UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
`
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner.
`
`IPR2020-00126
`IPR2020-00128
`IPR2020-00129
`IPR2020-00132
`IPR2020-00134
`IPR2020-00135
`IPR2020-00137
`
`PETITIONERS’ REPLY TO PATENT OWNER’S RESPONSE
`ADDRESSING CONCEPTION AND REDUCTION TO PRACTICE
`
`

`

`TABLE OF CONTENTS
`
`I.
`II.
`
`III.
`
`IV.
`
`A.
`B.
`
`A.
`B.
`
`C.
`
`D.
`
`1.
`2.
`
`INTRODUCTION ........................................................................................... 1
`TELEFLEX DOES NOT ARGUE CRTP CLAIM-BY-CLAIM
`AND, THUS, HAS NOT CARRIED ITS BURDEN. ..................................... 2
`TELEFLEX CANNOT PROVE CONCEPTION BEFORE
`ITOU. ............................................................................................................... 3
`Teleflex proffers no corroborating evidence. ............................................. 4
`Teleflex’s conception documents do not disclose a side
`opening. ...................................................................................................... 5
`TELEFLEX CANNOT PROVE REDUCTION TO PRACTICE
`BEFORE ITOU................................................................................................ 7
`Teleflex is missing key documents. ............................................................ 8
`Teleflex’s documents do not prove reduction to practice. ....................... 11
`At most four documents relate to particular prototypes. ..................... 11
`No document shows that VSI assembled RX prototypes. ..................16
`No evidence shows that VSI performed tests to determine
`that RX would work for its intended purpose. .........................................17
`No testimony corroborates the inventors. ................................................19
`Erb .......................................................................................................19
`Schmalz ...............................................................................................21
`Keith ....................................................................................................22
`VSI’s complete GuideLiner record shows that VSI could not
`have reduced to practice before Itou. .......................................................22
`In mid-to-late 2005, GuideLiner was in early-stage
`concept development. ..........................................................................22
`VSI was still experimenting into 2006. ...............................................24
`2.
`VSI still did not have a working prototype in 2008. ...........................26
`3.
`TELEFLEX CANNOT PROVE DILIGENCE. ............................................28
`V.
`VI. CONCLUSION ..............................................................................................30
`
`1.
`2.
`3.
`
`E.
`
`1.
`
`ii
`
`

`

`TABLE OF AUTHORITIES
`
`Cases
`Apator Miitors ApS v. Kamstrup A/S,
`887 F.3d 1293 (Fed. Cir. 2018) ..................................................................... passim
`ATI Techs. ULC v. Iancu,
`920 F.3d 1362 (Fed. Cir. 2019) .........................................................................2, 28
`Curt Mfg., LLC v. Horizon Global Ams. Inc.,
`IPR2019-00625, 2020 WL 4687044 (PTAB Aug. 11, 2020) ................................. 4
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) ............................................................................... 2
`Gen. Access Sols., Ltd. v. Sprint Spectrum L.P.,
`811 F. App’x 654 (Fed. Cir. 2020) .......................................................................... 2
`Hahn v. Wong,
`892 F.2d 1028 (Fed. Cir. 1989) ............................................................................... 8
`In re Meyer Mfg. Corp.,
`411 F. App’x 316 (Fed. Cir. 2010) ........................................................................30
`Kolcraft Enters., Inc. v. Graco Children’s Prods., Inc.,
`927 F.3d 1320 (Fed. Cir. 2019) ............................................................................... 4
`Medichem, S.A. v. Rolabo, S.L.,
`437 F.3d 1157 (Fed. Cir. 2006) ............................................................................... 8
`Perfect Surgical Techniques, Inc. v. Olympus Am., Inc.,
`841 F.3d 1004 (Fed. Cir. 2016) .............................................................................28
`REG Synthetic Fuels, LLC v. Neste Oil Oyj,
`841 F.3d 954 (Fed. Cir. 2016) ................................................................................. 3
`Singh v. Brake,
`222 F.3d 1362 (Fed. Cir. 2000) ............................................................................... 8
`Sprint Commc’ns Co. v. Comcast IP Holdings, LLC,
`No. 12-1013-RGA, 2015 WL 452289 (D. Del. Jan. 30, 2015) ............................20
`
`iii
`
`

