Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 1 of 72
`1 of 72
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page
`
`EXHIBIT (cid:22)
`
`EXHIBIT 3
`
`MEDTRONIC 1154
`
`MEDTRONIC 1154
`
`

`

`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 2 of 72
`2 of 72
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page
`
`EXHIBIT (cid:22)(cid:36)
`
`EXHIBIT 3A
`
`

`

`pins and sealing zone.” Endurant II/IIs: Summary of Safety and Effectiveness (Exh. D) at p. 3.
`family aortic stent grafts (Endurant/Endurant II/Endurant IIs) are identical with respect to the design of the proximal end, including the suprarenal stent, anchor
`The differences in these devices are described in the Annual Physician Clinical Update for the Endurant/Endurant II/Endurant IIs Stent Graft Systems. All Endurant
`1 “The Endurant II/IIs Stent Graft System stent graft is based on the Endurant stent graft. The Endurant II/IIs Stent Graft System comprises a product line extension.
`
`1
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`Accused Products in (cid:87)(cid:75)(cid:76)(cid:86)(cid:3)(cid:72)(cid:91)(cid:75)(cid:76)(cid:69)(cid:76)(cid:87) applies to all of the foregoing Accused Products.
`Products and discovery may reveal additional products and/or variants. Unless specified otherwise, use of the term
`L, “Medtronic Catalog 2020”) at pp. 4-27.1 This listing is based on TMT’s present understanding of the Accused
`27; see also Medtronic U.S. Aortic Product Catalog, Rev. UC201806182b EN (Bates Nos. TMT_0000706-765) (Exh.
`Product Catalog, Rev. UC201806182a EN (Bates Nos. TMT_0000766-825) (Exh. A, “Medtronic Catalog”) at pp. 4-
`(Endurant II AUI); and ETC/ETT-products (Endurant II Aortic Extensions). See, e.g., Medtronic U.S. Aortic
`products (Endurant II System Bifurcations); ESB-products (Endurant IIs System Bifurcations); ETU-products
`Products”), including the following product codes as referenced in Medtronic’s U.S. Aortic Product Catalog: ETB-
`Accused Products: Medtronic Endurant II, Endurant II AUI, Medtronic Endurant IIs, and variants thereof (collectively, the “Accused
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 3 of 72
`
`interior wall of
`apparatus to an
`endovascular
`for securing an
`second state
`state to a
`from a first
`expandable
`device that is
`attachment
`[1PRE] An
`
`’393 Patent
`
`Patient Information Booklet: Endovascular Stent Grafts: A Treatment for Abdominal Aortic Aneurysms (Bates Nos.
`(Exh. D, “Endurant II/IIs: Summary of Safety and Effectiveness”) at pp. 3-4; Endurant II/IIs: FDA PMA labeling:
`Drug Administration (“FDA”) Pre-Market Approval (“PMA”) No. P100021/S063 (Bates Nos. TMT_0000505-554)
`Website”), last accessed December 30, 2020; Endurant II/IIs: Summary of Safety and Effectiveness, U.S. Federal
`cardiovascular/aortic-stent-grafts/endurantii.html (Bates Nos. TMT_0000691-705) (Exh. C, “Endurant II/IIs
`Systems
`https://www.medtronic.com/us-en/healthcare-professionals/products/
`TMT_0000832-913) (Exh. B, “Endurant II/IIs Instructions for Use”) at pp. 6, 60-64, 75; Endurant II Stent Graft
`Instructions for Use, Manual Doc. No. M052195T001 REV. AA, website publication date: 2020-11-09 (Bates Nos.
`see also Medtronic Catalog 2020 (Exh. L) at pp. 10-27; Medtronic: Endurant™ II/IIs Stent Graft System:
`figures below. See, e.g., Medtronic Catalog (Exh. A) at pp. 10-27 (showing Endurant II and Endurant IIs products);
`The Accused Products include an attachment device, for example, as shown in the red boxes within the annotated
`
`accessible
`
`website,
`
`at:
`
`

