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`UNITED STATES PATENT AND TRADEMARK OFFICE
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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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`
`
`Case IPR2020-01341
`U.S. Patent No. 8,142,413
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`PATENT OWNER SUR-REPLY
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`B.
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`C.
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`E.
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`B.
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`I.
`II.
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`Page
`INTRODUCTION ........................................................................................... 1
`ITOU IS NOT PRIOR ART ............................................................................ 1
`A.
`Petitioner’s Arguments Would Impose Erroneous Evidentiary
`Burdens on Patent Owner, and Ignore Its Own ................................... 1
`The Board Already Rejected Petitioner’s Argument that Patent Owner
`Failed to Show Assembly of Prototypes ............................................... 3
`Patent Owner Performed and Tested the Claimed Methods ................. 8
`1.
`Petitioner Proposes an Improper Standard for Performance of
`a Method Claim ........................................................................... 9
`Patent Owner Timely Performed and Tested the Claimed
`Methods ..................................................................................... 12
`3.
`Testing was sufficient ................................................................ 15
`D. Diligent Work Was Performed on the Invention Through the Filing of
`the First Patent Application ................................................................ 17
`Continued Work on Commercialization of GuideLiner Does Not
`Undo Reduction to Practice ................................................................ 19
`III. GROUND 1: EVEN IF ITOU WERE CONSIDERED PRIOR ART, IT
`DOES NOT ANTICIPATE THE ʼ413 PATENT ........................................ 20
`A. Claims 1-2, 4, 7-14: Itou’s “Protective Catheter” Is Not an
`“Interventional Cardiology Device” .................................................. 20
`Claims 1-2, 4, 7-14: Itou’s Protective Catheter Is Not Inserted
`“Alongside of the Substantially Rigid Portion . . . and [Advanced] Into
`Contact with or Past a Lesion” .......................................................... 22
`1.
`Itou Does Not Disclose “inserting the interventional cardiology
`device into and through the continuous lumen of the standard
`guide catheter alongside of the substantially rigid portion” ... 24
`Itou Does Not Disclose “advancing the interventional
`cardiology device . . . into contact with or past a lesion in the
`second artery” .......................................................................... 25
`
`TABLE OF CONTENTS
`
`2.
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`2.
`
`ii
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`
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`C. Dependent Claim 2: Itou Does Not Disclose “applying a force to . . .
`the coaxial guide catheter such that the distal portion of the coaxial
`guide catheter remains seated . . . in response to an opposing
`backward force exerted by the interventional cardiology device” ..... 25
`D. Dependent Claims 9-12: Itou Does Not Disclose “extending the
`interventional cardiology device through a proximal side opening . . .
`while the proximal portion remains within the lumen of the guide
`catheter” ............................................................................................. 26
`IV. GROUNDS 2-3: EVEN IF ITOU WERE CONSIDERED PRIOR ART,
`THE CHALLENGED CLAIMS ARE NOT OBVIOUS .............................. 26
`A. Claims 1-2, 4-5, 7-14: Petitioner Has Not Proved a Motivation to Use
`Itou’s Suction Catheter to Provide Backup Support When Delivering
`ICDs ..................................................................................................... 27
`Claims 1-2, 4-5, 7-14: Petitioner Has Not Proved Reasonable
`Expectation of Success ........................................................................ 29
`V. COMPELLING OBJECTIVE EVIDENCE CONFIRMS THAT CLAIMS 4,
`9-12, AND 14 OF THE ’413 PATENT WOULD NOT HAVE BEEN
`OBVIOUS ...................................................................................................... 30
`A.
`The Objective Evidence Is Undisputed ............................................... 30
`B.
`The Combination of Features That Resulted in GuideLiner’s Success
`and Praise Is Not in the Prior Art ........................................................ 31
`The Fact that GuideLiner’s Competitors Copied its Design Confirms
`Non-Obviousness ................................................................................ 33
`VI. CONCLUSION .............................................................................................. 35
`
`
`B.
