throbber
BSC USP 8,048,032
`Exhibit 1029
`
`Page 1 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 1 of 41
`
`UNITED STATES DISTRICT COURT
`
`DISTRICT OF MINNESOTA
`
`
`VASCULAR SOLUTIONS, INC.,
`
`
`Plaintiff,
`
`
`
`v.
`
`BOSTON SCIENTIFIC CORPORATION,
`
`
`
`Civil No. 13-1172 (JRT/SER)
`
`FILED UNDER SEAL
`
`MEMORANDUM OPINION AND
`ORDER GRANTING IN PART
`PLAINTIFF’S MOTION FOR A
`PRELIMINARY INJUNCTION
`
`Defendant.
`
`
`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
`
`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
`
`24
`
`

`
`Page 2 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 2 of 41
`
`preparing derivative works from Vascular’s Instructions for Use (“IFUs”) and copying or
`
`distributing copies of Guidezilla’s IFUs.
`
`
`
`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
`
`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
`
`preliminary injunction. To the extent Vascular seeks an injunction enjoining Boston
`
`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
`
`Vascular began working on its guide extension catheter in approximately 2004,
`
`filed its first patent application directed to the invention in 2006, and started selling its
`
`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.)
`
`
`
`- 2 -
`
`
`
`

`
`Page 3 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 3 of 41
`
`A.
`
`Cardiac Catheterization and Existing Methods and Devices
`
`In a cardiac catheterization procedure, a physician inserts a needle into the wrist
`
`
`
`(radial) or leg (femoral) artery of a patient. (See id. ¶ 9.) A guidewire is inserted through
`
`the needle. (See id.) An introducer sheath is introduced over the wire and is used to
`
`provide access for “guidewires, catheters, and stents” during either a diagnostic or
`
`interventional procedure. (Id. ¶¶ 8-9, 11.) Either a guidewire or a catheter may be
`
`inserted through the arteries to the aorta. (See id. ¶ 9.)
`
`
`(Id.) During an interventional catheterization procedure, a cardiologist must introduce a
`
`
`
`“guide catheter” deep into the coronary artery to deliver medical devices and stents, for
`
`example to treat coronary artery stenosis. (Id. ¶ 6, 11.)
`
`
`
`- 3 -
`
`
`
`

`
`Page 4 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 4 of 41
`
`
`(Id. ¶ 6.) In order to reach the coronary arteries, the inserted guidewire or catheter must
`
`
`
`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.)
`
`
`
`- 4 -
`
`
`
`

`
`Page 5 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 5 of 41
`
`
`(Id. ¶ 11 (modified).)
`
`
`
`
`
`Before Vascular’s invention, cardiologists used several types of standard guide
`
`catheters to place catheters and stents. One example of a standard guide catheter is an
`
`“over-the-wire” catheter. (See id. ¶ 19.) To use an over-the-wire catheter, the
`
`cardiologist inserts a guidewire first and then the catheter is delivered over the guidewire.
`
`(See id.)
`
`
`
`(Id.) One uninterrupted lumen runs the length of the catheter. (Id.)
`
`
`
`
`
`- 5 -
`
`
`
`

`
`Page 6 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 6 of 41
`
`Another type of guide catheter, the monorail or rapid exchange catheter, is also
`
`delivered over a guidewire, but the device’s lumen is shorter than the full length of the
`
`catheter and passes over only part of the wire. (See id. ¶ 20.) A push rod adds additional
`
`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.)
`
`
`
`
`
`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
`
`proximal end of the catheter for this purpose. (Id.)
`
`(Id. ¶ 19 (modified).)
`
`
`
`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.)
`
`
`
`- 6 -
`
`
`
`

`
`Page 7 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 7 of 41
`
`
`(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,
`
`any guidewires or devices already inserted through the mother catheter must be removed.
`
`(Id.)
`
`
`
`- 7 -
`
`
`
`

`
`Page 8 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 8 of 41
`
`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
`
`
`
`- 8 -
`
`
`
`

`
`Page 9 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 9 of 41
`
`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:
`
`
`
`
`
`
`
`- 9 -
`
`
`
`

`
`Page 10 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 10 of 41
`
`(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.).
`
`
`
`
`
`
`
`(’032 patent, Fig. 8 (modified).)
`
`
`
`- 10 -
`
`
`
`

