Appendix A-10
`Invalidity of U.S. 9,125,739 in View of Paniagua
`
`The asserted claims of the ‘739 patent are anticipated or obvious over United States Patent Publication No. 2005/0113910
`(“Paniagua”), 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.
`
`Paniagua was filed on July 10, 2004, published on May 26, 2005, and is prior art under 35 U.S.C. § 102(a), (b) and (e) because the
`’739 patent is not entitled to any priority date earlier than April 15, 2014.
`
`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 2016, Page 1 of 10
`
`

`

`
`
`Appendix A-10
`Invalidity of U.S. 9,125,739 in View of Paniagua
`
`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, Paniagua 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,
`
`
`The present invention comprises a percutaneously implantable replacement heart
`valve device and a method of making same. The replacement heart valve device
`comprises a stent member made of stainless steel or self-expanding nitinol, a
`biological tissue artificial valve means disposed within the inner space of the stent
`member. An implantation and delivery system having a central part which consists
`of a flexible hollow tube catheter that allows a metallic wire guide to be advanced
`inside it. The endovascular stented-valve is created from a glutaraldehyde fixed
`biocompatible tissue material which has two or three cusps that open distally to
`permit unidirectional blood flow. The present invention also comprises a novel
`method of making a replacement heart valve by taking a fragment of biocompatible
`tissue material and treating, drying, folding and rehydrating it in such a way that
`forms a two- or three-leaflet/cusp valve with the leaflets/cusps formed by folding,
`thereby eliminating the extent of suturing required, providing improved durability
`and function.
`
`Paniagua at Abstract.
`
`Paniagua 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, Paniagua’s artificial valve includes a stent member (100) having an inner channel:
`
`
`1.a
`
`a prosthetic heart valve
`including: a stent
`member having an
`inner channel, the stent
`member collapsible,
`expandable and
`configured for
`transluminal
`
`2
`
`Colibri Heart Valve LLC, Exhibit 2016, Page 2 of 10
`
`

`

`Appendix A-10
`Invalidity of U.S. 9,125,739 in View of Paniagua
`
`percutaneous delivery,
`wherein
`
`The valve means 200 is then attached to the inner channel of the stent member 100
`by suturing the outer surface of the valve means' pericardium material to the stent
`member.
`
`Paniagua at paragraph [0049]. Paniagua further discloses that the stent member collapsible,
`expandable and configured for transluminal percutaneous delivery:
`
`
`The present invention comprises a percutaneously implantable replacement heart
`valve and a method for making same. The artificial heart valve device of the present
`invention is capable of exhibiting a variable diameter between a compressed or
`collapsed position and an expanded position. A preferred embodiment of the
`replacement heart valve device according to the present invention is set forth in FIG.
`5. The replacement heart valve device comprises a stent member 100 and a flexible
`valve means 200. The stent member 100 is preferably self-expanding, although
`balloon-expandable stents can be used as well, and has a first polygonal shape in its
`compressed or collapsed configuration and a second, larger polygonal shape in its
`expanded configuration.
`
`Paniagua at paragraph [0037]. The drawings below show the expanded and collapsed
`configurations of the stent:
`
`
`
`
`
`3
`
`Colibri Heart Valve LLC, Exhibit 2016, Page 3 of 10
`
`

`

`Appendix A-10
`Invalidity of U.S. 9,125,739 in View of Paniagua
`
`Paniagua at FIG. 5 (showing stent in the 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
`
`Paniagua at FIG. 6 (showing stent in the collapsed configuration).
`
`Paniagua 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:
`
`
`
`
`The stent used in a preferred embodiment of the present invention is fabricated from
`a “shaped memory” alloy, nitinol, which is composed of nickel and titanium. Nitinol
`wire is first fashioned into the desired shape for the device and then the device is heat
`annealed. A meshwork of nitinol wire of approximately 0.008 inch gauge is formed
`into a tubular structure with a minimum central diameter of 20 min to make the stent.
`Away from its central portion, the tubular structure flares markedly at both ends in a
`trumpet-like configuration. The maximum diameter of the flared ends of the stent is
`approximately 50 mm. The purpose of the stent is to maintain a semi-rigid patent
`channel through the diseased cardiac valve following its implantation.
`
`1.c
`
`a valve means
`including two to four
`individual leaflets
`made of fixed
`pericardial tissue,
`
`
`Paniagua at paragraph [0041].
`
`Paniagua 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”
`
`
`4
`
`Colibri Heart Valve LLC, Exhibit 2016, Page 4 of 10
`
`

