`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
`
`Case IPR2020-01343
`U.S. Patent No. RE 46,116
`
`
`
`
`
`
`
`
`
`
`
`PATENT OWNER RESPONSE
`
`

`

`B.
`
`2.
`
`3.
`
`V.
`
`
`INTRODUCTION ........................................................................................... 1
`I.
`BACKGROUND ............................................................................................. 2
`II.
`III. THE PERSON OF ORDINARY SKILL IN THE ART ................................. 5
`IV. PRIORITY DATE ........................................................................................... 5
`The ‘380 Patent Is Not Subject to AIA First-to-File Provisions
`A.
`Because its Effective Filing Date is October 23, 2012 ......................... 6
`Petitioner’s Written Description Argument Fails Both Procedurally
`and on the Merits ................................................................................... 7
`PETITIONER HAS NOT SHOWN THAT THE CLAIMS CHALLENGED
`UNDER GROUNDS 2-3 ARE INVALID ...................................................... 9
`A. Grounds 2 and 3: Itou Is Not Prior Art ................................................. 9
`The GuideLiner Invention Was Conceived by at Least Early
`1.
`2005 ............................................................................................. 9
`The GuideLiner Invention Was Reduced to Practice Prior to
`Itou’s Filing Date ...................................................................... 13
`Initial Prototypes and Tests ............................................ 15
`a.
`b.
`April and July 2005 Prototypes and Tests ...................... 16
`c.
`The Road to Commercialization ..................................... 25
`Reasonably Diligent Work on the Invention Continued Through
`the Filing of the Patent Application on May 3, 2006 ............... 28
`B. Ground 2: Even if Itou Were Prior Art, Petitioner Fails to Show That
`the Challenged Claims Would Have Been Obvious Over Itou in View
`of Ressemann and the Knowledge of a POSITA ................................ 29
`Itou (Ex-1007) .......................................................................... 29
`1.
`2.
`Ressemann (Ex-1008) .............................................................. 31
`3.
`Petitioner failed to show that it would have been obvious to use
`Itou’s suction catheter as a guide extension catheter for balloon
`catheters or stents (all challenged claims) ............................... 33
`
`TABLE OF CONTENTS
`
`Page
`
`i
`
`

`

`i.
`
`ii.
`
`4.
`
`ii.
`
`iii.
`
`Petitioner Has Not Shown that Itou’s Suction Catheter Is
`Inherently Capable of “advancing the balloon catheter or
`stent…through the side opening, and through the tubular
`structure” When the Suction Catheter Is Inside the Guide
`Catheter ........................................................................... 33
`Petitioner Has Not Shown that It Would Have Been
`Obvious to Use Itou’s Suction Catheter as a Guide
`Extension Catheter .......................................................... 38
`Petitioner has not shown it would have been obvious to advance
`a balloon catheter or stent though a “side-opening structure
`having at least two inclined slopes” (claim 45) ...................... 42
`Ressemann Undisputedly Does Not Disclose Advancing
`i.
`a Stent or Balloon Catheter Through a Side Opening
`“having at least two inclined slopes” ............................. 42
`The So-Called “Incline #1” in Ressemann’s Support
`Collar Services No Purpose in Ressemann .................... 47
`Petitioner’s Purported Motivation Is Unsupported and
`Hindsight-Driven ............................................................ 48
`Even Assuming a POSITA Was Motivated to Combine
`Itou and Ressemann, the Resulting Combination Would
`Not Work and Would Not Satisfy the Claim Language . 50
`C. Ground 3: Petitioner Fails to Show that Claim 45 Would Have Been
`Obvious Over Itou in View of Ressemann, Kataishi, and the
`Knowledge of a POSITA .................................................................... 55
`Kataishi (Ex-1025) ................................................................... 55
`1.
`2.
`Petitioner’s Arguments Based on Kataishi’s distal opening are
`Unsupported and Unpersuasive ................................................ 57
`The Objective, Real-World Evidence Shows That the Invention
`Recited in Claim 25 Was Not Obvious ............................................... 59
`Long-Felt Need ......................................................................... 61
`1.
`2.
`Commercial Success ................................................................. 63
`3.
`Industry Praise ........................................................................... 67
`4.
`Licensing ................................................................................... 68
`
`iv.
`
`D.
`
`ii
`
`

