United States Court of Appeals
for the Federal Circuit
__________________________
SPINE SOLUTIONS, INC.,
SYNTHES SPINE COMPANY, L.P.
AND SYNTHES, INC.,
Plaintiffs-Appellees,
v.
MEDTRONIC SOFAMOR DANEK USA, INC.,
AND MEDTRONIC SOFAMOR DANEK, INC.,
Defendants-Appellants.
__________________________
2009-1538
__________________________
Appeal from the United States District Court for the
Western District of Tennessee in case No. 07-CV-02175,
Judge Jon P. McCalla.
___________________________
Decided: September 9, 2010
___________________________
JEFFREY M. OLSON, Sidley Austin LLP, of Los Ange-
les, California, argued for plaintiffs-appellees. With him
on the brief were PAUL H. MEIER, ROBERT A. HOLLAND,
SEAN A. COMMONS, SAMUEL N. TIU and MATTHEW S.
JORGENSON.
SPINE SOLUTIONS v. MEDTRONIC SOFAMOR 2
SETH P. WAXMAN, Wilmer Cutler Pickering Hale and
Dorr LLP, of Washington, DC, argued for defendants-
appellants. With him on the brief were WILLIAM G.
MCELWAIN, JAMAICA P. SZELIGA and JASON A. SKINDER;
and MARK C. FLEMING of Boston, Massachusetts. Of
counsel on the brief were JAN M. CONLIN, MUNIR R.
MEGHJEE and CYRUS A. MORTON, Robins, Kaplan, Miller
& Ciresi LLP, of Minneapolis, Minnesota.
__________________________
Before DYK, FRIEDMAN, and MOORE, Circuit Judges.
MOORE, Circuit Judge.
Medtronic Sofamor Danek USA, Inc. and Medtronic
Sofamor Danek, Inc. (collectively, Medtronic) appeal the
decision of the United States District Court for the West-
ern District of Tennessee granting summary judgment
that Medtronic infringes the asserted claims of U.S.
Patent No. 6,936,071 (the ’071 patent). Medtronic also
appeals the court’s grant of summary judgment that the
asserted claims are not invalid for failure to satisfy the
written description requirement and the court’s denial of
its motions for judgment as a matter of law (JMOL) of
obviousness, no willfulness, and no entitlement to lost
profits. Further, Medtronic appeals the court’s order
permanently enjoining Medtronic from using or selling
any of the accused devices that are currently outside the
U.S. For the following reasons, we affirm-in-part, re-
verse-in-part, vacate-in-part, and remand.
I. BACKGROUND
This patent case relates to intervertebral implants,
which are also known as artificial intervertebral discs or
total disc replacement devices. Intervertebral implants
3 SPINE SOLUTIONS v. MEDTRONIC SOFAMOR
are used to replace discs between vertebrae in the spinal
column that have degenerated or become diseased.
Spine Solutions, Inc. (SSI) is the assignee of the ’071
patent. The ’071 patent discloses an intervertebral im-
plant that includes an upper part and a lower part, each
of which has a “support face” for an adjacent vertebra.
’071 patent col.1 ll.3-5. Each of the upper and lower parts
has a single anchor, or keel, that is centrally positioned on
the support face. Id. figs.1-7 (nos. 6, 14). The anchors
affix the upper and lower parts into the adjacent verte-
brae. Id. col.5 ll.59-64.
The ’071 patent discloses that the upper and lower
parts of the implant each have “protrusions and recesses .
. . which are offset laterally from one another in such a
way that . . . they mesh with each other” when the two
parts are brought close together. Id. col.1 ll.56-62. This
orientation allows the implant’s structural height to be
minimized during insertion, making it easier to insert the
implant into the intervertebral space. Id. col.1 ll.52-55,
col.4 ll.30-32. Figures 2 and 4 of the ’071 patent depict a
view of the implant’s upper and lower parts when brought
into maximum proximity with each other:
SPINE SOLUTIONS v. MEDTRONIC SOFAMOR 4
The ’071 patent discloses that “in a preferred em-
bodiment, the lower part and the upper part each have a
respective receptacle for a pivot insert.” Id. col.3 ll.1-2.
This pivot insert is placed between the upper and lower
parts after the implant is inserted. Id. col.5 ll.1-8. The
insert “supports the upper part and lower part against
one another” and “leads to a certain pivotability of the two
parts . . . relative to one another, so that a pivotability of
the adjacent vertebra is thus attainable as well.” Id. col.3
ll.2-9.
SSI sued Medtronic, alleging that Medtronic’s Maver-
ick, A-Maverick, and O-Maverick intervertebral implants
infringe independent claim 1 and dependent claims 2, 6,
7, 10, 11, and 13 of the ’071 patent. Medtronic raised
various defenses, including noninfringement and invalid-
ity for obviousness and failure to comply with the written
description requirement. After claim construction, Med-
tronic filed a motion for summary judgment of nonin-
fringement with respect to O-Maverick; SSI filed a cross-
motion for partial summary judgment that O-Maverick
infringes claims 1 and 2. The district court granted SSI’s
5 SPINE SOLUTIONS v. MEDTRONIC SOFAMOR
motion, ruling that O-Maverick infringes claims 1 and 2
both literally and under the doctrine of equivalents. The
court then denied Medtronic’s motion for summary judg-
ment that claim 1 is invalid for lack of written description
and granted SSI’s cross-motion to dismiss all of Med-
tronic’s 35 U.S.C. § 112 defenses. The parties then stipu-
lated that the accused products infringed all of the
asserted claims.
A few weeks before trial, Medtronic filed a motion in
limine to preclude SSI from offering any evidence relating
to lost profits. There is no dispute that SSI, the assignee
of the ’071 patent, does not make or sell any device cov-
ered by the patent. However, SSI’s sister company Syn-
thes Spine Co., L.P. (Synthes Spine) makes and sells the
ProDisc II implant, which is the commercial embodiment
of the ’071 patent. SSI opposed Medtronic’s motion and
sought to amend its complaint to add as co-plaintiffs
Synthes Spine and Synthes, Inc., SSI’s parent corpora-
tion. Medtronic objected, arguing that Synthes Spine and
Synthes, Inc. had no standing to bring an infringement
suit on the ’071 patent. As SSI was the sole owner, Med-
tronic argued that SSI alone could bring suit. The parties
ultimately agreed that Medtronic could submit an offer of
proof (outside the presence of the jury) as to the standing
issue, and the court allowed SSI to amend its complaint to
name SSI, Synthes Spine, and Synthes, Inc. (collectively,
SSI) as co-plaintiffs.
The case went to trial on Medtronic’s obviousness de-
fense, SSI’s willful infringement claim, and damages. At
trial, the jury rendered a verdict in favor of SSI. The jury
found that Medtronic did not prove that the ’071 patent
was invalid for obviousness. The jury also found that
Medtronic’s infringement was willful. The jury awarded
SSI $5.7 million in lost profits for the 2005-2007 time-
SPINE SOLUTIONS v. MEDTRONIC SOFAMOR 6
frame and an 18% reasonable royalty on the remaining
$9.1 million in revenue from infringing sales of the ac-
cused O-Maverick, A-Maverick, and Maverick products.
The court then denied Medtronic’s motions for JMOL of
obviousness and no willfulness. The court also found that
Medtronic waived its standing argument and therefore
denied Medtronic’s motion for JMOL that SSI was not
entitled to lost profits. The court doubled the damages
award pursuant to 35 U.S.C. § 284 and awarded attorney
fees under 35 U.S.C. § 285. Finally, the court entered a
permanent injunction that forbids Medtronic from, among
other things, using, selling, or transferring any accused
devices that are already outside the U.S. This extraterri-
torial portion of the injunction is stayed pending this
appeal.
Medtronic appeals, raising numerous issues. We have
jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).
II. DISCUSSION
A. Obviousness
Medtronic argues that the district court erred in deny-
ing its motion for JMOL that the asserted claims of the
’071 patent would have been obvious to one of skill in the
art. We review denials of JMOL under the law of the
regional circuit, here the Sixth Circuit. Gemtron Corp. v.
Saint-Gobain Corp., 572 F.3d 1371, 1379 (Fed. Cir. 2009).
The Sixth Circuit reviews a denial of a motion for JMOL
de novo. Imwalle v. Reliance Med. Prods., 515 F.3d 531,
543 (6th Cir. 2008). JMOL will be granted only where “a
party has been fully heard on an issue and there is no
legally sufficient evidentiary basis for a reasonable jury to
find for that party on that issue.” Id. “The grant is
7 SPINE SOLUTIONS v. MEDTRONIC SOFAMOR
appropriate only if, in viewing the evidence in the light
most favorable to the nonmoving party, reasonable minds
could come to but one conclusion, in favor of the moving
party.” Id. (citation omitted).
Claim 1 of the ’071 patent, the only independent claim
at issue, reads as follows:
An intervertebral implant insertable between ad-
jacent vertebrae, comprising,
an upper part having an upper surface for engag-
ing a vertebrae and a lower surface which in-
cludes a rounded portion,
a lower part having a lower surface for engaging a
vertebrae and an upper surface portion in opera-
tive engagement with the rounded portion of the
upper part,
said implant being constructed to be the sole im-
plant in its intervertebral space,
the implant having a lead end which leads as the
implant is inserted along a path into the interver-
tebral space and a trailing end opposite the lead
end, and lateral planes which pass through the
outermost boundaries of the implant and parallel
to the said path, and
a single anchor on each of the upper surface of the
upper part and the lower surface of the lower part,
each said anchor being elongated, having a height
greater than its width, and located along a line
parallel to said path, the two anchors lying essen-
tially in the same vertical plane, which plane is
essentially midway between said lateral planes,
SPINE SOLUTIONS v. MEDTRONIC SOFAMOR 8
each said anchor being adapted to enter a groove
in the adjacent vertebrae as the implant moves
along said path into the intervertebral space, to
anchor its respective part to the vertebrae which
its surface engages.
’071 patent col.6 l.54-col.7 l.13 (emphasis added).
It is undisputed that U.S. Pat. No. 5,314,477 (the ’477
patent) discloses every element of claim 1 except for the
“single anchor” limitation. The ’477 patent discloses an
intervertebral implant that includes a top plate and a
bottom plate, with the bottom plate having a “joint piece”
embedded by force. ’477 patent col.2 ll.26-32. Each plate
is equipped with two “anchoring flaps” positioned near the
outside edges of the plate that affix the implant into the
adjacent vertebrae. Id. col.4 ll.7-10. The named inventor
of the ’477 patent is Dr. Thierry Marnay, one of the
named inventors of the ’071 patent.
Medtronic asserts that several prior art references
disclose the claimed “single anchor” limitation. In par-
ticular, Medtronic focuses on Japanese Patent Application
No. H2-261446 (Nobuo), which discloses an artificial
vertebra with a single, central projection at each end.
Medtronic argues that because a “single anchor” was
known from various references, such as Nobuo, the com-
bination of Nobuo and the ’477 patent is “the product not
of innovation but of . . . common sense.” KSR v. Teleflex,
550 U.S. 398, 421 (2007). Indeed, Medtronic asserts, Dr.
Marnay knew about the possibility of using a single
anchor: Dr. Marnay testified that although he ultimately
decided on a dual-anchor design for the ’477 patent, he
knew about and considered single anchor designs as early
as 1989, ten years before the priority date of the ’071
patent. Therefore, Medtronic argues, the asserted claims
9 SPINE SOLUTIONS v. MEDTRONIC SOFAMOR
of the ’071 patent would have been obvious to one of skill
in the art over the ’477 patent in view of Nobuo.
SSI responds that Nobuo does not disclose a “single
anchor.” SSI also asserts that the record evidence shows
that a person of skill in the art would not have been
prompted to combine Nobuo’s single anchor with the
implant of the ’477 patent because he would not have
expected a single, centrally-placed keel to provide suffi-
cient fixation for an intervertebral implant.
We agree with Medtronic that Nobuo discloses the
claimed “single anchor.” The district court construed
“single anchor” as meaning, in relevant part, “[t]he upper
and lower surfaces of the implant each have one anchor
having the characteristics recited in the last paragraph of
[claim 1] (elongated, height greater than width, parallel to
an insertion path, lying essentially in a vertical plan[e]
essentially between lateral planes, and adapted to enter a
groove in the adjacent vertebrae).” Spine Solutions, Inc.
v. Medtronic Sofamor Danek, Inc., No. 07-2175, 2008 U.S.
Dist. LEXIS 116648, at *43 (W.D. Tenn. July 2, 2008)
(Claim Construction Order). Figure 6 of Nobuo depicts an
artificial vertebra with a single projection on each of its
top and bottom ends. J.A. 18665. Each projection is
elongated, with a height greater than its width, and is
centrally placed between the “lateral planes” defined by
the sides of the vertebra. Further, Nobuo discloses that
the projections are mounted in grooves formed in the
adjacent vertebrae. J.A. 18659 (“grooves 25 for mounting
the projections 13 and 17 are made in the removed verte-
bra 2 and the healthy vertebrae 1”). The projections of
Nobuo meet the limitation of a “single anchor,” as con-
strued by the court.
SPINE SOLUTIONS v. MEDTRONIC SOFAMOR 10
The combination of the ’477 patent and Nobuo plainly
discloses every limitation of claim 1; the question remains
whether the combination of those references would have
been obvious to a person of skill in the art. We agree with
the district court that the record contains substantial
evidence to support the jury’s fact finding, implicit in its
verdict of nonobviousness, that it would not have been
obvious to a person of skill in the art to use a single
anchor with the implant of the ’477 patent. In particular,
the record contains substantial evidence showing that a
person of skill in the art would not have viewed a single
keel as being stable enough for a disc replacement device.
The record contains evidence showing that the center of a
vertebra—the location of the ’071 patent’s single anchor—
is typically the weakest part of a diseased or degenerated
disc. J.A. 15306. Dr. Marnay testified that he decided
not to use a single keel for the implant of the ’477 patent
because he did not think a single keel would provide
sufficient stability. Id. Instead, Dr. Marnay chose to use
a dual-keel design that anchored the parts of the implant
into the stronger, outside portions of the vertebral bone.
J.A. 15297-99. Dr. Marnay testified that he performed
extensive testing of his single keel design prior to filing
the application that issued as the ’071 patent, due to his
uncertainty regarding the stability of the single keel. J.A.
15324-25. The record also contains deposition testimony
showing that Medtronic’s own engineers were unsure as
to whether a single keel would provide sufficient fixation
during the development of Maverick. J.A. 15416, 15470.
Viewing this evidence most favorably to SSI, we can-
not say that “reasonable minds could come to but one
conclusion,” in favor of Medtronic. See Imwalle, 515 F.3d
at 543. Rather, the record contains substantial evidence
to support the jury’s implicit findings underlying its
determination that it would not have been obvious to use
11 SPINE SOLUTIONS v. MEDTRONIC SOFAMOR
a single keel, such as that disclosed by Nobuo, with the
implant of the ’477 patent. Therefore, substantial evi-
dence exists to support the jury’s verdict of nonobvious-
ness, and we affirm the court’s denial of Medtronic’s
motion for JMOL of obviousness.
B. Written Description
Medtronic asserts that the district court erred in
granting summary judgment that the ’071 patent contains
adequate written description to support the limitation
“single anchor . . . adapted to enter a groove.” We review
a grant of summary judgment de novo, reapplying the
standard applicable at the district court. Young v. Lu-
menis, Inc., 492 F.3d 1336, 1345 (Fed. Cir. 2007). Sum-
mary judgment is appropriate “if the pleadings,
depositions, answers 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). “Compliance with the written
description requirement is a question of fact but is ame-
nable 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).
Claim 1 recites that the “single anchor” is “adapted to
enter a groove in the adjacent vertebrae.” ’071 patent
col.7 ll.3-10 (emphasis added). Medtronic argued that the
written description does not disclose the “adapted to enter
a groove” limitation. SSI argues that the ’071 patent
necessarily discloses anchors that are “adapted to enter a
groove” because it discloses that the adjacent vertebrae
rest on the support faces of the intervertebral implant
after insertion. The district court granted summary
SPINE SOLUTIONS v. MEDTRONIC SOFAMOR 12
judgment holding that the claim was adequately sup-
ported by the written description. We see no error in this
judgment.
Medtronic is correct that the ’477 patent disclosure
was not incorporated by reference and therefore cannot
provide the disclosure of the “adapted to enter a groove”
limitation. In the two pages Medtronic devotes to this
issue, it argues that the patent makes no mention of
grooves. See, e.g., Medtronic’s Br. at 37 (“patent’s failure
to disclose any information concerning the grooves located
in the vertebrae and their interaction with the anchor is a
prime example of SSI’s attempt to expand its claims
beyond its disclosures”); Medtronic’s Reply Br. at 8 (argu-
ing that the patent diagrams do not show any grooves).
Because the claims at issue relate to the implant and do
not cover the groove itself, applicants were not required to
disclose grooves or how grooves should be formed or cut.
The limitation at issue does not recite cutting a groove
into vertebrae, or even inserting an anchor into a groove;
rather, it recites “a single anchor . . . adapted to enter a
groove.” The issue for written description purposes is
whether a person of skill in the art would understand the
’071 patent to describe a single anchor that is adapted to
enter a groove. See Ariad Pharms., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (“the test
for sufficiency [of the written description requirement] is
whether the disclosure of the application relied upon
reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as
of the filing date”).
We see no error in the district court’s determination
that there is no genuine dispute of material fact; the
specification describes the claimed “single anchor” as
necessarily being “adapted to enter a groove.” The disclo-
13 SPINE SOLUTIONS v. MEDTRONIC SOFAMOR
sure of the shape of the anchor in combination with its
placement adequately describes an anchor adapted to
enter a groove. The specification discloses that each of
the top and bottom parts of the implant has a support
face that includes a single anchor. ’071 patent col.3 ll.56-
58, col.4 ll.9-12, figs. 1-7. These anchors affix the upper
and lower parts into the adjacent vertebrae such that the
end face of each vertebrae “rests . . . on the support face”
of the corresponding part of the implant. Id. col.3 ll.58-
60, col.5 ll.59-64. Thus, the specification discloses that
the single anchor enters the adjacent vertebrae in such a
way that the vertebrae “rest” on the support faces of the
top and bottom parts of the implant. For such direct
contact between the implant and vertebrae to occur, the
single anchor must be entirely inserted into the adjacent
vertebrae: that is, the anchors must be fully inserted into
a “groove” of some type, whether that groove is pre-cut or
formed by the anchor itself (e.g., by a “self-cutting” an-
chor). The specification, therefore, discloses that the
single anchor is inserted into a vertebral groove. The
record lacks adequate evidence to create a genuine dis-
pute over whether the specification discloses that the
anchors are “adapted to enter a groove.” The fact that the
specification never mentions the word groove is not suffi-
cient to create a genuine dispute of material fact.
We agree with the district court that the specification
of the ’071 patent provides adequate written description
to support the “single anchor . . . adapted to enter a
groove” limitation. Therefore, we affirm the court’s grant
of SSI’s motion for partial summary judgment dismissing
Medtronic’s 35 U.S.C. § 112 defenses.
SPINE SOLUTIONS v. MEDTRONIC SOFAMOR 14
C. Claim Construction
Medtronic asserts that the district court erred in con-
struing the claim term “operative engagement.” Claim
construction is a matter of law, and we review the court’s
claim construction without deference. Cybor Corp. v. FAS
Techs., Inc., 138 F.3d 1448, 1451 (Fed. Cir. 1998) (en
banc). In doing so, we are mindful of the principle that
“the claims of a patent define the invention to which the
patentee is entitled the right to exclude.” Phillips v. AWH
Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc). We
read the claims “in view of the specification,” which is
“the single best guide to the meaning of a disputed term.”
Id. at 1315.
Claim 1 recites the limitation of “a lower part having
a lower surface for engaging a vertebrae and an upper
surface portion in operative engagement with the rounded
portion of the upper part.” ’071 patent col.6 ll.60-62
(emphasis added). At claim construction, Medtronic
proposed construing “operative engagement” to mean “the
interaction between the pivot insert and the rounded
portion of the upper part.” Claim Construction Order,
2008 U.S. Dist. LEXIS 116648, at *18. The court ob-
served that although the preferred embodiment of the
’071 patent has a pivot, claim 1 does not recite such a
limitation: rather, claim 1 recites only an upper and a
lower part that are “in operative engagement” with each
other. The court also found that claim differentiation
weighed against reading a pivot limitation into claim 1,
because various dependent claims add limitations relating
to a two-piece lower part with a pivot insert. Therefore,
the court adopted SSI’s proposed construction, construing
“operative engagement” as “permitting movement (for
example pivotability).” Id. at *23.
15 SPINE SOLUTIONS v. MEDTRONIC SOFAMOR
Medtronic asserts that the court erred in construing
“operative engagement” as not incorporating a pivot
insert. According to Medtronic, the only “engagement”
disclosed by the specification occurs between the upper
part and the pivot insert, not between the upper and
lower parts. SSI asserts that the court’s construction is
correct because the plain language of the claim does not
limit the invention to the preferred three-piece embodi-
ment.
We agree with SSI that the court correctly construed
“operative engagement.” The language of the limitation is
straightforward: the lower part of the implant engages
“operatively” with the rounded portion of the upper part.
Given that the claimed invention is an intervertebral
implant designed to replace a disc in a spinal column,
“operative engagement” must be engagement such that
the upper and lower parts of the implant can move rela-
tive to each other; otherwise, the implant would be rigid
and would inhibit movement of the adjacent vertebrae.
