Case 8:20-cv-00847-DOC-JDE Document 30-3 Filed 06/12/20 Page 1 of 14 Page ID #:236
`
`
`
`
`
`
`
`EXHIBIT A
`
`Edwards Lifesciences Corporation, et al. Exhibit 1022, p. 1 of 14
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Claim
`
`Claim Element
`An assembly to treat a native heart
`valve in a patient, the assembly for
`use in combination with a guidewire,
`the assembly comprising1:
`
`1
`
`a prosthetic heart valve including:
`
`Case 8:20-cv-00847-DOC-JDE Document 30-3 Filed 06/12/20 Page 2 of 14 Page ID #:237
`
`CoreValve
`(Gen 1)
`The Medtronic CoreValve system is an
`assembly to treat a native heart valve in a
`patient in combination with a guidewire.
`
`For example:
`“The Medtronic CoreValve™ system
`consists of 3 components: the transcatheter
`aortic valve (bioprosthesis), the delivery
`catheter system (catheter), and the
`compression loading system (CLS)…. It is
`designed to replace the native or surgical
`bioprosthetic aortic heart valve without
`open heart surgery and without concomitant
`surgical removal of the failed valve…. The
`catheter with AccuTrak™ stability layer is
`compatible with a 0.035 in (0.889 mm)
`guidewire.” (Medtronic, Inc., CoreValve™
`System Instructions For Use (“IFU”), 2014,
`vdocuments.mx/reader/full/corevalve-
`system-transcatheter-aortic-valve-delivery-
`catheter-, at p. 2; Medtronic, CoreValve™
`System Instructions For Use (“IFU”), 2017,
`at pp. 2, 11, 17, 27, 30-31.)
`
`’739 Patent – Medtronic’s Infringing Products
`Evolut R
`(Gen 2)
`The Medtronic CoreValve™ Evolut™ R
`system is an assembly to treat a native
`heart valve in a patient in combination
`with a guidewire.
`
`For example:
`“The Medtronic CoreValve™ Evolut™
`R system is a recapturable transcatheter
`aortic valve implantation system, which
`includes the CoreValve™ Evolut™ R
`transcatheter aortic valve (bioprosthesis),
`the EnVeo™ R delivery catheter system
`(catheter), and the EnVeo™ R loading
`system (LS)…. It is designed to replace
`the native or surgical bioprosthetic aortic
`heart valve without open heart surgery
`and without concomitant surgical
`removal of the failed valve…. The
`catheter assembly is flexible and
`compatible with a 0.035 in (0.889 mm)
`guidewire.” (Medtronic, CoreValve™
`Evolut™ R System Instructions For Use
`(“IFU”), 2017, at p. 3.)
`
`Evolut Pro
`(Gen 3)
`“The Medtronic CoreValve™ Evolut™
`PRO system is an assembly to treat a
`native heart valve in a patient in
`combination with a guidewire.
`
`For example:
`“The Medtronic CoreValve™ Evolut™
`PRO system is a recapturable transcatheter
`aortic valve replacement system, which
`includes the CoreValve™ Evolut™ PRO
`transcatheter aortic valve (bioprosthesis),
`the EnVeo™ R delivery catheter system
`(catheter), and the EnVeo™ R loading
`system (LS)…. It is designed to replace
`the native or surgical bioprosthetic aortic
`heart valve without open heart surgery and
`without concomitant surgical removal of
`the failed valve…. The catheter assembly
`is flexible and compatible with a 0.035 in
`(0.889 mm) guidewire.” (Medtronic,
`CoreValve™ Evolut™ PRO System
`Instructions For Use (“IFU”), 2017, at pp.
`3-4, 14, 15, 21-22, 30-35.)
`
`Evolut Pro+
`(Gen 4)
`“The Medtronic Evolut™ PRO+ system is
`an assembly to treat a native heart valve in
`a patient in combination with a guidewire.
`
`For example:
`“The Medtronic Evolut™ PRO+ system is
`a recapturable transcatheter aortic valve
`replacement system, which includes the
`Evolut PRO+ transcatheter aortic valve
`(bioprosthesis)a, the delivery catheter
`system (catheter), and the loading system
`(LS)…. It is designed to replace the native
`or surgical bioprosthetic aortic heart valve
`without open heart surgery and without
`concomitant surgical removal of the failed
`valve…. The catheter assembly is flexible
`and compatible with a 0.035 in (0.889
`mm) guidewire. (Medtronic, Evolut™
`PRO+ System Instructions For Use
`(“IFU”), 2019, at pp. 2-3.)
`
`The Medtronic CoreValve system
`includes a prosthetic heart valve.
`
`For example:
`“The terms ‘bioprosthesis’ and
`‘transcatheter aortic valve’ are
`synonymous terms and are used
`interchangeably throughout the document
`to refer to the CoreValve™ device…. It is
`designed to replace the native or surgical
`bioprosthetic aortic heart valve without
`
`The Medtronic CoreValve™ Evolut™ R
`system includes a prosthetic heart valve.
`
`For example:
`“The terms ‘bioprosthesis’ and
`‘transcatheter aortic valve’ are
`synonymous terms and are used
`interchangeably throughout the document
`to refer to the CoreValve™ Evolut™ R
`device…. It is designed to replace the
`native or surgical bioprosthetic aortic
`
`The Medtronic CoreValve™ Evolut™
`PRO system includes a prosthetic heart
`valve.
`
`For example:
`“The terms ‘bioprosthesis' and
`‘transcatheter aortic valve’ are
`synonymous terms and are used
`interchangeably throughout the document
`to refer to the CoreValve™ Evolut™ PRO
`device…. It is designed to replace the
`
`The Medtronic Evolut™ PRO+ system
`includes a prosthetic heart valve.
`
`For example:
`“The terms ‘bioprosthesis’ and
`‘transcatheter aortic valve’ are
`synonymous terms and are used
`interchangeably throughout the document
`to refer to the Evolut PRO+ device…. It is
`designed to replace the native or surgical
`bioprosthetic aortic heart valve without
`
`
`1 Colibri does not concede that the preamble is limiting. Additionally, this Exhibit A to the First Amended Complaint is meant to illustrate Plaintiff’s infringement allegations made in the First Amended Complaint and is not meant to
`permanently restrict or limit Plaintiff’s claims, which may be amended under the Federal and Local Rules based on discovery and further case proceedings, including, but not limited to, formally served infringement contentions.
`
`
`
`Exhibit A
`76
`
`Edwards Lifesciences Corporation, et al. Exhibit 1022, p. 2 of 14
`
`

