United States Court of Appeals for the Federal Circuit
2007-1560
DR. PETER RENTROP,
Plaintiff-Appellee,
v.
THE SPECTRANETICS CORPORATION,
Defendant-Appellant.
Marvin S. Gittes, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo P.C., of New York,
New York, argued for plaintiff-appellee. With him on the brief was Timur E. Slonim.
Glenn E. Forbis, Rader, Fishman & Grauer PLLC, of Bloomfield Hills, Michigan,
argued for defendant-appellant. With him on the brief were R. Terrance Rader and
James F. Kamp.
Appealed from: United States District Court for the Southern District of New York
Judge P. Kevin Castel
United States Court of Appeals for the Federal Circuit
2007-1560
DR. PETER RENTROP,
Plaintiff-Appellee,
v
THE SPECTRANETICS CORPORATION,
Defendant-Appellant.
Appeal from the United States District Court for the Southern District of
New York in case no 04-CV-0101, Judge P Kevin Castel.
______________________________
DECIDED: December 18, 2008
______________________________
Before MICHEL, Chief Judge, FRIEDMAN, Circuit Judge, and WALKER * , Chief District
Judge.
WALKER, Chief District Judge.
Defendant-appellant The Spectranetics Corporation (“Spectranetics”) appeals
from a final judgment of the district court awarding $500,000 to plaintiff-appellee Dr
Peter Rentrop. The judgment was based on a jury’s verdict that found claim 1 of
Rentrop’s United States Patent No 6,673,064 (“the ’064 patent”) not invalid and
infringed. After trial, the district court considered and rejected Spectranetics’s defense
* Honorable Vaughn R Walker, Chief Judge, United States District Court for
the Northern District of California, sitting by designation.
of inequitable conduct, see Rentrop v Spectranetics Corp, 514 F Supp 2d 511 (SDNY
2007), and denied Spectranetics’s motion for judgment as a matter of law on
infringement. See Rentrop v Spectranetics Corp, 514 F Supp 2d 497 (SDNY 2007). On
appeal, Spectranetics challenges the lower court’s decisions on infringement and
inequitable conduct and also argues that it is entitled as a matter of law to judgment of
invalidity of claim 1 and other claims of the ’064 patent. For the reasons discussed
below, we affirm the judgment of the district court.
I
Dr Peter Rentrop is a cardiovascular interventionalist with over thirty years of
experience in medicine. He is chief of cardiovascular research at St Vincent’s Hospital
and Medical Center in New York City. Spectranetics is a Delaware corporation located
in Colorado Springs, Colorado. It specializes in the design, marketing and sale of
products for use in angioplasty (the widening of an obstructed blood vessel).
The ’064 patent, issued to Rentrop on January 6, 2004, describes an “Excimer
Laser Catheter.” Excimer laser catheters are used to perform angioplasty procedures.
The catheters deliver laser energy which penetrates arterial blockages, or occlusions, in
order to enlarge the arterial channel for increased bloodflow or, in the case of the
invention described by the ’064 patent, to enlarge the channel sufficiently to allow other
treatments, such as balloons or stents, to be administered.
Spectranetics is the only company with FDA approval to sell excimer laser
catheters for use in human angioplasty in the United States. Rentrop became involved
with Spectranetics when, from 1991 to 1996, he served as director of a cardiology
symposium of which Spectranetics was a sponsor. When Spectranetics’s first excimer
2007-1560 2
laser catheters became clinically available, Rentrop was trained in their use by
Spectranetics, and Rentrop began using them routinely in 1995. At that time,
Spectranetics sold excimer laser catheters in its “Extreme” catheter line with tip
diameters of 1.4 mm, 1.7 mm and 2 mm.
In around 1996 or 1997, Rentrop began to disfavor use of the Extreme catheters,
in part because he found them too inflexible to navigate bends in narrow arteries.