`
`Page 11 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 11 of 41
`
`Vascular’s invention works much like the “mother and child” guide catheter –
`
`placing a smaller, more flexible catheter inside a larger, stiffer catheter. But unlike the
`
`mother-and-child system, no separate hemostatic valve is required on the child (or guide
`
`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
`
`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
`
`threading the lumen of the flexible portion of the guide extension catheter over the
`
`guidewire. (See id. 9:48-50; Root Decl. ¶ 26.) The flexible tip is pushed through the
`
`guide catheter by the push rod and out the end of the guide catheter, into the coronary
`
`artery. (’032 patent, 9:50-58; Root Decl. ¶ 26.) The cardiologist can then insert devices,
`
`such as stents, through the guide catheter, into the guide extension catheter, and out the
`
`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
`
`
`
`- 11 -
`
`
`
`

`
`Page 12 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 12 of 41
`
`the “flexible tip portion.” According to dependent claim 2, the “proximal portion” of the
`
`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
`
`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
`
`“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
`
`smaller than the cross-sectional inner diameter of the guide catheter.” (’032 patent, claim
`
`
`
`- 12 -
`
`
`
`

`
`Page 13 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 13 of 41
`
`8.) A standard guide catheter has a diameter measured on the French scale where 1F is
`
`1/3mm. (Root Decl. ¶ 12.)2
`
`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.)
`
`
`
`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
`
`“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.)
`
`
`
`- 13 -
`
`
`
`

`
`Page 14 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 14 of 41
`
`(Id. ¶ 72.)
`
`
`
`The parties dispute, however, whether Guidezilla has “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,” 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
`
`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.)
`
`
`
`
`
`
`
`- 14 -
`
`
`
`

`
`Page 15 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 15 of 41
`
`(Id.) The hypotube is crushed flat at the other end for the final 2 cm before it is welded to
`
`the metal collar. (Id. ¶ 78.)
`
`
`(Id.) The middle of the hypotube is, nevertheless, still open in the middle, although the
`
`
`
`parties agree that there is no access to the opening.
`
`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
`
`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
`
`
`3 The Adams patent is now expired.
`
`
`
`
`
`- 15 -
`
`
`
`

`
`Page 16 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 16 of 41
`
`was assigned to SciMed Life Systems, Inc. – a company acquired by Boston in
`
`November 1994. (Def.’s Mem. in Opp. at 3 (filed under seal).)4 Adams claims a device
`
`for use in cardiac catheterization procedures (Adams patent 2:35-43) and discloses a
`
`“flexible tube” (id. 2:44) that can “extend from a distal end of a guide catheter” into the
`
`coronary arteries (id. 2:46-47, 52-57). Adams also discloses a “push rod” (id. 2:47) or
`
`“shaft” (id. 6:14) that is used to adjust the location of the flexible tube (see id. 6:56-65).
`
`(See also 7:13-21 (describing a tubular shaft member “preferably formed from stainless
`
`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.)
`
`
`
`- 16 -
`
`
`
`

`
`Page 17 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 17 of 41
`
`
`(Adams patent Fig. 12 (modified).)
`
`
`
`
`
`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
`
`flared interface (or funnel) is shown in the figure below:
`
`
`
`
`(Adams patent, Fig. 2 (modified).) The funnel “serves to direct an angioplasty device
`
`
`
`into the lumen of the extension.” (Adams patent, 16:12-13 (internal labels omitted).)
`
`
`
`- 17 -
`
`
`
`

`
`Page 18 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 18 of 41
`
`Adams notes that the “tube . . . does not have sufficient pushability to be independently
`
`advanced through the coronary artery of a patient” and that it must be advanced “in
`
`cooperation with another coronary treatment device.” (Id. 16:16-18)
`
`The expandable restriction balloon as an interface between the guide catheter and
`
`the flexible tube is shown in the following figure:
`
`
`
`
`(Id. Fig. 3 (modified).)
`
`
`III.
`
`
`INSTRUCTIONS FOR USE
`
`
`
`Vascular alleges that Boston copied “virtually every word” of the “Deployment
`
`Procedure” section of the GuideLiner IFU. (See Root Decl. ¶ 66 & Ex. 25-26.) The only
`
`material words Boston changed were the name of the device. (See id.)
`
`
`
`- 18 -
`
`
`
`

`
`Page 19 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 19 of 41
`
`For example:
`
`
`(Root Decl. ¶ 66.) Vascular copyrighted the IFU for GuideLiner. (Id. ¶ 65 & Ex. 27.) A
`
`
`
`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:
`
`
`
`
`
`
`
`- 19 -
`
`
`
`

