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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`PATENT OWNER’S CONSOLIDATED RESPONSE ADDRESSING
`CONCEPTION AND REDUCTION TO PRACTICE
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`TABLE OF CONTENTS
`INTRODUCTION ........................................................................................... 1
`I.
`EVIDENCE SUBMITTED IN SUPPORT OF PRIOR INVENTION ........... 2
`II.
`III. BACKGROUND ............................................................................................. 3
`A. VSI ......................................................................................................... 3
`B.
`Conception of the Invention of the GuideLiner Patents ....................... 3
`C.
`Reduction to Practice............................................................................. 7
`D.
`Continued Work Towards Commercialization ................................... 18
`ITOU IS NOT PRIOR ART TO THE CLAIMED INVENTIONS .............. 19
`A.
`The VSI Inventors Reduced the Claimed Invention to Practice
`Prior to September 23, 2005 ................................................................ 21
`Reasonably Diligent Work on the Invention Continued Through
`the Filing of the Patent Application on May 3, 2006 .......................... 28
`CONCLUSION .............................................................................................. 29
`V.
`CERTIFICATE OF WORD COUNT COMPLIANCE ........................................... 30
`CERTIFICATION OF SERVICE............................................................................ 31
`
`IV.
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`B.
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`
`ii
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`
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`TABLE OF AUTHORITIES
`
`Cases
`Arctic Cat Inc. v. GEP Power Prods.,
`919 F.3d 1320 (Fed. Cir. 2019) ............................................................... 19, 20, 28
`Cooper v. Goldfarb,
`154 F.3d 1321 (Fed. Cir. 1998) ............................................................................ 24
`DSL Dynamic Scis., Ltd. v. Union Switch & Signal, Inc.,
`928 F.2d 1122 (Fed. Cir. 1991) ............................................................................ 25
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) ..................................................................... 20, 21
`E.I. du Pont de Nemours & Co. v. Unifrax I LLC,
`921 F.3d 1060 (Fed. Cir. 2019) ............................................................................ 22
`In re Asahi/America Inc.,
`68 F.3d 442 (Fed. Cir 1995) ................................................................................. 21
`In re Dardick,
`496 F.2d 1234 (C.C.P.A. 1974) ............................................................................ 21
`In re Stryker,
`435 F.2d 1340 (C.C.P.A. 1971) ............................................................................ 23
`Loral Fairchild Corp. v. Matsushita Elec. Indus. Co.,
`266 F.3d 1358 (Fed. Cir. 2001) ............................................................... 22, 24, 27
`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572 (Fed. Cir. 1996) ........................................................... 20, 21, 25, 27
`Perfect Surgical Techniques, Inc. v. Olympus America, Inc.,
`841 F.3d 1004 (Fed. Cir. 2016) ............................................................................ 28
`Purdue Pharma L.P. v. Boehringer Ingelheim GmbH,
`237 F.3d 1359 (Fed. Cir. 2001) ............................................................................ 20
`Scott v. Finney,
`34 F.3d 1058 (Fed. Cir. 1994) ................................................................. 20, 21, 22
`
`iii
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`
`
`Statutes
`
`Statutes
`35 U.S.C. §102(e) ............................................................................................... 1, 19
`35 U.S.C. §102(e) ............................................................................................... 1, 19
`
`
`iv
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`iV
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`I.
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`INTRODUCTION
`This consolidated brief is submitted in response to the consolidated
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`scheduling order authorizing the parties to file consolidated briefs specifically
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`addressing the issues of conception and reduction to practice that are relevant to
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`IPR2020-00126, -00128, -00129, -00132, -00134, -00135 and -00137. The patents
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`at issue are collectively referred to as “the GuideLiner patents.”
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`
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`These IPRs all rely, in whole or in part, on U.S. Patent No. 7,736,355
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`(“Itou”), which Medtronic asserts is prior art under 35 U.S.C. §102(e) based on an
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`effective filing date of September 23, 2005. Itou is not prior art to the GuideLiner
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`patents. The evidence shows that between January and August 2005, the inventors
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`and others working on their behalf built and tested GuideLiner prototypes and
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`confirmed they would work for their intended purpose. Corroborating the success
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`of this testing, a decision was made in August 2005 to move forward with
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`commercializing the GuideLiner. Thus, the fully corroborated facts demonstrate
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`that the GuideLiner patents were actually reduced to practice prior to the effective
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`filing date of the Itou reference. Moreover, although not necessary to pre-date
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`Itou, diligent work on GuideLiner continued from September 2005 to the filing of
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`its original priority application on May 3, 2006, thus providing an additional basis
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`to conclude that Itou is not prior art.
