PETITIONER’S DEMONSTRATIVES
`Medtronic, Inc. and Medtronic Vascular, Inc.v.
`Teleflex Life Sciences Limited
`
`IPR2020-01341, -01342, -01343, -01344
`
`November 18, 2021
`ORAL HEARING
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`

`

`Conception and Reduction to Practice
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`

`

`New Issues: Method-of-Use Claims
`
`1.A method of providing backup support for an interven-
`tional cardiology device for use in the coronary vasculature,
`
`through, and beyond the distal end of, the guide cath-
`
`25. A method, comprising:
`advancing a distal end ofa guide catheter having a lumen
`through a main blood vessel to an ostium ofa coronary
`artery;
`advancing a distal end of a guide extension catheter
`
`413 patent, claim 1; ‘116 patent, claim 25.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`3
`
`

`

`Teleflex cannot proveprior invention before Itou.
`
`¢ No evidence corroborating assembly of RX prototypes.
`
`¢ No dispute that VSI did not perform the claimed methods.
`
`¢ No evidence of required intended purposetesting.
`
`¢ Affirmative evidence showing VSI back-burnered RX and could not
`have reduced to practice—actually or constructively—before Itou.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`4
`
`

`

`Teleflex must prove prior invention.
`
`Teleflex bears “the burden of going forward with evidence . . .
`and presenting persuasive argument based on” that evidence.
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375, 1379-80 (Fed. Cir. 2015).
`
`-01341 Reply at 8; -01343 Reply at 3.
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`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`5
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`

`

`Reduction to Practice
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`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`6
`
`

`

`Reduction to Practice
`
`To prove reduction to practice, Teleflex must show:
`
`(1) “performance of a processthat metall the limitations of the [claimed method];
`
`(2) determinationthat the invention would work forits intended purpose; and
`
`(3)
`
`the existence of sufficient evidence to corroborate inventor testimony
`regarding these events.”
`
`Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1169 (Fed. Cir. 2006).
`
`“Even the most credible inventor testimonyis a fortion required to be corroborated by
`independent evidence... .”
`
`-01341 Reply at 8; -01343 Reply at 3-4.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`Id. at 1171-72.
`
`7
`
`

`

`Reduction to Practice: Performing + Demonstrating
`
`1. Perform a process that meets
`all limitations of the claimed
`invention.
`
`2. Demonstrate that the invention
`would workforits intended
`
`purpose.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`8
`
`

`

`Reduction to Practice: Performing + Demonstrating
`
`1. Perform a process that meets
`all limitations of the claimed
`invention.
`
`2. Demonstrate that the invention
`would workforits intended
`
`purpose.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`9
`
`

`

` VSI intended to develop an OTW GuideLiner(priorart).
`
`OTW GEC:
`
`¢
`
`Full-length lumen
`
`e Mother-and-child
`
`¢
`
`Prior art
`
`Ex-2129.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`GuideLiner OTW Prototype
`
`

`

`VSI intended to develop an OTW GuideLiner(priorart).
`
`July 2005
`GuideLiner OTW
`“New Product{] on the Horizon”
`
`LERCLCCOMIomerliiiacas
`
`| Aeneas Dre haieite
`
`ae WVaSCU a
`
`BYsoLcuTIONS
`
`* Obturator pulled out and GuideLiner is deep seated
`
`»
`
`NewProducts on the Horizon
`(Ask questions at break-out)
`
`* Coaxial guide“liner” that allows safe deep seating
`* Extra back-up support for difficult cases (CTO’s)
`
`« Y-adaptoris attached to proximal hub of Guidel_iner
`
`Ex-2129.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`11
`
`

`

` VSI intended to develop an OTW GuideLiner(priorart).
`
`August/ September / November 2005
`GuideLiner OTW Testing
`
`Surferr bhoworv bre Woe Suictlimee Orvice
`
`NOTEBOOK No ed
`toate
`PROJECT Ovio€
`tinued From
`Paae
`Tes TING Ltv7s Kebced Za. Derexwe Ji “7 Convrtatie vser
`LNCHOPStrl foece AF61 ‘2? Fa M6uictivic€ Cle Orrexe
`Device ole cP ase C*ze@ 2 Uigtier THE JtP00 veeeazr- Hid
`
`Ex-1760, 86-93; -01341 Reply at 10, 18; -01343 Reply at 5, 13.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`12
`
`

