Edwards Lifesciences Corp. et al. vs Aortic Innovations LLC

Final Written Decision: original

Other: Hearing transcript

Petitioner's Updated Exhibit List

Petitioner Edwards Lifesciences’ Demonstratives for Oral Argument

Ex. 2123 - Patent Owner's Demonstrative Exhibits

Patent Owner's Updated Exhibit List

Patent Owner's Objections To Demonstratives

ORDER Setting Oral Argument 37 C.F.R. sec 42.70

Petitioners' Request for Oral Argument

Patent Owner's Statement Concerning Oral Argument

Patent Owner's Sur-Reply

Ex. 2122 - Buller Reply Depo.

Petitioner's Updated Exhibit List

Stowell Declaration

Notice of Second Deposition of Dr. Nigel P. Buller

Patent Owner's Objections to Reply Evidence

PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE

Petitioner's Updated Exhibit List

Deposition Transcript of Stephen Brecker from August 30, 2022

Deposition Transcript of Stephen Brecker from August 31, 2022

U.S. Patent No. 7,921,678 to Norris et al. (“Norris”)

Second Declaration of Dr. Nigel Buller, M.D.

Deposition Transcript of Stephen Brecker from February 8, 2023

Estridge, Trudy & Dale Feldman, Quantification of Vascular Ingrowth into Dacron® Velour

Hall, William C. et al., Velour Fabrics Applied to Medicine

Jonas, Richard A. et al., Biological Sealants and Knitted Dacron:

Ko, Frank K., Fabrics

Pourdeyhimi, B. & Text, C., A Review of Structural and Material Properties of Vascular Grafts

Scott, Steward M. et al., A Collogen Coated Vascular Prosthesis

Stegmann, Th et al., Clinical Experience with a New Collagen-coated Dacron Double-velour Prosthesis

PMA P140031/S112: FDA Summary of Safety and Effectiveness Data

Petitioner's Objections to Evidence in Patent Owner's Updated Exhibit List

Notice of Cross-Examination Deposition of Dr. Brecker

Petitioners' Objections to Evidence

Ex. 2005 - SOURCE

Ex. 2008 - -00193 Declaration of Nigel P. Buller, M.D.

Ex. 2009 - Russell

Ex. 2049 - Blumenstein

Ex. 2050 - Schymik

Ex. 2052 - -00034 Deposition of Nigel P. Buller, M.D.

Ex. 2053 - IPR2017-00060 Dr. Buller. Depo. Tr.

Ex. 2056 - Hartley

Ex. 2006 - PARTNER

Ex. 2057 - Chu

Ex. 2058 - Walther II

Ex. 2064 - Liebig

Ex. 2068 - Vasa-Nicotera

Ex. 2069 - Kodali

Ex. 2083 - '428 Filing History

Ex. 2087 - Preliminary Invalidity Contentions

Ex. 2100 - Ultra Images

Ex. 2101 - Dehdashtian

Ex. 2102 - '442 Application

Ex. 2103 - Second Declaration of Dr. Stephen Brecker

Ex. 2104 - Deposition of Dr. Nigel P. Buller

Ex. 2105 - Woven Textiles for Medical Applications

Ex. 2106 - Boston Ex. 2035

Ex. 2107 - Dehdashtian '757

Ex. 2108 - -00034 Pet. Reply to Patent Owner's Response

Ex. 2019 - -01527 Pet. Reply to Patent Owner's Response

Ex. 2110 - -01584 Pet. Reply to Patent Owner's Response

Ex. 2111 - Lichtenstein

Ex. 2112 - Vahanian

Ex. 2114 - '834 Pros. Hist.

Patent Owner's Response

Order: Conduct of the Proceeding 37 C.F.R. sec. 42.5

Notice of Joint Stipulation to Modify Schedule

Patent Owner's Second Updated Mandatory Notice

Notice of Deposition of Dr. Nigel P. Buller

Patent Owner's Objections Pursuant to 37 C.F.R. �� 42.64(b)(1)

Petitioner's Objections to Evidence in Patent Owner's Preliminary Response

Granting Institution of Inter Partes Review 35 U.S.C. § 314, 37 C.F.R. § 42.4

SCHEDULING ORDER

Other: Granting Patent Owner's Motions for Pro Hac Vice

Patent Owner's Preliminary Response

Ex. 2002 - Brecker Declaration

Ex. 2019 - Meslmani

Ex. 2020 - Rodrigues

Ex. 2021 - De Bock

Ex. 2022 - FDA P200015

Ex. 2023 - FDA P140031S085d

Ex. 2024 - FDA P140031S112

Ex. 2025 - FDA P140031-S125C

Ex. 2026 - Thomas

Ex. 2027 - FDA P140031C

Ex. 2028 - FDA P100041C

Ex. 2029 - FDA P110021C

Ex. 2031 - IPR2021-01527 Petition

Ex. 2035 - IPR2017-00060 Buller Tr.