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`C.
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`iii
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`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Arctic Cat Inc. v. GEP Power Prods.,
`919 F.3d 1320 (Fed. Cir. 2019) ................................................................................ 17
`Cooper v. Goldfarb,
`154 F.3d 1321 (Fed. Cir. 1998) ......................................................................... 2, 3, 4
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) .................................................................................. 1
`E.I. du Pont de Nemours & Co. v. Unifrax I LLC,
`921 F.3d 1060 (Fed. Cir. 2019) ..............................................................................2, 4
`Ethicon, Inc. v. U.S. Surgical Corp.,
`135 F.3d 1456 (Fed. Cir. 1998) .................................................................................. 4
`Focal Therapeutics, Inc. v. Senorx, Inc.,
`IPR2014-00116, Paper 19 (PTAB, July 21, 2014) .................................................... 7
`
`Huawei Technologies, Co. v. Samsung Electronics Co.,
`340 F. Supp. 3d 934 (N.D. Cal. 2018) ..................................................................... 12
`
`In re Steed,
`802 F.3d 1311 (Fed. Cir. 2015) ........................................................................... 2, 11
`
`In re Stempel,
`241 F.2d 755 (CCPA 1957) ................................................................................ 8, 15
`
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ................................................................................ 29
`
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ......................................................................... 34, 35
`
`Knorr v. Pearson,
`671 F.2d 1368 (CCPA 1982) ..................................................................................... 4
`
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 (PTAB Jan. 24, 2020) ................................................... 33
`
`iv
`
`
`
`Loral Fairchild Corp. v. Matsushita Elec. Indus. Co.,
`266 F.3d 1358 (Fed. Cir. 2001) ................................................................. 2, 3, 19, 20
`
`Lucent Techs., Inc. v. Gateway, Inc.,
`No. 02-cv-2060-B(CAB), 2007 U.S. Dist. LEXIS 50891 (S.D. Cal. July 12, 2007)
` .................................................................................................................................. 11
`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572 (Fed. Cir. 1996) .................................................................................... 2
`
`Mann v. Werner,
`347 F.2d 636 (CCPA 1965) ....................................................................................... 4
`
`Medichem, S.A. v. Rolabo, S.L.,
`437 F.3d 1157 (Fed. Cir. 2006) ......................................................................... 10, 11
`
`Mosaid Technologies Inc. v. Samsung Electronics Co.,
`362 F. Supp. 2d 526 (D.N.J. 2005) .......................................................................... 12
`
`NFC Tech., LLC v. Matal,
`871 F.3d 1367 (Fed. Cir. 2017) ................................................................................ 18
`
`Perfect Surgical Techniques, Inc. v. Olympus America, Inc.,
`841 F.3d 1004 (Fed. Cir. 2016) ................................................................................ 17
`
`Scott v. Finney,
`34 F.3d 1058 (Fed. Cir. 1994) ............................................................................. 9, 10
`
`Taskett v. Dentlinger,
`344 F.3d 1337 (Fed. Cir. 2003) ................................................................................ 10
`
`TC Tech. LLC v. Sprint Corp.,
`379 F. Supp. 3d 305 (D. Del. 2019) ......................................................................... 12
`
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ......................................................................... 33, 34
`
`Other Authorities
`
`37 C.F.R. § 42.23(b) ................................................................................................ 29
`
`v
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`
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`PTAB Consolidated Trial Practice Guide (November 2019) .................................. 29
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`vi
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`I.
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`INTRODUCTION
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`The Board already found in related IPRs that Itou is not prior art. The same
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`result should follow here.
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`Even if Itou were prior art, it does not disclose the claimed methods of the
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`ʼ413 patent. Petitioner’s obviousness arguments also fail. Itou (a suction catheter)
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`and Ressemann (an embolic protection device) are very different from each other.
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`Unrebutted objective evidence shows that using Itou’s suction catheter as a guide
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`extension catheter to provide backup support for delivering interventional
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`cardiology devices was not, in the real world, an obvious thing to do.