`

`2
`
`2 The annotations herein, in red, are exemplary only.
`
`(ETB-product. Medtronic Catalog (Exh. A) at p. 10).
`
`Nos. TMT_0000568-690) (Exh. F, “Endurant II/IIs PMA Instructions for Use”) at pp. 4, 94-106.2
`Endurant™ IIs Stent Graft System: Instructions for Use, Manual Doc. No. M052195T001 REV. 1D (© 2017) (Bates
`TMT_0000555-567) (Exh. E, “Endurant II/IIs: FDA PMA labeling”) at pp. 10, 14; Medtronic: Endurant™ II
`
`comprising:
`device
`a lumen, the
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 4 of 72
`
`

`

`
`
`
` 3
`
`(ETB-product. Medtronic Catalog (Exh. A) at p. 16).
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 5 of 72
`
`

`

`
`
`
`
`
` 4
`
`(ESB-product. Medtronic Catalog (Exh. A) at p. 11).
`
`
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 6 of 72
`
`

`

`
`
`
`
`
` 5
`
`(ETC/ETT-product. Medtronic Catalog (Exh. A) at p. 13).
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 7 of 72
`
`

`

`
`
`
` 6
`
`G)at p. 4 (“The proximal section of the bifurcated stent graft component is deployed into the proximal neck and
`deployment of device); Endurant Summary of Safety and Effectiveness Data (Bates Nos. TMT_0000384-436) (Exh.
`an interior wall of a lumenas depicted below.See, e.g., Endurant II/IIs Website (Exh. C at p. 3) (describing
`The attachment device is expandable from a first state to a second state for securing an endovascular apparatus to
`
`(ETU-product. Medtronic Catalog (Exh. A) at p. 25).
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 8 of 72
`
`

`

`
`
`
` 7
`
`(First State – unexpanded attachment device, in red box. Endurant II/IIs Instructions for Use (Exh. B) at p. 60).
`
`
`
`
`
`
`
`Use (Exh. F) at pp. 4, 94-106; Endurant II/IIs Website (Exh. C).
`figure. See Endurant II/IIs Instructions for Use (Exh. B) at pp. 60-73; see also Endurant II/IIs PMA Instructions for
`unexpanded state in the first figure whereas the attachment device is in a partially expanded state in the second
`Instructions for Use (Exh. F) at pp. 4, 94-106. For example, as depicted below, the attachment device is in an
`upper section of the aneurysm.”); Endurant II/IIs Instructions for Use (Exh. B) at pp. 60-73; Endurant II/IIs PMA
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 9 of 72
`
`

`

`
`
`
` 8
`
`infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated
`Endurant II Stent Graft System aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of
`Endurant II/IIs Website (Exh. C at pp. 1-2); Endurant II/IIs PMA Instructions for Use (Exh. F) at pp. 3, 9. “The
`aortoiliac aneurysms.” Medtronic Catalog (Exh. A) at p. 50; see also Medtronic Catalog 2020 (Exh. L) at p. 50;
`explain that the Accused Products “are indicated for the endovascular treatment of infrarenal abdominal aortic or
`The Accused Products are classified as endovascular apparatuses. The Medtronic Catalog and Medtronic’s website
`
`(Second State – expanded attachment device, in red box. Endurant II/IIs Instructions for Use (Exh. B) at p. 61).
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 10 of 72
`
`