`

`VSI intended to develop an OTW GuideLiner(priorart).
`
`August / September / November 2005
`GuideLiner OTW Testing
`
`Listeo6id, Kaan WA6 -teet “Ostia”.
`
`A Ge spenusee Core AAAS Len Ve bRowaee A litt2
`fowce Ta Kit 2.018 Dit Gerobtthe, Once £05 (Tien2r€d
`JN Te THe Vlevte, THE BCC C1, 2.0/4) CUIDEWIIE
`Lees. fest (lovTHe LASTimOfRDO TAFGpEeCnTr2
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`ELTIASE L)ist206eo AkOnT
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`Level Of Geuecwuee Cas flenmvidg front THe
`Lwek Conmectoe | Te Hie Cvrwweik’e Rex uIRL £29.
`
`ALERT #4 Curoelin ee. LAS fat TRODCEY_ TRO THE
`SGViNeECATHETER fia ExterneBerend) THe, Gerre-
`CarevereR_ er. Mettes THE ZCOCM * 0.018 "FoiwtiKee”
`wets Motiaster Cn tit. Alo bartTHeR Lf Yth? COMTLLaS
`fess (ate £ivO TACOUDECATHETER.
`eweLin BK Becunr
`
`GC Backup
`Support Test
`
`GEC Backup
`Support Test
`
`13
`
`Ex-1760, 86-93; -01341 Reply at 10, 18; -01343 Reply at 5, 13.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`

`

`VSI intended to develop an OTW GuideLiner(priorart).
`
`August/ September / November 2005
`GuideLiner OTW Testing
`
`Kovelsaaoedewee, Cathe4 |
`GFR, Avocet Garage
`ae
`Uren,
`fo @eats216|
`+cre g
`
`e
`
`‘| DS. = ery | Be ACayLA
`
`Ex-1761, 107; -01341 Reply at 10, 18; -01343 Reply at 5, 13.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`14
`
`

`

`VSI developed and tested GuideLiner OTW.
`
`¢ OTW meetings.
`
`¢ OTW testing.
`
`¢ OTW photographs.
`
`¢ OTW presentations.
`
`¢ OTW laboratory
`notebook entries.
`
`Ex-2129; Ex-1760; Ex-1761.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`15
`
`

`

` VSI did not perform critical RX work.
`
`¢ No prototypes.
`
`¢ No photographs.
`
`¢ Noassembly documents.
`
`¢ No laboratory notebookentries.
`
`¢
`
`Notesting protocols.
`
`¢ Notesting notes / data/results.
`
`Ex-1796 (Sutton); Ex-1758 (Welch); Ex-1760 (Kauphusman); Ex-1761 (Mytty); -01341 Reply at 10; -01343 Reply at 5.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`LABORATORY NOTEBOOK
`
`aa <
`Notebook No
`Assigned ta Kati a RA WY
`date: VO> ze O3 “
`
`LABORATORY NOTEBOOK
`
` LABORATORY NOTEBOOK
`
`

`

`No documentshowsthat VSI assembled an RX prototype.
`
`Ex-2089; Ex-2113; Ex-2092; Ex-2114; -01341 Reply at 10; -01343 Reply at 5.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`17
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`

`

`Exhibit 2022 does not show that VSI assembled an RX prototype.
`
`Ex-2022; -01341 Reply at 10 n.4; -01343 Reply at 5 n.2.
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`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`18
`
`

`

`
`
`Exhibit 2022 does not showthat VSI assembled an RX prototype.
`
`Root:
`
`Q.
`
`Okay. Now go back to my original question.
`
`same answer.
`
`(YOU dO not contend in your
`
`opening, no.
`
`In your declaration assessing reduction to practice,
`
`including your charts in Exhibit A, You d6 hot Contend
`
`that VSI built prototypes according to Exhibit 2022,
`
`prior to September 23rd, 2005; right?
`
`A. Not with that specific dimensions of the
`
`side opening, I'm not doing -- I'm not claiming that.
`
`I'm claiming it's built along the lines of 2114 for
`
`the July, and 2113 for the April.
`
`reduction-to-practice analysis, that this Exhibit 2022
`
`was tested and shownto workfor its intended purpose
`
`prior to September 23, 2005; right?
`
`A. Not that specific dimension of the side
`
`Ex-1798, 55:16-56:14; -01341 Reply at 10 n.4; -01343 Reply at 5 n.2.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`19
`
`

`

`Reduction to Practice: Performing + Demonstrating
`
`1. Perform a process that meets
`all limitations of the claimed
`invention.
`
`2. Demonstrate that the invention
`would workforits intended
`
`purpose.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`20
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`