`

`Toshiba Memory Corp. v. Anza Tech., Inc.,
`IPR2018-01597, 2020 WL 1229855 (PTAB Mar. 12, 2020) ...............................30
`Tyco Healthcare Grp. v. Ethicon Endo-Surgery, Inc.,
`514 F. Supp. 2d 351 (D. Conn. 2007) ...................................................................26
`Valencell, Inc. v. Fitbit, Inc.,
`784 F. App’x 1005 (Fed. Cir. 2019) ......................................................................16
`
`Statutes
`37 C.F.R. § 42.6(a)(3) ..........................................................................................2, 29
`
`iv
`
`

`

`I.
`
`INTRODUCTION
`Teleflex asserts invention before Itou’s September 23, 2005 effective filing
`
`date. But Teleflex cannot prove reduction to practice because no documents show
`
`that VSI built and tested prototypes. And no documents or testimony address
`
`testing the intended purpose: providing increased backup support during complex
`
`PCI procedures. Indeed, non-inventor Erb, on whom Teleflex relies for
`
`corroboration, shredded his laboratory notebook. Teleflex blames its lack of proof-
`
`of-concept documents on VSI’s practice of not retaining them, but documents that
`
`VSI did keep show that it built and tested non-inventive over-the-wire (OTW)
`
`GuideLiner devices, not rapid-exchange (RX) devices. Indeed, the more complete
`
`record shows that VSI could not have reduced to practice in 2005.
`
`Moreover, Teleflex’s claim-by-claim arguments sit in appendices to a
`
`declaration: Teleflex improperly incorporates by reference. That error ends the
`
`analysis because Teleflex bears the burden of proving prior invention.
`
`Substantively and procedurally, Teleflex’s attempt to show prior invention fails.1
`
`1 Further, because the ’380, ’760, ’776, and ’379 patents lack written description
`
`for at least one claim, they are AIA patents (first to file, not first to invent), and
`
`Teleflex cannot swear behind. See Medtronic’s Reply.
`
`1
`
`

`

`II. TELEFLEX DOES NOT ARGUE CRTP CLAIM-BY-CLAIM AND,
`THUS, HAS NOT CARRIED ITS BURDEN.
`Teleflex “bears the burden of proof to establish either: (1) prior reduction to
`
`practice; or (2) prior conception coupled with due diligence.” ATI Techs. ULC v.
`
`Iancu, 920 F.3d 1362, 1369 (Fed. Cir. 2019). Though Medtronic must prove
`
`unpatentability, Teleflex must prove invention before Itou. Apator Miitors ApS v.
`
`Kamstrup A/S, 887 F.3d 1293, 1297 (Fed. Cir. 2018) (Teleflex must “prove [VSI]
`
`did conceive of [the inventions] prior to [Itou’s] effective filing date, not
`
`[Medtronic] prove [VSI] did not.”); Dynamic Drinkware, LLC v. Nat’l Graphics,
`
`Inc., 800 F.3d 1375, 1378-80 (Fed. Cir. 2015).
`
`Teleflex does not show that VSI conceived of and reduced to practice each
`
`claimed invention. Instead, it tries to circumvent the word limit and incorporates
`
`claim-by-claim arguments from Root’s declaration. PO’s Consolidated Response
`
`Addressing Conception and Reduction to Practice (CRTP Response), 22
`
`(incorporating 100+ pages “that map the GuideLiner patent claims to the
`
`prototypes and establish that the prototypes contained all limitations”). Teleflex
`
`violates the Board’s rule against incorporation by reference. 37 C.F.R. § 42.6(a)(3).
`
`Teleflex must “establish prior [invention] of every claim limitation”—
`
`referencing claim-by-claim charts “fail[s] to meet this burden.” Gen. Access Sols.,
`
`Ltd. v. Sprint Spectrum L.P., 811 F. App’x 654, 658 (Fed. Cir. 2020) (“To identify
`
`GAS’s substantive arguments, the Board was forced to turn to a
`
`2
`
`

`

`declaration…and…delve into a twenty-nine-page claim chart attached as an
`
`exhibit. This exercise of playing archaeologist with the record is precisely what the
`
`rule against incorporation by reference was intended to prevent, and the Board was
`
`within its discretion in excluding the arguments made in the claim chart.”). The
`
`Board need not consider Root’s claim-by-claim charts. Without them, Teleflex
`
`cannot carry its burden.2
`
`Even if the Board considers Teleflex’s claim-by-claim arguments, Teleflex
`
`still cannot prove invention before Itou.
`
`III. TELEFLEX CANNOT PROVE CONCEPTION BEFORE ITOU.
`To prove conception, Teleflex must show “the formation, in the mind of the
`
`inventor of a definite and permanent idea of the complete and operative
`
`invention.” REG Synthetic Fuels, LLC v. Neste Oil Oyj, 841 F.3d 954, 962 (Fed.
`
`Cir. 2016). “Conception must include every feature or limitation of the claimed
`
`invention.” Id.
`
`“[W]hen a party seeks to prove conception through an inventor’s testimony
`
`the party must proffer evidence, in addition to the inventor’s own statements and
`
`documents, corroborating the inventor’s testimony.” Apator, 887 F.3d at 1295. The
`
`
`2 Regardless, Root’s charts do not show reduction to practice of each claimed
`
`invention. Ex-1755, Appendices A-E.
`
`3
`
`