`

`
`
`
` 9
`
`(Medtronic Catalog (Exh. A) at p. 8).
`
`
`
`that are operatively connected to one another so as to form a perimeter of variable length.
`The red box in the following annotated image shows an attachment device including a plurality of telescoping arms
`
`PMA Instructions for Use (Exh. F) at pp. 4, 94-106.
`and Effectiveness (Exh. D) at pp. 3-4; Endurant II/IIs: FDA PMA labeling (Exh. E) at pp. 10, 14; Endurant II/IIs
`grafts conforming to the anatomy of patient); Endurant II/IIs Website (Exh. C); Endurant II/IIs: Summary of Safety
`10-27; Endurant II/IIs Instructions for Use (Exh. B) at pp. 6, 60-64, 75 (showing expansion of Endurant II/IIs stent
`one another to form a stent with a perimeter of variable length); see also Medtronic Catalog 2020 (Exh. L) at pp. 8,
`(showing Endurant II and Endurant IIs products having multiple sets of telescoping arms operatively connected to
`to one another so as to form a perimeter of variable length. See, e.g., Medtronic Catalog (Exh. A) at pp. 8, 10-27
`An attachment device of the Accused Products includes a plurality of telescoping arms that are operatively connected
`
`(Exh. C at pp. 1-2); Endurant II/IIs PMA Instructions for Use (Exh. F) at p. 5.
`stent graft.” Medtronic Catalog (Exh. A) at p. 50; Medtronic Catalog 2020 (Exh. L) at p. 50; Endurant II/IIs Website
`
`shape of a M.
`arms form the
`telescoping
`multiple
`angle so that
`another at an
`coupled to one
`operatively
`arms are
`telescoping
`wherein the
`length,
`variable
`perimeter of
`as to form a
`one another so
`connected to
`operatively
`being
`arms, the arms
`telescoping
`plurality of
`[1a]a
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 11 of 72
`
`

`

`10
`
`
`
`
`
`(ETB-product. Medtronic Catalog (Exh. A) at p. 10).
`
`
`
`
`
`10, 14; Endurant II/IIs PMA Instructions for Use (Exh. F) at pp. 4, 94-106.
`II/IIs: Summary of Safety and Effectiveness (Exh. D) at pp. 3-4; Endurant II/IIs: FDA PMA labeling (Exh. E) at pp.
`27; Endurant II/IIs Instructions for Use (Exh. B) at pp. 6, 60-64, 75; Endurant II/IIs Website (Exh. C); Endurant
`products having telescoping arms forming the shape of a M); see also Medtronic Catalog 2020 (Exh. L) at pp. 10-
`arms form the shape of an M. Medtronic Catalog (Exh. A) at pp. 10-27 (showing Endurant II and Endurant IIs
`As shown below, the telescoping arms are operatively coupled to one another at an angle so that four telescoping
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 12 of 72
`
`

`

`11
`
`
`
`
`
`(ETB-product. Medtronic Catalog (Exh. A) at p. 16).
`
`
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 13 of 72
`
`

`

`12
`
`
`
`
`
`(ESB-product. Medtronic Catalog (Exh. A) at p. 11).
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 14 of 72
`
`

`

`13
`
`
`
`
`
`(ETC/ETT-product. Medtronic Catalog (Exh. A) at p. 13).
`
`
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 15 of 72
`
`

`

`14
`
`
`
`
`
`stents provide wall apposition and minimize in-folding.” Endurant II/IIs Website (Exh. C at p. 3).
`Medtronic’s Endurant II/IIs website explains that to achieve “[o]ptimal seal[ing] and fixation,” “M-shaped proximal
`
`(ETU-product, Medtronic Catalog (Exh. A) at p. 25).
`
`
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 16 of 72
`
`

