United States District Court, D. Minnesota
Courtland C. Merrill and Philip J. Kaplan, ANTHONY OSTLUND
BAER & LOUWAGIE P.A., for plaintiff.
Thomas Vitt, Emily Justine Tait, Patrick J. O'Rear, and
Sanjiv Prakash Laud, JONES DAY; Kenneth E. Levitt, DORSEY
& WHITNEY, for defendants.
Patrick J. Schiltz United States District Judge
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.”
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.
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
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”), and then pushes the
balloon or stent through the guide extension catheter and
into the coronary artery.
GuideLiner catheter that Vascular Solutions manufactures is
depicted in the following diagram:
125-22 at 32. The GuideLiner catheter
manufactured by Vascular Solutions-as well as the Boosting
Catheter manufactured by QXMedical-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).
Standard of Review
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
Validity-Indefiniteness of “Substantially
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
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
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
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.” 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.
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.”).
argument that “substantially rigid” and
“flexible” are mutually exclusive is also belied
by its own proposed constructions of those terms. During the
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.
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
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.
‘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.
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 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).
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.
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 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.
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).
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- 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.
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.
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.
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.
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 Aߠ.
Suppose further that the examiner denies the application
because the prior art already discloses Aߠ. If the
applicant adds limitation D to Aߠ 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.
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.
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
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 presumption is not dispositive, but is instead
rebuttable. The Court finds that there is ample
evidence in the prosecution history to rebut the presumption:
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,
and Solar clearly and undisputedly discloses a pushrod
without a lumen. If the patent examiner was competent (as he
is presumed to be), he could not possibly have suggested
adding “without a lumen” to escape prior art.
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 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 ...