Synthes USA, LLC v. Spinal Kinetics, Inc.

United States Court of Appeals
for the Federal Circuit
______________________
SYNTHES USA, LLC (formerly known as Synthes
(U.S.A.)) AND DEPUY SYNTHES PRODUCTS, LLC,
Plaintiffs-Appellants,
v.
SPINAL KINETICS, INC.,
Defendant-Cross Appellant.
______________________
2013-1047, -1059
______________________
Appeals from the United States District Court for the
Northern District of California in No. 09-CV-1201, Senior
Judge Ronald M. Whyte.
______________________
Decided: October 29, 2013
______________________
JEFFREY M. OLSON, Sidley Austin, LLP, of Los Ange-
les, California, argued for plaintiffs-appellants. With him
on the brief was MATTHEW S. JORGENSON. Of counsel on
the brief was CONSTANTINE L. TRELA, JR., of Chicago,
Illinois.
ROBERT W. DICKERSON, Dickstein Shapiro, LLP, of Ir-
vine, California, argued for defendant-cross appellant.
With him on the brief were ALLAN W. JANSEN, CHARLES A.
KERTELL, EHAB M. SAMUEL and MARK A. STIRRAT. Of
2 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
counsel was JAMES W. GERIAK, Sheppard Mullin Richter
& Hampton, LLP, of Costa Mesa, California.
______________________
Before PROST, O’MALLEY, and TARANTO, Circuit Judges.
Opinion for the court filed by Circuit Judge O’MALLEY.
Dissenting opinion filed by Circuit Judge TARANTO.
O’MALLEY, Circuit Judge.
Synthes USA, LLC and DePuy Synthes Products, LLC
(collectively, “Synthes”) 1 appeal from a jury verdict find-
ing that Spinal Kinetics, Inc. (“SK”) did not infringe
claims 29–31 (“asserted claims”) of U.S. Patent No.
7,429,270 (“the ’270 patent”) and that the claims were
invalid for lack of written description. SK cross-appeals
contending that the district court erred in denying SK’s
motion for fees under 35 U.S.C. § 285. Both appeals are
timely, and we have jurisdiction under 28 U.S.C.
§ 1295(a)(1). For the reasons below, we affirm the jury
verdict of invalidity for lack of written description and
affirm the district court’s denial of SK’s request for attor-
neys’ fees.
1 During the pendency of the district court proceed-
ings through final judgment and at the time the present
appeal was docketed, the patent-in-suit was assigned to
Synthes. After briefing on this appeal was completed but
before oral argument, the patent-in-suit was assigned to
DePuy Synthes Products, LLC (“DePuy”). To reflect that
change, DePuy was added as an appellant in this case and
the caption was modified to reflect that addition. See
Synthes USA, LLC v. Spinal Kinetics, 13-1047, ECF No.
48 (Fed. Cir. July 3, 2013).
SYNTHES USA, LLC v. SPINAL KINETICS, INC. 3
I. BACKGROUND
A. The ’270 Patent and Accused Devices
Synthes filed this action alleging that SK’s M6-C and
M6-L intervertebral implants infringed claims 29–31 of
the ’270 patent. See Synthes (USA) v. Spinal Kinetics,
Inc., 5:09-cv-1201-RMW, ECF No. 1 (N.D. Cal. Nov. 12,
2008). The ’270 patent originated from a German lan-
guage PCT application filed on April 14, 2003. The as-
serted claims were added by amendment on February 19,
2008. The ’270 patent is directed to an “Intervertebral
Implant,” which is a prosthetic device designed to replace
a diseased or degenerated disc located between adjacent
vertebrae of the human spine:
A healthy disc (depicted below) has a fibrous, outer band
called the annulus fibrosus, which surrounds a central,
gel-like substance called the nucleus pulposus:
4 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
A natural disc provides shock-absorbing functions and
helps maintain proper spacing, stability, and motion
within the spine. Artificial discs attempt to replace some
or all of these functions. Claim 29, the independent claim
from which claims 30 and 31 depend, provides:
29. An intervertebral implant for implantation be-
tween an upper and lower vertebrae, the implant
having a central axis, the implant comprising:
a first substantially rigid bone contacting plate
having an external surface extending generally
transversely to the central axis for contacting at
least a portion of the upper vertebra;
a second substantially rigid bone contacting plate
having an external surface extending generally
transversely to the central axis for contacting at
least a portion of the lower vertebra;
a third plate operatively coupled to the first bone
contacting plate, the third plate including a plu-
rality of openings;
a fourth plate operatively coupled to the second
bone contacting plate, the fourth plate including a
plurality of openings;
SYNTHES USA, LLC v. SPINAL KINETICS, INC. 5
a central part substantially located between the
third and fourth plates, the central part including
a flexible core and a fiber system, wherein the
core is substantially cylindrical and includes a top
surface and a bottom surface, the top surface of
the core being in contact with the third plate and
the bottom surface of the core being in contact
with the fourth plate, and wherein the fiber sys-
tem at least partially surrounds the core, and is at
least partially received within the plurality of
openings formed in the third and fourth plates so
that the fiber system is joined to the third and
fourth plates; and
an elastic sheathing body at least partially sur-
rounding the fiber system and the core, and con-
nected to the third and fourth plates.
