`Exhibit 1026
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`Page 1 of 41
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`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 1 of 41
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`UNITED STATES DISTRICT COURT
`
`DISTRICT OF MINNESOTA
`
`
`VASCULAR SOLUTIONS, INC.,
`
`
`Plaintiff,
`
`
`
`v.
`
`BOSTON SCIENTIFIC CORPORATION,
`
`
`
`
`Defendant.
`
`Civil No. 13-1172 (JRT/SER)
`
`
`
`FILED UNDER SEAL
`
`MEMORANDUM OPINION AND
`ORDER GRANTING IN PART
`PLAINTIFF’S MOTION FOR A
`PRELIMINARY INJUNCTION
`
`
`J. Thomas Vitt and Heather D. Redmond, DORSEY & WHITNEY LLP,
`50 South Sixth Street, Suite 1500, Minneapolis, MN 55402, for plaintiff.
`
`Edward Han, Matthew M. Wolf, and Tara Williamson, ARNOLD &
`PORTER LLP, 555 Twelfth Street N.W., Washington, DC 20004; Jeffer
`Ali, CARLSON CASPERS VANDENBURGH LINDQUIST &
`SCHUMAN PA, 225 South Sixth Street, Suite 4200, Minneapolis, MN
`55402, for defendant.
`
`
`
`
`Plaintiff Vascular Solutions, Inc. (“Vascular”) owns three patents directed to a
`
`device and method of using a guide catheter extension in cardiac catheterization
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`procedures accessing coronary arteries. Vascular alleges that defendant Boston Scientific
`
`Corp.’s (“Boston”) guide extension catheter, the Guidezilla, not only infringes Vascular’s
`
`patents but is also a copy of Vascular’s guide extension catheter, the GuideLiner.
`
`Vascular seeks a preliminary injunction enjoining Boston from making, using, or offering
`
`for sale its Guidezilla product or any other product that would infringe Vascular’s guide
`
`extension catheter patents. Vascular also seeks an injunction enjoining Boston from
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`24
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`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 2 of 41
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`preparing derivative works from Vascular’s Instructions for Use (“IFUs”) and copying or
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`distributing copies of Guidezilla’s IFUs.
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`
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`The Court will grant in part Vascular’s motion for a preliminary injunction,
`
`enjoining Boston from making, using, or offering for sale its Guidezilla product. The
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`Court concludes that, at this stage, Vascular has shown a likelihood of success on the
`
`merits – that is, that Vascular will be able to prove infringement and overcome Boston’s
`
`invalidity contentions for at least one of its patents’ claims. The Court also finds that
`
`Vascular has demonstrated it is likely to suffer irreparable harm to its market and
`
`reputation, the balance of harms favors Vascular, and the public interest favors a
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`preliminary injunction. To the extent Vascular seeks an injunction enjoining Boston
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`from preparing derivative works from Vascular’s IFUs and copying or distributing copies
`
`of Guidezilla’s IFUs, however, Vascular’s motion will be denied because Vascular fails
`
`to identify any irreparable harm stemming from Boston’s alleged copyright infringement.
`
`
`
`
`I.
`
`
`
`BACKGROUND
`
`GUIDE EXTENSION CATHETERS
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`Vascular began working on its guide extension catheter in approximately 2004,
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`filed its first patent application directed to the invention in 2006, and started selling its
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`GuideLiner device in 2009.1 (Decl. of Howard Root ¶ 21 & Ex. 2, June 10, 2013, Docket
`
`No. 12.) In order to understand Vascular’s invention, it is necessary to understand the
`
`previously existing cardiac catheterization methods and devices.
`
`
`1 After launching the original GuideLiner in 2009, Vascular developed a second version
`which it began selling in 2012. (Root Decl. ¶ 31.)
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`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 3 of 41
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`A.
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`Cardiac Catheterization and Existing Methods and Devices
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`
`
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`In a cardiac catheterization procedure, a physician inserts a needle into the wrist
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`(radial) or leg (femoral) artery of a patient. (See id. ¶ 9.) A guidewire is inserted through
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`the needle. (See id.) An introducer sheath is introduced over the wire and is used to
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`provide access for “guidewires, catheters, and stents” during either a diagnostic or
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`interventional procedure. (Id. ¶¶ 8-9, 11.) Either a guidewire or a catheter may be
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`inserted through the arteries to the aorta. (See id. ¶ 9.)