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`II.
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`ITOU IS NOT PRIOR ART
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`A.
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`Petitioner’s Arguments Would Impose Erroneous Evidentiary
`Burdens on Patent Owner, and Ignore Its Own
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`The burden of persuasion on invalidity rests on Petitioner and never shifts to
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`Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375,
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`1378 (Fed. Cir. 2015). Patent Owner’s burden is one of production, or “going
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`forward with evidence,” not the ultimate issue of validity. Id., 1379. When Patent
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`Owner produced evidence that it antedated the reference, the burden returned to
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`Petitioner to prove that the invention was not reduced to practice. Id., 1380.
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`Patent Owner has produced robust, corroborated evidence of GuideLiner’s prior
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`reduction to practice. Even if the Board were uncertain about the evidence,
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`1
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`Petitioner, the party with the ultimate burden, loses. Id., 1378-79; see also
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`Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577 (Fed. Cir. 1996).
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`In an apparent attempt to minimize the strength of Patent Owner’s evidence
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`contained in detailed, inventor and non-inventor declarations, Petitioner quotes In
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`re Steed to argue that “[a]ntedating a reference ‘requires documentary support.’”
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`Reply, 7 (quoting In re Steed, 802 F.3d 1311, 1316 (Fed. Cir. 2015)). But in In re
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`Steed, antedating evidence (third-party affidavits) was improper because it was
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`provided to the Board too late—not because it was the wrong kind of evidence.
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`802 F.3d at 1318-1320.
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`Corroborating evidence of inventor testimony is evaluated under the “rule of
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`reason,” which considers all pertinent evidence to determine whether the inventor’s
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`testimony is credible. Loral Fairchild Corp. v. Matsushita Elec. Indus. Co., 266
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`F.3d 1358, 1363-65 (Fed. Cir. 2001); see also E.I. du Pont de Nemours & Co. v.
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`Unifrax I LLC, 921 F.3d 1060, 1077 (Fed. Cir. 2019). Proof of reduction to
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`practice “does not require corroboration for every factual issue contested by the
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`parties.” Cooper v. Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998). The
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`corroborating evidence must merely be sufficient to render the inventor’s
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`testimony credible. Id.
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`Indeed, in Loral Fairchild, the Federal Circuit reversed the district court for
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`requiring documentary evidence of test results, stating that “the inventor’s
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`2
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`
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`testimony must be sufficiently corroborated by independent evidence, but not
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`necessarily documentary evidence.” Loral Fairchild, 266 F.3d at 1364 (emphasis
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`in original) (obtaining material necessary to practice invention and corroborating
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`non-inventor testimony was sufficient to avoid summary judgment of no reduction
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`to practice). In Cooper, the Federal Circuit held that the inventor’s testimony was
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`sufficiently corroborated by his co-workers’ testimony that the inventor told them
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`about his reduction to practice, and that they had seen him obtain materials of the
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`type necessary to practice the invention. Cooper, 154 F.3d at 1330.
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`Here, the evidence supporting the inventors’ testimony is much more robust
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`than in Loral Fairchild and Cooper.
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`B.
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`The Board Already Rejected Petitioner’s Argument that Patent
`Owner Failed to Show Assembly of Prototypes
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`Petitioner asserts that Patent Owner failed to adduce evidence showing the
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`April and July 2005 prototypes were assembled, citing Valencell to argue that
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`“[c]omponent parts, alone, cannot prove assembled prototypes”—as if that were all
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`the evidence Patent Owner provided. Reply, 9. The Board already considered and
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`squarely rejected Petitioner’s argument in the related IPRs. E.g. IPR2020-00126,
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`Paper 129 at 46-51 (recounting detailed testimony from Mr. Root and Mr. Sutton,
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`and extensive corroborating documents and testimony). Notably, the Board
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`specifically found that evidence of assembled prototypes was “more detailed than
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`that found insufficient in Valencell.” E.g., id., 51. Here too, Patent Owner has
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`3
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`
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`provided extensive testimony and documentary evidence showing that GuideLiner
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`prototypes were assembled, tested, and determined to work for their intended
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`purpose prior to Itou. Patent Owner Response (“POR”), 17-36; e.g. Ex-2118,
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`App’x A; Ex-1798, 41:9-22 (Root testifying assembly and testing occurred soon,
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`“within a matter of a week or two,” of receiving parts in April and July 2005).