Thus, the court correctly determined that “operative
engagement” relates to permitting movement. The court
also did not err in identifying pivotability as an example
type of movement; the ’071 patent specifically discloses
pivotability in association with the preferred embodiment.
However, nothing in the claim suggests that the upper
part of the implant must be specifically engaged with a
pivot insert, as opposed to the lower part of the implant.
To the contrary, the claim indicates that the upper and
lower parts are engaged with each other directly. ’071
patent col.6 ll.60-62 (“a lower part having . . . an upper
surface portion in operative engagement with the rounded
portion of the upper part”). Therefore, the court did not
err in construing “operative engagement” as “permitting
movement (for example pivotability).”
SPINE SOLUTIONS v. MEDTRONIC SOFAMOR 16
Medtronic asserts, in the alternative, that under the
court’s construction claim 1 is invalid for failure to comply
with the written description requirement. Therefore,
Medtronic argues, the court erred in granting summary
judgment that the ’071 patent contains adequate written
description to support the limitation “lower part having . .
. an upper surface portion in operative engagement with
the rounded portion of the upper part.” Medtronic argues
that the ’071 patent only describes a three-piece device
with a separate pivot insert, not a two-piece device that
permits movement between the top and bottom parts.
However, Figures 3 and 6 of the ’071 patent illustrate the
implant outside the intervertebral space (i.e., prior to
insertion) and show the pivot insert as embedded in the
lower part. Additionally, the evidence at summary judg-
ment included deposition testimony from Medtronic’s
expert that a person of skill in the art would have known
that an implant having a lower plate with an embeddable
pivot insert—such as that disclosed by the ’071 patent—
could have been assembled prior to insertion and inserted
into the patient as a two-piece device. Medtronic does not
point to any evidence rebutting this testimony. Therefore,
we agree with the district court that a person of skill in
the art would have understood the ’071 patent to describe
an implant that could be pre-assembled prior to insertion,
such that the upper surface of the lower part is “opera-
tively engaged” with the lower surface of the upper part.
Medtronic contends that the ’071 patent does not de-
scribe a two-piece implant because the ’071 patent ac-
tively disparages the two-piece design of the ’477 patent.
In discussing the two-piece design of the ’477 patent, the
’071 patent notes that it is “particularly difficult” to
achieve a minimum structural height for an implant if the
pivot is embedded prior to insertion. Id. col.1 ll.11-19.
However, this does not rise to the level of an express
17 SPINE SOLUTIONS v. MEDTRONIC SOFAMOR
disclaimer sufficient to limit the scope of the claims;
“[d]isavowal requires expressions of manifest exclusion or
restriction, representing a clear disavowal of claim scope.”
Epistar Corp. v. ITC, 566 F.3d 1321, 1335 (Fed. Cir.
2009). Further, claim 1 is not directed to the height-
minimizing embodiment. The originally-filed claims
recited limitations directed to “protrusions and recesses . .
. which are offset laterally from one another in such a way
that . . . [the upper and lower parts] mesh with one an-
other,” see J.A. 17167; claim 1 as issued recites no such
limitation.
D. Noninfringement
Medtronic asserts that the district court erred in
granting summary judgment that the O-Maverick im-
plant infringes claims 1 and 2 of the ’071 patent both
literally and under the doctrine of equivalents. Although
“infringement is a question of fact, we review a district
court's grant of summary judgment without deference.”
Schindler Elevator Corp. v. Otis Elevator Co., 593 F.3d
1275, 1281 (Fed. Cir. 2010). “Prosecution history estoppel
is a legal question subject to de novo review on appeal.”
Cybor Corp., 138 F.3d at 1460.
O-Maverick is a two-piece implant arranged as an ar-
ticulating ball-and-socket joint. As shown below, each of
the top and bottom pieces includes an anchoring structure
that consists of two tabs separated by a one-millimeter
wide gap:
SPINE SOLUTIONS v. MEDTRONIC SOFAMOR 18
Medtronic moved for summary judgment that O-
Maverick does not infringe claims 1 and 2, arguing that
O-Maverick has two anchors on each piece and therefore
does not meet the “single anchor” limitation. SSI cross-
moved for summary judgment of infringement, arguing
that O-Maverick has a single, “slotted” keel and infringes
both literally and under the doctrine of equivalents.
The district court determined on summary judgment
that the O-Maverick anchoring structure meets the
claimed “single anchor” limitation. The court acknowl-
edged that the issue of infringement turned on whether
the O-Maverick anchoring structure was properly deemed
to be one or two anchors. The court held, effectively as a
matter of law, that the O-Maverick anchoring structure
qualified as a “single anchor.” The court characterized
the gap between the tabs as “a diagonal slot” and stated
that its construction of “single anchor” did not exclude
such a feature. J.A. 57. Therefore, the court held that O-
Maverick literally infringed claims 1 and 2 as a matter of
law. The court also held as a matter of law that the
anchoring structure met the “single anchor” limitation
19 SPINE SOLUTIONS v. MEDTRONIC SOFAMOR
under the doctrine of equivalents. Medtronic argued that
prosecution history estoppel barred SSI from arguing
equivalence because applicants disavowed the use of dual
anchors during prosecution of the ’071 patent; the court
rejected this argument, concluding that applicants’ dis-
avowal was not “a clear and unmistakable surrender of
the type of keel structure on the [O-Maverick].” J.A. 61.
The court therefore granted SSI’s motion for summary
judgment of infringement with respect to O-Maverick,
both literally and under the doctrine of equivalents, and
denied Medtronic’s motion for summary judgment of
noninfringement.