`
`
`(Id.) During an interventional catheterization procedure, a cardiologist must introduce a
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`
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`“guide catheter” deep into the coronary artery to deliver medical devices and stents, for
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`example to treat coronary artery stenosis. (Id. ¶ 6, 11.)
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`(Id. ¶ 6.) In order to reach the coronary arteries, the inserted guidewire or catheter must
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`
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`make sharp turns, as shown in the following figure:
`
`
`(Id. ¶ 7.) Because of the curve and rigidity of guide catheters, the catheters are difficult
`
`
`
`to extend past the ostium, the opening of the coronary artery, into the coronary arteries.
`
`(See id. ¶ 15.)
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`(Id. ¶ 11 (modified).)
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`
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`Before Vascular’s invention, cardiologists used several types of standard guide
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`catheters to place catheters and stents. One example of a standard guide catheter is an
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`“over-the-wire” catheter. (See id. ¶ 19.) To use an over-the-wire catheter, the
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`cardiologist inserts a guidewire first and then the catheter is delivered over the guidewire.
`
`(See id.)
`
`
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`(Id.) One uninterrupted lumen runs the length of the catheter. (Id.)
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`Another type of guide catheter, the monorail or rapid exchange catheter, is also
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`delivered over a guidewire, but the device’s lumen is shorter than the full length of the
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`catheter and passes over only part of the wire. (See id. ¶ 20.) A push rod adds additional
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`length to the catheter, connecting the lumen portion, which is placed towards the end of
`
`the guidewire, to the outside (or proximal end) of the catheter. (See id.)
`
`(Id.)
`
`
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`
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`During use of guide catheters, the outside end of the catheter must be sealed to
`
`prevent blood loss during the procedure. (Id. ¶ 13.) A hemostasis valve is attached to the
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`proximal end of the catheter for this purpose. (Id.)
`
`(Id. ¶ 19 (modified).)
`
`
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`Because of the curve and rigidity of the coronary arteries, however, guide
`
`catheters are often difficult to extend past the ostium. (See id. ¶ 15.) Prior attempts to
`
`solve this problem have included a “mother and child” guide catheter where a smaller,
`
`more flexible catheter is placed inside a larger, stiffer catheter. (Id. ¶ 16.)
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`(Id.) The smaller, more flexible, “child” catheter can then be extended through the
`
`
`
`ostium into the coronary artery. (Id.)
`
`
`(Id.) This system has several drawbacks, including its need for two hemostatic valves
`
`
`
`and the length of the system. (Id. ¶ 18.) In addition, before placing the child catheter,
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`any guidewires or devices already inserted through the mother catheter must be removed.
`
`(Id.)
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`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 8 of 41
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`B.
`
`Vascular’s Invention
`
`
`
`Vascular sought to invent a “guide extension catheter that would provide ‘mother
`
`and child’ guide extension, but without
`
`the disadvantages of [over-the-wire]
`
`construction.” (Id. ¶ 21.) Vascular’s invention is described in U.S. Patent No. 8,048,032
`
`(the “’032 patent”) (Root Decl., Ex. 2), claiming the guide extension catheter device;
`
`U.S. Patent No. 8,142,413 (the “’413 patent”) (Root Decl., Ex. 3), directed to methods of
`
`using the guide extension catheter; and U.S. Patent No. 8,292,850 (the “’850 patent”)
`
`(Root Decl., Ex. 4), directed to a system for using the guide extension catheter with a
`
`standard guide catheter. (See Root Decl. ¶ 32.)
`
`Vascular devoted much of its opening brief describing its product, the GuideLiner.
`
`But “it is error for a court to compare in its infringement analysis the accused product or
`
`process with the patentee’s commercial embodiment or other version of the product or
`
`process; the only proper comparison is with the claims of the patent.” Zenith Labs.,
`
`Inc. v. Bristol-Myers Squibb Co., 19 F.3d 1418, 1423 (Fed. Cir. 1994) (emphasis added).
`
`The infringement analysis must, therefore, focus on the claims of the patent, not
`
`Vascular’s GuideLiner.
`
`
`
`1.