’270 patent, col. 8, ll. 19–48.
Claim 30 requires that the first and second bone con-
tacting plates recited in claim 29 be made from titanium
or titanium alloy. Id. at col. 8, ll. 49–51. Claim 31 re-
quires the fiber system recited in claim 29 to be con-
structed of an “ultra high molecular weight polyethylene
material.” Id. at col. 8, ll. 52–54. According to Synthes,
claims 30 and 31 stand or fall with claim 29. The main
features of claim 29 are depicted in Figures 3 and 4 of
the ’270 patent:
SYNTHES USA, LLC v. SPINAL KINETICS, INC. 7
Except for the shape of the cores, the M6-C and M6-L are
identical for purposes of this litigation.
B. Proceedings Below
During the course of the litigation, the district court
construed a number of terms contained in claim 29 of
the ’270 patent. Of particular relevance to the current
appeal is the court’s construction of the phrase “the third
plate including a plurality of openings.” 2 Synthes, ECF
No. 84 (N.D. Cal. June 23, 2010). SK argued that “plural-
ity of openings” should be limited to grooves on the cir-
cumference of the claimed cover plates. Id. SK’s
argument was predicated on its contention that the
written description of the ’270 patent does not describe a
structure with holes or slots in the cover plates, but only
describes grooves on the circumference of the cover plate
that radially penetrate into the lateral surface of the
plate. Id. Those grooves are depicted as element 18 in
Figure 2 of the ’270 patent:
2 Claim 29 recites that both the third and fourth plates
include a “plurality of openings.” See ’270 patent, col. 8,
ll. 19–48. The court’s claim construction of the phrase
applied to both limitations, but for ease of reference we
only recite the third plate.
8 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
See ’270 patent, col. 5, ll. 11–13.
Synthes, on the other hand, contended that the claim
was not so limited, and urged the court for a broader
construction: “a third plate including two or more open-
ings.” Id. While the district court did not adopt Synthes’
construction wholesale, it did side with Synthes regarding
the breadth of the phrase and construed it as “the third
plate including two or more openings to allow the fiber
system to be joined or anchored to that plate.” Id. The
court concluded that claim 29 requires openings in the
cover plates, or third and fourth plates, which make it
possible for the claimed fiber system to be joined or an-
chored to the plates. Id.The importance of the “plurality of openings” limita-
tion to Synthes’ infringement case is evident when viewed
in light of the accused devices. SK devices do not employ
SYNTHES USA, LLC v. SPINAL KINETICS, INC. 9
peripheral grooves, but instead use slots, or openings, on
the cover plates. The M6 lumbar device uses trapezoidal
slots, while the cervical device uses elongated circle slots:
Joint Appendix (“J.A.”) at 24515; 24172. According to SK,
Synthes amended the application that led to the ’270
patent during prosecution to add claims 29–31 only after
the M6 devices were on the market and Synthes was
advised that SK’s M6 devices were a significant improve-
ment in the technology. See J.A. at 20676; 25947.
After the court construed the disputed terms of the
patent, it entertained motions for summary judgment.
The district court granted Synthes’ motions dismissing
SK’s enablement, indefiniteness, and utility defenses, but
denied Synthes’ motion to dismiss SK’s written descrip-
tion and best mode defenses. See Synthes, ECF No. 298
(N.D. Cal. Aug. 19, 2011). The parties proceeded to trial
on the remaining issues. After hearing all of the evidence,
followed by four days of deliberation, the jury concluded
that SK’s M6 devices did not infringe the asserted claims
of the ’270 patent and that SK proved by clear and con-
vincing evidence that claim 29, and consequently claims
30 and 31, were invalid for a lack of written description
support. See Synthes, ECF No. 497 (N.D. Cal. Dec. 13,
2011).
