BSC USP 8,048,032
`Exhibit 1030
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`Page 1 of 79
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`Case: 14-1185 Document: 2-1 Page: 1 Filed: 12/27/2013
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`
`No. 2014-____
`________________________________________________________
`
`IN THE UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`________________________________________________________
`
`VASCULAR SOLUTIONS, INC.,
`
`
`Plaintiff-Appellee,
`
`
`
`
`
`v.
`
`BOSTON SCIENTIFIC CORPORATION,
`
`
`Defendant-Appellant.
`________________________________________________________
`
`Appeals from the United States District Court for the District of
`Minnesota in case no.13-1172 (JRT/SER), Judge John R. Tunheim
`________________________________________________________
`
`DEFENDANT-APPELLANT’S MOTION FOR AN INTERIM
`STAY AND STAY PENDING APPEAL
`
`
`
`
`
`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
`
`December 27, 2013
`
`
`
`

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`UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
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`VASCULAR SOLUTIONS v. BOSTON SCIENTIFIC
`
`2014-____
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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: December 27, 2013
`
`
`1
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`

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`Page 3 of 79
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`Respectfully submitted,
`
`
`By: /s/ Matthew M. Wolf
`Matthew M. Wolf
`Arnold & Porter LLP
`555 Twelfth Street NW
`Washington, DC 20004
`Telephone: (202) 942-5000
`Facsimile: (202) 942-5999
`Counsel for Defendant-Appellant
`
`
`
`
`
`
`
`2
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`

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`PRELIMINARY STATEMENT
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`Defendant-Appellant Boston Scientific Corporation (“BSC”) respectfully
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`submits this motion, pursuant to FED. R. APP. P. 8, to stay and suspend, pending
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`appeal, the December 9, 2013 order of the U.S. District Court for the District of
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`Minnesota preliminarily enjoining BSC from making or selling its Guidezilla guide
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`catheter in the United States (the “Injunction”). Memorandum Opinion and Order
`
`Granting In Part Plaintiff’s Motion for Preliminary Injunction, Vascular Solutions,
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`Inc. v. Boston Scientific Corp., No. 0:13-cv-1172-JRT-SER (D. Minn. Dec. 9,
`
`2013), ECF No. 76 (Addendum (“Add.”) B). On December 23, 2013, the district
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`court denied BSC’s motion for leave to file a motion for reconsideration and ruled
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`that the Injunction will take effect on January 13, 2014. Add. C at 4-5. BSC also
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`requests an interim stay of the Injunction pending expedited consideration of this
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`motion on an emergency basis.
`
`The district court granted the Injunction not on the basis of the asserted
`
`independent claim that was the exclusive focus of the opening brief of plaintiff-
`
`appellee Vascular Solutions, Inc. (“VSI”), but based on dependent claims directed
`
`to one narrow limitation—an angled (or “skived”) side opening in the claimed
`
`tubular structure (the “side opening” claims). In fact, as VSI tacitly acknowledged,
`
`BSC’s own prior art patent—U.S. Patent No. 5,527,292 (the “Adams patent”)—
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`disclosed virtually every other element of the asserted claims.
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`1
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`In granting the Injunction, the district court: (1) improperly limited and
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`misapplied the “without a lumen” limitation that appears in every claim; (2) failed
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`to address BSC’s principal invalidity argument—that, by 2004 (when the VSI
`
`patents were purportedly conceived), the claimed side openings would have been
`
`an obvious design choice for a person of ordinary skill in the art making the Adams
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`device; (3) incorrectly found a lack of motivation to combine Adams with prior art
`
`catheters arising from the same narrow field of invention and addressing the same
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`problem; (4) ignored U.S. Patent No. 5,776,141 (“Klein”), which discloses an
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`angled proximal opening that addresses all of the court’s objections to the other
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`prior art cited by BSC; (5) relied on secondary indicia of nonobviousness, such as
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`the commercial success of VSI’s GuideLiner product, even though VSI provided
`
`no evidence that such success or other indicia were attributable to the purportedly
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`inventive side opening; and (6) found irreparable harm, despite VSI’s failure to
`
`show a specific nexus between its alleged harm and any infringement of the side
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`opening claims. At a minimum, substantial questions should have precluded the
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`Injunction.