`
`Exemplary Claim
`
`
`Vascular identified claim 1 of the ’032 patent as an exemplary claim. (See Pl.’s
`
`Mem. in Supp. at 20-21.) Claim 1 is directed to:
`
`A device for use with a standard guide catheter, the standard guide
`catheter having a continuous lumen extending for a predefined length from
`a proximal end at a hemostatic valve to a distal end adapted to be placed in
`a branch artery, the continuous lumen of the guide catheter having a
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`circular cross-sectional inner diameter sized such that interventional
`cardiology devices are insertable into and through the lumen to the branch
`artery, the device comprising:
`
`
`a flexible tip portion defining a tubular structure having a circular
`cross-section and a length that is shorter than the predefined length
`of the continuous lumen of the guide catheter, the tubular structure
`having a cross-sectional outer diameter sized to be insertable
`through the cross-sectional inner diameter of the continuous lumen
`of the guide catheter and defining a coaxial lumen having a cross-
`sectional inner diameter through which interventional cardiology
`devices are insertable; and
`a substantially rigid portion proximal of and operably connected
`to, and more rigid along a longitudinal axis than, the flexible tip
`portion and defining a rail structure without a lumen and having a
`maximal cross-sectional dimension at a proximal portion that is
`smaller than the cross-sectional outer diameter of the flexible tip
`portion and having a length that, when combined with the length of
`the flexible distal tip portion, defines a total length of the device
`along the longitudinal axis that is longer than the length of the
`continuous lumen of the guide catheter,
`such that when at least a distal portion of the flexible tip portion is
`extended distally of the distal end of the guide catheter, at least a
`portion of the proximal portion of the substantially rigid portion
`extends proximally through the hemostatic valve in common with
`interventional cardiology devices that are insertable into the guide
`catheter.
`
`
`(’032 patent, claim 1 (emphasis added).)
`
`The guide extension catheter (or “coaxial guide catheter”) described in the ’032
`
`patent is delivered through a standard guide catheter such as an over-the-wire catheter
`
`(see e.g., ’032 patent, 2:53-56, 4:23-25), pictured below:
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`Page 10 of 41
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`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 10 of 41
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`(Root Decl. ¶ 19.) The patented device itself (the guide extension catheter) consists of “a
`
`flexible tip portion” and “a substantially rigid portion.” (’032 patent, claim 1.)
`
`(’032 patent, Fig. 4 (modified).) When the device is inserted through the guide catheter
`
`into a patient, the flexible tip portion extends out of the guide catheter through the
`
`patient’s ostium (id.) into the coronary artery (id. 5:37-39, 7:49-53 & Fig. 8.).
`
`
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`
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`(’032 patent, Fig. 8 (modified).)
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`Page 11 of 41
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`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 11 of 41
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`Vascular’s invention works much like the “mother and child” guide catheter –
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`placing a smaller, more flexible catheter inside a larger, stiffer catheter. But unlike the
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`mother-and-child system, no separate hemostatic valve is required on the child (or guide
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`extension) catheter of the patented device because “the proximal portion of the
`
`substantially rigid portion extends proximally through the hemostatic valve in common
`
`with interventional cardiology devices that are insertable into the guide catheter.” (’032
`
`patent, claim 1.) In the GuideLiner product, this proximal portion is called the “push
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`rod.” (Root Decl. ¶ 24.) The patent indicates that this “rigid portion” may be formed
`
`from “a hypotube or a section of stainless steel or Nitinol tubing.” (’032 patent, 6:34-37;
`
`id. 7:24-25; see also id. 3:47-48 (“Preferably, the rigid portion may be advantageously
`
`formed from a stainless steel or Nitinol tube.”).)
`
`
`
`In use, the guide extension catheter is inserted into the mother/guide catheter by
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`threading the lumen of the flexible portion of the guide extension catheter over the
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`guidewire. (See id. 9:48-50; Root Decl. ¶ 26.) The flexible tip is pushed through the
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`guide catheter by the push rod and out the end of the guide catheter, into the coronary
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`artery. (’032 patent, 9:50-58; Root Decl. ¶ 26.) The cardiologist can then insert devices,
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`such as stents, through the guide catheter, into the guide extension catheter, and out the
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`distal end, into the artery to be treated. (See ’032 patent, 9:59-63; Root Decl. ¶ 26.)
`
`
`
`
`
`2.
`
`Dependent Claims
`
`The dependent claims of the ’032 patent describe and claim additional structures
`
`of the guide extension catheter. Claims 2 and 3 further describe the “tubular structure” of
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`the “flexible tip portion.” According to dependent claim 2, the “proximal portion” of the
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`flexible end “remains within the lumen of the guide catheter.” (’032 patent, claim 2.)
