BSC USP 8,142,413
`Exhibit 1029
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`Page 1 of 57
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`Case: 14-1185 CASE PARTICIPANTS ONLY Document: 19 Page: 1 Filed: 01/07/2014Case: 14-1185 Document: 21 Page: 1 Filed: 01/07/2014
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`No. 2014-1185
`________________________________________________________
`
`IN THE UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`________________________________________________________
`
`VASCULAR SOLUTIONS, INC.,
`
`
`Plaintiff-Appellee,
`
`
`
`
`
`v.
`
`BOSTON SCIENTIFIC CORPORATION,
`
`
`Defendant-Appellant.
`________________________________________________________
`
`Appeal from the United States District Court for the District of Minnesota
`in case no.13-CV-1172 (JRT/SER), Judge John R. Tunheim
`________________________________________________________
`
`CORRECTED BRIEF OF DEFENDANT-APPELLANT
`BOSTON SCIENTIFIC CORPORATION
`
`Matthew M. Wolf
`Counsel of Record
`
`Edward Han
`John E. Nilsson
`Seth I. Heller
`ARNOLD & PORTER LLP
`555 Twelfth Street, N.W.
`Washington, D.C. 20004
`Telephone: 202.942.5000
`Facsimile: 202.942.5999
`
`Counsel for Defendant-Appellant
`Boston Scientific Corporation
`
`
`
`January 7, 2014
`
`DM_US:23362604_1
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`Page 2 of 57
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`UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`
`VASCULAR SOLUTIONS v. BOSTON SCIENTIFIC
`2014-1185
`
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`CERTIFICATE OF INTEREST
`
`Counsel for Defendant-Appellant Boston Scientific Corporation certifies the
`following:
`
`1.
`
`The full name of every party or amicus represented by me is:
`Boston Scientific Corporation
`
`The name of the real party in interest (if the party named in the caption is not
`2.
`the real party in interest) represented by me is:
`Same.
`
`
`All parent corporations and any publicly held companies that own 10 percent
`3.
`or more of the stock of the party or amicus curiae represented by me are:
`No publicly held corporation owns more than 10% of the stock of
`Boston Scientific Corporation.
`
`
`The names of all law firms and the partners or associates that appeared for
`4.
`the party or amicus now represented by me in the trial court or agency or are
`expected to appear in this court are:
`Matthew M. Wolf
`Edward Han
`John E. Nilsson
`Seth I. Heller
`Tara Williamson
`Arnold & Porter LLP
`555 Twelfth Street NW
`Washington, DC 20004
`Telephone: (202) 942-5000
`Facsimile: (202) 942-5999
`
`
`DATED: January 7, 2014
`
`
`
`
`
`/s/ Matthew M. Wolf
`Matthew M. Wolf
`
`
`
`
`
`
`DM_US:23362604_1
`
`i
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`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES .................................................................................... iv
`
`STATEMENT OF RELATED CASES ..................................................................... 1
`
`JURISDICTIONAL STATEMENT .......................................................................... 1
`
`STATEMENT OF THE ISSUES............................................................................... 2
`
`STATEMENT OF THE CASE .................................................................................. 3
`
`STATEMENT OF THE FACTS ............................................................................... 5
`
`SUMMARY OF THE ARGUMENT ...................................................................... 16
`
`ARGUMENT ........................................................................................................... 18
`
`I.
`
`II.
`
`STANDARD OF REVIEW ........................................................................... 18
`
`BSC’S GUIDEZILLA PRODUCT DOES NOT INFRINGE THE
`SIDE OPENING CLAIMS OF THE VSI PATENTS ................................... 20
`
`A.
`
`The “Substantially Rigid Portion” Must “Define” The “Rail
`Structure Without A Lumen” .............................................................. 21
`
`B.
`
`The District Court Erred In Construing “Lumen” .............................. 22
`
`III. THE SIDE OPENING CLAIMS WERE OBVIOUS .................................... 28
`
`A.
`
`B.
`
`C.
`
`D.
`
`By 2004, Skived Proximal Lumen Openings Were Typical Of
`Rapid Exchange Catheters .................................................................. 29
`
`The District Court Wrongly Concluded That There Would
`Have Been No Motivation To Combine Prior Art Rapid
`Exchange Catheters With The Device Of The Adams Patent ............ 34
`
`Klein Disclosed A Skived Opening Through Which
`Intravascular Devices Entered The Lumen ......................................... 35
`
`By 2004, Modification Of Adams To Include A Skived
`Proximal Opening Was An Obvious Design Choice .......................... 39
`
`
`
`
`ii
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`E.
`
`F.
`
`There Is No Nexus Between The Claimed Side Openings And
`Any Indicia Of Non-Obviousness ....................................................... 41
`
`VSI Failed To Establish Irreparable Harm Attributable To
`Infringement Of The Side Opening Claims ........................................ 46
`
`CONCLUSION ........................................................................................................ 47
`
`iii
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`Page 5 of 57
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`
`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Abbott Labs. v. Andrx Pharms., Inc.,
`452 F.3d 1331 (Fed. Cir. 2006) .......................................................................... 20
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
`239 F.3d 1343 (Fed. Cir. 2001) .................................................................... 19, 20
`
`Anton/Bauer, Inc. v. PAG, Ltd.,
`329 F.3d 1343 (Fed. Cir. 2003) .......................................................................... 18
`
`Apple Inc. v. Samsung Elecs. Co.,
`695 F.3d 1370 (Fed. Cir. 2012) .................................................................... 18, 46
`
`ArcelorMittal France v. AK Steel Corp.,
`700 F.3d 1314 (Fed. Cir. 2012) .......................................................................... 27
`
`B.F. Goodrich Co. v. Aircraft Braking Sys. Corp.,
`72 F.3d 1577 (Fed. Cir. 1996) ............................................................................ 41
`
`Briggs & Stratton Corp. v. Chongqing RATO Power Co.,
`No. 5:13-cv-0316, 2013 WL 3972391 (N.D.N.Y Jul. 23, 2013)........................ 46
`
`Chef Am. v. Lamb-Weston, Inc.,
`358 F.3d 1371 (Fed. Cir. 2004) .......................................................................... 22
`
`Cybor Corp. v. FAS Techs.,
`138 F.3d 1448 (Fed. Cir. 1998) .......................................................................... 18
`
`Deere & Co. v. Bush Hog,
`703 F.3d 1349 (Fed. Cir. 2012) .......................................................................... 24
`
`Douglas Dynamics, LLC v. Buyers Prods. Co.,
`717 F.3d 1336 (Fed. Cir. 2013) .......................................................................... 24
`
`Galderma Labs., L.P. v. Tolmar, Inc.,
`No. 2013-1034, 2013 WL 6483704 (Fed. Cir. Dec. 11, 2013) .......................... 44
`
`Helmsderfer v. Bobrick Washroom Equip., Inc.,
`527 F.3d 1379 (Fed. Cir. 2008) .......................................................................... 21
`
`
`DM_U
`
`iv
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`
`
`Howes v. Med. Components, Inc.,
`814 F.2d 638 (Fed. Cir. 1987) ................................................................ 17, 23, 24
`
`In re Huai-Hung Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .......................................................................... 42
`
`Intel Corp. v. ULSI Sys. Tech., Inc.,
`995 F.2d 1566 (Fed. Cir. 1993) .......................................................................... 19
`
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) .......................................................................... 43
`
`J.T. Eaton & Co. v. Atl. Paste & Glue Co.,
`106 F.3d 1563 (Fed. Cir. 1997) .......................................................................... 43
`
`K-2 Corp. v. Salomon S.A.,
`191 F.3d 1356 (Fed. Cir. 1999) .......................................................................... 21
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................................................................... 34, 41
`
`Laryngeal Mask Co. v. Ambu AS,
`618 F.3d 1367 (Fed. Cir. 2010) .......................................................................... 25
`
`Lucent Techs., Inc. v. Gateway, Inc.,
`525 F.3d 1200 (Fed. Cir. 2008) .......................................................................... 22