`
`Page 20 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 20 of 41
`
`(Root Decl. ¶ 39.) GuideLiner sales currently make up about 20% of Vascular’s revenue
`
`– its 2012 revenue totaled $98 million – and GuideLiner is Vascular’s fastest growing
`
`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.)
`
`
`
`Boston received FDA clearance for the Guidezilla in March 2013 (id. ¶ 56) and
`
`launched the Guidezilla in June 2013 (Rasmussen Decl. ¶ 10 (filed under seal)). Boston
`
`sells a wide range of medical devices and reported revenues of $7.2 billion in 2012.
`
`(Root Decl., Ex. 17.)
`
`
`
`Boston provided physicians testing Guidezilla with a “New Product Evaluation
`
`Form” that included questions regarding how often the physician used Vascular’s
`
`GuideLiner, how much a GuideLiner catheter was sold for, and requesting a comparison
`
`of Guidezilla with GuideLiner, including “Pushability Performance,” “and “Overall
`
`Deliverability.” (Root Decl. ¶ 67 & Ex. 28.) Boston provided the declaration of a
`
`physician who had used both GuideLiner and Guidezilla (Decl. of Tony J. DeMartini,
`
`M.D. ¶ 5, July 8, 2013, Docket No. 32), outlining differences between the devices (id.
`
`¶¶ 5-8), and stating that “Guidezilla is easier to deliver to the treatment site . . . and
`
`maintains its position better during the delivery of stents and other devices” (id. ¶ 8).
`
`
`
`- 20 -
`
`
`
`

`
`Page 21 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 21 of 41
`
`Boston and Vascular are currently competing for accounts with hospitals and
`
`physicians. (See Root Decl. ¶ 113.) In at least one instance, a Boston sales representative
`
`undercut Vascular’s price for GuideLiner by $29 per unit, causing that customer to
`
`purchase Boston’s product instead. (id.; see also Second Root Decl. ¶ 45 (stating Boston
`
`has repeatedly provided free samples of Guidezilla or offered it for sale at prices below
`
`GuideLiner).)
`
`
`
`
`I.
`
`
`STANDARD OF REVIEW
`
`ANALYSIS
`
`“A plaintiff seeking a preliminary injunction must establish that he is likely to
`
`succeed on the merits, that he is likely to suffer irreparable harm in the absence of
`
`preliminary relief, that the balance of equities tips in his favor, and that an injunction is in
`
`the public interest.” Apple Inc. v. Samsung Elecs. Co., 695 F.3d 1370, 1373-74 (Fed. Cir.
`
`2012) (quoting Winter v. Natural Res. Def. Council, Inc., 555 U.S. 7, 20 (2008)) (citation
`
`omitted). “These traditional four factors apply with equal force to disputes arising under
`
`the Patent Act.” Id. (internal quotation marks omitted).
`
`
`LIKELIHOOD OF SUCCESS
`
`II.
`
`
`In order to establish a likelihood of success on the merits, “the patentee seeking a
`
`preliminary injunction in a patent infringement suit must show that it will likely prove
`
`infringement, and that it will likely withstand challenges, if any, to the validity of the
`
`patent.” Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1376 (Fed. Cir.
`
`2009). To succeed on the merits Vascular must show that it will be able to prove
`
`
`
`- 21 -
`
`
`
`

`
`Page 22 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 22 of 41
`
`infringement and that its patents will withstand Boston Scientific’s attack on their
`
`validity.
`
`
`A.
`
`
`
`Infringement – Construction of Lumen
`
`“A finding of patent infringement requires a two-step process: first, the court
`
`determines the meaning of the disputed claim terms, then the accused device is compared
`
`to the claims as construed to determine infringement. Acumed LLC v. Stryker Corp., 483
`
`F.3d 800, 804 (Fed. Cir. 2007) (citing Markman v. Westview Instruments, Inc., 52 F.3d
`
`967, 976 (Fed. Cir. 1995), aff’d, 517 U.S. 370 (1996)).
`
`Boston argues that Vascular will be unable to show infringement by the Guidezilla
`
`device because the Guidezilla’s “substantially rigid portion” has at least one lumen and is
`
`not, therefore, “without a lumen” as required by the Vascular patents. (See, e.g., ’032
`
`patent, claim 1.) The relevant part of claim 1 states:
`
`A device for use with a standard guide catheter . . . the device comprising:
`
`. . .
`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 . . . .
`
`
`
`(Id.)
`
`First, Boston argues that Guidezilla does not infringe because the Guidezilla collar
`
`is part of the “substantially rigid portion” of the device and contains a lumen. Vascular
`
`argues that the claim 1 does not require a “substantially rigid portion” without a lumen, it
`
`
`
`- 22 -
`
`
`
`