`

`Board considers whether evidence corroborates inventor statements under the “rule
`
`of reason,” considering the record as a whole. “[E]vidence of corroboration must
`
`not depend solely on the inventor.” Id. One inventor cannot corroborate another.
`
`Curt Mfg., LLC v. Horizon Global Ams. Inc., IPR2019-00625, 2020 WL 4687044,
`
`at *7 (PTAB Aug. 11, 2020).
`
`Teleflex cites only inventor testimony and three documents to try to prove
`
`conception in early 2005. But an inventor authored each document. And none
`
`discloses a critical feature: a side opening. Ex-2118 ¶13 (side opening “[a]n
`
`important feature”).
`
`A. Teleflex proffers no corroborating evidence.
`Inventor documents cannot, alone, corroborate inventor testimony, Apator,
`
`887 F.3d at 1297, and an inventor authored each of Teleflex’s conception
`
`documents. Teleflex cites inventor Sutton’s laboratory notebook, which co-
`
`inventor Welch witnessed (Ex-2002; Ex-2119 ¶7); inventor Root’s unwitnessed
`
`notes (Ex-2004); and Root’s unwitnessed memo (Ex-2127). Because “[a]ll cited
`
`evidence of prior conception…originated with the inventors,” those documents
`
`cannot corroborate the inventors’ testimony. Kolcraft Enters., Inc. v. Graco
`
`Children’s Prods., Inc., 927 F.3d 1320, 1324 (Fed. Cir. 2019).
`
`4
`
`

`

`B.
`
`Teleflex’s conception documents do not disclose a side opening.
`
`None of Teleflex’s “conception” documents shows that VSI conceived of a
`
`rapid-exchange guide extension catheter with a side opening. Numerous
`
`challenged claims recite that feature.
`
`Sutton’s notebook does not disclose a side opening. Ex-2002; Ex-l755 1180.
`
`Sutton’s sketches show an end opening to the distal lumen:
`
` “rug?" Kane/33"
`
`Id. Teleflex does not contend otherwise. Indeed, Sutton testified that_
`
`—Ex-uosmosmo&
`
`70:18—71:23, 79:14-80:24.3
`
`Root’s unwitnessed notes do not disclose a side opening, either. Ex-2004;
`
`EX-l755 111183-84. The first page includes a sketch similar to the Patent’s Figure 1:
`
`3 Ex-1108, Ex-1308, or Ex-1708, depending on the IPR proceeding.
`
`'JI
`
`

`

`
`
`54
`’
`
`,
`
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`
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`r46
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`\22
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`\ 20
`18
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`
`14 —~
`
`Ex-2004; Ex—lOOl. The sketch, alone, does not disclose a side opening. Indeed,
`
`Sutton testified that— Ex-1108/1308/1708,
`
`73: 19-23. The third page includes a sketch of an indecipherable “proximal metal”
`
`section:
`
`Hi
`31:
`
`itw
`
`l?
`
`Ex-2004. The sketch does not disclose a side opening. Ex-l755 111183-84; EX-
`
`-. Without Root’s declaration, no one would know what it—or the
`
`shading in the first sketch—shows. An inventor cannot explain a document to, in
`
`

`

`turn, corroborate his testimony. That creates “a catch-22 of corroboration.” Apator,
`
`887 F.3d at 1296.4
`
`Last, Root’s unwitnessed memo discloses other design features but not a
`
`side opening. Ex-2127; Ex-1755 ¶81.
`
`Teleflex’s conception evidence—inventor testimony and inventor
`
`documents—is insufficient as a matter of law and cannot prove conception of the
`
`complete inventions in early 2005.
`
`IV. TELEFLEX CANNOT PROVE REDUCTION TO PRACTICE
`BEFORE ITOU.
`To prove reduction to practice, Teleflex must show “(1) construction of an
`
`embodiment…that met all the limitations of the [claimed invention]; (2)
`
`determination that the invention would work for its intended purpose; and (3) the
`
`existence of sufficient evidence to corroborate inventor testimony regarding these
`
`
`4 Even if the third page did show a side opening, the page is undated, unwitnessed,
`
`and from a different set of notes than the previous two pages (lined versus unlined
`
`paper). Ex-2004. Sutton testified that
`
`
`
`
`
`. Ex-1108/1308/1708, 41:1-6,
`
`46:7-47:3. Root cannot date the document and then rely on it to corroborate.
`
`Apator, 887 F.3d at 1296.
`
`7
`
`