We agree with Medtronic that the court erred in de-
termining that O-Maverick literally infringes claims 1
and 2. The court construed “single anchor” to mean, in
relevant part, that “[t]he upper and lower surfaces of the
implant each have one anchor having the characteristics
recited in the last paragraph of [claim 1].” Claim Con-
struction Order, 2008 U.S. Dist. LEXIS 116648, at *43
(emphasis added). A simple observation of O-Maverick
confirms that the implant has two anchors on each of the
upper and lower pieces, not one. The anchors are sepa-
rated by a one-millimeter gap that extends all the way to
the base of the implant; at no point are the two anchors
joined or connected in any way. O-Maverick clearly has
two anchors on each piece, not a “single anchor” as recited
by claims 1 and 2. Therefore, we hold as a matter of law
that O-Maverick does not literally infringe claims 1 and 2.
With respect to the doctrine of equivalents, Medtronic
argues that applicants made a clear surrender of any
designs containing more than one anchor during prosecu-
tion of the ’071 patent. We agree. During prosecution,
applicants expressly distinguished the claimed invention
over the ’477 patent by asserting that “a reference disclos-
SPINE SOLUTIONS v. MEDTRONIC SOFAMOR 20
ing two anchors does not disclose a device affirmatively
claiming a single anchor . . . reciting a negative limitation
in the form of a single element is not disclosed by prior art
which teaches more than one element.” J.A. 17524. This
is a clear disclaimer of claim scope, and prosecution
history estoppel therefore bars SSI from arguing that a
two-anchor device is equivalent to the claimed implant.
Because we hold that O-Maverick is a two-anchor device,
SSI cannot argue that O-Maverick infringes claims 1 and
2 under the doctrine of equivalents.
Because O-Maverick has two anchors, we hold as a
matter of law that it does not literally infringe claims 1
and 2 of the ’071 patent. Further, because prosecution
history estoppel bars SSI from arguing that O-Maverick’s
two anchors are equivalent to the claimed “single anchor,”
we hold as a matter of law that O-Maverick does not
infringe claims 1 and 2 under the doctrine of equivalents.
Therefore, we reverse the district court’s grant of sum-
mary judgment of infringement and denial of summary
judgment of noninfingement, and we remand for the court
to enter judgment of noninfringement with respect to O-
Maverick. 1
E. Standing and Lost Profits
Medtronic asserts that the court abused its discretion
in allowing SSI to amend its complaint to add Synthes
Spine and Synthes, Inc. as co-plaintiffs. Medtronic argues
that Synthes Spine and Synthes, Inc. lack standing to sue
1 As it appears to be undisputed that Maverick and
A-Maverick are both single-anchor implants, our holding
of noninfringement with respect to O-Maverick does not
disturb the parties’ stipulation that Maverick and A-
Maverick infringe the asserted claims.
21 SPINE SOLUTIONS v. MEDTRONIC SOFAMOR
for infringement of the ’071 patent because they are
neither owners nor exclusive licensees of the patent. “The
question of standing to sue is a jurisdictional one, which
we review de novo.” Rite-Hite Corp. v. Kelley Co., 56 F.3d
1538, 1551 (Fed. Cir. 1995) (en banc). “The party bringing
the action bears the burden of establishing that it has
standing.” Sicom Sys. v. Agilent Techs., Inc., 427 F.3d
971, 976 (Fed. Cir. 2005).
It is well-settled that “[o]nly a patent owner or an ex-
clusive licensee can have constitutional standing to bring
an infringement suit; a non-exclusive licensee does not.”
Mars, Inc. v. Coin Acceptors, Inc., 527 F.3d 1359, 1367
(Fed. Cir. 2008). To be an exclusive licensee for standing
purposes, “a party must have received, not only the right
to practice the invention within a given territory, but also
the patentee’s express or implied promise that others
shall be excluded from practicing the invention within
that territory as well.” Id. (citing Rite-Hite, 56 F.3d at
1552). “If the party has not received an express or im-
plied promise of exclusivity under the patent, i.e., the
right to exclude others from making, using, or selling the
patented invention,” the party has only a “bare license”—
and a “bare license to sell an invention in a specified
territory, even if it is the only license granted by the
patentee, does not provide standing without the grant of a
right to exclude others.” Rite-Hite, 56 F.3d at 1552, 1553.
It is undisputed that SSI is the sole owner of the ’071
patent. With respect to Synthes, Inc., SSI’s parent corpo-
ration, the record contains no evidence that Synthes, Inc.
is an exclusive licensee of the ’071 patent. In fact, the
amended complaint does not even allege that Synthes,
Inc. licenses the ’071 patent. Given that nothing in the
record indicates that Synthes, Inc. is an owner or exclu-
sive licensee of the ’071 patent, we agree with Medtronic
SPINE SOLUTIONS v. MEDTRONIC SOFAMOR 22
that SSI failed to show that Synthes, Inc. had standing to
bring this suit. Therefore, the district court abused its
discretion in allowing SSI to amend its complaint to add
Synthes, Inc. as a co-plaintiff.
The question remains whether Synthes Spine, SSI’s
sister corporation that makes and sells ProDisc II, is an
exclusive licensee for purposes of standing. Medtronic
argues that the record does not contain sufficient evidence
to establish that Synthes Spine has an exclusive license to
the ’071 patent. SSI acknowledges that there is no
agreement, either oral or written, between SSI and Syn-
thes Spine with respect to the ’071 patent. However, SSI
asserts that an “understanding” exists within the Synthes
family that Synthes Spine has the exclusive right to
practice the ’071 patent. SSI points to deposition testi-
mony from its corporate representative—Robert Donohue,
the Chairman of SSI and Chief Financial Officer of Syn-
thes, Inc.—that this “understanding” is “based on the fact
that [Synthes Spine] has the exclusive right to market
and distribute all spine-related products in the U.S. . . .
