United States Court of Appeals
for the Federal Circuit
__________________________
BOSTON SCIENTIFIC CORPORATION AND
BOSTON SCIENTIFIC SCIMED, INC.,
Plaintiffs-Appellees,
v.
JOHNSON & JOHNSON (ALSO KNOWN AS
JOHNSON & JOHNSON, INC.),
CORDIS CORPORATION, AND WYETH,
Defendants-Appellants.
__________________________
2010-1230, -1231, -1233, -1234
__________________________
Appeals from the United States District Court for the
District of Delaware in consolidated case nos. 07-CV-0333,
07-CV-0348, 07-CV-0409, and 07-CV-0765, Judge Sue L.
Robinson.
___________________________
Decided: June 7, 2011
___________________________
MATTHEW M. WOLF, Arnold & Porter LLP, of Wash-
ington, DC, argued for plaintiffs-appellees. With him on
the brief were EDWARD HAN and JOHN E. NILSSON.
DAVID T. PRITIKIN, Sidley Austin LLP, of Chicago, Il-
linois, argued for defendants-appellants. With him on the
brief were CONSTANTINE L. TRELA, JR., WILLIAM H.
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 2
BAUMGARTNER, JR., RUSSELL E. CASS and JUSTIN B.
WEINER.
SANDRA A. FRANTZEN, McAndrews, Held & Malloy,
Ltd., of Chicago, Illinois for amicus curiae Abbott Cardio-
vascular Systems Inc. With her on the brief were
EDWARD A. MAS, II, STEPHANIE F. SAMZ and KATHLEEN A.
DORTON.
__________________________
Before BRYSON, GAJARSA, and MOORE, Circuit Judges.
Opinion for the court filed by Circuit Judge MOORE.
Circuit Judge GAJARSA concurs-in-part.
MOORE, Circuit Judge.
Johnson & Johnson, Inc. (J&J), Cordis Corp. (Cordis)
and Wyeth (collectively, Appellants) appeal the decision of
the United States District Court for the District of Dela-
ware granting summary judgment that certain claims of
U.S. Patent Nos. 7,217,286 (the ’7286 patent), 7,223,286
(the ’3286 patent), 7,229,473 (the ’473 patent), and
7,300,662 (the ’662 patent) (collectively, the patents-in-
suit) are invalid for failure to comply with
35 U.S.C. § 112, ¶ 1. Boston Scientific Corp. v. Johnson &
Johnson, Inc., 679 F. Supp. 2d 539 (D. Del. 2010). The
district court determined that the asserted claims of the
’7286 patent, the ’3286 patent, and the ’473 patent (collec-
tively, the 1997 patents) are invalid for lack of adequate
written description and lack of enablement, and that the
asserted claims of the ’662 patent are invalid for lack of
adequate written description. Because no finder of fact
could reasonably determine that the asserted claims of
the patents-in-suit contained an adequate written de-
scription, we affirm.
3 BOSTON SCIENTIFIC v. JOHNSON & JOHNSON
BACKGROUND
I. Drug-Eluting Stents
The patents-in-suit relate to drug-eluting coronary
stents used in the treatment of coronary artery disease.
Coronary artery disease is caused, in part, by atheroscle-
rosis, a build-up of arterial plaque. Atherosclerosis limits
the flow of blood and oxygen to the heart and can result in
chest pain, blood clots, heart attacks, and other ailments.
In 1977, physicians first used a procedure called bal-
loon angioplasty to reopen arteries closing because of
atherosclerosis. During the procedure, the physician
inserts a balloon catheter into an artery near the patient’s
groin and threads the catheter through the artery to the
site of the blockage. The physician then inflates the
balloon to reopen the narrowed artery. In many balloon
angioplasty patients, the opened artery narrows again – a
process known as restenosis. One of the key components
of restenosis is a phenomenon called neointimal prolifera-
tion, wherein the smooth muscle cells of the artery multi-
ply over time in response to injury caused by the inflation
of the balloon. The result of neointimal proliferation is
the renarrowing of the artery.
In the 1980s, physicians began using bare metal coro-
nary stents to support the artery after the physician
deflates the balloon. Although these bare metal coronary
stents prevented the collapse of the artery and constric-
tion due to scarring, restenosis remained a problem
because the bare metal stents did not prevent neointimal
proliferation.
Researchers turned to a myriad of techniques in an
attempt to prevent restenosis following balloon angio-
plasty. For example, researchers tested numerous oral
drugs for the treatment of restenosis. J.A. 14732-39. One
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 4
of Appellants’ experts characterized the number and
variety of drugs tested as “reflect[ing] the lack of any clear
path or direction toward a particular drug therapy for
restenosis.” J.A. 14732. Researchers also experimented
with drug-eluting stents in an effort to prevent restenosis.
Researchers believed that the drugs contained on such
stents could help prevent neointimal proliferation.
Cordis’s Cypher® stent was the first drug-eluting stent
approved by the United States Food and Drug Admini-
stration (FDA) and sold in the United States.
II. The Patents-In-Suit
The 1997 patents claim drug-eluting stents using ei-
ther rapamycin or a macrocyclic lactone analog of rapa-
mycin as the therapeutic agent. The ’662 patent claims
drug-eluting stents using either rapamycin or a macrocyc-
lic triene analog of rapamycin. 1 The rapamycin molecule
has a number of structural features including lactone and
triene moieties. Thus, rapamycin is both a macrocyclic
triene and a macrocyclic lactone. Rapamycin is depicted
below with the macrocyclic ring, the lactone group, and
the triene group identified:
1 Under the district court’s construction of the
terms “macrocyclic lactone analog” and “macrocyclic
triene analog,” an analog of rapamycin is broadly defined
as any molecule with structural similarity to rapamycin.
See Boston Scientific Corp. v. Johnson & Johnson, Inc.,
Civ. Nos. 07-333, 07-348, 07-409, 07-765-SLR, 2010 WL
331764, *2 (D. Del. Jan. 20, 2010) (Markman). The par-
ties do not appeal the district court’s claim construction
ruling.
5 BOSTON SCIENTIFIC v. JOHNSON & JOHNSON
Appellees’ Br. 10.
Cordis’s Cypher® drug-eluting stent utilizes rapamy-
cin as a therapeutic ingredient. Rapamycin (also called
sirolimus) is a naturally occurring compound produced by
the bacterium Streptomyces hygroscopicus. Scientists at
Ayerst Research Laboratories (which later became part of
Wyeth) isolated rapamycin, and the compound was first
publicly described in articles published in 1975.
Researchers first investigated rapamycin as a poten-
tial antifungal. Later, researchers discovered that rapa-
mycin exhibited other properties, including anti-tumor
activity and immunosuppressant activity. In the early
1990s, researchers at Stanford University discovered that
rapamycin inhibited restenosis after oral administration
to rats.
Prior to the filing of the 1997 patents, some analogs of
rapamycin were disclosed in the prior art. For example,
PCT application WO 94/09010 (the Cottens publication)
describes “novel alkylated derivatives of rapamycin
having pharmaceutical utility, especially as immunosup-
pressants.” J.A. 11059-11100. The Cottens publication
specifically describes twenty-eight “preferred novel com-
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 6
pounds,” twenty-five of which contain the same macrocyc-
lic ring as rapamycin. J.A. 11063-64. These preferred
analogs include everolimus. Everolimus is made by
modifying rapamycin at a single location and is both a
macrocyclic lactone and triene analog of rapamycin.
Boston Scientific Corp., 679 F. Supp. 2d at 543 n.3.
Similarly, U.S. Patent No. 5,362,718 (the Skotnicki pat-
ent) claims and describes macrocyclic analogs of rapamy-
cin and provides examples of fourteen specific structures.
J.A. 10595-608.
A. The 1997 Patents
The ’7286 patent, the ’3286 patent and the ’473 patent
all descend from a provisional application filed in April
1997. The 1997 patents share a common specification and
generally claim drug-eluting stents utilizing “rapamycin,
or a macrocyclic lactone analog thereof” as the therapeutic
agent. Cordis first added the phrase “macrocyclic lactone
analog” to the claims during an April 7, 2006 claim
amendment during prosecution of the ’3286 patent. J.A.
20328-36. Cordis added these claims shortly after a
competitor, Guidant, received European approval to sell a
drug-eluting stent containing everolimus.
The 1997 patents’ “Summary of the Invention” de-
scribes “[a] stent designed to include reservoirs . . . [,] a
new approach which offers several important advantages
over existing technologies.” ’7286 patent col.3 ll.43-45.
The “Summary of the Invention” does not mention any
particular therapeutic agent or any particular polymer
coatings. The shared specification discloses that the
reservoirs could be loaded with drugs and “[a] coating or
membrane of biocompatible material could be applied over
the reservoirs [to] control the diffusion of the drug from
the reservoirs to the artery wall.” Id. col.3 ll.61-65.
7 BOSTON SCIENTIFIC v. JOHNSON & JOHNSON
Later, in the “Detailed Description of Illustrative Em-
bodiments,” the shared specification discusses rapamycin
for the first time. The specification identifies rapamycin
as one of the “[n]umerous agents [that] are being actively
studied as antiproliferative agents for use in restenosis
and [that] have shown some activity in experimental
animal models.” Id. col.5 ll.8-10, 33. The 1997 patents
indicate that rapamycin is of particular interest because
it “is capable of inhibiting both the inflammatory response
known to occur after arterial injury and stent implanta-
tion, as well as the [smooth muscle cell] hyperproliferative
response.” Id. col.5 ll.47-51. However, the specification
also states that “the precise mechanism of rapamycin is
still under active investigation,” id. col.5 ll.36-38, and that
“the ideal agent for restenosis has not yet been identified,”
id. col.5 ll.59-60.
The specification of the 1997 patents contains only a
single reference to the claimed macrocyclic lactones.
Under a subheading “Experiments,” the specification
states, “Agents: Rapamycin (sirolimus) structural analogs
(macrocyclic lactones) and inhibitors of cell-cycle progres-
sion.” Id. col.6 ll.4-5. The experiments disclosed under
this subheading, however, only use rapamycin. The
specification does not include any experiments using a
macrocyclic lactone analog or even provide a single exam-
ple of a macrocyclic lactone analog.
B. The ’662 Patent
Cordis filed the application that issued as the ’662
patent in 2004, but asserts that the claims are entitled to
an effective filing date of January 25, 2001. The ’662
patent defines rapamycin broadly to include “rapamycin,
rapamycin analogs, derivatives and congeners that bind
FKBP12 and possess the same pharmacologic properties
as rapamycin.” See, e.g., ’662 patent col.5 ll.48-51. The
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 8
’662 patent, like the 1997 patents, does not identify any
specific species of rapamycin analogs.
Furthermore, the ’662 patent does not identify what
constitutes the claimed “macrocyclic triene analogs” of
rapamycin, and provides no examples of “macrocyclic
triene analogs.” In fact, the only time the term “macro-
cyclic triene” is used in the specification is the brief state-
ment that “[r]apamycin is a macroyclic [sic] triene
antibiotic.” Id. col.5 l.31. Unlike the 1997 patents where
the shared specification mentions the genus (macrocyclic
lactone analogs of rapamycin) and claims it in combina-
tion with other elements, here the inventors disclosed a
genus (analogs of rapamycin), but claimed a narrower
sub-genus of analogs (macrocyclic triene analogs of rapa-
mycin) in combination with other elements. All of the
data in the ’662 patent relate to studies done with rapa-
mycin coated stents ─ there is no data on stents using any
rapamycin analog. As with the 1997 patents, Cordis
added claim language specifying “macrocyclic triene
analogs” only after Guidant received approval for an
everolimus coated stent.
III. District Court Proceedings
Appellees Boston Scientific Corporation and Boston
Scientific Scimed, Inc. (collectively, BSC), filed four com-
plaints (later consolidated) against J&J and Cordis seek-
ing declaratory judgments that the claims of the four
patents-in-suit are invalid. Boston Scientific Corp., 679 F.
Supp. 2d at 542. BSC sells the accused Promus® Ever-
olimus-Eluting Coronary Stent System (the Promus
stent), which uses everolimus to prevent restenosis follow-
ing implantation. Id. at 543. The Promus stent is BSC’s
private labeled version of Abbott Cardiovascular Systems
Inc.’s (Abbott) XIENCE V® Everolimus-Eluting Coronary
Stent System. Id. Appellants previously asserted the
9 BOSTON SCIENTIFIC v. JOHNSON & JOHNSON
patents-in-suit against Abbott in four civil actions in the
District of New Jersey. Id. at 542.
In this action, the Appellants counterclaimed for in-
fringement. Id. at 542. Wyeth, as a co-owner of the ’662
patent with Cordis, is a party to the action involving the
’662 patent. Id. at n.1.
The parties filed several summary judgment motions
with the district court regarding validity and infringe-
ment. Id. at 542. Relevant to this appeal, BSC filed a
motion for summary judgment of invalidity of the as-
serted claims of the 1997 patents and the ’662 patent
under 35 U.S.C. § 112. Id. at 551-52. BSC argued that
the asserted claims of the patents-in-suit are invalid for
nonenablement, lack of adequate written description and
indefiniteness. 2 Id. at 552.
A. The 1997 Patents
The district court granted summary judgment that
the 1997 patents are invalid for nonenablement, id. at
557, and for failure to meet the written description re-
quirement, id. at 555. Addressing written description,
the district court determined that the 1997 patents dis-
close that the claimed analogs must have structural
similarity to rapamycin (i.e., they must be macrocyclic
lactones). Id. at 554. However, the district court also
noted that “this disclosure in no way restricts the uni-
verse of potential analogs fitting the limitations as con-
strued by the court.” Id. In a claim construction order
issued concurrently with its decision on the summary
judgment motion, the district court construed the phrase
2 Claims 1, 2, 5, 6, 40, 41, 44, 47, and 48 of the ’3286
patent are not at issue in this appeal because the parties
entered into a covenant not to sue. Id. at 543. All other
claims of the patents-in-suit are at issue.
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 10
“rapamycin or a macrocyclic lactone analog thereof” as
meaning “sirolimus or a macrocyclic lactone molecule with
a structure similar to sirolimus.” Markman at *2.
The district court also determined that the specifica-
tion fails to disclose any formulae or structures of any
specific analog or provide any “definitions, examples, or
experimental models . . . for determining whether a
compound is a structurally similar analog as contem-
plated by the patentees.” Boston Scientific Corp., 679 F.
Supp. 2d at 554. The district court acknowledged that at
the time of filing, a small number of macrocyclic lactone
analogs of rapamycin were known. Id. However, the
district court, without finding a specific quantity, noted
that there is “a general agreement among the parties that
there are numerous potential analogs of rapamycin.” Id.
at n.23.
The district court recognized that Appellants’ experts
opined that the specification discloses that the analogs
must have a particular function – the inhibition of cell-
cycle progression – and that a person of ordinary skill in
the art could identify structurally similar analogs with
the same function. Id. at 555. However, the district court
determined that this testimony was insufficient because
“describing certain functions of the genus of claimed
analogs does not equate to a description of the claimed
analogs themselves.” Id.
The district court noted that the inventors testified
they did not work with or test any analogs of rapamycin
prior to filing, and “no evidence contradicts the inventors’
deposition testimony or otherwise indicates that the
inventors had possession of the full scope of the invention
as claimed.” Id. The court concluded that “[l]ogically, the
inventors could not have described a knowledge that they
did not possess.” Id. The district court also concluded
11 BOSTON SCIENTIFIC v. JOHNSON & JOHNSON
that “no reasonable jury could find that the written de-
scription requirement has been met with respect to the
claimed analogs.” Id. The district court also held that the
1997 patents are invalid for nonenablement.
B. The ’662 Patent
The district court next addressed the ’662 patent. In
its claim construction order, the district court had con-
strued “macrocyclic triene analog” to mean “a macrocyclic
triene molecule with a structure similar to rapamycin and
that binds FKBP12.” Markman at *2. The district court
determined that the ’662 patent gives more detail, as
compared to the 1997 patents, regarding the mechanism
of action of rapamycin. Boston Scientific Corp., 679 F.
Supp. 2d at 558 n.37. The district court found that,
unlike the 1997 patents, “the ’662 patent explains that
rapamycin binds FKBP12 which, in turn, binds to and
inhibits the kinase TOR; this mechanism of action serves
to inhibit neointimal hyperplasia and reduce restenosis.”
Id. at 557-58.
However, the district court further noted that:
Notwithstanding the above disclosure, no macro-
cyclic triene analogs are named, structurally de-
picted, exemplified, or otherwise described in the
’662 patent specification. No assays or other ex-
perimental models are provided with respect to
testing an analog candidate’s ability to function as
rapamycin, that is, to bind FKBP12 which, in
turn, binds to and inhibits the kinase TOR. . . .
Thus, although limited by function, the claims of
the ’662 patent are drawn to a genus of macrocyc-
lic triene analogs without any description of any
species within the genus. The Federal Circuit has
required the identification of “sufficient species” to
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 12
show that the totality of a claimed genus was in-
vented and disclosed.
Id. at 558 (citing Carnegie Mellon Univ. v. Hoffmann-La
Roche Inc., 541 F.3d. 1115, 1126 (Fed. Cir. 2008)). The
district court determined that under our precedent “a
‘definition by function’ does not suffice to define or de-
scribe the genus” even if it allows one of skill to “guess
and check” what analogs could potentially work. Id. at
558-59 (citing Enzo Biochem, Inc. v. Gen-Probe Inc., 323
F.3d 956, 968 (Fed. Cir. 2002)).
The district court acknowledged that “some macrocyc-
lic triene analogs were known in the art” but found that
this “does not alleviate [Appellants’] obligation under
§ 112 to provide an example.” Id. at 559. The district
court concluded that “[t]he inventors were required to
describe at least one representative macrocyclic triene
analog; having failed to do so, the ’662 patent is [there-
fore] invalid for lack of written description.” Id. Thus,
the district court granted BSC’s motion for summary
judgment of invalidity of the ’662 patent for lack of ade-
quate written description. Id. The district court did not
separately rule on whether the ’662 patent is also invalid
for lack of enablement. Id. at n.41. We have jurisdiction
pursuant to 28 U.S.C. § 1295(a)(1). 3
DISCUSSION
Appellants argue that the district court improperly
granted BSC’s motion for summary judgment of invalidity
3 Appellants asserted the patents-in-suit against
Abbott Cardiovascular Systems, Inc., in four civil actions
before the District of New Jersey. On January 27, 2010,
the district court in New Jersey entered a judgment
against Appellants after concluding that their arguments
were collaterally estopped by the decision of the District
of Delaware that is now before us.
13 BOSTON SCIENTIFIC v. JOHNSON & JOHNSON
of the ’7286 patent, the ’3286 patent, the ’473 patent and
the ’662 patent under 35 U.S.C. § 112. Summary judg-
ment is appropriate “if the pleadings, depositions, an-
swers to interrogatories, and admissions on file, together
with the affidavits, if any, show that there is no genuine
issue as to any material fact and that the moving party is
entitled to judgment as a matter of law.” Fed. R. Civ. P.
56(c). We review a district court’s grant of summary
judgment de novo, reapplying the appropriate standard
applicable before the district court. See, e.g., Univ. of
Rochester v. G. D. Searle & Co. 358 F.3d 916, 919-20 (Fed.
Cir. 2002). Because issued patents are presumed valid,
35 U.S.C. § 282, a party seeking to invalidate a patent
must submit clear and convincing evidence of invalidity.
Id. at 920. In deciding a motion for summary judgment,
“[t]he evidence of the nonmovant is to be believed, and all
justifiable inferences are to be drawn in his favor.”
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).
“Compliance with the written description requirement is
a question of fact but is amenable to summary judgment
in cases where no reasonable fact finder could return a
verdict for the non-moving party.” PowerOasis, Inc. v. T-
Mobile USA, Inc., 522 F.3d 1299, 1307 (Fed. Cir. 2008).
Section 112, paragraph 1, requires that the specifica-
tion contain a written description of the invention.
35 U.S.C. § 112, ¶ 1. “[T]he hallmark of written descrip-
tion is disclosure.” Ariad Pharm., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). A specifi-
cation adequately describes an invention when it “rea-
sonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as
of the filing date.” Id. at 1351. “A ‘mere wish or plan’ for
obtaining the claimed invention is not adequate written
description.” Centocor Ortho Biotech, Inc. v. Abbott Labs,
636 F.3d 1341, 1348 (Fed. Cir. 2011).
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 14
I. The 1997 Patents
The parties dispute whether the shared specification
of the 1997 patents contains adequate written description
regarding the claimed genus of macrocyclic lactone ana-
logs of rapamycin. Appellants argue that the specifica-
tion’s description of macrocyclic lactone analogs was
sufficient to satisfy the written description requirement in
light of the state of the art as of the effective filing date.
Appellants contend that they submitted detailed evidence
regarding the state of the art that precludes a finding on
summary judgment. For example, Appellants relied on
the declaration of their expert witness Dr. David Sabatini
as well as publications that they allege demonstrate: 1)
that the structure and the mechanism of action of rapa-
mycin were known; 2) that the correlation between the
structural elements of rapamycin and its mechanism of
action and biological activity was known; 3) that dozens of
rapamycin analogs having the same macrocyclic ring
structure as rapamycin and comparable biological activity
were known; and 4) that persons of ordinary skill knew of
assays to determine if analogs had the same mechanism
of action as rapamycin and thus would also inhibit cell
proliferation. Appellants’ Br. 43-44.
Appellants contend that because information regard-
ing the structure, mechanism of action, and biological
activity of rapamycin and its analogs was set forth in the
prior art, it was not necessary for the patent to disclose
“formulae or structures” or set forth “definitions, exam-
ples, or experimental models” of particular macrocyclic
lactone analogs. Instead, Appellants argue that the
specification combined with the knowledge of one skilled
in the art “provided a template for those of ordinary skill
to use for identifying analogs falling within the scope of
the claims.” Appellants’ Br. 45-46. Appellants, relying
upon In re Herschler, 591 F.2d 693, 702 (CCPA 1979) and
15 BOSTON SCIENTIFIC v. JOHNSON & JOHNSON
In re Fuetterer, 319 F.2d 259 (CCPA 1963), 4 argue that
when claiming a combination of known elements, as
opposed to a novel compound, the specification “need not
list examples” nor is any “comprehensive description”
required. Appellants’ Br. 32-34. Appellants argue that
the claimed macrocyclic lactone analogs were sufficiently
well known such that “the written description need be
‘only so specific as to lead one having ordinary skill in the
art to that class of compounds.’” Id. at 34 (quoting
Herschler).
Appellants further contend that the prior art con-
tained a known correlation between the structure of
rapamycin and its analogs and their function. Appellants
argue that because “functional claim language can meet
the written description requirement when the art has
established a correlation between structure and function,”
Ariad, 598 F.3d at 1350, the specification does not need to
contain examples of specific macrocyclic lactone analogs of
rapamycin.
BSC contends that the specification of the 1997 pat-
ents contains nothing to indicate that the inventors were
in possession of the claimed inventions in 1997. BSC
argues that, as construed by the district court, the “mac-
rocyclic lactone analog” limitation represents a broad
genus that covers any macrocyclic lactone molecule that is
structurally similar to rapamycin. BSC contends that our
precedent sets out a clear test to determine whether a
specification adequately describes a claimed chemical
genus:
4 Fuetterer is not binding precedent because only
two judges on the five judge panel joined the opinion
(Judge Martin concurred in the result only). 319 F.2d at
266.
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 16
A written description of an invention involving a
chemical genus, like a description of a chemical
species, “requires a precise definition, such as by
structure, formula, [or] chemical name,” of the
claimed subject matter sufficient to distinguish it
from other materials.
Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d
1559, 1568 (Fed. Cir. 1997) (hereinafter, Eli Lilly).
BSC argues that the specification of the 1997 patents
fails to meet this test. BSC notes that there are no exam-
ples of “macrocyclic lactone analogs” of rapamycin in the
patents. BSC also argues that the patents fail to disclose
the structures or features that render a molecule suffi-
ciently similar to rapamycin to classify it as a “macrocyc-
lic lactone analog.” BSC contends that because the
specification fails to disclose any of this essential informa-
tion, there is nothing in the 1997 patents showing that
the inventors possessed drug-eluting stents employing the
broad genus of claimed macrocyclic lactone analogs.
