`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`The asserted claims of the ‘739 patent are anticipated or obvious over United States Patent No. 5,855,601 (“Bessler”) and U.S. Patent
`No. 5,332,402 (“Teitelbaum”), 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 2013, Page 1 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`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 Teitelbaum, which was filed on May 12, 1992, published on July 26, 1994, 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 discloses “[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 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.
`
`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
`
`Bessler at col. 7, lines 35-38.
`
`Bessler 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, Bessler discloses an artificial heart valve with a stent member that is self-
`expandable:
`
`
`
`
`2
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 2 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`The invention includes a new heart valve which may be implanted
`percutaneously and transluminally, which heart valve comprises a stent
`member and a valve means. The stent member is self-expanding and has within
`it valve means that permit flow in only one direction.
`
`Bessler at col. 2, lines 57-62. Bessler further discloses that the artificial heart valve is
`configured for percutaneous delivery.
`
`
`The present invention includes methods and devices for implanting a heart
`valve percutaneously and transluminally. The artificial heart valves of the
`invention, which are capable of exhibiting a variable diameter between a
`compressed or collapsed position and an expanded position, comprise (1) a
`relatively rigid stent member and (2) a flexible valve means. The stent member
`is self-expanding and has a first cylindrical shape in its compressed or
`collapsed configuration and a second, larger cylindrical shape in its expanded
`configuration.
`
`Bessler at col. 3, lines 46-55. The drawings below show the stent in an expanded and
`collapsed configuration:
`
`
`
`
`
`
`
`
`3
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 3 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`Bessler at FIG. 4 (showing stent in an expanded configuration).
`
`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
`
`
`
`Bessler at FIG. 5 (showing stent in a collapsed configuration).
`
`
`
`The combination of Bessler and U.S. Patent No. 5,332,402 (“Teitelbaum”) 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, Teitelbaum teaches a tubular structure away from a central portion that flares
`at both ends in a trumpet-like configuration:
`
`
`The percutaneous cardiac valve has two possible designs, each of which
`consists of two components. In the first design, one of the components is a
`meshwork of nitinol wire of approximately 0.008 inch gauge formed into a
`tubular structure with a minimum central diameter of 20 min. Away from its
`central portion, the tubular structure flares markedly at both ends in a trumpet-
`like configuration. The maximum longitudinal dimension of this component
`which shall be referred to as the stent or doubly-flared stent is approximately
`20 mm. The maximum diameter of the flared ends of the stent is approximately
`30 mm. The purpose of the stent is to maintain a semi-rigid patent channel
`through the diseased cardiac valve following its balloon dilation. The flared
`
`
`
`4
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 4 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`ends of the stent maintain the position of this component across the native
`valve following deployment. The stent contains a thin hydrophilic plastic
`coating that helps prevent thrombus formation along the inner surface of the
`stent.
`
`Teitelbaum at col. 2, lines 21-39.
`
`
`
`
`Teitelbaum at FIG. 2.
`
`
`Both Bessler and Teitelbaum recognize the desirability of “anchor[ing] the expanded stent
`member at a desired site” Bessler at col. 2, lines 62-63). Bessler teaches the optional use of
`barbs to aid in achieving this goal (id.). Teitelbaum explains that the purpose of the flared
`stent is to “maintain the position of this component across the native valve following
`deployment” Teitelbaum at col. 2, lines 34-36 and col. 5, lines 63-65. Thus, a POSITA
`
`
`
`5
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 5 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`1.c
`
`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
`
`would have been motivated to modify Bessler’s device by using a flared stent as taught by
`Teitelbaum in conjunction with, or as an alternative to, Bessler’s optional barbs in order to
`better anchor the device in place and improve sealing, reducing leakage of blood around the
`valve device (known as “paravalvular leakage”).
`
`Bessler 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, Bessler’s valve includes two to four individual leaflets made of fixed
`pericardial tissue:
`
`
`The invention can perhaps be better appreciated by reference to the drawings.
`An artificial heart valve according to the present invention is set forth in FIGS.
`1 to 3. The artificial heart valve 20 is comprised of a stent member 21 and a
`flexible valve means 22. In this embodiment the stent member 21 is comprised
`of stainless steel wire in a sine wave-like configuration as shown in FIG. 1.
`The center portion 23 of valve member 22 is generally arcuate in shape and
`comprises three leaflets 24 as shown, although it is understood that there could
`be from 2 to 4 leaflets. A cuff portion 25 extends from the periphery of the
`circular portion 27 along the outside of the stent member 21 and is attached to
`the stent member 21 by a plurality of sutures 26.
`
`Bessler at col. 5, lines 15-27. To the extent that Bessler does not disclose that the porcine
`pericardium is fixed, it would have been obvious to a POSITA to fix the porcine
`pericardium valve with, for example, glutaraldehyde to improve antigenicity as such was
`well-known in the art as recognized in Bessler at 6:19-23 and in other prior art including
`U.S. Pat. No. 5713950 (“Cox”) at 4:42-45 and 6:26-32, and U.S. Pat. No. 4218782 (Rygg)
`at 2:1-12.
`
`
`
`
`
`6
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 6 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`Bessler at FIG. 2
`
`
`
`
`
`
`Bessler at FIG. 3
`
`
`Bessler further discloses that valve resides entirely within an inner channel of the stent
`member:
`
`
`
`7
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 7 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`The flexible valve means is disposed within the cylindrical stent member with
`the arcuate portion transverse of and at some acute angle relative to the stent
`walls.
`
`Bessler at col. 3, lines 57-60.
`
`To the extent that Patent Owner argues that Bessler’s “cuff portion” is part of the valve
`means, Bessler discloses a cuff portion that can be, but is not required to be, on the outside
`of the stent.
`
`For example,
`
`
`In some of the preferred embodiments of the artificial heart valve of the
`invention, the cuff portion of the valve means extends on only one side of the
`circular portion of the stent member. The flexible valve means preferably
`comprises porcine pericardium configured with three leaflets.
`
`Bessler at col. 4, lines 6-11.
`
`
`According to claim 1 of Bessler, the “cuff portion” is on the outer surface of the stent:
`
`
`An artificial heart valve comprising
`
`a self-expanding, cylindrical stent member having first and second ends and
`an outer surface, and
`
`a valve member comprising one-way valve means arranged within the stent
`and a cuff portion extending on said outer surface to a point between the
`first and second ends,
`
`wherein the cuff portion is configured to position the valve snugly and
`sealingly at a valve site; and
`
`
`
`8
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 8 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`wherein the stent member has a plurality of barbs extending from the outer
`surface of the stent member to engage the natural tissue of the heart to hold the
`valve in place after implantation.
`
`Bessler at claim 1 (emphasis added).
`
`
`According to claim 13 of Bessler, the “cuff portion” is on the inner surface of the stent:
`
`
`An artificial heart valve comprising a relatively rigid stent member and a
`flexible valve means disposed in said stent member, said stent member
`comprising a wire formed into a closed zig-zag configuration having an
`endless series of straight sections and a plurality of bends connecting said
`straight sections, said stent member having a first collapsed cylindrical shape
`and being self-expandable to a second expanded cylindrical shape, said stent
`member having a plurality of barbs extending from its outer surface, said valve
`member comprising a circular portion, said circular portion having a
`plurality of leaflets extending from the periphery of said circular portion
`towards the center thereof, said leaflets allowing for flow of blood through
`the valve in one direction only, the diameter of said circular portion being
`substantially the same as the inside diameter of said stent member when
`said stent member is in its expanded cylindrical shape, said valve member
`having a cuff portion extending from the periphery of said circular
`portion, said cuff portion being disposed downstream of said valve
`member and substantially parallel to the cylindrical surface of said stent
`member and said cuff portion being attached to said stent member with a
`plurality of sutures.
`
`1.d
`
`a delivery system including a
`pusher member and a
`moveable sheath, the pusher
`
`
`
`Bessler at claim 13 (emphasis added).
`
`
`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”
`
`9
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 9 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`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.
`
`Bessler at col. 6, lines 9-23.
`
`
`
`Bessler at FIG. 12.
`
`
`10
`
`
`
`
`
`
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 10 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`
`
`
`Bessler at FIG. 13.
`
`
`
`
`
`
`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
`
`1.e
`
`
`
`
`
`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:
`
`
`11
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 11 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`moveable sheath, wherein a
`distal end of the prosthetic
`heart valve is located at a
`distal end of the moveable
`sheath, and wherein
`
`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
`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).
`
`
`
`
`
`12
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 12 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`
`
`
`
`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 artificial
`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 artificial valve 101. As such, the “pusher member” (103, 105
`and 107) passes through the interior of the replacement valve 101. Therefore, artificial valve
`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.
`
`Bessler 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
`in said collapsed
`
`
`
`13
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 13 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`configuration and is
`configured to continue to
`reside entirely within the
`inner channel of the stent
`member upon deployment in
`the patient
`
`For example,
`
`See claim 1.c above, which is incorporated by reference. Bessler’s artificial valve resides
`entirely within an inner channel of the stent member:
`
`
`The flexible valve means is disposed within the cylindrical stent member with
`the arcuate portion transverse of and at some acute angle relative to the stent
`walls.
`
`Bessler at col. 3, lines 57-60. The drawings below show the valve means residing entirely
`within the inner channel of the stent member in collapsed configuration and expanded
`configuration:
`
`
`Bessler at FIG. 5 (showing stent in a collapsed configuration).
`
`
`
`
`
`
`
`14
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 14 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`
`Bessler at FIG. 4 (showing stent in a fully expanded configuration). The drawing below
`shows the valve means fully ejected in an expanded configuration:
`
`
`
`
`Bessler at FIG. 15 (showing artificial heart valve fully ejected).
`
`
`
`
`
`
`15
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 15 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`2.
`
`The assembly of claim 1,
`wherein the stent member is
`self-expanding
`
`Bessler discloses “the stent member is self-expanding.”
`
`For example,
`
`See claim 1 above, which is incorporated by reference.
`
`
`An artificial heart valve comprises a relatively rigid stent member having a
`first cylindrical shape and a flexible valve disposed in the stent member, the
`stent member being self-expandable to a second cylindrical shape and
`collapsible to its first cylindrical shape.
`
`3.
`
`The assembly of claim 2,
`wherein the stent member
`comprises nitinol
`
`Bessler at Abstract.
`
`Bessler discloses “the stent member comprises nitinol.”
`
`For example,
`
`See claim 2 above, which is incorporated by reference.
`
`
`The stent members of the artificial heart valves of the present invention may
`be made from Elgiloy alloy, titanium, titanium alloy, nitinol, stainless steel, or
`other
`resilient,
`flexible non-toxic, non-thrombogenic, physiologically
`acceptable and biocompatible materials.
`
`Bessler at col. 6, lines 3-7.
`
`Bessler discloses “the pusher member includes a controlled release mechanism that can be
`activated”
`
`For example,
`
`See claim 1 above, which is incorporated by reference.
`
`
`5.
`
`The assembly of claim 1,
`wherein the pusher member
`includes a controlled release
`mechanism that can be
`activated.
`
`
`
`16
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 16 of 17
`
`
`
`Appendix A-3
`Invalidity of U.S. 9,125,739 in View of Bessler and Teitelbaum
`
`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 problem with the positioning or the like. The catheter is
`them retracted slightly and the artificial heart valve is completely pushed out
`of the catheter and released from the catheter to allow the stent member to fully
`expand.
`
`Bessler at col. 4, line 63- col. 5, line 6.
`
`
`
`
`
`
`
`
`
`17
`
`Colibri Heart Valve LLC, Exhibit 2013, Page 17 of 17
`
`