`

`15
`
`
`
`
`
`Ms); Endurant II/IIs PMA Instructions for Use (Exh. F) at pp. 4, 94-106 (same); Endurant II/IIs Website (Exh. C).
`device with multiple sets of telescoping arms operatively connected to one another so as to form the shape of multiple
`II/IIs Instructions for Use (Exh. B) at pp. 6, 60-64, 75 (showing Endurant II/IIs stent grafts having an attachment
`one another so as to form the shape of multiple Ms); see also Medtronic Catalog 2020 (Exh. L) at pp. 10-27; Endurant
`Endurant IIs products having an attachment device with multiple sets of telescoping arms operatively connected to
`Accused Products shares this feature. See, e.g., Medtronic Catalog (Exh. A) at pp. 10-27 (showing Endurant II and
`For example, the shape of multiple Ms are annotated in the image of the Endurant IIs stent graft, below. Each of the
`
`F) at pp. 4, 94-106 (same); Endurant II/IIs Website (Exh. C).
`connected to one another so as to form the shape of multiple Ms); Endurant II/IIs PMA Instructions for Use (Exh.
`(showing Endurant II/IIs stent grafts having an attachment device with multiple sets of telescoping arms operatively
`Medtronic Catalog 2020 (Exh. L) at pp. 2, 10-27; Endurant II/IIs Instructions for Use (Exh. B) at pp. 6, 60-64, 75
`stents provide wall apposition and minimize infolding for a short sealing zone in the infrarenal aorta”); see also
`arms operatively connected to one another so as to form the shape of multiple Ms); id. at p. 2 (“M-shaped proximal
`27 (showing Endurant II and Endurant IIs products having an attachment device with multiple sets of telescoping
`viewed from a plane containing the perimeter of variable length. See, e.g., Medtronic Catalog (Exh. A) at pp. 10-
`of telescoping arms arranged so as to form the shape of multiple Ms whereby the shape of the M is visible when
`The perimeter of variable length of the attachment device of the Accused Products consists essentially of the plurality
`
`See claim 1.
`
`
`
`containing the
`plane
`viewed from a
`visible when
`the M is
`the shape of
`and wherein
`multiple Ms,
`the shape of
`so as to form
`arms arranged
`telescoping
`the plurality of
`essentially of
`consists
`variable length
`perimeter of
`wherein the
`claim 1,
`device of
`attachment
`[2] The
`
`between the artery and the grafts as well.”).
`to improve migration resistance. . . . Endurant ha[s] nitinol struts in an expanding M-configuration, providing friction
`without vertical linkage, permitting flexibility. The proximal side has five suprarenal nitinol anchoring pins designed
`188, 190 (“The Medtronic Endurant is made of multi-filament polyester and has wire-formed M-shape body stents,
`In Vitro Study, 39 Eur J Vasc Endovasc Surg 187 (2010) (Bates Nos. TMT_0000826-831) (Exh. H, “Bosman”) at
`W.M.P.F. Bosman et al., The Proximal Fixation Strength of Modern EVAR Grafts in a Short Aneurysm Neck. An
`Third-party literature has described the “M-shape body stents” in Medtronic’s Endurant products. See, e.g.,
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 17 of 72
`
`
`
`
`
`

`

`16
`
`
`
`
`
`(ESB-product. Medtronic Catalog (Exh. A) at p. 11).
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 18 of 72
`
`
`
`
`
`length.
`variable
`perimeter of
`containing the
`to the plane
`perpendicular
`direction
`viewed from a
`device is
`when the
`not visible
`length, but is
`variable
`perimeter of
`
`’393 Patent
`
`

`

`17
`
`
`
`
`
`(ETB-product. Medtronic Catalog (Exh. A) at p. 10).
`
`
`
`X
`
`
`
`variable length.
`As shown below, the shape of the M is visible when viewed from a plane(X, below) containing the perimeter of
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 19 of 72
`
`

`

`18
`
`
`
`
`
`
`
`(ETB-product. Medtronic Catalog (Exh. A) at p. 16).
`
`
`
`X
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 20 of 72
`
`

`

`19
`
`
`
`
`
`
`
`(ESB-product. Medtronic Catalog (Exh. A) at p. 11).
`
`X
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 21 of 72
`
`

`

`20
`
`
`
`
`
`(ETC/ETT-product. Medtronic Catalog (Exh. A) at p. 13).
`
`X
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 22 of 72
`
`

