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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.
`Petitioner,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`Case IPR2020-01343
`Patent RE46,116
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`PATENT OWNER SUR-REPLY
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`I.
`II.
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`C.
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`2.
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`TABLE OF CONTENTS
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`Page
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`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
`B. 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 ................. 7
`1.
`Petitioner proposes an improper standard for performance
`of a method claim ........................................................................ 8
`Patent owner timely performed and tested the claimed
`methods ..................................................................................... 11
`Testing was sufficient ............................................................... 14
`3.
`4. Diligent work was performed on the invention through the
`filing of the first patent application ........................................... 16
`5. Continued work on commercialization of GuideLiner does
`not undo reduction to practice ................................................... 18
`III. GROUNDS 2-3: EVEN IF ITOU WERE CONSIDERED PRIOR
`ART, PETITIONER HAS NOT SHOWN THAT THE CHALLENGED
`CLAIMS ARE OBVIOUS ............................................................................ 20
`A. GROUND 2—Itou and Ressemann (Claims 25-40, 42, 44-48,
`52 and 53) ............................................................................................ 20
`1.
`Petitioner fails to show that it would have been obvious
`to use Itou’s suction catheter as a guide extension catheter
`for receiving “balloon catheters or stents” into a proximal
`side opening while the side opening “remains within the
`guide catheter” (all challenged claims) ..................................... 20
`a.
`Petitioner fails to prove motivation ................................ 20
`
`
`
`i
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`2.
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`Petitioner fails to show that Itou’s structure is capable
`of receiving stents or balloon catheters .......................... 23
`Petitioner fails to show it would have been obvious to
`redesign Itou’s proximal opening to have “at least two
`inclined slopes” (dependent claim 45) ...................................... 24
`B. GROUND 3—Itou, Ressemann, and Kataishi (Claim 45) ................. 28
`IV. COMPELLING OBJECTIVE EVIDENCE CONFIRMS THAT
`INDEPENDENT CLAIM 25 (AND DEPENDENT CLAIMS 26-40,
`42, 44-48) WOULD NOT HAVE BEEN OBVIOUS ................................... 30
`A. The Objective Evidence Is Undisputed ............................................... 31
`B. The Combination of Features That Resulted in GuideLiner’s
`Success and Praise Is Not in the Prior Art .......................................... 31
`C. GuideLiner and Telescope Practice Claim 25 ..................................... 32
`D. That GuideLiner’s Competitors Copied its Design Confirms
`Non-Obviousness ................................................................................ 34
`CERTIFICATE OF WORD COUNT COMPLIANCE ........................................... 37
`CERTIFICATION OF SERVICE............................................................................ 38
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`
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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) ............................................................................ 16
`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, 2
`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) .................................................................. 11
`In re Steed,
`802 F.3d 1311 (Fed. Cir. 2015) ....................................................................... 2, 10
`In re Stempel,
`241 F.2d 755 (C.C.P.A. 1957) .............................................................................. 14
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ............................................................................ 35
`Knorr v. Pearson,
`671 F.2d 1368 (CCPA 1982) .................................................................................. 4
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .............................................................................................. 21
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 (PTAB Jan. 24, 2020) ................................................ 32
`
`iii
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`

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`Loral Fairchild Corp. v. Matsushita Elec. Indus. Co.,
`266 F.3d 1358 (Fed. Cir. 2001) ............................................................. 2, 3, 18, 19
`Lucent Techs., Inc. v. Gateway, Inc.,
`No. 02-cv-2060-B(CAB), 2007 U.S. Dist. LEXIS 50891 (S.D. Cal. July 12,
`2007) ..................................................................................................................... 10
`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) ....................................................................... 9, 10
`Mosaid Technologies Inc. v. Samsung Electronics Co.,
`362 F. Supp. 2d 526 (D.N.J. 2005) ....................................................................... 11
`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) ............................................................................ 16
`Scott v. Finney,
`34 F.3d 1058 (Fed. Cir. 1994) ............................................................................8, 9
`Taskett v. Dentlinger,
`344 F.3d 1337 (Fed. Cir. 2003) .............................................................................. 9
`TC Tech. LLC v. Sprint Corp.,
`379 F. Supp. 3d 305 (D. Del. 2019) ...................................................................... 11
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ..................................................................... 32, 35
`Statutes
`35 U.S.C. § 103 ........................................................................................................ 22
`37 C.F.R. § 42.23(b) ......................................................................................... 23, 26
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`iv
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`Other Authorities
`PTAB Consolidated Trial Practice Guide (November 2019) ........................... 23, 26
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`v
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`I.