`

`Claim
`
`Claim Element
`
`a stent member having an inner
`channel,
`
`Case 8:20-cv-00847-DOC-JDE Document 30-3 Filed 06/12/20 Page 3 of 14 Page ID #:238
`
`CoreValve
`(Gen 1)
`open heart surgery and without
`concomitant surgical removal of
`the failed valve.” (Medtronic
`CoreValve™ System IFU 2014, at p. 2;
`Medtronic CoreValve™ System IFU
`2017, at p. 2.)
`
`The Medtronic CoreValve system
`includes a stent member having an inner
`channel.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and a skirt, made
`from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of Nitinol.”
`(Medtronic CoreValve™ System IFU 201,
`at p. 2; Medtronic CoreValve™ System
`IFU 2017, at p. 2.)
`
`Evolut R
`(Gen 2)
`heart valve without open heart surgery and
`without concomitant surgical removal of
`the failed valve.” (Medtronic
`CoreValve™ Evolut™ R System IFU
`2017, at p. 3.)
`
`Evolut Pro
`(Gen 3)
`native or surgical bioprosthetic aortic
`heart valve without open heart surgery and
`without concomitant surgical removal of
`the failed valve.” (Medtronic Evolut™
`PRO System IFU 2017, at p. 3.)
`
`Evolut Pro+
`(Gen 4)
`open heart surgery and without
`concomitant surgical removal of the failed
`valve.” (Medtronic Evolut™ PRO+ System
`IFU 2019, at p. 2.)
`
`The Medtronic CoreValve™ Evolut™ R
`system includes a stent member having an
`inner channel.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and a skirt, made
`from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of Nitinol.”
`(Medtronic CoreValve™ Evolut™ R
`System IFU 2017, at p. 3; Medtronic,
`CoreValve™ Evolut™ R System
`Instructions for Use (“IFU”), 2019, at p.
`3.)
`
`
`
`The Medtronic CoreValve™ Evolut™
`PRO system includes a stent member
`having an inner channel.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and an inner skirt,
`made from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of Nitinol.”
`(Medtronic Evolut™ PRO System IFU
`2017, at p. 3; Medtronic Evolut™ PRO
`System Instructions For Use (“IFU”)
`2019, at p. 3.)
`
`
`
`
`
`The Medtronic Evolut™ PRO+ system
`includes a stent member having an inner
`channel.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and an inner skirt,
`made from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of Nitinol.”
`(Medtronic Evolut™ PRO+ System IFU
`2019, at p. 2.)
`
`
`
`(Medtronic, CoreValve™ Evolut™ R
`System Product Brochure (“PB”), 2017, at
`p. 3.)
`
`
`
`(Medtronic, Evolut™ PRO System Product
`Brochure (“PB”), 2017, at p. 5.)
`
`
`(Medtronic, Evolut™ PRO+ Product
`Brochure (“PB”), 2019, at p, 1.)
`
`Exhibit A
`77
`
`
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1022, p. 3 of 14
`
`