`

`21
`
`
`
`
`
`Medtronic Catalog (Exh. A) at p. 10 (whereby the bifurcated proximal markers (black and yellow dots) are consistent
`perpendicular to the plane containing the perimeter of variable length (i.e., from a top-down position). See, e.g.,
`As shown below, the shape of the M is not visible when the device is viewed from a direction (Y axis, below)
`
`(ETU-product. Medtronic Catalog (Exh. A) at p. 25).
`
`
`
`X
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 23 of 72
`
`

`

`22
`
`
`
`
`
`(ETB-product with an exemplary expansion circumference within the red box.
`
`Medtronic Catalog (Exh. A) at p. 10).
`
`
`
`X
`
`
`
`Y
`
`
`
`the straight on view of the same); Medtronic Catalog 2020 (Exh. L)at p. 10.
`between a top-down representation of the expanded proximal portions of the stent graft, in the red boxes below, and
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 24 of 72
`
`

`

`23
`
`
`
`
`
`
`
`(ETB-product with an exemplary expansion circumference within the red box.
`
`Medtronic Catalog (Exh. A) at p. 16).
`
`X
`
`Y
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 25 of 72
`
`

`

`24
`
`
`
`
`
`
`
`(ESB-product with an exemplary expansion circumference within the red box.
`
`Medtronic Catalog (Exh. A) at p. 11).
`
`
`
`X
`
`Y
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 26 of 72
`
`

`

`25
`
`
`
`
`
`
`
`(ETC/ETT-product with an exemplary expansion circumference within the red box.
`
`Medtronic Catalog (Exh. A) at p. 13).
`
`
`
`X
`
`Y
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 27 of 72
`
`

`

`26
`
`
`
`
`
`Medtronic’s website explains that to achieve “[o]ptimal seal[ing] and fixation,” “M-shaped proximal stents provide
`The ends of adjacent telescoping arms of the Accused Products are operatively connected for pivotable movement.
`
`See claim 1.
`
`
`
`claim 1,
`device of
`attachment
`[4] The
`
`(ETU-product with an exemplary expansion circumference within the red box.
`
`Medtronic Catalog (Exh. A) at p. 25).
`
`
`
`X
`
`Y
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 28 of 72
`
`

`

`are operatively connected to allow for pivotable movement.
`14; Endurant II/IIs PMA Instructions for Use (Exh. F) at pp. 4, 94-106. As shown in the figure below, adjacent arms
`Summary of Safety and Effectiveness (Exh. D) at pp. 3-4; Endurant II/IIs: FDA PMA labeling (Exh. E) at pp. 10,
`2020 (Exh. L) at pp. 10-27; Endurant II/IIs Instructions for Use (Exh. B) at pp. 6, 60-64, 75; Endurant II/IIs:
`188; Medtronic Catalog (Exh. A) at pp. 10-27 (showing Endurant II and Endurant IIs products); Medtronic Catalog
`wall apposition and minimize in-folding.” Endurant II/IIs Website (Exh. C at p. 3); see also Bosman (Exh. H) at p.
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 29 of 72
`
`27
`
`
`
`
`
`(Showing pivotal movement upon expansion, in red box. Endurant II/IIs Instructions for Use (Exh. B) at p. 61).
`
`
`
`
`
`
`
`movement.
`pivotable
`connected for
`are operatively
`adjacent arms
`ends of
`wherein the
`
`’393 Patent
`
`

