QXMedical, LLC v. Vascular Solutions, Inc.
Filing
156
ORDER granting in part and denying in part 122 Motion for Summary Judgment; granting in part and denying in part 130 Motion for Summary Judgment. See order for details. (Written Opinion) Signed by Judge Patrick J. Schiltz on 10/2/2019. (ECW)
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 and Philip J. Kaplan, ANTHONY OSTLUND BAER
& LOUWAGIE P.A., for plaintiff.
J. Thomas Vitt, Emily Justine Tait, Patrick J. O’Rear, and Sanjiv Prakash
Laud, JONES DAY; Kenneth E. Levitt, DORSEY & WHITNEY, for
defendants.
This lawsuit involves six patents—U.S. Patent Nos. 8,048,032 (the “‘032 patent”),
8,142,413 (the “‘413 patent”), RE45,380 (the “RE’380 patent”), RE45,760 (the “RE’760
patent”), RE45,776 (the “RE’776 patent”), and RE46,116 (the “RE’116 patent”). All six
patents descend from a common patent application and share a common specification
and common drawings. The patents are owned by defendant Teleflex Innovations
S.à.r.l., whose parent corporation acquired defendant Vascular Solutions, LLC, in
February 2017. A third defendant, Arrow International, Inc., has the right to sell
products practicing the patents. For convenience, the Court will refer to the defendants
collectively as “Vascular Solutions.”
In April 2017, Vascular Solutions accused plaintiff QXMédical, LLC of patent
infringement. In response, QXMédical brought this action, seeking a declaration that its
Boosting Catheter does not infringe any of Vascular Solutions’s patents and that
Vascular Solutions’s patents are invalid. Vascular Solutions counterclaimed, seeking
judgment against QXMédical for infringement.
On October 30, 2018, the Court issued an order construing certain terms of the
patents in suit pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370, 390‐91
(1996). See QXMédical, LLC v. Vascular Solutions, No. 17‐CV‐1969 (PJS/TNL), 2018 WL
5617568, at *1 (D. Minn. Oct. 30, 2018). After the close of discovery, the parties filed
cross‐motions for summary judgment. For the reasons that follow, the Court mostly
grants Vascular Solutions’s motion, and mostly denies QXMédical’s motion.
I. BACKGROUND
The Court will assume familiarity with its Markman order. Very briefly, the
patents in suit relate to a medical device known as a “guide extension catheter.” A
guide extension catheter is used by a heart surgeon to deliver a balloon or stent into a
coronary artery that has been narrowed by a buildup of plaque. The surgeon pushes
the guide extension catheter though a larger catheter (known as the “guide catheter”),
-2-
and then pushes the balloon or stent through the guide extension catheter and into the
coronary artery.
The GuideLiner catheter that Vascular Solutions manufactures is depicted in the
following diagram:
ECF No. 125‐22 at 32.1 The GuideLiner catheter manufactured by Vascular
Solutions—as well as the Boosting Catheter manufactured by QXMédical—are
composed of three main parts: (1) a pushrod, (2) a side opening, and (3) a flexible tip.
In this diagram, the pushrod is on the left, the side opening is in the middle (within the
blue section), and the flexible tip is on the right (in yellow).
1
When citing documents by ECF number, the Court cites the page number
generated by the electronic docketing system rather than the document’s internal
pagination.
-3-
II. DISCUSSION
A. Standard of Review
Summary judgment is warranted “if the movant shows that there is no genuine
dispute as to any material fact and the movant is entitled to judgment as a matter of
law.” Fed. R. Civ. P. 56(a). A dispute over a fact is “material” only if its resolution
might affect the outcome of the suit under the governing substantive law. Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A dispute over a fact is “genuine” only if
“the evidence is such that a reasonable jury could return a verdict for the nonmoving
party.” Id. When considering a summary‐judgment motion, the Court “must view the
evidence and the inferences that may be reasonably drawn from the evidence in the
light most favorable to the non‐moving party.” Winthrop Res. Corp. v. Eaton Hydraulics,
Inc., 361 F.3d 465, 468 (8th Cir. 2004).
B. Validity—Indefiniteness of “Substantially Rigid”
All of the claims asserted against QXMédical disclose a “substantially rigid”
segment, which is informally referred to as the “pushrod.” QXMédical argues that
these claims are fatally indefinite because of the way that the Court defined
“substantially rigid” in its Markman order. Both parties have moved for summary
judgment on the issue.
-4-
“A claim is invalid for indefiniteness if its language, when read in light of the
specification and the prosecution history, ‘fail[s] to inform, with reasonable certainty,
those skilled in the art about the scope of the invention.’” Biosig Instruments, Inc. v.
Nautilus, Inc., 783 F.3d 1374, 1377 (Fed. Cir. 2015) (citation omitted). Because a patent is
presumed to be valid, an accused infringer must prove indefiniteness by clear and
convincing evidence. See Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91, 95 (2011).
Summary judgment may be granted on the issue of indefiniteness when there is no
genuine dispute as to any material fact. See Akzo Nobel Coatings, Inc. v. Dow Chem. Co.,
811 F.3d 1334, 1336 (Fed. Cir. 2016) (affirming a district court’s grant of summary
judgment that a patent is not invalid for indefiniteness).
In its Markman order, the Court adopted a functional definition of “substantially
rigid,” construing the term to mean “rigid enough to allow the device to be advanced
within the guide catheter.” QXMédical, 2018 WL 5617568, at *5. QXMédical does not
actually argue that the term (as defined by the Court) is indefinite. In other words,
QXMédical does not argue that a person of ordinarily skill in the art would have any
difficulty determining whether a particular portion of a guide extension catheter is rigid
enough to push a flexible tubular structure through a guide catheter.
Rather, QXMédical argues that the problem with the Court’s definition is that a
portion of a guide extension catheter could be both “substantially rigid” and “flexible.”
-5-
Specifically, QXMédical contends that the material that comprises the tip portion (which
must be “flexible”) might be “rigid enough to allow the device to be advanced within
the guide catheter” (and thus also “substantially rigid”). Likewise, the pushrod (which
must be “substantially rigid”) must be able to bend enough to navigate the vascular
system of a human being (and thus must also be “flexible”). Under the Court’s
definition, says QXMédical, a person of ordinary skill would be unable to distinguish
the “substantially rigid” portion of the device from the “flexible” portion.
The problem with QXMédical’s argument is that its premise is flawed: Nothing
in any of the patents in suit says that “substantially rigid” and “flexible” are mutually
exclusive. In other words, nothing in any of the patents says that a segment of the
device cannot be both “substantially rigid” and “flexible.” Instead, the claims that
disclose a “flexible tip” portion simply require that the substantially‐rigid pushrod be
“more rigid” than the flexible tip. See, e.g., ‘032 at 10:38‐40 (emphasis added). This is a
comparative limitation—a limitation that would be superfluous if “substantially rigid”
and “flexible” were mutually exclusive categories. See Bicon, Inc. v. Straumann Co., 441
F.3d 945, 950 (Fed. Cir. 2006) (“[C]laims are interpreted with an eye toward giving effect
to all terms in the claim.”).
