BSC USP 8,048,032
`Exhibit 1034
`
`Page 1 of 40
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`Case: 14-1185 CASE PARTICIPANTS ONLY Document: 36 Page: 1 Filed: 02/03/2014Case: 14-1185 Document: 41 Page: 1 Filed: 02/03/2014
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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
`________________________________________________________
`
`REPLY 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
`
`February 3, 2014
`
`DM_US:23362604_1
`
`

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`Page 2 of 40
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`UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`
`VASCULAR SOLUTIONS, INC. v. BOSTON SCIENTIFIC CORPORATION
`No. 2014-1185
`
`
`
`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: February 3, 2014
`
`
`
`
`
`/s/ Matthew M. Wolf
`Matthew M. Wolf
`
`
`
`
`
`
`DM_US:23362604_1
`
`i
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`

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`Page 3 of 40
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`
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION ..................................................................................................... 1
`
`ARGUMENT ............................................................................................................. 2
`
`I.
`
`THE DISTRICT COURT ERRED IN FINDING A LIKELIHOOD
`OF SUCCESS .................................................................................................. 3
`
`A.
`
`The District Court Erred In Construing “Substantially Rigid
`Portion Defining A Rail Structure Without A Lumen” ........................ 3
`
`1.
`
`2.
`
`The District Court Improperly Redefined
`“Defining” To Mean “Including” ..................................... 3
`
`The District Court Improperly Narrowed The
`Ordinary Meaning Of “Lumen” ....................................... 6
`
`B.
`
`The District Court Erred In Concluding That BSC Failed To
`Raise A Substantial Question Of Validity .......................................... 13
`
`1.
`
`2.
`
`3.
`
`VSI Continues To Urge An Improper Standard At
`The Preliminary Injunction Stage ................................... 13
`
`The Evidence Shows A Substantial Question Of
`Invalidity ......................................................................... 14
`
`The District Court Erred In Concluding That
`Objective Evidence Supported A Finding Of Non-
`Obviousness .................................................................... 24
`
`II.
`
`VSI FAILED TO MEET THE REQUIREMENTS NECESSARY TO
`SHOW IRREPARABLE HARM .................................................................. 29
`
`CONCLUSION ........................................................................................................ 30
`
`
`
`
`
`
`
`
`ii
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`
`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Apple Inc. v. Samsung Elecs. Co.,
`695 F.3d 1370 (Fed. Cir. 2012) .......................................................................... 29
`
`Aria Diagnostics, Inc. v. Sequenom, Inc.,
`726 F.3d 1296 (Fed. Cir. 2013) ............................................................................ 2
`
`Ball Aerosol & Specialty Container, Inc. v. Limited Brands, Inc.,
`555 F.3d 984 (Fed. Cir. 2009) ............................................................................ 21
`
`Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc.,
`334 F.3d 1294 (Fed. Cir. 2003) ............................................................................ 7
`
`Dippin’ Dots, Inc. v. Mosey,
`476 F.3d 1337 (Fed. Cir. 2007) ............................................................................ 5
`
`Ecolochem, Inc. v. S. Cal. Edison Co.,
`227 F.3d 1361 (Fed. Cir. 2000) .......................................................................... 27
`
`Festo Corp. v. Shoketsu,
`535 U.S. 722 (2002) ............................................................................................ 12
`
`Friskit, Inc. v. RealNetworks, Inc.,
`306 F.Appx. 610 (Fed. Cir. 2009) ...................................................................... 25
`
`Golden Bridge Tech., Inc. v. Nokia, Inc.,
`527 F.3d 1318 (Fed. Cir. 2008) .......................................................................... 20
`
`Graver Tank & Mfg. Co. v. Line Air Prods. Co.,
`339 U.S. 605 (1950) ............................................................................................ 12