`

`a guidewire. the standard guide catheter having adistal DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`The patents claim methods of using GECs.
`1. A method ofproviding backup support for an interven-
`further inserting a substantiallyrigid portion that is proxi-
`tional cardiology device for use in the coronary vasculature,
`mal of, operably connected to, and morerigid along a
`the interventional cardiology device being adapted to be
`longitudinal axis than the flexible tip portion, into the
`passedthrough astandardguide catheter, (he standard puide
`continuous lumen of the standard guide catheter, the
`catheter having a continuous lumen extending for a pre-
`substantially rigid portion defininga rail structure with-
`defined length from a proximal end at a hemostatic valve to a
`out a lumen and having a maximal cross-sectional
`distal end adapted to be placed in a branchartery, the con-
`dimension ata proximal portion that is sunaller than the
`Unuous lumen of the guide catheter having a circular cross-
`cross-sectional outer diameter of the flexible tip portion
`sectionalinner diameter sized suchthat interventional cardi-
`and having a length that, when combined with the length
`ologydevices are insertable into and through the lumen, the
`of the flexible distal tip portion, definesa total length of
`method comprising:
`the device along the longitudinal axis that is longer than
`the length of the continuouslumenof the guide catheter:
`inserting the standard guide catheter into alfitst artery over
`advancing a distal portion ofthe flexible tip portion distally
`beyond the distal end ofthe standard guide catheter and
`intothe second arterysuch thal the distal poruonextends,
`into the secondalteryjand suchthatat least a portion of
`the: proximalportion ofthe substantiallyrigid partion
`extends proximally through the hemostatic valve; and
`inserting the interventional cardiology device into and
`throughthe cQnunuoUs lumen ol the standard guide
`catheter alongside OF the substantially rigid porgon and
`advancing the intervenuional cardiologydevice through
`and beyond a lumenofthe flexible tip portionimife Gon
`tact with or past a lesion in the second artery.
`
`
`
`état:
`positioning the distal end of the standard guide catheter in
`a branch arterythat branches off from thefirst artery;
`inserting a flexible tip portion of a coaxial guide catheter
`defining a tubularstructure having a circular cross-sce-
`tion anda length that is shorter than the predefined
`length ofthe continuous lumen ofthe standard guide
`catheter, into the continuous lumen ofthe standard guide
`cathetor: and.
`'413 patent, claim 1--01341 Reply at 12-13.
`
`

`

`The patents claim methods of using GECs.
`
`lumenofthe guide catheter;
`
`25. A method, comprising:
`advancing a distal end ofa guide catheter having a lumen||maintaining the distal endportion ofthe tubular structure
`
`
`
`throughamainbloodvesseltoanostiumofacoronaryofthe guide extension catheter in position bevond the
`artery;
`distal end of the guide catheter; and
`advancing a distal end of a guide extension catheter\\while maintaining the distal end of the guide extension
`through, and beyond the distal end of, the guide cath-
`catheter positioned beyond the distal end of the guide
`eter,
`including advancing a distal end portion ofa
`catheter, advancing a balloon catheter or stent at least
`tubular structure of the guide extension catheter
`partially through the guide catheter and the guide
`
`beyond the distal end ofthe guide catheter while a extension catheter andiSGRECSFananarterpinclud-
`segment defining a side opening ofthe guide extension
`ing advancing the balloon catheter or stent through a
`catheter remains within the guide catheter,
`the side
`hemostatic valve associated with a proximal endofthe
`opening extendingfor a distance along a longitudinal
`guide catheter, along a substantially rigid segment of
`axis ofthe guide extension catheter and accessiblefrom
`the guide extensioncatheter, through the side opening,
`a longitudinalside defined transverse to the longitudi-
`and through the tubular structure,
`nal axis, the tubular structure having a cross-sectional
`inner diameter that is not more than one French size
`smaller than a cross-sectional inner diameter ofthe
`
`116 patent, claim 25; -01343 Reply at 7-8.
`
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`22
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`

`

`Teleflex must showthat VSI performed the methods,as claimed.
`
`Possibility or capability is not enough:
`
`. would perform all the method steps of
`.
`Though “a computer executing the algorithm .
`claim 13, the thesis alone cannot showthat the method was ever performed.”
`
`Lucent Techs., Inc. v. Gateway, Inc., No. 02-cv-2060-B(CAB),
`2007 WL 2070346,at *2 (S.D. Cal. July 12, 2007).
`
`-01341 Reply at 12; -01343 Reply at 7.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`23
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`

`

` Teleflex must showthat VSI performed the methods,as claimed.
`
`Simulating the claimed method is not enough:
`
`“{Cjomputer simulations could not meetall the limitations of the asserted claims,[thus]
`they are insufficient to show actual reduction to practice.”
`
`TC Tech. LLC v. Sprint Corp., 379 F. Supp. 3d 305, 319 (D. Del. 2019).
`
`-01341 Reply at 13; -01343 Reply at 7-8.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`24
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`

`

` Teleflex cannot showthat VSI performed the methods,as claimed.
`
`Ex-2129.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`25
`
`