`

`5.
`
`6.
`
`Copying ..................................................................................... 68
`Boston Scientific’s Guidezilla ........................................ 69
`i.
`ii.
`QXM’s Boosting Catheter .............................................. 71
`iii.
`Petitioner’s Telescope ..................................................... 71
`There is nexus between the invention of claim 25 and the
`objective evidence of nonobviousness ...................................... 75
`The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional .................................................................................. 80
`VI. CONCLUSION .............................................................................................. 81
`
`
`
`E.
`
`
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
`
`Cases
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016) ................................................................................ 74
`Arctic Cat Inc. v. GEP Power Prods.,
`919 F.3d 1320 (Fed. Cir. 2019) ........................................................................... 9, 28
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`941 F.3d 1320 (Fed. Cir. 2019) ................................................................................ 80
`DSL Dynamic Scis., Ltd. v. Union Switch & Signal, Inc.,
`928 F.2d 1122 (Fed. Cir. 1991) ................................................................................ 14
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) .................................................................................. 9
`Ethicon Endo-Surgery, Inc. v. United States Surgical Corp.,
`93 F.3d 1572 (Fed. Cir. 1996) .................................................................................... 8
`Fox Factory, Inc. v. SRAM, LLC,
` 944 F.3d 1366 (Fed. Cir. 2019) ........................................................................ 75, 80
`Fox Grp., Inc. v. Cree, Inc.,
`700 F.3d 1300 (Fed. Cir. 2012) ................................................................................ 12
`Gambro Lundia AB v. Baxter Healthcare Corp.,
`110 F.3d 1573 (Fed. Cir. 1997) ................................................................................ 77
`In re Stempel,
`241 F.2d 755 (C.C.P.A. 1957) ................................................................................. 24
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) ......................................................................... 67, 68
`Intendis GmbH v. Glenmark Pharm., Inc.,
`822 F.3d 1355 (Fed. Cir. 2016) ................................................................................ 74
`Intri-Plex Techs., Inc. et al. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309, Paper 83 (PTAB Mar. 23, 2015) .................................................. 69
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ................................................................................ 74
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 (PTAB Jan. 24, 2020) ................................................... 75
`
`iv
`
`

`

`Loral Fairchild Corp. v. Matsushita Elec. Indus.,
`266 F.3d 1358 (Fed. Cir. 2001) ................................................................................ 27
`Lucia v. SEC,
`138 S. Ct. 2044 (2018) ............................................................................................. 81
`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572 (Fed. Cir. 1996) ....................................................................... 9, 12, 14
`Medichem, S.A. v. Rolabo, S.L.,
`437 F.3d 1157 (Fed. Cir. 2006) ................................................................................ 12
`Motorola Mobility LLC v. Intellectual Ventures II LLC,
`IPR2014-00504, Paper 84 (PTAB Mar. 13, 2020) .................................................... 9
`Perfect Surgical Techniques, Inc. v. Olympus America, Inc.,
`841 F.3d 1004 (Fed. Cir. 2016) ................................................................................ 28
`Pfizer, Inc. v. Genentech, Inc.,
`IPR2017-01488, Paper 87 (PTAB, Nov. 29, 2018) ................................................. 24
`Purdue Pharma L.P. v. Boehringer Ingelheim GmbH,
`237 F.3d 1359 (Fed. Cir. 2001) .................................................................................. 9
`Scott v. Finney,
`34 F.3d 1058 (Fed. Cir. 1994) ........................................................................... 13, 14
`Securus Techs., Inc. v. Glob. Tel*Link Corp.,
`701 F. App’x 971 (Fed. Cir. 2017) .......................................................................... 58
`See In re Asahi/America Inc.,
`68 F.3d 442 (Fed. Cir 1995) ..................................................................................... 14
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) ................................................................................ 59
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ......................................................................... 61, 75
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ................................................................................ 68
`Other Authorities
`35 U.S.C. §100(i)(2) ..............................................................................................6, 7
`35 U.S.C. §112 ........................................................................................................... 7
`35 U.S.C. §311(b) ...................................................................................................... 7
`
`
`v
`
`

