Element
`[1 preamble1]
`A stent delivery system
`comprising:
`
`Ex. A: CLAIM CH AR T FO R INFR INGEM ENT O F
`U.S. PATENT NO . 6,007,543 ByEdwards
`
`Claim 1
`
`AccusedProducts
`
`To the extent the preamble is deemed a limitation, on information and belief, Edwards made, used, offered to
`sell, and/or sold in the United States, and/or imported into the United States each of the balloon catheters used
`in its Commander Delivery System (“Commander”), Certitude Delivery System (“Certitude”), NovaFlex
`Delivery System (“NovaFlex”), and RetroFlex Delivery System (“RetroFlex”) for delivery and deployment of
`its Sapien 3, Sapien XT, and/or Sapien products. 2
`For example:
`Commander:
`
`Source: Edwards SAPIEN 3 Transcatheter Heart Valve with the Edwards Commander Delivery System:
`Instructions for Use at 2 available at http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031c.pdf.
`
`1
`The designations in square brackets before the claim language in each row is added to permit convenient reference to specific
`claim language. These added designations are not part of the claim language and are not intended to limit the claims in any way. No
`interpretation is intended to be conveyed by the words grouped together with each designation.
`2
`The Sapien 3, Sapien XT, and Sapien, and their corresponding delivery systems, are collectively referred to herein as the
`“Sapien products.” On information and belief, unless otherwise noted, any differences between various versions or models of the
`delivery systems identified herein or between the Sapien 3, Sapien XT, and Sapien are immaterial to the assertions set forth herein.
`
`Page 1 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 1
`
`
`[1 preamble1]
`A stent delivery system
`comprising:
`
`Ex. A: CLAIM CH AR T FO R INFR INGEM ENT O F
`U.S. PATENT NO . 6,007,543 ByEdwards
`
`Claim 1
`
`AccusedProducts
`
`To the extent the preamble is deemed a limitation, on information and belief, Edwards made, used, offered to
`sell, and/or sold in the United States, and/or imported into the United States each of the balloon catheters used
`in its Commander Delivery System (“Commander”), Certitude Delivery System (“Certitude”), NovaFlex
`Delivery System (“NovaFlex”), and RetroFlex Delivery System (“RetroFlex”) for delivery and deployment of
`its Sapien 3, Sapien XT, and/or Sapien products. 2
`For example:
`Commander:
`
`Source: Edwards SAPIEN 3 Transcatheter Heart Valve with the Edwards Commander Delivery System:
`Instructions for Use at 2 available at http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031c.pdf.
`
`1
`The designations in square brackets before the claim language in each row is added to permit convenient reference to specific
`claim language. These added designations are not part of the claim language and are not intended to limit the claims in any way. No
`interpretation is intended to be conveyed by the words grouped together with each designation.
`2
`The Sapien 3, Sapien XT, and Sapien, and their corresponding delivery systems, are collectively referred to herein as the
`“Sapien products.” On information and belief, unless otherwise noted, any differences between various versions or models of the
`delivery systems identified herein or between the Sapien 3, Sapien XT, and Sapien are immaterial to the assertions set forth herein.
`
`Page 1 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 1
`
`
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/commander.aspx.
`
`Page 2 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 2
`
`
`
`Certitude:
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/certitude.aspx.
`
`Page 3 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 3
`
`
`
`NovaFlex:
`
`Source: Edwards SAPIEN XT Transcatheter Heart Valve with the NovaFlex+ Delivery System: Instructions
`for Use at 2 available at http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009S037d.pdf.
`
`Page 4 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 4
`
`
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/novaflex.aspx.
`
`Page 5 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 5
`
`
`
`R etroFlex:
`
`Source: Edwards SAPIEN Transcatheter Heart Valve with the RetroFlex 3 Delivery System: Instructions for
`Use at 1 available at http://www.fda.gov/downloads/Adviso...orySystemDevicesPanel/UCM262938.pdf.
`
`Page 6 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 6
`
`
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/pulmonicmodels.aspx.
`
`Page 7 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 7
`
`
`
`The Commander, Certitude, NovaFlex, and RetroFlex include delivery systems for the Sapien products.
