CASE 0:17-cv-01969-PJS-TNL Document 102 Filed 10/30/18 Page 1 of 32
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`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
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`QXMÉDICAL, LLC,
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`Case No. 17‐CV‐1969 (PJS/TNL)
`
`Plaintiff,
`
`v.
`
`ORDER
`
`VASCULAR SOLUTIONS, LLC; TELEFLEX
`INNOVATIONS S.À.R.L.; and ARROW
`INTERNATIONAL, INC.,
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`Defendants.
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`Courtland C. Merrill, Philip J. Kaplan, and Ariel O. Howe, ANTHONY
`OSTLUND BAER & LOUWAGIE P.A., for plaintiff.
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`Luke L. Dauchot and Alyse Wu, KIRKLAND & ELLIS LLP; and Tom Vitt
`and Patrick J. O’Rear, JONES DAY, for defendants.
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`This lawsuit involves six patents—U.S. Patent Nos. 8,048,032 (the “‘032 patent”),
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`8,142,413 (the “‘413 patent”), RE45,380 (the “‘380 patent”), RE45,760 (the “‘760 patent”),
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`RE45,776 (the “‘776 patent”), and RE46,116 (the “‘116 patent”). All six patents descend
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`from a common patent application and share a common specification and common
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`drawings. The patents are owned by defendant Teleflex Innovations S.à.r.l., whose
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`parent corporation acquired defendant Vascular Solutions, LLC, in February 2017.
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`A third defendant, Arrow International, Inc., has the right to sell products practicing the
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`patents. For convenience, the Court will refer to the defendants collectively as
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`“Vascular Solutions.”
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`Page 1
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`Medtronic Exhibit 1013
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`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
`
`QXMÉDICAL, LLC,
`
`Case No. 17‐CV‐1969 (PJS/TNL)
`
`Plaintiff,
`
`v.
`
`ORDER
`
`VASCULAR SOLUTIONS, LLC; TELEFLEX
`INNOVATIONS S.À.R.L.; and ARROW
`INTERNATIONAL, INC.,
`
`Defendants.
`
`Courtland C. Merrill, Philip J. Kaplan, and Ariel O. Howe, ANTHONY
`OSTLUND BAER & LOUWAGIE P.A., for plaintiff.
`
`Luke L. Dauchot and Alyse Wu, KIRKLAND & ELLIS LLP; and Tom Vitt
`and Patrick J. O’Rear, JONES DAY, for defendants.
`
`This lawsuit involves six patents—U.S. Patent Nos. 8,048,032 (the “‘032 patent”),
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`8,142,413 (the “‘413 patent”), RE45,380 (the “‘380 patent”), RE45,760 (the “‘760 patent”),
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`RE45,776 (the “‘776 patent”), and RE46,116 (the “‘116 patent”). All six patents descend
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`from a common patent application and share a common specification and common
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`drawings. The patents are owned by defendant Teleflex Innovations S.à.r.l., whose
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`parent corporation acquired defendant Vascular Solutions, LLC, in February 2017.
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`A third defendant, Arrow International, Inc., has the right to sell products practicing the
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`patents. For convenience, the Court will refer to the defendants collectively as
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`“Vascular Solutions.”
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`Page 1
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`Medtronic Exhibit 1013
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`CASE 0:17-cv-01969-PJS-TNL Document 102 Filed 10/30/18 Page 2 of 32
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`In April 2017, Vascular Solutions accused plaintiff QXMédical, LLC
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`(“QXMédical”) of patent infringement. In response, QXMédical brought this action,
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`seeking a declaration that its “Boosting Catheter” does not infringe any of Vascular
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`Solutions’s patents. This matter is before the Court for construction of certain terms of
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`the patents‐in‐suit in accordance with Markman v. Westview Instruments, Inc., 517 U.S.
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`370, 390‐91 (1996).
