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 .
Claim Status
Applicant’s Remarks and Amendments filed 17 June 2026 have been entered. Claims 1-15 are pending.
Response to Arguments
Applicant’s arguments, see pages 10-13 of remarks, filed 17 September 2026, with respect to the rejection(s) of claim(s) 1-15 under USC 102(a)(1) and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a newly found prior art reference.
Applicant’s arguments, see page 8 of remarks, filed 17 September 2026, with respect to claim 14 have been fully considered and are persuasive. The objection to the Drawings has been withdrawn.
Applicant’s arguments, see pages 8-9 of remarks, filed 17 September 2026, with respect to the Specification have been fully considered and are persuasive. The objection to the Specification has been withdrawn.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Vidlund et al. (US 2019/0388220 A1), “Vidlund” in view of Morriss et al. (US 2019/0321171 A1), “Morriss”.
Regarding claim 1, Vidlund teaches a prosthetic heart valve (Fig. 17, heart valve prosthesis) comprising: a collapsible and expandable frame (Fig. 17, wire frame 1720 capable of radially expanding and contracting [0086]) that, in an expanded condition, includes a central portion (Fig. 17, region of prosthesis comprising flow control sleeve (FCS) 1724 and plication windows 1712, 1714, 1716), an atrial portion flaring radially outwardly from the central portion (Fig. 17, upper cuff 1718), and a ventricular portion flaring radially outwardly from the central portion (Fig. 17, lower flange 1728); a tube positioned within the frame (Fig. 17, flow control sleeve (FCS) 1724), the tube having a lumen extending along a longitudinal axis from the atrial portion toward the ventricular portion of the frame (Fig. 17, FCS 1724 provides an axial tube valve through the entire prosthesis [0019, 0182]), wherein the tube is formed of tissue or fabric (Fig. 17, FCS is formed from decellularized pericardium or polymer [0132]); the valve allowing blood to flow through the lumen of the tube in an antegrade direction but blocking blood from flowing through the lumen of the tube in a retrograde direction (Fig. 17, FCS is open to blood flow during diastole from atrium to ventricle and closed form systolic ventricular pressure [0064]), but fails to teach a plurality of prosthetic leaflets directly coupled to the tube to form a valve, and a plurality of cords each having a first portion coupled to the frame and a second portion coupled to the tube, each of the plurality of cords extending in a radial direction toward the longitudinal axis.
Morriss teaches a prosthetic heart valve comprising a plurality of prosthetic leaflets directly coupled to the tube to form a valve (Fig. 21E, leaflets 132 of prosthetic valve 130 [0276]), and a plurality of cords each having a first portion coupled to the frame and a second portion coupled to the tube (Fig. 21E, tethers 194 extend between outer portion 146A and valve support 120), each of the plurality of cords extending in a radial direction toward the longitudinal axis (Fig. 21E, tethers 194 extend almost perpendicularly compared to the length of anchoring member 110). Morriss discloses that the tethers work to inhibit collapse of the tubular member during atrial systole [0276]. 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 tube taught by Vidlund with the leaflets and cords taught by Morriss in order to avoid structural compromise of the tube when undesired.
Regarding claim 2, Vidlund teaches wherein the tube excludes any metal structure directly attached to the tube (Fig. 17, sleeve comprises panels of pericardial material jointed together to form a triangular cylinder).
Regarding claim 3, Vidlund teaches the tube (Fig. 17, flow control sleeve (FCS) 1724), but fails to teach at least one metal underwire disposed between the plurality of prosthetic leaflets and the tube.
Morriss teaches a prosthetic heart valve comprising at least one metal underwire disposed between the plurality of prosthetic leaflets and the tube (Fig. 21C, valve support 120 comprises longitudinal struts 190 of metal which are coupled to or embedded within the walls of tubular member 148 which further comprises leaflets 132 [0276]). Morriss discloses that the metal struts give the implant greater strength and help to retain a desirable shape for operation [0276]. 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 tube taught by Vidlund with the metal underwire taught by Morriss in order to provide a stronger implant that can withstand repeated forces of the heart.
Regarding claim 4, Vidlund fails to teach the limitations of claim 4. Morriss teaches a prosthetic heart valve wherein each of the plurality of cords is a suture (Fig. 21E, tethers 194). Morriss further teaches tethers that may be a suture (Fig. 45A, tethers 360 [0316]). Morriss discloses that the tethers work to inhibit collapse of the tubular member during atrial systole [0276]. 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 tube taught by Vidlund with the leaflets and cords taught by Morriss in order to avoid structural compromise of the tube when undesired.
Regarding claim 5, Vidlund teaches further comprising a skirt coupled to the frame (Fig. 17, covering 1722), the skirt including an atrial portion extending radially inwardly from the frame and being connected to a first end of the tube (Fig. 17, covering 1722 surrounds cuff 1718), and a ventricular portion extending radially inwardly from the frame and being connected to a second end of the tube (Fig. 17, covering 1722 surrounds lower flange 1728).
Regarding claim 6, Vidlund teaches wherein the skirt is formed of a woven synthetic fabric (prosthesis covering may be a polyester material to promote tissue in-growth [0017]).
Regarding claim 7, Vidlund teaches wherein the skirt is formed of PET, PTFE, or UHMWPE (covering may comprise PTFE [0111]).
Regarding claim 8, Vidlund teaches wherein the skirt includes an outer section attached to the frame (Fig. 17, covering 1722 surrounds wire frame 1720), the outer section being configured to contact a native valve annulus upon implantation to help seal against the native valve annulus and to prevent paravalvular leakage (polyester covering material provides a septal seal and in-growth without trauma [0093]).
Regarding claim 9, Vidlund fails to teach the limitations of claim 9. Morriss teaches a prosthetic heart valve wherein the plurality of cords only provide support in tension, helping to minimize movement of the tube and the plurality of prosthetic leaflets directly coupled to the tube during normal operation of the prosthetic heart valve (Fig. 21E, tethers 194 work to inhibit collapse of the tubular member during atrial systole [0276]). Morriss discloses that the tethers work to inhibit collapse of the tubular member during atrial systole [0276]. 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 tube taught by Vidlund with the leaflets and cords taught by Morriss in order to avoid structural compromise of the tube when undesired.
Regarding claim 10, Vidlund fails to teach the limitations of claim 9. Morriss teaches a prosthetic heart valve wherein upon compression of the frame, compressive force is not translated via the plurality of cords to the tube (Fig. 21E, tethers 194 work to inhibit collapse of the tubular member during atrial systole [0276] (i.e., collapse/compression of the frame inhibits the tethers from extending or exerting force on the valve)). Morriss discloses that the tethers work to inhibit collapse of the tubular member during atrial systole [0276]. 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 tube taught by Vidlund with the leaflets and cords taught by Morriss in order to avoid structural compromise of the tube when undesired.
Claims 11-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Vidlund et al. (US 2019/0388220 A1), “Vidlund” in view of Morriss et al. (US 2019/0321171 A1), “Morriss”, and further in view of Vidlund (US 2022/0087814 A1), “Vidlund 814”.
Regarding claim 11, Vidlund teaches a prosthetic heart valve (Fig. 17, heart valve prosthesis) comprising: a collapsible and expandable frame (Fig. 17, wire frame 1720 capable of radially expanding and contracting [0086]) that, in an expanded condition, includes a central portion (Fig. 17, region of prosthesis comprising flow control sleeve (FCS) 1724 and plication windows 1712, 1714, 1716), an atrial portion flaring radially outwardly from the central portion (Fig. 17, upper cuff 1718), and a ventricular portion flaring radially outwardly from the central portion (Fig. 17, lower flange 1728); a tube positioned within the frame (Fig. 17, flow control sleeve (FCS) 1724), the tube having a lumen extending along a longitudinal axis from an inflow end to an outflow end (Fig. 17, FCS 1724 provides an axial tube valve through the entire prosthesis [0019, 0182]), wherein the tube is formed of tissue or fabric (Fig. 17, FCS is formed from decellularized pericardium or polymer [0132]), but fails to teach a plurality of first cords.