`

`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
`
`Appendix A-10
`Invalidity of U.S. 9,125,739 in View of Paniagua
`
`For example, Paniagua’s artificial valve includes two to four individual leaflets made of fixed
`pericardial tissue:
`
`
`The present invention also comprises a method of making a replacement heart valve
`device. In order to make the valve, the biocompatible tissue material is isolated and
`all the fat tissue and extra fibers are removed. Cleaning is preferably accomplished
`by using a hydromechanical force-based cleaning device to separate tissue layers and
`hydration with distilled water to remove unwanted layers. Once the pericardium is
`completely clean, it is subjected to photo-mechanical compression, then the valve is
`formed and placed in sequential solutions of isopropyl alcohol of about 70-100%,
`ethanol of about 70-100% glycerol and gluteraldehyde preferably at a concentration
`of about 0.07-25% for about 36 hours, respectively. The material is preferably
`photomechanically compressed to remove lipids and produce protein coagulation to
`make the surface smoother and more compact and biocompatible, decreasing the
`molecular distance of collagen fibers. The exposure to light and mechanical
`compression cause protein denaturation making the material stronger and more
`homogeneous and biocompatible. Gas sterilization can also be used to sterilize the
`tissue membrane material. The valve is formed by taking a flat sheet of the material
`and folding it in such a way that forms a three-leaflet or desired number of leaflet
`valve as shown in FIGS. 3A and 3B and/or FIGS. 9A, 9B and 9C. The folding of the
`pericardium material to create the cusps or leaflets reduces the extent of suturing
`otherwise required, and resembles the natural form and function of the valve leaflets.
`It also greatly reduces the risk of tearing of the cusps or leaflets, since they are
`integral to the valve rather than being attached by suturing.
`
`Paniagua at paragraph [0046]. Paniagua further discloses that the valve means (200) resides
`entirely within the inner channel of the stent member (100), and wherein no reinforcing members
`reside within the inner channel of the stent member:
`
`
`The valve means 200 is then attached to the inner channel of the stent member 100
`by suturing the outer surface of the valve means' pericardium material to the stent
`member. FIG. 7 depicts preferred suture points of one embodiment of the present
`invention: 3-point fixation or 6-point fixation at each border of the stent. Other
`
`5
`
`Colibri Heart Valve LLC, Exhibit 2016, Page 5 of 10
`
`

`

`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
`
`Appendix A-10
`Invalidity of U.S. 9,125,739 in View of Paniagua
`
`fixation schemes can be utilized, such as, by way of non-limiting example, fixation
`on both borders 18 points at each end following a single plane and 36 fixation points
`following to adjacent vertical planes. The use of only one plane of fixation points
`helps prevent systolic collapse of the proximal edge of the valve means. A fold on
`the border of the pericardium material prevents tearing. The attachment position of
`the valve is preferably closer to the proximal and wider part of the stent.
`
`Paniagua at paragraph [0049].
`
`Paniagua 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, Paniagua discloses a delivery system (400) that includes a pusher member (420) and
`a moveable sheath (460), the pusher member including a guidewire lumen (410), wherein the
`pusher member is disposed within a lumen (430) of the moveable sheath:
`
`
`The delivery and implantation system of the replacement artificial heart valve of the
`present invention percutaneously and transluminally includes a flexible catheter 400
`which may be inserted into a vessel of the patient and moved within that vessel as
`depicted in FIG. 8. The distal end 410 of the catheter 400, which is hollow and carries
`the replacement heart valve device of the present invention in its collapsed
`configuration, is guided to a site where it is desired to implant the replacement heart
`valve. The catheter has a pusher member 420 disposed within the catheter lumen 430
`and extending from the proximal end 440 of the catheter to the hollow section at the
`distal end 410 of the catheter.
`
`Referring to FIG. 8, the implantation system comprises a flexible hollow tube
`catheter 410 with a metallic guide wire 450 disposed within it. The stented valve
`device is collapsed over the tube and is covered by a moveable sheath 460. The
`moveable sheath 460 maintains the stented valve device in the collapsed position.
`
`Paniagua at paragraphs [0053]-[0054].
`
`
`6
`
`Colibri Heart Valve LLC, Exhibit 2016, Page 6 of 10
`
`

`

`Appendix A-10
`Invalidity of U.S. 9,125,739 in View of Paniagua
`
`Paniagua at FIG. 8.
`
`
`
`
`7
`
`Colibri Heart Valve LLC, Exhibit 2016, Page 7 of 10
`
`