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`FACTUAL BACKGROUND
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`This case relates to devices used in intravascular interventions, in which
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`flexible, thin treatment devices such as balloon catheters are advanced through the
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`blood vessels to the site of a blockage, where a treatment to relieve the blockage—
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`2
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`such as the placement of a stent—is performed. At issue in this case particularly
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`are guide catheters—flexible tubes inserted into the vasculature early in the
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`procedure, through which treatment devices are guided to the treatment site. See
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`Exhibit to the Declaration of Seth I. Heller (“Ex.”) 1 at 2-3.
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`In 1996, the Adams patent was awarded and assigned to BSC’s predecessor,
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`Scimed Life Systems, Inc. Adams disclosed, inter alia:
`
`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.
`
`Ex. 2 at Abstract. One benefit of the invention was explained as follows:
`
`A proximal end of the flexible tube 32 is advanced so that a significant
`portion of the flexible tube 32 extends into the artery beyond the distal
`end of the guide catheter 12 to secure the guide catheter 12 at the
`coronary ostium [the opening into a branch artery] for guiding a
`coronary treatment device into the arteries beyond….”
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`Id. at 9:12-24.
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`Beginning in 2009, VSI marketed various versions of its GuideLiner
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`product. VSI explained that “[t]he distal end … of the GuideLiner is a relatively
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`flexible tube.…” Ex. 3 at 6. Proximal to the flexible tube is a “push rod.” Id. at 7
`
`(showing “GuideLiner substantially rigid push rod”). VSI claims that, “[b]y
`
`extending the GuideLiner’s flexible portion past the end of the guide catheter and
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`3
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`

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`into the coronary artery to be treated, the GuideLiner provides effective deep
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`seating”—i.e., extension past the ostium, which prevents the guide catheter from
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`“back[ing] out of the coronary ostium,” thereby “providing a secure passageway to
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`deliver devices….” Id. at 7, 4. Thus, Adams disclosed both the main structural
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`features and the function of GuideLiner. Despite the district court’s odd statement
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`that Adams is “not at issue in this case,” Add. B at 37 n.10, BSC has filed a
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`counterclaim for infringement of the Adams patent by VSI’s GuideLiner. Ex. 4.
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`In 2006, VSI filed the first of the patent applications that issued, beginning
`
`in 2011, as U.S. Patent Nos. 8,048,032 B2 (the “ ‘032 patent”), 8,142,413,
`
`and 8,292,850 B2 (collectively, the “VSI patents”). VSI did not cite, and the
`
`examiner never considered, the Adams patent during prosecution.
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`VSI initiated this action on May 16, 2013, alleging that BSC’s Guidezilla
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`product infringed at least 43 claims of the VSI patents, Ex. 5 at ¶¶ 39, 45, 55, and
`
`moved for a preliminary injunction on June 10, 2013, purportedly based on all 43
`
`of those claims. In its opening brief, VSI focused exclusively on the limitations of
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`“representative” claim 1 of the ‘032 patent. Ex. 3 at 20 (“Using claim 1 of the ‘032
`
`patent as an example …”). In its opposition, however, BSC demonstrated that its
`
`Adams patent disclosed every element of claim 1 and also anticipated the vast
`
`majority of the other asserted claims. See Ex. 1 at 19-25. As the district court
`
`noted, VSI “provided no argument [in its Reply] to support its contention that
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`4
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`[claim 1] could withstand Boston’s invalidity attack.” Add. B at 31. The court thus
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`concluded that “claim 1 is likely to be found anticipated.” Id. at 36.
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`Having abandoned claim 1, VSI based its preliminary injunction arguments
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`in its Reply on a handful of dependent claims adding two narrow limitations—
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`(1) the side opening, exemplified by claims 3 and 4 of the ‘032 patent, and (2) a
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`tube “not more than one French smaller” than the guide catheter (see, e.g., claims 8
`
`and 17). Ex. 6 at 2. The district court correctly noted that the “one French”
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`limitation was disclosed in the prior art. Add. B at 32, n.9. Thus, its decision
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`granting the Injunction rested entirely on the “side opening” claims, to which VSI
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`had devoted absolutely no discussion in its opening brief.