`

`28
`
`
`
`
`
`stent graft via the arterial vasculature (e.g., femoral arteries).”); Endurant II/IIs: FDA PMA labeling (Exh. E) at pp.
`at p. 6 (“The Endurant Delivery System, which constrains the Endurant Stent Graft, facilitates the placement of the
`pp. 6, 60-64, 75; Endurant II/IIs Website (Exh. C); Endurant II/IIs: Summary of Safety and Effectiveness (Exh. D)
`accessories . . . .”); Medtronic Catalog 2020 (Exh. L) at pp. 4-5, 50; Endurant II/IIs Instructions for Use (Exh. B) at
`characteristics: Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or
`6-6.67 mm); id. at p. 50 (“The Endurant II/IIs Stent Graft System is indicated for use in patients with the following
`5 (exemplary Endurant II/IIs products with catheter outer diameters of 18-20 French gauge, which is equivalent to
`percutaneously inserted via catheter into a patient’s femoral artery. See, e.g., Medtronic Catalog (Exh. A) at pp. 4-
`In the first state, the Accused Product possesses a first profile that is sufficiently small to permit it to be
`
`See claim 1.
`
`
`
`
`
`
`
`(Endurant II/IIs Instructions for Use (Exh. B) at p. 7).
`
`a nickel-titanium alloy, as shown in the figure below.
`between the artery and the grafts as well.”); Endurant II/IIs PMA Instructions for Use (Exh. F) at pp. 3-5. Nitinol is
`also Bosman (Exh. H) at 190 (“Endurant ha[s] nitinol struts in an expanding M-configuration, providing friction
`configurations are composed of nitinol stents sewn to a fabric graft with nonresorbable sutures.”); id. at p. 7; see
`fabric graft.” See, e.g., Endurant II/IIs Instructions for Use (Exh. B) at p. 6 (“All Endurant II/IIs stent graft
`In its Instructions for Use, Medtronic indicates that the Accused Products “are composed of nitinol stents sewn to a
`
`
`
`See claim 1.
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 30 of 72
`
`that is
`first profile
`possesses a
`the first state
`device when in
`attachment
`wherein the
`claim 1,
`device of
`attachment
`[11] The
`
`titanium alloy.
`of a nickel-
`arms are made
`wherein the
`claim 1,
`device of
`attachment
`[10] The
`
`
`
`
`
`

`

`29
`
`
`
`
`
`profile that is sufficiently small to permit it to be percutaneously inserted via catheter into a patient’s femoral artery.
`Product into the aortic anatomy having the attachment device in the first (unexpanded) state and possessing a first
`Endurant II/IIs Instructions for Use (Exh. B) at pp. 58-60. The following figure depicts the placement of an Accused
`
`
`
`
`
`in the target proximal aortic neck (Figure 9). . . .
`2. Advance over the guidewire so that the proximal most stents and the radiopaque markers are visualized
`1. Slowly insert the delivery system.
`Warning: Do not advance the delivery system without placing a guidewire.
`
`11.2.1 Introduction of main body configuration
`
`. . .
`5. Take an angiogram.
`4. Over this guidewire, place an angiography catheter above the renal arteries.
`artery and direct to the abdominal aorta.
`3. When implanting a bifurcated stent graft, place a second guidewire via the contralateral side femoral
`2. Place a guidewire in the ipsilateral femoral artery and advance it above the renal arteries.
`1. Following aseptic procedure, perform a vascular access at the femoral arteries.
`
`11.1.1 Vascular access
`
`techniques, devices, or accessories.” Medtronic Endurant II/IIs Website (Exh. C).
`the Accused Products allow for “[a]dequate iliac or femoral access that is compatible with vascular access
`7-9; Endurant II/IIs PMA Instructions for Use (Exh. F) at pp. 4, 94-106. On its website, Medtronic indicates that
`
`
`
`Medtronic instructs users of Endurant II/IIs in its Implant Instructions as follows:
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 31 of 72
`
`femoral artery.
`patient’s
`catheter into a
`inserted via
`percutaneously
`it to be
`small to permit
`sufficiently
`
`’393 Patent
`
`
`
`
`
`