10 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
Synthes then moved the district court for judgment as
a matter of law (“JMOL”) or new trial as to literal in-
fringement and invalidity, among other things. Id. SK
moved for attorneys’ fees, among other things. Id. The
district court denied Synthes’ motion for JMOL or new
trial as to literal infringement, but granted-in-part Syn-
thes’ motion regarding invalidity for lack of written
description. See Synthes, ECF No. 577 (N.D. Cal. Sept.
27, 2012). According to the district court, the jury found
the ’270 patent invalid for lack of written description on
four claim limitations: (1) “plate including a plurality of
openings”; (2) “wherein the core is substantially cylindri-
cal”; (3) “flexible core”; and (4) “substantially rigid bone
contacting plate.” Id. Synthes argued that SK failed to
produce substantial evidence as to all four. Id. The
district court agreed with Synthes that SK failed to carry
its burden on “substantially cylindrical core” and “sub-
stantially rigid bone contacting plate.” Id. The court
affirmed the jury verdict, however, on “plate including a
plurality of openings” and “wherein the core is substan-
tially cylindrical.” Id. The court also denied SK’s motion
for attorneys’ fees under 35 U.S.C. § 285. Id. Synthes
then filed this appeal and SK cross-appealed.
II. DISCUSSION
The district court found substantial evidence support-
ed the jury verdict that the term “plate including a plural-
ity of openings” lacked written description support,
rendering the asserted claims invalid. The district court
also concluded that SK failed to demonstrate that it was
entitled to attorneys’ fees. We agree with the district
court on both counts. Consequently, we find the remain-
ing issues on appeal moot.
A. Legal Standard
We review the denial of JMOL or request for a new
trial after a jury verdict under the same standard of
review as the trial court. Lucent Techs., Inc. v. Gateway,
SYNTHES USA, LLC v. SPINAL KINETICS, INC. 11
Inc., 580 F.3d 1301, 1309 (Fed. Cir. 2009) (citing Wechsler
v. Macke Int’l Trade, Inc., 486 F.3d 1286, 1290 (Fed. Cir.
2007)). The grant or denial of JMOL is a procedural issue
not unique to patent law; therefore, we apply the law of
the relevant regional circuit. Id. (citing Summit Tech.,
Inc. v. Nidek Co., 363 F.3d 1219, 1223 (Fed. Cir. 2004)).
The Ninth Circuit reviews denial of JMOL de novo. First
Nat’l Mortg. Co. v. Fed. Realty Inv. Trust, 631 F.3d 1058,
1067 (9th Cir. 2011) (citing Lakeside-Scott v. Multnomah
Cnty., 556 F.3d 797, 802 (9th Cir. 2009)). We must draw
all reasonable inferences in favor of the jury’s verdict, and
the evidence is viewed in the light most favorable to the
non-moving party. Id. The jury’s “verdict will be upheld
if it is supported by substantial evidence, ‘even if it is also
possible to draw a contrary conclusion.’” Id. at 1067–68
(quoting Pavao v. Pagay, 307 F.3d 915, 918 (9th Cir.
2002)).
1. Written Description
The district court, at Synthes’ urging, broadly con-
strued the phrase “third plate including a plurality of
openings,” which appears in claim 29. The relevant
claims, moreover, include broad language added during
prosecution. Synthes amended the application that
became the ’270 patent to add the concept of “openings” in
claim 29 almost five years after the application was
originally filed, and after SK’s M6 devices were already on
the market. See J.A. at 20676; 25157–25179. The origi-
nal disclosure claimed and disclosed a plurality of grooves
and a plurality of channels, but did not describe “open-
ings” generally. See id. While broadening claims during
prosecution to capture a competitor’s products is not
improper, the written description must support the
broadened claims. See Liebel-Flarsheim Co. v. Medrad,
Inc., 358 F.3d 898, 909 n.2 (Fed. Cir. 2004) (“[I]t is not
improper for an applicant to broaden his claims during
prosecution in order to encompass a competitor’s prod-
ucts, as long as the disclosure supports the broadened
12 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
claims.”) (citing Kingsdown Med. Consultants, Ltd. v.
Hollister, Inc., 863 F.2d 867, 874 (Fed. Cir. 1988)). After
hearing the testimony of SK’s expert, Dr. Lee, and its
research and development manager, Mr. Koske, indicat-
ing that the as-filed disclosure did not demonstrate pos-
session of an intervertebral implant that employed any
sort of openings anywhere on the cover plates, the jury
determined that the ’270 patent was invalid under § 112,
paragraph 1. As the district court did before us, we find
that substantial evidence supports that conclusion.
Section 112, paragraph one of Title 35 requires a pa-
tentee to provide a written description that allows a
person of skill in the art to recognize that the patentee
invented what is claimed. 3 See Ariad Pharms., Inc. v. Eli
Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc)
(citing Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562–
63 (Fed. Cir. 1991)). “[T]he test for sufficiency is whether
the disclosure of the application relied upon reasonably
conveys to those skilled in the art that the inventor ha[d]
possession of the claimed subject matter as of the filing
date.” Id. Determination of whether a patent satisfies
the written description requirement is a question of fact.
Id. (citing Capon v. Eshar, 418 F.3d 1349, 1357–58 (Fed.
Cir. 2005)). The “level of detail required to satisfy the
written description requirement varies depending on the
nature and scope of the claims and on the complexity and
predictability of the relevant technology.” Id.Synthes contends that the jury’s verdict of invalidity
for a lack of adequate written description was not sup-
ported by substantial evidence. Synthes asserts that
the ’270 patent’s written description does not limit the
3 Congress recently changed the language and
structure of 35 U.S.C. § 112. See Leahy-Smith America
Invents Act, PUB. L. NO. 112-29. Those amendments
made no changes of relevance to this appeal.
SYNTHES USA, LLC v. SPINAL KINETICS, INC. 13
claimed “plurality of openings” to peripheral grooves.
Synthes next argues that the testimony and evidence
presented by SK via its expert and fact witnesses regard-
ing the “plurality of openings” limitation did not support
the jury’s verdict. Synthes also disputes the district
court’s post-trial conclusion that SK produced evidence
demonstrating that the field of intervertebral implants
was sufficiently unpredictable such that a disclosure of
one species of openings would not be enough to claim the
entire genus. We disagree on all counts.
The ’270 patent’s written description, filed on April
14, 2003, discloses that the fiber system may be anchored
by various means. See ’270 patent, col. 2, ll. 4–6. The
written description then discloses a series of examples of
how the fiber system may be anchored on the cover plates,
i.e., third and fourth plates. All of these examples employ
“grooves,” not slots or openings on the plates. See
e.g., ’270 patent, col. 3, ll. 22–26 (describing anchoring the
fiber system “through grooves and over the external
surfaces of the cover plates from one groove to another
one”); id., col. 3, ll. 32–34 (anchoring the fiber system by
using “a wedge-shaped construction of the grooves”); id.,col. 3, ll. 36–41 (describing the cover plates as comprising
“a lateral surface [with] grooves distributed on the cir-
cumference and radially penetrating into the lateral
surfaces”); id., col. 5, ll. 10–14 (disclosing an embodiment
wherein the cover plates have “grooves distributed on the
circumference and radially protruding into the lateral
surfaces”); id., col. 5, ll. 65–67 (describing an embodiment
with the fiber system “anchored on the cover plates by
means of grooves”). Claims 29–31 recite a “plurality of
openings” used to “join” or “anchor” the fiber system to the
cover plates, which Synthes contends supports any type of
openings located anywhere on the plates. The written
description, however, never discloses anything broader
than using grooves to anchor the fiber system to the cover
plates.
14 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
The parties appear to agree that “grooves” are a spe-
cies of “opening,” but do not agree that “grooves” consti-
tute an adequate disclosure to claim all openings that
may be used in the cover plates to anchor the fiber sys-
tem. In other words, the jury was asked to determine
whether the written description disclosure of “grooves”
“reasonably convey[ed] to those skilled in the art that the
inventor had possession of [an intervertebral implant that
could utilize any sort of opening located anywhere on the
cover plates to anchor the fiber system] as of the filing
date.” Ariad, 598 F.3d at 1351. The jury did not believe
so and, when all reasonable inferences are drawn in favor
of the jury verdict, we must affirm that decision.
