Bruce Saffran v. Johnson & Johnson

United States Court of Appeals
for the Federal Circuit
______________________
BRUCE N. SAFFRAN, M.D., PH.D.,
Plaintiff-Appellee,
v.
JOHNSON & JOHNSON AND CORDIS
CORPORATION,
Defendants-Appellants.
______________________
2012-1043
______________________
Appeal from the United States District Court for the
Eastern District of Texas in No. 07-CV-0451, Judge T.
John Ward.
______________________
Decided: April 4, 2013
______________________
DAVID C. FREDERICK, Kellogg, Huber, Hansen, Todd,
Evans & Figel, P.L.L.C., of Washington, DC, argued for
plaintiff-appellee. With him on the brief were MICHAEL E.
JOFFRE, KIRAN S. RAJ, MELANIE L. BOSTWICK and
CHRISTOPHER C. FUNK. Of counsel on the brief were PAUL
R. TASKIER, JAMES W. BRADY, JR. and JEREMY A. CUBERT,
Dickstein Shapiro LLP, of Washington, DC. Of counsel
was ERIC M. ALBRITTON, Albritton Law Firm, of
Longview, TEXAS; RYAN H. FLAX and KIMBERLY R. PARKE,
Dickstein Shapiro LLP, of Washington, DC; MATTHEW R.
2 SAFFRAN v. JOHNSON & JOHNSON
RODGERS and DANNY L. WILLIAMS, Williams Morgan &
Amerson P.C., of Houston, Texas.
GREGORY L. DISKANT, Patterson Belknap Webb & Ty-
ler LLP, of New York, New York, argued for defendants-
appellants. With him on the brief were EUGENE M.
GELERNTER, SCOTT B. HOWARD and IRENA ROYZMAN. Of
counsel on the brief was RICHARD A. SAYLES, Sayles
Werbner, of Dallas. Texas.
MICHAEL A. MORIN, Finnegan, Henderson, Farabow,
Garrett & Dunner, LLP, of Washington, DC, for amicus
curiae Abbott Laboratories. With him on the brief were
KARA F. STOLL, JAMES R. BARNEY and JASON W. MELVIN.
JONATHAN S. MASSEY, Massey & Gail, LLP, of Wash-
ington, DC, for amici curiae Scientists Tonia M. Young-
Fadok, et al.
JENNIFER KUHN, Law Office of Jennifer Kuhn, of Aus-
tin, Texas, for amicus curiae Professor Lara A. Estroff.
______________________
Before LOURIE, MOORE, and O’MALLEY, Circuit Judges.
Opinion for the court filed by Circuit Judge LOURIE, in
which Circuit Judge MOORE joins except as to Parts II-A-2
and II-B-2, and in which Circuit Judge O’MALLEY joins
except as to Parts II-A-1 and II-B-1.
Opinion concurring in part filed by
Circuit Judge MOORE.
Opinion concurring in part filed by
Circuit Judge O’MALLEY.
LOURIE, Circuit Judge.
Johnson & Johnson and Cordis Corporation (collec-
tively, “Cordis”) appeal from the final judgment of the
SAFFRAN v. JOHNSON & JOHNSON 3
United States District Court for the Eastern District of
Texas in favor of Dr. Bruce N. Saffran (“Saffran”), in
which the district court held Cordis liable for infringing
claims 1–3, 6, 8, 9, 11, 13, 15, and 17 of Saffran’s U.S.
Patent 5,653,760 (the “’760 patent”). Saffran v. Johnson
& Johnson, No. 2:07-cv-451 (E.D. Tex. Mar. 31, 2011),
ECF No. 326 (“Final Judgment”). We conclude that the
district court erroneously construed the claims of the ’760
patent and that, under the correct construction, Cordis is
entitled to a judgment of noninfringement as a matter of
law. Accordingly, we reverse.
I. BACKGROUND
Saffran is the owner and sole named inventor of the
’760 patent, which is entitled “Method and Apparatus for
Managing Macromolecular Distribution” and concerns
“the treatment of injured tissues within human or animal
bodies, specifically . . . the way injured tissues are joined
and the way macromolecules are directed to promote
healing.” ’760 patent col. 1 ll. 21–24. In particular, the
’760 patent discloses methods and devices for treating
injured tissues by sequestering particles and macromole-
cules in a defined space using a selectively permeable
barrier.
The specification primarily describes the invention in
terms of a strategy for treating serious bone fractures,
known as complex or comminuted fractures, where the
bone has been shattered into numerous fragments. In
such cases, standard treatment may involve surgical
intervention to align the bone fragments and affix a
stabilizing device across the fracture site in order to
enable new bone to form between, and eventually unite,
the fragments during healing. The specification teaches
that such complex fractures often heal poorly, requiring
repeated operations and leading to permanent disability.
See id. col. 1 l. 43 – col. 2 l. 16.
4 SAFFRAN v. JOHNSON & JOHNSON
The specification describes several cellular and mo-
lecular processes that may influence clinical outcomes
following a complex fracture. For one, cells at the site of
injury secrete growth-promoting proteins (growth factors)
into the interfragmentary spaces, where those proteins
can, in sufficient concentrations, stimulate cellular prolif-
eration and the assembly of a “scaffolding” matrix be-
tween fragments that serves as a prelude to new bone
formation. If the local concentration of growth factors is
too low, the scaffolding process does not occur—small
bone fragments instead remain isolated and are eventual-
ly absorbed by the body, leaving persistent and ever-
larger gaps between the major fragments. In addition,
when bone growth factors diffuse away from the fracture
site and into adjacent soft tissues, they can spur calcifica-
tion and heterotopic bone growth within the muscles,
which can permanently limit the patient’s range of mo-
tion. Id. col. 2 ll. 17–64.
To improve the treatment of such injuries, the ’760
patent discloses “a unique method of fracture stabilization
and a means to restrain interfragmentary macromole-
cules using a single, flexible minimally porous sheet.” Id.
col. 7 ll. 34–36. For purposes of the ’760 patent, substanc-
es larger than about 500 daltons1 (e.g., proteins and many
drugs) are considered macromolecules. Id. col. 8 ll. 3–6.
The single-layered sheet serves as a selective barrier that
blocks macromolecules and larger particles, such as tissue
fragments and cells, yet contains micropores sized to
allow free passage for small molecules (e.g., water). See
id. col. 13 ll. 39–57. Other sheets might be designed to
screen molecules according to properties such as ionic
charge or hydrophobicity rather than size. Id. col. 8
1 The dalton is a standard unit of measure used for
quantifying mass on a molecular scale. One dalton is
approximately equal to the mass of one hydrogen atom.
SAFFRAN v. JOHNSON & JOHNSON 5
ll. 15–24. Once selected and cut to the desired size and
shape, the sheet (1) is wrapped around or affixed to the
fracture site, for example, with staples (6), as shown
below.
’760 patent fig. 4a; see also id. col. 16 ll. 13–47. Because
of the invention’s barrier properties, the growth factors
and other macromolecules (8) produced by the injured
tissues at the fracture site are restrained and concentrat-
ed within the interfragmentary spaces (4), as illustrated
in a cross-sectional diagram of the device after implanta-
tion:
6 SAFFRAN v. JOHNSON & JOHNSON
’760 patent fig. 4b. In addition to pre-formed sheets, the
specification also discloses that “the invention can be
applied to the site of injury as a spray . . . such that it is
deposited as a thin film on the tissue . . . to maximize the
surface area being treated while minimizing the need to
dissect and staple.” Id. col. 18 ll. 29–47.
Id. fig. 6a; see also id. fig. 6b.
In addition to its above-described properties, the sheet
can also be configured to deliver a drug or other therapeu-
tic agent (a “treating material”) to the treatment site. In
such embodiments, the ’760 patent teaches that the
treating material “is affixed directly to one surface of the
minimally-porous sheet.” Id. col. 8 ll. 31–32. In particu-
lar, the ’760 patent describes affixing a treating material
(12) to one side of the sheet (1) through a hydrolyzable
chemical bond (24), which in the preferred embodiment
can be severed to release the treating material by means
SAFFRAN v. JOHNSON & JOHNSON 7
of water molecules present at the treatment site.2 Id.
col. 14 ll. 65–67. Figure 3a of the ’760 patent represents a
sheet configured for drug delivery as described above:
’760 patent fig. 3a. Lysis of the bonds occurs at a constant
rate, releasing a steady dose of treating material. Id.
col. 14 l. 43 – col. 15 l. 20, col. 22 ll. 4–17. Moreover,
because the released treating material (10) is too large to
pass through the minimally porous sheet, the disclosed
device can deliver such therapeutics in a spatially di-
rected manner—generally, the treating material is deliv-
ered from and then maintained adjacent to the side of the
sheet facing the injured tissue, as illustrated in the ’760
patent:
’760 patent fig. 3b.
As another use for the invention, the ’760 patent also
describes intravascular stents incorporating the disclosed
technology. See id. col. 20 l. 9 – col. 21 l. 3. According to
2 A hydrolyzable bond is one that can be broken by
means of a chemical reaction with water.
8 SAFFRAN v. JOHNSON & JOHNSON
the specification, vascular plaques form in response to
microscopic injuries to a blood vessel wall: “When the
vessel attempts to heal, neighboring cells [secrete] a
series of macromolecules to ‘patch’ the defect. If the
macromolecules are not kept substantially in place, they
will be swept away by moving blood. . . . [T]he sooner the
injury is repaired, the smaller the resulting plaque will
be.” Id. col. 20 ll. 14–21. In this regard, the ’760 patent
criticizes prior art stents consisting of an open wire mesh
because the holes (27) in the mesh between adjacent stent
struts (29) are so large that “both cells and macromole-
cules [(8)] are free to move through them” and into the
blood vessel lumen (38), id. col. 20 ll. 34–38, as illustrated
below.
’760 patent fig. 8c. The specification notes prior art U.S.
Patent 5,383,928 (“Scott”) as an improvement to the
traditional open mesh stent design, incorporating a
“sheath that can cover the metallic mesh of a porous stent
thereby somewhat limiting its porosity.” ’760 patent
col. 20 ll. 38–45; see also id. fig. 8d. The ’760 patent also
observes that Scott described embedding a drug within
the sheath for local delivery but explains that Scott “does
not have means to restrain macromolecules between their
sheath and the vessel wall” and therefore cannot provide
“‘directional drug delivery means’ necessary to restrain
SAFFRAN v. JOHNSON & JOHNSON 9
the medicine that their sheath delivers.” Id. col. 20 ll. 42–
58.
In contrast, the minimally porous sheet of the ’760 pa-
tent “provides the means to restrain the macromolecules
elaborated by the healing tissue, as well as the ability to
restrain any number of medicines in the space adjacent to
the injured blood vessel wall.” Id. col. 20 ll. 59–62. The
’760 patent provides several figures depicting the dis-
closed stents in operation:
10 SAFFRAN v. JOHNSON & JOHNSON
’760 patent figs. 8e–f; see also id. figs. 8g–9e. The draw-
ings show the disclosed minimally porous sheet (1)
wrapped around a mesh stent and positioned inside a
partly occluded blood vessel containing an atherosclerotic
plaque (18). The sheet has treating material (12) bound
to one side facing the blood vessel wall (39). Tissue-
derived macromolecules (8) and released treating materi-
al (10) remain sequestered between the sheet and the
vessel wall, while water and other small molecules (16)
pass freely into the blood vessel lumen (38). See id. col. 11
ll. 28–53, col. 12 l. 21 – col. 13 l. 18.
The specification of the ’760 patent concludes with 18
claims reciting devices and methods for treating damaged
tissues using the disclosed minimally porous devices.
Independent claims 1 and 8 are representative:
1. A flexible fixation device for implantation into
human or animal tissue to promote healing of a
damaged tissue comprising:
a layer of flexible material that is minimally
porous to macromolecules, said layer having a
first and second major surface, the layer being ca-
pable of being shaped in three dimensions by ma-
nipulation by human hands,
the first major surface of the layer being
adapted to be placed adjacent to a damaged tis-
sue,
the second major surface of the layer being
adapted to be placed opposite to the damaged tis-
sue,
the layer having material release means for
release of an at least one treating material in a di-
rectional manner when said layer is placed adja-
cent to a damaged tissue,
the device being flexible in three dimensions
by manipulation by human hands,
SAFFRAN v. JOHNSON & JOHNSON 11
the device being capable of substantially re-
stricting the through passage of at least one type
of macromolecule therethrough.
....
8. A method of treating a damaged tissue to pro-
mote repair comprising:
a) providing a device including, a layer of flex-
ible material that is minimally porous to macro-
molecules, said layer having a first and second
major surface, the layer being capable of shaping
in three dimensions by manipulation by human
hands,
the first major surface of the layer being
adapted to be placed adjacent to the damaged tis-
sue,
the second major surface of the layer being
adapted to be placed opposite to the damaged tis-
sue,
the layer having material release means for
release of an at least one treating material in a
unidirectional manner when said layer is placed
adjacent to the damaged tissue,
the device being flexible in three dimensions
by manipulation by human hands,
the device being capable of restricting the
through passage of at least one type of macromol-
ecule therethrough,
b) placing the device adjacent to a damaged
tissue,
c) whereby the placed device results in direc-
tional presentation of the at least one treating
material.
Id. col. 22 ll. 29–47, col. 23 ll. 14–37 (emphases added).
12 SAFFRAN v. JOHNSON & JOHNSON
On October 9, 2007, Saffran filed suit against Cordis
alleging infringement of the ’760 patent. According to the
complaint, Cordis infringed by making, using, and selling
drug-eluting stents marketed under the brand name
Cypher®. Briefly, the accused stents comprise a metallic
mesh with a microscopic layer of polymer that coats the
surface of each strut. The coating applied to the Cordis
stents contains two polymers mixed with the macromo-
lecular drug sirolimus,3 which diffuses out of the device in
a controlled fashion after implantation, gradually escap-
ing through gaps in the polymer matrix over a 90-day
period. The holes between the coated struts remain open,
as shown in images of the accused products:
The district court conducted Markman proceedings to
construe several disputed claim limitations. Saffran v.
Johnson & Johnson, 740 F. Supp. 2d 899 (E.D. Tex. 2010)
(“Claim Construction Order”). The district court first
addressed the term “device,” which it viewed as non-
limiting preamble language that “merely gives a descrip-
tive name to the set of limitations in the body of the
claim.” Id. at 911. Accordingly, the district court con-
strued “device,” as used in the claims of the ’760 patent, to
mean “a device having the limitations called out by the
body of the claim.” Id. The district court also interpreted
the language “minimally porous to macromolecules” as
3 Sirolimus, also known as rapamycin, is an immu-
nosuppressive drug that has a molecular weight of ap-
proximately 914 daltons.
SAFFRAN v. JOHNSON & JOHNSON 13
meaning “substantially impermeable to macromolecules,”
in view of the phrase’s ordinary meaning and the ’760
patent’s specification. Id. at 913–14. Finally, the district
court concluded that the language “means for release of at
least one treating material in a directional manner” is a
means-plus-function limitation governed by 35 U.S.C.
§ 112, ¶ 6.4 Accordingly, the district court held that the
function of the claimed “means for release” is “to release a
drug preferentially toward the damaged tissue” and
defined the corresponding structures disclosed in the ’760
patent’s specification as “chemical bonds and linkages.”
Id. at 914–19.
The case proceeded to trial and the jury returned a
verdict in favor of Saffran on January 28, 2011. Specifi-
cally, the jury found that the ’760 patent was not proven
invalid; that Cordis had willfully infringed the ’760 patent
through the manufacture, use, and sale of its accused
stent products; and that Saffran was entitled to damages
totaling $482,000,000. Saffran v. Johnson & Johnson,
No. 2:07-cv-451, 2011 WL 1299607, at *1 (E.D. Tex. Mar.