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`Petitioner argues for an artificially narrow evidentiary standard for the
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`corroboration of inventor testimony. Reply, 10 (“[n]o document shows that VSI
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`assembled its April and July components”). Petitioner cites its expert for the
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`proposition that joining the steel and polymer components of the GuideLiner
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`prototypes “would have been difficult and required documentation.” Id. (citing
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`Dr. Zalesky (emphasis added)). Again, the Board already rejected Petitioner’s
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`artificially stringent standard. E.g. IPR2020-00126, Paper 129 at 47-49 (citing
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`and/or quoting Cooper, 154 F.3d at 1330; Knorr v. Pearson, 671 F.2d 1368, 1373
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`(CCPA 1982); Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1464 (Fed. Cir.
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`1998); Mann v. Werner, 347 F.2d 636, 640 (CCPA 1965); E.I. du Pont De
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`Nemours, 921 F.3d at 1077); id. (citing Ex-2237, 63:20-64:9).
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`As was the case in the prior IPRs, here there is significant evidence of
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`assembled prototypes, including detailed inventor and non-inventor declarations,
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`(Ex-2118 through Ex-2123; Ex-2039), extensive documentary evidence including
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`drawings and invoices for component parts (id. (discussing documentary
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`4
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`
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`evidence)), and Petitioner’s own expert admitting that it “doesn’t make a lot of
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`sense” for Patent Owner to have ordered all the component parts for the April and
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`July prototypes, but not assemble them (Ex-2237, 208:10-25)1. POR, 17-37.
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`Petitioner wrongly asserts that “no non-inventor corroborates the inventors
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`or confirms assembly before Itou.” Reply, 10. As the Board already noted, there
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`was significant, non-inventor testimony that corroborated assembly of prototypes
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`in the prior IPRs. E.g. IPR2020-00126, Paper 129 at 34-35, 48-49. Here, non-
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`inventor testimony is even more robust than in the prior IPRs (Ex-2122; Ex-1756;
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`Ex-1799; Ex-2248; see also Ex-2039; Ex-2120; Ex-2121; Ex-2123). In view of
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`how particularly problematic Mr. Erb’s testimony is for its position, Petitioner tries
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`to convince the Board to ignore his testimony altogether. Reply, 10-11, n.5. There
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`is no reason to discount Mr. Erb’s testimony—Petitioner’s efforts to discredit him
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`are unfounded, undeserved, and belied by the evidence.
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`Petitioner takes aim at Mr. Erb’s testimony regarding components for the
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`April and July 2005 GuideLiner prototypes, arguing that he did “not remember
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`1 Much of the expert declaration testimony that Petitioner submitted in support of
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`its replies is identical to the testimony the same experts provided in the earlier IPR
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`proceedings. Petitioner has agreed that Patent Owner may use previous deposition
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`testimony in these proceedings.
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`5
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`
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`reviewing those drawings separate from these proceedings.” Id. In fact, Mr. Erb
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`testified during deposition that he used the drawing that Spectralytics used to make
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`the July proximal GuideLiner component (Exhibit 2114) to machine prototype
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`hyptotubes himself around June 2005. Ex-1799, 27:25-28:10. Mr. Erb further
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`testified that he observed testing performed on a GuideLiner prototype made from
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`components shown in Exhibits 2114 and 2092 (the July prototype), and he heard
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`about testing performed on a GuideLiner prototype made from components shown
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`in Exhibits 2113 and 2089 (the April prototype). Id., 36:7-38:15. Mr. Erb testified
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`that in each instance, prototypes were assembled and tested shortly after the
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`components were received, i.e. in roughly April and July of 2005. Id.