QXMédical’s argument that “substantially rigid” and “flexible” are mutually
exclusive is also belied by its own proposed constructions of those terms. During the
-6-
Markman proceedings, QXMédical asked the Court to define “substantially rigid” as
“largely, but not wholly unable to bend,” and “flexible” as “capable of bending.” ECF
No. 56 at 21. Obviously something that is ”largely, but not wholly unable to bend” (and
thus “substantially rigid” as QXMédical would define that term) is also “capable of
bending” (and thus “flexible” as QXMédical would define that term). In other words,
under QXMédical’s own proposed definitions, anything that is “substantially rigid”
would necessarily be “flexible” as well.
There is, at bottom, no evidence in the record supporting QXMédical’s argument
that a person of ordinary skill would be unable to distinguish between the
“substantially rigid” pushrod and the “flexible” distal tip. The experts on both sides
agree that a person of ordinary skill would have no trouble determining whether a
pushrod is “rigid enough to allow the device to be advanced within the guide catheter.”
See ECF No. 134‐2 at 4‐5; ECF No. 137 at 31‐32. And the experts on both sides agree that
a person of ordinary skill would have no difficulty determining whether a substantially
rigid pushrod is “more rigid” than a flexible tip portion. ECF No. 134‐2 at 6; ECF No.
137 at 31‐33.2
2
Not all of the asserted claims describe the distal tip as “flexible,” and the claims
that do not are clearly not indefinite. QXMédical’s indefiniteness challenge relies on the
indeterminacy allegedly created by the interplay between “substantially rigid” and
“flexible.” There is no such interplay in claims that do not use the term “flexible.”
-7-
Because there is no evidence—much less clear and convincing evidence—that the
boundaries of the claims cannot be understood by a person of ordinary skill, the Court
grants Vascular Solutions’s motion for summary judgment on the issue of
indefiniteness.
C. Validity—Recapture Rule
The ‘032 patent claims a pushrod “without a lumen.” Three of the reissued
patents—the RE’760, RE’776, and RE’116 patents—do not include this limitation,
however, and thus those reissued patents claim pushrods that have lumens, as well as
pushrods that do not. The parties dispute whether, by removing the “without a lumen”
limitation from the reissued patents, Vascular Solutions violated the “recapture rule”
and thereby rendered those patents invalid.
The recapture rule “prevents a patentee from regaining through reissue the
subject matter that he surrendered in an effort to obtain allowance of the original
claims.” In re Clement, 131 F.3d 1464, 1468 (Fed. Cir. 1997). “To decide whether a
patentee surrendered certain subject matter, [courts] must determine ‘whether an
objective observer viewing the prosecution history would conclude that the purpose of
the patentee’s amendment or argument’ . . . [was] ‘to overcome prior art and secure the
patent.’” Greenliant Sys., Inc. v. Xicor LLC, 692 F.3d 1261, 1267 (Fed. Cir. 2012) (quoting
Kim v. ConAgra Foods, Inc., 465 F.3d 1312, 1323 (Fed. Cir. 2006)). A reissued claim is
-8-
invalid if it violates the rule against recapture. MBO Labs., Inc. v. Becton, Dickinson &
Co., 602 F.3d 1306, 1313 (Fed. Cir. 2010). Whether a reissued claim violates the recapture
rule is a question of law. Medtronic, Inc. v. Guidant Corp., 465 F.3d 1360, 1373 (Fed. Cir.
2006).
Courts follow a three‐step inquiry when deciding if a patentee has violated the
recapture rule:
“(1) first, we determine whether, and in what respect, the
reissue[d] claims are broader in scope than the original
patent claims; (2) next, we determine whether the broader
aspects of the reissue[d] claims relate to subject matter
surrendered in the original prosecution; and (3) finally, we
determine whether the reissue[d] claims were materially
narrowed in other respects, so that the claims may not have
been enlarged, and hence avoid the recapture rule.”
Greenliant Sys., 692 F.3d at 1267 (quoting N. Am. Container, Inc. v. Plastipak Packaging,
Inc., 415 F.3d 1335, 1349 (Fed. Cir. 2005)). “[T]he recapture rule applies only if the
patentee surrendered subject matter in the original prosecution in order to overcome a
prior art rejection.” Cubist Pharm., Inc. v. Hospira, Inc., 805 F.3d 1112, 1121 (Fed. Cir.
2015).
Here, the parties agree that the reissued claims are broader in scope than the
original claims, as the reissued claims capture all pushrods, and not just pushrods
without a lumen (step one). The parties also agree that the reissued claims were not
materially narrowed in other respects, such that the overall scope of the reissued claims
-9-
is not broader than the original claims (step three). The parties disagree about step two.
Specifically, the parties dispute whether Vascular Solutions added the “without a
lumen” limitation during the prosecution of the ‘032 patent “in order to overcome a
prior art rejection.” Id.
There is no factual dispute about the history of the ‘032 patent’s prosecution:
In May 2006, Vascular Solutions sought a patent for a guide extension catheter
with a pushrod described as a “substantially rigid portion.” ECF No. 125‐3 at 27. This
patent would have covered pushrods with and without lumens. The examiner denied
the application as obvious in light of prior art. Specifically, the examiner concluded that
the claims were “unpatentable over Niazi . . . in view of Solar.” ECF No. 125‐4 at 3.
Solar discloses a rapid exchange balloon catheter with a pushrod “formed of a flexible
wire, or, alternately, of spring hollow hypotubing.” ECF No. 125‐18 at 12. Thus, the
prior art cited by the examiner included both a pushrod with a lumen (the Solar
embodiment with hypotubing, see ECF No. 125‐2 at 23 (describing a hypotube as a
“hollow metal shaft”)), and a pushrod without a lumen (the Solar embodiment with the
wire pushrod, ECF No. 134‐2 at 4).
In February 2010, Vascular Solutions filed new claims describing its pushrod as
“an elongated structure . . . having a non‐circular cross‐section.” ECF No. 125‐9 at 4, 19.
The examiner rejected those claims because they failed to comply with the written‐
-10-
description requirement, 35 U.S.C. § 112(a), and they were obvious in light of prior art,
ECF No. 125‐10. The examiner wrote that “it would have been an obvious matter of
design choice to a person of ordinary skill to modify [Solar’s pushrod] to be
non‐circular . . . because a non‐circular cross‐section would have the ability to perform
the same function as the rod taught by Solar with only the expected result of
minimizing the profile of the rod inside the device.” ECF No. 125‐10 at 7.
In response, Vascular Solutions requested a continued examination and amended
the proposed claim language to cover “non‐tubular” and “non‐circular” pushrods. ECF
No. 125‐11 at 7, 10. The examiner rejected the amendment as obvious and because it
lacked an adequate written description. ECF No. 125‐12.
In February 2011, Vascular Solutions amended its claims yet again, this time
describing the pushrod as “more rigid . . . than[] the flexible tip portion.” ECF No.
125‐15 at 9, 22. In response, the examiner proposed an amendment describing the
pushrod as a “rail structure without a lumen.” Vascular Solutions accepted the
proposal, and the examiner finally allowed the application. ECF No. 125‐16. The
examiner explained that he allowed the application because “the arrangement of a
claimed rail structure with the claimed flexible tip that is insertable through a
hemostatic valve is not taught or suggested by the prior art.” Id. at 7.