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`I. BACKGROUND
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`Vascular Solutions’s patents relate to a medical device known as a “guide
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`extension catheter.” A guide extension catheter is used by a heart surgeon to deliver an
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`interventional cardiology device (such as a balloon or stent) into a coronary artery.
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`Coronary arteries are the arteries that supply oxygenated blood from the aorta to
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`the heart muscle. The buildup of plaque inside a coronary artery can create a
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`“stenosis”—that is, a narrowing of the coronary artery—that decreases blood flow to
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`the heart and increases the risk of heart attack. A coronary artery stenosis looks
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`something like this:
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`CASE 0:17-cv-01969-PJS-TNL Document 102 Filed 10/30/18 Page 3 of 32
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`Root Decl. ¶ 8 (ECF No. 59).
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`One way to treat a stenosis is to use a balloon or stent to reopen the coronary
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`artery. Id. ¶ 10. To do so, of course, the surgeon must deliver the balloon or stent to the
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`site of the stenosis. Typically, the surgeon will first insert a long, thin tube called a
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`“guide catheter” into the patient’s femoral artery (near the patient’s groin) or the
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`patient’s radial artery (near the patient’s wrist). Then the surgeon will push the guide
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`catheter through the patient’s body until the tip of the guide catheter reaches the
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`opening (or “ostium”) of the coronary artery. Next, the surgeon will push a long, thin
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`wire—known as a “guidewire”—through the guide catheter, into the coronary artery,
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`and through the site of the stenosis. Finally, the surgeon will slide a balloon or stent
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`CASE 0:17-cv-01969-PJS-TNL Document 102 Filed 10/30/18 Page 4 of 32
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`along the guidewire to the site of the stenosis, where the balloon or stent will be
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`expanded. Id. ¶¶ 11‐13.
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`The guide catheter is relatively rigid and often has a curved tip. Id. ¶ 15. The
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`combination of these two characteristics means that it is generally unsafe for a surgeon
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`to extend the guide catheter past the ostium and into the coronary artery. Id. ¶¶ 15‐16.
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`That is why a surgeon uses a guidewire to deliver the balloon or stent to the site of the
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`stenosis. Sometimes, though, a surgeon has to push a balloon or stent through a
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`particularly difficult stenosis. In this situation, the resulting backwards force can cause
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`the guide catheter to dislodge, preventing the surgeon from successfully deploying the
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`balloon or stent. The dotted lines in the diagram below illustrate this problem:
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`Id. ¶¶ 12, 15‐17.
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`To solve this problem, inventors came up with the idea of using a second
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`catheter within the guide catheter. In this “coaxial” arrangement, the inner catheter (the
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`CASE 0:17-cv-01969-PJS-TNL Document 102 Filed 10/30/18 Page 5 of 32
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`“child catheter”) is straighter and more flexible than the outer catheter (the “mother
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`catheter”). This allows the child catheter to be pushed past the end of the mother
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`catheter and into the coronary artery, thereby anchoring the mother catheter and
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`reducing the likelihood of the mother catheter dislodging. The picture below illustrates
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`the use of a child catheter:
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`Id. ¶ 18.
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`Vascular Solutions did not invent the mother‐and‐child catheter system. But
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`Vascular Solutions combined the mother‐and‐child catheter system with another
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`concept known as a “monorail,” “rapid exchange,” or “sliding rail” system. Id. ¶ 22.
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`A typical child catheter is a long tube that runs along a guidewire from the beginning of
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`the mother catheter (that is, from the opening in the patient’s femoral artery or radial
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`artery) past the end of the mother catheter (that is, into the coronary artery). By
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`contrast, a monorail catheter is not tubular along its entire length. Instead, a monorail
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`catheter combines a short tube at the “distal” end (that is, the end closest to the heart)
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`with a long non‐tubular push rod at the “proximal” end (that is, the end closest to the
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`surgeon). The push rod “is used to push and retract the catheter but runs independent
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`of and next to the guidewire.” Id. ¶ 21. The drawing below depicts a monorail catheter:
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`Id. This drawing refers to the child catheter as “Guidewire Lumen.” All of the items
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`depicted in this drawing would be situated within the mother catheter.