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`This testimony also refutes Petitioner’s attempts to confine Mr. Erb’s
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`knowledge of prototypes to only “early GuideLiner prototype components, before
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`VSI outsourced the April/July components work.” Reply, 11 (emphasis in
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`original). Mr. Erb unequivocally stated in his declaration that while he was
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`primarily involved in making prototypes before VSI began outsourcing component
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`work, he “did help assemble some of the subsequent prototypes” (Ex-2122, ¶19)
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`and, as described above, he observed or knew of testing performed specifically on
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`the April and July 2005 prototypes.
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`In a footnote, Petitioner accuses Mr. Erb of adding to his declaration
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`testimony during deposition only “after conferring with his counsel for 30
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`6
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`
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`minutes.” Reply, 11, n.5. First, there is no evidence that Mr. Erb conferred with
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`Patent Owner’s counsel during his deposition; Petitioner’s counsel never asked
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`whether he had done so. Ex-1799, 34:18-35:5; 38:24-40:21. Even if they had
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`conferred, it would have been entirely proper. Focal Therapeutics, Inc. v. Senorx,
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`Inc., IPR2014-00116, Paper 19, 3 (PTAB, July 21, 2014) (precedential).
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`Petitioner’s effort to impugn Mr. Erb’s testimony with this unsubstantiated and
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`baseless attack is simply an effort to distract from the significance of his testimony.
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`Additionally, it is misleading and irrelevant for Petitioners to claim that Mr.
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`Erb testified for the first time at deposition that VSI assembled the April and July
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`2005 components. See Reply, 11, n.5. In his declaration, after explaining that VSI
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`started outsourcing prototype components to Spectralytics and MED and
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`describing those parts, as shown in Exhibits 2113, 2114, 2089, and 2092, Mr. Erb
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`stated that he helped assemble “some of the subsequent prototypes” and that he
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`watched Mr. Root and others “test these subsequent prototypes.” Ex-2122, ¶¶13-
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`19. This is entirely consistent with his deposition, where he provided additional
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`detail on the assembly and testing of the April and July prototypes. Petitioner did
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`not object to the questions regarding assembly of these prototypes during his
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`deposition. Ex-1799, 36:7-19. The assertion that Mr. Erb’s unobjected to
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`testimony “cannot qualify as sufficient corroborating evidence” is unsupported—
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`and wrong.
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`7
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`
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`Finally, Petitioner claims that the GuideLiner prototypes did not meet the
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`limitations of claims 9-12 because they did not have a side opening in the proximal
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`portion of the tubular structure, but rather in the distal portion of the component
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`made out of hyptotube. Reply, 12. But Petitioner contends that Itou’s suction
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`catheter, which has a side opening formed from a cut metal pipe, meets the side
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`opening limitation of claims 9-12:
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`
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`Petition, 59-66 (showing a side opening in Itou’s tubular portion 24, circled in red).
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`Petitioner cannot have it both ways. In re Stempel, 241 F.2d 755, 759 (CCPA
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`1957) (all the patentee needs to show is “so much of the claimed invention as the
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`reference happens to show”).
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`Patent Owner Performed and Tested the Claimed Methods
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`C.
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`Petitioner acknowledges that there is evidence of Patent Owner building
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`GuideLiner prototypes that “it could have used to perform the claimed methods.”
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`Reply, 12. However, Petitioner argues that because the method claims of the ʼ413
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`8
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`
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`patent include anatomical limitations (e.g. inserting a guide catheter into a “first
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`artery”) and the prototypes were not tested in vivo, Patent Owner did not actually
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`perform the claimed methods. Id., 12-13. As discussed below and in prior
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`briefing, Patent Owner’s testing of its GuideLiner protypes in simulated anatomy
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`was timely and more than sufficient.
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`1.