I’m not aware of an expressed agreement that is oral or
written. I believe it’s an agreement between the parties
based on the way Synthes is organized.” J.A. 13588. SSI
also relies on Mr. Donohue’s testimony that “based on the
way Synthes is organized and operates,” SSI would not be
able to license the ’071 patent to any party other than
Synthes Spine. J.A. 14101. SSI asserts that the only
reasonable conclusion to be drawn from Synthes’ organ-
izational structure is that SSI has made an implied
promise to exclude entities other than Synthes Spine from
practicing the ’071 patent.
We agree with Medtronic that SSI failed to establish
that Synthes Spine had standing to join SSI’s infringe-
ment suit. The evidence of record shows that SSI owns
23 SPINE SOLUTIONS v. MEDTRONIC SOFAMOR
and enforces the ’071 patent and that Synthes Spine is
the only entity that makes and sells products practicing
the patent. Based solely on this “organization,” SSI asks
us to infer that it made an implied promise to exclude all
entities other than Synthes Spine from practicing the ’071
patent. However, the fact that Synthes Spine is currently
the only entity practicing the ’071 patent does not mean
that SSI has promised to exclude all others from doing so.
Nothing in the record shows that SSI would be prohibited
from licensing the ’071 patent to a third party, should it
so desire. Indeed, Mr. Donohue’s testimony shows that
the “understanding” regarding the ’071 patent is based on
nothing more than the way in which the various Synthes
entities presently operate. This indicates that by allowing
Synthes Spine to practice the claimed invention, SSI has
granted it at most a bare license.
If we were to find standing on these facts, this would
mean that any company related to a patent owner could
be treated as an exclusive licensee, so long as the patent
owner allows only that company to practice the patent,
regardless of any actual agreement as to exclusivity. This
is plainly contrary to our case law, which specifies that a
“bare license . . . even if it is the only license granted by
the patentee, does not provide standing without the grant
of a right to exclude others.” Rite-Hite, 56 F.3d at 1553.
Given that SSI fails to point to any evidence other than
its current “organization” to show that Synthes Spine is
an exclusive licensee, we conclude that SSI failed to meet
its burden of establishing that Synthes Spine has stand-
ing to bring suit. Therefore, the district court abused its
discretion in allowing SSI to amend its complaint to add
Synthes Spine as a co-plaintiff.
SSI asserts that Medtronic waived the right to chal-
lenge the availability of lost profits through reliance on
SPINE SOLUTIONS v. MEDTRONIC SOFAMOR 24
any “corporate distinctions” between the Synthes entities
because Medtronic allegedly treated the various Synthes
entities as one throughout discovery. Regardless of how
SSI characterizes Medtronic’s position, however, Med-
tronic is challenging the standing of Synthes, Inc. and
Synthes Spine to bring suit on the ’071 patent. Under
Article III of the Constitution, “standing . . . is jurisdic-
tional and not subject to waiver.” Pandrol USA, LP v.
Airboss Ry. Prods., 320 F.3d 1354, 1367 (Fed. Cir. 2003)
(citation omitted).
Because we conclude that neither Synthes Spine nor
Synthes, Inc. has standing to sue on the ’071 patent, SSI
is not entitled to recover for any lost profits suffered by
Synthes Spine or Synthes, Inc. It is undisputed that SSI
does not itself sell any products. Therefore, SSI is not
entitled to any lost profits damages. See Poly-America,
L.P. v. GSE Lining Tech., Inc., 383 F.3d 1303, 1311 (Fed.
Cir. 2004) (“the patentee needs to have been selling some
item, the profits of which have been lost due to infringing
sales, in order to claim damages consisting of lost prof-
its”). We reverse the district court’s denial of Medtronic’s
motion for JMOL of no lost profits and vacate the jury’s
award of lost profits damages. We remand to the court for
a determination of the proper reasonable royalty to which
SSI might be entitled on the infringing sales of Maverick
and A-Maverick for which the jury awarded lost profits.
F. Willfulness
Medtronic asserts that the court erred in denying its
motion for JMOL of no willfulness because SSI failed to
establish that Medtronic’s manufacture of the Maverick
products was objectively reckless. Medtronic argues that
its infringement defenses, and its reliance on those de-
fenses, were reasonable. Willfulness is a question of fact,
25 SPINE SOLUTIONS v. MEDTRONIC SOFAMOR
and our review on appeal is “limited to asking whether
[the jury’s] verdict is supported by substantial evidence.”
i4i Ltd. P’ship v. Microsoft Corp., 598 F.3d 831, 859 (Fed.
Cir. 2010).
To establish willful infringement, “a patentee must
show by clear and convincing evidence that the infringer
acted despite an objectively high likelihood that its ac-
tions constituted infringement of a valid patent.” In re
Seagate Tech., LLC, 497 F.3d 1360, 1371 (Fed. Cir. 2007).
This “objective” prong of Seagate tends not to be met
where an accused infringer relies on a reasonable defense
to a charge of infringement. E.g., Depuy Spine, Inc. v.
Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1336-37
(Fed. Cir. 2009) (holding that the district court correctly
granted JMOL of no willfulness where defendant “pre-
sented a substantial question” of noninfringement under
the doctrine of equivalents, even though the jury found
equivalence); cf. i4i, 598 F.3d at 860 (affirming the district
court’s denial of JMOL of no willfulness because “the jury
was free to decide for itself whether Microsoft reasonably
believed there were any substantial defenses to a claim of
infringement”). If Seagate’s objective prong is met, “the
patentee must also demonstrate that this objectively-
defined risk . . . was either known or so obvious that it
should have been known to the accused infringer.” Id.
Medtronic raised a substantial question as to the ob-
viousness of the ’071 patent. The combination of the ’477
patent and Nobuo plainly discloses all of the claimed
limitations. Although we hold that the record contains
substantial evidence to support the jury’s implicit finding
that one of skill in the art would not have found the
combination obvious, Medtronic was not objectively
reckless in relying on this defense. Seagate, 497 F.3d at
1371 (“proof of willful infringement permitting enhanced
SPINE SOLUTIONS v. MEDTRONIC SOFAMOR 26
damages requires at least a showing of objective reckless-
ness”). Indeed, the district court expressly noted in the
context of its enhanced damages analysis that Medtronic’s
obviousness arguments were “reasonable.” J.A. 198. We
conclude that substantial evidence does not support the
jury’s finding that Medtronic acted despite an objectively
high likelihood that its actions constituted infringement
of a valid patent. Therefore, we reverse the district
court’s denial of Medtronic’s motion for JMOL of no
willfulness.
Because we reverse the denial of JMOL of no willful-
ness, we also vacate the award of enhanced damages. i4i,
598 F.3d at 858 (“A finding of willful infringement is a
prerequisite to the award of enhanced damages.”). Fur-
ther, as the court’s finding of exceptionality was based
solely on “evidence of Medtronic’s willful infringement,”
we also vacate the award of attorney fees under 35 U.S.C.
§ 285. J.A. 202.
G. Permanent Injunction
Finally, Medtronic argues that the court abused its
discretion in permanently enjoining sales of Maverick
devices that are already outside of the U.S. “We review
the decision to grant an injunction, as well as the scope of
that injunction, for abuse of discretion.” i4i, 598 F.3d at
861.
The court’s injunction prohibits Medtronic from,
among other things, “using, selling, offering for sale, or
otherwise transferring” any of the accused devices that
have already been exported. J.A. 232. Medtronic asserts,
citing 35 U.S.C. § 283, that an injunction is only proper to
prevent future infringement. Medtronic contends that
future sales of its Maverick devices outside the U.S.
27 SPINE SOLUTIONS v. MEDTRONIC SOFAMOR
cannot infringe any U.S. patent. Medtronic also contends
that there is no risk that the accused devices will be re-
imported because the Maverick devices are not sold
within the U.S.
A district court “may grant injunctions in accordance
with the principles of equity to prevent the violation of any
right secured by patent, on such terms as the court deems
reasonable.” 35 U.S.C. § 283 (emphasis added). An
injunction is only proper to prevent future infringement of
a patent, not to remedy past infringement. See also Johns
Hopkins Univ. v. Cellpro, Inc., 152 F.3d 1342, 1365 (Fed.
Cir. 1998) (“[A]n injunction is only proper to the extent it
is ‘to prevent the violation of any right secured by pat-
ent.’”) (quoting 35 U.S.C. § 283). As we noted in CellPro,
a patentee must seek compensation for past infringement
under 35 U.S.C. § 284; the purpose of an injunction is to
prevent future violations of the patent. Id. at 1367.
Medtronic’s overseas sales of the Maverick products
cannot infringe any U.S. patent, and there is little risk
that the infringing devices will be imported. 2 Thus, the
extraterritorial portion of the injunction appears to be
premised solely on Medtronic’s past infringement, not on
the prevention of future infringement. This is contrary to
the plain language of 35 U.S.C. § 283. Therefore, the
court abused its discretion in imposing the extraterrito-
rial restraints on Medtronic. On remand, the court is
directed to vacate the extraterritorial portion of the
injunction.
2 At oral argument, SSI’s counsel represented that
SSI agrees the injunction should be modified to delete the
extraterritorial portion. Trans. of Oral Arg. at 29:39-
30:08.
SPINE SOLUTIONS v. MEDTRONIC SOFAMOR 28
CONCLUSION
For the foregoing reasons, we affirm the district
court’s denial of Medtronic’s motion for JMOL that the
asserted claims of the ’071 patent are invalid for obvious-
ness. We also affirm the court’s denial of Medtronic’s
motion for summary judgment of invalidity for failure to
comply with the written description requirement; its
grant of SSI’s motion for partial summary judgment
dismissing Medtronic’s 35 U.S.C. § 112 defenses; and its
construction of the term “operative engagement.” We
reverse the court’s denial of Medtronic’s motion for sum-
mary judgment of noninfringement and its grant of sum-
mary judgment of infringement with respect to O-
Maverick, and we remand for the court to enter judgment
of noninfringement with respect to O-Maverick. We also
reverse the court’s denial of Medtronic’s motion for JMOL
of no lost profits, and we therefore vacate the jury’s award
of lost profits damages and remand for the court to de-
termine any additional reasonable royalty to which SSI
might be entitled. We reverse the court’s denial of Med-
tronic’s motion for JMOL of no willfulness and conse-
quently vacate the enhanced damages and attorney fee
awards. Finally, we remand for the court to modify the
terms of the permanent injunction by deleting the extra-
territorial portion.
AFFIRMED-IN-PART, REVERSED-IN-PART,
VACATED-IN-PART and REMANDED
COSTS
No costs.