`

`Teleflex cannot showthat VSI performed the methods.
`
`Root:
`
`Q.
`
`Okay. And so you can't pinpoint for me when
`
`Okay. And can you do that by reference to a
`
`any particular confirmatory test occurred; is that
`
`specific date and/or prototype?
`
`right?
`
`A. WellI can't do it to a date. I can give
`
` Q.
`
`Ican give you a pretty good range of when
`A.
`you a range of whenit occurred, but I can't give you
`
`it occurred, butIcan'tgiveyouanexactdate.
`
`a specific day that it happened.‘Andtheprototype--
`
`Q.
`Okay. And you also don't say who would have
`
`performed a confirmatory test; is that right?
`
`A.
`
`Idon't think I have namesin this -- in
`
`‘used.We also had a more three-dimensional model that
`we used in order to simulate the coronary anatomy.
`
`Q.
`Okay. So --
`this paragraph. I don't.
`
`@.Okay.Andsittingtoday,youcan'tsayhere
`
`All right. The picture you've got there,
`you've mentioned this several times, but we all know
`
`
`
`forsurewhoperformedconfirmatorytest.some
`
`that's not the rapid exchange version of GuideLiner;
`A. Well I -- I know that I did someof that
`
`testing, along with Gregg Sutton and Jason Garrity and
`A.
`I-I--
`Jeff Welch, and there were other people, butIcan't
`
`
`‘Yeah,Ithinkthisistheover-the-wire
`
`versioninthispicture.
`
`right?
`
`Ex-1798, 22:1-23:25; -01341 Reply at 13-14; -01343 Reply at 8-9.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`26
`
`

`

`Teleflex cannot show that VSI performed the methods.
`
`Erb worked on separate, early prototypes that did not embodythe inventions:
`
`8.
`
`_Asamachinist for the group, (SW@HSGISHRNeIeaeguGUleLie®
`
`
`
`
`
`
`
`the!proximalendOftheearlyprotoiypesofthataeVvice)| personally madeaspecial
`
`along their length.
`
`
`
`
`
`
`
`jig to hold the hypotubes and then usedavertical milling machine to cut the tubes
`
`Ex-2122 ¥[ 8; -01341 Reply at 9; -01343 Reply at 4.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`27
`
`

`

`Teleflex cannot showthat VSI performed the methods.
`
`Erb could barely rememberrelevant components when coached:
`
`Attempt #1
`Do you see the drawing that
`
`I'm looking at,
`
`Q.
`
`Attempt #2
`So if you look at
`the drawing, it's dated
`
`fr. Erb?
`
`Yes.
`
`dune 21st, 2005?
`
`. Correct.
`
`is the date on that drawing? And you
`What
`zoom in with the tool.
`ee
`You can zoom in. There's a little magnifying
`
`Is this a Vascular Solutions drawing?
`Yes
`And if you look at
`
`the drawing, you can see
`
`that there's a -- I guess, does the drawing look
`
`glass with a plus sign.
`
`A. Yes. Okay.
`
`It
`
`looks like 6/21/05.
`
`to you to be a cut-down hypotube?
`
`A. Yes,
`
`it does.
`
`2.[donotremember,
`
`
`
`
`
`2.Anddoyourecallseeingaprototypelike
`
`Ex-2248, 93:14-95:12; -01341 Reply at 11; -01343 Reply at 6.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`28
`
`

`

`Teleflex cannot show that VSI performed the methods.
`
`Erb reviewedthe relevant componentparts drawingsonly for this proceeding:
`
`Had you seen these engineering drawings
`Q
`Q. When did you first review the engineering
`drawings that you discuss in paragraphs 14 to 18?
`
`
`A‘ItwouldhavebeenwhenIdidmydeclarationbefore you created your declaration for these
`(@HereySo) As far as I remember,okay, so that was...
`proceedings?
`
`or not.
`
`A. Yeah, I don't -- I don't remember if I did
`
`Ex-1799, 22:5-8, 23:21-24:1.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`29
`
`

`

` Teleflex cannot show that VSI performed the methods.
`
`Erb “wasnotpersonally involved”in critical testing and only helped assemble
`unidentified “subsequent prototypes” subject to unidentified testing:
`
`|2.
`
`These prototypes were thentested, including for durability with basic
`
`19.
`
`T primarily was involvedin making prototypes before westarted
`
`pull-tests and for functionality in two-dimensional benchtop heart models to ensure
`
`outsourcing thelaser cutting to LSA and SPECTRAI|ytics. However, I did help
`
`that the device could get where it needed to goin the vasculature and to understand
`
`assemble some ofthe subsequent prototypes. Additional testing. including testing
`
`the forces involved in maneuvering the GuideLiner through the heart model.
`
`of the kinds mentioned above, was performed on these subsequent prototypes.
`
`|
`
`Althoughit goes without saying, as part of the testing, we also pulledthe
`
`recall watching HowardRoot andothers working in R&D test these subsequent
`
`GuideLiner prototype back out ofthe heart models.
`
`1 personally was involvedin
`
`
`
`someofthese tests on the GuideLinerprototypes.‘Talsowasawareof,thoughwas
`
`prototypes, as well.
`
`
`
`
`
`
`
`(GeliveryofStentsendballoonsinabenehiopheartmodel)Whenever a prototype
`
`Ex-2122 ff 12, 19; -01341 Reply at 14-15 n.7; -01343 Reply at 9-10 n.6.
`
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`30
`
`