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`1
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`II. EVIDENCE SUBMITTED IN SUPPORT OF PRIOR INVENTION
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`
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`Patent Owner submits the following evidence in support of its showing of
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`prior invention over Itou:
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`1.
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`2.
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`3.
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`4.
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`5.
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`6.
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`7.
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`8.
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`Declaration of Howard Root (inventor) (Ex. 2118)1;
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`Declaration of Gregg Sutton (inventor) (Ex. 2119);
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`Declaration of Steven Erb (VSI/Teleflex Technologist) (Ex. 2122);
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`
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`Declaration of Deborah Schmaltz (former VSI employee) (Ex. 2039);
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`Declaration of Peter T. Keith (independent expert) (Ex. 2123);
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`Declaration of Amanda O’Neil (TE Connectivity employee) (Ex.
`2121);
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`Declaration of Mark Goemer (SPECTRAlytics employee) (Ex. 2120);
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`Exhibits 2002-2038, 2040-41, 2089-2117, and 2127-2134.2
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`
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`1 Patent Owner hereby withdraws the Declaration of Howard Root submitted as
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`Exhibit 2001 in connection with its Preliminary Response. Root’s declaration
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`submitted in support of this brief (Exhibit 2118), includes new evidence discovered
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`in the time since he submitted his prior declaration.
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`2 Patent Owner hereby withdraws it prior request to seal Exhibit numbers 2002,
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`2004-2011, 2013-2014, 2016, 2019-2035, and 2040. Each of these exhibits may be
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`considered public documents.
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`2
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`III. BACKGROUND
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`A. VSI
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`The patented GuideLiner rapid exchange guide extension catheter was
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`developed at Vascular Solutions, Inc. (“VSI”). VSI developed, manufactured, and
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`sold specialty products for interventional cardiology procedures and other medical
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`procedures. (Ex. 2118, ¶4.)
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`Post-conception, VSI’s development of new products typically occurred in
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`at least two phases. First, VSI would build and test prototypes to prove the
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`concept. When the concept was proven, VSI would move to the
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`commercialization phase, where it would refine the product so it could be cost-
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`effectively manufactured in accordance with exacting specifications and rigid
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`safety protocols required by the FDA. (Exs. 2118, ¶54; 2119, ¶44; 2039, ¶¶6-7,
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`11.) The dividing line between the phases was a “Product Requirements”
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`document that initiated tracking in VSI’s Quality system. (Id.) VSI would not
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`begin this Quality process unless and until it was confident that a product would
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`work for its intended purpose. (Id.)
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`B. Conception of the Invention of the GuideLiner Patents
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`In the fall of 2004, Root attended the annual Transcatheter Cardiovascular
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`Therapeutics conference (“TCT”) in Washington, D.C. (Ex. 2118, ¶5.) At that
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`time, he was aware that physicians conducting complex interventional coronary
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`3
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`procedures often had trouble with guide catheters backing out of the coronary
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`ostium during delivery of a stent or angioplasty balloon. (Id.) Around the time of
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`the conference, he conceived of the idea for a rapid exchange device that that
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`would provide improved back-up support and offer far more conveniences than
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`other options available at the time. (Id. at ¶¶5-6; see also Ex. 2119, ¶9.) After
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`TCT, but before 2005, Root and the other named inventors met to discuss how to
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`make such a device. (Ex. 2118, ¶6.)
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`At a high level, the inventors conceived of a rapid exchange guide extension
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`catheter to be used within a one French size larger guide catheter. (Exs. 2118, ¶¶7,
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`9, 12; 2119, ¶12; 2002; 2004.) The guide extension catheter included a
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`substantially rigid proximal portion comprising a “rail” structure and a tubular
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`portion with a lumen distal of the proximal portion, which together were longer
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`than the overall length of a standard guide catheter. (Exs. 2118, ¶¶7, 9; 2119,
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`¶¶11-13; 2002.) The distal tube portion was reinforced with a braid or coil, and
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`could have a highly flexible atraumatic “bumper tip.” (Exs. 2118, ¶¶7, 9; 2119,
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`¶11; 2002.)
