coupled to valve leaflets 68 [0081]), the outer skirt (Fig. 2, seal member 30) including a lower edge (Fig. 2, end of seal member 30 comprising reinforcing band 32); wherein the root edge of each of the plurality of valve leaflets (Fig. 3, edge of valve leaflets 68 connected to porous material 36) is attached to the lower edge of the outer skirt (Fig. 3, at least one seal stitch 40 and lashing suture 44 attach reinforcing band 32 with porous material 36 attached to valve leaflets 68 [0074]) at a position downstream of the inflow end of the expandable framework (Fig. 3, valve leaflets 68 are secured to porous material 36 by leaflet stitch 42 at a location proximal to inflow end 24 (Fig. 2)), but fails to teach the inflow end of the expandable framework extending upstream of the lower edge of the outer skirt.
Suri teaches a prosthetic heart valve comprising the inflow end of the expandable framework extending upstream of the lower edge of the outer skirt (Figs. 2C and 4B, frame of prosthetic heart valve 10 extends beyond seal member 70). Suri discloses that the seal member is positioned to maintain a seal slightly above the annulus of the valve while further comprising an inflow portion having material capable of exerting radial force enough to maintain a steady state (col. 6, par. 4). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the outer skirt taught by Hayes with the expandable framework taught by Suri in order to maintain a seal around the prosthetic valve and steady state of the prosthetic valve during use.
Regarding claim 2, Hayes teaches wherein the outer skirt (Fig. 2, seal member 30) is positioned along an outer surface of the expandable framework (Fig. 2, seal member 30 is outside expandable anchor member 70 [0064]).
Regarding claim 3, Hayes teaches wherein the plurality of valve leaflets is positioned within the lumen of the expandable framework (Fig. 2, expandable anchor member 70 forms a tubular structure defining a lumen extending through [0058] which comprises valve leaflets 68).
Regarding claim 4, Hayes teaches wherein the root edge of each of the plurality of valve leaflets (Fig. 2, valve leaflets 68 are secured to inflow end [0061]) is sutured to the lower edge of the outer skirt (Fig. 3, at least one seal stitch 40 and lashing sutures 44 attach reinforcing band 32 with thinned region 69 of valve leaflets 68 [0084]).
Regarding claim 5, Hayes teaches wherein root edge of each of the plurality of valve leaflets (Fig. 2, valve leaflets 68 are secured to inflow end [0061]) and the lower edge of the outer skirt (Fig. 2, reinforcing band 32) are sutured around the expandable framework (Fig. 3, lashing sutures 44 connect valve leaflets 68 to expandable anchor member 70) such that the root edge of the plurality of valve leaflets and the lower edge of the outer skirt may move relative to the expandable framework (Fig. 2, valve leaflets 68 and seal member 30 are attached to expandable anchor member 70 which expands [0058]).
Regarding claim 6, Hayes teaches wherein the outer skirt (Fig. 2, seal member 30) further includes a upper edge (Fig. 2, topmost region of seal member 30, opposite reinforcing band 32), and wherein the upper edge of the outer skirt is attached to one or more of the plurality of valve leaflets at one or more attachment points (Fig. 3, grommets 38 are embedded in seal member 30, which attached to valve leaflets 68, and are used by lashing sutures 46 to attach to expandable anchor member 70 [0066]).
Regarding claim 7, Hayes teaches wherein the outer skirt (Fig. 2, seal member 30) extends radially outward from the expandable framework (Fig. 2, seal member 30 is located outside expandable anchor member 70) to capture fluid flow around an exterior of the expandable framework within the outer skirt (Fig. 2, medical implant 16 is sealed against fluid flow around the exterior of the expandable anchor member 70 [0094]).
Regarding claim 8, Hayes teaches wherein the outer skirt (Fig. 2, seal member 30) is substantially impervious to fluid (Fig. 2, seal member 30 is impermeable to fluids [0068]).
Regarding claim 9, Hayes teaches wherein the expandable framework (Fig. 2, expandable anchor member 70) further comprises a lower crown (Fig. 2, seal stitches 40), at least a portion of which extends upstream from the lower edge of the outer skirt (Fig. 3, seal stitches 40 form a suture lattice which extends distally beyond seal member 30 [0075]).