`
`Each of the Sapien products comprises a radially expandable stent. For example:
`
`[1a]
`a radially expandable stent of
`generally cylindrical
`configuration, having a first
`end and a second end and a
`contracted state and an
`expanded state, and
`
`Source: Edwards SAPIEN 3 Transcatheter Heart Valve with the Edwards Commander Delivery System:
`Instructions for Use at 2 available at http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031c.pdf.
`
`Source: Edwards SAPIEN XT Transcatheter Heart Valve with the NovaFlex+ Delivery System: Instructions
`for Use at 2 available at http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009S037d.pdf.
`
`Source: Edwards SAPIEN Transcatheter Heart Valve with the RetroFlex 3 Delivery System: Instructions for
`Use at 1 available at http://www.fda.gov/downloads/Adviso...orySystemDevicesPanel/UCM262938.pdf.
`
`Each of the Sapien products has a generally cylindrical configuration with a first end and a second end. For
`example:
`
`Page 8 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 8
`
`
`
`Firstend
`
`Second end
`
`Source: Edwards SAPIEN 3 Transcatheter Heart Valve with the Edwards Commander Delivery System:
`Instructions for Use at 1 available at http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031c.pdf.
`
`Page 9 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 9
`
`
`
`Firstend
`
`Second end
`
`Source: Edwards SAPIEN XT Transcatheter Heart Valve with the NovaFlex+ Delivery System: Instructions
`for Use at 1 available at http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009S037d.pdf.
`
`Page 10 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 10
`
`
`
`Firstend
`
`Second end
`
`Source: Edwards SAPIEN Transcatheter Heart Valve with the RetroFlex 3 Delivery System: Instructions for
`Use at 1 available at http://www.fda.gov/downloads/Adviso...orySystemDevicesPanel/UCM262938.pdf.
`
`Each of the Sapien products has a contracted state and an expanded state. For example:
`
`Page 11 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 11
`
`
`
`Stentin
`contracted state
`
`Source: “thv_commander.mp4” available at http://www.edwards.com/eu/products/transcathetervalves
`/Pages/thvhome.aspx (follow “Edwards SAPIEN 3 Valve” hyperlink; then follow “Transfemoral Procedural
`Animation” hyperlink)
`
`Page 12 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 12
`
`
`
`Stentin
`expanded state
`
`Source: “thv_commander.mp4” available at
`http://www.edwards.com/eu/products/transcathetervalves/Pages/thvhome.aspx (follow “Edwards SAPIEN 3
`Valve” hyperlink; then follow “Transfemoral Procedural Animation” hyperlink)
`
`Each of the Sapien products includes a catheter having a shaft. An inflatable means at a distal part of the shaft
`comprises a balloon. For example:
`
`[1b]
`a catheter having a shaft
`having a diameter and
`expandable inflatable means
`associated therewith at a
`distal part of the shaft,
`wherein the inflatable means
`comprises a balloon,
`
`Page 13 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 13
`
`
`
`Commander:
`
`Balloon
`
`Shaft
`
`Source: Edwards SAPIEN 3 Transcatheter Heart Valve with the Edwards Commander Delivery System:
`Instructions for Use at 3 available at http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031c.pdf.
`
`Page 14 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 14
`
`
`
`Shaft
`
`Balloon
`
`Source: “thv_commander.mp4” available at
`http://www.edwards.com/eu/products/transcathetervalves/Pages/thvhome.aspx (follow “Edwards SAPIEN 3
`Valve” hyperlink; then follow “Transfemoral Procedural Animation” hyperlink)
`
`Page 15 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 15
`
`
`
`Certitude:
`
`Balloon
`
`Shaft
`
`Source: “thv_certitude.mp4” available at
`http://www.edwards.com/eu/products/transcathetervalves/Pages/thvhome.aspx (follow “Edwards SAPIEN 3
`Valve” hyperlink; then follow “Transapical Procedural Animation” hyperlink)
`
`Page 16 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 16
`
`
`
`NovaFlex:
`
`Balloon
`
`Shaft
`
`Source: Edwards SAPIEN XT Transcatheter Heart Valve with the NovaFlex+ Delivery System: Instructions
`for Use at 2 available at http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009S037d.pdf.