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`In use, a standard guide catheter would first be inserted into the vasculature
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`until the distal end was adjacent the ostium of a cardiac artery within the heart.
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`(Exs. 2118, ¶7, 10; 2119, ¶13; 2002.) The guide extension catheter would then be
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`inserted through the guide catheter until the tubular portion’s distal end extended
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`4
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`past the distal end of the guide catheter and into the cardiac artery. (Id.) An
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`interventional cardiology device, such as a stent or balloon catheter, would then be
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`inserted through the guide catheter (running alongside the rail of the guide
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`extension catheter), into and through the proximal end of the tubular portion of the
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`guide extension catheter, out the distal end of the tubular portion, and into the
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`cardiac artery. (Id.)
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`Conception of the invention is reflected, inter alia, in inventor Gregg
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`Sutton’s notebook, dated January 5, 2005, for the “Guide-Liner Device.” (Exs.
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`2119, ¶¶7-9; 2118, ¶¶8-10; 2002.) This notebook lays out the idea for the
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`invention and includes illustrations that are nearly identical to several figures in the
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`GuideLiner patents, including Figure 2:
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`5
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`(Exs. 2002; 1001, Fig. 2.) A February 2005 drawing by Root is very similar to
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`Figure 1 of the patents:
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`(Exs. 2004; 1001, Fig. 1.) This February 2005 document also reflects conception
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`of the “side opening” at the proximal end of the tubular portion that facilitates
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`entry of a stent or balloon catheter into the tubular portion. (Ex. 2118, ¶¶12-14.)
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`A February 4, 2005 memo further reflects the design features of the contemplated
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`GuideLiner device. (Exs. 2118, ¶11; 2127.)
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`6
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`C. Reduction to Practice
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`VSI immediately began prototyping and testing the GuideLiner concept to
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`confirm that it would work. (Exs. 2118, ¶¶15-18; 2119, ¶¶16, 18, 20; 2122, ¶¶5-
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`14.) In January 2005, a VSI technician ordered hypotubes and used an in-house
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`milling machine to cut down the proximal portion of what would become
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`GuideLiner prototypes. (Exs. 2122, ¶¶5-9; 2118, ¶¶16, 23-24; 2119, ¶20; 2110.)
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`These cut-down proximal portions were bonded to distal polymer tubular portions,
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`first using an adhesive, and for later prototypes, a heat-shrink tubing and a reflow
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`process. (Exs. 2122, ¶10; 2118, ¶¶16, 23-24; 2119, ¶35.) Significant testing was
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`performed on these early prototypes. (Exs. 2118, ¶¶16-18; 2119, ¶¶16-17, 23, 41;
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`2122, ¶¶5, 11-13; 2003.) From the beginning, the inventors and others at VSI were
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`confident the device would work for its intended purpose. (Exs. 2118, ¶¶15-18;
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`2119, ¶¶6, 16, 18, 23; 2122, ¶13.)
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`VSI soon began to make more sophisticated GuideLiner prototypes for
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`additional testing. These involved a distal tubular portion made of extruded
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`polymer around a PTFE liner with an embedded metal braid, and a proximal
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`portion made from a metal hypotube that was machined to remove varying
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`amounts of the side wall of the tube. (Exs. 2118, ¶¶23-35, 39-51, 84; 2119, ¶¶21-
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`36; 2122, ¶¶7-10; 2120, ¶¶6-12; 2121, ¶¶ 4-6; 2002; 2006-2011; 2013; 2020-2022;
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`2026-2027; 2032-2035; 2089; 2090-2091; 2092; 2094-2095; 2097l 2110; 2111-
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`7
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`2115.) The proximal portion served as a push member for the device, as well as
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`the opening into the distal tubular portion. (Exs. 2118, ¶¶18, 34, 41, 49-50, 84;
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`2119, ¶¶11, 24, 32.) VSI outsourced these and other parts and did the final
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`assembly and testing in-house. (Ex. 2118, ¶¶15-58; 2119, ¶¶ 36-37; 2122, ¶12.)