`

`I.
`
`INTRODUCTION
`The ’116 patent that is the subject of the present IPR is one of the family of
`
`patents covering an industry-changing product called GuideLiner. When Patent
`
`Owner’s predecessor, Vascular Solutions, Inc. (“VSI”), introduced GuideLiner in
`
`2009, it created a new product category called “guide extension catheters.”
`
`GuideLiner was the first product that solved the long-felt need for better backup
`
`support during the catheter-based treatment of diseased coronary arteries.
`
`The claims of the ’116 patent differ from those of other related GuideLiner
`
`patents in a way that is directly relevant to patentability over the Itou reference that
`
`is the primary reference for Grounds 2 and 3 of the present Petition. Specifically,
`
`the claims are directed to methods of using a guide extension catheter like
`
`GuideLiner to deliver a stent or balloon catheter into a coronary artery. As
`
`extensively briefed in related IPRs, Itou is not even prior art. But even if it were,
`
`Itou discloses a suction catheter and contains no disclosure regarding the delivery
`
`of stents or balloon catheters. Petitioner’s argument that it would have been
`
`obvious to use a suction catheter to perform a totally different surgical procedure is
`
`pure hindsight. Indeed, one of Petitioner’s experts candidly admitted he used the
`
`claimed invention as a roadmap for his obviousness analysis, testifying that he was
`
`“looking at how to combine the elements to arrive at the claimed invention,” and
`
`even that he “was tasked with” proposing combinations “directed at the device
`
`1
`
`

`

`that’s claimed in the ‘413 and ‘116 patents.” Ex-2244, 152:16-21, 161:5-9.
`
`Petitioner’s arguments are also belied by the wealth of objective indicia of
`
`nonobvious.
`
`In view of these overarching issues, and other deficiencies described below,
`
`the Petition fails to show that the claims challenged in Grounds 2 and 3 are invalid.
`
`II. BACKGROUND
`In 2004, VSI’s founder, Howard Root, recognized a need for a new product
`
`that would address backup support problems ICDs encountered when treating
`
`complex coronary lesions or tortuous anatomy, while overcoming the drawbacks of
`
`existing options. Ex-2118, ¶¶5-6; see also Ex-2145, ¶¶41-75; Ex-2151, ¶¶4-8; Ex-
`
`2215, ¶¶3-19. Mr. Root, with three coinventors, conceived of, built, and
`
`successfully tested working prototypes of the GuideLiner invention. Ex-2118, ¶¶5-
`
`61. Mr. Root and his team invented a rapid-exchange device that facilitated
`
`delivery of the full array of ICDs (including stents) deep into the vasculature with
`
`markedly improved backup support. GuideLiner succeeded beyond the inventors’
`
`wildest expectations. E.g., Ex-2118, ¶4; Ex-2151, ¶¶9-17; Ex-2215, ¶¶7, 9, 20-29;
`
`Ex-2060.
`
`The ’116 patent is directed to a method of using a guide extension catheter
`
`that is passed through the lumen of a guide catheter, advanced beyond the distal
`
`end of the guide catheter, and inserted into a branch artery of the aorta to facilitate
`
`2
`
`

`

`delivery of stents or balloon catheters. Ex-1001, Abstract; see also, e.g., id., cl. 25.
`
`The guide extension catheter generally includes, from distal to proximal direction,
`
`a soft tip portion, a tubular reinforced portion, and a substantially rigid portion that
`
`has a rail segment to permit delivery without blocking use of the guide catheter.
`
`E.g., id., 6:45-46, Figs. 1, 4, 20-22; Ex-2138, ¶86. An important advantage of the
`
`design is it only slightly reduces available space in the guide catheter to deliver
`
`interventional cardiology devices—by not more than one French size than that of
`
`the guide catheter in one embodiment. Ex-1001, 3:39-55; Ex-2138, ¶86.
`
`The guide extension catheter preferably includes, from distal to proximal
`
`direction, a first full circumference portion, a hemicylindrical portion, and an
`
`arcuate portion. Exemplary embodiments are shown below in Figures 4 and 12-13:
`
`
`
`3
`
`
`
`
`

`

`Ex-1001; see also id., 7:7-10 (red arrows added). This structure forms an opening
`
`that directs the cardiology device—in a proximal-to-distal direction as indicated by
`
`the red arrow annotation—into the tubular portion. Ex-2138, ¶87.
`
`Exemplary claim 25 recites:
`
`25. A method comprising:
`
`advancing a distal end of a guide catheter having a lumen
`through a main blood vessel to an ostium of a coronary artery;
`
`advancing a distal end of a guide extension catheter through,
`and beyond the distal end of, the guide catheter, including
`advancing a distal end portion of a tubular structure of the guide
`extension catheter beyond the distal end of the guide catheter
`while a segment defining a side opening of the guide extension
`catheter remains within the guide catheter, the side opening
`extending for a distance along a longitudinal axis of the guide
`extension catheter and accessible from a longitudinal side
`defined transverse to the longitudinal 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 of
`the lumen of the guide catheter;
`
`maintaining the distal end portion of the tubular structure of the
`guide extension catheter in position beyond the distal end of the
`guide catheter; and
`
`while maintaining the distal end of the guide extension catheter
`
`4
`
`

`

`positioned beyond the distal end of the guide catheter,
`advancing a balloon catheter or stent at least partially through
`the guide catheter and the guide extension catheter and into the
`coronary artery, including advancing the balloon catheter or
`stent through a hemostatic valve associated with a proximal end
`of the guide catheter, along a substantially rigid segment of the
`guide extension catheter, through the side opening, and through
`the tubular structure.
`
`III. THE PERSON OF ORDINARY SKILL IN THE ART
`For the purposes of this Response only, Patent Owner applies Petitioner’s
`
`proposed definition of a POSITA.1 Petition, 13-14.
`
`IV. PRIORITY DATE
`The ʼ116 patent claims priority to U.S. Patent No. RE 45,380 (“the ’380
`
`patent”), which is a reissue of Patent No. 8,292,850 (“the ʼ850 patent”), filed on
`
`
`1 Petitioner’s engineering expert, Richard Hillstead, does not meet its definition of
`
`a POSITA. Ex-2137, 462:8-13; Ex-1443, 2. Petitioner’s physician expert, Dr.
`
`Brecker, has conceded that he doesn’t “have huge experience of using the
`
`commercially available guide extensions” and that his practice has been more
`
`focused in the structural heart space than complex PCI. 2245, 39:5-7; see also id.,
`
`43:6-13, 36:19-21, 27:4-8, 44:17-23, 46:15-20, 67:15-68:13, 69:19-70:8. 46:15-20.
`
`5
`
`

`

`January 26, 2012. The ʼ850 patent claims priority as a divisional of two prior
`
`applications, the earliest of which was filed on May 3, 2006.
`
`Petitioner argues that Patent Owner is precluded from swearing behind Itou
`
`(Ex-1007) because the ’116 patent is subject to the AIA first-to-file provisions.
`
`Petition, 12-13. Petitioner makes two arguments: (1) that the ’380 patent is subject
`
`to the AIA first-to-file provisions; and (2) that the ’116 patent claims lack
`
`sufficient written description (and therefore pre-AIA priority). Id. Both of these
`
`arguments fail.
`
`A. The ʼ380 Patent Is Not Subject to AIA First-to-File Provisions
`Because its Effective Filing Date Is October 23, 2012
`The Board has already correctly rejected Petitioner’s argument that the ’380
`
`patent is subject to the AIA’s first-to-file provisions:
`
`“The effective filing date for a claimed invention in an
`application for reissue or reissued patent shall be determined by
`deeming the claim to the invention to have been contained in
`the patent for which reissue was sought.” 35 U.S.C. §100(i)(2).
`As the “patent for which reissue was sought” in this case was
`issued October 23, 2012, we are not persuaded that AIA’s first-
`to-file provisions apply to the ’380 patent. Indeed, Petitioner
`provides no statutory or case law support for the proposition
`that a reissue patent may lose the filing date of the original
`patent for which reissue was sought.
`
`6
`
`

`

`IPR2020-00128, Paper 22, 11-12 (PTAB June 8, 2020). The Board also explained
`
`that whether the original patent for which reissue was sought contains written
`
`description support for a reissue claim is “a question we may not address in an
`
`IPR.” Id., 12 n.5 (citing 35 U.S.C. §311(b)). That reasoning remains applicable.
`
`Petitioner’s first argument should be rejected.
`
`B.
`
`Petitioner’s Written Description Argument Fails Both
`Procedurally and on the Merits
`The Board also rejected Petitioner’s second argument as procedurally
`
`improper in related IPR proceedings concerning two other continuations of the
`
`ʼ380 patent: U.S. Patent Nos. RE45,760 (the “ʼ760 patent”) and RE45,776 (the
`
`“ʼ776 patent”). E.g., IPR2020-00135, Paper 22, 7 n.2 (PTAB June 8, 2020) (ʼ776
`
`patent); IPR2020-00132, Paper 22, 7 n.2 (PTAB June 8, 2020) (ʼ760 patent). The
`
`Board noted that “Petitioner’s priority date argument appear[s] to be a back door
`
`attempt to have us address whether the ʼ776 patent satisfies the written description
`
`requirement of 35 U.S.C. §112. But this is a question we may not address in an
`
`IPR.” IPR2020-00135, Paper 22, 8 n.2.
`
`The ʼ116 patent is no different from any of the other reissue patents that the
`
`Board has already considered. The law is clear: the effective filing date of the ’116
`
`patent is the priority date of the patent for which reissue was sought. See 35
`
`U.S.C. §100(i)(2). The ’116 patent, like the ’380, ʼ776, and ʼ760 patents, is a
`
`reissue of the ʼ850 patent, which was filed on January 26, 2012 and claims priority
`
`7
`
`

`

`as a divisional of two prior applications, the earliest of which was filed on May 3,
`
`2006. Therefore, the ʼ116 patent is not subject to the AIA’s first-to-file provisions.
`
`Moreover, even if Petitioner could properly challenge written description in
`
`this context, the challenged claims of the ʼ116 patent have written description
`
`support. Ex-2138, ¶¶297-304. First, the ’116 patent claims “a segment defining a
`
`side opening,” and the original application to which the ʼ116 patent claims priority
`
`(including at Figures 4 and 12-16) expressly discloses a segment defining a side
`
`opening. Ex-2138, ¶¶298-303. This is quintessential written description support.
`
`Moreover, the challenged claims do not require that the segment defining the side
`
`opening is not substantially rigid—rather, they are agnostic as to the material
`
`property of the segment defining the side opening. This type of broad claiming is
`
`perfectly permissible. Ethicon Endo-Surgery, Inc. v. United States Surgical Corp.,
`
`93 F.3d 1572, 1582 n.7 (Fed. Cir. 1996).
`
`Second, Figure 4 of the original application expressly shows an embodiment
`
`with a side opening having two different inclined slopes. Ex-2138, ¶304. Absent
`
`some indication that a side opening having only two inclined slopes (as opposed to
`
`three or more) is critical, there is nothing improper about claiming a side opening
`
`with “at least two” inclined slopes. There is nothing in the original application that
`
`suggests the existence of this type of criticality. Id. Moreover, a claim limitation
`
`reciting “at least two inclined slopes” is no different than a claim limitation that
`
`8
`
`

`

`recites “comprising two inclined slopes”—in both cases, the claim reads on a side
`
`opening that has two, three, or more inclined slopes. Just as a claim does not lack
`
`written description because it uses the open-ended term “comprising,” a claim also
`
`does not lack of written description because it uses the term “at least.”
`
`V.
`
`PETITIONER HAS NOT SHOWN THAT THE CLAIMS
`CHALLENGED UNDER GROUNDS 2-3 ARE INVALID
`A. Grounds 2 and 3: Itou Is Not Prior Art
`The GuideLiner invention was reduced to practice prior to Itou’s September
`
`23, 2005 filing date. Itou is therefore not prior art. See, e.g., Arctic Cat Inc. v.
`
`GEP Power Prods., 919 F.3d 1320, 1331-32 (Fed. Cir. 2019); Purdue Pharma L.P.
`
`v. Boehringer Ingelheim GmbH, 237 F.3d 1359, 1365-66 (Fed. Cir. 2001);
`
`Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577-79 (Fed. Cir. 1996). Even if the
`
`Board were uncertain about the evidence, Petitioner, the party with the burden,
`
`loses. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378-79
`
`(Fed. Cir. 2015); see also Motorola Mobility LLC v. Intellectual Ventures II LLC,
`
`IPR2014-00504, Paper 84 at 14-15 (PTAB Mar. 13, 2020).
`
`1.
`
`The GuideLiner Invention Was Conceived by at Least
`Early 2005
`
`When the inventors conceived of the GuideLiner, they knew that backup
`
`
`
`support could be achieved using two full-length over-the-wire catheters. This was
`
`called the “mother-and-child” approach. Ex-2254; Ex-2127; Ex-2119, ¶10; Ex-
`
`9
`
`

`

`2118, ¶6. The GuideLiner inventors built on that concept to implement the
`
`mother-and-child approach with rapid exchange conveniences. Ex-2253; Ex-2254;
`
`Ex-2127; Ex-2118, ¶¶5-14; Ex-2119, ¶¶7-17.
`
`In January 2005, Gregg Sutton memorialized the idea in his notebook,
`
`including illustrations that are nearly identical to several figures in the GuideLiner
`
`patents, including Figure 2:
`
`
`
`
`
`10
`
`

`

`Ex-2253; Ex-1001, Fig. 2. A February 2005 drawing by Mr. Root is very similar
`
`to Figure 1 of the patents:
`
`
`
`Ex-2255; Ex-1001, Fig. 1. This February 2005 document also reflects conception
`
`of the “side opening” at the proximal end of the tubular portion that facilitates
`
`entry of a stent or balloon catheter into the tubular portion. Ex-2118, ¶¶11-14. A
`
`February 4, 2005 memo further reflects design features of the contemplated
`
`GuideLiner device. Id.; Ex-2127.
`
`In use, a standard guide catheter is first inserted into vasculature over a
`
`guidewire until its distal end is adjacent the ostium of a cardiac artery of interest
`
`within the heart. Ex-2118, ¶¶7, 10, 18; Ex-2119, ¶13; Ex-22253. The guide
`
`extension catheter is then inserted through the guide catheter until the tip of its
`
`11
`
`

`

`distal end extends past the distal end of the guide catheter and into the cardiac
`
`artery, with the proximal end of the device extending proximally through a
`
`hemostatic valve connected to the proximal end of the guide catheter. Id. An
`
`interventional cardiology device (“ICD”), such as a stent or balloon catheter, is
`
`then inserted through the hemostatic valve and into the guide catheter (running
`
`alongside the rail of the guide extension catheter), into and through the proximal
`
`end of the tubular portion of the guide extension catheter, out the distal end of the
`
`tubular portion, and into the cardiac artery. Id.
`
`
`
`When, as here, the invention was reduced to practice prior to the critical
`
`date, separate proof of conception is not required. See Fox Grp., Inc. v. Cree, Inc.,
`
`700 F.3d 1300, 1304-05 (Fed. Cir. 2012). Nonetheless, there is ample inventor
`
`evidence of the GuideLiner’s conception. Ex-2253; Ex-2255; Ex-2127; Ex-2118,
`
`¶¶5-14; Ex-2119, ¶¶7-17. Corroboration is not required for signed and dated
`
`physical exhibits created by the inventors because the “trier of fact can conclude
`
`for itself what documents show, aided by testimony as to what the exhibit would
`
`mean to one skilled in the art.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157,
`
`1169-70 (Fed. Cir. 2006) (quoting Mahurkar, 79 F.3d at 1577-78). But here,
`
`corroboration of conception is provided by non-inventor fact witnesses, including
`
`VSI technician Steve Erb, who testified that in early 2005, he and others at the
`
`company started building and testing prototypes of the newly conceived
`
`12
`
`

`

`GuideLiner rapid exchange. Ex-2122, ¶¶5-21; Ex-2248 39:13-23, 49:18-50:3,
`
`57:24-59:7, 61:17-62:19, 65:11-22, 67:6-19, 68:13-17, 69:5-13, 72:21-73:3, 94:18-
`
`95:18, 96:20-23; see also Ex-2039, ¶¶4-12; Ex-2120, ¶¶6-12; Ex-2121, ¶¶5-6; Ex-
`
`2014; Ex-2089; Ex-2092; Ex-2113; Ex-2114. Conception is also corroborated by
`
`all of the evidence discussed below showing prototyping and testing resulting in
`
`reduction to practice by no later than August 2005.
`
`2.
`
`The GuideLiner Invention Was Reduced to Practice Prior
`to Itou’s Filing Date
`
`Reduction to practice of method claims occurs when the inventors perform a
`
`
`
`process that meets the claimed invention and demonstrates that the invention is
`
`“suitable for its intended purpose.” Scott v. Finney, 34 F.3d 1058, 1061 (Fed. Cir.
`
`1994) (citations omitted). Before the GuideLiner, standard guide catheters were
`
`limited in their ability to navigate past the ostium of a coronary artery of interest
`
`and to the point of the stenosis. Ex-1001, 1:44-3:11; see Ex-2151, ¶¶4-8; Ex-2215,
`
`¶¶10-19. The intended purpose of the GuideLiner invention was to provide
`
`increased backup support with a rapid exchange configuration that would allow
`
`physicians to more effectively deliver ICDs to the treatment site. E.g. Ex-1001,
`
`3:12-16; Ex-2118, ¶6, 19, 50; Ex-2123, ¶19.
`
`The type and amount of any testing needed to demonstrate suitability for an
`
`invention’s intended purpose depends on the nature of the invention. Scott, 34
`
`F.3d at 1061-62 (discussing cases). When the principles of operation of the
`
`13
`
`

`

`invention are not complex, little or no testing is required. See In re Asahi/America
`
`Inc., 68 F.3d 442, 446-47 (Fed. Cir 1995) (no testing required for pipe coupling
`
`system invention); Mahurkar, 79 F.3d at 1578 (flow and pressure drop testing in
`
`inventor’s kitchen held sufficient for dual lumen catheter invention); Scott, 34 F.3d
`
`at 1063 (inflation/deflation testing sufficient for penile implant invention). Where
`
`testing is required, it need not show utility to perfection or for every difficult case.
`
`Scott, 34 F.3d at 1062-63; DSL Dynamic Scis., Ltd. v. Union Switch & Signal, Inc.,
`
`928 F.2d 1122, 1126 (Fed. Cir. 1991).
`
`With GuideLiner, little to no testing was required to show the invention
`
`worked for its intended purpose. Ex-2123, ¶20-24; see Ex-2116, 110:20-113:24;
`
`Ex-2238, 87:18-89:5; Ex-2237, 182:19-184:22, 36:13-37:10, 57:19-60:8, 95:20-23;
`
`Ex-2241, 85:20-25, 86:21-89:2; see also Ex-1010 (successful testing of mother-
`
`and-child in chronic total occlusion cases). Nevertheless, the corroborated
`
`evidence shows that long before Itou was filed, VSI prototyped and tested
`
`prototypes of the GuideLiner and showed it would work for its intended purpose.
`
`Ex-2118, ¶¶15-61; Ex-2119, ¶¶16-46; Ex-2122, ¶¶5-21; Ex-2039, ¶¶4-12; Ex-
`
`2248, 39:13-23, 49:18-50:3, 57:24-59:7, 61:17-62:19, 65:11-22, 67:6-19, 68:13-17,
`
`69:5-13, 72:21-73:3, 94:18-95:18, 96:20-23; see also Ex-2120, ¶¶6-12; Ex-2121,
`
`¶¶5-6; Exs-22255-2257; Exs-2007-2011; Exs-2013-2014; Exs-2019-2022; Exs-
`
`2024-2036; Exs-2089-2095; Exs-2110-2111; Exs-2113-2114; Exs-2127-2130.
`
`14
`
`

`

`
`
`a.
`
`Initial Prototypes and Tests
`
`In January 2005, at the direction of the inventors, Mr. Erb ordered hypotubes
`
`and used an in-house milling machine to cut them down into the proximal portion
`
`of what would become early GuideLiner prototypes. Ex-2122, ¶¶5-10; Ex-2248,
`
`34:2-14, 49:18-50:3, 55:20-56:8, 57:24-60:4; Ex-2118, ¶¶16, 23-24; Ex-2119, ¶20;
`
`Ex-2110. In addition, Mr. Erb used an in-house lathe to create a reduced diameter
`
`portion and “shoulder” on the distal end of the hypotube so the proximal end of the
`
`distal polymer tubular portion could fit over the hypotube and abut the shoulder for
`
`purposes of attaching the two pieces together while maintaining a substantially
`
`uniform outer diameter. Ex-2122, ¶¶5-10. The earliest prototypes were bonded
`
`together using an adhesive. Soon thereafter VSI moved to a heat-shrink tubing and
`
`a reflow process to assemble the prototypes. Exs-2122, ¶11; Ex-2248, 64:12-21,
`
`65:11-22; 2118, ¶¶16, 23-24; 2119, ¶35.
`
`Significant testing was performed on these early GuideLiner prototypes,
`
`including functionality testing in two-dimensional benchtop heart models to ensure
`
`that the device could navigate the vasculature through and past the end of a
`
`standard guide catheter, and deliver an ICD beyond the GuideLiner’s distal flexible
`
`tip. Ex-2118, ¶¶16-20; Ex-2248, 61:17-62:19, 67:6-68:17, 69:5-13, 72:21-73:3;
`
`Ex-2119, ¶¶16-17, 23, 37, 41; Ex-2122, ¶¶5, 12, 20; Ex-2254. From the beginning,
`
`as verified by testing, the inventors and others at VSI were confident the
`
`15
`
`

`

`GuideLiner could perform this process. Ex-2118, ¶¶15-20, 51; Ex-2119, ¶¶6, 16,
`
`18, 23; Ex-2122, ¶¶12, 20; Ex-2248, 78:17-23.
`
`
`
`b.
`
`April and July 2005 Prototypes and Tests
`
`VSI made and tested more sophisticated prototypes in April and July 2005.
`
`These prototypes and tests involved a distal tubular portion made of extruded
`
`polymer around a PTFE liner with an embedded metal braid, and a proximal
`
`portion made from a metal hypotube that was machined to remove varying
`
`amounts of the side wall of the tube. Ex-2118, ¶¶17-18, 28, 34-38, 42-51; Ex-
`
`2119, ¶¶21-36; Ex-2122, ¶¶12-19; Ex-2120, ¶¶6-12; Ex-2121, ¶¶ 4-6; Ex-2089;
`
`Ex-2011; Ex-2013; Ex-2095; Ex-2113; Ex-2092; Ex-2021; Ex-2020; Ex-2111; Ex-
`
`2114; Ex-2248, 62:7-19, 67:6-19, 68:13-17, 69:5-13, 72:21-73:3, 78:17-23, 95:10-
`
`18. The proximal portion served as a push member for the device, as well as the
`
`opening into the distal tubular portion. Id. VSI outsourced these and other parts
`
`for the April and July 2005 prototypes and did the final assembly and testing in-
`
`house. Id.
`
`Here is the drawing for the GuideLiner distal tubular sections that VSI
`
`ordered from Medical Engineering & Design, Inc. (“MED”) on February 17, 2005,
`
`and received on April 5, 2005:
`
`16
`
`

`

`Distal end
`
`Tubular structure
`
`Reinforcing braid
`
`Ex-2089, 6, 8. This distal section was made up of three different Pebax polymers
`
`having different stiffnesses formed around a PTFE liner:
`
`
`
`