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`The tip of Vascular Solutions’s child catheter is a flexible straight tube that is
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`small enough to fit inside a standard guide catheter but large enough to accommodate
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`the delivery of balloons and stents. Id. ¶ 23. Near or at the junction of the flexible tube
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`and the push rod is a side opening that serves as an entry port—first for the guidewire,
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`and then for the balloon or stent that is pushed along the guidewire, through the
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`flexible tube, and into the coronary artery. Root Decl. ¶¶ 23‐24.1
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`1It should be noted that the commercial embodiment described in the Root
`declaration—as well as some of the devices claimed in the patents‐in‐suit—do not look
`much like the embodiments described and illustrated in the specification.
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`CASE 0:17-cv-01969-PJS-TNL Document 102 Filed 10/30/18 Page 7 of 32
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`In 2006, Vascular Solutions2 filed a patent application for a monorail‐type child
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`catheter. This application was ultimately issued as the ‘032 patent. Claim 1 of the ‘032
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`patent contains most of the terms whose meaning is contested in this Markman
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`proceeding, and the parties agree that each of the contested terms has the same
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`meaning across all of the patents‐in‐suit. Claim 1 of the ‘032 patent claims the
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`following:
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`1. A device for use with a standard guide catheter, . . . the device
`comprising:
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`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
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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 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,
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`2Technically, Howard Root and his co‐inventors applied for the patent, but after
`the patent was issued, they assigned it to Vascular Solutions.
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`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.
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`‘032 patent at 10:21‐54.
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`II. GENERAL PRINCIPLES
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`Courts, not juries, construe patent claims. Markman, 517 U.S. at 391. Disputed
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`terms in a claim must be construed in the context of both that individual claim and “the
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`entire patent, including the specification.” Phillips v. AWH Corp., 415 F.3d 1303, 1313
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`(Fed. Cir. 2005) (en banc). Indeed, the specification, read in light of the prosecution
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`history, is the primary basis for construing patent claims. Id. at 1315. Courts may also
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`rely on “extrinsic evidence”—anything other than the patent and its prosecution
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`history—but that evidence is less important than the intrinsic record. Id. at 1317.
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`In general, claim language means whatever it would have meant, ordinarily and
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`customarily, to a person of ordinary skill in the relevant art at the time the patent
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`application was filed. Id. at 1312‐13. In some cases, the ordinary and customary
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`meaning of claim language to a person of ordinary skill in the art may be identical to the
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`meaning of that language to a lay person who is not skilled in the art. See id. at 1314
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`(acknowledging that claim construction sometimes “involves little more than the
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`application of the widely accepted meaning of commonly understood words”).
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`CASE 0:17-cv-01969-PJS-TNL Document 102 Filed 10/30/18 Page 9 of 32
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`Neither of the parties has devoted much attention to defining a person of
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`ordinary skill in the art for purposes of this Markman proceeding. QXMédical’s expert
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`identifies a person of ordinary skill in the art as “a person having a bachelor’s, or higher
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`level, degree in either biomedical or mechanical engineering, or a medical degree,
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`combined with extensive experience working for at least three years as an
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`interventional cardiologist, interventional radiologist, cardiothoracic surgeon,
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`interventionalist, or biomedical engineer, biomedical device designer and/or
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`manufacturer.” ECF No. 36‐3 ¶ 15. Vascular Solutions’s expert identifies a person of
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`ordinary skill in the art as a person having “(1) a minimum of five years of experience
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`performing or observing interventional cardiology procedures and (2) a minimum of
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`five years of experience designing or manufacturing catheters or other devices used in
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`such procedures . . . .” ECF No. 36‐2 ¶ 34. Neither party has argued that anything turns
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`on the differences between these definitions. Indeed, neither party has argued (or at
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`least clearly argued) that someone of ordinary skill in the art would interpret any of the
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`disputed language differently than would an educated lay person.