`
`Lund Indus., Inc. v. GO Indus., Inc.,
`938 F.2d 1273 (Fed. Cir. 1991) .......................................................................... 19
`
`N. Am. Container, Inc. v. Plastipak Packaging, Inc.,
`415 F.3d 1335 (Fed. Cir. 2005) .......................................................................... 22
`
`Nat’l Steel Car, Ltd. v. Canadian Pac. Ry., Ltd.,
`357 F.3d 1319 (Fed. Cir. 2004) .......................................................................... 18
`
`New England Braiding Co. v. A.W. Chesterton Co.,
`970 F.2d 878 (Fed. Cir. 1992) ...................................................................... 19, 39
`
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 ..................................................................................................... 27
`
`
`
`
`v
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`
`
`Oatey Co. v. IPS Corp.,
`514 F.3d 1271 (Fed. Cir. 2008) .......................................................................... 22
`
`Ohio Willow Wood Co. v. Alps South, LLC,
`735 F.3d 1333 (Fed. Cir. 2013) .......................................................................... 42
`
`Ormco Corp. v. Algin Tech. Inc.,
`463 F.3d 1299 (Fed. Cir. 2006) .................................................................... 43, 44
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 38
`
`Princeton Biochem. v. Beckman Coultier,
`411 F.3d 1332 (Fed. Cir. 2005) .......................................................................... 34
`
`Randall Mfg. v. REA,
`733 F.3d 1355 (Fed. Cir. 2013) .......................................................................... 41
`
`Richdel, Inc. v. Sunspool Corp.,
`714 F.2d 1573 (Fed.Cir.1983) ............................................................................ 44
`
`Sciele Pharma, Inc. v. Lupin Ltd.,
`684 F.3d 1253 (Fed. Cir. 2012) .......................................................................... 18
`
`Thorner v. Sony Computer Entm’t Am. L.L.C.,
`669 F.3d 1362 (Fed. Cir. 2012) .......................................................................... 25
`
`Tokai Corp. v. Easton Enters., Inc.,
`632 F.3d 1358 (Fed. Cir. 2011) .......................................................................... 43
`
`Western Union Co. v. MoneyGram Payment Sys., Inc.,
`626 F.3d 1361 (Fed. Cir. 2010) .......................................................................... 42
`
`William Wrigley Jr. Co. v. Cadbury Adams USA LLC,
`683 F.3d 1356 (Fed. Cir. 2012) .......................................................................... 45
`
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed Cir. 2010) ........................................................................... 42
`
`STATUTES
`
`28 U.S.C. § 1292(a)(1) ............................................................................................... 1
`
`28 U.S.C. § 1292(c)(1) .............................................................................................. 1
`
`
`
`
`vi
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`28 U.S.C. § 1295(a)(1) ............................................................................................... 1
`
`28 U.S.C. § 1331 ........................................................................................................ 1
`
`28 U.S.C. § 1338 ........................................................................................................ 1
`
`35 U.S.C. § 271 .......................................................................................................... 1
`
`OTHER AUTHORITIES
`
`MCGRAW HILL DICTIONARY OF SCIENTIFIC AND TECHNICAL TERMS (6th ed.
`2003) ................................................................................................................... 27
`
`OXFORD DICTIONARY OF BIOCHEMISTRY AND MOLECULAR BIOLOGY (rev. ed.
`2006) ................................................................................................................... 27
`
`STEDMAN’S MEDICAL DICTIONARY (28th ed. 2006) ................................................ 27
`
`Takahashi, New Method to Increase Backup Support of a 6 French Guiding
`Coronary Catheter, CATHETERIZATION AND CARDIOVASCULAR
`INTERVENTIONS 63:452-456 (2004) .................................................................... 15
`
`
`
`
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`STATEMENT OF RELATED CASES
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`Defendant-Appellant’s counsel is unaware of any related cases within the
`
`meaning of Federal Circuit Rule 47.5.
`
`JURISDICTIONAL STATEMENT
`
`The district court properly exercised jurisdiction over this action pursuant to
`
`28 U.S.C. §§ 1331 and 1338. The plaintiff-appellee’s complaint contains claims
`
`for patent infringement under 35 U.S.C. § 271. (See, e.g., A145 ¶ 41; A147-46 ¶¶
`
`46, 48, 50; A148-50 ¶¶ 57, 58, 60.) The defendant-appellant has filed a
`
`counterclaim for patent infringement under 35 U.S.C. § 271. (A1008-09 ¶¶ 41-45.)
`
`On December 9, 2013, the district court granted-in-part the plaintiff-appellee’s
`
`motion for a preliminary injunction, enjoining the manufacture, use, offer for sale,
`
`or sale by defendant-appellant of the accused device or any other device that
`
`would, under the district court’s analysis, infringe certain claims of the plaintiff-
`
`appellee’s patents. (A1-41.) The district court denied the defendant-appellant’s
`
`request for leave to file a motion for reconsideration on December 23, 2013.
`
`(A1325-29.) The defendant-appellant filed its notice of appeal on December 26,
`
`2013. (A1330-32.) This Court has jurisdiction over the appeal pursuant to 28
`
`U.S.C. §§ 1292(a)(1), 1292(c)(1) and 1295(a)(1).
`
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`DM_US:23362604_1
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`STATEMENT OF THE ISSUES
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`(1) Whether the district court erred in holding that claim language
`
`requiring a substantially rigid portion that “defines a rail structure without a
`
`lumen” is literally infringed by an accused product with a substantially rigid
`
`portion including, in part, a lumen and in holding that the space within a hollow
`
`hypotube is not a “lumen”;
`
`(2) Whether the district court erred in finding that the asserted claims
`
`were not obvious despite undisputed evidence that a person of ordinary skill in the
`
`art would have, by the time of the alleged invention, modified a prior art patent to
`
`include the purportedly inventive feature as a matter of course and despite the
`
`appellees’ failure to show any nexus between any secondary indicia of non-
`
`obviousness and the purportedly inventive feature;
`
`(3) Whether the district court erred in finding irreparable harm, despite
`
`the appellee’s failure to show a specific nexus between its alleged harm and the
`
`appellant’s practice of the purportedly inventive feature; and
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`(4) Whether, in light of the above, the district court abused its discretion
`
`in entering a preliminary injunction.
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`2
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`STATEMENT OF THE CASE
`
`Defendant-Appellant Boston Scientific Corporation (“BSC”) respectfully
`
`appeals from the December 9, 2013 order of the U.S. District Court for the District
`
`of Minnesota preliminarily enjoining BSC from making, using or selling its
`
`Guidezilla guide catheter in the United States (the “Injunction”). Vascular
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`Solutions, Inc. v. Boston Scientific Corp., No. 12-1172 (JRT/SER), Dkt. 76, at 40-
`
`41 (D. Minn. Dec. 9, 2013) (Tunheim, J.). (See A40-41.)
`
`Plaintiff-Appellee Vascular Solutions, Inc. (“VSI”) initiated this action on
`
`May 16, 2013, alleging that BSC’s Guidezilla product infringed at least 43 of
`
`the 56 claims of U.S. Patent Nos. 8,048,032 B2 (the “‘032 patent”), 8,142,413 (the
`
`“‘413 patent”), and 8,292,850 B2 (the “‘850 patent”) (collectively, the “VSI
`
`patents”). (See, e.g., A145 ¶ 41; A146-47 ¶¶ 46, 48, 50; A148-50 ¶¶ 57, 58, 60.)
`
`Less than a month later, VSI moved for a preliminary injunction based on BSC’s
`
`alleged infringement of the 43 claims referenced in its complaint. (A155-56 ¶¶ 1-
`
`3.) VSI’s infringement analysis in its opening brief, however, focused exclusively
`
`on independent claim 1 of the ‘032 patent. (A184.)
`
`In its Opposition to VSI’s preliminary injunction motion, BSC asserted non-
`
`infringement for two independent reasons based on the ordinary meaning of two
`
`different claim terms. BSC also showed that the core of the “invention” claimed in
`
`the VSI patents was disclosed, more than a decade earlier, in BSC’s own patent—
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`3
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`U.S. Patent No. 5,527,292 (the “Adams patent”). (A851-76.) Shortly after filing
`
`its Opposition, BSC filed a counterclaim against VSI for VSI’s infringement of the
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`Adams patent. (A1008-09 ¶¶ 41-45.)