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`VSI built at least two different sets of these more sophisticated prototypes
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`prior to August 2005. For the first set, VSI ordered 20 distal tubular portions from
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`Medical Engineering & Design, Inc. (“MED”) on February 17, 2005. (Ex. 2118,
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`¶¶25, 31; 2119, ¶¶32-33; 2089 at 6; 2011.) Below is a drawing of the design for
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`the distal tubular portion, dated February 10, 2005, that VSI provided to MED for
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`this order:
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`8
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`(Exs. 2089 at 8; 2121, ¶5.) The distal section was made up of three different Pebax
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`polymers having different stiffnesses formed around a PTFE liner:
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`(Id.; see also Ex. 2118, ¶25.) A reinforcing braid was embedded along the entire
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`length of the polymer, except the most proximal and distal portions:
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`(Id.) The most distal, unreinforced portion provided a soft tip and the proximal
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`end was formed for connecting to the hypotube:
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`9
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`(Id.) The outer diameter of the tube was 0.066 inches, which is consistent with its
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`intended use inside a 6 French guide catheter having an ID of at least 0.070 inches,
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`and the inner diameter was 0.057 inches. (Ex. 2089 at 7.) MED delivered these
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`distal tubular sections to VSI on April 5, 2005. (Id. at 1.)
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`VSI also ordered hypotubes for the proximal portions of these prototypes
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`and outsourced them to be laser cut. On March 21, 2005, VSI placed an order with
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`SPECTRAlytics to laser cut 20 hypotubes for the prototypes. (Exs. 2118, ¶32-33;
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`Ex. 2119, ¶30; 2013 at 3; 2095 at 3.) SPECTRAlytics completed that order on
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`April 4 and 5, 2005. (Ex. 2095 at 1-2.) The hypotubes were cut to have a full
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`circumference at their distal end, multiple angled transition regions bookending
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`non-inclined regions, and a proximal rail structure. (Exs. 2118, ¶34; 2113.) Below
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`is a drawing, dated February 4, 2005, that VSI provided to SPECTRAlytics for the
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`order:
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`10
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`(Id.; Ex. 2120, ¶9.)
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` VSI then attached the distal end of the hypotubes cut down by
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`SPECTRAlytics to the proximal end of the tubular sections from MED to form
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`complete prototypes for analysis and testing. (Exs. 2118, ¶35; 2119, ¶35; 2122,
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`¶12.)
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`VSI’s testing of the prototypes included use of models that emulated the
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`coronary vasculature of a human heart. (Ex. 2118, ¶¶17-18, 38, 47; see also Exs.
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`2119, ¶41; 2122, ¶¶6, 11-12.) Attached is a picture showing a model that was used
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`for this testing:
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`11
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`
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`(Exs. 2018; 2118, ¶¶17, 38.) Such models were commonly used by VSI and other
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`medical device companies to test interventional cardiology devices and to confirm
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`they would serve their intended purpose inside a human heart. (Exs. 2118, ¶17;
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`2123, ¶¶20-24.) VSI’s testing included inserting a standard guide catheter into the
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`coronary model, advancing the GuideLiner prototype into the guide catheter until
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`the distal end of the prototype extended beyond the distal end of the standard guide
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`catheter, then delivering a stent or balloon catheter into the guide catheter, into and
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`through the tubular portion of the prototype, and out the distal end of the prototype.
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`(Exs. 2118, ¶¶17-18, 38, 47; see also Exs. 2119, ¶41; 2122, ¶¶11-12.) Testing is
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`further corroborated by records showing that VSI purchased Medtronic guide
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`catheters on April 6, 2005 to use in testing the prototypes (Exs. 2118, ¶¶36, 47;
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`2119, ¶37; 2016), as well as the July 2005 presentation showing an example of a
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`12
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`
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`guide catheter and a balloon catheter used in the testing. (Ex. 2118, ¶¶17, 38, 47;
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`2129.)3
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`Vendor records also corroborate that a second set of prototypes was built
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`and tested in June/July 2005. Specifically, VSI received another 21 “Guide Liner
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`Distal Sections” from MED on June 16, 2005. (Exs. 2118, ¶¶44-45, 51; 2119, ¶34;
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`2021; 2092 at 1-3), and ordered laser-cutting by SPECTRAlytics of another 20
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`hypotubes on June 23, 2005. (Exs. 2118, ¶43; 2019, ¶31; 2111; 2114; 2020.)