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`III. CLAIM CONSTRUCTION
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`A. “substantially rigid”
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`Claim 1 of the ‘032 patent describes the proximal portion of the claimed device as
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`being “substantially rigid.” ‘032 patent at 10:38. Both parties ask the Court to construe
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`this term.
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`QXMédical argues that “substantially rigid” means “largely, but not wholly
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`unable to bend or be forced out of shape; not flexible.” ECF No. 36‐1 at 2. It is not
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`apparent what would be gained by this construction. “Largely unable to bend” is no
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`clearer or more specific than “substantially rigid.” And “not flexible”—which connotes
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`no flexibility—would result in a device that does not work, as the substantially rigid
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`portion must be able to navigate the tortuous vascular system of a human being.
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`Vascular Solutions argues for a functional definition of “substantially rigid”:
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`“rigid enough to allow the device . . . to be advanced within the guide catheter.” ECF
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`No. 36‐1 at 2. It is not surprising that Vascular Solutions proposes a functional
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`definition. Unlike patents that provide specific guidance regarding the meaning of
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`terms of degree such as “substantially,”3 the only real evidence that the patents‐in‐suit
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`3See, e.g., BreathableBaby, LLC v. Crown Crafts, Inc., No. 12‐CV‐0094 (PJS/TNL),
`2013 WL 5230724, at *5 (D. Minn. Sept. 17, 2013) (specification defined “a substantial
`portion of a side rail” as “at least two‐thirds of the side rail”).
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`provide regarding the meaning of the term “substantially rigid” is their description of
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`the function of the substantially rigid portion.
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`Nonetheless, Vascular Solutions’s argument—that a structural limitation should
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`be defined in functional terms—initially gave this Court pause. After all, the Federal
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`Circuit has held that “[a]n invention claimed in purely structural terms generally resists
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`functional limitation.” Toro Co. v. White Consol. Indus., Inc., 266 F.3d 1367, 1371 (Fed. Cir.
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`2001). That is particularly true with respect to functions that are not recited in the
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`patent itself.
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`For example, in Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358 (Fed. Cir. 2001), one
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`of the claims described a solid detergent cast as “substantially uniform.” Id. at 1361.
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`The patentee persuaded the district court to construe “substantially uniform” to mean
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`“a level of continuity of the elements from top‐to‐bottom throughout the cast such that
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`a homogeneous cleaning solution is formed over the life of the cast.” Id. at 1363. On
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`appeal, however, the Federal Circuit noted that nothing in the intrinsic record provided
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`a basis for “adding a functional limitation” to the term “substantially uniform.” Id.
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`at 1366. Therefore, the Federal Circuit construed “substantially uniform” to mean
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`“largely, but not wholly the same in form,” and declined to add a “functional limitation
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`to this phrase.” Id. at 1369.
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`At the same time, the Federal Circuit has shown no reluctance to construe claim
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`limitations functionally when such a construction is supported by the intrinsic record.
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`For example, in Cordis Corp. v. Medtronic Ave, Inc., 511 F.3d 1157 (Fed. Cir. 2008), the
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`patent claimed a stent with a “smooth surface.” Id. at 1163. The district court defined
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`the term “smooth” structurally to mean “continuously even . . . , without roughness,
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`points, bumps or ridges . . . .” Id. at 1178. On appeal, however, the Federal Circuit
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`relied on the prosecution history to conclude that “the patentee intended for the term
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`‘smooth’ to be defined functionally, so that a stent would be considered ‘smooth’ if it
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`was smooth enough to be capable of intraluminal delivery.” Id. at 1180. Using that
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`functional definition, the Federal Circuit concluded that the defendant’s competing
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`product “infringed the ‘smooth surface’ limitation” because there was no dispute that it
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`was “capable of intraluminal delivery.” Id.