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`On December 12, 2013, BSC requested leave to file a motion for
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`reconsideration. (Ex. 9.) The district court denied the motion on December 23,
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`2013, noting that some of BSC’s “arguments are more properly presented to the
`
`Federal Circuit on appeal.” Add. C. BSC proposed expedited briefing of the
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`appeal, but VSI rejected that proposal. Add. D. BSC intends to move promptly for
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`expedited briefing.
`
`ARGUMENT
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`To obtain a stay of a preliminary injunction pending appeal, a movant must
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`either “establish a strong likelihood of success on the merits or, failing that,
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`nonetheless demonstrate a substantial case on the merits provided that the harm
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`5
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`factors militate in its favor.” Merial Ltd. v. Cipla Ltd., 426 Fed. App’x 915, 915
`
`(Fed. Cir. 2011) (unpublished) (citing Hilton v. Braunskill, 481 U.S. 770, 778
`
`(1987)); see E.I. DuPont de Nemours & Co. v. Phillips Petroleum Co., 835 F.2d
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`277, 278 (Fed. Cir. 1987). While the Court considers the present motion, BSC
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`respectfully requests that the Court grant a temporary stay, preventing the
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`Injunction from taking effect on January 13, 2014. See, e.g., Apple Inc. v.
`
`Samsung Electronics, Case. No. 2012-1507, Doc. 15 (Fed. Cir. July 6, 2012)
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`(granting temporary stay).
`
`As explained below (and as BSC will explain in more detail in this appeal),
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`the district court erred in construing a critical claim element common to all the
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`claims, and thus wrongly found that VSI was likely to prove infringement. The
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`court also erred in concluding that the dependent side opening claims were likely
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`valid, despite: (1) acknowledging that the independent claim was likely anticipated
`
`by Adams (Add. B at 36); (2) uncontested expert evidence that such side openings
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`would have been an obvious modification to Adams catheter (Ex. 7 at 11-16);
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`(2) numerous examples of prior art catheter patents in the same field of invention
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`that disclosed angled proximal lumen openings (id.); and (3) prior art catheter
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`patent (Klein) disclosed the supposedly distinctive aspect of VSI’s side opening
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`(Ex. 8 at 74-75, 78-79). The court also relied on secondary indicia of
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`nonobviousness, such as the commercial sales of the GuideLiner without any
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`6
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`evidence that those sales were attributable to the claimed side opening. Add. B at
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`35. Finally, the court found irreparable harm, despite the absence of any evidence
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`of a nexus between the alleged harm and any infringement of the side opening
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`claims. Id. at 38.
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`I.
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`BSC HAS A STRONG LIKELIHOOD OF SUCCEEDING ON
`THE MERITS OF ITS APPEAL
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`This Court has held that a preliminary injunction is an extraordinary remedy
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`that is not to be routinely granted. Intel Corp. v. ULSI Sys. Tech. Inc., 995
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`F.2d 1566, 1568 (Fed. Cir. 1993). If the accused infringer “raises a substantial
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`question concerning either infringement or validity, i.e., asserts an infringement or
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`invalidity defense that the patentee cannot prove ‘lacks substantial merit,’ the
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`preliminary injunction should not issue.” Amazon.com, Inc. v.
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`Barnesandnoble.com, Inc., 239 F.3d 1343, 1350-51 (Fed. Cir. 2001); see Abbott
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`Labs. v. Andrx Pharms., Inc., 452 F.3d 1331, 1335 (Fed. Cir. 2006). VSI also bore
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`a separate, additional burden of showing irreparable harm. See Amazon.com, 239
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`F.3d at 1350 (“Our case law and logic both require that a movant cannot be granted
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`a preliminary injunction unless it establishes both of the first two factors, i.e.,
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`likelihood of success on the merits and irreparable harm”) (emphasis in original).
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`Because BSC has, at a minimum, raised substantial questions as to both validity
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`and infringement, and VSI failed to show irreparable harm, the Injunction should
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`not have issued.