Regarding claim 10, Hayes teaches wherein the outer skirt further includes an upper edge (Fig. 2, topmost region of seal member 30), and wherein the expandable framework (Fig. 2, expandable anchor member 70) further includes an upper crown (Fig. 2, topmost region of expandable anchor member 70), wherein the upper edge of the outer skirt (Fig. 2, topmost region of seal member 30) is disposed upstream of the upper crown (Fig. 2, topmost region of seal member 30 is below (i.e., upstream, nearer inflow end) topmost region of expandable anchor member 70).
Regarding claim 11, Hayes teaches a heart valve (Fig. 2, medical implant 16), comprising: an expandable framework (Fig. 2, expandable anchor member 70) having an inflow end (Fig. 2, inflow end 24), an outflow end (Fig. 2, outflow end 26), and a medial region positioned between the inflow end and the outflow end (Fig. 2, center region of expandable anchor member 70); a plurality of valve leaflets (Fig. 2, valve leaflets 68) attached to the medial region of the expandable framework (Fig. 2, valve leaflets 68 are secured to expandable anchor member 70 [0058]), each of the plurality of valve leaflets including a root edge (Fig. 2, valve leaflets 68 secured to inflow end 24 [0061]); and an outer skirt (Fig. 2, seal member 30) disposed along an outer surface of the expandable framework (Fig. 2, seal member 30 is outside expandable anchor member 70), the outer skirt (Fig. 2, seal member 30) including a lower edge (Fig. 2, reinforcing band 32) and an upper edge (Fig. 2, topmost region of seal member 30); wherein the outer skirt (Fig. 2, seal member 30) is configured to shift between an unexpanded configuration and an expanded configuration relative to the expandable framework (Fig. 2, valve leaflets 68 and seal member 30 are attached to expandable anchor member 70 which expands [0058]); wherein the root edge of each of the plurality of valve leaflets (Fig. 3, edge of valve leaflets 68 connected to porous material 36) is attached to the lower edge of the outer skirt (Fig. 3, at least one seal stitch 40 and lashing suture 44 attach reinforcing band 32 with porous material 36 attached to valve leaflets 68 [0074]) at a position downstream of the inflow end of the expandable framework (Fig. 3, valve leaflets 68 are secured to porous material 36 by leaflet stitch 42 at a location proximal to inflow end 24 (Fig. 2)), but fails to teach the inflow end of the expandable framework extending upstream of the lower edge of the outer skirt.
Wang teaches a prosthetic heart valve system with the inflow end of the expandable framework extending upstream of the lower edge of the outer skirt (Fig. 1a, tabs 29 of stent frame 22 extend beyond valve structure 24 at inlet portion 25). Wang discloses the tabs can be used to retain the valve prosthesis to the delivery system [0056]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the heart valve taught by Hayes with the distally extended expandable framework taught by Wang in order to secure the prosthesis during delivery.
Regarding claim 12, Hayes teaches wherein the plurality of valve leaflets (Fig. 2, valve leaflets 68) is positioned within a lumen of the expandable framework (Fig. 2, valve leaflets 68 are within the center, tubular shape of expandable anchor member 70).
Regarding claim 13, Hayes teaches wherein the root edge of each of the plurality of valve leaflets (Fig. 2, valve leaflets 68 are secured to inflow end [0061]) is sutured to the lower edge of the outer skirt (Fig. 3, at least one seal stitch 40 and lashing sutures 44 attach reinforcing band 32 with thinned region 69 of valve leaflets 68 [0084]).
Regarding claim 14, Hayes teaches wherein root edge of each of the plurality of valve leaflets (Fig. 2, valve leaflets 68 are secured to inflow end [0061]) and the lower edge of the outer skirt (Fig. 2, reinforcement band 32) are sutured around the expandable framework (Fig. 3, lashing sutures 44 connect valve leaflets 68 to expandable anchor member 70) such that the root edge of the plurality of valve leaflets and the lower edge of the outer skirt may move relative to the expandable framework (Fig. 2, valve leaflets 68 and seal member 30 are attached to expandable anchor member 70 which expands [0058]).