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`Petitioner Proposes an Improper Standard for Performance of
`a Method Claim
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`As Petitioner acknowledges, the Federal Circuit has held that “human testing
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`
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`is not necessary to determine that a medical device would work for its intended
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`purpose.” Reply, 13, n.13 (citing Scott v. Finney, 34 F.3d 1058, 1063 (Fed. Cir.
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`1994)). Nevertheless, Petitioner argues that “separate from and in addition to
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`determining that the inventions would work for their intended purpose, VSI needed
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`to perform the claimed methods . . . in vivo.” Id.
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`Petitioner’s proposed standard would mean that in no case involving
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`anatomical limitations does reduction to practice occur where a Patent Owner
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`builds prototypes, tests them in anatomical models, and understands the prototypes
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`and claimed methods work for their intended purpose until or unless the invention
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`is tested in vivo. See id. Such a result would be inequitable, effectively precluding
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`actual reduction to practice at the development stage of medical device products
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`claimed as methods, and lead to dangerous incentives.
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`9
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`
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`In the very case cited by Petitioner, the Federal Circuit noted that “a certain
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`amount of common sense must be applied” in determining testing for reduction to
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`practice. Scott, 34 F.3d at 1062. Furthermore, it explained that “[t]esting for the
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`full safety and effectiveness of a prosthetic device is more properly left to the Food
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`and Drug Administration (FDA). Title 35 does not demand that such human
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`testing occur within the confines of Patent and Trademark Office (PTO)
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`proceedings.” Id., 1063. This delineation of responsibility is for good policy
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`reasons: the FDA is the agency best positioned to oversee the safety of human
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`testing of new medical devices and procedures, not the PTO. If reduction to
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`practice of claimed medical procedures required in vivo testing, inventors might be
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`tempted to rush to human testing before it is safe to do so, to secure their
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`intellectual property rights. The law should not (and does not) provide such an
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`incentive.
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`Petitioner cites the Medichem case for the proposition that reduction to
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`practice requires “performance of a process that met all the limitations of the
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`[claimed method].” Reply, 8 (citing Medichem, S.A. v. Rolabo, S.L., 437 F.3d
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`1157, 1169 (Fed. Cir. 2006)). But Medichem does not hold, and Petitioner does
`
`not cite any authority that holds, performing a claimed medical process must take
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`place in vivo rather than in a model. 437 F.3d at 1169-73; see Reply, 13 (citing
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`Taskett v. Dentlinger, 344 F.3d 1337, 1340-41 (Fed. Cir. 2003) (use of a “dummy
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`10
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`
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`checking account” sufficient to show testing of a method requiring “financial
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`authorization”). Rather, Medichem was concerned with corroboration, not
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`sufficient performance of a method. 437 F.3d at 1169-72. Medichem merely
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`provided an example in which spectral evidence would “generally not be
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`sufficient” to corroborate creation of a chemical compound by a particular process.
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`Id., 1171.2 That is not the bright-line rule for in vivo testing that Petitioner
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`proposes, nor are those the facts of this case.
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`Petitioner also cites Lucent, which found that an equation in a thesis could
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`not show performance of a claimed method of estimating pixel intensities as part of
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`video compression. Reply, 12 (citing Lucent Techs., Inc. v. Gateway, Inc., No. 02-
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`cv-2060-B(CAB), 2007 U.S. Dist. LEXIS 50891, at *15 (S.D. Cal. July 12, 2007).
`
`But again, those are not the facts of this case. Here, Patent Owner has adduced
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`evidence of testing, as well as testimony explaining that simulating a medical
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`procedure in a model was sufficient to understand the invention worked for its
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`intended purpose. E.g., Ex-2123, ¶¶20-24; Ex-2118, ¶¶17-19.
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`2 Petitioner also cites Steed for a similar proposition as Medichem, but Steed again
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`was concerned with corroboration, and contains even less discussion of performing
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`method claims than Medichem. Reply, 12 (citing In re Steed, 802 F.3d at 1318).