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`INTRODUCTION
`The Board has already found in related IPRs that Itou is not prior art; the
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`same result should follow here. For this reason alone Petitioner’s obviousness
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`challenges (Grounds 2 and 3) fail.
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`Petitioner’s obviousness challenges also fail to show that a POSITA would
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`have been motivated to use Itou’s suction catheter in a completely different
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`manner: as a guide extension catheter for receiving and delivering a balloon
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`catheter or stent in a proximal to distal direction, rather than sucking thrombus out
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`in a distal to proximal direction. Moreover, there is unusually compelling,
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`unrebutted objective evidence confirming the methods covered by independent
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`claim 25 and the claims depending from it were not obvious.
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`II.
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`ITOU IS NOT PRIOR ART
`Petitioner’s Arguments Would Impose Erroneous Evidentiary
`A.
`Burdens on Patent Owner, and Ignore Its Own
`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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`1
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`reduction to practice. Even if the Board were uncertain about the evidence,
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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, 3 (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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`2
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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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`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
`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, 4. 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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`3
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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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`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”), 9-29; e.g. Ex-2118, App’x
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`B; Ex-1798, 41:9-22 (Root testifying assembly and testing occurred soon, “within
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`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, 5 (“[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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`4
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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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`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). POR, 9-29.
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`Petitioner wrongly asserts that “no non-inventor corroborates the inventors
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`or confirms assembly before Itou.” Reply, 5. 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, 5-6, n.3. There is
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`no reason to discount Mr. Erb’s testimony—Petitioner’s efforts to discredit him are
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`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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`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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`5
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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, 6 (emphasis in original).
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`Mr. Erb unequivocally stated in his declaration that while he was primarily
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`involved in making prototypes before VSI began outsourcing component work, he
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`“did help assemble some of the subsequent prototypes” (Ex-2122, ¶19) and, as
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`described above, he observed or knew of testing performed specifically on the
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`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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`minutes.” Reply, 6, n.3. First, there is no evidence that Mr. Erb conferred with
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`Patent Owner’s counsel at any time during his deposition; Petitioner’s counsel
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`never asked whether he had done so. Ex-1799, 34:18-35:5; 38:24-40:21. Even if
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`6
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`they had conferred, it would have been entirely proper. Focal Therapeutics, Inc. v.
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`Senorx, Inc., IPR2014-00116, Paper 19, at 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, 6, n.3. 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 testimony, where he provided
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`additional detail on the assembly and testing of the April and July prototypes.
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`Petitioner did not object to the questions regarding assembly of these prototypes
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`during his deposition. Ex-1799, 36:7-19. The assertion that Mr. Erb’s unobjected
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`to testimony “cannot qualify as sufficient corroborating evidence” is
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`unsupported—and wrong.
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`Patent Owner Performed and Tested the Claimed Methods
`C.
`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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`7
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`Reply, 7. However, Petitioner argues that because the method claims of the ʼ116
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`patent include anatomical limitations (e.g. “blood vessel” and “coronary artery”)
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`and the prototypes were not tested in vivo, Patent Owner did not actually perform
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`the claimed methods. Id., 7-8. As discussed below and in prior briefing, Patent
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`Owner’s testing of its GuideLiner protypes in simulated anatomy was timely and
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`more than sufficient.
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`1.
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`Petitioner proposes an improper standard for performance
`of a method claim
`As Petitioner acknowledges, the Federal Circuit has held that “human testing
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`is not necessary to determine that a medical device would work for its intended
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`purpose.” Reply, 8, n.5 (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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`8
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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, 3 (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
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`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, 8 (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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`9
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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., 1171.1 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, 7 (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).
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`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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`1 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, 7 (citing In re Steed, 802 F.3d at 1318).
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`10
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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, 7-8 (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.