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`7
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`A. The District Court Erred In Construing And Applying The
`“Without A Lumen” Limitation
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`Before allowing the claims of the ‘032 patent, the examiner proposed
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`amending each independent claim to require that the “substantially rigid portion”
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`of the claimed device define “a rail structure without a lumen,” and VSI accepted
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`the amendment. Ex. 10. Thus, the limitation requiring “a substantially rigid
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`portion … defining a rail structure without a lumen” appears in each independent
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`claim of each of the VSI patents. See, e.g., Ex. 11, claims 1, 11. In construing and
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`applying this limitation, the district court committed at least two manifest errors.
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`1.
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`The “Substantially Rigid Portion” Must “Define” The
`“Rail Structure Without A Lumen”
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`The “substantially rigid portion” of BSC’s Guidezilla device allegedly
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`consists of two components: (1) a distal “collar” through which a treatment device
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`such as a balloon catheter may be inserted or withdrawn; and (2) a proximal
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`hypotube push rod. Ex. 12 at 94. Because, as VSI admits, the collar has a lumen,
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`id. at 95 (“there is a lumen in the distal section of the collar”), Guidezilla’s
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`substantially rigid portion does not “define” a rail structure without a lumen, as
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`required by every claim. Nonetheless, the district court found that “without a
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`lumen” modifies “rail structure,” not “substantially rigid portion”—“rejecting a
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`construction that would require the entire substantially rigid structure have no
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`8
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`lumen.” Add. B at 25. This analysis conflicts with the plain language of the claim,
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`which expressly uses the word “defines”—not “includes” or “comprises.”1
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`2.
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`The District Court Erred In Construing “Lumen”
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`BSC’s second noninfringement argument is directed to the very basis of
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`purported patentability. As the district court acknowledged, Guidezilla’s push rod
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`is formed of a round, hollow hypotube. Add. B at 14. The district court
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`nonetheless found that BSC’s Guidezilla product was “without a lumen” after
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`accepting VSI’s proposed construction of “lumen,” limiting the term to “the
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`interior of a tubular structure, open at both ends to allow the passage of medical
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`devices (for example, stents or balloons) and contrast medium.” Id. at 23
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`(emphasis added). The court concluded that Guidezilla’s hypotube lacks a
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`“lumen” because it is closed at one end.
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`As an initial matter, the district court’s construction conflicts directly with
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`this Court’s analysis in Howes v. Med. Components, Inc., 814 F.2d 638, 644 (Fed.
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`Cir. 1987). Analyzing the meaning of the term “lumen” in the same art (catheter
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`1 The district court relied on disclosed embodiments in which the “substantially
`rigid portion” has a “lumen” to find that the “substantially rigid portion” need only
`include a “rail structure without a lumen.” Add. B. at 25-26. When a claim is
`limited during prosecution, however, it need not be construed to cover all
`embodiments in the specification. See N. Am. Container, Inc. v. Plastipak
`Packaging, Inc., 415 F.3d 1335, 1346 (Fed. Cir. 2005) (“limitations may be
`construed to exclude a preferred embodiment if the prosecution history compels
`such a result”); Oatey Co. v. IPS Corp., 514 F.3d 1271, 1276-77 (Fed. Cir. 2008)
`(interpreting claims to exclude embodiments that were clearly disclaimed).
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`9
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`design), the Howes court explained that a “lumen” in such a device “is not by
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`definition unobstructed” and that “[w]ell-known prior art catheters contain fluid
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`passages which are blocked at their ends with balloons or are obstructed by wires
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`or electrical devices. These passages are known, and are specifically referred to, as
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`‘lumens.’” Id. at 644 (emphasis added) The district court dismissed this guidance,
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`noting that “the meaning of a particular term in one patent will not necessarily bear
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`on the interpretation of the same term in a subsequent patent.” (Add. B at 29
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`(citing Phillips, 415 F.3d at 1333)). The Howes court, however, addressed the
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`meaning of “lumen” in the relevant art. 814 F.2d at 644.
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`Here, the only disinterested evidence adduced by either party supported the
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`Howes court’s conclusion that a “lumen” in a device such as a catheter may be
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`closed or open. Medical dictionaries state that a “lumen” is the “space in the
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`interior of a hollow tubular structure,” for example “the bore of a catheter or
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`hollow needle.” STEDMAN’S MEDICAL DICTIONARY (4th ed.), Ex. 13; see OXFORD
`
`DICTIONARY OF BIOCHEMISTRY AND MOLECULAR BIOLOGY, Ex. 14. Scientific
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`dictionaries state that a “lumen” is merely “the space within a tube.” MCGRAW
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`HILL DICTIONARY OF SCIENTIFIC AND TECHNICAL TERMS, Ex. 15. Neither VSI nor
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`10
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`the district court cited a single reference indicating that a “lumen” cannot be closed
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`at one or both ends.2
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`Although the district court found it dispositive that “each lumen that is
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`described [in the VSI patents] would accommodate an interventional cardiology
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`device,” Add. B at 27, this Court has warned that “[i]t is not enough for a patentee
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`to simply disclose a single embodiment or use a word in the same manner in all
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`embodiments.” Thorner v. Sony Comp. Entertainment Am. L.L.C., 669 F.3d 1362,
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`1365 (Fed. Cir. 2012). Rather, the patentee must ‘clearly express an intent’ to
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`redefine the term.” Id. at 1365 (citation omitted); see Laryngeal Mask Co., Ltd. v.
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`Ambu A/S, 618 F.3d 1367, 1372 (Fed. Cir. 2010) (citation omitted) (to impart a
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`meaning to a claim term that is different from its ordinary meaning, such a
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`definition must be “clearly stated in the patent specification or file history”).
`
`
`2 The district court cited the opinion of Howard Root, an inventor of the VSI
`patents and VSI’s CEO, as to how one of ordinary skill would interpret “lumen.”
`Add. B at 25. The self-serving testimony of Mr. Root—a lawyer with no training
`as an engineer—is, however, entitled to little weight. E.g., O2 Micro Int’l Ltd. v.
`Beyond Innovation Tech. Co., Ltd, 521 F.3d 1351, 1362 n.3 (“an inventor’s self-
`serving statements are rarely relevant to the proper construction of a claim term”).
`At the same time, the court ignored the declaration of Tony Vrba, an engineer
`with 22 years’ experience in catheter design, who opined that “a hypotube has a
`lumen even if it is flattened or blocked at one or both ends.” Ex. 16 ¶ 6. At a
`minimum, there was a substantial question precluding the Injunction.
`
`11
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`Nowhere in the VSI patents do the inventors impart a special meaning to “lumen,”
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`limiting the term to “open passageways.”3
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`The district court also premised its construction on a misreading of the
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`specification, relying on the statement that “the rigid portion ‘is preferably formed
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`from a stainless steel or Nitinol tube’” to conclude that “without a lumen” does not
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`exclude the interior of a hypotube. Add. B at 27-28 (citing Ex. 11 at 3:49-59).
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`Because 45% to 90% of the circumference of that “tube” is removed during
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`manufacture, Ex. 11 at 3:49-59, the referenced passage says nothing about whether
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`the space enclosed within a hypotube is a “lumen.”4
`
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`3 Indeed, where the inventors sought to denote an open passageway for a device,
`they expressly described the “lumen” as “continuous.” See, e.g., Ex. 11 at 10:22-
`27 (“the standard guide catheter having a continuous lumen”). The presence of
`this modifier in the claim language is strong intrinsic evidence that a “lumen” is
`not necessarily “open” at both ends. See Merck & Co., Inc. v. Teva Pharm. USA,
`Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005) (“A claim construction that gives
`meaning to all the terms of the claim is preferred over one that does not do so”).
`
`4 The prosecution history confirms that “lumen” in the phrase “without a lumen”
`refers to the space in a hypotube that does not serve as a passageway for anything.
`The examiner initially rejected the first independent claim because “Solar [Pub No.
`U.S. 2003/0195546 A1] discloses … a pushing member…. Therefore, it would
`have been obvious to one of ordinary skill … to replace the elongate structure of
`Niazi proximal the coil 55 with a rigid pushing structure … as taught by Solar….”
`Ex. 17 at 4. The pushing structure of Solar may be “formed of … spring hollow
`hypotubing.” Ex. 18 ¶ 0025 (emphasis added). VSI’s claim was allowed only
`after the phrase “rail structure without a lumen” was added to the description of the
`substantially rigid push rod. Ex. 10. Nothing in Solar suggests, however, that its
`hypotube lumen was a passageway for anything. Thus, if “without a lumen”
`(continued . . . )
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`12
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`B.
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`The Side Opening Claims Were Obvious
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`1.
`
`By 2004, Modification Of Adams To Include A Skived
`Proximal Opening Was An Obvious Design Choice
`
`The district court wrongly focused on whether it would have been obvious to
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`combine the guide wire ports of particular prior art patents with the device
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`disclosed in BSC’s Adams patent. In so doing, the court failed to address BSC’s
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`principal argument—that modification of the Adams device by skiving the lumen
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`opening at an angle would have been an obvious design choice for a person of
`
`ordinary skill in the art in 2004. The undisputed record evidence—particularly the
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`declaration of Tony Vrba, an engineer with 22 years of experience with vascular
`
`devices, including guide catheters—supported this argument. Mr. Vrba states:
`
`The type of proximal side opening described in claim 3 was well known
`in the art prior to 2004 as a common means for shaping points of entry
`into a lumen though which devices are received for the facilitation of
`insertion and strengthening known points of weakness through gradual
`transitioning at portions joining one material to another or one degree of
`flexibility to another.
`
`Ex. 7 at 13. Because skived lumen openings were the default design choice for
`
`such devices by 2004, one of ordinary skill would have been motivated to make the
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`Adams catheter with a skived opening. In KSR Int’l Co. v. Teleflex Inc., 550 U.S.
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`398 (2007), the Supreme Court discouraged the “blinkered focus on individual
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`( . . . continued)
`means “not a passageway,” as the court concluded, Solar would have met that
`limitation and the claim would not have been allowed.
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`documents” and, instead, demanded consideration of “what one of ordinary skill in
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`the art would have known” and the “inferences and creative steps that a person of
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`ordinary skill in the art would employ.” Randall Mfg. v. REA, 733 F.3d 1355,
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`1362 (Fed. Cir. 2013) (quotations and citations omitted); see also B.F. Goodrich
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`Co. v. Aircraft Braking Systems Corp., 72 F.3d 1577, 1583 (Fed. Cir. 1996)
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`(“logical” modification of a single prior art reference rendered claims obvious).
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`2.
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`Prior Art Rapid Exchange Catheters Disclosed Skived
`Proximal Lumen Openings
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`BSC cited several examples of prior art catheters to show that, by 2004,
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`skived openings were standard in the art. U.S. Patent No. 5,690,613 (“Verbeek”),
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`issued in 1997, teaches: “Skive 95 the proximal end of the inner lumen tubing 70
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`at an angle of approximately 10 degrees for a length of 2mm.” Ex. 19 at 6:9-11.
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`Id., Fig. 1B. U.S. Patent No. 5,328,472 (“Steinke”), issued in 1994, shows a
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`“guidewire entry 12 (also referred to as the distal entry or side port entry),” Ex. 20
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`at 6:51-54, that is skived or cut at an angle:
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`Id., Fig. 3. Steinke shows that a tube skived or cut at an angle also defines both
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`fully and partially cylindrical portions, as claimed in claim 4 of the ‘032 patent:
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`Id., Figs. 4D, 4E; see U.S. Patent No. 5,102,403 (“Alt”), Ex. 21, Figs. 4, 7.
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`Though not its principal argument, BSC submits that, contrary to the district
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`court’s findings, a person of ordinary skill in the art would have been motivated to
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`combine any of these references—all of which addressed the same problem
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`(delivery of intravascular devices)—with Adams. See Tokai Corp. v. Easton Ent.,
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`Inc., 632 F.3d 1358, 1371 (Fed. Cir. 2011) (because “cigarette lighters and utility
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`lighters are analogous arts,” one of ordinary skill would have been led to combine
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`available utility lighters with prior art features of cigarette lighters; “courts ‘may
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`find a motivation to combine prior art references in the nature of the problem to be
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`solved’”) (citation omitted); DyStar Textilfarben GmbH & Co. Deutschland KG v.
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`C.H. Patrick Co., 464 F.3d 1356, 1368 (Fed.Cir.2006) (finding of nonobviousness
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`improper where “[t]he technical problem that the process of the ‘992 patent and the
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`prior art cited by Bann sought to solve is precisely the same”); KSR, 550 U.S.
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`at 417 (“When a work is available in one field of endeavor, … market forces can
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`prompt variations of it … in the same field…. If a person of ordinary skill can
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`implement a predictable variation, § 103 likely bars its patentability”).
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`3. Klein Disclosed A Skived Opening Through Which
`Intravascular Devices Entered The Lumen
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`The district court wrongly concluded that prior art rapid exchange catheters
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`with skived guide wire lumens did not render the side opening claims obvious
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`because such openings form “an exit for a guidewire, not an entrance for devices,
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`such as stents.” Add. B at 34 (emphasis in original). Even if these distinctions
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`would have prevented a skilled artisan from recognizing that the opening of Adams
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`could be skived (which they would not have), the Klein patent, which issued in
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`1998, disclosed a tubular delivery catheter capable of receiving a balloon catheter
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`while the proximal entry port remains in the guiding catheter.5 The proximal entry
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`port of the tubular catheter body in Klein is skived or cut at an angle, as shown in
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`numerous figures, see id., Figs. 1, 6-9A, 10-15, 20-28, forming an opening that
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`extends for a distance along the longitudinal axis and which is accessible from a
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`side transverse to the longitudinal axis (as required by claim 3 of VSI’s ‘032
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`5 See Ex. 22 at 9:17-23 (“Tubular catheter body 16 includes an internal lumen 24
`which extends from a proximal port … to receive the balloon catheter …. [T]he
`lumen 24 will be sized sufficiently large to receive the balloon ...”); 10:16-22 (“the
`entry port 26 will remain within the guiding catheter at all times”).
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`patent). For example, in figure 28, the balloon catheter (“BC”) is shown entering
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`the skived proximal entry port of the tube:
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`Thus, Klein addresses all of the objections raised by VSI—a device such as a
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`balloon catheter (not only a guide wire) enters the catheter lumen through the
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`proximal port, while it is inside the guide catheter.
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`Indeed, during the prosecution of the ‘032 patent, the examiner expressly
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`rejected the side opening claims as obvious over Klein and other prior art. In an
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`Office Action dated December 21, 2010, the examiner rejected then-claims 66, 69,
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`and 74 (corresponding to claims 3 and 4 of the ‘032 patent, see Ex. 23 at 5, 7, 8).
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`Ex. 17 at 8. Only after the applicant accepted the examiner’s amendment adding
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`“rail structure without a lumen” to each independent claim were any of the claims
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`allowed. Ex. 10 at 2. Thus, the angled openings of dependent claims 3 and 4 were
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`never found to be inventive.6
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`6 Because VSI did not address the side opening claims at all in its opening brief,
`BSC did not attach the Klein patent or excerpts of the prosecution history to its
`opposition. BSC tried to bring Klein to the district court’s attention during oral
`argument, Ex. 8 at 74-75, 78-79, but the court did not mention Klein in its opinion.
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`4.
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`There Is No Nexus Between The Claimed Side
`Openings And Any Indicia Of Nonobviousness
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`In its opinion, the district court relied on what it characterized as indicia of
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`nonobviousness, including the commercial success of VSI’s GuideLiner. Add. B
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`at 35. However, as this Court has cautioned, “[f]or objective evidence to be
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`accorded substantial weight, its proponent must establish a nexus between the
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`evidence and the merits of the claimed invention.” Ohio Willow Wood Co. v. Alps
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`South, LLC, 735 F.3d 1333, 1333, 1344 (Fed. Cir. 2013) (citation and quotation
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`omitted). In particular, objective indicia of nonobviousness must be attributable to
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`what is “both claimed and novel”; otherwise, there is “no nexus to the merits of the
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`claimed invention,” a “fundamental requirement that must be met before secondary
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`considerations can carry the day.” See In re Huai-Hung Kao, 639 F.3d 1057, 1068
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`(Fed. Cir. 2011). Here, the district court wrongly relied on evidence of the
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`GuideLiner’s commercial success without any analysis as to whether the device’s
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`angled side openings—the only identified points of novelty—contributed to that
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`success.
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`C. VSI Failed To Establish Irreparable Harm Attributable To
`Infringement Of The Side Opening Claims
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`By shifting the focus of the case from claims covering the entire accused
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`device to those covering one narrow feature, VSI further invited the district court
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`to commit legal error with respect to irreparable harm. To meet its burden, VSI