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`Similarly, in Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313 (Fed. Cir. 2005), the
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`Federal Circuit adopted a functional definition of “substantially uniform.” In Medrad,
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`the patent related to radio frequency coils that were used to create magnetic resonance
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`imaging (“MRI”) images. Id. at 1315. Citing Ecolab, the patentee argued that “it is never
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`proper for a court, when construing claim terms, to consider how a claimed device
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`functions.” Id. at 1319. The Federal Circuit rejected this argument, calling the
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`patentee’s reading of Ecolab “unsound” and holding that it is “entirely proper to
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`consider the functions of an invention in seeking to determine the meaning of particular
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`claim language.” Id. In Medrad, “the claim itself provide[d] little guidance” for how to
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`construe the term “substantially uniform.” Id. But the preamble of the patent claimed
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`“an imaging system for forming images of a region of interest.” Id. at 1320. The
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`specification stated that one object of the invention was “to provide greater image
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`uniformity than provided in the prior art.” Id. And an expert testified that “a
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`substantially uniform magnetic field ‘means a sufficient uniformity to give a good
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`image.’” Id. Therefore, the Federal Circuit defined a “substantially uniform magnetic
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`field” functionally to mean “a field that is sufficiently uniform to obtain useful MRI
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`images.” Id.
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`As in Cordis and Medrad, Vascular Solutions’s proposed functional definition is
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`amply supported by the record. That record makes at least two things clear about the
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`substantially rigid portion of the claimed device:
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`On the one hand, the substantially rigid portion must have a considerable degree
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`of flexibility. Otherwise, it would not be able to navigate past sharp bends in the
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`vascular system of a human being. This is clear from both the intrinsic and extrinsic
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`evidence. See, e.g., ECF No. 36‐2 ¶ 38 (stating that “the substantially rigid portion of the
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`device must be flexible enough to navigate the curve in the aorta and femoral and iliac
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`arteries and other angles in the arterial path”); see also Root Decl. ¶ 24 (describing the
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`substantially rigid portion of the embodiment as flexible enough “to bend to navigate
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`the arch in the aorta”).
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`On the other hand, the substantially rigid portion must be rigid enough to push
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`the tubular structure through the guide catheter and into the coronary artery. Neither
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`party contests this fact, which is supported not only by the specification’s description of
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`the functioning of the device, but by claim 1’s focus on the degree of rigidity along the
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`longitudinal axis: “a substantially rigid portion . . . more rigid along a longitudinal axis
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`than[] the flexible tip portion . . . .” ‘032 patent at 10:39‐40. It is difficult to imagine why
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`the claim would focus on the longitudinal rigidity of the substantially rigid portion
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`unless the purpose of the “substantially rigid” limitation is to ensure that the
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`substantially rigid portion will not buckle when it is used as a push rod.
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`The prosecution history also reflects the examiner’s understanding that the
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`purpose of the “substantially rigid” limitation is to ensure that the substantially rigid
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`portion can function as a push rod. Specifically, the examiner expressed his
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`understanding that “substantially rigid” was “only rigid enough to allow the device to
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`be advanced within the guide catheter.” ECF No. 60‐2 at 12. The examiner’s use of the
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`word “only” is puzzling, as it suggests that a push rod that is any more rigid than
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`necessary would not be “substantially rigid.” That would be a counterintuitive
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`construction that neither party advocates. But at a minimum, the examiner’s comments
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`provide further evidence that the function of the substantially rigid portion is to push
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`the tubular structure through the guide catheter and into the coronary artery.