`
`Page 17 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 17
`
`
`
`Shaft
`
`Balloon
`
`Source: “novaflexplusprocedural.mp4” available at
`http://www.edwards.com/eu/products/transcathetervalves/Pages/thvhome.aspx (follow “Edwards SAPIEN XT
`Valve” hyperlink; then follow “Transfemoral Procedural Animation” hyperlink)
`
`Page 18 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 18
`
`
`
`R etroFlex:
`
`Balloon
`
`Shaft
`
`Source: Edwards SAPIEN Transcatheter Heart Valve with the RetroFlex 3 Delivery System: Instructions for
`Use at 1 available at http://www.fda.gov/downloads/Adviso...orySystemDevicesPanel/UCM262938.pdf.
`
`Page 19 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 19
`
`
`
`Balloon
`
`Shaft
`
`Source: “pulmonicar06026.mp4” available at
`http://www.edwards.com/eu/products/transcathetervalves/Pages/thvhome.aspx (follow “Edwards SAPIEN
`Pulmonic” hyperlink; then follow “Procedural Animation” hyperlink)
`
`Each of the Commander, Certitude, NovaFlex, and RetroFlex includes a mounting and retaining means
`(mounting body) carried on and surrounding the shaft inside the inflatable means (balloon). The stent is
`received on the balloon by the mounting body inside the balloon. Inflation of the balloon causes radial
`expansion of the stent. For example:
`
`[1c]
`and including mounting and
`retaining means for receiving
`the stent on the expandable
`inflatable means for radial
`expansion of the stent upon
`inflation of the inflatable
`means, the mounting and
`retaining means including at
`
`Page 20 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 20
`
`
`
`least one mounting body
`carried on and surrounding
`the shaft inside the inflatable
`means,
`
`Commander:
`
`Stent
`
`Balloon
`
`M ounting body
`
`Source: “635907831022739465-EdwardsCommander-Distal.Expand.Valve.png” available at
`http://www.app.com/story/news/health/cardiac/2016/02/11/heart-research-stem-cell/80054246/.
`
`Page 21 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 21
`
`
`
`Certitude:
`On information and belief, the Certitude has a mounting and retaining means carried on and surrounding the
`shaft inside the inflatable means, as will be demonstrated with further discovery.
`
`NovaFlex:
`
`Stent
`
`Balloon
`
`M ounting body
`
`Source: The Edwards Transcatheter Heart Valve (THV) Newsletter Europe/May 2010 at 7 available at
`http://ht.edwards.com/scin/edwards/de/sitecollectionimages/products/transcathetervalves/tavitalk3.pdf.
`
`Page 22 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 22
`
`
`
`R etroFlex:
`
`Stent
`
`M ounting body
`
`Balloon
`
`Source: Nietlispach F, Wijesinghe N, Wood D, Carere RG, Webb JG., Current balloon-expandable
`transcatheter heart valve and delivery systems, Catheter Cardiovasc Interv 2010;75:295–300 at 298.
`
`For each of the Commander, Certitude, NovaFlex, and RetroFlex, the mounting body is substantially the same
`length as the stent. When the stent is loaded onto the balloon and the shaft in the stent’s contracted state, at
`least a portion of the mounting body is under the stent and between first and second ends of the stent. For
`example:
`
`[1d]
`the at least one mounting
`body being substantially the
`same length as the stent and
`being positioned on the shaft
`such that when the stent is
`loaded onto the inflatable
`means and the shaft in the
`stent's contracted state at
`least a portion of the at least
`one mounting body is under
`the stent and between the
`first and second ends of the
`stent,
`
`Page 23 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 23
`
`
`
`Commander:
`
`Stentin com pressed state
`w ith m ounting body understent
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/commander.aspx.
`
`Certitude:
`
`Stentin com pressed state
`w ith m ounting body understent
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/certitude.aspx.
`
`Page 24 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 24
`
`
`
`NovaFlex:
`
`Stentin com pressed state
`w ith m ounting body understent
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/novaflex.aspx.
`
`R etroFlex:
`
`Stentin com pressed state
`w ith m ounting body understent
`
`Source: Webb J, Altwegg L, Masson J, Al Bugami S, Al Ali A, Boone R, A New Transcatheter Aortic Valve
`and Percutaneous Valve Delivery System, J Am Coll Cardiol. 2009;53(20):1855-1858 at 1858.
`
`Page 25 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 25
`
`
`
`[1e]
`whereby the diameter of the
`shaft and inflatable portion
`are increased at the distal
`part for facilitating the
`mounting and retaining of
`the stent.
`
`For each of the Commander, Certitude, NovaFlex, and RetroFlex, the diameter of the shaft and inflatable
`portion are increased at the distal part for facilitating the mounting and retaining of the stent. For example:
`Commander:
`
`Increased diam eterpart
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/commander.aspx.
`
`Certitude:
`
`Increased diam eterpart
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/certitude.aspx.
`
`Page 26 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 26
`
`
`
`NovaFlex:
`
`Increased diam eterpart
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/novaflex.aspx.
`
`R etroFlex:
`
`Increased diam eterpart
`
`Source: Webb J, Altwegg L, Masson J, Al Bugami S, Al Ali A, Boone R, A New Transcatheter Aortic Valve
`and Percutaneous Valve Delivery System, J Am Coll Cardiol. 2009;53(20):1855-1858 at 1858.
`
`Page 27 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 27
`
`
`
`Claim 2
`
`AccusedProducts
`
`See claim chart for claim 1 above.
`
`The mounting bodies of each of the Commander, Certitude, NovaFlex, and RetroFlex are of materials which
`resiliently deform under radial pressure. For example:
`
`Element
`[2 preamble]
`The stent delivery system of
`claim 1
`[2a]
`wherein the mounting body
`is of a material which
`resiliently deforms under
`radial pressure.
`
`Page 28 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 28
`
`
`
`Commander:
`
`M ounting body
`
`Source: “635907831022739465-EdwardsCommander-Distal.Expand.Valve.png” available at
`http://www.app.com/story/news/health/cardiac/2016/02/11/heart-research-stem-cell/80054246/.
`
`Certitude:
`On information and belief, the Certitude has a mounting body of a material which resiliently deforms under
`radial pressure, as will be demonstrated with further discovery.
`
`Page 29 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 29
`
`
`
`NovaFlex:
`
`M ounting body
`
`Source: The Edwards Transcatheter Heart Valve (THV) Newsletter Europe/May 2010 at 7 available at
`http://ht.edwards.com/scin/edwards/de/sitecollectionimages/products/transcathetervalves/tavitalk3.pdf.
`
`Page 30 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 30
`
`
`
`R etroFlex:
`
`M ounting body
`
`Source: Nietlispach F, Wijesinghe N, Wood D, Carere RG, Webb JG., Current balloon-expandable
`transcatheter heart valve and delivery systems, Catheter Cardiovasc Interv 2010;75:295–300 at 298.
`
`Claim 3
`
`AccusedProducts
`
`See claim chart for claim 2 above.
`
`The mounting bodies of the Certitude, NovaFlex, and RetroFlex are of elastomeric material. For example:
`
`Element
`[3 preamble]
`The stent delivery system of
`claim 2
`[3a]
`wherein the material is
`elastomeric.
`
`Page 31 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 31
`
`
`
`Certitude:
`On information and belief, the Certitude has a mounting body of an elastomeric material, as will be
`demonstrated with further discovery.
`
`NovaFlex:
`
`M ounting body
`
`Source: The Edwards Transcatheter Heart Valve (THV) Newsletter Europe/May 2010 at 7 available at
`http://ht.edwards.com/scin/edwards/de/sitecollectionimages/products/transcathetervalves/tavitalk3.pdf.
`
`Page 32 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 32
`
`
`
`R etroFlex:
`
`M ounting body
`
`Source: Nietlispach F, Wijesinghe N, Wood D, Carere RG, Webb JG., Current balloon-expandable
`transcatheter heart valve and delivery systems, Catheter Cardiovasc Interv 2010;75:295–300 at 298.
`
`Claim 6
`
`AccusedProducts
`
`See claim chart for claim 1 above.
`
`The mounting body of the Commander includes a coil having at least one separation. For example:
`
`Element
`[6 preamble]
`The stent delivery system of
`claim 1
`[6a]
`wherein the at least one
`mounting body includes at
`least one separation whereby
`the flexibility of the body
`
`Page 33 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 33
`
`
`
`and catheter is increased.
`
`Commander:
`
`M ounting body including
`atleastone separation
`
`Source: “635907831022739465-EdwardsCommander-Distal.Expand.Valve.png” available at
`http://www.app.com/story/news/health/cardiac/2016/02/11/heart-research-stem-cell/80054246/.
`
`Page 34 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 34
`
`
`
`Element
`[7 preamble]
`The stent delivery system of
`claim 6
`[7a]
`wherein the separation is in
`the form of a spiral.
`
`Claim 7
`
`AccusedProducts
`
`See claim chart for claim 6 above.
`
`The mounting body of the Commander includes a coil having at least one separation in the form of a spiral.
`For example:
`
`Commander:
`
`M ounting body including
`a spiralseparation
`
`Source: “635907831022739465-EdwardsCommander-Distal.Expand.Valve.png” available at
`http://www.app.com/story/news/health/cardiac/2016/02/11/heart-research-stem-cell/80054246/.
`
`Page 35 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 35
`
`
`
`Element
`[8 preamble]
`The stent delivery system of
`claim 1
`[8a]
`wherein the stent is crimped
`to the mounting and retaining
`means for delivery.
`
`Claim 8
`
`AccusedProducts
`
`See claim chart for claim 1 above.
`
`For each of the Commander, Certitude, NovaFlex, and RetroFlex, the stent is crimped to the mounting and
`retaining means for delivery. For example:
`Commander:
`
`Stentcrim ped
`to m ounting body
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/commander.aspx.
`
`Page 36 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 36
`
`
`
`Certitude:
`
`Stentcrim ped
`to m ounting body
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/certitude.aspx.
`
`Page 37 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 37
`
`
`
`NovaFlex:
`
`Stentcrim ped
`to m ounting body
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/novaflex.aspx.
`
`R etroFlex:
`
`Stentcrim ped
`to m ounting body
`
`Source: Webb J, Altwegg L, Masson J, Al Bugami S, Al Ali A, Boone R, A New Transcatheter Aortic Valve
`and Percutaneous Valve Delivery System, J Am Coll Cardiol. 2009;53(20):1855-1858 at 1858.
`
`Page 38 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 38
`
`
`
`Claim 9
`
`AccusedProducts
`
`See claim chart for claim 1 above.
`
`The Certitude includes a pair of stops positioned at opposite ends of the stent and carried by the shaft inside
`the inflatable means. For example:
`
`Certitude:
`
`Stop
`
`Stop
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/certitude.aspx.
`
`Element
`[9 preamble]
`The stent delivery system of
`claim 1,
`[9a]
`wherein the stent has two
`opposite ends, the stent
`delivery system further
`including a pair of stops,
`each of which is respectively
`positioned at the opposite
`ends of the stent and carried
`by the shaft inside the
`inflatable means.
`
`Page 39 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 39
`
`
`
`Element
`[10 preamble]
`The stent delivery system of
`claim 9
`[10a]
`wherein the stops are conical
`in shape.
`
`Claim 10
`
`AccusedProducts
`
`See claim chart for claim 1 above.
`
`The stops of the Certitude are conical in shape. For example:
`
`Certitude:
`
`Stop
`
`Stop
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/certitude.aspx.
`
`Page 40 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 40
`
`
`
`Element
`[11 preamble]
`The stent delivery system of
`claim 1
`[11a]
`further including marker
`bands positioned proximally
`and distally of the stent.
`
`Claim 11
`
`AccusedProducts
`
`See claim chart for claim 1 above.
`
`Each of the Commander, Certitude, NovaFlex, and RetroFlex includes marker bands positioned proximally
`and distally of the stent. For example:
`Commander:
`
`Source: Edwards SAPIEN 3 Transcatheter Heart Valve with the Edwards Commander Delivery System:
`Instructions for Use at 3 available at http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031c.pdf.
`
`Source: Edwards SAPIEN 3 Transcatheter Heart Valve with the Edwards Commander Delivery System:
`Instructions for Use at 11 available at http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031c.pdf.
`
`Page 41 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 41
`
`
`
`Certitude:
`On information and belief, the Certitude has marker bands positioned proximally and distally of the stent, as
`will be demonstrated with further discovery.
`
`NovaFlex:
`
`Source: Edwards SAPIEN XT Transcatheter Heart Valve with the NovaFlex+ Delivery System: Instructions
`for Use at 2 available at http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009S037d.pdf.
`
`Source: Edwards SAPIEN XT Transcatheter Heart Valve with the NovaFlex+ Delivery System: Instructions
`for Use at 9 available at http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009S037d.pdf.
`
`Page 42 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 42
`
`
`
`R etroFlex:
`
`Source: Edwards SAPIEN Transcatheter Heart Valve with the RetroFlex 3 Delivery System: Instructions for
`Use at 1 available at http://www.fda.gov/downloads/Adviso...orySystemDevicesPanel/UCM262938.pdf.
`
`Claim 12
`
`AccusedProducts
`
`See claim chart for claim 1 above.
`
`Element
`[12 preamble]
`The stent delivery system of
`claim 1
`
`Page 43 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 43
`
`
`
`[12a]
`further including a stop
`carried by the shaft and
`positioned inside the
`inflatable means and axially
`spaced relative to the stent.
`
`Each of the Commander, Certitude, NovaFlex, and RetroFlex includes a stop carried by the shaft and
`positioned inside the inflatable means and axially spaced relative to the stent. For example:
`
`Commander:
`
`Stop
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/commander.aspx.
`Certitude:
`
`Stop
`
`Stop
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/certitude.aspx.
`
`Page 44 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 44
`
`
`
`NovaFlex:
`
`Stop
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/novaflex.aspx.
`
`R etroFlex:
`
`Stop
`
`Source: Webb J, Altwegg L, Masson J, Al Bugami S, Al Ali A, Boone R, A New Transcatheter Aortic Valve
`and Percutaneous Valve Delivery System, J Am Coll Cardiol. 2009;53(20):1855-1858 at 1858.
`
`Page 45 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 45
`
`
`
`Claim 19
`
`AccusedProducts
`
`See chart for claim [1 preamble] above.
`
`See chart for claim [1b] above.
`
`See chart for claim [1b] above.
`
`See chart for claim [1b] above.
`
`See chart for claim [1c] above.
`See chart for claim [1d] above.
`
`See chart for claim [1d] above.
`
`Element
`[19 preamble]
`A balloon catheter for
`intraluminal delivery of a
`stent, the catheter comprising
`[19a]
`a shaft having a diameter,
`[19b]
`a balloon associated with a
`distal portion of the shaft for
`receiving a stent,
`[19c]
`the stent having a first end
`and a second end and a
`contracted state and an
`expanded state, and means
`for inflating the balloon,
`[19d]
`the shaft including at least
`one mounting body radially
`carried on the shaft inside the
`balloon, the at least one
`mounting body being
`substantially the same length
`as the stent,
`[19e]
`the at least one mounting
`body being positioned on the
`shaft such that when the stent
`
`Page 46 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 46
`
`
`
`is loaded onto the inflatable
`means and the shaft in the
`stent's contracted state at
`least a portion of the at least
`one mounting body is under
`the stent and between the
`first and second ends of the
`stent.
`
`Element
`[20 preamble]
`The catheter of claim 19
`[20a]
`wherein the mounting body
`is of a material which
`resiliently deforms under
`radial pressure.
`
`Element
`[21 preamble]
`The catheter of claim 20
`[21a]
`wherein the material is
`elastomeric.
`
`Page 47 of 52
`
`Claim 20
`
`AccusedProducts
`
`See claim chart for claim 19 above.
`
`See claim chart for claim 2 above.
`
`Claim 21
`
`AccusedProducts
`
`See claim chart for claim 20 above.
`
`See claim chart for claim 3 above.
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 47
`
`
`
`Claim 24
`
`AccusedProducts
`
`See claim chart for claim 19 above.
`
`See claim chart for claim 6 above.
`
`Claim 25
`
`AccusedProducts
`
`See claim chart for claim 24 above.
`
`See claim chart for claim 7 above.
`
`Claim 26
`
`AccusedProducts
`
`See claim chart for claim 19 above.
`
`See claim chart for claim 9 above.
`
`Element
`[24 preamble]
`The catheter of claim 19
`[24a]
`wherein the mounting body
`is configured with at least
`one separation whereby
`trackability of the catheter is
`improved.
`
`Element
`[25 preamble]
`The catheter of claim 24
`[25a]
`wherein the separation is in a
`spiral configuration.
`
`Element
`[26 preamble]
`The catheter of claim 19
`[26a]
`further including a pair of
`spaced stops.
`
`Page 48 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 48
`
`
`
`Claim 27
`
`AccusedProducts
`
`See claim chart for claim 26 above.
`
`See claim chart for claim 10 above.
`
`Claim 28
`
`AccusedProducts
`
`See claim chart for claim 19 above.
`
`See claim chart for claim 11 above.
`
`Claim 29
`
`AccusedProducts
`
`See claim chart for claim 19 above.
`
`The mounting bodies of each of the Commander, Certitude, NovaFlex, and RetroFlex are cylindrical in shape.
`For example:
`
`Element
`[27 preamble]
`The catheter of claim 26
`[27a]
`wherein the stops are conical
`in shape.
`
`Element
`[28 preamble]
`The catheter of claim 19
`[28a]
`further including spaced
`marker bands.
`
`Element
`[29 preamble]
`The catheter of claim 19
`[29a]
`wherein the mounting body
`is cylindrical in shape.
`
`Page 49 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 49
`
`
`
`Commander:
`
`M ounting body
`
`Source: “635907831022739465-EdwardsCommander-Distal.Expand.Valve.png” available at
`http://www.app.com/story/news/health/cardiac/2016/02/11/heart-research-stem-cell/80054246/.
`
`Certitude:
`On information and belief, the Certitude has a mounting body that is cylindrical in shape, as will be
`demonstrated with further discovery.
`
`Page 50 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 50
`
`
`
`NovaFlex:
`
`M ounting body
`
`Source: The Edwards Transcatheter Heart Valve (THV) Newsletter Europe/May 2010 at 7 available at
`http://ht.edwards.com/scin/edwards/de/sitecollectionimages/products/transcathetervalves/tavitalk3.pdf.
`
`Page 51 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 51
`
`
`
`R etroFlex:
`
`M ounting body
`
`Source: Nietlispach F, Wijesinghe N, Wood D, Carere RG, Webb JG., Current balloon-expandable
`transcatheter heart valve and delivery systems, Catheter Cardiovasc Interv 2010;75:295–300 at 298.
`
`Page 52 of 52
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 52
`
`
`
`Element
`[1 preamble1]
`A system/assembly for
`delivery and deployment of
`an inflation expandable stent
`within a vessel, comprising:
`[1a]
`a catheter having proximal
`and distal ends;
`[1b]
`a stent, inflation expandable
`from a delivery diameter to a
`deployment diameter, such
`that the delivery diameter is
`reduced from the deployment
`diameter for conforming the
`stent to the catheter, such
`that the stent, in its delivery
`diameter, is coaxially
`mounted on the catheter near
`the catheter distal end;
`
`Ex. B: CLAIM CH AR T FO R INFR INGEM ENT O F
`U.S. PATENT NO . 6,203,558 ByEdwards
`
`Claim 1
`
`AccusedProducts
`
`To the extent the preamble is deemed a limitation, on information and belief, Edwards made, used, offered to
`sell, and/or sold in the United States, and/or imported into the United States the balloon catheter used in its
`Commander Delivery System (“Commander”) for delivery and deployment of its Sapien 3 product.
`Sapien 3 comprises an inflation expandable stent that is delivered and/or deployed within a vessel.
`
`The Commander has proximal and distal ends as further detailed below.
`
`The Commander comprises balloon-expandable stent which is coaxially mounted on the catheter near the
`catheter’s distal end. For example:
`
`Source: Edwards SAPIEN 3 Transcatheter Heart Valve with the Edwards Commander Delivery System:
`Instructions for Use at 2 available at http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031c.pdf.
`
`Source: Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery System: Instructions
`for Use at 1 available at http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009d.pdf.
`
`1
`The designations in square brackets before the claim language in each row is added to permit convenient reference to specific
`claim language. These added designations are not part of the claim language and are not intended to limit the claims in any way. No
`interpretation is intended to be conveyed by the words grouped together with each designation.
`Page 1 of 14
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 53
`
`
`
`Ex. B: CLAIM CH AR T FO R INFR INGEM ENT O F
`U.S. PATENT NO . 6,203,558 ByEdwards
`
`Source: Edwards SAPIEN Transcatheter Heart Valve with the RetroFlex 3 Delivery System: Instructions for
`Use at 1 available at http://www.fda.gov/downloads/Adviso...orySystemDevicesPanel/UCM262938.pdf.