`
`Claim 3, dependent on claim 2, further describes this “proximal portion of the tubular
`
`structure” requiring a “proximal side opening extending for a distance along the
`
`longitudinal axis, and accessible from a longitudinal side defined transverse to the
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`longitudinal axis, to receive an interventional cardiology device into the coaxial lumen.”
`
`(’032 patent, claim 3.) Claim 4, dependent on claim 3, further requires that this opening
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`“includes structure defining a full circumference portion and structure defining a partially
`
`cylindrical portion.” (’032 patent, claim 4.). In GuideLiner, this portion is the “collar.”
`
`(Root Decl. ¶ 23.) This structure is pictured in the following figure:
`
`(’032 patent, Fig. 4 (modified).)
`
`
`
`
`
`Dependent claim 8 is directed to “the device of claim 1 wherein the cross-sectional
`
`inner diameter of the coaxial lumen of the tubular structure is not more than one French
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`smaller than the cross-sectional inner diameter of the guide catheter.” (’032 patent, claim
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`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 13 of 41
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`8.) A standard guide catheter has a diameter measured on the French scale where 1F is
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`1/3mm. (Root Decl. ¶ 12.)2
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`
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`
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`C.
`
`Boston’s Guidezilla Device
`
`Boston began selling its Guidezilla device in June 2013. (See Decl. of Sam
`
`Rasmussen ¶ 10, July 7, 2013, Docket No. 33 (filed under seal).) Boston’s Guidezilla
`
`catheter is a guide extension catheter. (See Root Decl. ¶ 59 & Ex. 25, Guidezilla IFU at 2
`
`(“The Guidezilla guide extension catheter . . . .”).) Vascular contends – and Boston does
`
`not dispute – that Guidezilla is almost an exact copy of GuideLiner.
`
`(Id. ¶ 68.)
`
`
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`Guidezilla has a “flexible tip portion.” (Root Decl. ¶¶ 70-71 & Ex. 31.)
`
`Guidezilla has a “substantially rigid portion.” (Id. ¶¶ 73 & Ex. 31.) Guidezilla also has a
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`“collar” or “hemicylindrical portion.” (Id. ¶ 72, 76.)
`
`
`2 Prior art “mother and child” guide catheter systems included the Terumo system which
`had a 6F mother guide catheter and a 5F child catheter. (Id. ¶ 17.)
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`(Id. ¶ 72.)
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`
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`The parties dispute, however, whether Guidezilla has “a substantially rigid
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`portion proximal of and operably connected to, and more rigid along a longitudinal axis
`
`than, the flexible tip portion and defining a rail structure without a lumen,” as required
`
`by claim 1 of the ’032 patent. The parties agree that the rigid portion of Guidezilla is
`
`made of a hypotube (see Root Decl. ¶ 77; Def.’s Mem. in Opp. at 11, July 8, 2013,
`
`Docket No. 29 (filed under seal)), that is a stainless steel tube, used for example in
`
`hypodermic needles (Def.’s Mem. in Opp. at 11 (filed under seal)). The parties further
`
`agree that a hypotube contains “an open space in the middle.” (Pl.’s Mem. in Supp. at
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`25; Def.’s Mem. in Opp. at 11 (filed under seal).) Guidezilla’s hypotube is sealed at one
`
`end by placement into a plastic tab. (Root Decl. ¶ 74.)
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`(Id.) The hypotube is crushed flat at the other end for the final 2 cm before it is welded to
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`the metal collar. (Id. ¶ 78.)
`
`
`(Id.) The middle of the hypotube is, nevertheless, still open in the middle, although the
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`
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`parties agree that there is no access to the opening.
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`
`
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`
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`D.
`
`Prosecution History
`
`During prosecution of the ’032 patent, the examiner added the “rail structure
`
`without a lumen” language to claim 1 (and claim 11), replacing “structure.” (See Pl.’s
`
`Mem. in Supp. at 24; Root Decl. Ex. 38.) The same language was added to the other two
`
`Vascular patents during their prosecution by either the examiner or the applicant. (Root
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`Decl. ¶ 99 & Exs. 36-37.)
`
`
`II.
`
`
`THE ADAMS PATENT
`
`Boston argues that Vascular’s asserted patents are invalid because they are
`
`anticipated by or obvious in light of U.S. Patent No. 5,527,292 (the “Adams patent”).3
`
`(Decl. of Sarah M. Stensland, Ex. 1 (“Adams patent”), July 8, 2013, Docket No. 30.) The
`
`Adams patent was filed September 9, 1994 and issued June 19, 1996. (Id.) The patent
`
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`3 The Adams patent is now expired.
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`was assigned to SciMed Life Systems, Inc. – a company acquired by Boston in
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`November 1994. (Def.’s Mem. in Opp. at 3 (filed under seal).)4 Adams claims a device
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`for use in cardiac catheterization procedures (Adams patent 2:35-43) and discloses a
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`“flexible tube” (id. 2:44) that can “extend from a distal end of a guide catheter” into the
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`coronary arteries (id. 2:46-47, 52-57). Adams also discloses a “push rod” (id. 2:47) or
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`“shaft” (id. 6:14) that is used to adjust the location of the flexible tube (see id. 6:56-65).
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`(See also 7:13-21 (describing a tubular shaft member “preferably formed from stainless
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`steel hypotube”).)
`
`The device disclosed in the Adams patent works much like Vascular’s Invention.
`
`The Adams patent discloses an
`
`anchoring device for securing the guide catheter 287 relative to the
`coronary ostium of a patient to facilitate original insertion and subsequent
`insertion of a coronary treatment device. The anchoring device is defined
`by the flexible tube 255 and push rod 262 (i.e., the distal extension 250). A
`distal portion of the flexible tube 255 is advanced past the distal opening
`288 of the guide catheter 287 and past the coronary ostium into the artery
`requiring treatment, while a proximal portion thereof and the push rod 262
`remain within the guide catheter 287. Since the flexible tube 255 extends
`along a portion of the guide catheter 287 and through the coronary ostium
`along an extent of the artery, the flexible tube 255 serves to aid in securing
`the distal opening 288 of the guide catheter 287 relative to the coronary
`ostium.
`
`
`(Adams patent 16:55-17:2.)
`
`
`
`4 In their First Affirmative Defense, Vascular notes that it “has been unable to locate any
`assignment record in the Patent Office to either Boston Scientific Corporation or Boston
`Scientific SciMed, Inc.” (Aug. 22, 2013, Docket No. 54.)
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`(Adams patent Fig. 12 (modified).)
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`
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`The Adams patent describes the interface between the flexible tube and the push
`
`shaft in two ways: as a flared (or funnel) interface and as an expandable balloon. The
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`flared interface (or funnel) is shown in the figure below:
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`
`
`
`(Adams patent, Fig. 2 (modified).) The funnel “serves to direct an angioplasty device
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`
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`into the lumen of the extension.” (Adams patent, 16:12-13 (internal labels omitted).)
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`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 18 of 41
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`Adams notes that the “tube . . . does not have sufficient pushability to be independently
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`advanced through the coronary artery of a patient” and that it must be advanced “in
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`cooperation with another coronary treatment device.” (Id. 16:16-18)
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`The expandable restriction balloon as an interface between the guide catheter and
`
`the flexible tube is shown in the following figure:
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`
`
`
`(Id. Fig. 3 (modified).)
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`
`III.
`
`
`INSTRUCTIONS FOR USE
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`
`
`Vascular alleges that Boston copied “virtually every word” of the “Deployment
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`Procedure” section of the GuideLiner IFU. (See Root Decl. ¶ 66 & Ex. 25-26.) The only
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`material words Boston changed were the name of the device. (See id.)
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`For example:
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`
`(Root Decl. ¶ 66.) Vascular copyrighted the IFU for GuideLiner. (Id. ¶ 65 & Ex. 27.) A
`
`
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`copy of the IFU is included with every GuideLiner or Guidezilla sold, and a sales
`
`representative is not allowed to promote a use for a medical device not included in the
`
`IFU. (Second Root Decl. ¶ 46.)
`
`
`IV. VASCULAR’S SALES AND THE EFFECT OF GUIDEZILLA
`
`
`Vascular launched the GuideLiner product in November 2009 and has since netted
`
`more than $34 million in sales, as shown in the table below:
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`(Root Decl. ¶ 39.) GuideLiner sales currently make up about 20% of Vascular’s revenue
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`– its 2012 revenue totaled $98 million – and GuideLiner is Vascular’s fastest growing
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`product. (Id. ¶¶ 4, 40-41.) Vascular’s sales of the GuideLiner have helped it develop
`
`relationships with new customers to whom they also sell other Vascular products. (Id.
`
`¶ 115 & Ex. 41 (filed under seal).) GuideLiner has been discussed in at least twenty-two
`
`medical journal articles since 2010 as well as featured at medical symposia. (Id. ¶ 43 &
`
`Exs. 5-14.) Physicians have described GuideLiner as “a game changer” that allows them
`
`to “successfully complete previously unimaginable interventions.” (Root Decl. ¶ 45 &
`
`Ex. 15.)
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`Boston received FDA clearance for the Guidezilla in March 2013 (id. ¶ 56) and
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`launched the Guidezilla in June 2013 (Rasmussen Decl. ¶ 10 (filed under seal)). Boston
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`sells a wide range of medical devices and reported revenues of $7.2 billion in 2012.
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`(Root Decl., Ex. 17.)
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`Boston provided physicians testing Guidezilla with a “New Product Evaluation
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`Form” that included questions regarding how often the physician used Vascular’s
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`GuideLiner, how much a GuideLiner catheter was sold for, and requesting a comparison
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`of Guidezilla with GuideLiner, including “Pushability Performance,” “and “Overall
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`Deliverability.” (Root Decl. ¶ 67 & Ex. 28.) Boston provided the declaration of a
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`physician who had used both GuideLiner and Guidezilla (Decl. of Tony J. DeMartini,
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`M.D. ¶ 5, July 8, 2013, Docket No. 32), outlining differences between the devices (id.
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`¶¶ 5-8), and stating that “Guidezilla is easier to deliver to the treatment site . . . and
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`maintains its position better during the delivery of stents and other devices” (id. ¶ 8).
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`Boston and Vascular are currently competing for accounts with hospitals and
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`physicians. (See Root Decl. ¶ 113.) In at least one instance, a Boston sales representative
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`undercut Vascular’s price for GuideLiner by $29 per unit, causing that customer to
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`purchase Boston’s product instead. (id.; see also Second Root Decl. ¶ 45 (stating Boston
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`has repeatedly provided free samples of Guidezilla or offered it for sale at prices below
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`GuideLiner).)
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`I.
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`STANDARD OF REVIEW
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`ANALYSIS
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`“A plaintiff seeking a preliminary injunction must establish that he is likely to
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`succeed on the merits, that he is likely to suffer irreparable harm in the absence of
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`preliminary relief, that the balance of equities tips in his favor, and that an injunction is in
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`the public interest.” Apple Inc. v. Samsung Elecs. Co., 695 F.3d 1370, 1373-74 (Fed. Cir.
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`2012) (quoting Winter v. Natural Res. Def. Council, Inc., 555 U.S. 7, 20 (2008)) (citation
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`omitted). “These traditional four factors apply with equal force to disputes arising under
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`the Patent Act.” Id. (internal quotation marks omitted).
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`LIKELIHOOD OF SUCCESS
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`II.
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`In order to establish a likelihood of success on the merits, “the patentee seeking a
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`preliminary injunction in a patent infringement suit must show that it will likely prove
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`infringement, and that it will likely withstand challenges, if any, to the validity of the
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`patent.” Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1376 (Fed. Cir.
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`2009). To succeed on the merits Vascular must show that it will be able to prove
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`infringement and that its patents will withstand Boston Scientific’s attack on their
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`validity.
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`A.
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`Infringement – Construction of Lumen
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`“A finding of patent infringement requires a two-step process: first, the court
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`determines the meaning of the disputed claim terms, then the accused device is compared
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`to the claims as construed to determine infringement. Acumed LLC v. Stryker Corp., 483
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`F.3d 800, 804 (Fed. Cir. 2007) (citing Markman v. Westview Instruments, Inc., 52 F.3d
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`967, 976 (Fed. Cir. 1995), aff’d, 517 U.S. 370 (1996)).
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`Boston argues that Vascular will be unable to show infringement by the Guidezilla
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`device because the Guidezilla’s “substantially rigid portion” has at least one lumen and is
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`not, therefore, “without a lumen” as required by the Vascular patents. (See, e.g., ’032
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`patent, claim 1.) The relevant part of claim 1 states:
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`A device for use with a standard guide catheter . . . the device comprising:
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`. . .
`a substantially rigid portion proximal of and operably connected
`to, and more rigid along a longitudinal axis than, the flexible tip
`portion and defining a rail structure without a lumen and
`having a maximal cross-sectional dimension at a proximal portion
`that is smaller than the cross-sectional outer diameter of the
`flexible tip portion . . . .
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`
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`(Id.)
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`First, Boston argues that Guidezilla does not infringe because the Guidezilla collar
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`is part of the “substantially rigid portion” of the device and contains a lumen. Vascular
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`argues that the claim 1 does not require a “substantially rigid portion” without a lumen, it
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`requires a substantially rigid portion “defining a rail structure without a lumen.” (’032
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`patent, claim 1.) That is, the parties dispute whether “without a lumen” modifies “rail
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`structure” in the “substantially rigid portion” – rather than “without a lumen” modifying
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`“substantially rigid portion.”
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`Second, Boston argues that the Guidezilla does not infringe because its push rod is
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`a hypotube and so contains a lumen. Vascular argues that the Guidezilla’s push rod
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`lumen is not a “true” lumen because no medical device can pass through it. That is, the
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`parties dispute the construction of the “without a lumen” language of claim 1. Vascular
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`asks the Court to construe “lumen” as “the interior of a tubular structure, open at both
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`ends to allow the passage of medical devices (for example, stents or balloons) and
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`contrast medium.” (Pl.’s Mem. in Supp. at 22.) Boston argues that the Court should give
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`“lumen” its plain and ordinary meaning – and that “while a lumen may be open at one or
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`both ends, it need not be.” (Def.’s Mem. in Opp. at 12 (filed under seal).) In order to
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`determine if Vascular is likely to succeed on its infringement case, the Court must first
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`determine its likely construction of these disputed claim term.
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`
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`1.
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`Standard of Review: Claim Construction
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`Claim construction is a matter of law exclusively for the Court. Markman, 52
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`F.3d at 977-79. In construing claims, the Court should determine the “ordinary and
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`customary” meaning of the claim language to a person of skill in the art at the time of the
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`invention. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005). To determine
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`how a person of ordinary skill in the art would understand a claim term, the Court should
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`“read the claim term not only in the context of the particular claim in which the disputed
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`term appears, but in the context of the entire patent, including the specification.” Id. “In
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`some cases, the ordinary meaning of claim language as understood by a person of skill in
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`the art may be readily apparent even to lay judges, and claim construction in such cases
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`involves little more than the application of the widely accepted meaning of commonly
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`understood words.” Id. at 1314. If the meaning of a claim term as understood by person
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`of skill in the art is not immediately apparent, the Court should look to “the words of the
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`claims themselves, the remainder of the specification, the prosecution history, and
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`extrinsic evidence concerning relevant scientific principles, the meaning of technical
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`terms, and the state of the art.” Id. (quoting Innova/Pure Water, Inc. v. Safari Water
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`Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004)). The specification, however,
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`is “always highly relevant” and usually “dispositive; it is the single best guide to the
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`meaning of a disputed term.” Id. at 1315 (quoting Vitronics Corp. v. Conceptronic, Inc.,
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`90 F.3d 1576, 1582 (Fed. Cir. 1996)).
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`Although the Court can use extrinsic evidence as part of its claim construction
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`analysis, the Federal Circuit has cautioned that extrinsic evidence is “less significant” and
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`“less reliable.” Phillips, 415 F.3d at 1317-18. Extrinsic evidence includes “expert and
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`inventor testimony, dictionaries, and learned treatises.” Id. at 1317 (quoting Markman,
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`52 F.3d at 980). A dictionary definition may be relied on in construing claim terms “so
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`long as the dictionary definition does not contradict any definition found in . . . the patent
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`documents.” Vitronics, 90 F.3d at 1584 n.6.
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`2.
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`Construction of “Without a Lumen”
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`
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`Boston argues that Guidezilla does not infringe because the Guidezilla collar is
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`part of the “substantially rigid portion” of the device and contains a lumen. On the
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`evidence currently before the Court, however, the Court concludes that “without a
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`lumen” modifies “rail structure” – rejecting a construction that would require the entire
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`substantially rigid portion have no lumen. This interpretation is supported by the words
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`of claim 1, the words of the dependent claims, and the prosecution history. First, both the
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`words of the claim and the prosecution history suggest that a rail structure without a
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`lumen is one phrase. There is no “and” between “rail structure” and “without a lumen.”
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`The Examiner, in adding the entire phrase “rail structure without a lumen and” deleted
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`“structure.” (Root Decl., Ex. 39.) In addition, the rigid portion, as pictured in the patent,
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`includes a lumen. (’032 patent, 3:49-51 (“The rigid portion may