SK presented testimony regarding the plurality of
openings limitation via its expert, Dr. Lee, and its re-
search and development manager, Mr. Koske. Dr. Lee
testified, based on his experience in designing total disc
replacements, that a person of ordinary skill in the art
would not believe that Synthes had possession of an
intervertebral implant utilizing openings located any-
where on the cover plates based on the disclosure of
peripheral grooves in the written description. In particu-
lar, Dr. Lee testified that: (1) based on his reading of the
written description, the disclosure of peripheral grooves
would not disclose openings located anywhere on the
plates (see J.A. 20843–54, Tr. Transcript, Jan. 20, 2011 at
2453:24–2455:7); (2) there are significant biomechanical
property differences between using peripheral grooves
and interior slots (see id. at 2456:11–20); and (3) when the
fiber system is attached via peripheral grooves, the dis-
tance of the fibers to the central axis is limited, but when
openings are used anywhere on the cover plates, the
fibers are not so limited in proximity to the central axis of
the device (see id. at 2456:21–2458:10).
Mr. Koske buttressed Dr. Lee’s testimony that, based
on his direct experience developing the accused products,
the process of moving from peripheral grooves to internal
SYNTHES USA, LLC v. SPINAL KINETICS, INC. 15
slots is not a simple substitution, but a careful and time-
consuming task. Mr. Koske, for example, testified that
SK rejected early prototypes that used peripheral grooves
on the cover plates. See J.A. 20757–58, Tr. Transcript,
Nov. 20, 2011, 2076:21–2078:20. Mr. Koske was present-
ed with a photograph of various SK devices, which he
described as a “design time line” of M6 devices. See J.A.
20757, Tr. Transcript, Nov. 20, 2011, 2075:16–24; J.A.
27122 (DX1106). Mr. Koske then testified that the “early
prototypes” with peripheral grooves were repeatedly
rejected. See 20757–78, Tr. Transcript, Nov. 20, 2011,
2077:11–2081:3. Mr. Koske’s testimony and attendant
trial exhibits demonstrated that SK’s development pro-
cess from the peripheral grooves to the commercial prod-
ucts took months of work. See, e.g., J.A. 24054–56 (SK
meeting minutes from September 2003 describing M6
devices in development process); J.A. 24122–42 (SK
presentation from December 2003 illustrating design
history of the M6 devices); J.A. 20758, Tr. Transcript,
Nov. 20, 2011, 2081:4–12 (Koske testimony regarding
April 2004 slide show depicting design of M6 at the time).
Mr. Koske also testified that SK had to overcome
technical hurdles through its development process, one of
which was to reduce wear on the device. Because the
devices may be used on people in their 20s and 30s and
would be required to last a lifetime, wear was an im-
portant consideration in design choice. See J.A. 20736,
Tr. Transcript, Nov. 29, 2011, 1991:15–1993:3. In par-
ticular, Mr. Koske stated that the shape of the slots on the
cover plates played a role in wear reduction. Mr. Koske
explained that, because the metal cover plates are very
thin, if the slots were too large, it would increase the risk
of the cover plates breaking. See J.A. 20737, Tr. Tran-
script, Nov. 29, 2011, 1996:10–1997:12. SK, therefore,
had to determine the precise size and location of the slots
to ensure that the cover plates used as little metal as
16 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
possible, reduced fiber wear, and still performed all of the
necessary functions of the device. Id.Taken together, Mr. Koske’s testimony is at least cir-
cumstantial evidence that it would not be evident that
peripheral grooves on the cover plates would disclose to
skilled artisans that internal slots would serve the same
function. Mr. Koske’s testimony and the exhibits used
during it, coupled with Dr. Lee’s testimony, provided
ample evidence for the jury to conclude that the written
description did not support the broad claim limitations in
the asserted claims.
Synthes contends that the difference Dr. Lee identi-
fied is “specious.” Rather than provide contrary evidence,
however, Synthes points to a very curt cross-examination
wherein Dr. Lee agreed with Synthes’ counsel that deeper
grooves—or grooves cut deeper into the cover plates—
might reduce the distance of the fibers from the central
axis. J.A. at 20889; Tr. Transcript, Dec. 5, 2011, 2601:16–
23. Synthes’ cross-examination, however, does not ad-
dress any of Dr. Lee’s other points. And, even if Synthes’
cross-examination of Dr. Lee would allow us to draw a
different conclusion, so long as substantial evidence
supported the jury’s verdict, we must affirm its decision.