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`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 computer-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.
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`Patent owner timely performed and tested the claimed
`methods
`Petitioner repeats its claim that “no evidence” credibly supports testing of
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`the GuideLiner prototypes in April and July 2005. Reply, 8. This is wrong, as the
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`Board already found in the related IPRs. E.g., IPR2020-00126, Paper 129 at 61.
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`Petitioner provides no rebuttal to the charts in Mr. Root’s declaration that explain
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`how each element of the challenged claims was met by building and testing
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`GuideLiner prototypes. See Reply, 2-21; Ex-2118, App’x A-B. Petitioner’s RTP
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`11
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`

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`declarant, Dr. Zalesky, does not rebut Mr. Root’s charts addressing the ʼ116 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, 8-9. 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, 9. This
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`corroboration argument consists primarily of a nearly full-page footnote impugning
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`12
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`the credibility and character of non-inventor Mr. Erb. Id., 9-10, n.6. As discussed
`
`above, this character attack is unsupported, and wrong. In reality, the alleged
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`“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
`
`Teleflex employee) witness willing to change his testimony as needed.” Reply, 9-
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`10, n.6. 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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`13
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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 755, 759 (C.C.P.A. 1957). The April and July 2005 prototypes show all
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`of the structural features of Itou relied on by Petitioner for its obviousness
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`arguments. See Ex-2118, App’x B; Ex-2123, ¶28.
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`Testing was sufficient
`3.
`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, 12; see POR, 13-14. But in advancing its own arguments about
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`Itou, Petitioner’s expert, Dr. Brecker, testified no testing was required to know that
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`the Itou device would work to deliver balloons and stents, even though that is not
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`Itou’s purpose. Ex-2116, 110:20-113:24; Ex-2238, 87:18-89:5. Petitioner cannot
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`have it both ways.
`
`14
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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, 15-25. 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, 13. 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 occlusion. Id. But no
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`claimed method of the ʼ116 patent requires the GuideLiner to access and cross an
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`occlusion (claim 28 requires advancing the distal end of the guide extension
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`catheter “proximal to a location of a lesion to be treated”). Ex-1001, 13:63-18:25.
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`Other patents require an interventional cardiology device (i.e., a stent or balloon) to
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`be able to do so, and Mr. Root testified the proper testing was performed.
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`IPR2020-01341, Ex-1001, 11:4-6; 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 B. Furthermore, contrary to Petitioner’s insistent
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`assertions to the contrary, there is specific, non-inventor testimony that
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`corroborates the inventors’ testing of the GuideLiner prototypes. Ex-2122, ¶¶12,
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`15
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`19; Ex-1799, 37:8-38:15; see also IPR2020-00126, Paper 129 at 34-35, 37, 48-50,
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`57-59.
`
`4.
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`Diligent work was performed on the invention through the
`filing of the first patent application
`Petitioner argues that Patent Owner has not presented evidence of diligent
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`work on the invention up until the filing date of the original patent application on
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`May 3, 2006. Reply, 16-19. The Board has already found otherwise. IPR2020-
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`00126, Paper 129 at 62-71.
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`Diligence need only be reasonably continuous, not be perfectly continuous.
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`Arctic Cat Inc. v. GEP Power Prods., 919 F.3d 1320, 1331 (Fed. Cir. 2019) (citing
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`Perfect Surgical Techniques, Inc. v. Olympus America, Inc., 841 F.3d 1004, 1009
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`(Fed. Cir. 2016)). And the Board already noted that it should be “mindful of recent
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`Federal Circuit admonitions clarifying that we must not apply a standard that is
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`‘too exacting’ or ‘too rigid.’” IPR2020-00126, Paper 129 at 68 (citing Perfect
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`Surgical, 841 F.3d at 1008; Arctic Cat, 919 F.3d at 1331). Patent Owner has
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`presented significant evidence of diligence during the relevant time period—more
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`than enough to show reasonable diligence, and certainly that the project was never
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`abandoned. E.g., POR, 28-29; Ex-2118, ¶¶55-80; Ex-2119, ¶¶40, 42, 47-52.
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`As cited in POR, corroborating evidence includes that Patent Owner worked
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`with counsel to prepare its patent application. For