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`In sum, given that Federal Circuit case law supports giving a functional
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`definition to a structural term when such a construction is supported by the intrinsic
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`record—and given that the intrinsic record in this case leaves little doubt that the main
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`function of the substantially rigid portion is to act as a push rod—the Court accepts
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`Vascular Solutions’s argument that “substantially rigid” should be defined in the
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`patents‐in‐suit as “rigid enough to allow the device to be advanced within the guide
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`catheter.”
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`The Court notes that Vascular Solutions’ victory may be short‐lived—or even
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`pyrrhic. QXMédical argues that Vascular Solutions’s construction cannot possibly be
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`correct. First, QXMédical argues that the material that comprises the flexible tip portion
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`is “rigid enough to allow the device to be advanced within the guide catheter.” In other
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`words, according to QXMédical, if the flexible tubular structure were to be extended to
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`run throughout the entire guide catheter (similar to a conventional child catheter), the
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`flexible tubular structure could essentially act as its own push rod. Likewise,
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`QXMédical argues that a guidewire is “rigid enough to allow the device to be advanced
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`within the guide catheter.” In other words, QXMédical argues that if the flexible
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`tubular structure was attached to the end of a guidewire, the guidewire could push the
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`structure through the guide catheter and into the coronary artery.
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`Second, claim 1 of the ‘032 patent is crystal clear that the substantially rigid
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`portion must be “more rigid . . . than[] the flexible tip portion.” ‘032 patent at 10:39‐40.
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`Moreover, according to QXMédical, the specification indicates that the guidewire is
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`flexible. Cf. ‘032 patent at 1:16‐29, 2:56‐62. Thus, concludes QXMédical, “substantially
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`rigid” cannot mean “rigid enough to allow the device to be advanced within the guide
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`catheter” because both the flexible tip portion and the guidewire are “rigid enough to
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`allow the device to be advanced within the guide catheter” and the patents make clear
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`that both the flexible tip portion and the guidewire are not “substantially rigid,” but
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`instead “flexible.”
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`QXMédical would have a compelling argument, but for one problem: The
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`evidence in the record simply does not allow the Court to determine whether the factual
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`premises of the argument are true. At the Markman hearing, QXMédical could not point
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`to any record evidence proving that the flexible tip portion or the guidewire was rigid
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`enough to act as a push rod. In its brief, QXMédical emphasized that the specification
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`“states that the flexible tip portion, although flexible, can be advanced within the guide
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`catheter.” ECF No. 63 at 12. But that’s a different point. It is one thing for the flexible
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`tip portion to be rigid enough to be pushed, and another thing for the flexible tip portion
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`to be rigid enough to do the pushing. QXMédical also cited several paragraphs from the
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`specification and claimed in a footnote that “the proximal portion of the child catheter is
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`‘rigid enough to advance’ the distal portion of the catheter within the mother guide
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`catheter . . . .” Id. at 12 n.3 (citing Root Decl. ¶ 17 and ‘032 patent at 2:17‐44). But the
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`cited portions of the ‘032 patent describe the use of a conventional child catheter—that is,
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`the long tubal child catheter of the prior art. See ‘032 patent at 2:17‐44. The record does
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`not indicate whether the material that comprises a prior‐art child catheter is more or
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`less rigid than the material that comprises the flexible tip portion of the patented
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`inventions. At this point, then, the Court cannot conclude that Vascular Solutions’s
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`proposed construction of “substantially rigid” would capture anything that the patents
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`describe as “flexible.”
`
`B. “flexible”
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`Claim 1 of the ‘032 patent describes the tip portion of the claimed device as being
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`“flexible.” ‘032 patent at 10:29. QXMédical argues that “flexible” should be construed
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`to mean “capable of bending; not rigid.” ECF No. 36‐1 at 5. Vascular Solutions argues
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`that no construction of “flexible” is necessary and that “flexible” should instead be
`
`given its plain and ordinary meaning. Id. The Court agrees with Vascular Solutions.
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`QXMédical’s proposed construction of “flexible” as “not rigid” would imply a
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`complete absence of rigidity. Such a construction would not be consistent with the
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`‐17‐
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`Page 17
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`Medtronic Exhibit 1013
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`
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`CASE 0:17-cv-01969-PJS-TNL Document 102 Filed 10/30/18 Page 18 of 32
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`claims and specification. In addition, construing “flexible” to mean “capable of
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`bending” would not add anything to the plain and ordinary meaning.
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`C. “rail structure”
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`Claim 1 of the ‘032 patent provides that the “substantially rigid portion” must
`
`“defin[e] a rail structure without a lumen.” ‘032 patent at 10:40‐41. The parties dispute
`
`the meaning of “rail structure.”
`
`Every monorail system consists of at least three elements: (1) a rail, (2) a car that
`
`rides on the rail, and (3) a source of locomotion. It is clear that, in the patented devices,
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`the “rail” is the guidewire. The flexible tubular portion of the device rides along the
`
`guidewire, as does the balloon or stent that follows. Nothing rides along the push rod.
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`And thus, the “rail structure” that is defined by the substantially rigid portion cannot be
`
`the rail. That leaves the car and the source of locomotion as possibilities.
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`QXMédical argues that “rail structure” refers to the car that rides along the
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`guidewire. See ECF No. 56 at 29 (“[I]n order for the substantially rigid portion claimed
`
`in VSI’s patents to ‘defin[e] a rail structure[,]’ the substantially rigid portion must either
`
`surround or at least create a partial circumference portion to hold or ‘ride’ on the
`
`guidewire.”). Consistent with that argument, QXMédical proposes that “rail structure”
`
`be defined to mean a “full‐circumferential, greater than 180 degrees, hemicylindrical or
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`arcuate‐shaped distal end [that is] able to ‘ride’ on a guidewire.” ECF No. 56 at 27.
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`‐18‐
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`Page 18
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`Medtronic Exhibit 1013
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`
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`CASE 0:17-cv-01969-PJS-TNL Document 102 Filed 10/30/18 Page 19 of 32
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`One problem for QXMédical is that nothing in the patents‐in‐suit explicitly
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`requires the “rail structure” that is defined by the substantially rigid portion to ride on
`
`the guidewire. And that is unsurprising. As the Court has already discussed, the main
`
`function of the substantially rigid portion is to push the flexible tip portion along the
`
`guidewire and into the coronary artery. It is the flexible tip portion—which, again, is
`
`the tube through which the guidewire is threaded—that rides along the guidewire. Not
`
`only is there no reason for the push rod to also ride along the guidewire, but, if it did so,
`
`it might interfere with the ability of a balloon or stent to later be moved along the same
`
`guidewire.
`
`QXMédical’s proposed construction runs into another problem. In order for the
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`“rail structure” to function as a car, it would need a lumen—or something close to a
`
`lumen. QXMédical recognizes this fact in proposing to define the rail structure as being
`
`“full circumferential, greater than 180 degrees, hemicylindrical or arcuate‐shaped.” But
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`the patents specifically forbid the rail structure from having a lumen. See ‘032 patent
`
`at 10:40‐41 (stating that the rail structure must be “without a lumen”). This means that
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`the rail structure cannot be “full circumferential.” This also raises the question of why, if
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`the rail structure is meant to be the car, the patents would provide that the car cannot
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`have a lumen—the structure that would best allow it to ride along the guidewire
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`without impeding the passage of balloons or stents.
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`‐19‐
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`Page 19
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`Medtronic Exhibit 1013
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`
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`CASE 0:17-cv-01969-PJS-TNL Document 102 Filed 10/30/18 Page 20 of 32
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`Of course, a car does not have to be fully circumferential to ride on the
`
`guidewire. A less‐than‐fully‐circumferential car can still ride on the guidewire by
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`gripping the guidewire rather tightly. But the problem with this approach has already
`
`been noted: Any car that gripped the guidewire tightly would impede the passage of a
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`balloon or stent along the same guidewire. The specification specifically mentions that
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`the rail segment must not “block[] use of the guide catheter” to deliver balloons and
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`stents. ‘032 patent at 2:55‐56. QXMédical’s attempt to define “rail structure” to mean,
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`in essence, the car that rides along the guidewire cannot be reconciled with the claims or
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`specification.