`

`Reduction to Practice: Performing + Demonstrating
`
`1. Perform a process that meets
`all limitations of the claimed
`invention.
`
`2. Demonstrate that the invention
`would workforits intended
`
`purpose.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`31
`
`

`

`Intended Purpose
`
`Intended purpose: “to increase backup support for
`delivery of interventional cardiology devices,” with
`“crossing tough ortotal occlusions [being] one noted
`benefit of the invention.”
`
`IPR2020-00128 Final Written Decision (Paper 127), 55-56.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
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`32
`
`

`

`Intended Purpose
`
`Intended purpose: “to increase backup support for
`delivery of interventional cardiology devices,” with
`“crossing tough ortotal occlusions [being] one noted
`benefit of the invention.”
`
`Demonstrating that the invention would workforthat
`intended purpose: comparative benchtoptesting
`using simulated challenging anatomy.
`
`IPR2020-00128 Final Written Decision (Paper 127), 55-56.
`
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`33
`
`

`

` Demonstrating Intended Purpose
`
`Q. Sure. So those -- and we've talked about those
`before. tight lesions, tortuous anatomy,et cetera.
`Is it possible to test for those things in
`a benchtop modelorto create those kinds ofchallenging
`coronary anatomy?
`
`A. Yeah.(iiGHicanSimilarstantly
`
`A. Well, for example.Iwouldsetitupsothat
`
`1. Set up model simulating
`challenging anatomy,e.g., a
`lesion.
`
`Ex-1764, 64:2-17; -01341 Reply at 18; -01343 Reply at 13.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`Keith:
`
`Q. What do youhaveto do -- I don't know how
`benchtop models work.
`I assumethat they're pretty
`standard.
`
`But howdo youset up a benchtop model
`such that it's presenting challenging coronary anatomy?
`
`

`

`Demonstrating Intended Purpose
`
`2. Run prototype through and
`advanceICDto test
`accessing and crossing.
`
`Keith:
`
`Q. Sure. And you could also make observations
`about whether a GuideLinerprototype, for instance, had
`any kinking problems?
`A.
`Ifit kinked. that could be an observable
`
`thing, yes.
`as part ofthat testing if one wanted to.
`
`(@. And after you had used a prototype setup like
`wediscussed in tortuous anatomy with a tight lesion, you
`could see whether there was any issue with the connection
`between the distal and proximal portions on the way in or
`on the way out, right?
`A. Yeah, those are things that could be observed
`
`Ex-1764, 66:14-25, 67:4-10; -01341 Reply at 18; -01343 Reply at 13.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`35
`
`

`

`Comparative testing measuresrelative backup support.
`
`A.Youcoulddothat,oryoucouldput--you
`
`3. Comparethe prototype’s
`backup support to a standard
`GC.
`
`Ex-1797, 82:11-25; -01341 Reply at 18; -01343 Reply at 13.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`36
`
`Keith:
`
`Q.
`
`Okay. And so what you've said todayis that
`
`even if you don't havetortuosity and even if you
`
`don't have a tight passagewayor tough or chronic
`
`total occlusion, you could still perform comparative
`
`testing that would tell you something about how the
`
`device operates; right? I have that right?
`
`A. Yes.
`
`Q.
`And in that comparative testing I guess you
`would put two different devices through this same
`
`anatomy and -- and somehow see how they performed?
`
`

`

`VSI performed the requisite comparative testing—for OTW.
`
`August/ September / November 2005
`GuideLiner OTW Testing
`
`PROJECT Guroe lek
`
`Notebook No
`red Fi
`
`S3
`ma esye
`
`Surrerr- thowoev br We Swetliwee Orvic€
`
`TESTING: cc44s FeeKaen20 7s Cereee JE “7 Conrraevser
`LNCHOPStt Feace
`PL%L1ED Fo PYCulcbivie€ Cle Orvecxe
`Device Covwto| hs«\ (&e0\ Wa Latrr Whe rete vteetenzr-hs
`
`Ex-1760, 86-93; -01341 Reply at 10, 18; -01343 Reply at 5, 13.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`37
`
`

`

`VSI performed the requisite comparative testing—for OTW.
`
`August/ September / November 2005
`GuideLiner OTW Testing
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`1
`
`:
`:
`
` a ee weeootie
`
`Q.
`
`Okay. So this test would actually
`
`eee, cece cones can,,,| POtENtially show the improvement or measure the
`; oe ao improvement in back-up support?
`aaa
`A.
`I'd say it measured the improvement.
`
`JULY 15, 2021
`
`Ex-1798, 57:25-61:9; -01341 Reply at 18; -01343 Reply at 13.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`38
`
`