Additionally, BSC contends that upon consideration of
“the existing knowledge in the particular field, the extent
and content of the prior art, the maturity of the science or
technology [and] the predictability of the aspect at issue,”
Ariad, 598 F.3d 1359, the specification’s description of
macrocyclic lactone analogs is insufficient.
We agree with BSC that no reasonable jury could con-
clude that there is sufficient written description support
for the asserted claims of the 1997 patents. “A written
description of an invention involving a chemical genus,
like a description of a chemical species, ‘requires a precise
definition, such as by structure, formula, [or] chemical
name,’ of the claimed subject matter sufficient to distin-
guish it from other materials.” Eli Lilly, 199 F.3d at 1568
17 BOSTON SCIENTIFIC v. JOHNSON & JOHNSON
(quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir.
1993)).
We have “held that a sufficient description of a genus
requires the disclosure of either a representative number
of species falling within the scope of the genus or struc-
tural features common to the members of the genus so
that one of skill in the art can ‘visualize or recognize’ the
members of the genus.” Ariad, 598 F.3d at 1350. Because
each individual invention “has a novel relationship with
the state of the art from which it emerges” we have de-
clined to “set out any bright-line rules governing, for
example, the number of species that must be disclosed to
describe a genus claim . . . .” Id. at 1351. The appropriate
number of species that one must disclose when claiming a
genus “necessarily changes with each invention, and it
changes with progress in a field.” Id.
What is required to meet the written description re-
quirement “varies with the nature and scope of the inven-
tion at issue, and with the scientific and technologic
knowledge already in existence.” Capon v. Eshhar, 418
F.3d 1349, 1357 (Fed. Cir. 2005). As our en banc court
explained in Ariad, “[f]or generic claims, we have set forth
a number of factors for evaluating the adequacy of the
disclosure, including ‘the existing knowledge in the par-
ticular field, the extent and content of the prior art, the
maturity of the science or technology, [and] the predict-
ability of the aspect at issue.’” Ariad, 598 F.3d at 1351
(citing Capon, 418 F.3d at 1359).
Turning to the specification’s disclosure of macrocyclic
lactone analogs of rapamycin, we agree with BSC that no
reasonable jury could conclude that the inventor pos-
sessed the claimed subject matter. The shared specifica-
tion of the 1997 patents contains virtually no information
regarding macrocyclic lactone analogs of rapamycin. The
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 18
sole mention of the analogs outside of the claims (that the
applicant added nine years after the effective filing date)
is under the heading “Experiments.” ’7286 patent col.6
ll.4-5. The shared specification lists “Agents: Rapamycin
(sirolimus) structural analogs (macrocyclic lactones) and
inhibitors of cell cycle progression.” Id. Then four ex-
perimental delivery methods using only rapamycin are
detailed. No experiments are detailed using macrocyclic
lactone analogs nor does the specification even indicate
performance of any such experiments. An ipsis verbis
disclosure of a claimed genus (under the heading Experi-
ments) is not per se sufficient to meet the written descrip-
tion requirement. Enzo Biochem, 323 F.3d at 968. While
the shared specification demonstrates possession of
rapamycin in the claimed stent, it does not evidence
possession of the genus of macrocyclic lactone analogs of
rapamycin in the claimed invention to inhibit restenosis.
Although examples are not always required to satisfy
the written description requirement, the lack of any
disclosure of examples may be considered when determin-
ing whether the claimed invention is adequately de-
scribed. The 1997 patents contain no examples of
macrocyclic lactone analogs of rapamycin, and give no
guidance on how to properly determine whether a com-
pound is a macrocyclic lactone analog of rapamycin be-
sides vaguely indicating they must be “structural[ly]
similar” to rapamycin. Given the structural complexity of
rapamycin (rapamycin contains fifty-one carbon atoms,
seventy-nine hydrogen atoms, thirteen oxygen atoms and
a nitrogen atom), the universe of potential compounds
that are structurally similar to rapamycin and classifiable
as macrocyclic lactones is potentially limitless. As noted
by the district court, the Appellants do not specifically
contest that tens of thousands of potential macrocyclic
lactone analogs exist. Boston Scientific, 679 F. Supp. 2d
19 BOSTON SCIENTIFIC v. JOHNSON & JOHNSON
at 554 n.23. Furthermore, even the minor structural
changes to the molecular structure of rapamycin that are
necessary to create analogs may have significant and
unpredictable effects on functionality. J.A. 1764; J.A.
1769.
It is true that some species of this vast genus were
known in the art. For example, both the Cottens publica-
tion and the Skotnicki patent disclosed specific species of
the claimed genus of macrocyclic lactone analogs. Any
suggestion that these references represented existing
knowledge in the art so well known as to excuse including
a more detailed disclosure of the macrocyclic lactone
analogs genus in the specification is belied by the state of
the art at the time of the invention. Cf. Ariad, 598 F.3d
at 1354-55 (inventor has obligation to disclose molecules
when the art is unpredictable and existing knowledge
scant).
At the effective filing date, very little knowledge ex-
isted regarding the use of drug-eluting stents to inhibit
restenosis. In fact, Cordis’s Cypher® stent, which em-
ploys the patented technology, was the first drug-eluting
stent marketed and approved in the United States.
Appellants’ own expert declarations detail the failure of
others to develop drug-eluting stents to inhibit restenosis
and evidenced the “highly unexpected” and “remarkable
clinical results seen in Cordis’s Cypher® stent.” J.A.
14739-46; J.A. 14872-73. Appellants also argued in their
briefing in opposition to BSC’s § 103 summary judgment
motion that the state of the art was highly unpredictable.
J.A. 14698 (“[P]ersons of ordinary skill were faced with a
multitude of possible therapeutic approaches and a multi-
tude of possible drug and polymer combinations. Addi-
tionally, these proposed solutions were anything but
predictable. Researchers in the field had little idea
which, if any would prove successful.”).