Rentrop believed a smaller diameter laser catheter could be developed that would be
useful in narrow arteries. In 1998, Rentrop communicated his idea for a 0.9 mm
excimer laser catheter to Spectranetics. Over the course of twenty months of frequent
communication with Kevin Taylor, Spectranetics’s director of engineering, Rentrop
helped Spectranetics create a prototype of Rentrop’s proposed laser catheter. This
involved an iterative process in which Kenneth Harlan, a Spectranetics technician,
created prototypes of the proposed laser catheter and presented them to Rentrop, who
inspected them and proposed modifications. After the final prototype was created,
Rentrop conducted an animal study of the device in early 2000. A clinical trial followed,
and Spectranetics gained FDA approval for and began marketing several models of 0.9
mm excimer laser catheters based on the prototype; these are the accused products in
this patent litigation.
During their collaboration on development of the prototype, a disagreement arose
between Rentrop and Spectranetics regarding financial recognition of Rentrop’s work.
Rentrop and Spectranetics were not able to reach an agreement, so Rentrop sought to
patent his invention. The ’064 patent, which is at issue in this appeal, was issued to
2007-1560 3
Rentrop on January 6, 2004. It is a continuation of and claims priority to a patent
application filed January 4, 2000.
The claim at issue in this appeal is claim 1 of the ’064 patent. It states:
An excimer laser catheter, comprising:
a catheter shaft containing optical fibers in a concentric
arrangement, a tip extending from the catheter shaft and
having a diameter that is smaller than that of the catheter
shaft, the tip having a length of at least 1 cm and a diameter
less than 1 millimeter, each of the optical fibers extending
through a full length of the tip and a full length of the catheter
shaft, the catheter shaft being configured to be stiffer and
less flexible than the tip so as to be pushable to push the tip
into a desired site even though the tip negotiates arterial
bends to reach the desired site.
’064 patent col 4, ln 60 – col 5, ln 4 (emphasis added).
On January 6, 2004, Rentrop filed a complaint alleging that Spectranetics’s
accused products infringed various claims, including claim 1, of the ’064 patent.
Spectranetics asserted defenses including obviousness and inequitable conduct and
counterclaimed to, among other things, correct inventorship of the ’064 patent. A jury
trial was held and on December 8, 2006, the jury returned its verdict that the accused
products infringed claim 1, but not claim 2, 3 or 7, of the ’064 patent, that the ’064 patent
was not invalid, and that Rentrop was the sole inventor of the ’064 patent. 1 After trial,
Spectranetics filed a renewed motion for judgment as a matter of law on infringement,
which the district court denied on August 23, 2007. Rentrop, 514 F Supp 2d at 499.
Spectranetics did not challenge the jury’s validity determination in the trial court. The
1
The parties stipulated that the jury’s verdict on infringement and validity of:
(a) claim 1 also will apply to claims 8, 15, 16 and 17; (b) claim 2 also will apply to claims
9 and 18; (c) claim 3 also will apply to claims 4, 10, 11, 19 and 20; and (d) claim 7 also
will apply to claims 14 and 23.
2007-1560 4
district court also considered and rejected Spectranetics’s defense of inequitable
conduct. Rentrop, 514 F Supp 2d 511.
Spectranetics timely appealed. We have jurisdiction pursuant to 28 USC
§ 1295(a)(1).
II
We turn first to Spectranetics’s argument regarding obviousness. Spectranetics
cannot, of course, attack the basis for the jury’s obviousness verdict directly as it did not
move for judgment as a matter of law on obviousness. Rather, Spectranetics argues
that claim 1 of the ’064 patent was so clearly obvious based on the prior art presented
to the jury that the only possible explanation for the jury not finding the claim to be
obvious was that the district court gave a rigid “teaching, suggestion or motivation” jury
instruction in violation of the Supreme Court’s recent decision in KSR Int’l Co v Teleflex
Inc, 550 US 398 (2007).
Rentrop argues that Spectranetics waived its argument based on KSR because
Spectranetics did not bring this argument to the district court’s attention before entry of
judgment. We agree. KSR was decided on April 30, 2007. The jury returned its verdict
on December 8, 2006, and briefing on post-trial motions was completed by February 20,
2007 — over two months before KSR was decided. The district court, however, did not
decide the post-trial motions until August 23, 2007, and judgment was not entered until
August 24, 2007, almost four months after the decision in KSR.
In Sage Products, Inc v Devon Industries, Inc, 126 F3d 1420 (Fed Cir 1997), we
had occasion to discuss why we do not allow new arguments to be presented for the
first time on appeal:
2007-1560 5
This is an appellate court. By and large, it is our place to
review judicial decisions—including claim interpretations and
grants of summary judgment—reached by trial courts. No
matter how independent an appellate court’s review of an
issue may be, it is still no more than that—a review. With a
few notable exceptions, such as some jurisdictional matters,
appellate courts do not consider a party’s new theories,
lodged first on appeal. If a litigant seeks to show error in a
trial court's overlooking an argument, it must first present
that argument to the trial court. In short, this court does not
“review” that which was not presented to the district court.
Id, 126 F3d at 1426. Although Sage Products involved new arguments presented on
appeal of summary judgment of non-infringement that were not based on an intervening
change in the law, its reasoning applies here. Where possible, every legal argument
should be presented first to the trial court. KSR was decided almost four months before
the trial court entered judgment, giving Spectranetics ample time to bring that decision
to the trial court’s attention. Had Spectranetics done so, the trial court — if it agreed
that the jury instructions on obviousness were incorrect under KSR — could have taken
appropriate action and possibly obviated the need for this appeal. Spectranetics points
out that we have taken up the KSR jury instruction issue several times where it had not
been brought before the district court first, but in the cases Spectranetics cites,
judgment was entered by the district court before KSR was decided. See Cordis Corp v
Medtronic AVE, Inc, 511 F3d 1157 (Fed Cir 2008); Black & Decker, Inc v Robert Bosch
Tool Corp, 260 Fed App’x 284 (Fed Cir 2008).
We hold that when there is a relevant change in the law before entry of final
judgment, a party generally must notify the district court; if the party fails to do so, it
waives arguments on appeal that are based on that change in the law. Spectranetics
did not bring KSR to the attention of the district court and therefore has waived its
2007-1560 6
arguments based on KSR. The jury’s determination that the ’064 patent is not invalid
will not be disturbed.
Although we hold that Spectranetics waived its arguments based on KSR, we
note that the jury instructions on obviousness in this case appear to be consistent with
KSR. KSR — a case in which jury instructions were not at issue — rejected a
“formalistic conception of the words teaching, suggestion and motivation.” KSR, 127 S
Ct at 1741. The Court held that the commonly used teaching, suggestion and
motivation (“TSM”) test provides a “helpful insight,” noting that “it can be important to
identify a reason that would have prompted a person of ordinary skill in the relevant field
to combine the elements in the way the claimed new invention does.” Id. But the
Court held that applying the TSM principle as a rigid rule is error. Id.
Spectranetics challenges the jury instruction because it stated:
In evaluating the scope and content of the prior art,
you should keep in mind that there must have been some
suggestion for a person skilled in the art to make the
combination covered by the claims of the patent in issue in
order for the claims to have been obvious.
In other words, a claim in a patent is not obvious and
invalid, simply because the claim combines elements that
can all be found among the prior art references. It must
have been a motivation or a suggestion to combine the limits
in a manner disclosed by the patent.
While this instruction might violate KSR if it were the only instruction, the district
court went on to define motivation for the jury: “The motivation may arise from common
knowledge, or common sense of the person of ordinary skill in the art, without any
specific hint or suggestion in a particular reference.”
2007-1560 7
Thus, the court instructed the jury on the TSM principle, but described it in unrigid
terms. These instructions on the TSM principle are similar to the instructions in Cordis,
511 F3d at 1172, where we held the instructions at issue did not conflict with KSR.
Spectranetics also challenges the jury instructions as impermissibly prohibiting
an “obvious to try” inquiry. In KSR, the Court held it was error to conclude that a “patent
claim cannot be proved obvious merely by showing that the combination of elements
was obvious to try.” KSR, 127 S Ct at 1742 (internal quotation omitted). But the portion
of the jury instructions Spectranetics challenges reads:
You must also keep in mind that the test for obviousness is
not whether or not it would have been obvious to try to make
the invention, but rather whether or not the inconvenience
[sic] would have been obvious to a person of ordinary skill in
the inventor’s field at the time the invention was made.