`

`events.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1169 (Fed. Cir. 2006). The
`
`corroboration requirement is “more stringent” than for conception. Singh v. Brake,
`
`222 F.3d 1362, 1370 (Fed. Cir. 2000); Hahn v. Wong, 892 F.2d 1028, 1032-33
`
`(Fed. Cir. 1989) (corroborating evidence must be “independent of information
`
`received from the inventor”).
`
`Teleflex does not offer evidence sufficient to prove reduction to practice.
`
`GuideLiner’s path from alleged conception to commercialization proves that VSI
`
`could not have reduced to practice before September 23, 2005.
`
`A. Teleflex is missing key documents.
`No document shows that VSI built, much less tested, RX prototypes. Had
`
`VSI built RX prototypes, it would have photographs, assembly instructions, and
`
`subassembly drawings. Ex-1755 ¶¶66-74, 143-45. Had VSI tested RX prototypes,
`
`it would have testing protocols and data/results. Id. No VSI laboratory notebook
`
`includes an entry related to a 2005 RX prototype. Teleflex contends that Sutton and
`
`Welch built and tested prototypes. Ex-2118 ¶15; Ex-1756, 67:20-69:11. But after
`
`Sutton recorded concept notes, he did not write in his notebook again. Ex-
`
`1109/1309/1709; Ex-1757, 57:11-62:1. Teleflex declined to offer a Welch
`
`declaration, and Welch’s notebook—
`
`
`
` Ex-1758, 12-14.
`
`8
`
`

`

`In contrast, VSI kept OTW prototype documents.—
`
`Ex-1759; EX-1757, 333-3725. Kauphusman worked on
`
`OTW—not RX—in 2005. He has notes to prove it.—
`
`
`
`

`

`
`
`- EX-1761, 107-13; EX-1755 '1209. No notebooks suggest that anyone was
`
`building or testing RX prototypes.
`
`10
`
`

`

`Teleflex cannot justify the paucity of reduction-to-practice documents.
`
`Apparently VSI did not keep documents until after reduction to practice, when
`
`efforts turned to “optimizing.” Ex-1762, 85:11-16 (“[T]he early stage was not a
`
`document creation and retention stage.”). Root “wrote things down” related to
`
`prototyping/testing but did not save those evaluations. Ex-1762, 83:19-84:15. Erb
`
`shredded his notebook. Ex-1756, 25:12-30:13, 33:2-8. VSI’s failure to maintain its
`
`reduction-to-practice documents runs contrary to federal law and industry practice.
`
`Ex-1755 ¶¶66-74, 143-45. That Teleflex cannot now produce documents necessary
`
`to prove reduction to practice is its own fault.
`
`Moreover, Teleflex would have reduction-to-practice documents if VSI
`
`created them. Without prototype, testing, and other proof-of-concept records, VSI
`
`could not have improved its design. Ex-1755 ¶¶71-74. If VSI created proof-of-
`
`concept documents for RX prototypes, it would have maintained them, as it did for
`
`its OTW prototypes. Id.
`
`B.
`
`Teleflex’s documents do not prove reduction to practice.
`At most four documents relate to particular prototypes.
`1.
`Missing common proof-of-concept documents, Teleflex papered the record
`
`with purchase documents to try to prove reduction to practice, but at most four
`
`relate to particular prototypes. The rest are irrelevant, documenting only generic
`
`component parts purchases untethered to particular projects or prototypes.
`
`11
`
`