Ex. 2039 - IPR2021-01527 Institution Decision

Ex. 2040 - Excerpts from the opposition proceeding to European Patent 2982337_part1

Ex. 2040 - Excerpts from the opposition proceeding to European Patent 2982337_part2

Ex. 2042 - IPR2022-00034 Buller Declaration

Ex. 2043 - IPR2022-00034 Institution Decision

Ex. 2045 - IPR2021-01584 Institution Decision

Ex. 2046 - IPR2022-00034 Rehearing Request

Ex. 2047 - IPR2022-00034 Petition

Ex. 2048 - IPR2022-00034 POPR

Motion for Pro Hac Vice Admission of Nathan Lowenstein

Ex. 2001 Lowenstein Declaration

Patent Owner's Updated Mandatory Notice Information

Notice: Notice filing date accorded

Patent Owner Mandatory Notices

Patent Owner Power of Attorney

PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 10,987,236

Petitioners' Power of Attorney

U.S. Patent No. 10,792,172 B2 (������236 patent���)

Excerpts from the prosecution history of the ���236 patent

Declaration of Nigel P. Buller, M.D.

Curriculum Vitae of Nigel P. Buller, M.D.

U.S. Provisional Application No. 61/567,458

U.S. Provisional Application No. 61/723,446

Trans-catheter valve-in-valve implantation ("Walther")

U.S. Patent No. 9,393,110 B2 to Levi et al. (���Levi���)

Conradi, Lenard, et al., Transcatheter aortic and mitral valve interventions

U.S. Patent No. 7,510,575 B2 to Spenser et al. (���Spenser���)

WO 2006/005015 A2 to Spenser et al. (���Spenser II���)

Cribier, Alain, et al., Technique of Transcatheter Aortic Valve Implantation

U.S. Patent No. 3,365,728

U.S. Patent No. 5,411,552

U.S. Patent Pub. No. 2003/0153974

Alkashkari, MD, et al., Percutaneous Pulmonary Valve Implantation

Cheung, Anson, et al., Transapical Transcatheter Mitral Valve-in-Valve Implantation

PCT Publication No. WO 98/29057

U.S. Patent No. 6,893,460

Yuksel, Uygar, Balloon-Expandable Transcatheter Aortic Valve Implantation

Walther, Thomas, et al., Transapical Minimally Invasive Aortic Valve Implantation ("Walther II")

Smith, Craig R., et al., Transcatheter versus Surgical Aortic-Valve Replacement

Webb, John G. and Binder, Ronald K., Transcatheter aortic valve implantation

Zajarias, Alan and Cribier, Alain G., Outcomes and Safety of Percutaneous Aortic Valve Replacement

Cribier, Alain, et al., Percutaneous Transcatheter Implantation

U.S. Patent No. 7,393,360

Roselli, E.E., Engineering transcatheter aortic valve devices

Tyagi, G.K., Yarn structure and properties from different spinning techniques

Kothari, V K, Hairiness properties of polyester-cotton blended yarns

Cribier, Alain, et al., Early Experience with Percutaneous Transcatheter Implantation

Akin, Jodi and Sharma, Pooja, ���Chapter 8: The Edwards SAPIEN Transcatheter Aortic Heart Valve System,���

Press Release

Press Release

Andersen, Henning, et al., Transluminal implantation of artificial heart valves

U.S. Patent No. 5,957,949

Nietlispach, Fabian, et al., Current Balloon-Expandable Transcatheter Heart Valve

U.S. Patent Application Publication No. US 2009/0281619

Press Release

Amendment with RCE for Patent Application No. 17/213,251

SAPIEN Instructions For Use

Saia, Francesco, et al., In-hospital and thirty-day outcomes of the SAPIEN 3

Press Release

Kainuma, Satoshi, et al., Transcatheter aortic valve implantation

Craido, Frank, Iliac Arterial Conduits for Endovascular Access

U.S. Patent No. 7,585,321 B2

Preliminary Amendment for Patent Application No. 17/096,253

Piazza, Nicolo, et al., Anatomy of the Aortic Valvar Complex

WO 2011/051043

Excerpts from the prosecution history of U.S. Patent No. 10,792,172

Complaint from Edwards Lifesciences Corp. v. Aortic Innovations, LLC

U.S. Patent No. 6,730,118

PCT Publication No. WO 2006/124649

U.S. Patent Pub. No. 2002/0052649

U.S. Patent Pub. No. 2011/0098802

Excerpts from the prosecution history of U.S. Patent No. 10,857,011

Excerpts from the prosecution history of U.S. Patent No. 10,881,538

U.S. Patent No. 7, 524,331

Declaration of Sylvia D. Hall-Ellis PhD

Walther, Thomas, et al., Trans-catheter valve-in-valve implantation

European Journal of Cardio-thoracic Surgery MARC Record from the OCLC Database

Library of Congress subject heading sh85059711

Library of Congress subject heading sh85099890

Library of Congress subject heading sh85023143

Azadani, Ali N., Transcatheter Heart Valves for Failing Bioprostheses

Cribier, Alain, et al., Technique of Transcatheter Aortic Valve Implantation

Herz MARC Record from the British Library

Library of Congress subject heading sh2009118412

Herz MARC Record from the OCLC Database

Curriculum Vitae of Sylvia D. Hall-Ellis PhD