`
`In its Reply brief in support of its motion for a preliminary injunction, VSI
`
`shifted its focus to a handful of dependent claims, tacitly acknowledging that the
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`Adams patent anticipated most of the claims of the VSI patents. Indeed, the
`
`district court observed that VSI had not attempted to defend claim 1 of the ‘032
`
`patent against BSC’s validity challenges and found that the claim was likely
`
`anticipated. (A31, A36) Nevertheless, the district court granted the injunction
`
`based on BSC’s alleged infringement of dependent claims directed to one narrow
`
`limitation—cutting (or “skiving”) the proximal opening of the disclosed tubular
`
`structure at an angle (the “side opening” claims). (A36.) The district court ruled
`
`that VSI was likely to succeed in proving infringement despite the fact that every
`
`claim requires a substantially rigid portion that “defines a rail structure without a
`
`lumen,” and despite the fact that the “substantially rigid portion” of the Guidezilla
`
`includes both a lumen at one end and also a hollow, tubular push rod. (Id.)
`
`Notwithstanding its assessment that independent claim 1 of the ‘032 was
`
`likely anticipated by Adams, the district court concluded that the side opening
`
`claims were likely to be found valid. In reaching this conclusion, the district court
`
`disregarded undisputed expert evidence that, by 2004 (when the VSI patents were
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`purportedly conceived), a person of skill in the art would have known to modify
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`Adams to include a skived proximal opening, a standard feature on such devices by
`
`that time. (A818-22.) The district court also relied heavily on supposed objective
`
`indicia of non-obviousness such as commercial success and praise of the invention
`
`by others. (A35.) It did so, however, without any evidence of a nexus between
`
`those objective indicia and the purportedly inventive side opening elements of the
`
`dependent claims. Similarly, the district court ruled that VSI had established
`
`irreparable harm, (A36-38), despite the absence of any evidence of a specific nexus
`
`between the alleged harm to VSI and BSC’s alleged practice of the side opening
`
`claims.
`
`STATEMENT OF THE FACTS
`
`This case relates to devices used in intravascular interventions, in which
`
`physicians deploy thin, flexible treatment devices, such as balloon catheters and
`
`stents, to treat blockages in coronary (or other) arteries. (See A204-05 ¶ 11.) The
`
`physician introduces the treatment device into the patient’s vascular system
`
`through the groin or wrist and advances it to the site of a blockage. (See A203-04
`
`¶ 9.) There, the physician typically performs some procedure—such as the
`
`inflation of a balloon or the placement of a stent—to relieve the blockage and
`
`restore blood flow. (See A203 ¶ 8.) Often, to create a passage for such treatment
`
`devices, physicians insert a wider “guide catheter” earlier in the procedure. (See
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`A206 ¶ 12.) In coronary interventions, this guide catheter typically runs from the
`
`groin or wrist to one of the coronary ostia (two openings in the aorta that open into
`
`the coronary arteries), but is too wide to fit within either coronary ostium. (See
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`A208 ¶ 15.) The patents at issue in this appeal concern variations on guide
`
`catheter technology. (See A693-94.)
`
`A.
`
`The Adams Patent
`
`In 1994, BSC’s predecessor, Scimed Life Systems, Inc. (“Scimed”), applied
`
`for a patent on a new guide catheter extension technology developed by two
`
`Scimed engineers, Dan Adams and Scott Thome. The resulting patent, the Adams
`
`patent, was awarded in 1996 and assigned to Scimed. (A851-76.)
`
`The inventors pointed out the need for technology that would permit more
`
`effective deployment and replacement of treatment devices. Specifically, the
`
`inventors noted that, when traditional guide catheter technology was used, there
`
`was a danger that the guide catheter’s distal end1 would shift away from the
`
`coronary ostium (into which it was too wide to fit), thereby “making placement of
`
`the coronary treatment device into the coronary artery requiring treatment more
`
`difficult.” (A870 at 16:44-53.) They invented a device that could extend beyond
`
`
`1 In patents and publications relating to interventional devices such as balloon
`catheters and guide catheters, “distal” typically means further from the operator,
`and “proximal” typically means closer to the operator.