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 20
Indeed, the shared specification of the 1997 patents
acknowledges the uncertainties surrounding rapamycin,
restenosis, and drug-eluting stents as of the effective
filing date of the patents. See, e.g., ’7286 patent col.1
ll.38-40 (“The exact hormonal and cellular processes
promoting restenosis are still being determined.”); id.
col.2 ll.49-52 (“The exact mechanism for restenosis is still
under active investigation.”); id. col.1 ll.54-56 (“The
mechanisms for most agents employed [to prevent smooth
muscle cell proliferation] are still unclear.”); id. col.5 ll.59-
60 (“The ideal agent for restenosis has not yet been identi-
fied.”); id. col.5 ll.36-38 (“The precise mechanism of rapa-
mycin is still under active investigation.”).
This case, in many respects, parallels our decision in
Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541
F.3d. 1115, 1126 (Fed. Cir. 2008). In Carnegie Mellon, the
court held that our case law regarding generic claims is
applicable to both inventions claiming novel genera of
chemical and biological compounds as well as inventions
claiming combinations of prior art compounds with other
elements. 541 F.3d at 1124. In Carnegie Mellon, the
patentee argued that our holding in “Eli Lilly is distin-
guishable from the present case because the invention in
Eli Lilly was tied to a specific cDNA sequence, whereas
the invention here involves a combination of well known
elements that create a generic biotechnological tool.” Id.
at 1122-23. The patentee argued that species of the
claimed genus “were well known in the art” and that the
district court in granting summary judgment of no writ-
ten description “failed to draw inferences in [the pat-
entee’s] favor.” Id. at 1123. We rejected these arguments
in Carnegie Mellon and likewise find them unavailing
here. The test for written description is the same whether
the claim is to a novel compound or a novel combination of
known elements. The test is the same whether the claim
21 BOSTON SCIENTIFIC v. JOHNSON & JOHNSON
element is essential or auxiliary to the invention. Cf. Aro
Mfg. Co. v. Convertible Top Replacement Co., 365 U.S.
336, 345 (1961) (“[T]here is no legally recognizable or
protected ‘essential’ element, ‘gist’ or ‘heart’ of the inven-
tion in a combination patent.”).
We conclude that in this case, like Carnegie Mellon,
summary judgment was appropriately granted. In Car-
negie Mellon, the court noted that only three bacterial
genes out of thousands of species had been cloned, and
only one was disclosed in the specification. 541 F.3d at
1125. The court contrasted Carnegie Mellon with Capon,
a case where the prior art contained “extensive knowledge
of the nucleotide structure” of the relevant DNA including
785 mouse antibody DNA light chains and 1,327 mouse
antibody DNA heavy chains. Id. Here, no analogs are
disclosed in the specification. While a small number of
such analogs were known in the prior art, the claims
cover tens of thousands of possible macrocyclic lactone
analogs. With no guidance at all in the specification as to
how to properly identify or choose the claimed analogs,
and in light of the unpredictability and nascent state of
using drug-eluting stents to treat restenosis, we agree
with the district court that appellants have failed to
create genuine issues of material fact.
Although it is true that functional claim language can
meet the written description requirement when there is
an established correlation between structure and func-
tion, Appellants fail to establish any such correlation.
See, e.g., Univ. of Rochester, 358 F.3d at 925 (explaining
that “functional descriptions of genetic material can, in
some cases, meet the written description requirement if
the functional characteristics are coupled with a known or
disclosed correlation between function and structure”)
(citations and internal quotations omitted). Appellants
contend that the declaration of Dr. Sabatini and prior art
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 22
patents and articles indicate that “the structure and
mechanism of action of rapamycin were known” and that
“the correlation between the structural elements of rapa-
mycin and its mechanism of action and biological activity
was known.” See, e.g., Appellants’ Br. at 43-44. In par-
ticular, Appellants rely on a July 1996 article from Sci-
ence (the Choi article) that discloses how rapamycin
interacts with FKBP12 and mTOR. J.A. 11162-65.
However, both the Choi article and Dr. Sabatini’s declara-
tion directly conflict with the shared specification of the
1997 patents, which explicitly states that “the precise
mechanism of rapamycin is still under active investiga-
tion.” ’7286 patent col.5 ll.36-38 (emphasis added).
The shared specification indicates that the alleged
correlation between structure and function was not well
known by the effective filing date. Dr. Sabatini’s declara-
tion explains that, based on the Choi article, rapamycin
must first bind to FKBP12 via rapamycin’s pipecolinyl
ring to form a rapamycin/FKBP12 complex in order to
inhibit restenosis. J.A. 10556. Then this rapamy-
cin/FKBP12 complex binds with mTOR. Id. Specifically,
rapamycin’s triene group interacts with mTOR. Id.
Therefore, Dr. Sabatini’s declaration indicates that rapa-
mycin’s structural features that allow it to function to
inhibit restenosis are: 1) the pipecolinyl ring and 2) the
triene group. However, the specification of the 1997
patents is silent about the need for the claimed analogs to
maintain these two structural features.
When determining whether a specification contains
adequate written description, one must make an “objec-
tive inquiry into the four corners of the specification from
the perspective of a person of ordinary skill in the art.”
Ariad, 598 F.3d at 1351. Because the specification is
viewed from the perspective of one of skill, in some cir-
cumstances, a patentee may rely on information that is
23 BOSTON SCIENTIFIC v. JOHNSON & JOHNSON
“well-known in the art” for purposes of meeting the writ-
ten description requirement. See Falko-Gunter Falkner v.
Inglis, 448 F.3d 1357 1366-68 (Fed. Cir. 2006). However,
when the four corners of the specification directly contra-
dict information that the patentee alleges is “well-known”
to a person of skill at the effective filing date, no reason-
able jury could conclude that the patentee possessed the
invention. Here, the specification of the 1997 patents
itself refutes any conclusion that “the structural elements
of rapamycin and its mechanism of action and biological
activity was known.” See Univ. of Rochester, 358 F.3d at
930 (“Although section 282 places the burden of proof on
the party seeking to invalidate a patent, it does not fore-
close the possibility of that party demonstrating that the
patent in suit proves its own invalidity.”). Thus, there is
insufficient correlation between the function and struc-
ture of rapamycin and its analogs to provide adequate
written description support for the entire genus of macro-
cyclic lactone analogs of rapamycin.