`
`Page 23 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 23 of 41
`
`requires a substantially rigid portion “defining a rail structure without a lumen.” (’032
`
`patent, claim 1.) That is, the parties dispute whether “without a lumen” modifies “rail
`
`structure” in the “substantially rigid portion” – rather than “without a lumen” modifying
`
`“substantially rigid portion.”
`
`Second, Boston argues that the Guidezilla does not infringe because its push rod is
`
`a hypotube and so contains a lumen. Vascular argues that the Guidezilla’s push rod
`
`lumen is not a “true” lumen because no medical device can pass through it. That is, the
`
`parties dispute the construction of the “without a lumen” language of claim 1. Vascular
`
`asks the Court to construe “lumen” as “the interior of a tubular structure, open at both
`
`ends to allow the passage of medical devices (for example, stents or balloons) and
`
`contrast medium.” (Pl.’s Mem. in Supp. at 22.) Boston argues that the Court should give
`
`“lumen” its plain and ordinary meaning – and that “while a lumen may be open at one or
`
`both ends, it need not be.” (Def.’s Mem. in Opp. at 12 (filed under seal).) In order to
`
`determine if Vascular is likely to succeed on its infringement case, the Court must first
`
`determine its likely construction of these disputed claim term.
`
`
`
`
`
`1.
`
`Standard of Review: Claim Construction
`
`Claim construction is a matter of law exclusively for the Court. Markman, 52
`
`F.3d at 977-79. In construing claims, the Court should determine the “ordinary and
`
`customary” meaning of the claim language to a person of skill in the art at the time of the
`
`invention. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005). To determine
`
`how a person of ordinary skill in the art would understand a claim term, the Court should
`
`
`
`- 23 -
`
`
`
`

`
`Page 24 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 24 of 41
`
`“read the claim term not only in the context of the particular claim in which the disputed
`
`term appears, but in the context of the entire patent, including the specification.” Id. “In
`
`some cases, the ordinary meaning of claim language as understood by a person of skill in
`
`the art may be readily apparent even to lay judges, and claim construction in such cases
`
`involves little more than the application of the widely accepted meaning of commonly
`
`understood words.” Id. at 1314. If the meaning of a claim term as understood by person
`
`of skill in the art is not immediately apparent, the Court should look to “the words of the
`
`claims themselves, the remainder of the specification, the prosecution history, and
`
`extrinsic evidence concerning relevant scientific principles, the meaning of technical
`
`terms, and the state of the art.” Id. (quoting Innova/Pure Water, Inc. v. Safari Water
`
`Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004)). The specification, however,
`
`is “always highly relevant” and usually “dispositive; it is the single best guide to the
`
`meaning of a disputed term.” Id. at 1315 (quoting Vitronics Corp. v. Conceptronic, Inc.,
`
`90 F.3d 1576, 1582 (Fed. Cir. 1996)).
`
`Although the Court can use extrinsic evidence as part of its claim construction
`
`analysis, the Federal Circuit has cautioned that extrinsic evidence is “less significant” and
`
`“less reliable.” Phillips, 415 F.3d at 1317-18. Extrinsic evidence includes “expert and
`
`inventor testimony, dictionaries, and learned treatises.” Id. at 1317 (quoting Markman,
`
`52 F.3d at 980). A dictionary definition may be relied on in construing claim terms “so
`
`long as the dictionary definition does not contradict any definition found in . . . the patent
`
`documents.” Vitronics, 90 F.3d at 1584 n.6.
`
`
`
`
`
`- 24 -
`
`
`
`

`
`Page 25 of 41
`
`CASE 0:13-cv-01172-JRT-SER Document 76 *SEALED* Filed 12/09/13 Page 25 of 41
`
`2.
`
`Construction of “Without a Lumen”
`
`
`
`Boston argues that Guidezilla does not infringe because the Guidezilla collar is
`
`part of the “substantially rigid portion” of the device and contains a lumen. On the
`
`evidence currently before the Court, however, the Court concludes that “without a
`
`lumen” modifies “rail structure” – rejecting a construction that would require the entire
`
`substantially rigid portion have no lumen. This interpretation is supported by the words
`
`of claim 1, the words of the dependent claims, and the prosecution history. First, both the
`
`words of the claim and the prosecution history suggest that a rail structure without a
`
`lumen is one phrase. There is no “and” between “rail structure” and “without a lumen.”
`
`The Examiner, in adding the entire phrase “rail structure without a lumen and” deleted
`
`“structure.” (Root Decl., Ex. 39.) In addition, the rigid portion, as pictured in the patent,
`
`includes a lumen. (’032 patent, 3:49-51 (“The rigid portion may include a cutout portion
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket