Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`The asserted claims of the ‘739 patent are anticipated or obvious over United States Patent No. 5,855,601 (“Bessler”) in view of U.S.
`Patent No. 5,957,949 (“Leonhardt”), U.S. Patent Publication No. 2001/0044633 (“Klint”), U.S. Patent No. 4,218,782 (“Rygg”) and/or
`U.S. Pat. No. 5,713,950 (“Cox”), alone or in combination with the knowledge of a person of ordinary skill in the art ("POSITA")
`and/or in combination with one or more other references disclosed in Medtronic's Invalidity Contentions, including other charted
`references.
`
`Bessler was filed on June 21, 1996, published on January 5, 1999, so it is prior art under 35 U.S.C. § 102(a), (b) and (e).
`
`The citations provided below are exemplary and do not necessarily include each and every disclosure of the limitation in the reference.
`Medtronic has endeavored to cite to the most relevant portions of the identified prior art, but other portions may additionally disclose,
`either expressly or inherently, and/or render obvious one or more limitations of the asserted claims. Thus, Medtronic reserves the
`right to rely on: (1) uncited portions of the identified prior art; (2) other prior art not identified herein; (3) references that show the
`state of the art (irrespective of whether such references themselves qualify as prior art to the asserted patents); (4) factual testimony
`from the inventors or authors of the prior art references, or purveyors of prior art devices; and/or (5) expert testimony, to provide
`context to or aid in understanding the prior art and the state of the art at the time of the alleged invention.
`
`The lack of a citation for an element should not be deemed an admission that the element is not disclosed or is not inherent in the
`reference. When the chart indicates a particular reference discloses or embodies a limitation, the terms “discloses,” “disclosed,”
`“embodies,” and “embodied” refer to explicit and/or inherent disclosure and/or obvious variations of the actual disclosure. Further, to
`the extent Medtronic asserts that a claim is indefinite, Medtronic has used its best efforts to reasonably interpret the claims to fulfill
`their duties in charting the prior art references.
`
`Where Medtronic cites to a particular drawing or figure in the accompanying charts, the citation encompasses the description of the
`drawing or figure, as well as any text associated with the drawing or figure. Similarly, where citations are made to particular text
`concerning a drawing or figure, the citation encompasses that drawing or figure. Certain identified prior art inherently discloses
`features of the asserted claims. Medtronic reserves the right to rely on inherency to demonstrate the invalidity of the asserted claims.
`Moreover, certain prior art references may inherently disclose certain features of the asserted claims as construed by Colibri.
`Medtronic may rely on cited or uncited portions of the prior art, other documents, factual testimony, and expert testimony to establish
`the inherency of certain features of the prior art to invalidate the asserted claims.
`
`To the extent Colibri contends that the prior art reference does not disclose any particular limitation of the asserted claims of this
`patent, either expressly or inherently, it would have been obvious to a person of ordinary skill in the art as of the date of the alleged
`invention to modify the reference and/or to combine its teachings with other prior art references, including but not limited to the prior
`art references identified in Medtronic’s invalidity contentions and the relevant sections of the claim charts for those references, in a
`manner that renders such claims invalid as obvious.
`
`
`
`1
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 1 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`It would have been obvious under 35 U.S.C. § 103 to a person having ordinary skill in the art at the time of the alleged
`invention to combine the teachings of Bessler with the following references:
`
`
`1.
`
`2.
`
`3.
`
`4.
`
`Leonhardt, which was filed on May 1, 1997, published on September 28, 1999, so it is prior art under 35 U.S.C. § 102(a),
`(b) and (e).
`Klint, which was filed on January 26, 2001, published on November 22, 2001, so it is prior art under 35 U.S.C. § 102(a),
`(b) and (e).
`Rygg, which was filed on May 19, 1978, published on August 8, 1980, so it is prior art under 35 U.S.C. § 102(a), (b) and
`(e).
`Cox, which was filed on November 1, 1993 and issued on February 3, 1998, so it is prior art under 35 U.S.C. § 102(a), (b)
`and (e).
`
`Claim language
`
`1.pre An assembly to treat a native
`heart valve in a patient, the
`assembly for use in
`combination with a
`guidewire, the assembly
`comprising:
`
`Exemplary disclosure
`To the extent this preamble is limiting, Bessler and Leonhardt disclose “[a]n assembly to
`treat a native heart valve in a patient, the assembly for use in combination with a guidewire,
`the assembly comprising.”
`
`For example, Bessler discloses an assembly (an “artificial heart valve”) to treat a native
`valve in a patient:
`
`
`The present invention relates to novel artificial heart valves. More particularly,
`the present invention relates to novel heart valves that are especially adapted
`for placement using minimally invasive surgical techniques and to the method
`and device useful for such placement.
`
`Bessler at col. 1, lines 7-11. Bessler further discloses that the artificial valve is used in
`combination with a guidewire:
`
`
`A guidewire 94 having a blunt end 95 is disposed through a lumen 97 of the
`pusher member 93 and is used to guide the distal end of the catheter 91 to the
`desired site.
`
`
`
`2
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 2 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`Bessler at col. 7, lines 35-38. Leonhardt discloses an assembly to treat a native valve in a
`patient:
`
`
`those placed
`to artificial valves, specifically
`invention relates
`This
`percutaneously by a catheter. The artificial valve disclosed may replace
`existing valves such as are in the heart or esophagus, or may be placed where
`fluid flow needs to be maintained in one direction only.
`
`Leonhardt at col. 1, lines 5-9. Leonhardt further discloses that the artificial valve is used in
`combination with a guidewire:
`
`
`
`If valve stent 20 is to be placed at mitral valve 14, entry may be made through
`the right internal jugular vein. A guide wire is advanced through the entry site
`to the right atrium and interatrial septum 16. A catheter and needle
`combination (not shown) is advanced over the guide wire to interatrial septum
`16 and used to puncture septum 16 and access left atrium 18. The guide wire
`is advanced into left atrium 18 and through mitral valve 14 and the catheter
`and needle combination is removed.
`
`Leonhardt at col. 10, lines 22-30.
`
`
` A
`
` POSITA would have been motivated to combine Bessler and Leonhardt by substituting
`Leonhardt’s mitral valve stent 20 for Bessler’s valve 30 in a mitral valve replacement
`scenario in order to realize the advantages associated with Leonhardt’s valve including a)
`sealing to natural tissue to prevent microleaks [Leonhardt at 3:41-44; 5:48-50); 8:51-54; b)
`better shape with trumpet-like configuration for keeping valve stent in place for replacement
`of a mitral valve where parts of valve stent are on opposite sides of mitral valve and one side
`extends into ventricle; and c) reducing chance of thrombosis by having stent entirely
`covered by outer material (Leonhardt at 5:62-6:8).
`
`
`
`
`3
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 3 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`1.a
`
`a prosthetic heart valve
`including: a stent member
`having an inner channel, the
`stent member collapsible,
`expandable and configured
`for transluminal percutaneous
`delivery, wherein
`
`Leonhardt discloses “a prosthetic heart valve including: a stent member having an inner
`channel, the stent member collapsible, expandable and configured for transluminal
`percutaneous delivery, wherein.”
`
`For example, Leonhardt’s artificial valve is configured for transluminal (“by a catheter”)
`percutaneous delivery:
`
`those placed
`to artificial valves, specifically
`invention relates
`This
`percutaneously by a catheter. The artificial valve disclosed may replace
`existing valves such as are in the heart or esophagus, or may be placed where
`fluid flow needs to be maintained in one direction only.
`
`Leonhardt at col. 1, lines 5-9.
`
`
`
`Stent 26 is a continuous super elastic nitenol wire having a distal end and a
`proximal end. Both the distal end and the proximal end are substantially
`identical, both forming a cylinder wall 64 of six zig-zags 40 or waves. Each
`end is pre-sized in diameter to be approximately thirty percent (30%) larger in
`diameter than the largest diameter of the tissue against which the valve stent
`20 (FIG. 3) will seal. The overall length of stent 26 is also pre-sized to be
`sufficient to maintain patency against fluid flow in the vessel or natural valve
`position, as well as completely support the biological valve (or mechanical or
`synthetic valve) without causing valve 22 to suffer prolapse or insufficiency.
`
`Leonhardt at col. 4, line 66 – col. 5, line 10. Leonhardt’s stent member 26 includes an inner
`channel as shown in the drawing below:
`
`
`
`
`4
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 4 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`Leonhardt at FIG. 3.
`
`
`
`
`
`Also refer to FIG. 4 to identify elements in the following discussion. Mitral
`valve 14 has been prepared for deployment by valvuloplasty to remove plaque
`and fistulas if necessary. Valve stent 20 comprises a malleable graft material
`24 enclosing deformable self-expanding stent 26 to which a biological valve
`22 is attached. Stent 26 biases the proximal and distal ends of valve stent 20
`into conforming and sealingly fixed engagement with the tissue of mitral valve
`14. The deployed valve stent 20 creates a patent one way fluid passageway.
`
`Leonhardt at col. 5, lines 42-52.
`
`
`
`
`5
`
`
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 5 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`1.b
`
`the stent member includes a
`tubular structure away from a
`central portion that flares at
`both ends in a trumpet-like
`configuration; and
`
`
`
`
`
`Leonhardt at FIG. 4.
`
`Leonhardt discloses “the stent member includes a tubular structure away from a central
`portion that flares at both ends in a trumpet-like configuration; and”
`
`For example:
`
`
`Where other vessels or passages leave the vessel receiving valve stent 20 at a
`placement site, or when valve stent 20 must flair at one or both ends as is
`shown in FIG. 2, graft material 24 may be cut out between the plurality of
`distensible fingers 46 formed by zig-zags 40 of stent 26. Distensible fingers 46
`form a conical tip when compressed together which facilitates loading valve
`stent 20 in the deployment catheter (FIG. 5) prior to the procedure and if
`retrieval after deployment is necessary. Valve stent 20 may be placed such that
`other vessels are not blocked by placing distensible fingers 46 on either side
`
`
`
`6
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 6 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`of the vessel junction. Stent 26 is pre-sized to open beyond the width of the
`natural valve mouth and will flair sufficiently to conform and seal to the tissue.
`
`Leonhardt at col. 6, lines 9-23.
`
`
`
`
`
`Leonhardt at FIG. 2.
`
`
`Leonhardt in combination with Rygg or Cox discloses “a valve means including two to four
`individual leaflets made of fixed pericardial tissue, wherein the valve means resides entirely
`within the inner channel of the stent member, and wherein no reinforcing members reside
`within the inner channel of the stent member.”
`
`For example, Leonhardt discloses a valve means (valve 22) that resides entirely within an
`inner channel of a stent member (stent 26):
`
`
`Biological valve 22 is preferably a porcine valve treated and prepared for use
`in a human. It has two or more commissural points 68 as is seen in FIG. 4.
`Biological valve 22 is attached to stent 26, to graft material 24, or both with
`sutures 60 or biocompatible adhesive or a combination of the two. Biological
`
`7
`
`a valve means including two
`to four individual leaflets
`made of fixed pericardial
`tissue, wherein the valve
`means resides entirely within
`the inner channel of the stent
`member, and wherein no
`reinforcing members reside
`within the inner channel of
`the stent member
`
`1.c
`
`
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 7 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`valve 22 is pre-sized to fit within the internal diameter of cylinder 48 formed
`by stent 26 attached to graft material 24. Attachment is along biological valve's
`22 commissural points 68 and around its base. Whereas a biological valve is
`preferred, a mechanical valve or a synthetic leaflet valve may also be
`employed.
`
`Leonhardt at col. 6, lines 9-23
`
`
`
`Leonhardt at FIG. 4.
`
`
`
`
`
`
`
`
`To the extent that Leonhardt does not expressly and/or inherently disclose “leaflets made of
`fixed pericardial tissue”, it would have been obvious in view of the knowledge of one of
`skill in the art in light of Leonhardt alone or it would have been obvious to combine
`Leonhardt with one or more of the prior art references identified in the pleading to which
`
`
`
`8
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 8 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`this chart is attached. For example, a POSITA would have known that as of the priority date
`of the '739 patent, that a biological valve can be made of a fixed pericardial tissue as
`disclosed in Rygg and Cox.
`
`Leonhardt, Rygg and Cox are all directed to heart valve prosthesis made from a biological
`material. A POSITA would have been motivated to use a valve with leaflets made of fixed
`pericardial tissue to obtain considerable advantages, as described in Rygg:
`
`
`The membranes which are used today in the clinics are pericardium and dura
`mater. Considerable advantages are attached to constructing a heart valve from
`these membranes instead of utilizing the heretofore most used natural heart
`valves from animals or dead human beings. The rather difficult and laborious
`dissection of the heart valve itself is obviated and likewise the shaping and
`stabilizing of said valve in its naturally dilated state. Further, the valves of the
`patient as well as of the donor exhibit individual variations, and it is therefore
`a problem to find suitable sizes. Finally, the problems of suspending or
`attaching such a prosthesis in a form corresponding to its normal position are
`obviated. Thus, the use of a biological membrane results in a simplification of
`the production of the heart valves in several respects and also in a considerably
`better standardization. It further provides a greater choice of attachment
`methods, and finally it gives better possibilities of procuring suitable raw
`materials far more easily.
`
`Rygg at col. 1, lines 50-68; see also Rygg at 2:1-12 (discussing use of fixing porcine
`pericardium valve with glutaraldehyde). Alternately, a POSITA would have been motivated
`to use a valve with leaflets made of fixed pericardial tissue to obtain the benefits of reduced
`clotting as described in Cox and its relatively low profile and ease of manipulation into a
`desired shape:
`
`
`Most tissue valves are constructed by sewing the leaflets of pig aortic valves
`to a stent (to hold the leaflets in proper position), or by constructing valve
`leaflets from the pericardial sac (which surrounds the heart) of cows or pigs
`and sewing them to a stent. The stents may be rigid or slightly flexible and are
`covered with cloth (usually a synthetic material sold under the trademark
`
`
`
`9
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 9 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`Dacron™) and attached to a sewing ring for fixation to the patient's native
`tissue. The porcine or bovine tissue is chemically treated to alleviate any
`antigenicity (i.e., to reduce the risk that the patient's body will reject the foreign
`tissue). These tri-leaflet valves may be used to replace any of the heart's four
`valves. The only tissue valves currently approved by the FDA for implantation
`in the U.S.A. are the Carpentier-Edwards Porcine Valve, the Hancock Porcine
`Valve, and the Carpentier-Edwards Pericardial Valve.
`
`1.d
`
`a delivery system including a
`pusher member and a
`moveable sheath, the pusher
`member including a
`guidewire lumen, wherein the
`pusher member is disposed
`within a lumen of the
`moveable sheath, wherein
`
`Cox at col. 4, lines 35-50; see also 6:26-32 (fixing with glutaraldehyde to reduce
`antigenicity).
`
`Bessler discloses “a delivery system including a pusher member and a moveable sheath, the
`pusher member including a guidewire lumen, wherein the pusher member is disposed within
`a lumen of the moveable sheath, wherein”
`
`For example, Bessler discloses a delivery system (device 90) that includes a pusher member
`(pusher member 93 (103 in FIG. 14) + threads 105 (shown in FIG. 14) + loop 107 (shown in
`FIG. 14)) that includes a guidewire lumen (lumen 97) disposed within a lumen of a movable
`sheath (catheter 94):
`
`
`The device set forth in FIGS. 12 and 13 represents a novel device for
`implanting the artificial heart valves of the present invention. The device 90
`comprises a flexible catheter 91 for percutaneous and transluminal delivery of
`the heart valve to the desired site. A heart valve 92 of the invention is carried,
`in its collapsed state, at the distal end of the catheter 91 where the catheter
`walls maintain the valve 92 in its collapsed state. Disposed within the catheter
`91 is a hollow flexible pusher member 93, which is movable longitudinally
`with respect to the catheter 91. A guidewire 94 having a blunt end 95 is
`disposed through a lumen 97 of the pusher member 93 and is used to guide the
`distal end of the catheter 91 to the desired site. Means 96 is also disposed
`through lumen 97 of the pusher member 93 for holding the valve 92 in place
`and allowing release of the valve 92 when desired, as will be more fully
`described in conjunction with FIGS. 14 and 15.
`
`
`
`10
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 10 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`Bessler at col. 6, lines 9-23.
`
`
`
`Bessler at FIG. 12.
`
`
`
`
`Bessler at FIG. 13.
`
`
`
`
`
`
`
`
`
`
`
`
`11
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 11 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`1.e
`
`the prosthetic heart valve is
`collapsed onto the pusher
`member to reside in a
`collapsed configuration on
`the pusher member and is
`restrained in the collapsed
`configuration by the
`moveable sheath, wherein a
`distal end of the prosthetic
`heart valve is located at a
`distal end of the moveable
`sheath, and wherein
`
`
`
`Bessler at FIG. 14.
`
`Bessler discloses “the prosthetic heart valve is collapsed onto the pusher member to reside
`in a collapsed configuration on the pusher member and is restrained in the collapsed
`configuration by the moveable sheath, wherein a distal end of the prosthetic heart valve is
`located at a distal end of the moveable sheath, and wherein”
`
`For example:
`
`See claim 1.d above, which is incorporated by reference
`
`
`The device set forth in FIGS. 12 and 13 represents a novel device for
`implanting the artificial heart valves of the present invention. The device 90
`comprises a flexible catheter 91 for percutaneous and transluminal delivery of
`the heart valve to the desired site. A heart valve 92 of the invention is carried,
`in its collapsed state, at the distal end of the catheter 91 where the catheter
`walls maintain the valve 92 in its collapsed state. Disposed within the catheter
`91 is a hollow flexible pusher member 93, which is movable longitudinally
`with respect to the catheter 91. A guidewire 94 having a blunt end 95 is
`disposed through a lumen 97 of the pusher member 93 and is used to guide the
`distal end of the catheter 91 to the desired site. Means 96 is also disposed
`through lumen 97 of the pusher member 93 for holding the valve 92 in place
`
`
`
`12
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 12 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`and allowing release of the valve 92 when desired, as will be more fully
`described in conjunction with FIGS. 14 and 15.
`
`Bessler at col. 6, lines 9-23.
`
`
`Bessler at FIG. 14 (showing artificial heart valve partially ejected).
`
`
`
`
`
`
`13
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 13 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`
`
`Bessler at FIG. 15 (showing artificial heart valve fully ejected).
`
`To the extent that the purpose of the “pusher member” is to eject or push out the
`replacement valve 101 from the catheter 102, the “pusher member” includes pair of threads
`105 with a loop 107 connected to the pusher member 103 because these items, in
`combination, facilitate the ejection of the prosthetic valve 101. As such, the “pusher
`member” (103, 105 and 107) passes through the interior of the artificial valve 101.
`Therefore, artificial valve 101 is collapsed onto the pusher member. The artificial valve 101
`is also collapsed onto the pusher member in the sense that when the artificial valve 101 is
`collapsed and restrained in the collapsed position by the inside wall of catheter 102, the
`diameter of the artificial valve 101 is approximately the same diameter of the pusher
`member 103 and for that reason is collapsed onto the distal end of the pusher member 103
`as shown in Fig. 14 above.
`
`To the extent that Patent Owner argues that Bessler does not disclose this element, Klint
`additionally teaches this element and it would have been obvious to a POSITA to combine
`Bessler with Leonhardt and Klint.
`
`
`
`
`14
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 14 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`For example, Klint broadly teaches a delivery system for implantable devices:
`
`
`In a second embodiment, the medical device may be a delivery system for a
`prosthesis such as a stent, a stent graft, a valve member, or a filter, wherein the
`prosthesis is compressible to be placed within a receptacle at the distal end of
`the delivery catheter and is then radially expandable upon delivery to a
`treatment site after being urged from receptacle.
`
`Klint at paragraph [0021]. Klint’s delivery system includes a shaft portion with a lumen
`extending along its length, wherein a self-expandable prosthesis is arranged in a receptacle
`at the distal end of the delivery device, and a pusher member with engagement means
`extends through the lumen of the delivery device, as shown in the following drawings:
`
`
`
`Klint at FIG. 13 (showing the delivery system).
`
`
`
`
`
`
`15
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 15 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`
`Klint at FIG. 16 (showing the distal end of the delivery system and a partially deployed
`prosthesis).
`
`Klint discloses embodiments with two alternative designs for the engagement of the pusher
`member with the prosthesis: (1) delivery systems where the pusher member is adjacent to
`and in contact with the prosthesis; and (2) delivery systems where the pusher member passes
`through the collapsed prosthesis. Klint further explains that the latter arrangement “can be
`an advantage if the prosthesis has an extensive length, and in particular if it has a
`construction having a tendency to buckle when pushed upon.”:
`
`
`At the distal end of the pusher member 216 an engagement means 222 can act
`on the prosthesis 220. The engagement means can be for example a plate of a
`dimension fitting into receptacle 208 and abutting the proximal end of the
`prosthesis so that the plate pushes the prosthesis out of the receptacle when the
`pusher member is pushed forwardly. The engagement means can also be
`designed as an elongate member that extends coaxially inside the radially
`compressed prosthesis and engages the prosthesis at several locations along
`the length thereof so that the prostheses is partly pulled, partly pushed out of
`the receptacle. These engagement points or areas can be effected by radial
`projections, hooks, ridges, or another kind of engagement means such as a high
`friction material. This can be an advantage if the prosthesis has an extensive
`
`
`
`16
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 16 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`length, and in particular if it has a construction having a tendency to buckle
`when pushed upon.
`
`Klint at paragraph [0094].
`
` A
`
` POSITA would have been motivated to modify Bessler and Leonhardt in light of the
`teachings of Klint, because a POSITA would recognize the advantage of this design, as
`explained by Klint (reducing the risk that the prosthesis will buckle or be damaged during
`delivery from having force applied to it by a pusher member located adjacent to the device).
`A POSITA would also have been motivated to make these combinations because a POSITA
`would recognize that collapsing the prosthesis onto the pusher member permits the
`operator to hold the apparatus steady, increasing the precision of device placement over
`pushing a device out of a catheter.
`
` A
`
` POSITA would have had a reasonable expectation of success in making these
`combinations, because these combinations represent a simple substitution of one known
`prior art delivery system element (a pusher member adjacent to the collapsed prosthesis)
`with another (a pusher member that extends through the interior of the collapsed prosthesis).
`Indeed, Klint’s use of these two delivery systems as alternatives demonstrates that a
`POSITA would have recognized their interchangeability. And the results of these
`combinations would be predictable as “[c]atheters for medical diagnostic or therapeutic use
`[were] [ ] well known”, including catheters that include “a pusher to push a device such as a
`stent from the distal end of the catheter.” Klint at paragraphs [0007]-[0009].
`
`Leonhardt provides further evidence that a POSITA would have had a reasonable
`expectation of success in making the combination of Bessler, Leonhardt, and Klint, because
`as discussed above, Leonhardt teaches embodiments in which portions of the delivery
`system pass through the interior of the prosthetic heart valve. Leonhardt at 6:46-49, 7:11-17,
`7:21-29, 8:23-31.
`
`Leonhardt discloses “the valve means resides entirely within the inner channel of the stent
`member in said collapsed configuration and is configured to continue to reside entirely
`within the inner channel of the stent member upon deployment in the patient”
`
`1.f
`
`the valve means resides
`entirely within the inner
`channel of the stent member
`
`
`
`17
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 17 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`in said collapsed
`configuration and is
`configured to continue to
`reside entirely within the
`inner channel of the stent
`member upon deployment in
`the patient
`
`
`For example,
`
`
`Stent 26 is a continuous super elastic nitenol wire having a distal end and a
`proximal end. Both the distal end and the proximal end are substantially
`identical, both forming a cylinder wall 64 of six zig-zags 40 or waves. Each
`end is pre-sized in diameter to be approximately thirty percent (30%) larger in
`diameter than the largest diameter of the tissue against which the valve stent
`20 (FIG. 3) will seal. The overall length of stent 26 is also pre-sized to be
`sufficient to maintain patency against fluid flow in the vessel or natural valve
`position, as well as completely support the biological valve (or mechanical or
`synthetic valve) without causing valve 22 to suffer prolapse or insufficiency.
`
`Leonhardt at col. 4, line 66 – col. 5, line 10.
`
`
`
`Biological valve 22 is preferably a porcine valve treated and prepared for use
`in a human. It has two or more commissural points 68 as is seen in FIG. 4.
`Biological valve 22 is attached to stent 26, to graft material 24, or both with
`sutures 60 or biocompatible adhesive or a combination of the two. Biological
`valve 22 is pre-sized to fit within the internal diameter of cylinder 48 formed
`by stent 26 attached to graft material 24. Attachment is along biological valve's
`22 commissural points 68 and around its base. Whereas a biological valve is
`preferred, a mechanical valve or a synthetic leaflet valve may also be
`employed.
`
`Leonhardt at col. 6, lines 9-23.
`
`
`
`
`
`18
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 18 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`
`Leonhardt at FIG. 3 (showing valve 22 in a collapsed configuration).
`
`
`
`
`
`19
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 19 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`2.
`
`The assembly of claim 1,
`wherein the stent member is
`self-expanding
`
`Leonhardt at FIG. 2 (showing valve 22 upon deployment in the patient).
`
`Leonhardt discloses “the stent member is self-expanding”
`
`For example,
`
`See claim 1 above, which is incorporated by reference.
`
`
`
`
`
`
`20
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 20 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`Valve stent 20 comprises a malleable graft material 24 enclosing deformable
`self-expanding stent 26 to which a biological valve 22 is attached.
`
`3.
`
`The assembly of claim 2,
`wherein the stent member
`comprises nitinol
`
`Bessler at col. 5, lines 45-47.
`
`Leonhardt discloses “the stent member comprises nitinol”
`
`For example,
`
`See claim 2 above, which is incorporated by reference.
`
`
`The nitinol wire used to form stent 26 is a super elastic straight annealed
`material formed substantially of titanium and nickel.
`
`5.
`
`The assembly of claim 1,
`wherein the pusher member
`includes a controlled release
`mechanism that can be
`activated
`
`Bessler at col. 6, lines 9-23
`
`Bessler discloses “the pusher member includes a controlled release mechanism that can be
`activated”
`
`See claim 1 above, which is incorporated by reference.
`
`
`To use Applicant's invention, a guidewire is inserted percutaneously and
`transluminally using standard vascular or angiography techniques. The distal
`end of the guidewire is manipulated to extend through and across the defective
`heart valve. Then a catheter corresponding to catheter 74 is advanced distally
`through the femoral artery to a point proximal to the defective heart valve,
`between the origin of the coronary artery and the origin of the right subclavian
`artery. The position of the distal end of catheter 74 can be monitored by
`observation of radiopaque markers. Collector member 80 is preferably inflated
`and occludes the aorta at a point between the origin of the coronary artery and
`the right subclavian artery.
`
`
`
`Bessler at col. 8, lines 7-15.
`
`
`21
`
`Colibri Heart Valve LLC, Exhibit 2014, Page 21 of 22
`
`

`

`Appendix A-4
`Invalidity of U.S. 9,125,739 in View of Bessler, Leonhardt, Klint and Rygg or Cox
`
`
`
`Once the distal end of the catheter is positioned as desired, the pusher
`mechanism is activated and the distal portion of the artificial heart valve is
`pushed out of the catheter and the stent member partially expands. In this
`position the stent member is restrained so that it doesn't pop out and is held for
`controlled release, with the potential that the artificial heart valve can be
`recovered if there is a pro