Given the absence of information regarding structural
characteristics of macrocyclic lactone analogs or examples
of macrocyclic lactone analogs in the specification, the
unpredictability of the art and the nascent state of using
drug-eluting stents to inhibit restenosis, we affirm the
district court’s grant of summary judgment. The patent
laws do not reward an inventor’s invitation to other
researchers to discover which of the thousands of macro-
cyclic lactone analogs of rapamycin could conceivably
work in a drug-eluting stent. Because we affirm the
district court’s holding that no reasonable jury could
conclude that the 1997 patents contained sufficient writ-
ten description support, we need not separately address
Appellants’ arguments regarding enablement.
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 24
II. The ’662 Patent
The ’662 patent claims “rapamycin or a macrocyclic
triene analog thereof” in combination with specific drug-
eluting stents. Therefore, we must analyze whether a
reasonable juror could conclude that the inventors of the
’662 patent were in possession of the claimed genus of
“macrocyclic triene analogs” in combination with the other
claim elements. Although Appellants make many of the
same arguments regarding the ’662 patent as they did for
the 1997 patents, Appellants argue that the ’662 patent
sets forth even more information regarding rapamycin
and its analogs. We agree with the district court that no
reasonable juror could determine that the specification
adequately describes the claimed genus of “macrocyclic
triene analogs.”
As shown by Appellants’ own experts, at the effective
filing date of the ’662 patent, researchers continued to
struggle to find compounds that would work in a drug-
eluting stent to prevent restenosis. J.A. 14739-46; J.A.
14872-73. Therefore, at the time of effective filing date of
the ’662 patent, such technology was still in its infancy.
Despite this fact, the ’662 patent fails to disclose even a
single member of either the genus of “analogs” of rapamy-
cin, or the more specific genus of “macrocyclic triene
analogs” of rapamycin. In fact, even though the specifica-
tion of the ’662 patent contains more information regard-
ing rapamycin and discloses the broad genus of “analogs”
of rapamycin, it never discloses the sub-genus of “macro-
cyclic triene analogs” of rapamycin. Instead, the only
mention of the term “macrocyclic triene” in the patent
specification is the statement that “[r]apamycin is a
macroyclic [sic] triene antibiotic.” ’662 patent col.5 l.31.
In Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed.
Cir. 1996), we addressed the written description require-
25 BOSTON SCIENTIFIC v. JOHNSON & JOHNSON
ment in a situation where a patentee claimed a sub-genus
that was not disclosed ipsis verbis in the specification.
There, as here, instead of disclosing the sub-genus, the
patentee disclosed only the broader genus. Id. We held
that in the absence of blaze marks “as to what compounds
other than those disclosed as preferred, might be of spe-
cial interest . . . simply describing a large genus of com-
pounds is not sufficient to satisfy the written description
requirement as to particular species or sub-genuses.” Id.
at 1570-71. Here, the inventors similarly disclosed a
genus (analogs of rapamycin), but claimed a narrower
sub-genus (macrocyclic triene analogs of rapamycin).
However, nothing in the ’662 patent indicates that the
claimed triene analogs might be of special interest. Given
the nascent state of using drug-eluting stents to treat
restenosis at this time, the lack of such blaze marks in the
’662 patent prevents any conclusion that the patent
contains sufficient written description of the claimed
triene analogs of rapamycin. No reasonable juror could
determine that the specification “reasonably convey[s] to
persons skilled in the art that the inventor had posses-
sion” of the claimed sub-genus. Id. at 1570.
Moreover, the functional disclosures in the ’662 patent
fail to sufficiently describe the claimed sub-genus of
macrocyclic triene analogs or provide sufficient blaze
marks as to which analogs might successfully work in
drug-eluting stents. Even at the 2001 effective filing date,
the relationship between the function of rapamycin and
its structure was not so well known that it excuses the
patentee’s failure to explicitly disclose the claimed sub-
genus or any species within the sub-genus. Like the 1997
patents, the ’662 patent confirms that the mechanism of
action of rapamycin was not well known at the effective
filing date. Although the patent explains the binding of
rapamycin to FKBP12 to form a complex and the subse-
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 26
quent binding of this complex to mTOR, the patent also
admits that “[t]he molecular events that are responsible
for the actions of rapamycin, a known anti-proliferative,
which acts to reduce the magnitude and duration of
neointimal hyperplasia, are still being elucidated.” ’662
patent col.5 l.62 – col.6 l.3.
Furthermore, the ’662 patent states that “[r]apamycin
functions to inhibit smooth muscle cell proliferation
through a number of mechanisms.” Id. col.5 ll.43-44. The
patent then gives details regarding how the compound
and its analogs function, including stating that “there is
evidence that rapamycin may also inhibit the other major
component of restenosis, namely, negative remodeling.”
Id. col.6 ll.12-14. However, the specification states that it
is unknown how rapamycin functions to inhibit negative
remodeling:
It may be hypothesized that rapamycin acts to re-
duce negative remodeling in several ways. By
specifically blocking the proliferation of fibroblasts
in the vascular wall in response to injury, rapa-
mycin may reduce the formation of vascular scar
tissue. Rapamycin may also affect the translation
of key proteins involved in collagen formation or
metabolism.
Id. col.7 ll.22-27. Thus, the ’662 patent indicates that the
mechanism of action corresponding to the function of
rapamycin and its analogs is still under investigation. As
with the 1997 patents, this characterization of the state of
the art directly contradicts Appellants’ assertion that
there was a well known correlation between the structure
of rapamycin and its function.
The ’662 patent also contains insufficient support for
the highly specific functional requirements claimed. For
example, claim 1, which is representative of all of the
27 BOSTON SCIENTIFIC v. JOHNSON & JOHNSON
independent claims of the ’662 patent, requires “from
about 64 µg to about 197 µg of rapamycin or a macrocyclic
triene analog thereof . . . wherein said device provides an
in-stent late loss in diameter at 12 months following
implantation in a human of less than about 0.5 mm[.]”
The ’662 patent includes no information suggesting how a
person of skill in the art would select macrocyclic triene
analogs with such highly specific performance require-
ments. There is also no indication of which structural
features of analogs of rapamycin are necessary to achieve
these results. Although it is possible that one could use
trial and error, one would have to wait a full year in order
to determine whether a specific analog in combination
with the other claimed elements achieved the claimed
results. The specification fails to convey to one of skill in
the art that the inventors were in possession of any
analogs that achieve these highly specific results as the
written description requirement mandates.
Given the state of the art, and the lack of any success-
ful combination of elements, a person of skill in the art
would expect more than the meager disclosure of “ana-
logs” in the ’662 patent. The specification fails to disclose
the sub-genus of “macrocyclic triene analogs” by name, by
functionality, or even by implication. The specification
similarly fails to disclose a single species of “macrocyclic
triene analogs” or a single species of any analog of rapa-
mycin. Furthermore, the plethora of test results in the
’662 patent are devoted exclusively to rapamycin itself,
with no results from the testing of analogs. Given the
paucity of disclosure regarding the claimed sub-genus, no
reasonable juror could conclude that the specification of
the ’662 patent discloses to a person of ordinary skill in
the art that the inventors were in possession of the
claimed invention.
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 28
CONCLUSION
We hold that no reasonable juror could determine that
the asserted claims of the patents-in-suit contain ade-
quate written description of the claimed analogs of rapa-
mycin. Therefore, we affirm the judgment of the district
court.
AFFIRMED
United States Court of Appeals
for the Federal Circuit
__________________________
BOSTON SCIENTIFIC CORPORATION AND
BOSTON SCIENTIFIC SCIMED, INC.,
Plaintiffs-Appellees,
v.
JOHNSON & JOHNSON (ALSO KNOWN AS
JOHNSON & JOHNSON, INC.),
CORDIS CORPORATION, AND WYETH,
Defendants-Appellants,
__________________________
2010-1230, -1231, -1233, -1234
__________________________
Appeals from the United States District Court for the
District of Delaware in consolidated case nos. 07-CV-0333,
07-CV-0348, 07-CV-0409, and 07-CV-0765, Judge Sue L.
Robinson
__________________________
GAJARSA, Circuit Judge, concurring-in-part.
I agree with the majority that the asserted claims of
U.S. Patent Nos. 7,217,286 (the “’7286 patent”); 7,223,286;
7,229,473 (collectively, the “1997 patents”); and 7,300,662
(the “’662 patent”) are invalid, but would hold the 1997
patents invalid for lack of enablement. Therefore, I
concur only in judgment as to the 1997 patents. I join
fully the majority’s opinion regarding the ’662 patent.
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 2
The claimed invention is a combination of a stent,
polymeric carrier, and therapeutic agent. The majority
focuses solely on the written description aspect of whether
the therapeutic agent’s analogs were adequately described
and ignores that in nearly all of the asserted claims, the
agents must effectively inhibit neointimal proliferation.
Because undue experimentation was required to practice
the 1997 patents, the district court’s grant of summary
judgment of invalidity should have been affirmed on
enablement grounds.
The enablement requirement of 35 U.S.C. § 112 ¶ 1 is
the appropriate tool for invalidating claims that are
broader than their disclosure. The majority blurs the line
between enablement and written description and does not
address the claim language that “rapamycin, or a macro-
cyclic lactone analog thereof, and is present in an amount
effective to inhibit neointimal proliferation.” ’7286 patent,
col.8 ll.15-23 (emphasis added).
The majority’s opinion further extends the written de-
scription requirement into the realm of enablement.
Much of the confusion in this case is due to the difficulty
of determining what constitutes a genus or a subgenus,
the relationship between the structure and the function of
compounds, and how the written description requirement
applies to novel compounds as opposed to novel combina-
tions of known elements. These are legal inquiries predi-
cated on disputed issues of material fact. Applying the
enablement requirement would help to clear the thicket of
jurisprudence regarding § 112 ¶ 1. As discussed briefly
below, in this case, the enablement analysis is simpler
and more appropriate.
The relevant test for enablement is whether the speci-
fication enables one of skill in the art to practice the
claimed invention without undue experimentation. In re
3
BOSTON SCIENTIFIC v. JOHNSON&JOHNSON
Wands lists the factors to be considered in determining
whether a disclosure would require undue experimenta-
tion. 858 F.2d 731, 737 (Fed. Cir. 1988). The district
court correctly applied the Wands factors and held that
practicing the claimed invention with a macrocyclic
lactone analog would have required undue experimenta-
tion in 1997. The district court noted that “there is no
direction or guidance disclosed in the patents and no
working examples” (factors 2 and 3); “the claims are
moderately broad insofar as there is no limit, aside from
function (determined through experimentation), regard-
ing the number of potential analogs” (factor 8); “there is
no genuine dispute that the invention concerns a very
complex chemical and biomechanical art germane to
highly skilled cardiologists” (factors 4 and 6); “the 1997
patents were filed on the heels of a decade marked by
failed attempts to reduce restenosis” (factor 5); and “the
chemical arts have long been acknowledged to be unpre-
dictable” (factor 7). Boston Scientific v. Johnson & John-
son, 679 F. Supp. 2d 539, 557 (D. Del. 2010). These
findings were consistent with Appellants’ opposition to
Appellees’ § 103 motion. The Appellants argued that “the
development of the Cypher stent required trial-and-error
experimentation with many drugs and polymers.” J.A.
17718.
To satisfy a majority of the asserted claims, a rapa-
mycin analog not only needs to generally prevent resteno-
sis, but must also prevent restenosis when used on a
drug-eluting stent. Once rapamycin's structure was
known, scientists could hypothesize that useful analogs
could potentially be created by changing parts of that
molecule, particularly outside of the critical macrocyclic
ring structure. The 1997 patents did not need to explain
how to synthesize, identify, or determine the biological
BOSTON SCIENTIFIC v. JOHNSON & JOHNSON 4
activity of a suitable macrocyclic lactone analog. The
patents did, however, need to disclose where the rapamy-
cin molecule should be modified to obtain a suitable
analog with the desired efficacy in stents. It is not enough
that a person of ordinary skill in 1997 could have readily
determined whether a compound was a claimed macrocyc-
lic lactone; for most of the claims, the analog needed to
prevent restenosis when used on a drug eluting stent.
Because no one knew of any rapamycin analogs with the
desired efficacy when delivered by stents as of the filing
date of the 1997 patents, Appellants’ claims are not
enabled.
The claims of the 1997 patents are invalid for lack of
enablement but because the majority decided that the
asserted claims were invalid solely for lack of written
description, I concur only in the judgment as to those
patents.