`

`VSI Benchtop Model (with OTW)
`July 2005
`
`Sakurada
`Demonstrating Improved
`
`Teleflex cannot showthat VSI performedrequiredtesting.
`
`hidedkeT.Renoy
`
`CrossingAbility aeeiaeleae”)aresmee)
`
`Ex-2129; Ex-1010; Ex-1055; -01341 Reply at 18-20; -01343 Reply at 13-15.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`39
`
`

`

`Teleflex cannot show that VSI performed required testing.
`
`Erb “wasnot personally involved”in critical testing and only helped assemble
`unidentified “subsequent prototypes” subject to unidentified testing:
`
`|2.
`
`These prototypes were thentested, including for durability with basic
`
`19.
`
`T primarily was involvedin making prototypes before westarted
`
`pull-tests and for functionality in two-dimensional benchtop heart models to ensure
`
`outsourcing thelaser cutting to LSA and SPECTRAI|ytics. However, I did help
`
`that the device could get where it needed to goin the vasculature and to understand
`
`assemble some ofthe subsequent prototypes. Additional testing. including testing
`
`the forces involved in maneuvering the GuideLiner through the heart model.
`
`of the kinds mentioned above, was performed on these subsequent prototypes.
`
`|
`
`Althoughit goes without saying, as part of the testing, we also pulledthe
`
`recall watching HowardRoot andothers working in R&D test these subsequent
`
`GuideLiner prototype back out ofthe heart models.
`
`1 personally was involvedin
`
`
`
`someofthese tests on the GuideLinerprototypes.‘Talsowasawareof,thoughwas
`
`prototypes, as well. (GEEROPERaaNTAAENCHTGPMEAAAGAE
`
`Whenever a prototype
`
`Ex-2122 ff 12, 19; -01341 Reply at 14-15 n.7; -01343 Reply at 9-10 n.6.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`40
`
`

`

` Teleflex cannot show that VSI performed required testing.
`
`A. That is correct.
`
`Schmalz
`VSI VP of Regulatory
`Q. Understood. Now, you did not conceive of the
`GuideLiner rapid exchange invention: is that
`correct?
`
`Q.
`
`Ex-1766, 34:11-35:1; -01341 Reply at 14-16; -01343 Reply at 9-10.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`41
`
`

`

`The Board needsto be able to assesstesting evidence.
`
`The Board judges“[t]he adequacyof a reduction to practice . .. by what oneof
`ordinary skill in the art would concludefrom the results of the tests.”
`
`Slip Track Sys., Inc. v. Metal-Lite, Inc., 304 F.3d 1256, 1265 (Fed. Cir. 2002).
`
`The Board considers “whetherthe testing in fact demonstrated a solution to the
`problem intended to be solved by the invention.”
`
`Scott v. Finney, 34 F.3d 1058, 1063 (Fed. Cir. 1994).
`
`-01341 Reply at 20; -01343 Reply at 15.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`42
`
`

`

`Diligence
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`43
`
`

`

` Teleflex cannot provethat VSI wasdiligent.
`
`“[T]o antedate a reference, the applicant must not only have conceived the invention
`before the reference date, but must have reasonably continued activity to reduce
`the inventionto practice.”
`
`All Techs. ULCv. lancu, 920 F.3d 1362, 1369 (Fed. Cir. 2019).
`
`“Reasonable diligence must be shown throughout the entire critical period, which
`beginsjustprior to the competing reference’s effective date and ends onthe date
`of the invention’s reduction to practice.”
`
`Perfect Surgical Techniques, Inc. v. OlympusAm., Inc.,
`841 F.3d 1004, 1007 (Fed. Cir. 2016).
`
`-01341 Reply at 21; -01343 Reply at 16.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`44
`
`

`

`Teleflex cannot provethat VSI wasdiligent.
`
`ComponentParts Drawings
`
`
`
`Sept. 23, 2005
`
`Ex-2115; -01341 Reply at 22-23; -01343 Reply at 17-18.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`May 3, 2006
`
`45
`
`

`

`Teleflex cannot provethat VSI wasdiligent.
`
`Parts Purchases
`
`Sept. 23, 2005
`
`May 3, 2006
`
`Ex-2104; Ex-2106; Ex-2107; Ex-2108; -01341 Reply at 22-23; -01343 Reply at 17-18.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`46
`
`

`

`Teleflex cannot provethat VSI wasdiligent.
`
`Prosecution Work
`
`One email
`
`~27 hours
`~22 hours
`attorney work attorney work
`
`~9 hours
`attorney work
`
`
`
`Sept. 23, 2005
`
`May 3, 2006
`
`Ex-2101; Ex-2102; Ex-2103; Ex-2117; -01341 Reply at 22-23; -01343 Reply at 17-18.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`47
`
`

`

`Teleflex cannot prove that VSI wasdiligent.
`
`Root:
`
`Q.
`
`Okay. And do you know specifically any of
`
`Q.
`
`In order to meet that deadline that we know
`
`HappenedlatWiatdateonthattiniehame) But it wasa||irefore the goal wasn't achieved.
`
`was not met, and not even close to being met; right?
`that activity you're talking about occurred between
`
`
`Septemberof 2005 and May of 2006?theworkwasn'tdone,soA. Well again,
`
`
`
`
`
`
`
`A._Tknowthatthatworkoccurredduringthat||thereforethedeadline,ofTwouldcallitthegoal,
`
`
`periodoftime,butIcan'tspecifywhatevent‘wasn'tmet.It took longer to get the work done,
`
`Ex-1798, 74:19-24, 87:3-8; -01341 Reply at 23; -01343 Reply at 18.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`48
`
`

`

`The Counter-Narrative
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`49
`
`

`

`VSI did not reduceto practice—actually or constructively—before Itou. ————— .June 2005
`
`project, and is usually amongthe veryearliest entries into a DHF
`
`
`
`Ex-2118 {| 37, citing Ex-2017. In my experivace,USSessiiigHankelfeasibilityiaun
`
`which he discusses both an OTWandan RX version of the GuideLinercatheter.
`
`172. Mr. Root discusses a market feasibility memodated June 23, 2005, in
`
`Ex-2128; Ex-1755 J 172; -01341 Reply at 24; -01343 Reply at 19.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`work.It providesjustification for allocating resources to the prospective new
`
`Market Feasibility Memo
`Vascular Solutions,Inc.
`
`Memo
`From; Howard Root
`To:
`GudeLiner DHF
`Date:
`June 23,2005
`RE: Market Feasibility for the Guidel iner catheters
`
`
`
`the GankeLin
`
`an Over-the=Win
`
`a Rapid Exchange Ver
`
`or both
`
`

`

`VSI did not reduceto practice—actually or constructively—before Itou.
`—=ee
`
`July 2005
`RX Design TBD
`
`Vascular Solutions, Inc.
`Research & Development Update
`July 2005
`
`Dev
`=oséBeee~~=5ssi)
`
`=3SFa
`
`== =
`
`= 4 s 5
`
`R
`
`>
`
`
`rapid exchangeversion to follow.
`
`
`
`Ex-2130; -01341 Reply at 24; -01343 Reply at 19.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`51
`
`

`

` VSI did not reduceto practice—actually or constructively—before Itou.
`Se
`
`August 2005(?)
`RX Product Requirements Incomplete
`PRODUCT REQUIREMENTS:
`GaldeLiner Cathaer System
`
`
`
`
`
`
`
`Ex-2024; Ex-1755 {J 196-200; -01341 Reply at 24; -01343 Reply at 19.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`52
`
`

`

`VSI did not reduceto practice—actually or constructively—before Itou.
`SS
`
`September 2005
`Itou
` Pateai Ne:
`Daweof Pate:
`
`US 7,736,355 B2
`Jun. 15, 2018
`
`» United States Patent
`Tow etal.
`
`©)
`
`
`
`
`
`Ex-1007.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`53
`
`

`

`
`VSI did not reduceto practice—actually or constructively—beforeItou.
`=Sseeeeee
`
`December 2005
`Additional Engineering Required
`
`Vascular Solutions, Inc.
`2006Seaee Cpecives
`The rapid exchange version
`|
`requires additional engineering and is not included in our 2006 forecasts’
`
`
`
`
`
`Ex-2131; -01341 Reply at 25; -01343 Reply at 20.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`54
`
`

`

`
`VSI did not reduceto practice—actually or constructively—before Itou.
`2005
`f
`
`December 2005
`
`AdditionalSeeRequired
`pet~tow GagetneSTBate—Ser=aTaal4,
`
`eSee Z/
`nf.
`Fa
`a-akonicSerBe
`car|)apene=—|pa
`
`shespodebybeets|eetH A
`le ec
`Net
`SerronsexidetirrBVTbanrfissyStim YY
`Dt a Daag} HAY|
`PSPTaoeee eeeeee82
`9288S m
`-a-
`
`
`Q. What is design verification testing?
`A
`
`Sutton:
`
`Ex-1768, 14; Ex-1757, 77:16-18; -01341 Reply at 25; -01343 Reply at 20.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`55
`
`