`

`30
`
`
`
`
`
`pp. 6, 60-64, 75; Endurant II/IIs Website (Exh. C); Endurant II/IIs: Summary of Safety and Effectiveness (Exh. D)
`products); see also Medtronic Catalog 2020 (Exh. L) at pp. 10-27; Endurant II/IIs Instructions for Use (Exh. B) at
`figures below. See, e.g., Medtronic Catalog (Exh. A) at pp. 10-27 (showing Endurant II and Endurant IIs
`The Accused Products include an attachment device, for example, as shown in the red boxes within the annotated
`
`expandable
`device that is
`attachment
`[26PRE] An
`
`
`
`(First State – unexpanded attachment device, in red box, and femoral artery identified with red arrow. Endurant II/IIs
`
`Instructions for Use (Exh. B) at p. 60).
`
`
`
`
`
`Femoral artery
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 32 of 72
`
`

`

`31
`
`
`
`
`
`(ETB-product, Medtronic Catalog (Exh. A) at p. 10).
`
`
`
`(Exh. F) at pp. 4, 94-106.
`at pp. 3-4; Endurant II/IIs: FDA PMA labeling (Exh. E) at pp. 10, 14; Endurant II/IIs PMA Instructions for Use
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 33 of 72
`
`comprising:
`device
`a lumen, the
`interior wall of
`apparatus to an
`endovascular
`for securing an
`second state
`state to a
`from a first
`
`’393 Patent
`
`

`

`32
`
`
`
`
`
`
`
`(ETB-product. Medtronic Catalog (Exh. A) at p. 16).
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 34 of 72
`
`

`

`33
`
`
`
`
`
`
`
`(ESB-product. Medtronic Catalog (Exh. A) at p. 11).
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 35 of 72
`
`

`

`34
`
`
`
`
`
`
`
`(ETC/ETT-product. Medtronic Catalog (Exh. A) at p. 13).
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 36 of 72
`
`

`

`35
`
`
`
`
`
`of the bifurcated stent graft component is deployed into the proximal neck and upper section of the aneurysm.”);
`deployment of device); Endurant Summary of Safety and Effectiveness Data (Exh. G)at p. 4 (“The proximal section
`an interior wall of a lumenas depicted below.See, e.g., Endurant II/IIs Website (Exh. C at p. 3) (describing
`The attachment device is expandable from a first state to a second state for securing an endovascular apparatus to
`
`(ETU-product. Medtronic Catalog (Exh. A) at p. 25).
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 37 of 72
`
`

`

`36
`
`
`
`
`
`(First State – unexpanded attachment device, in red box. Endurant II/IIs Instructions for Use (Exh. B) at p. 60).
`
`
`
`
`
`
`
`106; Endurant II/IIs Website (Exh. C).
`Instructions for Use (Exh. B) at pp. 60-73; see also Endurant II/IIs PMA Instructions for Use (Exh. F) at pp. 4, 94-
`whereas the attachment device is in a partially expanded state in the second figure, below. See Endurant II/IIs
`4, 94-106. For example, as depicted below, the attachment device is in an unexpanded state in the first figure, below,
`Endurant II/IIs Instructions for Use (Exh. B) at pp. 60-73; Endurant II/IIs PMA Instructions for Use (Exh. F) at pp.
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 38 of 72
`
`

`

`37
`
`
`
`
`
`Use (Exh. F) at pp. 4, 94-106.
`(Exh. D) at pp. 3-4; Endurant II/IIs: FDA PMA labeling (Exh. E) at pp. 10, 14; Endurant II/IIs PMA Instructions for
`(Exh. B) at pp. 6, 60-64, 75; Endurant II/IIs Website (Exh. C); Endurant II/IIs: Summary of Safety and Effectiveness
`Endurant IIs products); see also Medtronic Catalog 2020 (Exh. L) at pp. 10-27; Endurant II/IIs Instructions for Use
`defines a plane by its circumference. See, e.g., Medtronic Catalog (Exh. A) at pp. 10-27 (showing Endurant II and
`The attachment device contains a plurality of telescoping arms forming a closed loop, wherein the closed loop
`
`
`
`(Second State – expanded attachment device, in red box. Endurant II/IIs Instructions for Use (Exh. B) at p. 61).
`
`closed loop
`wherein the
`a closed loop,
`arms forming
`telescoping
`plurality of
`[26a] A
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 39 of 72
`
`