31, 2011). After the verdict, Cordis moved for judgment
as a matter of law on invalidity, infringement, willfulness,
and damages. The district court held that sufficient
evidence supported the jury’s conclusions as to invalidity,
infringement, and damages, denying Cordis’s motions on
those grounds. Id. at *2–8, *10–11. Regarding willful-
ness, however, the district court determined that Saffran
had not satisfied the objective prong of the willfulness test
and therefore granted Cordis’s motion for judgment as a
matter of law on that issue. Id. at *8–9. Having upheld
4 Paragraph 6 of 35 U.S.C. § 112 was replaced with
newly designated § 112(f) when § 4(c)(6) of the Leahy-
Smith America Invents Act (“AIA”), Pub. L. No. 112-29,
took effect on September 16, 2012. Because this case was
filed before that date, we will refer to the pre-AIA version
of § 112.
14 SAFFRAN v. JOHNSON & JOHNSON
the jury’s calculation of damages, the district court
awarded an additional $111,364,281 in prejudgment
interest, bringing the total award to $593,364,281. Final
Judgment, slip op. at 1–2. Cordis now appeals; we have
jurisdiction under 28 U.S.C. § 1295(a)(1).
II. DISCUSSION
Claim construction is an issue “exclusively within the
province of the court.” Markman v. Westview Instru-
ments, Inc., 517 U.S. 370, 372 (1996). We apply regional
circuit law in assessing the grant or denial of a motion for
judgment as a matter of law. Summit Tech., Inc. v. Nidek
Co., 363 F.3d 1219, 1223 (Fed. Cir. 2004). The Fifth
Circuit reviews orders granting or denying a motion for
judgment as a matter of law without deference, applying
“the same standard to review the verdict that the district
court used in first passing on the motion.” Hiltgen v.
Sumrall, 47 F.3d 695, 699 (5th Cir. 1995). Accordingly,
judgment as a matter of law is appropriate if “the facts
and inferences point so strongly and overwhelmingly in
favor of one party that the court concludes that reasona-
ble jurors could not arrive at a contrary verdict.” Bellows
v. Amoco Oil Co., 118 F.3d 268, 273 (5th Cir. 1997).
On appeal, Cordis disputes, inter alia, the district
court’s construction of the claim limitations “device” and
“release means for release of an at least one treating
material in a directional manner.” Under the correct
constructions, according to Cordis, its products cannot be
found to infringe the ’760 patent as a matter of law. We
will consider those arguments as set forth below.
A. Claim Construction
1. Device
The term “device” appears in every claim of the ’760
patent—in the preamble and body of independent claim 1,
in the bodies of independent claims 8 and 15, and at least
by reference in each of the dependent claims. In its Claim
SAFFRAN v. JOHNSON & JOHNSON 15
Construction Order, the district court nonetheless con-
cluded that, as used in the ’760 patent, the term “device”
serves only as non-limiting preamble language that does
not require a sheet and “merely gives a descriptive name
to the set of limitations in the body of the claim that set
forth the invention.” 740 F. Supp. 2d at 911.
Cordis argues that the term “device” should be con-
strued to mean a continuous sheet. According to Cordis,
the specification of the ’760 patent consistently and exclu-
sively describes the device of the invention as a sheet.
Furthermore, Cordis asserts, the ’760 patent highlights
the sheet’s ability to sequester macromolecules near an
injury as a “critical” feature of the invention, while criti-
cizing stents with uncovered mesh holes as unable to
prevent tissue macromolecules from escaping. Cordis also
contends that during prosecution of the ’760 patent,
Saffran defined the claimed “device” as a sheet in at-
tempting to overcome cited prior art, and that he there-
fore cannot now assert a broader meaning in litigation.
Finally, Cordis argues that the district court erroneously
relied on certain embodiments described in the ’760
patent as disclosing alternatives to, rather than forms of,
a sheet.
Saffran responds that the district court correctly de-
clined to limit the term “device” to require a sheet. Saf-
fran accuses Cordis of limiting the claims to certain
preferred embodiments while ignoring other disclosures.
Furthermore, Saffran contends that Cordis misunder-
stands the invention’s macromolecular restraint function,
arguing that the disclosed device need not restrain all
macromolecules from all injured tissue. Instead, accord-
ing to Saffran, the device must simply be capable of
restraining at least one type of macromolecule at locations
where the stent strut contacts the blood vessel wall.
Finally, Saffran asserts that the prosecution history of the
’760 patent evinces no clear and unambiguous disavowal
16 SAFFRAN v. JOHNSON & JOHNSON
of claim scope and instead supports a broad reading of the
asserted claims.
We conclude that Saffran’s statements during prose-
cution of the ’760 patent limit “device” to a continuous
sheet. On multiple occasions during prosecution, Saffran
sought to distinguish prior art by representing to the
examiner that “[t]he device used is a sheet rather than a
pre formed chamber (Gaskill).” J.A. 1100, 1119, 1127.
Saffran contends that his statements merely disclaimed
the rigid pre-formed chambers disclosed in U.S. Patent
4,911,717 (“Gaskill”) without further limiting the inven-
tion to a sheet. While Saffran surely disclaimed pre-
formed chambers during prosecution, we disagree that his
statements have such limited import.
Saffran’s arguments to the examiner presented two
bases for distinguishing Gaskill: (i) that his device is a
sheet, and (ii) that his device is not a pre-formed chamber.
Even if, as Saffran suggests, the examiner had relied only
on the latter, that would not annul the remainder of his
statement. “Rather, as we have made clear, an appli-
cant’s argument that a prior art reference is distinguisha-
ble on a particular ground can serve as a disclaimer of
claim scope even if the applicant distinguishes the refer-
ence on other grounds as well.” Andersen Corp. v. Fiber
Composites, LLC, 474 F.3d 1361, 1374 (Fed. Cir. 2007).
Furthermore, the record before us makes clear that the
examiner shared Saffran’s stated view of the claimed
device as a continuous sheet. In recording his reasons for
allowance, the examiner noted that “[t]he claimed inven-
tion embodies a unique method of [macromolecular re-
straint] using a single flexible minimally porous sheet
layer.” J.A. 530.
To be sure, a prosecution disclaimer requires “clear
and unambiguous disavowal of claim scope,” Storage
Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 833 (Fed. Cir.
2003), but applicants rarely submit affirmative disclaim-
SAFFRAN v. JOHNSON & JOHNSON 17
ers along the lines of “I hereby disclaim the following . . .”
during prosecution and need not do so to meet the appli-
cable standard. In this case, Saffran’s unqualified asser-
tion that “the device used is a sheet” extends beyond
illuminating “how the inventor understood the invention,”
Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir.
2005) (en banc), to provide an affirmative definition for
the disputed term. Given such definitive statements
during prosecution, the interested public was entitled to
conclude that the “device” recited in the claims of the ’760
patent is a continuous sheet.
Saffran’s arguments alleging that the ’760 patent con-
tains contrary embodiments are not persuasive. Saffran
first contends that the “spray” embodiment disclosed in
the ’760 patent does not yield an unbroken sheet but
forms a layer only where it contacts bone or some other
solid surface, such as the struts of a stent. But the record
belies that assertion. The figures illustrating the spray
embodiment show a spray nozzle depositing a continuous,
unbroken sheet that spans open gaps between individual
bone fragments. ’760 patent figs. 6a–b; see also id. col. 12
ll. 21–22. More fundamentally, and as Saffran acknowl-
edged during trial, the ’760 patent never mentions spray-
ing the device onto a stent or any other support substrate
except the injured tissue itself. See, e.g., id. col. 18 ll. 30–
32 (explaining that the spray “is deposited in a thin film
on the tissue”) (emphasis added). On that very basis, in
fact, Saffran attempted to distinguish his spray embodi-
ment from a prior art vascular graft (disclosed in U.S.
Patent 5,152,782 (“Kowligi”)) that was subjected to spray
coating before implantation: “The critical difference here
is that Kowligi disclose[s] a way to make their device,
while I disclose a way to deploy mine.” J.A. 385. The ’760
patent’s spray embodiment thus concerns depositing a
continuous sheet of material onto injured tissue, not
preparing a support structure such as a stent for later
implantation into a patient.
18 SAFFRAN v. JOHNSON & JOHNSON
The specification supports this conclusion. Through-
out its specification, the ’760 patent consistently describes
the disclosed “device” as a sheet, whether wrapped around
a stent, affixed to a fractured bone, or applied as a spray.
See, e.g., ’760 patent at [57] (“The device is composed of a
single sheet of material . . . .”); id. col. 7 ll. 35–37 (“The
invention is a unique method . . . to restrain interfrag-
mentary macromolecules using a single, flexible minimal-
ly porous sheet.”); id. col. 13 l. 39 (stating that “[t]he
device, 1, is composed of a single sheet of material”); id.
col. 14 ll. 34–42 (“Attachment of a treating material to the
device of the invention: I have found unexpectedly that
medicine or other treating materials can be attached
directly to the flexible, minimally-porous sheet . . . .”); see
id. col. 16 ll. 8–47 (using the terms “device,” “sheet,” and
“the invention” interchangeably). In addition, every
drawing in the ’760 patent depicts the claimed device as a
sheet. E.g., id. figs. 4a, 5a, 8e; see also id. col. 12 ll. 21–22
(defining reference numeral 1, which appears in every
figure depicting the invention,5 as a “[s]ingle-layered,
flexible, minimally-porous sheet having macromolecular
restrainment means”). Extensive, consistent usage in the
specification therefore suggests that the claimed “device”
should be understood as a sheet, which, rather than
confining the term to a single embodiment, would accord
with every embodiment and description presented in the
’760 patent, not to mention the prosecution history.
Furthermore, the ’760 patent emphasizes macromo-
lecular containment as a key feature of the invention,
and, in the specific context of vascular stents, expressly
relies on the sheet to distinguish the claimed device from
5 Fig. 2b lacks reference numeral 1 but contains a
sheet labeled with reference numeral 21, which the speci-
fication defines as: “Positively-charged, single-layered,
flexible, minimally-porous sheet.” ’760 patent col. 12
ll. 52–53 (emphasis added).
SAFFRAN v. JOHNSON & JOHNSON 19
prior art open mesh stents. The specification describes
the device’s ability to restrain tissue macromolecules near
the site of injury as a “cardinal” and “exceedingly im-
portant” feature of the invention. ’760 patent col. 7 ll. 38–
46, col. 20 ll. 49–51. The specification also criticizes prior
art stents as unable to restrain macromolecules between
the stent and the vessel wall; according to the ’760 patent,
prior art stents “are porous meshes” characterized by
holes so large that “both cells and large macromolecules
are free to move through them.” Id. col. 20 ll. 22–48;
compare id. fig. 8c (showing tissue macromolecules (8)
passing through the holes (27) between the struts (29) of a
prior art open-mesh stent and into the vessel lumen), with
id. fig. 8e (showing sheet (1) covering holes (27) and
containing tissue macromolecules (8) between the device
and the vessel wall). In short, the specification makes
clear that restraining tissue macromolecules is not only a
key feature of the invention, but also one that open mesh
stents cannot provide. Therefore, reading the claim term
“device” to both require a sheet and exclude stents having
open mesh holes “most naturally aligns with the patent’s
description of the invention.” Ormco Corp. v. Align Tech.,
Inc., 498 F.3d 1307, 1313 (Fed. Cir. 2007) (quoting Phil-
lips, 415 F.3d at 1316).
Finally, Saffran relies on an alleged “stent coating”
embodiment in the specification. But that “embodiment”
is no more than an isolated phrase taken out of context;
the cited passage occurs in a section summarizing poten-
tial uses of the previously described sheet-wrapped vascu-
lar stents within the biliary or digestive systems. See id.
col. 21 ll. 5–37 (“The stent coating properties of this device
are not limited to use within the vascular system.”); see
also id. figs. 9a–b. The cited passage is consistent with
interpreting the device as a continuous sheet.
In summary, we reverse the district court’s claim con-
struction and construe the term “device,” as used in the
claims of the ’760 patent, to mean a continuous sheet and
20 SAFFRAN v. JOHNSON & JOHNSON
to exclude stents having open mesh holes. While the
district court was clearly correct that the term “device”
must possess all the “limitations in the body of the claim,”
the term itself requires construction beyond those limita-
tions, as we have indicated above.
2. Release Means
Cordis also disputes the district court’s construction of
the “release means” limitation recited in each independ-
ent claim of the ’760 patent. The claims require a “means
for release of an at least one treating material in a direc-
tional manner,” ’760 patent col. 22 ll. 41–43,6 and the
district court construed that language as a means-plus-
function limitation governed by 35 U.S.C. § 112, ¶ 6. The
district court identified the claimed function as “to release
a drug preferentially toward the damaged tissue” and the
corresponding structure as “chemical bonds and linkages.”
Claim Construction Order, 740 F. Supp. 2d at 916–19. On
appeal, Cordis and Saffran agree that the disputed claim
language should be analyzed as a means-plus-function
limitation pursuant to § 112, ¶ 6; neither side disputes
the district court’s definition of the claimed function. The
parties differ, however, as to the district court’s identifica-
tion of corresponding structures disclosed to carry out
that function.
Cordis argues that the district court erred in identi-
fying the corresponding structures disclosed in the ’760
patent. According to Cordis, the district court’s generic
6 Independent claims 8 and 15 recite “means for re-
lease of an at least one treating material in a unidirec-
tional manner” rather than a “directional manner” as
recited in claim 1. Compare ’760 patent col. 22 ll. 41–43,
with id. col. 23 ll. 26–28, and id. col. 24 ll. 23–25. The
parties have agreed, however, that the terms “directional”
and “unidirectional” are equivalent. Claim Construction
Order, 740 F. Supp. 2d at 915.
SAFFRAN v. JOHNSON & JOHNSON 21
construction is overbroad, erroneously sweeping undis-
closed types of “chemical bonds and linkages” into the
scope of the claims. Cordis contends that the correct
structure is a hydrolyzable bond—the only type of bond
identified in the ’760 patent for performing the claimed
directional drug release function.
In contrast, Saffran defends the district court’s con-
struction as correct under § 112, ¶ 6, arguing that the ’760
patent broadly discloses “chemical bonds and linkages” as
a clear category of structures that would be readily un-
derstood by one of ordinary skill in the art as suitable for
performing the claimed function.
We conclude that although the district court correctly
identified the claimed function as “to release a drug
preferentially toward the damaged tissue,” it erred in
identifying the corresponding structure disclosed in the
specification. The claimed structure for the “release
means” limitation is correctly construed as a hydrolyzable
bond.
Under § 112, ¶ 6, a means-plus-function claim “shall
be construed to cover the corresponding structure, materi-
al, or acts described in the specification or equivalents
thereof.” 35 U.S.C. § 112, ¶ 6 (2006) (emphasis added).
We have held that “structure disclosed in the specification
is ‘corresponding’ structure only if the specification or
prosecution history clearly links or associates that struc-
ture to the function recited in the claim. This duty to link
or associate structure to function is the quid pro quo for
the convenience of employing § 112, ¶ 6.” B. Braun Med.,
Inc. v. Abbott Labs., 124 F.3d 1419, 1424 (Fed. Cir. 1997).
Applying those standards, we agree with Cordis that
the types of bonds set forth in the ’760 patent as corre-
sponding to the claimed release function are limited to
hydrolyzable bonds. The specification repeatedly de-
scribes the linkage between treating materials and the
sheet as a hydrolyzable bond. E.g., ’760 patent col. 8
22 SAFFRAN v. JOHNSON & JOHNSON
ll. 37–43 (“[I]f one wishes to release medicine . . . at differ-
ent rates, one simply has to manufacture the device with
bonds that become hydrolyzed at a different rate.”).
Moreover, the specification distinguishes the invention
over the prior art based on the use of hydrolyzable bonds:
A surprising new feature of this device is the im-
provement in the medicine release kinetics com-
pared to the prior art. Whereas [prior art devices]
rely on the random diffusion of medicine from mi-
cropores, I have found that I can achieve a pro-
longed duration and much more stable rate of
efflux from the device when medicine is attached
using a hydrolyzable bond.
Id. col. 14 ll. 53–61. At a minimum, it is thus clear that
the specification sets forth hydrolyzable bonds as at least
one structure linked to the release function of the claims.
The ’760 patent does not, however, link any additional
structures to the release function with sufficient specifici-
ty to satisfy § 112, ¶ 6. In arguing otherwise, Saffran
again relies on fragmentary statements taken out of
context from the specification. For example, Saffran
points to a statement in the ’760 patent that “the linkages
can be made of any suitable bond.” But the full passage
states: “In the preferred embodiment, these linkages are
hydrolyzable by the water within the interfragmentary
space; however the linkages can be made of any suitable
bond, e.g., a bond that requires a particular enzyme for
hydrolysis.” Id. col. 14 l. 65 – col. 15 l. 2. Read in context,
“suitable” bonds may thus include hydrolyzable bonds
that, unlike the preferred embodiment, cannot be broken
by water alone and may also require, for example, an
enzyme to trigger hydrolysis. No non-hydrolyzable bonds
are discussed or suggested. Similarly, Saffran stresses
another isolated passage from the specification suggesting
that one of the figures shows a medicine “affixed to the
invention by means of a chemical bond.” Id. col. 14 ll. 43–
SAFFRAN v. JOHNSON & JOHNSON 23
45. Elsewhere in the specification, however, the specific
description of that same figure clarifies that it depicts a
hydrolyzable chemical bond: “This drawing shows an
embodiment in which a treating material has been affixed
to the invention. In this example, medicine is attached to
the invention using a hydrolyzable chemical bond.” Id.
col. 10 ll. 10–13. In another instance, Saffran mischarac-
terizes the specification’s disclosure that certain sheet
materials may restrain macromolecules by physical
properties such as charge or hydrophobicity rather than
size; that portion of the specification relates to the sheet’s
ability to block macromolecules from passing and does
not, as Saffran suggests, concern drug delivery, let alone
affirmatively disclose ionic or so-called “hydrophobic”
bonds between a treating material and the sheet as
structures that correspond to the “release means” limita-
tion. See id. col. 8 ll. 15–24. Accordingly, we are not
persuaded that the specification’s scattered use of the
generic phrase “chemical bonds” conveys additional,
specific corresponding structures separate and apart from
hydrolyzable bonds.
In urging otherwise, Saffran has expended considera-
ble effort arguing that given the claimed function, a
person of ordinary skill would “understand the range of
chemical bonds and linkages that could be used.” Appel-
lee’s Br. 60, 2012 WL 2375038. As we have explained,
however, “[a] patentee cannot avoid providing specificity
as to structure simply because someone of ordinary skill
in the art would be able to devise a means to perform the
claimed function.” Blackboard, Inc. v. Desire2Learn, Inc.,
574 F.3d 1371, 1385 (Fed. Cir. 2009). Under § 112, ¶ 6,
the question is not what structures a person of ordinary
skill in the art would know are capable of performing a
given function, but what structures are specifically dis-
closed and tied to that function in the specification.
Saffran also argues that limiting the disclosed corre-
sponding structures to hydrolyzable bonds would make
24 SAFFRAN v. JOHNSON & JOHNSON
dependent claim 3—which specifies drug release “by lysis
of a chemical bond”—broader than claim 1, citing Wenger
Manufacturing, Inc. v. Coating Machinery Systems, Inc.,
239 F.3d 1225 (Fed. Cir. 2001). In Wenger, the district
court had construed the means-plus-function term “air
circulation means” in an independent claim to require
structures for both circulating and recirculating air, even
though the recirculation function was recited separately
in a dependent claim and the specification disclosed
distinct structures for performing the two functions. 239
F.3d at 1232–35. In that case, we held that claim differ-
entiation supported the conclusion that “air circulation
means” “should not be interpreted as requiring structure
capable of performing the additional function of recircula-
tion” that was entirely absent from the independent
claim. Id. at 1234 (emphasis added). But that is not the
case before us. Here, claims 1 and 3 concern the same
function, and the only structure disclosed in the ’760
patent for performing that function is a hydrolyzable
bond. In such circumstances, we have long held that a
patentee cannot rely on claim differentiation to broaden a
means-plus-function limitation beyond those structures
specifically disclosed in the specification. Laitram Corp.
v. Rexnord, Inc., 939 F.2d 1533, 1538 (Fed. Cir. 1991).
Saffran’s claim differentiation arguments are therefore
unavailing, and we conclude that hydrolyzable bonds are
the sole type of chemical bond linked to the claimed
“release means” function in the specification.
In view of the foregoing, we conclude (i) that the “re-
lease means” limitation recited in the claims of the ’760
patent is a means-plus-function limitation governed by
§ 112, ¶ 6; (ii) that the recited function is “to release a
drug preferentially toward the damaged tissue”; and
SAFFRAN v. JOHNSON & JOHNSON 25
(iii) that “hydrolyzable bonds” constitute the correspond-
ing structures disclosed in the ’760 patent’s specification.7
B. Infringement
As described above, we agree with Cordis that the dis-
trict court misconstrued the “device” and “release means”
limitations of the asserted claims. Cordis further con-
tends that, applying the correct constructions, it is enti-
tled to a judgment of noninfringement as a matter of law.
Specifically, Cordis argues that its accused stents both
lack a sheet covering the open mesh holes between their
struts and lack a drug affixed to their surfaces via hydro-
lyzable bonds and therefore cannot infringe the asserted
claims. We agree.
1. Device
Under the correct construction of the term “device,”
Cordis cannot infringe the asserted apparatus or method
claims unless its accused stent products include a contin-
uous sheet and lack uncovered holes in the stent mesh.
The accused Cordis stents all exhibit a metallic mesh
structure, their struts coated with a thin layer comprising
polymer and sirolimus. But that layer is akin to paint on
a chain link fence, not a continuous sheet wrapped around
the mesh, and open holes remain between the struts of
the accused devices—as Saffran has acknowledged.
Therefore, no reasonable jury could conclude that Cordis’s
accused stents infringe the asserted claims of the ’760
7 While not controlling here, we also note that the
United States Patent and Trademark Office (“PTO”)
arrived at a similar definition during an ex parte reexam-
ination of the ’760 patent (Reexamination Control No.
90/009,795), limiting even its broadest reasonable inter-
pretation of the “release means” limitation to require
hydrolyzable bonds. The PTO ultimately confirmed the
patentability of each reexamined claim in that proceeding.
26 SAFFRAN v. JOHNSON & JOHNSON
patent, and Cordis is entitled to a judgment of nonin-
fringement as a matter of law.
2. Release Means
In addition, our construction of the “release means”
limitation provides a separate and independent basis for a
judgment of noninfringement. As construed, each of the
asserted apparatus and method claims requires a treating
material attached to the substantially impermeable sheet
via hydrolyzable bonds or an equivalent thereof, 35 U.S.C.
§ 112, ¶ 6, but the sirolimus provided by the Cordis prod-
ucts is not attached by hydrolyzable bonds. It is instead
embedded within the polymer layer and held in place by
intermolecular “hydrophobic” interactions that facilitate
its slow diffusion through the polymer matrix. Saffran
has not argued otherwise. Moreover, Saffran stipulated
before trial that he would not pursue any infringement
arguments representing that so-called “hydrophobic”
interactions are equivalent to hydrolyzable bonds, and he
is therefore precluded from doing so now. See Saffran v.
Johnson & Johnson, No. 2:07-cv-451 (E.D. Tex. Dec. 1,
2010) (Cordis motion in limine), ECF No. 185; Saffran v.
Johnson & Johnson, No. 2:07-cv-451 (E.D. Tex. Jan. 13,
2011) (Order granting stipulated motion), ECF No. 269.
Accordingly, Cordis is also entitled to a judgment of
noninfringement because its accused products do not
satisfy the properly construed “release means” limitation.
3. Remaining Arguments
Because we hold that Cordis does not infringe the as-
serted claims of the ’760 patent as correctly construed, we
need not reach Cordis’s additional contention that its
products are not “minimally porous to macromolecules” as
further required by the claims.
III. CONCLUSION
The district court erred in construing the asserted
claims of the ’760 patent; because the accused products do
SAFFRAN v. JOHNSON & JOHNSON 27
not satisfy those claims as correctly construed, Cordis is
entitled to a judgment of noninfringement as a matter of
law. We therefore reverse the judgment of the district
court.
REVERSED
United States Court of Appeals
for the Federal Circuit
______________________
BRUCE N. SAFFRAN, M.D., PH.D.,
Plaintiff-Appellee,
v.
JOHNSON & JOHNSON AND CORDIS
CORPORATION,
Defendants-Appellants.
______________________
2012-1043
______________________
Appeal from the United States District Court for the
Eastern District of Texas in No. 07-CV-0451, Judge T.
John Ward.
______________________
MOORE, Circuit Judge, concurring-in-part.
I join Judge Lourie’s opinion except for Parts II-A-2
and II-B-2. Respectfully, I conclude that the district court
adopted the correct claim construction of “release means.”
The only issue in dispute is the identification of the
corresponding structure for the release means. The
district court concluded that the corresponding structure
was “chemical bonds and linkages.” I agree. The specifi-
cation is clear: “[t]he rate of healing can be . . . accelerat-
ed by attachment of a treating material, either
mechanically or by chemical bond, to the inner surface of
2 SAFFRAN v. JOHNSON & JOHNSON
the device,” which includes a “method of medicine release
by chemical bond.” ’760 patent, col.22 l.4–7. This passage
directly associates the claimed “release means” with the
chemical bond structure, which is sufficiently specific to
satisfy § 112 ¶ 6. See, e.g., Med. Inst. & Diagnostics Corp.
v. Elekta AB, 344 F.3d 1205, 1213–14 (Fed. Cir. 2003)
(explaining that § 112 ¶ 6 requires only “some link be-
tween a generic structural reference and a claimed func-
tion” understandable to a person of skill in the art). I
simply cannot fathom what more the patentee must do “to
link or associate structure to function” so as to provide
“sufficient specificity.” Op. at 21–22. By limiting the
structure to “hydrolyzable bonds,” my colleagues punish
the patentee for providing a detailed description of his
preferred embodiment.
My colleagues’ erroneous construction of the “release
means” limitation is all the more puzzling because it is
unnecessary to resolve this case. As Parts II-A-1 and II-
B-1 convincingly explain, the clear prosecution disclaimer
of “devices” other than “sheets” mandates reversal of the
infringement verdict. Parts II-A-2 and II-B-2 are thus
entirely dicta. For these reasons, I decline to join Parts
II-A-2 and II-B-2.
United States Court of Appeals
for the Federal Circuit
______________________
BRUCE N. SAFFRAN, M.D., PH.D.,
Plaintiff-Appellee,
v.
JOHNSON & JOHNSON AND CORDIS
CORPORATION,
Defendants-Appellants.
______________________
2012-1043
______________________
Appeal from the United States District Court for the
Eastern District of Texas in No. 07-CV-0451, Judge T.
John Ward.
______________________
O’MALLEY, Circuit Judge, concurring in part.
I concur in the result my colleagues reach today be-
cause I agree that, under the proper construction of the
“release means” limitation, Cordis does not infringe the
asserted claims of U.S. Patent No. 5,653,760 (“the ’760
patent” or “the patent”). I disagree, however, with my
colleagues’ construction of the term “device.” Accordingly,
I do not join Parts II-A-1 or II-B-1 of the majority opinion.
I. CONSTRUCTION OF “DEVICE”
The majority construes “device” to mean a continuous
sheet that excludes stents with open mesh holes. Majori-
ty Op. at 14-20. Upon review of the intrinsic record, I do
2 SAFFRAN v. JOHNSON & JOHNSON
not agree. The claim language is broad and the written
description, while focused on the treatment of fractured
bones with a sheet, discloses a host of other embodiments
and treatment applications. Several of those embodi-
ments cannot fairly be characterized as sheets. And, I
find no clear and unambiguous disclaimer of those embod-
iments in the prosecution history. Accordingly, I would
affirm the district court’s construction of “device” as
something which comprises the limitations set out in the
body of the claim.
Turning first to the claim language, it does not limit
the claimed “device” to a “sheet.” It only describes three
characteristics of the “device:” it comprises a layer; it is
“capable of being shaped in three dimensions by manipu-
lation by hands;” and it is “capable of substantially re-
stricting the through passage of at least one type of
macromolecule therethrough.” ’760 patent col. 22 ll. 29-
47. As my colleagues recognize, “device” is a generic term,
Majority Op. at 15, that under its common usage is not
limited to devices in the form of a sheet. Accordingly, the
proper inquiry before us is whether the meaning of “de-
vice” as it appears in the asserted claims is narrowed by
the written description or prosecution history. In my
opinion, it is not.
To find a special definition mandated by the written
description, a term must be “clearly” redefined, and an
“express intent” to do so must be evident from the patent.
See Elekta Instrument S.A. v. O.U.R. Scientific Int’l, Inc.,
214 F.3d 1302, 1307 (Fed. Cir. 2000) (“While we have held
many times that a patentee can act as his own lexicogra-
pher to specifically define terms of a claim contrary to
their ordinary meaning, the written description in such a
case must clearly redefine a claim term so as to put a
reasonable competitor or one reasonably skilled in the art
on notice that the patentee intended to so redefine that
claim term. Absent an express intent to impart a novel
meaning, claim terms take on their ordinary meaning.”)
SAFFRAN v. JOHNSON & JOHNSON 3
(citations and internal quotation marks omitted); see also
Edwards Lifesciences LLC v. Cook Inc., 582 F.3d 1322,
1329 (Fed. Cir. 2009) (“Similarly, we will adopt a defini-
tion that is different from the ordinary meaning when the
patentee acted as his own lexicographer and clearly set
forth a definition of the disputed claim term in either the
specification or prosecution history.”) (internal quotation
marks omitted); Cannon Rubber Ltd. v. The First Years,
Inc., 163 F. App’x 870, 875 (Fed. Cir. 2005) (“These two
cited instances, however, do not clearly indicate that the
patentee intended to assign a more narrow definition to
the phrase ‘in the body’ than it would otherwise pos-
sess.”). In my view, the patent contains no clear defini-
tion of “device” or express intent to narrow its meaning.
Admittedly, in many instances, the patent includes
descriptions of the invention being composed of a sheet, 1
accomplishing certain functionality using a sheet, 2 or
being provided as a sheet. 3 Those statements, standing
alone, could conceivably impart a special definition to
“device” by implication. 4 When read as a whole, however,
1 See ’760 patent col. 13 ll. 39-41 (“The device, 1, is
composed of a single sheet of material that in its principal
embodiment is supplied as a thin, pliable, fabric that is
flexible in three dimensions by human hands.”).
2 See id. col. 7 ll. 34-36 (“The invention is a unique
method of fracture stabilization and way to restrain
interfragmentary macromolecules using a single flexible
minimally porous sheet.”).
3 See id. col. 16 ll. 9-10 (“The invention is to be pro-
vided as a sterile sheet.”).
4 See, e.g., Bell Atl. Network Servs., Inc. v. Covad
Commc’ns Grp., Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001)
(“However, a claim term may be clearly redefined without
4 SAFFRAN v. JOHNSON & JOHNSON
the written description detracts from the notion that
“device” has a special meaning. Although it focuses on
the treatment of fractured bones with a sheet, the written
description discloses numerous other physical forms
which the patented invention can take, some of which
decidedly are not sheets. It describes a sheet as one
possible embodiment. See, e.g., ’760 patent col. 7 ll. 57-60
(“According to one embodiment, a single sheet that is
flexible in three dimensions and minimally porous to
macromolecules, is wrapped around or affixed to a frac-
tured tissue.”); id. col. 13 l. 66 – col. 14 l. 2 (“The principal
embodiment of the present invention is a sheet with the
same characteristics as the malleable, minimally-porous
anchoring component, 3, of the Malleable Fracture Sta-
balization Device with Micropores.”). It is almost unnec-
essary to restate that, “although the specification often
describes very specific embodiments of the invention, we
have repeatedly warned against confining the claims to
those embodiments.” Phillips v. AWH Corp., 415 F.3d
1303, 1323 (Fed. Cir. 2005) (en banc).
A close look at the written description reveals the
breadth of its disclosure. The written description begins
with a “Background of the Invention” section with a “Field
of the Invention” subsection stating the “invention relates
to the treatment of injured tissues within human or
animal bodies, specifically to the way injured tissues are
joined and the way macromolecules are directed to pro-
an explicit statement of redefinition. Indeed, we have
specifically held that the written description of the pre-
ferred embodiments can provide guidance as to the mean-
ing of the claims, thereby dictating the manner in which
the claims are to be construed, even if the guidance is not
provided in explicit definitional format.”) (citations and
internal quotation marks omitted).
SAFFRAN v. JOHNSON & JOHNSON 5
mote healing.” ’760 patent col. 1 ll. 21-24. This statement
seemingly refers to embodiments relating to the treat-
ment of fractured bones. But the Field of Invention
section goes on to say that, “[a]lthough I [the inventor]
will frame this invention initially in terms of traumatic
injuries, I will also discuss this invention in the treatment
of many other conditions including metastases, infections,
metabolic conditions such as osteoporosis, primarily
neoplasms, and vascular disease.” Id. col. 1 ll. 27-32.
This statement significantly broadens the scope of the
disclosure, as does the text that follows.
The Background section proceeds to discuss the state
of the art in the field of bone fracture fixation, in a subsec-
tion titled “Description of Prior Art.” Id. col. 1 l. 33 – col.
6 l. 10. But the patent notes that other injuries are also
implicated by the invention: “many tissues are commonly
fractured in traumatic injury, e.g., the liver, the kidney,
the bowel, the bladder, the spleen and the testicle, per-
haps the most often injured tissues are the bones.” Id.
col. 1 ll. 39-42. Returning to bone fractures, the patent
discusses techniques used to treat bone fractures, prob-
lems arising when bone fractures are treated, and differ-
ent fixation devices used on bone fractures (including
compressions plates, intramedullary rods, porous sub-
strates, bone chips, implantable gels, injectable cements,
polymer coated sheets, non-porous grafts, and Saffran’s
microporous device disclosed in U.S. Patent Application
Ser. No. 08/11,745, which issued as U.S. Patent No.
5,466,262 (“the ’262 patent”)). Id. col. 2 l. 43 – col. 6 l. 10.
Still within the Background of the Invention section, the
patent describes the present invention, calling it an
improvement of the device disclosed in the ’262 patent
and discussing it specifically in the context of bone frac-
ture fixation. Id. col. 6 ll. 11-62. But, in a subsection
entitled “Objectives of the Present Invention,” the patent
moves beyond bone fractures and discloses features of the
invention touching upon other medical applications, i.e.,
6 SAFFRAN v. JOHNSON & JOHNSON
the invention provides “a unique method and apparatus
that can be deployed via endoscope, catheter, or open
surgical procedure that can serve both to preferentially
direct endogenous macromolecules and release treating
materials while also providing structural support to
hollow viscera, solid organs, or blood vessels.” Id. col. 7 ll.
20-26. 5
The next subsection, entitled “Summary of the Inven-
tion,” focusing again on bone fractures, states that “[t]he
invention is a unique method of fracture stabilization and
way to restrain interfragmentary macromolecules using a
single, flexible minimally porous sheet.” Id. col. 7 ll. 34-
36. It goes on to describe aspects of the patented inven-
tion, such as its one-layer construction, its ability to
selectively restrain macromolecules, and the option of
affixing treating material to its surface. Id. col. 7 l. 38 –
col. 9 l. 11. Although, up to now, this section seems
limited to bone fracture applications, the patent next
states that the invention can “be introduced into the
medullary cavity, blood vessel and hollow viscera using a
percutaneous delivery system.” Id. col. 9 ll. 12-14. It
discusses embodiments in which the invention is rolled up
and deployed via catheter or introducer needle, manufac-
tured as a stent, or deployed via endoscope. Id. col. 9 ll.
15-30. These embodiments, the patent explains, can be
used to treat the inner walls of bones, blood vessel walls,
hollow viscera lumen, abscess cavities, medullary cavities,
solid organs (e.g., the liver, biliary system), or hollow
organs (e.g., the esophagus), allowing for the treatment of
inflammatory conditions or metabolic conditions such as
osteoporosis. Id.
5 The majority of the stated objectives, however, do
relate to treatment of bone fractures. See ’760 patent col.
6 l. 63 – col. 7 l. 31.
SAFFRAN v. JOHNSON & JOHNSON 7
After sections describing the drawings and figures of
the patent, a section entitled “Description of the Preferred
Embodiments” elaborates on the numerous applications
for the claimed invention. This section first describes the
structure of the claimed device, the attachment of treating
material to its surface via chemical bond, the construction
material for the device, and the various treating materials
that can be used. Id. col. 13 l. 48 – col. 16 l. 6. Regarding
potential treating materials, the patent states that,
“[a]lthough originally engineered to deliver bone growth
factors, the device can deliver any of a number of treating
materials including but not limited to bone morphogenetic
proteins, nerve growth factors, extracellular matrix
components, e.g., fibronectin and laminin, connective
tissue growth factors such as fibroblast growth factors,
antibiotics, vitamins, cofactors, a growth factor, a gly-
cosaminoglycan, a bioactive ion, nuclear or ionic radia-
tion, radiofrequency, a molecule produced by fractured
tissue, a pharmaceutical, a hormone, and living cells—
either wild-type or genetically engineered.” Id. col. 15 l.
63 – col. 16 l. 6. Next, in a subsection entitled “Operation
of the Invention,” the patent returns to bone fracture
applications. Id. col. 16 ll. 7-64. But the patent proceeds,
in separate subsections, to discuss “several new and
unexpected applications” of the inventions. Id. col. 17 ll.
2-3. The invention can be used, for example, “to treat
metastases,” id. col. 17 ll. 16-46, (by delivering chemo-
therapeutic medicines), “to treat osteomyelitis,” id. col. 17
ll. 47-59, to treat herniated disks, id. col. 19 ll. 21-23, to
treat osteoporosis, id. col. 19 ll. 27-37, to treat intra-
abdominal abscesses resulting from diverticulitis and
inflammatory bowel disease, id. col. 19 l. 46 – col. 20 l. 7,
to treat cystic tumors and aneurysms, id. col. 19 ll. 7-8, “to
treat vascular disease,” id. col. 20 ll. 9-67, “to treat mycot-
ic aneurysms,” id. col. 21 ll. 1-3, to treat malignant biliary
strictures cause by pancreatic head tumors, id. col. 21 l. 6-
11, and to “deliver radiofrequency energy or radioactivity
directed to the tumor,” id. col. 21 ll. 38-47.
8 SAFFRAN v. JOHNSON & JOHNSON
And, the invention can take many forms, being ap-
plied, for example, “within a fenestrated IM [intramedul-
lary] rod,” id. col. 17 l. 63, “as a thin film to the surface of
a solid rod,” id. col. 18 ll. 12-13, as a solid, rigid Krishner
wire used to treat finger fractures, id. col. 18 ll. 21-29, as
a spray “such that it is deposited in a thin film on the
tissue,” id. col. 18 ll. 31-32, as a rolled up sheet, id. col. 19
ll. 5-20, and as a coating for vascular and biliary stents,
id. col. 20 l. 9 – col. 21 l. 47. Most pertinently, when
discussing the use of the invention as a coating for stents,
the written description states that the “device can be
manufactured with any stent,” id. col. 20 l. 65, and has
“stent coating properties,” and the stents are described as
“invention-coated,” id. col. 21 ll. 5-7. In its final section,
entitled “Ramifications and scope,” the patent describes
the device again in the context of bone fractures, id. col.
21 ll. 49-59, but then mentions applications in “the medul-
lary canal, hollow organs, and blood vessels,” id. col. 21. ll.
66-67, and states that “the device and method provided is
not only a major advance in bone fracture treatment over
the prior art, but is also a significant advance in the
treatment of other seemingly unrelated soft tissue pathol-
ogy,” id. col. 22 ll. 18-22.
In sum, while long-winded and rambling at times, the
written description provides a broad disclosure touching
upon several medical applications and physical struc-
tures. Its primary focus is the treatment of bone fractures
with a minimally-porous sheet, but it also discloses a
laundry list of other embodiments. Following this broad
disclosure, the patent contains several claims that are
limited to no specific medical application. Instead, they
are directed generally to devices that “promote healing of
a damaged tissue,” id. col. 22 l. 30, methods “of treating
damaged tissue to promote repair,” id. col. 23 ll. 14-15,
and methods “of treating tissues in human or veterinary
medicine,” id. col. 24 ll. 13-14. With this broad disclosure
in mind, I turn to the present claim construction dispute.