`

`Table 1 catalogs VSI’s pre-Itou purchases; gray shading identifies those that
`
`Teleflex cannot tie to a particular prototype with particular features.5 Engineers use
`
`hypotubing, forming tips, guide catheters, ring gages, and capture tubes to develop
`
`a variety of interventional cardiology devices, likely including—
`
`1111121-32, 153, 161, 203; Ex-1757, 68:25-69:4 (VSI “likely” used hypotube for
`
`multiple projects). VSI could have used most parts purchased for the “GuideLiner”
`
`project to prototype an OTW device, built and tested in 2005. Ex-2118 1119. Thus,
`
`gray-shaded purchases cannot prove that VSI ordered parts for RX prototypes.
`
`Table 1
`
`Exhibit
`
`Component
`
`21 10
`
`1/ 14/2005
`
`Hypotubing
`
`OTW/RX7
`
`Application
`
`Widespread
`
`Widespread
`
`2006
`
`2/8/2005
`
`Hypotubing
`
`2008
`
`2/24/2005
`
`Dilators
`
`5 Teleflex offers only Root’s equivocal testimony to connect generic parts to
`
`featureless prototypes. Ex-2118 111123, 48 (components “likely used” for
`
`undescribed RX prototypes).
`
`6 “New Modalities,” catch-all “new ideas” account. EX-2118 1122.
`
`7 Ex-2128 (dilator for OTW and RX); Ex-2129, 11 (obturator for OTW); Ex—l762,
`
`57:24—58:6 (“dilator” and “obturator” are “the same thing”).
`
`12
`
`

`

`
`
`
`
`
`Exhibit
`
`~Date
`
`Component
`
`Project
`
`Application
`
`2027
`
`2007
`
`3/3/2005
`
`Hypotubing
`
`3/4/2005
`
`Hypotubing
`
`HE
`
`Widespread
`
`Widespread
`
`2009
`
`3/10/2005
`
`Hypotubing
`
`Unknown
`
`Widespread
`
`2090
`
`3/ 15/2005
`
`Forming Tips
`
`2091
`
`3/18/2005
`
`Hypotubing
`
`2010
`
`3/21/2005
`
`Hypotubing
`
`2013/2095/
`
`2113
`
`4/5/2005
`
`Laser-Cut
`
`Hypotubing
`
`2011/2089
`
`4/5/2005
`
`Distal Section
`
`2016
`
`4/6/2005
`
`Guide Catheter
`
`2093
`
`4/20/2005
`
`Ring Gages
`
`2094
`
`4/20/2005
`
`Hypotubing
`
`a?zz
`
`Unkn
`
`Widespread
`
`Widespread
`
`OTW/RX8
`
`E5
`
`OTW
`
`Widespread
`
`Widespread
`
`Widespread
`
`2030
`
`5/ 1 1/2005
`
`Ring Gages
`
`GuideLiner
`
`OTW
`
`2029
`
`5/ 1 2/2005
`
`Dilators
`
`GuideLiner
`
`OTW/RX
`
`2032
`
`5/ l 8/2005
`
`Forming Tips
`
`2033
`
`5/26/2005
`
`Forming Tips
`
`22222022
`
`2262225
`
`2026
`
`7/15/2005
`
`Hypotubing
`
`OTW/RX9
`
`OTW/RX
`
`22222222
`
`OTW/RX
`
`8 Invoice specifies “GuideLiner” hypotubing.— Ex-
`
`1763, 6; Ex-1755, 11102. Also, Ex—2094 notes hypotubing for “[b]oth Liner.”
`
`9 EX-1762, 129: l3—130:4.
`
`13
`
`

`

`
`
`Exhibit
`
`Component
`
`Application
`
`2031
`
`7/18/2005
`
`Ring Gages
`
`2034
`
`7/26/2005
`
`Capture Tubes
`
`2035
`
`7/27/2005
`
`Forming Tips
`
`OTW/RX
`
`OTW/RX
`
`OTW/RX
`
`
`
`2020/2028/
`
`Laser-Cut
`
`.
`
`.
`
`2097
`
`9/7/2005
`
`Forming Tips
`
`OTW/RX
`
`Ex-2118 111122-60.
`
`Acknowledging that most purchases do not move the reduction-to-practice
`
`needle, Root cites only four (red boxes) to try to map particular prototypes to the
`
`challenged claims. Root’s claim-by-claim charts rely on Exhibits 2089 (distal
`
`section) and 2113 (proximal section) (the “April” prototypes) and Exhibits 2092
`
`(distal section) and 2114 (proximal section) (the “July” prototypes). Ex-2118,
`
`Appendices A—E. But those four documents do not corroborate the inventors’
`
`testimony that VSI built RX prototypes.
`
`The distal sections relate to RX prototypes only on the inventors ’ say-s0. Ex-
`
`2118 111125, 44; Ex-2119 111132-34. The documents are not labeled “.”RX Instead,
`
`OTW concept drawings match these purchases:
`
`14
`
`

`

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`
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`
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`
`could have used the distal sections it purchased to build OTW prototypes, fusing
`
`them to a proximal tubular portion. Id. 111195, 103, 179, 182, 190. Teleflex cannot
`
`connect these purchases to an RX concept drawing—none exists from 2005—2006.
`
`The distal section purchases are not unique to RX and cannot prove that VSI
`
`purchased parts for RX prototypes.
`
`Teleflex cannot prove that VSI purchased RX-specific proximal sections,
`
`either. One of the proximal sections does not match the RX design, providing an
`
`unexplained lS-degree decline:
`
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`
`Ex-2113. The document is not labeled “GuideLiner.” The decline resembles a
`
`different VSI project:- Ex—1755 1111162-66. Teleflex’s one “complete”
`
`RX drawing, Ex-2022, provides a part number for the proximal section, but
`
`nowhere in the record is a purchase document for that part.
`
`Teleflex’s purchase documents pile shrinks to four when it tries to show
`
`reduction to practice of each claimed invention. And those documents do not prove
`
`that VSI purchased parts for RX prototypes.
`
`2.
`
`No document shows that VSI assembled RX prototypes.
`
`Even if VSI purchased RX parts, Teleflex offers no assembly evidence. The
`
`components, alone, cannot prove that VSI assembled prototypes. Valence”, Inc. v.
`
`Fitbit, Inc., 784 F. App’x 1005, 1009 (Fed. Cir. 2019). No document shows
`
`whether/when/how VSI attached distal and proximal sections. Teleflex concedes as
`
`16
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`much, arguing only that “that the components for at least two sets of prototypes
`
`were delivered to VSI.” CRTP Response, 23. Root testified only that VSI “likely”
`
`combined the “April” distal and proximal sections. Ex-2118 ¶35.
`
`Teleflex should have documents showing assembly if VSI reduced to
`
`practice. Joining dissimilar materials—e.g., stainless steel and polymer—requires
`
`an assembly protocol. Ex-1755 ¶¶72-74. Assembly would require trying various
`
`methods—e.g., epoxy bonding, shrink tube enclosure, polymer melt-and-flow—
`
`tensile strength and flexibility testing, repeated testing for different methods, and
`
`recording/comparing results. Id. This trial-and-error process would be documented
`
`if it occurred (for OTW, it was, id. ¶211, citing Ex-1774, 10-12).
`
`C. No evidence shows that VSI performed tests to determine that RX
`would work for its intended purpose.
`Even if VSI built RX prototypes, Teleflex offers no documents or testimony
`
`regarding testing the prototype’s intended purpose: providing backup support
`
`necessary for accessing and crossing tough or chronic occlusions. Ex-2002; Ex-
`
`2118 ¶18; Ex-2119 ¶9; Ex-1762, 47:11-52:17. Sutton testifies that the RX was
`
`“new” and required significant work. Ex-2119 ¶¶15-17. Yet no one describes—
`
`much less cites documents showing—testing to determine whether RX would
`
`provide its intended backup support for complex PCI procedures.
`
`Particular benchtop simulations can test that intended purpose. Ex-1764,
`
`64:4-67:12. Keith, Teleflex’s expert, testified that benchtop models can simulate
`
`17
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`

`challenging coronary anatomy for testing and measuring backup support in that
`
`context, if set up to do so—curvature representing tortuous anatomy, restricted
`
`areas representing lesions. Id. The proper simulation can test backup support,
`
`whether the tip deforms under pressure, kinking, and stent hang-up. Id. Root
`
`concedes that to reduce to practice, VSI needed to (1) navigate RX through a guide
`
`catheter and out its distal end in a benchtop model, (2) deliver an interventional
`
`cardiology device, and (3) retrieve RX in one piece. Ex-1762, 100:1-102:3. But to
`
`determine that the prototype worked for its intended purpose, VSI needed to do so
`
`using simulated tough lesions. Ex-1764, 64:4-67:12; Ex-1755 ¶¶233-37. Only then
`
`would VSI know that RX provided the backup support intended. Putting a
`
`prototype through a model without particular conditions is not the same as
`
`confirming that the device would work for its intended purpose.10
`
`Teleflex cannot prove that VSI performed any testing, much less testing to
`
`confirm intended purpose. Teleflex cites only “an example of a benchtop coronary
`
`
`10 Root’s testimony proves that Teleflex glosses over testing the intended purpose.
`
`Root testified that he knew that his invention would work for its intended purpose
`
`at conception and at all times after. Ex-2118 ¶48. He goes so far as to say that
`
`every single prototype worked for its intended purpose. Ex-1762, 96:25-97:10. But
`
`not once does he describe testing the intended backup support.
`
`18
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`

`

`model” (shown with OTW) and “an example of a standard guide catheter.” CRTP
`
`Response, 23. Examples are not evidence. Teleflex’s inventors testify that VSI
`
`performed successful benchtop tests, without dates, testing protocols, or specifics
`
`regarding how VSI knew RX worked for its intended purpose. See, e.g., Ex-2118
`
`¶¶35, 47. Nothing—no document, no non-inventor testimony—corroborates that
`
`testimony, and more to the point, no one offers testimony sufficient to address
`
`testing the intended purpose.11
`
`D. No testimony corroborates the inventors.
`Even though the inventors say that VSI built and tested RX prototypes, no
`
`non-inventor corroborates that narrative.
`
`Erb
`1.
`Erb offers no testimony regarding the only “prototypes” that Teleflex maps
`
`to the challenged claims. He machined a component for a prototype that Teleflex
`
`does not argue embodies any claim. Ex-2122 ¶¶8-9. The only testimony that Erb
`
`
`11 Teleflex suggests that the bar for “works for its intended purpose” must be low
`
`because Medtronic’s expert testified that a POSA would know that Itou provided
`
`particular functionality by looking at its drawings. CRTP Response, 25-26. That
`
`comparison misapplies the law, conflating obviousness with Teleflex’s reduction-
`
`to-practice burden (i.e., building and testing).
`
`19
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`

`offers regarding relevant prototypes was “coached” out of him during his
`
`deposition. Teleflex’s counsel introduced Ex-2114. Erb testified that he did not
`
`“recall seeing a prototype made using this part.” Ex-1756, 93:5-25. Counsel asked
`
`again; Erb did not remember. Id., 94:1-12. Counsel asked a third time, leading Erb
`
`and asking, “Does that refresh your memory at all of whether [a] prototype was
`
`made using this part in 2005?” Id., 94:13-20. Only then could Erb respond “yes.”
`
`Id., 94:21-95:3.
`
`Erb’s testimony is too conclusory to corroborate. Erb is missing dates,
`
`prototype and testing specifics, and any detail regarding how VSI knew that
`
`prototypes “worked.” Ex-2122 ¶¶9-14. His role during “testing” was to “stand[]
`
`there next to whoever was testing.” Ex-1756, 66:25-67:22. He was not involved in
`
`testing involving delivering stents/balloons. Id., 71:11-73:20. Because Erb’s
`
`testimony is devoid of “any of the specific features of the demonstrated invention,”
`
`he offers “no evidence that the [prototypes] incorporated all of the limitations of
`
`the claimed invention.” Sprint Commc’ns Co. v. Comcast IP Holdings, LLC, No.
`
`12-1013-RGA, 2015 WL 452289, at *3 (D. Del. Jan. 30, 2015).
`
`Erb is not the person with the relevant knowledge. Erb was a “machinist,”
`
`“not the type to maintain a laboratory notebook.” Ex-1757, 43:10-45:3.
`
`Kauphusman, an engineer, led the project, with support from a different technician
`
`(Mytty) who kept a notebook. Id., 70:2-71:7; Ex-1761. Erb could not remember
`
`20
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`

`any projects that he worked on between 2006 and 2009. Ex-1756, 39:4-12, 77:9-
`
`22.
`
`Schmalz
`2.
`Like Erb, former VP Regulatory and Clinical Affairs Schmalz offers no
`
`specifics regarding purported prototypes embodying the claimed inventions. She
`
`has no personal knowledge of the relevant prototypes and never reported on
`
`GuideLiner in her role. Ex-1766, 34:11-35:1, 71:16-80:19. Schmalz is not an
`
`engineer or a POSA. Id., 19:23-20:10. She cannot judge whether prototypes work
`
`for their intended purpose, even if she had personal knowledge of the same. Id.,
`
`49:22-50:1 (“I am not an engineer, so I can’t…talk about the technical aspects of
`
`[RX].”).
`
`Schmalz relies on a Product Requirements document to assume that
`
`engineers had completed working RX prototypes. Ex-2024. Neither she nor anyone
`
`on her team created that document. Ex-1766, 44:20-45:18. Even if that type of
`
`document can suggest that RX development had progressed to a certain point, the
`
`version Schmalz cites is incomplete and cannot mean what she says it means: the
`
`Product Requirements document marks the alleged “culmination” of the proof-of-
`
`concept phase only if it includes the “main goal” and “how do they get there.” Id.,
`
`50:8-12. The Product Requirements document that Schmalz cites is missing the
`
`“how”—Product Specifications and Test Methods. Infra, §IV.E.1.
`
`21
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`

`

`3. Keith
`Keith will not help the Board decide CRTP. He offers no claim-by-claim
`
`analysis. He has not “form[ed] a specific opinion on [testing required to reduce to
`
`practice], whether it would require some or whether it would require none.” Ex-
`
`1764, 49:8-14. He offers only a vague statement that the RX device required
`
`“little” or possibly “no” testing to reduce to practice. Ex-2123 ¶20. First, Root
`
`undermines Keith, testifying that VSI needed to “evaluate” and test prototypes to
`
`confirm they would work for their intended purpose. Ex-1762, 100:1-102:22.
`
`Second, Keith concedes that he does not know what “reduce to practice”
`
`requires—his opinion is not reliable. Ex-1764, 52:7-15 (Q: “So it’s possible you
`
`could reduce to practice and know that it would work for its intended purpose
`
`without a prototype?” A: “I don’t know.”), 84:2-10 (same).12
`
`E. VSI’s complete GuideLiner record shows that VSI could not have
`reduced to practice before Itou.
`In mid-to-late 2005, GuideLiner was in early-stage concept
`development.
`GuideLiner did not advance past early-stage concept development in 2005.
`
`1.
`
`In June 2005, Root authored a Market Feasibility Memo. Ex-2128. That memo is
`
`an early step in a new device’s Concept/Feasibility Phase, prepared before
`
`
`12 Keith even believes that if an RX device came apart in the vasculature, it
`
`wouldn’t matter for reduction to practice. Ex-1764, 62:12-17.
`
`22
`
`

`

`technical work begins. Ex-2128 (memo part of “Phase I” under VSI standard
`
`operating procedures); Ex-1755 ¶¶172, 222. By July 2005, VSI had only an OTW
`
`design; RX development was slated for the future. Ex-2130, 3 (RX “to follow”).
`
`VSI’s August 2005 Product Requirements document indicates that VSI had
`
`not yet reduced to practice. Ex-2024. Companies prepare Product Requirements
`
`documents before preliminary design work, let alone prototype work. Ex-1755
`
`¶¶196-99. Even if, in VSI’s practice, the document did divide the concept and
`
`regulatory phases, the August 2005 document is an early, incomplete draft, missing
`
`entire sections, including Product Specifications. Compare Ex-2024 with Ex-1767
`
`¶200. Indeed,
`
`; Ex-1755
`
`
`
` Ex-1767. The August 2005
`
`document is not the dividing line that Teleflex claims. Indeed, Root and Schmalz
`
`testified that the August 2005 document’s revision number indicates that it is pre-
`
`regulatory. Ex-1762, 117:19-118:3; Ex-1766, 62:18-25. And Root states that the
`
`August 2005 document should signal a design-frozen product when in reality VSI
`
`would not freeze the RX designs for years. Compare Ex-2118 ¶54 with Ex-2109
`
`(GuideLiner “prior to design lock” in May 2006); Ex-1775
`
`
`
`.
`
`23
`
`

`

`VSI’s August 2005 Clinical Technical Report, Ex-2025, is also a draft of an
`
`early-concept-phase document indicating only that VSI added GuideLiner to an
`
`already-complete literature review. Ex-1766, 65:21-24 (“someone prepared this
`
`document and then after the fact, added GuideLiner”); Ex-1762, 126:11-127:7; Ex-
`
`1755 ¶¶201-02. These versions of these documents do not support that VSI
`
`reduced to practice in 2005.
`
`VSI was still experimenting into 2006.
`2.
`Even if VSI purchased parts for RX and assembled prototypes and tested
`
`them, as Teleflex contends, VSI was still experimenting into 2006. As discussed,
`
`Teleflex relies on two prototypes to try to prove reduction to practice: “April” and
`
`“July.” Critical changes from the purported “April” to “July” designs indicate that
`
`VSI was experimenting with its RX design and had not found a working prototype.
`
`Indeed, even according to Teleflex’s story, between April and July, VSI dropped
`
`key features of the claimed inventions:
`
`Feature
`Flexible tip
`
`April
`
`July
`
`
`
`13
`
`
`13 Removed 0.5” “no braid” d