`
`Deploym entdiam eter
`
`Delivery diam eter
`
`Source: Schymik, M.D., et. al., “How to Adapt the Implantation Technique for the New SAPIEN 3
`Transcatheter Heart Valve Design,” Journal of Interventional Cardiology, 2014.
`
`Source: http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031c.pdf, p. 2.
`
`Page 2 of 14
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 54
`
`
`
`Ex. B: CLAIM CH AR T FO R INFR INGEM ENT O F
`U.S. PATENT NO . 6,203,558 ByEdwards
`
`The Commander has a balloon that functions as an expandable inflation means and is mounted coaxially on
`the catheter. The stent is then mounted on the catheter and balloon and is expanded by the balloon from the
`delivery diameter to the deployment diameter. For example:
`
`Balloon expansion ofstentfrom delivery to deploym entdiam eter
`
`Stent
`
`Stent
`
`Balloon
`
`Balloon
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/commander.aspx
`Source: http://www.edwards.com/eu/products/transcathetervalves/Pages/thvhome.aspx
`
`The Commander has a mounting and retaining means coaxially mounted on the catheter within the expandable
`inflation means (the balloon) that provides a securement for the stent in the delivery diameter and maintains
`the stent in position on the catheter during delivery to the deployment site. For example:
`
`[1c]
`an expandable inflation
`means coaxially mounted on
`the catheter within the stent,
`for expansion of the stent
`from the delivery diameter to
`the deployment diameter
`upon application of
`deployment pressure to the
`expandable inflation means;
`and
`
`[1d]
`a mounting and retaining
`means coaxially mounted on
`the catheter within the
`expandable inflation means,
`the mounting and retaining
`means designed and adapted
`to provide a securement for
`the stent in the delivery
`diameter to maintain the
`stent in position on the
`catheter during delivery to
`the deployment site,
`
`Page 3 of 14
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 55
`
`
`
`Ex. B: CLAIM CH AR T FO R INFR INGEM ENT O F
`U.S. PATENT NO . 6,203,558 ByEdwards
`
`M ounting and retaining m eans
`
`Balloon
`Source: http://www.healthwellnesscolorado.com/wp-
`content/uploads/2016/01/TAVR_EdwardsCommander_Distal.Expand.Valve_.jpg
`
`M ounting and retaining m eans
`understent,in delivery diam eter
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/commander.aspx
`
`Page 4 of 14
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 56
`
`
`
`Ex. B: CLAIM CH AR T FO R INFR INGEM ENT O F
`U.S. PATENT NO . 6,203,558 ByEdwards
`
`The Commander has a shaft, with the expandable inflation means (the balloon) at the distal end. The
`mounting and retaining means of the Commander is positioned for receiving the stent on the balloon for radial
`expansion of the stent upon expansion of the balloon. For example:
`Commander:
`
`M ounting and retaining m eans
`
`Shaft
`
`[1e]
`the catheter having a shaft
`and the expandable inflation
`means being positioned at a
`distal part of the shaft, the
`mounting and retaining
`means being positioned for
`receiving the stent on the
`expandable inflation means
`for radial expansion of the
`stent upon expansion of the
`expandable inflation means,
`
`Balloon
`Source:http://www.healthwellnesscolorado.com/wpcontent/uploads/2016/01/TAVR_EdwardsCommander_Distal.Expand.
`Valve_.jpg
`
`Distalend
`
`RadialExpansion ofstent
`
`Distalend
`
`Distalend
`
`Source: http://www.edwards.com/eu/Products/TranscatheterValves/Pages/commander.aspx
`Source: http://www.edwards.com/eu/products/transcathetervalves/Pages/thvhome.aspx
`
`Page 5 of 14
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1006 - Page 57
`
`
`
`Ex. B: CLAIM CH AR T FO R INFR INGEM ENT O F
`U.S. PATENT NO . 6,203,558 ByEdwards
`
`In the Commander, the mounting and retaining means includes a mounting body carried by the shaft inside the
`balloon whereby the diameter of the shaft and balloon are increased at the distal
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