`
`Helmsderfer v. Bobrick Washroom Equipment, Inc.,
`527 F.3d 1379 (Fed. Cir. 2008) ............................................................................ 7
`
`Howes v. Med. Components, Inc.,
`814 F.2d 638 (Fed. Cir. 1987) .............................................................................. 8
`
`J.T. Eaton & Co. v. Atl. Paste & Glue Co.,
`106 F.3d 1563 (Fed. Cir. 1997) .......................................................................... 28
`
`
`DM_U
`
`iii
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`
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................................................................... 18, 23
`
`Lamex Foods, Inc. v. Audeliz Lebron Corp.,
`646 F.3d 100 (1st Cir. 2011) ............................................................................... 23
`
`Lucent Techs., Inc. v. Gateway, Inc.,
`525 F.3d 1200 (Fed. Cir. 2008) .......................................................................... 11
`
`Medrad, Inc. v. MRI Devices Corp.,
`401 F.3d 1313 (Fed. Cir. 2005) ............................................................................ 8
`
`Monsanto Co. v. Bayer, Bioscience N.V.,
`363 F.3d 1235 (Fed. Cir. 2004) ............................................................................ 8
`
`Myspace v. GraphOn Corp.,
`672 F.3d 1250 (Fed. Cir. 2012) .......................................................................... 10
`
`N. Am. Container, Inc. v. Plastipak Packaging, Inc.,
`415 F.3d 1335 (Fed. Cir. 2005) .......................................................................... 10
`
`New England Braiding Co., Inc. v. A.W. Chesterton Co.,
`970 F.2d 878 (Fed. Cir. 1992) ............................................................ 2, 14, 19, 20
`
`Norian Corp. v. Stryker Corp.,
`432 F.3d 1356 (Fed. Cir. 2005) .......................................................................... 11
`
`Novo Nordisk A/S v. Eli Lilly & Co.,
`185 F.3d 884, 1999 WL 96413 (Fed. Cir. 1999) ................................................ 13
`
`Ormco Corp. v. Algin Tech., Inc.,
`463 F.3d 1299 (Fed. Cir. 2006) .......................................................................... 28
`
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) .......................................................................... 22
`
`Perfect Web Techs. Inc., v. Info USA, Inc.,
`587 F.3d 1324 (Fed. Cir. 2009) .......................................................................... 21
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ................................................ 7, 10, 19
`
`
`
`
`iv
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`
`
`Rentrop v. Spectranetics Corp.,
`550 F.3d 1112 (Fed. Cir. 2008) .......................................................................... 20
`
`Scanner Techs. Corp. v. ICOS Vision Sys.,
`528 F. 3d 1365 (Fed. Cir. 2008) ......................................................................... 23
`
`Teva Pharms. USA, Inc., v. Sandoz, Inc.,
`723 F.3d 1363 (Fed. Cir. 2013) .......................................................................... 28
`
`Thorner v. Sony Computer Entm’t Am. LLC,
`669 F.3d 1362 (Fed. Cir. 2012) ........................................................................ 5, 7
`
`Titan Tire Corp. v. Case New Holland, Inc.,
`566 F.3d 1372 (Fed. Cir. 2009) .................................................................... 13, 14
`
`Univ. of Texas v. Camenisch,
`451 U.S. 390 (1981) ............................................................................................ 13
`
`Voda v. Cordis Corp.,
`536 F.3d 1311 (Fed. Cir. 2008) ............................................................................ 7
`
`Walters v. National Ass’n of Radiation Survivors,
`473 U.S. 305 (1985) ............................................................................................ 20
`
`We Care, Inc. v. Ultra-Mark Int’l Corp.,
`930 F.2d 1567 (Fed. Cir. 1991) ............................................................................ 2
`
`Yamaha Corp. v. ESS Technology, Inc.,
`82 F.3d 435, 1996 WL 146499 (Fed. Cir. 1996) .............................................. 5, 6
`
`OTHER AUTHORITIES
`
`Fed. R. App. P. 10(a) ................................................................................................. 4
`
`
`
`
`v
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`BSC
`
`VSI
`
`ABBREVIATIONS
`
`Defendant-Appellant Boston Scientific
`Corporation
`
`Plaintiff-Appellee Vascular Solutions, Inc.