SAFFRAN v. JOHNSON & JOHNSON 9
Given the host of medical applications disclosed for
the claimed device and the various structural forms the
invention can take, I am unable to limit the broadly
worded claims to any particular embodiment or applica-
tion. The term “device” provides no vehicle for doing so.
It is not possible, moreover, to describe some of the dis-
closed embodiments as “sheets.” For example, one would
not describe a thin film on the surface of a solid rod, see
id. col. 18 ll. 12-14, or wire-like structures used to treat
finger fractures, see id. col. 18 ll. 21-29, as “sheets.” This
is so even if one can stretch the spray and stent-coating
embodiments so as to call them sheets. See Majority Op.
at 17-19. Additionally, the patent indicates that it is the
claimed “layer,” as opposed to the claimed “device,” that is
a sheet; it makes several references to the “minimally
porous sheet,” and it is the “layer” that, according to the
claims, is “minimally porous.” Compare ’760 patent col.
22 ll. 32-34 (claim 1 indicating that the “layer” is made “of
flexible material that is minimally porous to macromole-
cules”), with id. col. 8 l. 4 (“minimally-porous sheet”), and
id. col. 8 ll. 33 (“the minimally-porous sheet”). I simply
cannot agree that the written description clearly redefines
“device” as a “sheet.” See Elekta Instrument, 214 F.3d at
1307.
The portion of my colleague’s construction excluding
“stents having open mesh holes” is unnecessary, moreo-
ver. See Majority Op. at 19. It is true that the patent
distinguishes U.S. Patent No. 5,383,928 (“Scott”) because
the sheath-covered stent disclosed in Scott “does not have
means to restrain macromolecules between their sheath
and the vessel wall,” and “cannot have the ‘directional
drug delivery means’ necessary to restrain the medicine
that their sheath delivers.” ’760 patent col. 20 ll. 46-55.
But the claims themselves already require that “the
device be[] capable of substantially restricting the
through passage of at least one type of macromolecule
therethrough” and that “the layer hav[e] material release
10 SAFFRAN v. JOHNSON & JOHNSON
means for release of an at least one treating material in a
directional manner. . . .” Id. col. 22 ll. 40-41, 45-47. By
focusing on the stent embodiments, my colleague’s con-
struction loses sight of the various other embodiments
disclosed in the written description.
Perhaps aware of the weakness of their position under
standard claim construction principles, my colleagues
resort to the concept of prosecution history disclaimer to
justify reversing the district court’s construction of this
claim language. Indeed, they take the unusual step of
beginning with a discussion of the prosecution history,
elevating it to a prominence it does not deserve under
Phillips. As noted by this court en banc, “because the
prosecution history represents an ongoing negotiation
between the PTO and the applicant, rather than the final
product of that negotiation, it often lacks the clarity of the
specification and thus is less useful for claim construction
purposes.” Phillips, 415 F.3d at 1317. The majority does
not heed the hierarchy counseled in Phillips and, instead,
begins by finding disclaimer and then searches the speci-
fication for disclosures consistent with their take away
from the prosecution history. I cannot agree with either
the structure or the result of their analysis.
As my colleagues concede, prosecution disclaimer re-
quires “clear and unambiguous disavowal of claim scope.”
Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 833
(Fed. Cir. 2003). The burden to show prosecution dis-
claimer is high because “[c]laim terms are entitled to a
heavy presumption that they carry their ordinary and
customary meaning to those skilled in the art in light of
the claim term’s usage in the patent specification.” Elbex
Video, Ltd. v. Sensormatic Elecs. Corp., 508 F.3d 1366,
1371 (Fed. Cir. 2007) (internal quotation marks omitted).
In this vein, we have “consistently rejected prosecution
statements too vague or ambiguous to qualify as a disa-
vowal of claim scope.” Omega Eng’g, Inc, v. Raytek Corp.,
334 F.3d 1314, 1325 (Fed. Cir. 2003). Instead, “we have
SAFFRAN v. JOHNSON & JOHNSON 11
required the alleged disavowing statements to be both so
clear as to show reasonable clarity and deliberateness and
so unmistakable as to be unambiguous evidence of dis-
claimer.” Id. at 1325 (citations omitted). I see no such
unambiguous, deliberate disavowal in the relevant ex-
changes with the examiner.
During prosecution, Saffran admittedly distinguished
U.S. Patent No. 4,911,717 (“Gaskill”) by stating that
“[t]he device is a sheet rather than a pre formed chamber
(Gaskill).” See, A1100; A119; A1127. This statement no-
doubt clearly and unambiguously disclaims the embodi-
ments disclosed in Gaskill; i.e., pre-formed chambers. But
this statement does not unambiguously limit to “sheets”
all forms which the claimed device can take. There was
no need to do so to differentiate the claims at issue here
from what was disclosed in Gaskill. Gaskill was not
about stents or treating bone fractures. Gaskill is ad-
dressed to an “intravascular emplaced” “artificial organ”
“having a cell culture chamber adapted to receive living
cells or tissue.” Gaskill col. 3 ll. 54-58. In context, the
point of Saffran’s disclaimer over Gaskill was that pre-
formed chambers such as the disclosed “cell culture
chamber” were not even within the scope of his claims.
Instead, Saffran’s claims cover either chambers that are
not pre-formed—because they are formed by the physician
using a sheet 6—or embodiments, both with and without
sheets, that do not involve chambers at all. It would
make no sense for Saffran to disclaim multiple embodi-
ments in his own specification that have nothing to do
with pre-formed chambers when a far narrower disclaim-
er was sufficient to differentiate his invention from Gas-
kill, as the district court found.
6 Allowed claims in the ’760 patent expressly include
chambers formed during implantation—i.e., ones not “pre-
formed.” See ’760 patent col. 22 ll. 60-61.
12 SAFFRAN v. JOHNSON & JOHNSON
Although Saffran made this supposedly damning dis-
claimer when discussing a prior art reference dealing with
pre-formed chambers—not sheets—my colleagues feel
that his disclaimer is sufficient to notify the public that
Saffran definitively and unambiguously redefined “device”
as a “sheet.” See Omega Eng’g, 334 F.3d at 1325 (“To
balance the importance of public notice and the right of
patentees to seek broad patent coverage, we have thus
consistently rejected prosecution statements too vague or
ambiguous to qualify as a disavowal of claim scope.”). To
find so, they must not only take Saffran’s statement out of
the context of the actual negotiation with the examiner,
but disregard the multiple other embodiments disclosed
in the patent. What Saffran unambiguously, clearly, and
deliberately disclaimed were pre-formed chambers. I
cannot find from this very directed exchange regarding
Gaskill that Saffran unambiguously intended to disclaim
such a substantial number of the embodiments disclosed
in the written description.
Because a special definition of “device” is not mandat-
ed by either the written description or the prosecution
history, I do not join Parts II-A-1 or II-B-1 of the majority
opinion. I would instead affirm the district court’s con-
struction of this term.
II. CONSTRUCTION OF “RELEASE MEANS” LIMITATION
As stated above, I join Judge Lourie’s decision regard-
ing the construction of the “release means” limitations. I
write separately on this term only to note that, since this
is a means-plus-function element construed under 35
U.S.C. § 112 ¶ 6, the scope of the term is inherently
narrowed by the disclosure. Therefore, unlike our task
when construing “device,” we are not required to examine
the intrinsic record for a clear and unmistakable disa-
vowal of claim scope when construing the “release means”
SAFFRAN v. JOHNSON & JOHNSON 13
limitation. 7 Limiting the scope of the “release means”
limitation is analytically distinct from limiting the mean-
ing of the term “device.” While, had Saffran chosen not to
use a means-plus-function limitation, I might hesitate to
limit the scope of the “release means” term, the outcome I
reach today flows from his drafting choice.
7 We look instead to the specification or prosecution
history for a clearly linked structure to perform the recit-
ed function. See B. Braun Med., Inc. v. Abbott Labs., 124
F.3d 1419, 1424 (Fed. Cir. 1997).