`

`
`
`
`
`Claim
`
`Claim Element
`the stent member collapsible,
`expandable and configured for
`transluminal percutaneous delivery,
`
`Case 8:20-cv-00847-DOC-JDE Document 30-3 Filed 06/12/20 Page 4 of 14 Page ID #:239
`
`Evolut R
`(Gen 2)
`The Evolut R stent member is collapsible,
`expandable and configured for
`transluminal percutaneous delivery.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and a skirt, made
`from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of
`Nitinol…. Note: Vascular access should
`be achieved per standard practice (either
`percutaneously or via surgical cutdown).
`Note: The primary access artery will be
`used to introduce the CoreValve™
`Evolut™ R device and, if predilatation is
`performed, the balloon catheter; the
`secondary access artery will be used to
`introduce the reference pigtail.”
`(Medtronic CoreValve™ Evolut™ R
`System IFU 2017, at pp. 3, 24-34;
`Medtronic CoreValve™ Evolut™ R
`System IFU 2019, at pp. 3, 26-43.)
`
`Evolut Pro
`(Gen 3)
`The Evlolut Pro stent member is
`collapsible, expandable and configured
`for transluminal percutaneous delivery.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and an inner skirt,
`made from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of
`Nitinol…. Note: Vascular access should
`be achieved per standard practice (either
`percutaneously or via surgical cutdown).
`Note: The primary access artery will be
`used to introduce the CoreValve™
`Evolut™ PRO device and, if predilatation
`is performed, the balloon catheter; the
`secondary access artery will be used to
`introduce the reference pigtail.”
`(Medtronic Evolut™ PRO System IFU
`2017, at pp. 3, 25-34; Medtronic Evolut™
`PRO System IFU 2019, at pp. 3, 26-42.)
`
`
`
`Evolut Pro+
`(Gen 4)
`The Evolut Pro + stent member is
`collapsible, expandable and configured
`for transluminal percutaneous delivery.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and an inner skirt,
`made from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of
`Nitinol…. Note: Vascular access should
`be achieved per standard practice (either
`percutaneously or via surgical cutdown).
`Note: The primary access artery will be
`used to introduce the Evolut PRO+ device
`and, if predilatation is performed, the
`balloon catheter; the secondary access
`artery will be used to introduce the
`reference pigtail.” (Medtronic Evolut™
`PRO+ System IFU 2019, at pp. 2, 30.)
`
`“The Evolut TAV’s supra-annular, self-
`expanding valve design delivers
`exceptional hemodynamics and is the only
`TAVR device to demonstrate
`hemodynamic superiority in a low-risk
`clinical trial vs. SAVR.” (Medtronic
`Evolut™ PRO+ PB 2019, at p. 3.)
`
`CoreValve
`(Gen 1)
`The CoreValve stent member is
`collapsible, expandable and configured
`for transluminal percutaneous delivery.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and a skirt, made
`from a single layer of porcine pericardium,
`onto a self-expanding, multi-level,
`radiopaque frame made of Nitinol…. Note:
`Vascular access should be achieved per
`hospital protocol (either percutaneously or
`via surgical cutdown). Note: The primary
`access artery will be used to introduce the
`CoreValve™ system and, if predilatation is
`performed, the balloon catheter; the
`secondary access artery will be used to
`introduce the reference pigtail.” (Medtronic
`CoreValve™ System IFU 2014, at pp. 2,
`22-30; Medtronic CoreValve™ System IfU
`2017, at pp. 2, 21-29.)
`
`“The leaflets that control the flow of blood
`are secured to a flexible, self-expanding
`metal frame (nickel-titanium) for
`support.” (Medtronic, Inc., CoreValve®
`TransCatheter Aortic Valve Replacement
`(TAVR) Platform Patient Booklet, 2014, at
`p. 5.)
`
`“A Typical CoreValve® Transcatheter
`Procedure …. 2. The interventional
`cardiologist or cardiac surgeon will make
`an incision and guide a long, hollow tube
`(sheath) into your blood vessel.”
`(Medtronic, Inc., CoreValve®
`TransCatheter Aortic Valve
`Replacement (TAVR) Platform Patient
`Booklet, 2014, at p. 8.)
`
`
`
`
`
`
`
`Exhibit A
`78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1022, p. 4 of 14
`
`