Read in context, this instruction states, correctly, that the test for obviousness is
not whether it would be obvious to try to solve the problem that the invention solves.
The instruction does not imply that a showing that the specific combination of elements
was obvious to try is insufficient to find obviousness.
Even if Spectranetics had not waived its KSR argument, it appears that it would
not have been entitled to relief from the jury’s finding of nonobviousness.
III
We turn next to Spectranetics’s appeal from the district court’s denial of judgment
as a matter of law on infringement.
The Federal Circuit “defers to the law of the regional circuits on matters of
procedural law that do not implicate issues of patent law.” Duro-Last, Inc v Custom
Seal, Inc, 321 F3d 1098, 1106 (Fed Cir 2003). “Thus for questions relating to Rule 50
2007-1560 8
motions generally, this court has applied regional circuit law.” Id. The Second Circuit
has stated that a “Rule 50 motion may be granted only when, considering the evidence
in the light most favorable to the non-moving party and drawing all reasonable
evidentiary inferences in that party’s favor, there was ‘no legally sufficient evidentiary
basis for a reasonable jury to find’ in favor of the non-moving party.” Nimely v City of
New York, 414 F3d 381, 390 (2d Cir 2005) (quoting Fed R Civ P 50(a)). We agree with
the district court that sufficient evidence was presented to sustain the jury’s finding that
Spectranetics’s accused products infringed claim 1 of the ’064 patent.
Spectranetics’s non-infringement argument centers on the claim term “tip.” The
district court construed “tip” as “that which serves as the end, cap or point of an object.”
While Spectranetics’s accused products have a component that has all the
characteristics of the “tip” described in claim 1, the accused products also have a hard
glue and platinum band at the very end of the device. This hard band, Spectranetics
argues, is the “tip” of their accused products. Because claim 1 of the ’064 patent
requires that “the catheter shaft be[] configured to be stiffer and less flexible than the
tip,” Spectranetics argues that its products’ hard and stiff “tip” is not covered by the
claim.
Rentrop’s infringement expert, Dr Edward Sinofsky, explained, however, that the
hard glue and platinum band, a radiopaque feature included so the device would be
visible on a scanning machine, was not the entire tip of the accused products (the entire
tip of the accused products being more flexible and less stiff than the catheter shaft).
Spectranetics argues that Sinofsky’s testimony was not based on the court’s
construction of “tip” and that therefore his testimony was confusing to the jury.
2007-1560 9
Spectranetics relies on the following exchange during the cross-examination of
Sinofsky:
Q. Dr Sinofsky, when you gave your opinion on
infringement, did you take into account the Court’s Markman
ruling?
A. I’m not sure what that is.
Q. All right. So you don’t know what I’m talking about?
A. I’ve heard of the Markman ruling, but I don’t know what it
is.
Spectranetics is overreaching. The exchange above demonstrates only that
Sinofsky was unfamiliar with the legal term “Markman hearing,” not that he was
unaware of the court’s construction of “tip.” Indeed, on redirect examination, Sinofsky
testified that he had heard of and understood the district court’s definition of “tip.”
Sinofsky’s identification of the tip of Spectranetics’s accused products and his
explanation of how the tip read on claim 1 of the ’064 patent were consistent with the
court’s claim construction, and the jury was entitled to credit them. Spectranetics is not
entitled to judgment as a matter of law of noninfringement of claim 1 of the ’064 patent.
IV
Finally, we turn to Spectranetics’s appeal of the district court’s determination that
Spectranetics failed to establish the affirmative defense of inequitable conduct.