`
`
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`the distal end of the guide catheter past the ostium, thereby securing the guide
`
`catheter in position and facilitating delivery of treatment devices:
`
`The construction of the guide catheter (diameter and rigidity) does not
`permit the guide catheter to advance beyond the ostium into the artery
`requiring treatment. The distal extension however … may be
`advanced into and through the coronary arteries to the lesion or
`obstruction to facilitate original placement of angioplasty devices by
`serving to anchor the guide catheter at the coronary ostium of the
`vessel requiring treatment for placement of an angioplasty device or
`other coronary treatment device into the vessel….
`
`(A864-65 at 4:58-5:2; see also A867 at 9:12-25; A870-71 at 16:54-17:2.)
`
`The main structural components of the Adams device are (1) an elongated
`
`flexible tube and (2) a push rod:
`
`An intravascular device having an elongated flexible tube sized for
`insertion into a coronary vessel beyond a distal end of a guide
`catheter. In use, the flexible tube has its proximal end within a guide
`catheter and has its distal end extending to a treatment site in a
`coronary artery. The device also including a push rod attached to a
`proximal end of the flexible tube to facilitate placement of the flexible
`tube within the coronary artery requiring treatment.
`
`(A851 at Abstract; see also A865 at 5:38-40 (“The guide catheter extension (distal
`
`extension) 14 comprises an elongated flexible tube 32 defining a second guide
`
`catheter lumen 33 and a shaft 19 or a push rod”).)
`
`In Adams’s preferred embodiments, the elongated flexible tube portion of
`
`the invention is about 10 inches long. (A865 at 5:61-63) (“The length of the
`
`flexible tube 32 is preferably approximately 6 to 10 inches”). Its outer diameter is
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`sized so as to fit within the guide catheter. (Id. at 5:64-6:1) (“The outer diameter
`
`
`
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`7
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`of the elongated flexible tube 32 is smaller than the first guide catheter lumen 27
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`defined by the guide catheter 12 so that it may be slidably disposed therethrough
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`…”). Its inner diameter, though, is large enough to accommodate intravascular
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`devices, such as balloon catheters. (A863 at 2:62-64 (“The inner diameter of the
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`flexible tube is larger than the outer diameter of a typical angioplasty balloon
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`catheter or other coronary treatment device”); see also id. at 2:50-51.) The tube
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`may be made from a metal coil surrounded by a plastic material. (A865 at 5:47-52
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`(“Preferably, the elongated flexible tube 32 is formed of a coil spring 40 made
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`from stainless steel or a platinum alloy…. An outer coating of plastic is then
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`added around the coil spring … to define the tube 32”).) Adams also taught that
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`radiopaque markers of a platinum alloy may be placed on the proximal and distal
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`ends of the tube to enhance imaging of its position in the body. (Id. at 6:42-50.)
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`In Adams’s preferred embodiments, the push rod portion of the invention
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`takes the form of an elongated wire. (Id. at 6:14-18) (“the shaft 19 or push rod is
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`defined by an elongated wire 34”). At its proximal end, this push rod extends out
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`of the patient allowing the physician to adjust the position of the tube in the
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`coronary artery by manipulating the push rod. (Id. at 6:18-23.) Adams also
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`disclosed a control knob attached to the proximal end of the push rod for
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`manipulating the tube. (A869 at 14:6-7, A870 at 15:12-15.)
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`B. VSI’s GuideLiner Product
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`VSI’s GuideLiner product, introduced in 2009, incorporates the central
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`insights and advances described and claimed in the Adams patent. In its opening
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`brief below, VSI depicted the main components of the GuideLiner—(1) a flexible
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`tube with a lumen and (2) a substantially rigid shaft or push rod, without a lumen:
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`(A170) (“The distal end (the left side above) of the GuideLiner is a relatively
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`flexible tube …”); (A171) (“a substantially rigid push rod … extends for the
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`remainder of the GuideLiner”).