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`11
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`
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`Finally, Petitioner cites TC Technology for the proposition that simulating
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`the anatomy cannot satisfy the “artery” and “lesion” limitations in the challenged
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`claims. Reply, 13 (citing TC Tech. LLC v. Sprint Corp., 379 F. Supp. 3d 305, 319
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`(D. Del. 2019)). As an initial matter, TC Technology is not controlling, and
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`acknowledges that a different court has allowed simulations to show reduction to
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`practice. 379 F. Supp. 3d at 319 (citing Huawei Technologies, Co. v. Samsung
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`Electronics Co., 340 F. Supp. 3d 934 (N.D. Cal. 2018); Mosaid Technologies Inc.
`
`v. Samsung Electronics Co., 362 F. Supp. 2d 526 (D.N.J. 2005)). There is no
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`reason why TC Technology should determine the outcome of this case, especially
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`when another court has come to different conclusions. Moreover, TC Technology
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`is another computed-based case, unlike the medical technology of the present case.
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`Simulating a medical procedure in a model is sufficient to understand the invention
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`works. E.g., Ex-2123, ¶¶20-24; Ex-2118, ¶¶17-19.
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`2.
`
`Patent Owner Timely Performed and Tested the Claimed
`Methods
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`Petitioner repeats its claim that “no evidence” credibly supports testing of
`
`
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`the GuideLiner prototypes in April and July 2005. Reply, 13. This is wrong, as
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`the Board already found in the related IPRs. E.g., IPR2020-00126, Paper 129 at
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`61. Petitioner provides no rebuttal to the charts in Mr. Root’s declaration that
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`explain how each element of the challenged claims was met by building and testing
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`GuideLiner prototypes. See Reply, 7-26; Ex-2118, App’x A-B. Petitioner’s RTP
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`12
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`
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`declarant, Dr. Zalesky, does not rebut Mr. Root’s charts addressing the ʼ413 patent.
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`Ex-1755, App’x A-E (providing old charts for wrong patents). Thus, Mr. Root’s
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`testimony in the charts stands unrebutted.
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`Petitioner argues that there is no evidence of a testing timeline and that
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`witnesses simply “swear that VSI accomplished what it needed to accomplish
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`before Itou.” See Reply, 13-14. This is both wrong and misleading. For example,
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`Petitioner cites Mr. Root’s deposition to argue that there was no date provided for
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`the testing of the GuideLiner prototypes. Id. (citing Ex-1798, 22:1-23:25). But
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`while Mr. Root testified he could not recall the exact date of testing (unsurprising
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`after fifteen years), he also said he could provide “a pretty good range of when it
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`occurred.” Ex-1798, 22:1-5. Later Mr. Root quite precisely testified that testing
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`occurred “within a matter of a week or two” of receiving parts in April and July
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`2005. Id., 41:9-22. Petitioner’s claim that Mr. Root provided no evidence of when
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`the GuideLiner prototypes were tested is belied by the evidence. Id.; see also, e.g.,
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`Ex-2118, ¶¶15-22, 38-42, 47-51, 55; Ex-2119, ¶¶16-17, 23, 37-38, 41; Ex-2122,
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`¶¶5, 12, 19-20; Ex-1799, 10:14-11:1, 37:2-38:6; Ex-1798, 34:18-24, 39:22-40:13,
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`40:24-41:8, 78:17-79:5.
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`Petitioner next alleges that “even if inventors did date particular testing
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`before Itou, no evidence corroborates that testimony.” Reply, 14. This
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`corroboration argument consists primarily of a nearly full-page footnote impugning
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`13
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`
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`the credibility and character of non-inventor Mr. Erb. Id., 14-15, n.7. As
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`discussed above, this character attack is unsupported, and wrong. In reality, the
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`alleged “180-degree pivot” Petitioner accuses Mr. Erb of performing amounts to a
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`misconceived understanding of his declaration, which stated he “was aware of,
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`though was not personally involved in, tests of the GuideLiner prototypes
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`involving the delivery of stents and balloons,” and his subsequent deposition
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`testimony in which he testified that he observed such testing for the July prototypes
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`and was aware of such testing for the April prototypes. Compare Ex-2122, ¶12
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`(emphasis added) with Ex-1799, 36:13-38:15. There is no substantive discrepancy
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`between this declaration and deposition testimony. As Mr. Erb explained, he was
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`not “personally involved” with delivering balloons or stents, but he did observe.