`

`
`VSI did not reduceto practice—actually or constructively—before Itou.
`SS——_eSeo
`April 2007
`RX Design In Progress
`
`R&D Device Idea List 04-30-2007 page 1
`
`
`
`Idea Name
`Status (Comments
`_ Concept
`Design
`
`
`
`Concept Drawing: TBD
`|
`Leader
`| Drawing
`Freeze
`1
`J Welch
`4/2007,
`-
`
`Vanilase Bright Tip Raul
`
`
`- Coors Tec quoting price and lead time for
`
`mokd
`Design Freeze: May 30, 2007
`
`+ Project review scheduled for teday
`
`
`
`
` 307|~ Asseintly of polymer shaft to NiTi
`backbone repeatability issues.
`
`
`
`- New adhesive with new LED light scarce
`being investigated
`
`~ Assembly cost for GuideLiner wih
`
` We did manypull tests on
`
`22. How strong is the bond betweenthe metal collar and the guide extension on the
`GuideLiner?
`
`validation lots of the GuideLiner and the catheter would withstand at least a 3.5 Ib. pull force.
`To give you some idea of whatthat feels like, that pull force is about the same as whatit takes to
`lift a half-gallon of milk.
`
`Ex-1769; Ex-1770; -01341 Reply at 25-26; -01343 Reply at 20-21.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`56
`
`

`

`VSI did not reduceto practice—actually or constructively—beforeltou
`
`GuideLiner 57
`
`
`
`Ex-1765; -01341 Reply at 26; -01343 Reply at 21.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`ycan GENERATED DRAWING,
`DO NOT MANUALLY
`UPDATEj
`BO NOT SCALEeneee
`10 VAAcrsovunte” anzi0g
`iver
`TSI:
`DPEIEEION
`emf02108 ne
`THIRD ANGLE PROJECTION |!
`
`oy,Ww vascular
`
`rSOLUTIONS'
`
`

`

`VSI did not reduceto practice—actually or constructively—beforeItou.
`SSS8FS
`
`July 2008
`RX Design Pushed Out
`
`Research & Development Update — July 2008
`Jeff Welch (Devices) and Steve Penegor(Biologics)
`
`Gui_iner
`Acoaxtalliner forguidecatheterstopravideextraback-upsupportduringPTCAprocedures.
`‘ timelines have peespushed 0outsadto grate design changes
`
`
`with a 510k sulaba
`
`on in Nov
`
`effective. We are planning on an Aug
`
`20 8 des
`
`Ex-2132; -01341 Reply at 26; -01343 Reply at 20-21.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`J
`
`58
`
`

`

`
`VSI did not reduceto practice—actually or constructively—before Itou.
`eSeSSTSSoeee
`May 2009
`RX Product Requirements Complete
`PRODUCT REQUIREMENTS:
`GuideLiner
`
`Reviewer
`
`
`
`3.1.3 The GuideLiner (6Fr, 7Fr, & 8Fr)
`
`
`must be capable of advancing through a
`
`guide catheter that is placed in simulated
`
`anatomy until 10cm of the GuideLiner
`—[
`
`[USER REQUIREMENTS
`a
`have extended passthe tip of the guide
`
`
`
`The device(s) must pass Uirough ¢ guide
`
`| Design Specification
`3.1.1 She GuideLiner (6Fr, 7Fr, & 8Fr)
`catheter and into the vasculature withou
`shafts’ distal 1Sem mast have a coil, and|TPIIS2
`kinking or seizing.
`
`catheter.
`be capabe of a {" bend radius without
`
`janking._ = ee ——
`3.12 The GuideLines (6Fr, 7Fr, & 8Fr)
`Design Specification
`
`shafts’ distal 1Sem must haveasilicone
`coatiny
`
`
`
`5/4/09 Documentation
`
`tai
`
`Dean Peterson
`
`Laura Thomas
`
`5/5/09
`
`
`
`avaiomy antil 10cm of the Guideline:
` have extended pass the tip of the guide
`
`catheter.
`
`}
`The device(s) must have a labricious inner 3.14 The PTFElined inner diameterof|Print Verification
`
`with the largest possible I.D, while
`maintaining stracteral integeny
`
`
`
`Ex-1767; -01341 Reply at 24-25; -01343 Reply at 19.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`59
`
`

`

`
`VSI did not reduce to practice—actually or constructively—before Itou.
`Phase!
`RX Design
`Prod. Regs.
`Add’ Engineering
`Itou
`Feasibility
`TBD
`_Incomplete
`Required
`
`
`2005
`
`
`2006
`
`Assembly
`Issues
`
`2007
`=|
`
`Changes”
`Drawing
`
`—
`== EE)
`tl
`Prod. Reqs.
`‘————
`Complete
`
`sii
`SSI
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`60
`
`

`

`Teleflex cannot proveprior invention of its method claims.
`
`¢ No evidence corroborating assembly of RX prototypes.
`
`¢ No dispute that VSI did not perform the claimed methods.
`
`¢ No evidence of required intended purposetesting.
`
`¢ Affirmative evidence showing VSI back-burnered RX and could not
`have reduced to practice—actually or constructively—beforeItou.
`
`DEMONSTRATIVE EXHIBIT—NOT EVIDENCE
`
`61
`
`

`

`Introduction
`
`DEMONSTRA