Morriss teaches a prosthetic heart valve comprising a plurality of first cords each having a first portion coupled to the frame and a second portion coupled to the inflow end of the tube (Fig. 21E, tethers 194 extend between outer portion 146A and valve support 120) the first plurality of cords maintaining the inflow end of the tube in an open condition (Fig. 21E, tethers 194 work to inhibit collapse of the tubular member during atrial systole [0276]). Morriss discloses that the tethers work to inhibit collapse of the tubular member during atrial systole [0276]. 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 tube taught by Vidlund with the leaflets and cords taught by Morriss in order to avoid structural compromise of the tube when undesired. However, Vidlund in view of Morriss fails to teach a pair of second cords.
Vidlund 814 teaches a prosthetic heart valve comprising a pair of second cords each having a first portion coupled to the frame and a second portion coupled to the outflow end of the tube (Fig. 5B, constraining members 400 which extend from outflow end of inner frame 205 to outer frame 201 [0054]), the pair of second cords coupled to diametrically opposed portions of the outflow end of the tube so that two free edges of the outflow end of the tube are capable of collapsing toward each other and opening away from each other (Fig. 5B, constraining members 400 align with each other on opposite sides of heart valve 200 and apply equal force to prosthetic heart valve 100 and allow for repeatable deployment within the desired position and orientation (i.e., opening and closing) [0058]). Vidlund 814 discloses that the constraining members work to delay prosthesis deployment to ensure proper positioning and orientation of the device [0055]. 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 frame and tube taught by Vidlund with the first cords taught by Morriss and the second cords taught by Vidlund 814 in order to ensure proper positioning and orientation of the device when implanted.
Regarding claim 12, Vidlund teaches wherein the plurality of first cords are sutures, and the pair of second cords are sutures (Fig. 21E, tethers 194). Morriss further teaches tethers that may be a suture (Fig. 45A, tethers 360 [0316]). Morriss discloses that the tethers work to inhibit collapse of the tubular member during atrial systole [0276]. 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 tube taught by Vidlund with the leaflets and cords taught by Morriss in order to avoid structural compromise of the tube when undesired.
Regarding claim 13, Vidlund teaches wherein the tube is formed of tissue that is rolled into a cylindrical shape (Fig. 17, flow control sleeve (FCS) 1724 is a tube or conduit (i.e., cylinder) of flexible material [0064]). The prior art is not required to disclose a “rolled” as it pertains to a step of manufacture, which is not germane to the issue of patentability of the final product.
Regarding claim 15, Vidlund teaches wherein the prosthetic heart valve excludes prosthetic leaflets separate from the tube (Fig 17, flow control sleeve (FCS) 1724 is a non-leaflet containing reciprocating tube [0093]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Vidlund et al. (US 2019/0388220 A1), “Vidlund” in view of Morriss et al. (US 2019/0321171 A1), “Morriss”, and Vidlund (US 2022/0087814 A1), “Vidlund 814”and further in view of Salahieh et al. (US 2022/0175522 A1), “Salahieh”.
Regarding claim 14, Vidlund teaches the tube which forms a cylindrical shape (Fig. 17, FCS 1724 is a tube or conduit (i.e., cylinder) of flexible material [0064]), but Vidlund in view of Morriss fails to teach wherein the tube is formed as two pieces of fabric that are coupled together, via a pair of seams, to form a cylindrical shape, the pair of seams aligning with the pair of second cords.
Vidlund 814 teaches a prosthetic heart valve comprising the pair of second cords (Fig. 5B, constraining members 400). Vidlund 814 discloses that the constraining members work to delay prosthesis deployment to ensure proper positioning and orientation of the device [0055]. 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 tube taught by Vidlund with the second cords taught by Vidlund 814 in order to ensure proper positioning and orientation of the device when implanted. However, Vidlund in view of Morriss and Vidlund 814 fails to teach the tube is formed as two pieces of fabric that are coupled together, via a pair of seams, to form a cylindrical shape.
Salahieh teaches a valve segment that is formed as two pieces of fabric that are coupled together, via a pair of seams (Fig. 28, skirt 230 is manufactured from a flat sheet of material that is laser cut and sewn together along seam 231 [0132]). Salahieh discloses that the unitary skirt can help prevent bunching or folding that may occur with separate skirts [0132]. 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 frame and tube taught by Vidlund with the second cords taught by Vidlund 814 and the sewing of two pieces of fabric together taught by Salahieh in order to prevent malfunctions of the device during deployment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA G. B. RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 9:00AM-6:00PM CST.
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/G.G.R./ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