`
`‘032 patent
`
`U.S. Patent No. 8,048,032
`
`‘413 patent
`
`U.S. Patent No. 8,142, 413
`
`‘850 patent
`
`U.S. Patent No. 8,292,850
`
`VSI patents
`
`The ‘032 Patent, ‘413 Patent, and ‘850 Patent
`
`Adams
`
`Verbeek
`
`Steinke
`
`Alt
`
`Klein
`
`PTO
`
`Blue Brief
`
`Red Brief
`
`U.S. Patent No. 5,527,292
`
`U.S. Patent No. 5,690,613
`
`U.S. Patent No. 5,328,472
`
`U.S. Patent No. 5,102,403
`
`U.S. Patent No. 7,776,141
`
`United States Patent and Trademark Office
`
`Opening Brief of Plaintiff-Appellee Boston
`Scientific Corporation (filed January 7, 2014)
`
`Responsive Brief of Plaintiff-Appellee
`Vascular Solutions, Inc. (filed January 27,
`2014)
`
`A______
`
`Page in Joint Appendix
`
`vi
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`

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`
`
`A____x:yy-zz
`
`Page in Joint Appendix citing patent at column
`x, lines yy-zz
`
`All emphasis in this brief has been added unless otherwise noted.
`
`
`
`NOTE:
`
`
`
`
`
`
`
`
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`vii
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`
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`INTRODUCTION
`
`In finding a “likelihood of success,” the district court erred as a matter of
`
`law by misinterpreting the phrase “substantially rigid portion defining a rail
`
`structure without a lumen” and, consequently, concluding that VSI was likely to
`
`prove infringement. The court further erred in: (1) failing to find that the prior art
`
`disclosed the elements of the side opening claims; (2) imposing an improper
`
`standard to determine that one of ordinary skill in the art would not have been
`
`“motivated to combine” Adams with this prior art; (3) giving any weight to VSI’s
`
`supposed objective indicia of non-obviousness; and (4) finding that VSI had made
`
`the necessary showing to establish “irreparable harm” absent a preliminary
`
`injunction.
`
`Recognizing these errors, VSI argues that they are effectively immune from
`
`review because arguments made and evidence cited by BSC at the preliminary
`
`injunction hearing are not “part of the record,” which (according to VSI) consists
`
`only of the parties’ briefs and supporting papers. Indeed, VSI takes the remarkable
`
`position that the prosecution history of the asserted patents, and references
`
`discussed therein, are not part of the “record.” VSI’s insistence on a “fixed record”
`
`is an attempt to exploit its tactic of shifting the focus of its argument, in its reply
`
`brief below, to a few dependent claims addressing a narrow limitation not
`
`
`DM_US:23362604_1
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`discussed in its opening preliminary injunction brief. As explained herein, all of
`
`BSC’s arguments and evidence are properly before this Court and show that the
`
`district court’s order should be reversed.
`
`ARGUMENT
`
`As shown in BSC’s opening brief, a preliminary injunction is “extraordinary
`
`relief.” New England Braiding Co., Inc. v. A.W. Chesterton Co., 970 F.2d 878,
`
`882-83 (Fed. Cir. 1992) (citing Nutrition 21 v. United States, 930 F.2d 867, 869
`
`(Fed. Cir. 1991)). Although VSI asserts that “BSC severely understates its burden
`
`when it argues that it ‘need only show that one of the factual premises upon which
`
`the district court relied was clearly erroneous’” (Red Brief 30-31), that is precisely
`
`what this Court advised in New England Braiding. Id. at 882; see also Aria
`
`Diagnostics, Inc. v. Sequenom, Inc., 726 F.3d 1296, 1300 (Fed. Cir. 2013). A
`
`single error of law, which this Court reviews without deference, also suffices. See
`
`We Care, Inc. v. Ultra-Mark Int’l Corp., 930 F.2d 1567, 1570 (Fed. Cir. 1991).
`
`Here, VSI persuaded the district court to make several legal and factual errors,
`
`each of which compels reversal.
`
`
`
`
`
`
`
`
`2
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`

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`
`
`I.
`
`THE DISTRICT COURT ERRED IN FINDING A
`LIKELIHOOD OF SUCCESS
`
`A. The District Court Erred In Construing
`“Substantially Rigid Portion Defining A Rail
`Structure Without A Lumen”
`
`Despite acknowledging the settled rule that “words in patent claims are
`
`given their ordinary meaning in the usage of the field of the invention, unless the
`
`text of the patent makes clear that a word was used with a special meaning” (A26
`
`(quoting Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299 (Fed. Cir.
`
`1999))), the district court departed from that rule in two ways. It construed
`
`“defining” in “substantially rigid portion defining a rail structure without a lumen”
`
`more broadly than the term’s ordinary meaning; and it defined “lumen” in the same
`
`phrase more narrowly than the term’s ordinary meaning. Both constructions
`
`violated this Court’s precedent.
`
`1.
`
`The District Court Improperly Redefined
`“Defining” To Mean “Including”
`
`As shown in BSC’s opening brief, all of the asserted claims require a
`
`“substantially rigid portion defining a rail structure without a lumen.” (Blue
`
`Brief 20-21.) VSI argued below that one piece of the accused “substantially rigid
`
`portion” was the rail structure; and another (the “collar”) possesses a lumen:
`
`
`
`
`3
`
`

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`
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`Id. VSI’s brief leaves the crucial question conspicuously unanswered—what does
`
`“defining” mean in the phrase “substantially rigid portion defining a rail structure
`
`without a lumen” other than that the two pieces are coextensive?
`
`Seeking to avoid the issue, VSI claims it is “new.” (Red Brief 33.) It is not.
`
`At the preliminary injunction hearing, BSC emphasized the fundamental dispute as
`
`to the meaning of “defining.” (A2159.)1 Fully on notice of BSC’s position, VSI
`
`argued that “[t]he claim language doesn’t require that everything that is rigid not
`
`have a lumen.” (A2119.) Citing the word “comprising” in the claims’ preamble,
`
`
`1 VSI’s arguments that the “record” in this appeal does not include arguments or
`evidence presented after its reply brief are without merit (see infra Part I.B.2.c).
`Moreover, that VSI seeks to exclude arguments made at the hearing (Red Brief 56-
`58) even though Rule 10(a) of the Federal Rules of Appellate Procedure requires
`the record on appeal to include “the transcript of proceedings, if any[.]” Fed. R.
`App. P. 10(a).
`
`
`
`
`4
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`

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`VSI urged the construction “includes but not limited to,” so that “there can be other
`
`structure that is rigid, as long as you find a substantially rigid portion defining a
`
`rail structure without a lumen.” (A2119.) As this Court has instructed, however,
`
`“‘[c]omprising’ is not a weasel word with which to abrogate claim limitations.”
`
`Dippin’ Dots, Inc. v. Mosey, 476 F.3d 1337, 1343 (Fed. Cir. 2007) (quoting
`
`Spectrum Int’l v. Sterilite Corp., 164 F.3d 1372, 1380 (Fed. Cir. 1998)). The claim
`
`may recite “the device comprising,” but it further requires “a substantially rigid
`
`portion … defining a rail structure without a lumen.” The use of both
`
`“comprising” and “defining” in the claims demonstrates VSI’s recognition that the
`
`terms are different. Yet it adopted language requiring that the “substantially rigid
`
`portion” “define” the “rail structure without a lumen.” As this Court has
`
`cautioned, “we do not redefine words. Only the patentee can do that.” Thorner v.
`
`Sony Computer Entm’t Am. LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012); see also
`
`Yamaha Corp. v. ESS Technology, Inc., 82 F.3d 435, 1996 WL 146499,*3 (Fed.
`
`Cir. 1996) (unpublished) (“Unless there exists a strong indication to the contrary,
`
`[the patentee] must live with its choice of claim language and the inferences to be
`
`drawn therefrom.”).
`
`VSI complains that if “defining” actually means “defining” (as opposed to
`
`merely “including”), dependent claims 13 and 18 of the ‘032 patent and claim 4 of
`
`the ‘413 patent would be read “completely out of the patent[s].” (A2120; Red Brief
`
`
`
`
`5
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`2
`32-33.)
`
` Claim 13 merely states, however, that the “substantially rigid portion” of
`
`independent claim 11 “includes a partially cylindrical portion,” which is not a
`
`3
`
`lumen.
`
` The “full circumference portion” of claim 18 of the ‘032 and “cylindrical
`
`portion” of claim 4 of the ‘413 patent only arguably contain lumens, but need not,
`
`depending on whether they immediately transition to the claimed “hemicylindrical
`
`portion” (in the case of claim 18) or “partially cylindrical portion” (in the case of
`
`claim 4). This is certainly not a “strong indication” that “defining” in the
`
`independent claims means something broader than its ordinary meaning—
`
`especially when the “defining” language was added during prosecution.
`
`2.
`
`The District Court Improperly Narrowed The
`Ordinary Meaning Of “Lumen”
`
`VSI also convinced the court to interpret “lumen” more narrowly than its
`
`ordinary meaning. In so doing, VSI—not BSC—“follow[-ed] a methodology
`
`rejected by this Court.” (Red Brief 26.) Although “the specification often
`
`
`2 In its preliminary injunction papers, VSI made this claim differentiation
`argument only as to dependent claim 13 but, at the hearing, expanded it to
`dependent claims 18 and 4. (A2120.) Apparently, the record before this Court
`includes arguments made originally at the hearing only when it suits VSI.
`
`3 VSI argues that the language “extending for a distance along the side thereof”
`in the phrase proves that it need not extend along the entire distance of the side
`opening and, thus, that “defining” means something less than “defining” in the VSI
`patents. (Red Brief 32-33.) At best, this syntactical inference is equivocal; it does
`not constitute “a strong indication” that the word has been redefined. See Yamaha,
`1996 WL 146499 at *3.
`
`
`
`
`6
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`
`describes very specific embodiments of the invention,” this Court has “repeatedly
`
`warned against confining the claims to those embodiments.” Phillips v. AWH
`
`Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005) (en banc). Instead, a court must start
`
`with the plain language of the claim, allowing it its full range of ordinary meaning
`
`to one of skill in the art. Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 334 F.3d
`
`1294, 1298 (Fed. Cir. 2003) (“[Absent] an express intent to impart a novel
`
`meaning to the claim terms, the words are presumed to take on the ordinary and
`
`customary meanings attributed to them by those of ordinary skill in the art”).
`
`Courts must apply that meaning unless the intrinsic evidence shows that the patents
`
`use the term in a narrower way or otherwise disavow some portion of the full scope
`
`of the term’s ordinary meaning. Thorner, 669 F.3d at 1366-67; see also Voda v.
`
`Cordis Corp., 536 F.3d 1311, 1320 (Fed. Cir. 2008). The VSI patents do not
`
`redefine “lumen” or otherwise disavow the term’s full scope.
`
`As BSC has shown, the general definition of “lumen” is a “space within a
`
`tube.” (Blue Brief 27.) Some lumens are closed at one or both ends, even in the
`
`context of medical devices, like the bores of syringe needles. (Blue Brief 26-27;
`
`4
`A2203-06; A2216; A2148-49)
`
`
`
`
`4 This Court has advised—even after Phillips—that “[w]hen the intrinsic
`evidence is silent as to the plain meaning of a term, it is entirely appropriate for the
`district court to look to dictionaries or other extrinsic sources for context – to aid in
`(continued . . . )
`
`
`
`
`7
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`Howes v. Med. Components, Inc., 814 F.2d 638, 644 (Fed. Cir. 1987), which
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`offers this Court’s own guidance on the full scope of the ordinary meaning of
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`“lumen” in the art of catheter design, confirms that a “lumen” may be “open” (or
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`5
`“unobstructed), “blocked” or “obstructed.” (Blue Brief 23-24.)