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`As shown in GuideLiner’s Instructions for Use (“IFU”), the length of the
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`tube is 25cm—approximately 10 inches:
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`(A495.) The GuideLiner comes in several diameters, each designed to be inserted
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`through a guide catheter. (Id.) (“The GuideLiner catheter is delivered through a
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`guide catheter …”). The inner diameter of the GuideLiner is sufficient to
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`accommodate interventional devices. (Id.) (“If performing an interventional
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`procedure, … advance the [interventional] device through the guide catheter and
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`GuideLiner catheter into the desired vascular space”). The GuideLiner’s flexible
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`tube includes a coil reinforcement and more or less flexible polymers:
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`(A170) (“The distal end has three zones: a very flexible yellow tip, a less flexible
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`yellow coil reinforced portion, and a further less flexible blue portion made from a
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`stiffer polymer”). There are two radiopaque markers on the GuideLiner tube.
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`(A495) (“The GuideLiner catheter has two platinum-iridium marker bands, which
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`enable visibility while using standard fluoroscopic methods”).
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`The GuideLiner’s shaft or push rod is made of stainless steel. (Id.) (“The
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`150cm device has a stainless steel shaft …”). The GuideLiner’s push rod is used
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`to position the guide extension portion. (A794 at 76-77) (“We use the push rod to
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`push the guide extension portion through the guide catheter and out the distal
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`end.”) The proximal end of the push rod is embedded into a proximal tab that
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`prevents the GuideLiner from being pushed too far into the guide catheter. (A171.)
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`VSI describes the function of the GuideLiner as follows: “By extending the
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`GuideLiner’s flexible portion past the end of the guide catheter and into the
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`coronary artery to be treated, the GuideLiner provides effective deep seating”—
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`i.e., extension past the ostium—which prevents the guide catheter from “back[ing]
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`out of the coronary ostium,” thereby “providing a secure passageway to deliver
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`devices….” (A168, A171.)
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`In sum, BSC’s Adams patent discloses virtually the entire structure of VSI’s
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`GuideLiner, as well as its principal function. Notwithstanding the district court’s
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`odd statement that Adams is “not at issue in this case,” (A37, n.10), it is actually at
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`the very heart of the parties’ dispute. Not only has BSC identified Adams as
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`invalidating prior art, BSC has also filed a counterclaim for infringement of the
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`Adams patent by VSI’s GuideLiner. (A1008-09 ¶¶ 41-45.)
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`C.
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`The VSI Patents
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`VSI’s ‘032 patent issued in 2011, based on a patent application filed in 2006.
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`(A52-72.) Claim 1 of the ‘032 patent discloses a device comprising (1) “a flexible
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`tip portion defining a tubular structure …” and (2) a substantially rigid portion
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`proximal of and operably connected to, and more rigid along a longitudinal axis
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`than, the flexible tip portion and defining a rail structure without a lumen….”
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`(A70 at 10:29, 10:38-41.) The tubular structure has “a cross-sectional outer
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`diameter sized to be insertable through the cross-sectional inner diameter of the
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`continuous lumen of the guide catheter ...” and “a cross-sectional inner diameter
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`though which interventional cardiology devices are insertable….” (Id. at 10:32-
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`37.) “[W]hen at least a distal portion of the distal portion of the flexible tip portion
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`is extended distally of the distal end of the guide catheter, at least a portion of the
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`proximal portion of the substantially rigid portion extends proximally through the
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`hemostatic valve [outside the patient’s body]….” (Id. at 10:48-52.)
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`Dependent claim 2 of the ‘032 patent describes a function of the device:
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`[T]he tubular structure includes a distal portion adapted to adapted to
`be extended beyond the distal end of the guide catheter while a
`proximal portion remains within the lumen of the guide catheter, such
`that the device assists in resisting axial and shear forces exerted by the
`interventional cardiology device passed through and beyond the
`coaxial lumen that would otherwise tend to dislodge the guide catheter
`from the branch artery.
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`(Id. at 10:55-62.