`

`38
`
`
`
`
`
`
`
`(ETB-product showing the representative plane defined by the circumference of the closed loop as a red line.
`
`Medtronic Catalog (Exh. A) at p. 10).
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 40 of 72
`
`
`
`configuration
`M
`together in an
`coupled
`arms are
`telescoping
`plurality of
`wherein the
`plane, --
`below the
`arm above or
`telescoping
`another
`connected to
`arm is
`telescoping
`wherein each
`circumference,
`by its
`defines a plane
`
`’393 Patent
`
`

`

`39
`
`
`
`
`
`
`
`(ETB-product showing the representative plane defined by the circumference of the closed loop as a red line.
`
`Medtronic Catalog (Exh. A) at p. 16).
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 41 of 72
`
`

`

`40
`
`
`
`
`
`
`
`(ESB-product showing the representative plane defined by the circumference of the closed loop as a red line.
`
`Medtronic Catalog (Exh. A) at p. 11).
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 42 of 72
`
`

`

`41
`
`
`
`
`
`(ETC/ETT-product showing the representative plane defined by the circumference of the closed loop as a red line.
`
`Medtronic Catalog (Exh. A) at p. 13).
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 43 of 72
`
`

`

`PMA labeling (Exh. E) at pp. 10, 14; Endurant II/IIs PMA Instructions for Use (Exh. F) at pp. 4, 94-106.
`Website (Exh. C); Endurant II/IIs: Summary of Safety and Effectiveness (Exh. D) at pp. 3-4; Endurant II/IIs: FDA
`Catalog 2020 (Exh. L) at pp. 10-27; Endurant II/IIs Instructions for Use (Exh. B) at pp. 6, 60-64, 75; Endurant II/IIs
`Medtronic Catalog (Exh. A) at pp. 10-27 (showing Endurant II and Endurant IIs products); see also Medtronic
`telescoping arms are coupled together in an M configuration, as shown in the red box annotations below. See, e.g.,
`Each telescoping arm is connected to another telescoping arm above or below the plane and the plurality of
`
`
`
`
`
`42
`
`
`
`
`
`(ETU-product showing the representative plane defined by the circumference of the closed loop as a red line.
`
`Medtronic Catalog (Exh. A) at p. 25).
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 44 of 72
`
`

`

`43
`
`
`
`
`
`(ETB-product with telescoping arms coupled together in an M configuration in the red box and the representative
`
`plane defined by the circumference of the closed loop. Medtronic Catalog (Exh. A) at p. 10).
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 45 of 72
`
`

`

`44
`
`
`
`
`
`(ETB-product with telescoping arms coupled together in an M configuration in the red box and the representative
`
`plane defined by the circumference of the closed loop. Medtronic Catalog (Exh. A) at p. 16).
`
`
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 46 of 72
`
`

`

`45
`
`
`
`
`
`(ESB-product with telescoping arms coupled together in an M configuration in the red box and the representative
`
`plane defined by the circumference of the closed loop. Medtronic Catalog (Exh. A) at p. 11).
`
`
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 47 of 72
`
`

`

`46
`
`
`
`
`
`representative plane defined by the circumference of the closed loop. Medtronic Catalog (Exh. A) at p. 13).
`
`(ETC/ETT-product with telescoping arms coupled together in an M configuration in the red box and the
`
`
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38-2 Filed 04/19/21 Page 48 of 72
`
`

`

`47
`
`
`
`
`
`(ETU-product with telescoping arms coupled together in an M configuration in the red box and the representative
`
`plane defined by the circumference of the closed loop. Medtronic Catalog (Exh. A) at p. 25).
`
`
`
`
`
`
`
`The Accused Products (Endurant II, Endurant II AUI, and Endurant IIs)
`
`’393 Patent
`
`Case 6:20-cv-00973-ADA Document 38