Regarding claim 15, Hayes teaches wherein the upper edge of the outer skirt (Fig. 2, topmost region of seal member 30, opposite reinforcing band 32) is attached to one or more of the plurality of valve leaflets at one or more attachment points (Fig. 3, grommets 38 are embedded in seal member 30, which attached to valve leaflets 68, and are used by lashing sutures 46 to attach to expandable anchor member 70 [0066]).
Regarding claim 16, Hayes teaches wherein the outer skirt (Fig. 2, seal member 30) is configured to capture fluid flow around an exterior of the expandable framework within the outer skirt (Fig. 2, medical implant 16 is sealed against fluid flow around the exterior of the expandable anchor member 70 [0094]).
Regarding claim 17, Hayes teaches wherein the outer skirt (Fig. 2, seal member 30) is substantially impervious to fluid (Fig. 2, seal member 30 is impermeable to fluids [0068]).
Regarding claim 18, Hayes teaches wherein the expandable framework (Fig. 2, expandable anchor member 70) further comprises a lower crown (Fig. 2, seal stitches 40), at least a portion of which extends upstream from the lower edge of the outer skirt (Fig. 3, seal stitches 40 form a suture lattice which extends distally beyond seal member 30 [0075]).
Regarding claim 19, Hayes teaches wherein the expandable framework (Fig. 2, expandable anchor member 70) further includes an upper crown (Fig. 2, topmost region of expandable anchor member 70), wherein the upper edge of the outer skirt (Fig. 2, topmost region of seal member 30) is disposed upstream of the upper crown (Fig. 2, topmost region of seal member 30 is below topmost region of expandable anchor member 70).
Regarding claim 20, Hayes teaches a method for delivering a heart valve implant at a target site, the method comprising: advancing a heart valve implant to a target site adjacent the heart (Fig. 1, delivery system 10 is used to deliver medical implant 16 (i.e., a replacement heart valve)), the heart valve implant (Fig. 2, medical implant 16) including: an expandable framework (Fig. 2, expandable anchor member 70) configured to shift from a closed configuration to an expanded configuration (Fig. 2, valve leaflets 68 and seal member 30 are attached to expandable anchor member 70 which expands [0058]), the expandable framework having an inflow end (Fig. 2, inflow end 24), an outflow end (Fig. 2, outflow end 26) and a lumen extending therein (Fig. 2, expandable anchor member 70 forms a tubular structure defining a lumen extending through [0058]); a plurality of valve leaflets (Fig. 2, valve leaflets 68) coupled to the expandable framework (Fig. 2, valve leaflets 68 are secured to expandable anchor member 70 [0058]), each of the plurality of valve leaflets (Fig. 2, valve leaflets 68) including a root edge (Fig. 2, valve leaflets 68 secured to inflow end 24 [0061]) and a free edge (Fig. 2, valve leaflets 68 topmost portion); and an outer skirt (Fig. 2, seal member 30) coupled to the plurality of valve leaflets, the outer skirt (Fig. 2, seal member 30) including a lower edge (Fig. 2, reinforcing band 32); wherein the root edge of each of the plurality of valve leaflets (Fig. 3, edge of valve leaflets 68 connected to porous material 36) is attached to the lower edge of the outer skirt (Fig. 3, at least one seal stitch 40 and lashing suture 44 attach reinforcing band 32 with porous material 36 attached to valve leaflets 68 [0074]) at a position downstream of the inflow end of the expandable framework (Fig. 3, valve leaflets 68 are secured to porous material 36 by leaflet stitch 42 at a location proximal to inflow end 24 (Fig. 2)), and deploying the implantable heart valve at the target site (Fig. 2, medical implant 16 is deployed within the native heart valve [0052]), but fails to teach the inflow end of the expandable framework extending upstream of the lower edge of the outer skirt.
Wang teaches a prosthetic heart valve system with the inflow end of the expandable framework extending upstream of the lower edge of the outer skirt (Fig. 1a, tabs 29 of stent frame 22 extend beyond valve structure 24 at inlet portion 25). Wang discloses the tabs can be used to retain the valve prosthesis to the delivery system [0056]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the heart valve taught by Hayes with the distally extended expandable framework taught by Wang in order to secure the prosthesis during delivery.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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