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` The authority
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`cited by VSI in response is inapposite. In Medrad, Inc. v. MRI Devices Corp., 401
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`F.3d 1313, 1318 (Fed. Cir. 2005), the Court merely observed that “[a] particular
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`term used in one patent need not have the same meaning when used in an entirely
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`separate patent, particularly one involving different technology” because “the
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`generally understood meaning of particular terms may vary from art to art” and
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`that analyzing a term used in one patent to illuminate the meaning of the same term
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`in another would be improper where “[a] patentee … define[s] a particular term in
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`a particular way” in the patent in question. Id.; see Monsanto Co. v. Bayer,
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`Bioscience N.V., 363 F.3d 1235, 1244 (Fed. Cir. 2004) (“similar terms can have
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`different meanings in different patents depending on the specifics of each
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`( . . . continued)
`arriving at the plain meaning of a claim term.” Helmsderfer v. Bobrick Washroom
`Equipment, Inc., 527 F.3d 1379, 1382 (Fed. Cir. 2008).
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`5 Although, the Howes Court was formally construing the terms “joined” and
`“freely” (see Red Brief 41), it went on to explain the customary meaning of
`“lumen.” 814 F.2d at 644. The district court had rejected a construction of
`“extending freely” (describing a lumen in a catheter) as “unobstructed” because it
`believed that a lumen was inherently “unobstructed.” The Howes Court disagreed:
`“[w]ell-known prior art catheters contain fluid passages which are blocked at their
`ends with balloons or are obstructed by wires or electrical devices.” Id.
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`patent”). Because there is no definition of “lumen” whatsoever in the VSI patents,
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`and Howes examined the meaning of “lumen” in precisely the same art, it is
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`appropriate to consider Howes’ guidance.6
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`The district court agreed with Howes “that a lumen may be obstructed or
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`unobstructed.” (A29.) It nonetheless concluded that “the general definition of
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`lumen” should not apply because, it reasoned, “the intrinsic evidence in this case
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`suggest[s] that a lumen, as used in this patent, is unobstructed.” Id. In so
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`concluding, the court relied on the same “intrinsic evidence” that VSI identifies
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`here — the “[c]onsistent use of the term ‘lumen’” as an “open passage”
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`“throughout the claims and specification.” (Red Brief 37.) As BSC explained in its
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`opening brief, however, consistent use of a term—even with respect to all
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`disclosed embodiments—is not enough to narrow its ordinary meaning absent clear
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`evidence of intent to redefine the term. (Blue Brief 25.)
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`VSI’s reliance on examples from the specification is especially inappropriate
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`because the “without a lumen” limitation was added during prosecution—long
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`after the specification was drafted. The applicants faced rejection in view of the
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`Solar reference, which disclosed a rigid proximal “advancement member” formed
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`6 VSI appears to suggest that because Howes is “a 16-year old decision” is
`somehow less pertinent. (Red Brief 41.) There is no evidence (or even reason) to
`suggest that the meaning of “lumen” changed in the art of catheter design in the
`seven years between Howes and the VSI patents’ application.
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`of a “[s]tiff yet flexible stainless steel hypotube shaft” (A2148-49)—i.e., a
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`“substantially rigid proximal portion” formed of “hollow hypotubing.” (A1476;
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`A2418 ¶ 0025.) To allow the claims, the Examiner required that the “substantially
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`rigid portion defin[e] a rail structure without a lumen,” an amendment that VSI
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`accepted without argument or alteration. (A765-67.) Thus, even if the inventors
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`originally believed their invention encompassed a “substantially rigid portion”
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`formed of a closed tube, they gave up that claim scope during prosecution in order
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`to avoid the prior art. Myspace v. GraphOn Corp., 672 F.3d 1250, 1256 (Fed. Cir.
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`2012) (“An inventor is entitled to claim in a patent what he has invented, but no
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`more. He can, however, claim less, to avoid prior art …”); Phillips, 415 F.3d at
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`1317 (“The prosecution history can often inform the meaning of the claim
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`language by demonstrating … whether the inventor limited the invention in the
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`course of prosecution, making the claim scope narrower than it would otherwise
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`be”). This decision in the prosecution is also fatal to VSI’s argument that BSC’s
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`construction would exclude supposedly “preferred embodiments” disclosed in the
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`specification in which the proximal portion is formed of a hypotube. (Red Brief
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`37.) This Court has made clear that “limitations may be construed to exclude a
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`preferred embodiment if the prosecution history compels such a result.” N. Am.
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`Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 1346 (Fed. Cir.
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`2005).7
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`VSI’s argument that the Examiner merely sought to distinguish substantially
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`rigid proximal portions that allowed for passage of medical devices (Red Brief 39)
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`also fails because, as noted in BSC’s opening brief (Blue Brief 26 n.5), nothing in
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`Solar suggests that its hypotube was anything more than a stiffening element, like
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`Guidezilla’s. In any case, VSI was free to press for an alternative limitation that
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`excluded only lumens open for the passage of medical devices or a “continuous
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`lumen,” a phrase it uses repeatedly elsewhere in the patents. (Blue Brief 24, 25.)
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`VSI failed to do so, instead disavowing substantially rigid proximal portions
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`possessing any lumen whatsoever, no matter how narrow. See Norian Corp. v.
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`Stryker Corp., 432 F.3d 1356, 1361-62 (Fed. Cir. 2005) (“[Where patentees have
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`surrendered more claim scope than necessary], we have held the patentees to the
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`scope of what they ultimately claim, and we have not allowed them to assert that
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`claims should be interpreted as if they had surrendered only what they had to.”)
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`(citation omitted).
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`7 Indeed, where (as here), the ordinary meaning of the added claim language is
`clear, the Court has “construed the claims to exclude all disclosed embodiments.”
`Lucent Techs., Inc. v. Gateway, Inc., 525 F.3d 1200, 1215 (Fed. Cir. 2008)
`(citations omitted).
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`VSI’s real argument appears to be that Guidezilla’s hypotube, which has a
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`lumen, is not materially different from a “substantially rigid portion defining a rail
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`structure without a lumen” because the hypotube’s lumen is “functionless”—an
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`assertion supported only by attorney argument. (Red Brief 14, 17, 27, 35, 43.)
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`BSC has presented evidence that the hypotube is more resistant to “kinking” than a
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`solid wire and, thus, serves an important function. (A2149-50.) Moreover, if there
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`truly is an immaterial difference at a functional level between a hypotube with a
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`closed lumen, and substantially rigid proximal member with no lumen at all, that is
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`properly the province of the doctrine of equivalents. See, e.g., Graver Tank &
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`Mfg. Co. v. Line Air Prods. Co., 339 U.S. 605, 608 (1950). The doctrine of
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`equivalents implicates an intensely factual inquiry unlikely to support a
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`preliminary injunction and, in any event, VSI is estopped from asserting the
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`doctrine by the very amendment that added the “without a lumen” limitation.
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`Festo Corp. v. Shoketsu, 535 U.S. 722, 740-41 (2002) (explaining that presumptive
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`estoppel from amendment is only overcome by evidence that amendment was not
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`made for reasons of patentability or alleged equivalent was not foreseeable at time
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`of amendment). Because hypotubes as stiffening elements were foreseeable at the
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`time of the amendment (as disclosed in prior art such as Solar), VSI could not
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`overcome the presumption that it had surrendered that claim scope. Id.
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`Case: 14-1185 CAS