-11-
The question for this Court is whether this prosecution history provides clear
and convincing evidence that Vascular Solutions surrendered pushrods that have
lumens in order to overcome a prior‐art rejection. The complication, of course, is that
the “without a lumen” limitation was proposed by the examiner, not Vascular
Solutions. The examiner did not explain why he proposed that particular limitation,
and Vascular Solutions did not explain why it accepted the limitation. Moreover,
whatever the motivations of the examiner and Vascular Solutions, it is absolutely clear
that the “without a lumen” limitation was not in fact necessary to overcome the prior
art, as Solar disclosed pushrods without lumens.
QXMédical nevertheless argues that Vascular Solutions surrendered pushrods
that have lumens in order to overcome a prior‐art rejection. In support of its argument,
QXMédical cites language in the Manual of Patent Examining Procedure (“the manual”)
addressing the following situation: Suppose that a patent application claims A+B+C.
Suppose further that the examiner denies the application because the prior art already
discloses A+B+C. If the applicant adds limitation D to A+B+C without explaining
why—and if the application gets approved—then, according to the manual, “it must be
presumed that the D limitation was added to obviate the rejection” even if “there is no
argument as to the addition of limitation D.” M.P.E.P § 1412.02.
-12-
According to QXMédical, the hypothetical case described in the manual is
materially identical to the facts of this case. Vascular Solutions submitted a patent
application claiming all pushrods. The examiner denied the application. Vascular
Solutions then added the “without a lumen” limitation at the examiner’s suggestion,
without any explanation as to why such a limitation was necessary. The application
was approved. And thus, argues QXMédical, the manual directs the Court to presume
that the “without a lumen” limitation was added to overcome prior art.
The Court has its doubts, as QXMédical’s argument overlooks the fact that the
hypothetical case described in the manual is distinguishable from this case in one
crucial respect: In the hypothetical case described in the manual, the D limitation added
a limitation that was not taught by the prior art. Here, however, the “without a lumen”
limitation was taught by the prior art. It makes no sense to presume that the “without a
lumen” limitation was added to overcome prior art, when it is clear that the prior art
disclosed a pushrod without a lumen. See ECF 134‐2 at 4 (QXMédical’s expert agreeing
that Solar disclosed a pushrod without a lumen).
The Court will nevertheless assume (for the sake of argument) that QXMédical is
correct and that the manual’s so‐called “presumption of surrender” applies. That
-13-
presumption is not dispositive, but is instead rebuttable.3 The Court finds that there is
ample evidence in the prosecution history to rebut the presumption:
First, as the Court has already explained, no rational patent examiner could have
believed that the “without a lumen” limitation was necessary to overcome prior art.
The examiner was intimately familiar with Solar,4 and Solar clearly and undisputedly
discloses a pushrod without a lumen. If the patent examiner was competent (as he is
presumed to be5), he could not possibly have suggested adding “without a lumen” to
escape prior art.
Second, in trying to discern the reason for the examiner’s proposed amendment,
the Court need not apply a presumption because the examiner explained the reason why
3
See In re Clement, 131 F.3d at 1469 (“Deliberately canceling or amending a claim
in an effort to overcome a reference strongly suggests that the applicant admits that the
scope of the claim before the cancellation or amendment is unpatentable, but it is not
dispositive because other evidence in the prosecution history may indicate the contrary.”
(emphasis added)).
4
Patent Examiner Bradley J. Osinski wrote all six rejections of Vascular
Solutions’s ‘032 patent applications. See ECF Nos. 125‐4, 125‐6, 125‐8, 125‐10, 125‐12,
125‐14. Every one of those rejections discusses Solar, and every one of those discussions
specifically mentions Solar’s pushrod.
5
This presumption is well‐supported by case law. See K/S Himpp v. Hear‐Wear
Techs., LLC, 751 F.3d 1362, 1369 (Fed. Cir. 2014) (“The assumption that PTO examiners
will use their knowledge of the art when examining patents is the foundation for the
presumption in 35 U.S.C. § 282(a) that issued patents are valid.”); see also Microsoft Corp.,
564 U.S. at 97 (explaining that § 282 codified the common‐law presumption of patent
validity based on “the basic proposition that a government agency such as the [PTO]
was presumed to do its job” (citation and quotation marks omitted)).
-14-
he allowed the amended application: “While many of the structures are known, the
arrangement of a claimed rail structure with the claimed flexible tip that is insertable
through a hemostatic valve is not taught or suggested by the prior art.” ECF No. 125‐16
at 7. This explanation is admittedly vague in some respects, but it is clear on one point:
The addition of the “without a lumen” limitation had nothing to do with the examiner’s
decision to allow the application. Indeed, the examiner does not even mention that
limitation in explaining why he allowed the application.6
6
QXMédical relies on MBO Laboratories, Inc. v. Becton, Dickinson & Co., 602 F.3d
1306 (Fed. Cir. 2010), in which the Federal Circuit invalidated four claims of a reissued
patent because the patentee violated the recapture rule. But MBO Laboratories is
distinguishable. In MBO Laboratories, the inventor of a hypodermic safety syringe
successfully persuaded the examiner to allow its original patent application by pointing
out that two items of prior art involved a guard that moved forward to cover a fixed
needle, whereas its invention involved a needle being retracted backward into a fixed
guard. Id. at 1315. In the reissued patent, however, the inventor claimed both guards
that moved forward to cover needles and needles that moved backward into guards. Id.
The patentee argued (among other things) that because both techniques were disclosed
in the prior art, the patentee could not have surrendered either technique when it
emphasized its retractable needle. Id. at 1316. The Federal Circuit disagreed, holding,
in essence, that when a patentee clearly and unmistakably argues in the prosecution of
its original patent that its invention does not cover certain subject matter in order to
overcome some prior art, the recapture rule applies even if the surrender of the subject
matter did not overcome other prior art. Id. (“The fact that some of the prior art may
have disclosed a retractable needle cannot save MBO’s reliance on its retractable needle
to distinguish other prior art.”).
Here, however, Vascular Solutions did not argue that the “without a lumen”
limitation was necessary to overcome any prior art. Indeed, Vascular Solutions did not
even propose the “without a lumen” limitation. Moreover, the examiner who did
propose the limitation (and who eventually allowed the ‘032 patent) never expressed
(continued...)
-15-
For these reasons, the Court finds that Vascular Solutions has overcome any
presumption that the “without a lumen” limitation was added to overcome prior art.
Because there is no genuine dispute that Vascular Solutions did not surrender pushrods
with lumens “in order to overcome a prior art rejection,” Cubist Pharm., 805 F.3d at 1121,
the Court will grant Vascular Solutions’s motion for summary judgment that the
RE’760, RE’776, and RE’116 patents do not violate the recapture rule.
D. Infringement—Lumen
The ‘032, ‘413, and RE’380 patents all disclose a pushrod “without a lumen.”
Both parties move for summary judgment on whether the Boosting Catheter meets this
limitation.
1. Literal Infringement
Vascular Solutions argues that the Boosting Catheter literally infringes the
asserted claims because it does not have a lumen. QXMédical argues that the Boosting
Catheter does not literally infringe the asserted claims because it does have a lumen.
The Court is inclined to agree with Vascular Solutions, but, for the reasons discussed on
the record at the hearing, the Court finds that a reasonable jury could agree with either
6
(...continued)
the opinion that the “without a lumen” limitation was necessary to overcome prior art.
To the contrary, the examiner made it clear that he was concerned about a particular
item of prior art (Solar) that disclosed pushrods without lumens. The limitation that he
proposed obviously was not intended to overcome that aspect of the prior art.
-16-
party, and thus the Court denies both summary‐judgment motions on literal
infringement. This issue will be tried.
2. Doctrine of Equivalents
Next, Vascular Solutions argues that, even if the Boosting Catheter does not
literally infringe—that is, even if the Boosting Catheter does have a lumen—the
Boosting Catheter nevertheless infringes under the doctrine of equivalents.
“Infringement under the doctrine of equivalents requires the patentee to prove that the
accused device contains an equivalent for each limitation not literally satisfied.”
Wi‐Lan, Inc. v. Apple, Inc., 811 F.3d 455, 463 (Fed. Cir. 2016). “An element in the accused
product is equivalent to a claim limitation if the differences between the two are
‘insubstantial’ to one of ordinary skill in the art.” Catalina Mktg. Int’l v. Coolsavings.com,
Inc., 289 F.3d 801, 812 (Fed. Cir. 2002) (citation omitted). Whether an accused device
infringes under the doctrine of equivalents is a question of fact. Akzo Nobel Coatings,
Inc., 811 F.3d at 1342. Consequently, summary judgment of noninfringement is
appropriate only when “the evidence is such that no reasonable jury could determine
two elements to be equivalent.” Id. (citation and quotation marks omitted).
The Court concludes that the question of infringement under the doctrine of
equivalents, like the question of literal infringement, must be tried to a jury. The parties
have submitted conflicting expert reports regarding whether the Boosting Catheter’s
-17-
pushrod (which has a microscopic hollow space that runs its length) is the equivalent of
a pushrod without a lumen. Resolving this dispute is “an intensely factual inquiry”
best suited for a jury. Toro Co. v. White Consol. Indus., Inc., 266 F.3d 1367, 1369 (Fed. Cir.
2001) (citation and quotation marks omitted).
QXMédical raises several defenses to application of the doctrine of equivalents,
including (1) claim vitiation, (2) prosecution‐history estoppel, and (3) ensnarement of
prior art. These are all legal defenses that the Court—not the jury—must resolve. See
Warner‐Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 39 n.8 (1997) (explaining that
“the various legal limitations on the application of the doctrine of equivalents” such as
claim vitiation or prosecution‐history estoppel are to be “determined by the court”);
DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1324 (Fed. Cir. 2009)
(ruling that ensnarement is a “question of law” which must be decided by the court).
The Court need not rule on the merits of these defenses at this time, however. If
the jury finds literal infringement, then the jury will not be asked to determine whether
the Boosting Catheter infringes under the doctrine of equivalents, and the Court will not
have to rule on QXMédical’s defenses to that doctrine. Likewise, if the jury finds no
literal infringement and no infringement under the doctrine of equivalents, the Court
will not have to rule on QXMédical’s defenses. Only if the jury finds that the Boosting
Catheter does not literally infringe but does infringe under the doctrine of equivalents
-18-
will the Court be required to rule on QXMédical’s defenses. See G. David Jang, M.D. v.
Boston Sci. Corp., 872 F.3d 1275, 1288 (Fed. Cir. 2017) (giving district courts discretion
about when and how to rule on an ensnarement defense). In that event, QXMédical
may raise its defenses “on a motion for judgment as a matter of law at the close of the
evidence and after the jury verdict.” Warner‐Jenkinson Co., 520 U.S. at 39 n.8.
E. Infringement—“One French”
The patents in suit generally disclose a guide extension catheter “for use with” a
guide catheter. See, e.g., ‘032 at 10:21; RE’380 at 10:57; RE’776 at 13:36, 15:15. Certain of
the asserted claims—specifically, claim 8 of the ‘032 patent (apparatus), claim 8 of the
RE’380 patent (system), claims 25 and 48 of the RE’760 patent (system), claims 30 and 53
of the RE’776 patent (apparatus), and claim 25 of the RE’116 patent (method)—require
that the “tubular structure” of the guide extension catheter have a “cross‐sectional inner
diameter” that is “not more than one French smaller than the cross‐sectional inner
diameter of the guide catheter.” See, e.g., ‘032 at 11:17‐20. As noted, these claims
include apparatus, system, and method claims.
Vascular Solutions argues that one device manufactured by QXMédical—its
6 French Boosting Catheter model BC57‐150 (“6F Boosting Catheter”)—directly
infringes the apparatus claims. Vascular Solutions also argues that QXMédical has
-19-
induced others to infringe the system and method claims. The Court will first analyze
the apparatus claims, and then turn to the system and method claims.
1. Direct Infringement of the Apparatus Claims
The 6F Boosting Catheter plainly meets the “for use with” limitation. “The
Federal Circuit has generally held that use of the word ‘for’ within apparatus claims
provides functional limitations that ‘describe capabilities . . . .’” M2M Sols. LLC v.
Motorola Sols., Inc., No. 12‐33‐RGA, 2016 WL 70814, at *4 (D. Del. Jan. 6, 2016) (quoting
Finjan, Inc. v. Secure Computing Corp., 626 F.3d 1197, 1204‐05 (Fed. Cir. 2010)); see
Ericsson, Inc. v. D‐Link Sys., Inc., 773 F.3d 1201, 1216‐17 (Fed. Cir. 2014) (explaining how
“for preventing,” “for arranging,” and “for obtaining” are examples of claim limitations
reciting capability). Here, “for use with” recites a capability that the patented device
must have—specifically, the capability of being used with a guide catheter. See HSM
Portfolio LLC v. Elpida Memory Inc., 160 F. Supp. 3d 708, 720 (D. Del. 2016) (interpreting
the claim language “for receiving” to recite capability); McAfee Enters., Inc. v. Yamaha
Corp., CV 2:16‐2562 BRO (FFM), 2016 WL 6920675, at *2 (C.D. Cal. June 24, 2016)
(interpreting the claim language “for counting” to recite capability).
The Federal Circuit has repeatedly explained that a claim limitation reciting
capability is satisfied so long as the accused device is “reasonably capable” of being
used in an infringing manner. Ericsson, Inc., 773 F.3d at 1217; see Finjan, Inc., 626 F.3d
-20-
at 1204 (“[T]o infringe a claim that recites capability and not actual operation, an
accused device ‘need only be capable of operating’ in the described mode.” (citation
omitted)). Here, there is no dispute that the 6F Boosting Catheter is “reasonably
capable” of being used with a guide catheter. Without question, then, the 6F Boosting
Catheter meets the “for use with” limitation.
Unfortunately for Vascular Solutions, however, the 6F Boosting Catheter does not
meet the one‐French limitation. The one‐French limitation recites structure, not
capability. An accused device cannot meet a structural limitation in an apparatus claim
unless the limitation is present in the device as it comes off of the assembly line. The
fact that the accused device is “reasonably capable of being put into the claimed
configuration is insufficient for a finding of infringement.” Ball Aerosol & Specialty
Container, Inc. v. Ltd. Brands, Inc., 555 F.3d 984, 995 (Fed. Cir. 2009).
To meet the one‐French limitation, then, a device must incorporate both a guide
catheter and a guide extension catheter, and the guide extension catheter must not be
more than one French smaller than the guide catheter. The 6F Boosting Catheter
obviously does not meet this limitation, as it is only a guide extension catheter. It does
not incorporate a guide catheter of any size.
QXMédical does not manufacture guide catheters, sell guide catheters, or
package the 6F Boosting Catheter with a guide catheter. Instead, a surgeon will
-21-
purchase a 6F Boosting Catheter from QXMédical and pair it with a guide catheter that
the surgeon purchases from another manufacturer. Depending on the size of the guide
catheter chosen by the surgeon, the 6F Boosting Catheter may or may not be more than
one French smaller than the guide catheter. Critically, though, that decision will be
made by the surgeon based on the needs of the patient, not by QXMédical.
This case resembles Cross Medical Products, Inc. v. Medtronic Sofamor Danek, Inc.,
424 F.3d 1293 (Fed. Cir. 2005). Cross Medical owned an apparatus patent covering an
orthopedic surgical implant used to stabilize and align the bones of a patient’s spine.
The asserted claim recited a “device for the posterior stabilization of one or more bone
segments of the spine” comprising, among other things, “a lower bone interface
operatively joined to said bone segment.” Id. at 1299 (emphasis omitted). The district
court construed “operatively joined” to mean “connect[ed] during a surgical
procedure,” and further defined “connect[ed]” to mean “in contact.” Id. at 1305.
Cross Medical argued that the “operatively joined” limitation was directed to
capability, not structure, and thus the accused device (manufactured by Medtronic)
infringed because it was capable of being operatively joined to a bone segment.
Medtronic argued that the “operatively joined” limitation was directed to structure, not
capability, and thus the accused device did not infringe because, as it came off of the
assembly line, it was not “operatively joined” to a bone segment.
-22-
The Federal Circuit agreed with Medtronic, finding that the “operatively joined”
limitation “does not require that the interface be merely ‘capable’ of contacting bone;
the claim has a structural limitation that the anchor seat be in contact with bone.” Id. at
1311. The Federal Circuit held that “Medtronic does not directly infringe” because it
“does not itself make an apparatus with the ‘interface’ portion in contact with bone.” Id.
According to the Federal Circuit, ”if anyone makes the claimed apparatus, it is the
surgeons.” Id.
Like the “operatively joined” limitation in Cross Medical, the one‐French
limitation is directed to structure, not capability. The 6F Boosting Catheter does not
meet that structural limitation because, as it comes off the assembly line, its “tubular
structure” does not have a “cross‐sectional inner diameter” that is “not more than one
French smaller than the cross‐sectional inner diameter of the guide catheter.” ‘032 at
11:17‐20. That limitation can be met only later, after a surgeon—a third party over
whom QXMédical has no control—chooses to pair the 6F Boosting Catheter with a
guide catheter of a particular size. And thus, “if anyone makes the claimed apparatus,
it is the surgeons.” Cross Medical, 424 F.3d at 1311.7 QXMédical is entitled to summary
7
See also Omega Patents, LLC v. CalAmp Corp., 920 F.3d 1337, 1345 (Fed. Cir. 2019)
(holding that an accused infringer was entitled to JMOL of no direct infringement
where the patentee “[did] not provide all the required claim elements” because a third
party provided the cell tower which enabled all of the limitations of the systems claim
to be met); Acantha LLC v. DePuy Orthopaedics Inc., No. 15‐C‐1257, 2018 WL 1951228, at
(continued...)
-23-
judgment that its 6F Boosting Catheter does not directly infringe any apparatus claim
that includes the one‐French limitation.8
2. Indirect Infringement of the System and Method Claims9
7
(...continued)
*4 (E.D. Wis. Apr. 25, 2018) (granting summary judgment of no direct infringement to
defendants because the claim was not met until an independent third party assembled
the accused product to create the completed structure); Energy Heating, LLC v. Heat
On‐the‐Fly, LLC, No. 4:13‐CV‐10, 2013 WL 5954805, at *8 (D.N.D. Nov. 6, 2013) (refusing
to find infringement where the “claimed apparatus is not complete until the final
limitation” is fulfilled, “not by [the accused infringer], but by [a third party]”); Lutron
Elecs. Co. v. Crestron Elecs., Inc., 970 F. Supp. 2d 1229, 1233‐36 (D. Utah 2013) (refusing to
find infringement where the accused device omitted a structural limitation that would
not be met until the accused infringers sold the device to the distributors who then
made changes which met the claim limitation).
8
Vascular Solutions devotes three sentences of its 60 pages of briefing to arguing
that QXMédical directly infringed the apparatus claims containing the one‐French
limitation when it tested the 6F Boosting Catheter. Although “[t]esting is a use of the
invention that may infringe under § 271(a),” Waymark Corp. v. Porta Sys. Corp., 245 F.3d
1364, 1366 (Fed. Cir. 2001), the factual record and legal analysis that the parties have
provided are not adequate to allow the Court to rule on Vascular Solutions’s claim as a
matter of law. The claim will have to be tried.
9
In its briefing and during oral argument, Vascular Solutions appeared to argue
that QXMédical induced infringement when it tested its own products. This is an odd
argument. If QXMédical committed direct infringement during product testing, then it
can be held liable for that direct infringement, but it cannot also be held liable for
inducing itself to infringe. If QXMédical did not commit direct infringement during
product testing, then it obviously cannot be held liable for inducing infringement,
because there was no infringement. See AIDS Healthcare Found. v. Gilead Sci., Inc., 890
F.3d 986, 992‐93 (Fed. Cir. 2018) (finding no induced infringement where there was no
underlying act of direct infringement).
-24-
Vascular Solutions alleges that a surgeon who uses a 6F Boosting Catheter with a
guide catheter that has a lumen of .070 inches or less directly infringes system and
method claims containing the one‐French limitation. Its math is as follows: The
6F Boosting Catheter has an inner diameter of .057 inches. One French equals .0131
inches. Thus, if the 6F Boosting Catheter is used with a guide catheter that has a lumen
of .070 inches or less, the one‐French limitation is met; if it is used with a guide catheter
that has a lumen of .071 inches or more, the limitation is not met.
Vascular Solutions further argues that QXMédical should be held liable for
inducing any such infringement by a surgeon. “Whoever actively induces infringement
of a patent shall be liable as an infringer.” 35 U.S.C. § 271(b). In order to hold
QXMédical liable for induced infringement, Vascular Solutions must establish (1) an
underlying act of direct infringement by a surgeon (or someone else), Limelight
Networks, Inc. v. Akamai Techs., Inc., 134 S. Ct. 2111, 2115 (2014); and (2) that QXMédical
“took an affirmative act to encourage infringement with the knowledge that the
induced acts constitute patent infringement,” Microsoft Corp. v. DataTern Inc., 755 F.3d
899, 904 (Fed. Cir. 2014).
-25-
a. Underlying Act of Direct Infringement
Vascular Solutions does not have evidence that anyone has ever directly
infringed one of its system or method claims, with one exception: Dr. Yale Wang—a
heart surgeon who is affiliated with QXMédical—performed all of the claimed steps
when, in the course of operating on a patient, he used a 6F Boosting Catheter with a .070
guide catheter. ECF No. 134‐2 at 14‐15. Thus, Vascular Solutions has shown that the
method claim has been directly infringed, Akamai Techs., Inc. v. Limelight Networks, Inc.,
797 F.3d 1020, 1022 (Fed. Cir. 2015) (en banc) (per curiam) (“Direct infringement under
§ 271(a) occurs where all steps of a claimed method are performed by or attributable to
a single entity.”), and that the systems claims have been directly infringed, Georgetown
Rail Equip. Co. v. Holland L.P., 867 F.3d 1229, 1239 (Fed. Cir. 2017) (“[D]irect
infringement by use of a system claim requires a party . . . to use each and every . . .
element of a claimed system.” (citation and quotation marks omitted)).
b. Inducement
In order to hold QXMédical liable for Dr. Wang’s single instance of infringement,
Vascular Solutions must prove that QXMédical took an affirmative act with the specific
intent of inducing Dr. Wang to infringe. See Cleveland Clinic Found. v. True Health
Diagnostics LLC, 859 F.3d 1352, 1364 (Fed. Cir. 2017); Tegal Corp. v. Tokyo Electron Co., 248
F.3d 1376, 1378‐79 (Fed. Cir. 2001). “[M]ere inaction” in the face of infringement by a
-26-
third party is not sufficient. Tegal Corp., 248 F.3d at 1379; see Takeda Pharm. U.S.A., Inc. v.
West‐Ward Pharm. Corp., 785 F.3d 625, 630‐31 (Fed. Cir. 2015) (selling a product while
knowing that an unaffiliated third party may engage in infringing uses in not enough to
create inducement liability); see also Beverly Hills Fan Co. v. Royal Sovereign Corp., 21 F.3d
1558, 1569 (Fed. Cir. 1994) (explaining that “active inducement of infringement requires
the commission of an affirmative act”). Vascular Solutions must also show that the
affirmative act taken by QXMédical in fact led Dr. Wang to infringe. See Dynacore
Holdings Corp. v. U.S. Philips Corp., 363 F.3d 1263, 1274 (Fed. Cir. 2004) (“To prevail
under a theory of indirect infringement, Dynacore must first prove that the defendants’
actions led to direct infringement of the [patent].”); see also DSU Med. Corp. v. JMS Co.,
471 F.3d 1293, 1304 (Fed. Cir. 2006) (en banc) (explaining that the “plaintiff has the
burden of showing that the alleged infringer’s actions induced infringing acts”).
Vascular Solutions cannot meet its burden. Vascular Solutions provided no
evidence that QXMédical engaged in any “affirmative act” with the specific intent to
induce Dr. Wang to infringe, much less any evidence that any such act led to Dr.
Wang’s infringing conduct. Vascular Solutions points out that QXMédical has
repeatedly said—in the patents themselves, in its submissions to the Food and Drug
Administration, in its instructions for use, and in its marketing materials—that its
6F Boosting Catheter is generally compatible with “guide catheters” or “standard guide
-27-
catheters” or “6F guide catheters.” Because guide catheters come in both “infringing”
(.070 inches or smaller) and “non‐infringing” (.071 inches or larger) sizes, Vascular
Solutions argues that QXMédical’s communications are the type of affirmative conduct
that can given rise to liability for induced infringement.
The Court disagrees. In its instructions for use, QXMédical specifically instructs
surgeons not to use the 6F Boosting Catheter with guide catheters that are .070 inches or
smaller. ECF No. 125‐23 at 5‐6. QXMédical does so not for any medical reason, but
(presumably) to prevent surgeons from directly infringing any of Vascular Solutions’s
patents, and to protect QXMédical from induced‐infringement claims. Given that
QXMédical instructs surgeons not to infringe—and given the broad nature of
QXMédical’s general communications about the compatibility of the 6F Boosting
Catheter with standard guide catheters—the Court does not believe that a reasonable
jury could find that these communications represent affirmative acts undertaken with
the specific intent to induce surgeons to infringe. And, in any event, the only instance
of direct infringement of which Vascular Solutions is aware is a single procedure
conducted by Dr. Wang, and Vascular Solutions has no evidence that any of the
challenged communications were read by Dr. Wang or had any impact on his decision
to use a 6F Boosting Catheter with a .070‐inch guide catheter during that procedure.
-28-
For these reasons, the Court grants summary judgment to QXMédical on
Vascular Solutions’s induced‐infringement claims.
F. Infringement—Side Opening
Three of the reissued patents require the side opening of the guide extension
catheter to be more rigid than the tubular structure.10 RE’760 at 14:6‐7, 15:51‐53; RE’776
at 13:41‐49, 15:22‐28; RE’116 at 17:21‐24. Both parties move for summary judgment on
whether the Boosting Catheter meets this limitation.11
As illustrated below, the tubular structure of the Boosting Catheter contains two
marker bands, one near the side opening and the other near the distal end:
10
The patents use different language to convey the same basic idea: the portion of
the guide extension catheter that contains or comprises the opening to the tubular
structure must be more rigid than the tubular structure itself. See, e.g., RE’760 at 14:5‐7
(claiming a “material forming the segment defining the side opening” that is “more
rigid than the tubular structure”); RE’776 at 15:22‐28 (claiming a “segment defining the
partially cylindrical opening” that is “formed from a material having a greater flexural
modulus than a flexural modulus of the tubular structure”). For ease of reference, the
Court will refer simply to the “side opening” being more rigid than the “tubular
structure.”
11
The parties do not agree on what counts as the “segment defining the side
opening” on the Boosting Catheter. As the parties acknowledged at oral argument,
however, the Court need not resolve that dispute in order to rule on QXMédical’s
“marker band” defense.
-29-
ECF No. 124 at 33.
QXMédical asserts that the material forming these marker bands is more rigid
than the material forming the side opening. Thus, says QXMédical, the Boosting
Catheter does not infringe because, thanks to the presence of the marker bands, the
Boosting Catheter’s side opening is not more rigid than its tubular structure. The Court
will refer to this as the “marker‐band defense.”
Vascular Solutions has two responses. First, Vascular Solutions argues that
QXMédical waived the marker‐band defense by failing to adequately disclose the
defense in its noninfringement chart. And second, Vascular Solutions argues that the
marker‐band defense fails because the Boosting Catheter’s side opening is more rigid
than its tubular structure, when the tubular structure is considered as a whole (as
Vascular Solutions says it should be).
The Court agrees with Vascular Solutions that QXMédical did not provide
adequate notice of its marker‐band defense. The pretrial scheduling order required
QXMédical to “indicate with specificity the elements, on the Claim Chart of the party
alleging infringement . . . which it contends are absent” and “set forth in detail the basis
for its contention that the element is absent.” ECF No. 20 at 4 (emphasis added); see
also ECF Nos. 45, 98, 106. QXMédical did not come close to following these instructions
with respect to its marker‐band defense. Instead, QXMédical’s claim chart vaguely
-30-
asserted that the Boosting Catheter did not infringe the relevant claims because “the
proximal opening to the Boosting Catheter tube is not more rigid than the distal end of
the tube.” ECF 134‐14 at 4. That “disclosure” did nothing more than parrot the relevant
claim language. It did not explain at all—much less “in detail”—why the element was
absent. It gave Vascular Solutions no clue that QXMédical intended to argue that the
element was not met because of the presence of the two marker bands in the tubular
structure.
Had Vascular Solutions been given notice of QXMédical’s marker‐band defense,
Vascular Solutions undoubtedly would have asked the Court during the Markman
proceedings to construe the term “tubular structure” to mean, roughly speaking, “the
tubular structure as a whole,” rather than any isolated portion of the tubular structure.
Indeed, in responding to QXMédical’s marker‐band defense, Vascular Solutions mostly
relies on arguments about the meaning of “tubular structure.” To resolve those
arguments, the Court would have to conduct a second Markman proceeding, and then a
second round of summary‐judgment motions. The Court is unwilling to conduct—or
force Vascular Solutions to endure—multiple Markman and summary‐judgment
proceedings. That is precisely why the Court ordered the parties to disclose their
positions “in detail” in their claim charts.
-31-
QXMédical was on notice that violating the pretrial scheduling order could result
in sanctions. The scheduling order itself warned that “[f]ailure to comply with any
provision of this Order . . . shall subject the non‐complying party . . . to any and all
appropriate remedies, sanctions and the like.” ECF No. 20 at 9; see also ECF Nos. 45, 98,
106. These remedies include “waiver of rights to object; exclusion or limitation of
witnesses, testimony, exhibits and other evidence; . . . and/or any other relief that this
Court may from time to time deem appropriate.” Id. The Federal Rules of Civil
Procedure likewise caution litigants that “the court may issue any just orders” to
sanction a party who “fails to obey a scheduling or other pretrial order.” Fed. R. Civ.
P. 16(f)(1). Among the sanctions available for violating a scheduling order is
“prohibiting the disobedient party from supporting or opposing designated claims or
defenses, or from introducing designated matters in evidence.” Fed. R. Civ. P.
37(b)(2)(A)(ii).
Because QXMédical violated the pretrial scheduling order by failing to disclose
its marker‐band defense, the Court will not permit QXMédical to assert that defense at
this late date. The Court finds that such a sanction is warranted in light of the fact that
QXMédical has no excuse for its failure to disclose its marker‐band defense and the fact
that permitting QXMédical to assert its marker‐band defense at this point would
prejudice Vascular Solutions and compromise the Court’s ability to manage this
-32-
litigation. See Changzhou Kaidi Elec. Co. v. Okin Am., Inc., 112 F. Supp. 3d. 330, 337‐38 (D.
Md. 2015) (barring consideration of invalidity theories as a sanction for not disclosing
those theories in the manner required by the local rules); see also SanDisk Corp. v.
Memorex Prods., Inc., 415 F.3d 1278, 1292 (Fed. Cir. 2005) (granting “broad deference to
the trial court’s application of local procedural rules in view of the trial court’s need to
control the parties and flow of litigation before it” and affirming a district court’s
exclusion of evidence pertaining to theories of claim construction and infringement not
disclosed as required by the local patent rules and the court’s scheduling order).
Vascular Solutions has moved for summary judgment that the Boosting Catheter
meets the limitation that the side opening of the guide extension catheter must be more
rigid than the tubular structure. The only defense that QXMédical has asserted to
Vascular Solutions’s motion is the marker‐band defense. Because the Court has held
that QXMédical is precluded from asserting that defense, the Court grants Vascular
Solutions’s motion. See Hologic, Inc. v. SenoRx, Inc., No. C‐08‐0133 RMW, 2009 WL
8760730, at *14 (N.D. Cal. Oct. 30, 2009) (granting defendant’s summary‐judgment
motion for noninfringement when the plaintiff failed to “disclose a theory of
infringement until after the claim construction, the close of fact and expert discovery,
and opening summary judgment briefs”).
-33-
G. Validity—Anticipation
QXMédical argues that claim 53 of the RE’116 patent is invalid because it was
anticipated by U.S. Patent No. 5,527,292 (“Adams”). “A patent is invalid for
anticipation under 35 U.S.C. § 102 if a single prior art reference discloses each and every
limitation of the claimed invention.” Purdue Pharma L.P. v. Epic Pharma, LLC, 811 F.3d
1345, 1351 (Fed. Cir. 2016). As discussed above, one of the limitations of claim 53 is that
the side opening of the guide extension catheter must be more rigid than the tubular
structure. See RE’116 at 17:21‐24 (“wherein the segment defining the side opening
comprises a portion of the guide extension catheter that is more rigid than the distal end
portion of the tubular structure”). And thus, to anticipate claim 53, Adams must
disclose a side opening that is more rigid than the tubular structure.
Adams discloses a pushrod (formed of nitinol wire) and a tubular structure. ECF
No. 125‐27 at 21. Adams also discloses an opening in the tubular structure, which
QXMédical characterizes as a “side opening.” ECF No. 124 at 41. (More on that in a
moment.) If Figure 10 of Adams is examined closely, it appears to show that the distal
end of the push rod is partially embedded in the proximal end of the flexible tube
alongside the opening. ECF No. 125‐27 at 9. Thus, argues QXMédical, “[t]he ‘side
opening’ portion of Adams is necessarily more rigid than the remaining distal portion
-34-
of the flexible tube because the ‘side opening’ contains the embedded pushrod,”
whereas the remaining portion of the tubular structure does not. ECF No. 124 at 41.
Vascular Solutions argues that QXMédical should be precluded from asserting
this defense because, once again, QXMédical failed to disclose the defense in violation
of the pretrial scheduling order. The Court agrees.
The pretrial scheduling order required QXMédical to provide a “detailed
explanation of what it alleges the prior art shows and how that prior art invalidates the
claim(s) asserted by the party alleging infringement,” including “where in such prior art
each element of the allegedly invalid claims may be found.” ECF No. 20 at 6. These
disclosures “must contain enough information to provide notice of the party’s
infringement contentions and defenses . . . .” Stratasys, Inc. v. Microboards Tech. LLC, No.
13‐CV‐3228 (DWF/TNL), 2015 WL 3869672, at *1 (D. Minn. June 23, 2015).
In response to the pretrial order, QXMédical identified Adams as one of many
prior‐art references and broadly alleged that the RE’116 patent was invalid on account
of Adams and other prior art. But nowhere did QXMédical explain how Adams
discloses each of the limitations contained in claim 53, including the requirement of a
side opening that is more rigid than the tubular structure. Indeed, QXMédical’s cursory
discussion of Adams does not even mention the side opening. See ECF No. 140‐2 at 4, 6.
-35-
This falls far short of providing the type of detailed explanation required by the
scheduling order.
Because QXMédical violated the scheduling order, the Court will preclude it
from arguing that claim 53 is invalid as anticipated by Adams. See O2 Micro Int’l Ltd. v.
Monolithic Power Sys., Inc., 467 F.3d 1355, 1367‐70 (Fed. Cir. 2006) (affirming the district
court’s grant of summary judgment of noninfringement after ruling that the district
court did not err by excluding evidence provided in violation of the pretrial scheduling
order); SanDisk Corp., 415 F.3d at 1292 (affirming a district court’s exclusion of evidence
pertaining to theories of claim construction and infringement not disclosed as required
by the local patent rules and the court’s scheduling order); Neonatal Prod. Grp. v. Shields,
276 F. Supp. 3d 1120, 1125‐28 (D. Kan. 2017) (granting a motion to strike an
infringement theory that was raised in violation of the pretrial scheduling order).