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`Ex-1799, 39:9-20. He confirmed that again in his most recent declaration that he
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`was aware of tests of the GuideLiner prototypes involving the delivery of stents
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`and balloons in a benchtop model. Id., 41:2-8; Ex-2122, ¶12.
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`Petitioner next accuses Mr. Erb of being an “unreliable, interested (current
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`Teleflex employee) witness willing to change his testimony as needed.” Reply,
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`14-15, n.7. These are serious allegations that deserved serious proof, yet Petitioner
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`cites nothing to support this character attack. As explained above, Mr. Erb did not
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`“change his testimony as needed.” Moreover, Mr. Erb is neither an “interested”
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`witness, nor was he even a “current Teleflex employee” at the time of his
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`14
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`
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`deposition. Mr. Erb has not at any point had a stake in the outcome of these IPRs.
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`And while Mr. Erb was an employee of Patent Owner at the time he wrote his most
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`recent declaration, he retired shortly before his most recent deposition—a fact
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`Petitioner would have learned had they asked.
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`In the end, because Itou does not disclose the claimed methods (it discloses a
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`suction catheter), and because Petitioner’s position is that it would have been
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`obvious to use Itou’s suction catheter to perform the claimed method that delivers
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`an interventional cardiology device in a proximal-to-distal direction, Patent Owner
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`need only show prior invention of as much as was disclosed in Itou. In re Stempel,
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`241 F.2d at 759. The April and July 2005 prototypes show all of the structural
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`features of Itou relied on by Petitioner for its obviousness arguments. See Ex-
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`2118, App’x A; Ex-2123, ¶28.
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`3.
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`Testing was sufficient
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`Petitioner takes issue with Patent Owner’s argument that little to no testing
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`would have been required because the principles of operation were not overly
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`complex. Reply, 17-18; see POR, 21-22. But in advancing its own arguments
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`about Itou, Petitioner’s expert, Dr. Brecker, testified no testing was required to
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`know the Itou device would work to deliver balloons and stents, even though that
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`is not Itou’s purpose. Ex-2116, 110:20-113:24; Ex-2238, 87:18-89:5. Petitioner
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`cannot have it both ways.
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`15
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`
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`Moreover, Patent Owner did in fact perform testing of the claimed methods.
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`See POR, 22, 24-33. In this regard, Petitioner appears to either misunderstand or
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`misrepresent part of the claimed methods, which in turn leads them to advocate for
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`irrelevant tests to show reduction to practice. Reply, 18. More specifically,
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`Petitioner argues reduction to practice could not be shown if the prototype
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`GuideLiner were not shown to access and cross a simulated lesion. Id. But the
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`claimed method does not require the GuideLiner to access and cross a lesion, it
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`requires an interventional cardiology device (i.e., a stent or balloon) to be able to
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`do so, and Mr. Root testified the proper testing was performed. Ex-1001, 11:4-6;
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`Ex-1762, 104:22-106:13, 100:18-102:13.
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`Regarding testing for backup support, Patent Owner’s expert testified that no
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`testing was required because it was already understood that mother-in-child
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`procedures provided back-up support. Ex-2123, ¶20; see also Ex-2237, 58:2-7,
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`62:9-21, 95:20-23. But again, Patent Owner did actually test the GuideLiner
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`prototypes to confirm that they provided backup support. E.g., Ex-1762, 193:8-
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`194:16; Ex-2118, App’x A. Furthermore, contrary to Petitioner’s insistent
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`assertions to the contrary, there is specific,