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`SPECTRAlytics cut this set of hypotubes with a revised design, shown in the June
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`21, 2005 drawing below, and received by SPECTRAlytics on June 28, 2005:
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`3 For a time, VSI pursued development of a non-patented, over-the-wire (“OTW”)
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`guide extension catheter, in parallel with the patented GuideLiner rapid exchange.
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`(Exs. 2118, ¶19; 2119, ¶15.) Because it was based on existing technology, and
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`would have fewer regulatory hurdles, the company believed it could bring the
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`OTW version to market quicker. (Exs. 2118, ¶19; 2017). Accordingly, the
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`GuideLiner prototype shown in the July presentation is the OTW version of the
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`product. (Ex. 2118, ¶38.) VSI ultimately abandoned the OTW version and only
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`commercialized the GuideLiner rapid exchange. (Id. at ¶19.)
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`13
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`
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`(Exs. 2118, ¶41; 2114; Ex. 2120, ¶11.) These drawings correspond almost
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`identically to Figures 12-16 of the GuideLiner patents:
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`14
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`(Ex. 1001.)
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`As with the first set, VSI did the final assembly of the prototypes in-house
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`and promptly tested them using the benchtop models discussed above. (Exs. 2118,
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`¶¶46-47; 2119, ¶¶22, 41, 43, 47; 2130 at 3; 2122, ¶¶11-12.) This testing confirmed
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`that the prototypes also could successfully deliver stents and balloon catheters
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`along the rail segment, into the side opening and distal tubular portion, out the
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`distal end of the distal tubular portion, and into challenging coronary anatomy.
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`(Exs. 2118, ¶¶17-18, 38, 47; 2119, ¶41; 2122, ¶¶11-12.)
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`
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`The following CAD drawing is dated August 1, 2005 and shows a complete
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`rapid exchange GuideLiner:
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`15
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`
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`(Ex. 2022; see also Exs. 2118, ¶¶49-51; 2119, ¶39.) These drawings are nearly
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`identical to Figures 3 and 4 of the GuideLiner patents:
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`(Ex. 1001.) The label on the drawing, “Preliminary Design Assumption Rev.
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`X03,” shows that VSI had made significant advances in its design and prototypes
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`16
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`and was getting ready to begin the formal Quality process for bringing the rapid
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`exchange GuideLiner to market. (Exs. 2118, ¶49; 2119, ¶39.)
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`
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`An August 24, 2005 “Product Requirements” document discusses both the
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`rapid exchange and OTW versions of the GuideLiner. (Exs. 2118, ¶54; 2119, ¶44;
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`2039, ¶6; 2024.) Product Requirements documents signaled VSI’s transition to the
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`formal Quality process for bringing medical devices to market. (Id.) According to
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`VSI’s standard practice, such documents would not be created until prototypes had
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`been made and tested to show that they would work for their intended purpose.
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`(Id.) An August 26, 2005 Clinical Technical Report further confirms that
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`GuideLiner worked as intended and was ready to move toward commercialization.
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`(Exs. 2118, ¶¶55-57; 2119, ¶¶45-46; 2039, ¶¶9-10; 2025; see also Ex. 2040.) Such
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`clinical literature reviews were conducted as part of the process for the FDA’s
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`510(k) regulatory approval. (Id.) According to VSI’s standard practice, a
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`regulatory strategy would not have been decided upon, and clinical technical
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`reviews would not have been pursued, unless prototypes had been made and
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`successfully tested to show that they worked for their intended purpose. (Id.)
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`17
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`D. Continued Work Towards Commercialization
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`
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`In August 2005, VSI began working with its outside patent counsel
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`(Patterson) on the application for the GuideLiner patents. On August 11, 2005,
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`Patterson opened a prior art search file for GuideLiner. (Exs. 2118, ¶¶52-53; 2023;
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`2096.) Patterson reported the results of its prior art search on September 14, 2005
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`and, at Root’s direction, opened a new patent application file for GuideLiner on
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`October 5, 2005. (Exs. 2118, ¶¶61-62; 2023; 2098.) Although not all of the
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`records relating to the patent application were maintained, existing documents
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`show ongoing work on the patent application. VSI provided Patterson with,
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`among other things, the August 1, 2005 CAD drawing discussed above. (Exs.
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`2118, ¶¶49-50; 2119, ¶39; 2022.) Billing records show that substantial work was
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`done by Patterson on the draft patent application in January and March 2006.
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`(Exs. 2118, ¶¶66, 68; 2101; 2013; 2117.) Inventor Sutton sent Patterson additional
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`sketches and drawings for the patent application on January 23, 2006 and March
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`21, 2006. (Exs. 2119, ¶¶40, 42; 2118, ¶¶42, 67; 2019; 2102.) The inventors and
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`Patterson also exchanged emails about the patent application on March 15, 2006
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`and April 12, 2006. (Ex. 2098.)
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`While Patterson prepared the patent applications, VSI refined details of the
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`rapid exchange GuideLiner for commercialization. Root and Sutton reported to the
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`VSI Board of Directors in October 2005 that VSI’s physician advisors had
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`18
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`
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`favorably evaluated the rapid exchange GuideLiner and that a 510(k) regulatory
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`submission was planned for the first quarter of 2006. (Exs. 2118, ¶62; 2119, ¶47;
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`2133.) That regulatory submission was postponed while the company continued to
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`optimize the device for commercialization. Although it knew the GuideLiner rapid
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`exchange would work for its intended purpose, the company needed time to
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`identify the materials and processing that would make the device both cost
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`effective and efficient to manufacture. (Exs. 2118, ¶¶65, 90-91; 2119, ¶¶48-49;
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`2122, ¶¶13-14; see also 2123, ¶¶25-27.) As shown by contemporaneous
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`documents, that process was ongoing, but required more time and resources than
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`the company originally anticipated. (Exs. 2118, ¶¶59-60, 62-65, 69-75, 87-91;
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`2119, ¶¶48-52; 2099; 2100; 2104; 2105; 2106; 2107; 2108; see also 2039, ¶12; Ex.
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`2123, ¶¶25-27.)
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`IV.
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`ITOU IS NOT PRIOR ART TO THE CLAIMED INVENTIONS
`Petitioner asserts that Itou is prior art under 35 U.S.C. §102(e) based on its
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`September 23, 2005 filing date. To qualify as prior art under §102(e), a reference
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`must have been filed in the United States before the applicant’s invention. Arctic
`
`Cat Inc. v. GEP Power Prods., 919 F.3d 1320, 1330 (Fed. Cir. 2019). As such,
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`Itou is not prior art if the VSI inventors either (a) reduced the claimed invention to
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`practice prior to September 23, 2005, or (b) conceived of the claimed invention
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`prior to September 23, 2005, and exercised reasonable diligence between
`
`19
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`
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`September 23, 2005 and a later actual or constructive reduction to practice. See
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`e.g., Arctic Cat, 919 F.3d at 1331; Purdue Pharma L.P. v. Boehringer Ingelheim
`
`GmbH, 237 F.3d 1359, 1365 (Fed. Cir. 2001); Mahurkar v. C.R. Bard, Inc., 79
`
`F.3d 1572, 1579 (Fed. Cir. 1996).4
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`The Petitioner bears the burden of proving that the references upon which it
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`relies constitute prior art. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800
`
`F.3d 1375, 1380 (Fed. Cir. 2015). That burden is initially met simply by showing
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`that the effective filing date of the reference is prior to that of the challenged
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`patent(s). Once the Patent Owner comes forward with evidence of an earlier
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`invention date, however, the burden then falls to Petitioner to prove that invention
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`did not occur prior to the filing date of the alleged prior art reference. Id. The
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`4 Some cases also recite conception as an element of proof in the case of actual
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`reduction to practice prior to the critical date. See Mahurkar, 79 F.3d 1572, 1578
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`(Fed. Cir. 1996). Given the practical reality that one cannot reduce something to
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`practice that has not been conceived, most actual reduction to practice cases do not
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`separately analyze conception. See, e.g., Scott v. Finney, 34 F.3d 1058, 1061 (Fed.
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`Cir. 1994). Regardless, the evidence of conception in this case is clear and
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`undisputable. (See Exs. 2118, ¶¶5-14; 2119, ¶¶7-15; 2002-2004.)
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`20
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`ultimate burden of proof remains on the Petitioner and never shifts to the Patent
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`Owner. Id. at 1378.
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`A.
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`The VSI Inventors Reduced the Claimed Invention to Practice
`Prior to September 23, 2005
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`Reduction to practice occurs when the inventor or those working on the
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`inventor’s behalf: (a) constructs an embodiment or performs a process that meets
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`the claimed invention; and (b) demonstrates that the invention is “suitable for its
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`intended purpose.” Scott v. Finney, 34 F.3d 1058, 1061 (Fed. Cir. 1994) (citations
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`omitted). Reduction to practice “does not require ‘that the invention, when tested,
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`be in a commercially satisfactory stage of development.’” Id. (quoting In re
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`Dardick, 496 F.2d 1234, 1238 (C.C.P.A. 1974)). Moreover, the type and amount
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`of any testing needed to demonstrate that the invention was suitable depends on the
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`nature of the invention. Id. at 1061-62 (discussing cases). Many cases have found
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`inventions to be reduced to practice based on little, or even no testing of the
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`invention when the principles of operation of the invention are not complex. See
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`In re Asahi/America Inc., 68 F.3d 442, 446-47 (Fed. Cir 1995) (no testing required
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`for pipe coupling system invention); Mahurkar, 79 F.3d at 1578 (flow and pressure
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`drop testing in inventor’s kitchen held sufficient for dual lumen catheter
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`invention); Scott, 34 F.3d at 1063 (inflation/deflation testing sufficient for penile
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`implant invention). In cases where testing is required, the testing need not show
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`21
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`utility beyond a possibility of failure, but only utility beyond a probability of
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`failure. Scott, 34 F.3d at 1062.
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`Like other issues associated with prior invention, testimonial evidence from
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`an inventor regarding reduction to practice must be corroborated by independent
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`evidence. Loral Fairchild Corp. v. Matsushita Elec. Indus. Co., 266 F.3d 1358,
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`1363-65 (Fed. Cir. 2001). The sufficiency of such corroborating evidence is
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`evaluated under the “rule of reason,” which considers all of the pertinent evidence
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`to determine whether the inventor(s)’ testimony regarding reduction to practice is
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`credible. Id.; see also E.I. du Pont de Nemours & Co. v. Unifrax I LLC, 921 F.3d
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`1060, 1077 (Fed. Cir. 2019).
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`Submitted herewith are Declarations testifying that, prior to September
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`2005, prototypes of the claimed invention were made and tested to confirm that
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`they would work for their intended purpose. (Ex. 2118, ¶¶15-58; Ex. 2119, ¶¶6,
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`16-46; 2122, ¶¶5-13; 2039, ¶¶6-10.) Root’s declaration also includes detailed
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`charts that map the GuideLiner patent claims to the prototypes and establish that
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`the prototypes contained all limitations of at least the claims for which Petitioner is
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`relying on Itou.5 (Ex. 2118, ¶¶78-82 and Appx. A-E; Ex. 2123, ¶28.)
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`5 In those instances where Petitioner is asserting obviousness based on Itou, the
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`evidence need only show prior invention of those aspects of the claims that
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`22
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`Testimony from Root and Sutton about the existence and testing of
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`prototypes is well corroborated by non-inventor testimony, as well as documentary
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`evidence, including engineering drawings, vendor invoices for components,
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`documents referring to prototypes having been built and evaluated, and the August
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`24, 2005 “Product Requirements” document. See supra pp. 7-17. As explained
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`above, the invoices and the drawings (many of which came out of the files of, and
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`are authenticated by, the third-party vendors) show that the components for at least
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`two sets of prototypes were delivered to VSI—the first set in April 2005, and the
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`second set in June/July 2005. Id. The July 2005 presentation shows an example of
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`a benchtop coronary model that was used for testing, as well as an example of a
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`standard guide catheter and balloon catheter that were used as part of the testing.
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`(Exs. 2018; 2118, ¶17.) Non-inventor testimony corroborates VSI’s testing of
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`GuideLiner prototypes. (Exs. 2039, ¶¶5-7, 9-12; 2122, ¶¶11-13.) And as further
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`corroborated by non-inventor testimony, the August 24, 2005 “Product
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`Requirements” document marked the transition to the formal Quality process of
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`Petitioner contends are present in Itou in order to remove Itou as prior art. See In
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`re Stryker, 435 F.2d 1340 (C.C.P.A. 1971) (holding that if an obviousness rejection
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`is well-founded, then prior invention of what is shown in primary reference is
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`sufficient to overcome the rejection).
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`23
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`
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`bringing a commercial product to market, and was only drafted after a product had
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`been built, tested, and determined to work for its intended purpose. (Ex. 2039,
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`¶¶6-7.)
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`Under the rule of reason, proof of reduction to practice “does not require
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`corroboration for every factual issue contested by the parties.” Cooper v.
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`Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998). Rather, the corroborating
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`evidence must merely be sufficient to render the inventor’s testimony credible. Id.
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`In Loral Fairchild, the Federal Circuit criticized the district court for requiring
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`documentary evidence of test results and held that evidence showing that a
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`component needed to practice the invention was delivered prior to the critical date
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`was alone sufficient to corroborate the inventor testimony’s on reduction to
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`practice. Loral Fairchild, 266 F.3d at 1364-65. In Cooper, the Federal Circuit
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`held that the inventor's testimony was sufficiently corroborated by testimony of his
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`co-workers that he had told them of his reduction to practice, and that they had
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`seen him obtain materials of the type necessary to practice the invention. Cooper
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`at 1330. Here, the evidence supporting the inventors’ testimony is much more
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`robust than that of either Loral Fairchild or Cooper.
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`As the corroborated evidence shows, testing in a benchtop model was
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`sufficient to establish reduction to practice of the GuideLiner invention. Even
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`when testing is necessary, there is no need to test the invention in its actual
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`24
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`
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`working environment as long as the test environment is sufficiently similar to
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`demonstrate workability. DSL Dynamic Scis., Ltd. v. Union Switch & Signal, Inc.,
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`928 F.2d 1122, 1125 (Fed. Cir. 1991). Catheter inventions are routinely
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`determined to work using benchtop models, and without human testing. (Ex. 2123,
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`¶¶20-24; see also Ex. 1010 (using tests performed in a desk-model to show that a
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`mother-and-child catheter provided increased back-up support).) Indeed, catheters
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`need not be tested in humans to obtain FDA approval. (Ex. 2123, ¶24.) In
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`Mahurkar, the Federal Circuit held as a matter of law that the invention was
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`reduced to practice based on evidence that, prior to the critical date, the inventor
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`conducted flow and pressure drop tests on his catheter invention in his kitchen.
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`Mahurkar, 79 F.3d at 1578. Here, the benchtop model emulated cardiac anatomy
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`and was sufficient to show that the prototype GuideLiners could serve their
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`intended purpose of being placed in a standard guide catheter and deliver
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`interventional cardiology devices alongside the rail segment, into the side opening
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`and distal tubular portion, and then out the distal end of the distal tubular portion
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`and into challenging coronary anatomy. (Exs. 2118, ¶¶17-18, 38, 47; 2119, ¶41;
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`2123, ¶¶20-24.)
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`This is particularly true in view of testimony given by Petitioner’s expert,
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`Dr. Brecker regarding the Itou reference. Itou is directed to a suction catheter and
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`thus is not designed to facilitate the delivery of stents or other interventional
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`25
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`
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`cardiology devices into cardiac vasculature. (Ex. 2123, ¶15.) Nonetheless, Dr.
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`Brecker enthusiastically testified that not only would Itou inherently perform the
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`function of facilitating the delivery of stents or other interventional cardiology
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`devices into the cardiac vasculature, but that a POSITA would know that Itou’s
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`suction catheter would work for this purpose simply by looking at Itou’s drawings
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`and without performing any testing whatsoever. (Ex. 2116, 104:13-109:9, 110:7-
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`113:24.) This testimony by Dr. Brecker esta