“To prove that a patent is unenforceable due to inequitable conduct, the alleged
infringer must provide clear and convincing evidence of (1) affirmative
misrepresentations of a material fact, failure to disclose material information, or
submission of false material information and (2) an intent to deceive.” Impax Labs, Inc v
Aventis Pharm Inc, 468 F3d 1366, 1374 (Fed Cir 2006). A fact is material if it is material
2007-1560 10
under either PTO Rule 56 or the “reasonable examiner” standard. Digital Control Inc v
Charles Machine Works, 437 F3d 1309, 1316 (Fed Cir 2006).
PTO Rule 56 states that:
[I]nformation is material to patentability when it is not
cumulative to information already of record or being made of
record in the application, and
(1) It establishes, by itself or in combination with other
information, a prima facie case of unpatentability of a claim,
or
(2) It refutes, or is inconsistent with, a position the applicant
takes in:
(i) Opposing an argument of unpatentability relied on by the
Office, or
(ii) Asserting an argument of patentability.
37 CFR § 1.56(b) (2008).
“Under the earlier ‘reasonable examiner’ standard, ‘information is material where
there is a substantial likelihood that a reasonable examiner would consider it important
in deciding whether to allow the application to issue as a patent.’” Cargill, Inc v Canbra
Foods, Ltd, 476 F3d 1359, 1364 (Fed Cir 2007) (quoting 37 CFR § 1.56(a) (1991)).
The intent element requires that “the involved conduct, viewed in light of all the
evidence, including evidence indicative of good faith, must indicate sufficient culpability
to require a finding of intent to deceive.” Impax Labs, 468 F3d at 1374-75. Intent need
not be proven by direct evidence; it is usually inferred from the facts and circumstances
surrounding the conduct at issue. Id at 1375.
If a district court finds materiality and intent by clear and convincing evidence, it
must “balance the equities to determine whether the patentee has committed
inequitable conduct that warrants holding the patent unenforceable.” Id. “The more
material the omission or the misrepresentation, the lower the level of intent required to
2007-1560 11
establish inequitable conduct, and vice versa.” Critikon, Inc v Becton Dickinson
Vascular Access, Inc, 120 F3d 1253, 1256 (Fed Cir 1997).
We review the district court’s findings on the issues of materiality and intent for
clear error. Impax Labs, 468 F3d at 1375. The ultimate decision regarding inequitable
conduct is reviewed for abuse of discretion. Id.
In this case, Spectranetics argues that the district court erred by not finding
inequitable conduct based on Rentrop’s nondisclosure or inadequate disclosure of
several items of prior art and his minimization of the role of Spectranetics in the
development of the invention disclosed by the ’064 patent. But the district court
considered these arguments and addressed each of them in a well-reasoned opinion.
See Rentrop, 514 F Supp 2d at 525-30. For only one of the alleged failures to disclose
material information (regarding Spectranetics technician Harlan’s performance of a
“chicken bone” test of the device that was referenced in the patent) did the district court
find even a weak inference of intent to deceive, and in that case, the district court found
the nondisclosure to be not highly material. Id at 529. In no other instance of non-
disclosure did the district court find even a threshold level of intent. Rather, it
determined that Rentrop’s testimony was “credible in all material respects.” To
establish that the district court abused its discretion when it balanced the equities and
held that the low materiality and weak inference of intent to deceive regarding the
“chicken bone” experiment did not warrant finding the ’064 patent unenforceable or that
it clearly erred by not finding clear and convincing evidence of materiality and intent to
deceive for the other alleged nondisclosures, Spectranetics would need to provide
2007-1560 12
compelling evidence of materiality and intent to deceive. It has not done so, and it is not
entitled to reversal of the district court’s rejection of the inequitable conduct defense.
CONCLUSION
For the reasons discussed above, we conclude that Spectranetics waived its
challenge to the jury instructions on obviousness, that the jury’s verdict of infringement
was supported by legally sufficient evidence and that the district court’s determination
that Spectranetics did not establish an inequitable conduct defense was not an abuse of
discretion or based on clearly erroneous findings of fact. Accordingly, we affirm the
judgment of the district court.
AFFIRMED
No costs.
2007-1560 13