`

`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
`
`Appendix A-10
`Invalidity of U.S. 9,125,739 in View of Paniagua
`
`Paniagua 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 distal end 410 of the catheter 400, which is hollow and carries the replacement
`heart valve device of the present invention in its collapsed configuration, is guided
`to a site where it is desired to implant the replacement heart valve. The catheter has
`a pusher member 420 disposed within the catheter lumen 430 and extending from
`the proximal end 440 of the catheter to the hollow section at the distal end 410 of the
`catheter. Once the distal end 410 of the catheter is positioned as desired, the pusher
`mechanism 420 is activated and the distal portion of the replacement heart valve
`device is pushed out of the catheter and the stent member 100 partially expands. In
`this position the stent member 100 is restrained so that it doesn't pop out and is held
`for controlled release, with the potential that the replacement heart valve device can
`be recovered if there is a problem with the positioning.
`
`1.f
`
`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
`
`Paniagua at paragraph [0053].
`
`Paniagua 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”
`
`For example, Paniagua discloses that the artificial valve resides entirely within the inner channel
`of the stent member:
`
`
`The valve means 200 is then attached to the inner channel of the stent member 100
`by suturing the outer surface of the valve means' pericardium material to the stent
`member.
`
`8
`
`Colibri Heart Valve LLC, Exhibit 2016, Page 8 of 10
`
`

`

`Appendix A-10
`Invalidity of U.S. 9,125,739 in View of Paniagua
`
`deployment in the
`patient
`
`Paniagua at paragraph [0049]. Paniagua further discloses that the artificial valve continues to
`reside entirely within the inner channel of the stent member upon deployment in the patient:
`
`
`Referring to FIG. 8, the implantation system comprises a flexible hollow tube
`catheter 410 with a metallic guide wire 450 disposed within it. The stented valve
`device is collapsed over the tube and is covered by a moveable sheath 460. The
`moveable sheath 460 maintains the stented valve device in the collapsed position.
`The implantation method comprises the following steps: inserting the replacement
`heart valve device in the lumen of a central blood vessel via entry through the
`brachial or femoral artery using a needle or exposing the artery surgically; placing a
`guide wire 450 through the entry vessel and advancing it to the desired position;
`advancing dilators over the wire to increase the lumen of the entry site, thereby
`preparing the artery to receive the heart-valve; and advancing the heart-valve device
`to the desired place. The stented-valve device is released by pulling the cover
`sheath 460 of the delivery system allowing the self-expanding stent to achieve its full
`expansion.
`
`2.
`
`The assembly of claim
`1, wherein the stent
`member is self-
`expanding.
`
`Paniagua at paragraph [0054].
`
`Paniagua discloses “the stent member is self-expanding.”
`
`For example:
`
`See claim 1 above, which is incorporated by reference.
`
`
`The replacement heart valve device comprises a stent member made of stainless steel
`or self-expanding nitinol, a biological tissue artificial valve means disposed within
`the inner space of the stent member.
`
`3.
`
`The assembly of claim
`2, wherein the stent
`
`Paniagua at Abstract.
`
`Paniagua discloses “the stent member comprises nitinol.”
`
`For example,
`
`9
`
`Colibri Heart Valve LLC, Exhibit 2016, Page 9 of 10
`
`

`

`Appendix A-10
`Invalidity of U.S. 9,125,739 in View of Paniagua
`
`member comprises
`nitinol.
`
`
`See claim 2 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.
`
`The replacement heart valve device comprises a stent member made of stainless steel
`or self-expanding nitinol, a biological tissue artificial valve means disposed within
`the inner space of the stent member.
`
`Paniagua at Abstract.
`
`Paniagua discloses “the pusher member includes a controlled release mechanism that can be
`activated.”
`
`For example:
`
`See claim 1 above, which is incorporated by reference.
`
`
`Once the distal end 410 of the catheter is positioned as desired, the pusher
`mechanism 420 is activated and the distal portion of the replacement heart valve
`device is pushed out of the catheter and the stent member 100 partially expands. In
`this position the stent member 100 is restrained so that it doesn't pop out and is held
`for controlled release, with the potential that the replacement heart valve device can
`be recovered if there is a problem with the positioning. The catheter 400 is then
`retracted slightly and the replacement heart valve device is completely pushed out of
`the catheter 400 and released from the catheter to allow the stent member 100 to fully
`expand.
`
`Paniagua at paragraph [0053].
`
`
`
`
`
`
`
`
`
`
`10
`
`Colibri Heart Valve LLC, Exhibit 2016, Page 10 of 10
`
`