Even if the Court did not preclude QXMédical from arguing that claim 53 is
invalid as anticipated by Adams, the Court would reject the defense on the merits.
Again, Adams does not anticipate claim 53 unless it “discloses each and every
limitation” of that claim. Purdue Pharma, 811 F.3d at 1351. One of claim 53’s limitations
is that the guide extension catheter have a “side opening.” RE’116 at 17:21.
-36-
Both Adams and claim 53 disclose a pushrod attached to a hollow tubular
structure, and both Adams and claim 53 disclose an opening in that tubular structure.
But the openings differ in one crucial respect.
As the parties agree, the opening disclosed in Adams is created by cutting the
tubular structure perpendicularly to its axis. In other words, the opening in Adams
resembles the end of a straw or a garden hose, as is illustrated (although not very well)
by Figure 10:
ECF No. 125‐27 at 9.
By contrast, the opening described in claim 53 is created by cutting the tubular
structure at an angle, so that a portion of the side of the tube is exposed. The type of
angled opening disclosed in claim 53 is illustrated by this photograph of the GuideLiner
Catheter:
-37-
ECF No. 125‐22 at 404.
As these figures illustrate, Adams discloses an end opening, while claim 53
discloses a side opening. The only way to insert something into the tubular structure
disclosed in Adams is through its end (just as the only way to insert something into a
straw or a garden hose is through its end). But the angled opening disclosed by
claim 53 permits entry into the tubular structure through its side—a much easier
passage.
The Court acknowledges that a patent examiner has described Adams as
disclosing “a segment defining a side opening,” ECF No. 140‐4 at 10, reflecting the
examiner’s view (shared by QXMédical) that “an end is . . . one of the three sides of a
cylinder,” ECF No. 125‐14 at 12. The Court respectfully disagrees with the examiner, to
whom the Court is not required to defer.12 The problem with the examiner’s view is
12
See Bradium Techs. LLC v. Iancu, 923 F.3d 1032, 1042 (Fed. Cir. 2019) (explaining
that courts review the Patent Trial and Appeal Board’s interpretation of claim language
de novo); SRAM Corp. v. AD‐II Eng’g, Inc., 465 F.3d 1351, 1359 (Fed. Cir. 2006) (“[T]his
court is not bound by the PTO’s claim interpretation because we review claim
construction de novo.”).
-38-
that it renders the term “side” completely superfluous. Tubes have only ends and sides.
If every end is a side, then every opening in a tube—no matter the shape or location of
the opening—is a “side” opening. The word “side”—which is used dozens of times in
the patents in suit to modify “opening”— would be redundant. (At oral argument,
QXMédical’s attorney was unable to provide a single example of an opening in a tube
that would not be a “side opening” under the examiner’s interpretation of “side.”)
Because “interpretations that render some portion of the claim language
superfluous are disfavored,” Power Mosfet Techs., L.L.C. v. Siemens AG, 378 F.3d 1396,
1410 (Fed. Cir. 2004), the Court agrees with Vascular Solutions that Adams does not
disclose a “side opening” and therefore does not anticipate claim 53 of RE’116. See Gen.
Am. Transp. Corp. v. Cryo‐Trans, Inc., 93 F.3d 766, 770 (Fed. Cir. 1996) (rejecting the
district court’s construction because it rendered claim language superfluous).
H. Vascular Solutions’s Summary‐Judgment Motion on Infringement
Vascular Solutions moves for summary judgment that the Boosting Catheter
infringes claims 25, 36, 52, and 53 of the RE’776 patent. Vascular Solutions argues that
all of the limitations of those claims are met, including the requirements that: (1) the
pushrod be “substantially rigid” (claim 25); (2) the angled proximal end of the tubular
structure have at least “one inclined region that tapers into a non‐inclined region”
-39-
(claim 36); and (3) the angled proximal end of the tubular structure have “at least two
inclined regions” (claims 52 and 53).
The only defense that QXMédical asserts to Vascular Solutions’s motion (in
addition to the defenses that the Court has already rejected) is the argument that the
claim limitations that the Court has just identified are present in the prior art.13 That
may or may not be true, but it is irrelevant to the question of whether the limitations are
met. The Court finds that the Boosting Catheter meets all of the limitations of claims 25,
36, 52, and 53 of the RE’776 patent, and therefore grants Vascular Solutions’s motion for
a declaration of infringement.
I. Conclusion
To summarize, the Court holds as follows: First, none of the claims asserted
against the Boosting Catheter are invalid as indefinite or anticipated or violate the
recapture rule. Second, QXMédical does not infringe—directly or indirectly—the
asserted “one French” claims of the ‘032, RE’380, RE’760, RE’776, and RE’116 patents.
Third, the Boosting Catheter meets the “side opening” limitation of claims 25 and 48 of
the RE’760 patent, claims 25 and 52 of the RE’776 patent, and claim 52 of the RE’116
patent. Fourth, the Boosting Catheter infringes claims 25, 36, 52, and 53 of the RE’776
patent. And finally, whether the Boosting Catheter also infringes the asserted “without
13
QXMédical also asks the Court to revisit its construction of the term
“substantially rigid.” The Court declines to do so.
-40-
a lumen” claims of the ‘032, ‘413, and RE’380 patents—either literally or under the
doctrine of equivalents—must be tried to a jury.
ORDER
Based on the foregoing, and on all of the files, records, and proceedings herein,
IT IS HEREBY ORDERED THAT:
1.
QXMédical’s motion for summary judgment [ECF No. 122] is GRANTED
IN PART AND DENIED IN PART as follows:
a.
QXMédical’s motion is GRANTED to the extent that it seeks a
declaration that the Boosting Catheter does not infringe—and that
QXMédical does not induce any person to infringe—claim 8 of the
‘032 patent, claim 8 of the RE’380 patent, claims 25 and 48 of the
RE’760 patent, claims 30 and 53 of the RE’776 patent, or claim 25 of
the RE’116 patent (all of which include the one‐French limitation).
b.
2.
QXMédical’s motion is DENIED in all other respects.
Vascular Solutions’s motion for summary judgment [ECF No. 130] is
GRANTED IN PART AND DENIED IN PART as follows:
a.
Vascular Solutions’s motion is GRANTED to the extent that it:
i.
Seeks a declaration that the asserted claims of the patents in
suit are not invalid as indefinite.
-41-
ii.
Seeks a declaration that the asserted claims of the RE’760,
RE’776, and RE’116 patents are not invalid under the
recapture rule.
iii.
Seeks a declaration that claim 53 of the RE’116 patent is not
invalid as anticipated.
iv.
Seeks a declaration that the Boosting Catheter meets the
“side opening” limitations of claims 25 and 48 of the RE’760
patent, claims 25 and 52 of the RE’776 patent, and claim 52 of
the RE’116 patent. And
v.
Seeks a declaration that QXMédical infringes claims 25, 36,
52, and 53 of the RE’776 patent.
b.
Vascular Solutions’s motion is DENIED in all other respects.
Dated: October 2, 2019
s/Patrick J. Schiltz
Patrick J. Schiltz
United States District Judge
-42-
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?