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`Given that the “rail structure” is neither the rail nor the car, the only major
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`component left is the source of locomotion—i.e., the push rod. Reflecting that fact,
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`Vascular Solutions asks that “rail structure” be defined as a “structure . . . that facilitates
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`monorail or sliding rail delivery,” ECF No. 36‐1 at 6—a definition that is sufficiently
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`broad to capture the push rod. The Court adopts Vascular Solutions’s proposed
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`definition.
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`‐20‐
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`Page 20
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`Medtronic Exhibit 1013
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`
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`CASE 0:17-cv-01969-PJS-TNL Document 102 Filed 10/30/18 Page 21 of 32
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`D. “lumen”
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`As the Court has already mentioned, claim 1 of the ‘032 patent specifies that the
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`rail structure cannot have a “lumen.” ‘032 patent at 10:40‐41. The parties disagree on
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`the meaning of “lumen.” In other words, the parties disagree about what cannot be
`
`included in the rail structure.
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`QXMédical asks the Court to construe “lumen” to mean a “passageway or
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`opening.” ECF No. 36‐1 at 6. Vascular Solutions asks the Court to construe “lumen”
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`more narrowly to mean a “passageway through which interventional cardiology
`
`devices are insertable.” Id. The Court declines to adopt either construction.
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`As a threshold matter, the Court rejects Vascular Solutions’s suggestion that
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`“lumen” refers to only some lumens—specifically, lumens that are large enough to
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`accommodate the passage of balloons and stents. The Court does so for two reasons:
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`First, claim 1 clearly specifies that the substantially rigid portion must define “a
`
`rail structure without a lumen.” ‘032 patent at 10:40‐41 (emphasis added). Claim 1 does
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`not say that the rail structure can have a lumen, as long as the lumen is small. And this
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`makes sense: As the specification makes clear—and as Vascular Systems itself has
`
`emphasized—it is important that the push rod take up as little space within the guide
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`catheter as possible, so as to leave space for the passage of balloons and stents along the
`
`‐21‐
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`Page 21
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`Medtronic Exhibit 1013
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`
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`CASE 0:17-cv-01969-PJS-TNL Document 102 Filed 10/30/18 Page 22 of 32
`
`guidewire. Requiring that the push rod have no lumen helps to accomplish that
`
`objective.
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`Second, if the Court were to read a size limitation into the term “lumen,” the
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`Court would render superfluous other language in the patents‐in‐suit. The claims and
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`specification of the patents often mention a lumen, and almost every time that a lumen
`
`is mentioned, its size is specified. For example, claim 1 of the ‘032 patent describes “the
`
`continuous lumen of the guide catheter” as “having a circular cross‐sectional inner
`
`diameter sized such that interventional cardiology devices are insertable into and
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`through the lumen.” ‘032 patent at 10:25‐28. Similarly, claim 1 describes the tip of the
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`child catheter as “defining a coaxial lumen having a cross‐sectional inner diameter
`
`through which interventional cardiology devices are insertable.” Id. at 10:35‐38. If
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`“lumen” meant what Vascular Solutions wants it to mean—a “passageway through
`
`which interventional cardiology devices are insertable”—then there would be no reason
`
`for the patents to provide (as they do repeatedly) that the lumens of both the guide
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`catheter and flexible tip portion must be large enough to allow the passage of
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`interventional cardiology devices. That size limitation would already be baked into the
`
`word “lumen.”
`
`Vascular Solutions points out that every mention of “lumen” in the patents “is in
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`connection with it serving as a passageway for inter
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