`

`
`
`
`
`Claim
`
`Claim Element
`wherein the stent member includes a
`tubular structure away from a central
`portion that flares at both ends in a
`trumpet-like configuration;
`
`Case 8:20-cv-00847-DOC-JDE Document 30-3 Filed 06/12/20 Page 5 of 14 Page ID #:240
`
`CoreValve
`(Gen 1)
`The CoreValve stent member includes a
`tubular structure away from a central
`portion that flares at both ends in a trumpet-
`like configuration.
`
`As depicted in Medtronic’s own
`documents, the CoreValve stent member
`includes a tubular structure away from a
`central portion that flares at both ends in a
`trumpet like configuration.
`
`For example:
`
`Evolut R
`(Gen 2)
`The Evolut R stent member includes a
`tubular structure away from a central
`portion that flares at both ends in a trumpet-
`like configuration.
`
`As depicted in Medtronic’s own
`documents, the Evolut R stent member
`includes a tubular structure away from a
`central portion that flares at both ends in a
`trumpet like configuration.
`
`For example:
`
`Evolut Pro
`(Gen 3)
`The Evolut Pro stent member includes a
`tubular structure away from a central
`portion that flares at both ends in a trumpet-
`like configuration.
`
`As depicted in Medtronic’s own
`documents, the Evolut Pro stent member
`includes a tubular structure away from a
`central portion that flares at both ends in a
`trumpet like configuration.
`
`For example:
`
`Evolut Pro+
`(Gen 4)
`The Evolut Pro+ stent member includes a
`tubular structure away from a central
`portion that flares at both ends in a trumpet-
`like configuration.
`
`As depicted in Medtronic’s own
`documents, the Evolut Pro+ stent member
`includes a tubular structure away from a
`central portion that flares at both ends in a
`trumpet like configuration.
`
`For example:
`
`
`(Medtronic Evolut™ PRO System PB 2017,
`at p. 3.)
`
`
`
`
`
`
`“22. After attaining optimal catheter
`position, slowly turn the micro knob and
`begin to deploy the bioprosthesis. As the
`inflow aspect of the bioprosthesis starts to
`flare outward, monitor bioprosthesis
`position under fluoroscopy.” (Medtronic
`CoreValve™ System IFU 2014, at pp. 2,
`29; Medtronic CoreValve™ System IFU
`2017, at pp. 2, 28.)
`
`
`
`(Medtronic CoreValve™ Evolut™ R
`System PB 2017, at pp. 2, 3, 4.)
`
`
`
`(Medtronic Evolut™ PRO System IFU
`2017, at p. 3; Medtronic Evolut™ PRO
`System IFU 2019, at p. 3.)
`
`
`
`
`
`Exhibit A
`79
`
`
`(Medtronic Evolut™ PRO+ PB 2019, at p.
`3.)
`
`(Medtronic, Evolut™ PRO+ TAVR
`Product Specifications, 2019, at p. 1.)
`
`
`
`
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1022, p. 5 of 14
`
`

`

`Case 8:20-cv-00847-DOC-JDE Document 30-3 Filed 06/12/20 Page 6 of 14 Page ID #:241
`
`Claim
`
`Claim Element
`
`CoreValve
`(Gen 1)
`
`Evolut R
`(Gen 2)
`
`Evolut Pro
`(Gen 3)
`
`Evolut Pro+
`(Gen 4)
`
`and a valve means including two to
`four individual leaflets made of fixed
`pericardial tissue,
`
`The CoreValve stent member includes a
`valve means including two to four
`individual leaflets made of fixed pericardial
`tissue.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and a skirt, made
`from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of Nitinol.”
`(Medtronic CoreValve™ System IFU
`2014, at p. 2; Medtronic CoreValve™
`System IFU 2017, at p. 2.)
`
`
`
`(Medtronic CoreValve™ Evolut™ R
`System IFU 2017, at p. 3; Medtronic
`CoreValve™ Evolut™ R System IFU 2019,
`at p. 3.)
`
`The Evolur R stent member includes a
`valve means including two to four
`individual leaflets made of fixed pericardial
`tissue.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and a skirt, made
`from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of Nitinol.”
`(Medtronic CoreValve™ Evolut™ R
`System IFU 2017, at p. 3; Medtronic
`CoreValve™ Evolut™ R System IFU
`2019, at p. 3.)
`
`
`
`(Medtronic Evolut™ PRO+ System IFU
`2019, at p. 2.)
`
`The Evolut Pro stent member includes a
`valve means including two to four
`individual leaflets made of fixed pericardial
`tissue.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and an inner skirt,
`made from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of Nitinol.”
`(Medtronic Evolut™ PRO System IFU
`2017, at p. 3; Medtronic Evolut™ PRO
`System IFU 2019, at p. 3.)
`
`The Evolut Pro+ stent member includes a
`valve means including two to four
`individual leaflets made of fixed
`pericardial tissue.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and an inner skirt,
`made from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of Nitinol.”
`(Medtronic Evolut™ PRO+ System IFU
`2019, at p. 2.)
`
`Exhibit A
`80
`
`
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1022, p. 6 of 14
`
`

`

`
`
`
`
`Claim
`
`Claim Element
`wherein the valve means resides
`entirely within the inner channel of
`the stent member,
`
`Case 8:20-cv-00847-DOC-JDE Document 30-3 Filed 06/12/20 Page 7 of 14 Page ID #:242
`
`CoreValve
`(Gen 1)
`The valve in the CoreValve stent member
`resides entirely within the inner channel
`of the stent member.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and a skirt, made
`from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of Nitinol.”
`(Medtronic CoreValve™ System IFU
`2014, at p. 2; Medtronic CoreValve™
`System IFU 2017, at p. 2.)
`
`
`Evolut R
`(Gen 2)
`The valve in the Evolut R stent member
`resides entirely within the inner channel
`of the stent member.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and a skirt, made
`from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of Nitinol.”
`(Medtronic CoreValve™ Evolut™ R
`System IFU 2017, at p. 3; Medtronic
`CoreValve™ Evolut™ R System IFU
`2019, at p. 3.)
`
`
`
`Evolut Pro
`(Gen 3)
`The valve in the Evolut Pro stent member
`resides entirely within the inner channel
`of the stent member.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and an inner skirt,
`made from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of Nitinol.”
`(Medtronic Evolut™ PRO System IFU
`2017, at p. 3; Medtronic Evolut™ PRO
`System IFU 2019, at p. 3.)
`
`
`
`“The bioprosthesis has a porcine
`pericardial tissue outer skirt (wrap), which
`is 1.5 cells in height and is sutured to the
`inflow section of the bioprosthesis.”
`(Medtronic Evolut™ PRO System IFU
`2017, at p. 3; Medtronic Evolut™ PRO
`System IFU 2019, at p. 3.) The outer skirt
`is not part of the “valve means.”
`
`Evolut Pro+
`(Gen 4)
`The valve in the Evolut Pro+ stent
`member resides entirely within the inner
`channel of the stent member.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and an inner skirt,
`made from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of Nitinol.”
`(Medtronic Evolut™ PRO+ System IFU
`2019, at p. 2.)
`
`“The bioprosthesis has a porcine pericardial
`tissue outer skirt (wrap), which is 1.5 cells
`in height and is sutured to the inflow
`section of the bioprosthesis.” (Medtronic
`Evolut™ PRO+ System IFU 2019, at p. 2.)
`The outer skirt is not part of the “valve
`means.”
`
`and wherein no reinforcing members
`reside within the inner channel of the
`stent member;
`
`No reinforcing members are present
`within the inner channel of the
`CoreValve stent member.
`
`
`No reinforcing members are present
`within the inner channel of the
`Evolut R stent member.
`
`For example:
`
`No reinforcing members are present
`within the inner channel of the
`Evolut Pro stent member.
`
`For example:
`
`No reinforcing members are present
`within the inner channel of the
`Evolut Pro+ stent member.
`
`For example:
`
`(Medtronic CoreValve™ Evolut™ R
`System PB 2017, at p. 3.)
`
`
`
`
`(Medtronic Evolut™ PRO System PB 2017,
`at p. 5.)
`
`
`(Medtronic Evolut™ PRO+ PB
`2019, at p, 1.)
`
`
`
`
`Exhibit A
`81
`
`Edwards Lifesciences Corporation, et al. Exhibit 1022, p. 7 of 14
`
`

`

`
`
`
`
`Claim
`
`Claim Element
`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,
`
`Case 8:20-cv-00847-DOC-JDE Document 30-3 Filed 06/12/20 Page 8 of 14 Page ID #:243
`
`CoreValve
`(Gen 1)
`The CoreValve system includes a delivery
`system with a pusher member and a
`moveable sheath, the pusher member
`includes a guidewire lumen and the pusher
`member is disposed within a lumen of the
`movable sheath.
`
`For example:
`“The catheter with AccuTrak™ stability
`layer is compatible with a 0.035 in (0.889
`mm) guidewire. The distal (deployment)
`end of the system features an atraumatic,
`radiopaque tip and a capsule that covers
`and maintains the bioprosthesis in a
`crimped position. The handle is located on
`the proximal end of the catheter and is
`used to load and deploy the bioprosthesis.
`The handle includes a macro slider to
`open and close the capsule and micro
`knob to facilitate precise bioprosthesis
`placement. The micro knob is turned
`counterclockwise to load the bioprosthesis
`and clockwise to deploy the bioprosthesis.
`The AccuTrak™ stability layer is fixed at
`the handle and extends down the outside
`of the catheter shaft approximately 91 cm.
`It provides a barrier between the
`retractable delivery catheter system,
`introducer sheath, and vessel walls, thus
`enabling the catheter to retract freely and
`providing a more stable platform for
`deployment….” (Medtronic CoreValve™
`System IFU 2014, at pp. 2-3, 27-30;
`Medtronic CoreValve™ System IFU 2017,
`at pp. 2-3, 26-29.)
`
`Evolut R
`(Gen 2)
`The Evolut R system includes a delivery
`system with a pusher member and a
`moveable sheath, the pusher member
`includes a guidewire lumen and the pusher
`member is disposed within a lumen of the
`movable sheath.
`
`For example:
`“The catheter facilitates the placement of
`the bioprosthesis within the annulus of the
`aortic valve. The catheter assembly is
`flexible and compatible with a 0.035 in
`(0.889 mm) guidewire. The distal
`(deployment) end of the system features
`an atraumatic, radiopaque catheter tip and
`a capsule that covers and maintains the
`bioprosthesis in a crimped position. The
`capsule includes a distal flare to enable the
`bioprosthesis to be partially or fully
`recaptured after partial deployment. A
`stability layer is fixed at the handle and
`extends down the outside of the catheter
`shaft. It provides a barrier between the
`retractable catheter and the introducer
`sheath and vessel walls, thus enabling the
`catheter to retract freely. An EnVeo R
`InLine™ sheath is assembled over the
`stability layer, which functions as a
`hemostatic introducer sheath and
`minimizes the access site size to the
`capsule diameter.” (Medtronic
`CoreValve™ Evolut™ R System IFU
`2017, at pp. 3-4, 31-34; Medtronic
`CoreValve™ Evolut™ R System IFU
`2019, at pp. 41-43.)
`
`Evolut Pro
`(Gen 3)
`The Evolut Pro system includes a delivery
`system with a pusher member and a
`moveable sheath, the pusher member
`includes a guidewire lumen and the pusher
`member is disposed within a lumen of the
`movable sheath.
`
`For example:
`“The catheter facilitates the placement of
`the bioprosthesis within the annulus of the
`aortic valve. The catheter assembly is
`flexible and compatible with a 0.035 in
`(0.889 mm) guidewire. The distal
`(deployment) end of the system features
`an atraumatic, radiopaque catheter tip and
`a capsule that covers and maintains the
`bioprosthesis in a crimped position. The
`capsule includes a distal flare to enable the
`bioprosthesis to be partially or fully
`recaptured after partial deployment. A
`stability layer is fixed at the handle and
`extends down the outside of the catheter
`shaft. It provides a barrier between the
`retractable catheter and the introducer
`sheath and vessel walls, thus enabling the
`catheter to retract freely. An EnVeo R
`InLine™ sheath is assembled over the
`stability layer, which functions as a
`hemostatic introducer sheath and
`minimizes the access site size to the
`capsule diameter.” (Medtronic Evolut™
`PRO System IFU 2017, at pp. 3-4, 31-36;
`Medtronic Evolut™ PRO System IFU
`2019, at pp. 4, 40-42.)
`
`
`
`Evolut Pro+
`(Gen 4)
`The Evolut Pro+ system includes a
`delivery system with a pusher member
`and a moveable sheath, the pusher
`member includes a guidewire lumen and
`the pusher member is disposed within a
`lumen of the movable sheath.
`
`For example:
`“The catheter facilitates the placement of
`the bioprosthesis within the annulus of the
`aortic valve. The catheter assembly is
`flexible and compatible with a 0.035 in
`(0.889 mm) guidewire. The distal
`(deployment) end of the system features
`an atraumatic, radiopaque catheter tip and
`a capsule that covers and maintains the
`bioprosthesis in a crimped position. The
`capsule includes a distal flare to enable the
`bioprosthesis to be partially or fully
`recaptured after partial deployment. A
`stability layer is fixed at the handle and
`extends down the outside of the catheter
`shaft. It provides a barrier between the
`retractable catheter and the introducer
`sheath and vessel walls, thus enabling the
`catheter to retract freely. An Evolut PRO+
`inline sheath is assembled over the
`stability layer, which functions as a
`hemostatic introducer sheath and
`minimizes the access site size to the
`capsule diameter.” (Medtronic Evolut™
`PRO+ System IFU 2019, at p. 3.)
`
`
`
`Exhibit A
`82
`
`Edwards Lifesciences Corporation, et al. Exhibit 1022, p. 8 of 14
`
`

`

`
`
`Claim
`
`Claim Element
`wherein 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,
`
`Case 8:20-cv-00847-DOC-JDE Document 30-3 Filed 06/12/20 Page 9 of 14 Page ID #:244
`
`CoreValve
`(Gen 1)
`The prosthetic heart valve in the
`CoreValve system is collapsed onto the
`pusher member, to reside in a collapsed
`configuration on the pusher member and
`is retained in the collapsed configuration
`by the movable sheath.
`
`For example:
`“The distal (deployment) end of the
`system features an atraumatic, radiopaque
`tip and a capsule that covers and maintains
`the bioprosthesis in a crimped position.”
`(Medtronic CoreValve™ System IFU
`2014, at pp. 2-3, 22-27; Medtronic
`CoreValve™ System IFU 2017, at pp. 2-3,
`21-26.)
`
`Evolut R
`(Gen 2)
`The prosthetic heart valve in the Evolut R
`system is collapsed onto the pusher
`member, to reside in a collapsed
`configuration on the pusher member and
`is retained in the collapsed configuration
`by the movable sheath.
`
`For example:
`“The distal (deployment) end of the
`system features an atraumatic, radiopaque
`catheter tip and a capsule that covers and
`maintains the bioprosthesis in a crimped
`position.” (Medtronic CoreValve™
`Evolut™ R System IFU 2017, at pp. 3-4,
`23-30; Medtronic CoreValve™ Evolut™
`R System IFU 2019, at pp. 4, 26-39.)
`
`
`Evolut Pro
`(Gen 3)
`The prosthetic heart valve in the Evolut
`Pro system is collapsed onto the pusher
`member, to reside in a collapsed
`configuration on the pusher member and
`is retained in the collapsed configuration
`by the movable sheath.
`
`For example:
`“The distal (deployment) end of the
`system features an atraumatic, radiopaque
`catheter tip and a capsule that covers and
`maintains the bioprosthesis in a crimped
`position.” (Medtronic Evolut™ PRO
`System IFU 2017, at pp. 4, 25-31;
`Medtronic Evolut™ PRO System IFU
`2019, at pp. 4, 26-38.)
`
`Evolut Pro+
`(Gen 4)
`The prosthetic heart valve in the Evolut
`Pro+ system is collapsed onto the pusher
`member, to reside in a collapsed
`configuration on the pusher member and
`is retained in the collapsed configuration
`by the movable sheath.
`
`For example:
`“The distal (deployment) end of the
`system features an atraumatic, radiopaque
`catheter tip and a capsule that covers and
`maintains the bioprosthesis in a crimped
`position.” (Medtronic Evolut™ PRO+
`System IFU 2019, at p. 3.)
`
`
`
`Exhibit A
`83
`
`Edwards Lifesciences Corporation, et al. Exhibit 1022, p. 9 of 14
`
`

`

`
`
`
`
`Claim
`
`Claim Element
`wherein a distal end of the prosthetic
`heart valve is located at a distal end
`of the moveable sheath,
`
`Case 8:20-cv-00847-DOC-JDE Document 30-3 Filed 06/12/20 Page 10 of 14 Page ID
` #:245
`Evolut R
`(Gen 2)
`In the Evolut R system the distal end of
`the prosthetic heart valve is located at a
`distal end of the moveable sheath.
`
`For example:
`“The distal (deployment) end of the
`system features an atraumatic, radiopaque
`catheter tip and a capsule that covers and
`maintains the bioprosthesis in a crimped
`position.”
`
`CoreValve
`(Gen 1)
`In the CoreValve system the distal end of
`the prosthetic heart valve is located at a
`distal end of the moveable sheath.
`
`For example:
`“The distal (deployment) end of the
`system features an atraumatic, radiopaque
`tip and a capsule that covers and maintains
`the bioprosthesis in a crimped
`position….”
`
`Evolut Pro
`(Gen 3)
`In the Evolut Pro system the distal end of
`the prosthetic heart valve is located at a
`distal end of the moveable sheath.
`
`For example:
`“The distal (deployment) end of the
`system features an atraumatic, radiopaque
`catheter tip and a capsule that covers and
`maintains the bioprosthesis in a crimped
`position.”
`
`Evolut Pro+
`(Gen 4)
`In the Evolut Pro+ system the distal end of
`the prosthetic heart valve is located at a
`distal end of the moveable sheath.
`
`For example:
`“The distal (deployment) end of the
`system features an atraumatic, radiopaque
`catheter tip and a capsule that covers and
`maintains the bioprosthesis in a crimped
`position.”
`
`
`
`
`
`
`(Medtronic CoreValve™ System IFU 2014,
`at pp. 2-3, 20; Medtronic CoreValve™
`System IFU 2017, at pp. 2-3, 19.)
`
`
`(Medtronic CoreValve™ Evolut™ R
`System IFU 2017, at pp. 3-5; Medtronic
`CoreValve™ Evolut™ R System IFU 2019,
`at pp. 4-5.)
`
`
`(Medtronic Evolut™ PRO System IFU
`2017, at pp. 4-5; Medtronic Evolut™ PRO
`System IFU 2019, at pp. 4-5.)
`
`
`
`
`(Medtronic Evolut™ PRO+ System IFU
`2019, at pp. 3-4.)
`
`
`
`Exhibit A
`84
`
`Edwards Lifesciences Corporation, et al. Exhibit 1022, p. 10 of 14
`
`

`

`Evolut Pro+
`(Gen 4)
`The valve in the Evolut Pro+ system
`resides entirely within the inner channel of
`the stent member both in the collapsed
`configuration and is configured to reside
`entirely within the inner channel of the
`stent member upon deployment in the
`patient.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and an inner skirt,
`made from a single layer of porcine
`pericardium, onto a self-expanding, multi-
`level, radiopaque frame made of Nitinol.”
`(Medtronic Evolut™ PRO+ System IFU
`2019, at p. 2.)
`
`Case 8:20-cv-00847-DOC-JDE Document 30-3 Filed 06/12/20 Page 11 of 14 Page ID
` #:246
`Evolut R
`(Gen 2)
`The valve in the Evolut R system resides
`entirely within the inner channel of the
`stent member both in the collapsed
`configuration and is configured to reside
`entirely within the inner channel of the
`stent member upon deployment in the
`patient.
`
`For example:
`“The bioprosthesis is manufactured by
`suturing 3 valve leaflets and a skirt, made
`from a sing