See First Nat’l Mortg. Co., 631 F.3d at 1067–68; see also
Guy v. City of San Diego, 608 F.3d 582, 588 (9th Cir.
2010) (“[I]t has long been held that a jury may properly
refuse to credit even uncontradicted testimony.”) (cita-
tions omitted); Watec Co. v. Liu, 403 F.3d 645, 651 n.5
(9th Cir. 2005) (“We will not weigh the evidence or assess
the credibility of witnesses in determining whether sub-
stantial evidence exists.”) (citations omitted).
Synthes also attempts to minimize the relevance of
Mr. Koske’s testimony by contending that his testimony
was not directed to differences between using peripheral
grooves and internal slots. Mr. Koske, however, testified
that the shape and size of the slots, and the optimization
SYNTHES USA, LLC v. SPINAL KINETICS, INC. 17
of those slots, were important design considerations. And,
while Synthes is correct that Mr. Koske did not use “mag-
ic words” to explain why SK chose internal slots instead of
peripheral grooves, the jury was free to draw its own
conclusions from Mr. Koske’s testimony. Coupled with
Dr. Lee’s expert testimony on the “plurality of openings”
limitation, the jury’s verdict that a person skilled in the
art would not understand that a disclosure of peripheral
grooves would teach that any and all openings on the
cover plates are disclosed is supported by substantial
evidence.
The jury was entitled to rely on the above testimony
and evidence to conclude that the ’270 patent’s written
description does not support the broad plurality of open-
ings limitation. Written description is a factual question,
and whether the requirement is met “varies depending on
the nature and scope of the claims and on the complexity
and predictability of the relevant technology.” Ariad, 598
F.3d at 1351. While the predictability of the “aspect at
issue” is not the dispositive factor in determining whether
the written description requirement is satisfied, the
district court relied on it, and Synthes strenuously dis-
putes the district court’s conclusion. We, thus, briefly
address it. Id.Synthes frames the “aspect at issue” as “the shape
and locations of openings used to join or anchor a fiber
system to a plate.” Synthes’ Reply Brief at 46. As chroni-
cled above, Dr. Lee testified that the difference between
peripheral grooves and internal slots would present
significant engineering and design choices and main-
tained that the differences between the two designs would
present substantial biomechanical differences. Mr. Koske
also explained that SK itself began its development
process with peripheral grooves and ended with internal
slots. Mr. Koske’s testimony also indicated that the shape
of the internal slots was an important design choice that
18 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
required testing to account for wear on the fiber system.
All of this testimony was unrebutted.
Based on this evidence, the jury was free to conclude
that, because the ’270 patent’s written description does
not disclose anything other than peripheral grooves, there
would be significant biomechanical differences between
using peripheral grooves and internal slots. The jury was
also free to determine that SK’s skilled artisans made a
specific design choice to change its first prototype with
peripheral grooves to specifically shaped and located
internal slots. And, the jury was free to conclude, based
on the evidence, that the use of internal slots for these
devices was not predictable.
SK is correct that a “disclosure of a species may be
sufficient written description support for a later claimed
genus including that species.” Bilstad v. Wakalopulos,
386 F.3d 1116, 1124 (Fed. Cir. 2004) (emphasis added).
But, as we stated in Bilstad:
[i]f the difference between members of [a species]
is such that [a] person skilled in the art would not
readily discern that other [species] of the genus
would perform similarly to the disclosed members,
i.e., if the art is unpredictable, then disclosure of
more species is necessary to adequately show pos-
session of the entire genus.
Id. at 1125. In other words, predictability is a factual
issue judged on a case-by-case basis. Here, SK presented
its case to the jury, and the jury inferred that, in the field
of intervertebral implants, the disclosure of peripheral
grooves does not adequately demonstrate possession of
the entire genus of possible openings. Because the jury’s
verdict is supported by substantial evidence, we must
defer to that finding.
Synthes contends that, because we remarked in
Bilstad that the “mechanical world” is a “fairly predicta-
SYNTHES USA, LLC v. SPINAL KINETICS, INC. 19
ble field,” SK had to satisfy a heightened burden to
demonstrate unpredictability. See Bilstad, 386 F.3d at
1126. First, SK had no higher burden than providing
clear and convincing evidence that the ’270 patent does
not satisfy the written description requirement on the
“plurality of openings” limitation. Second, while we did
state in Bilstad that the mechanical field was “fairly
predictable,” we did not hold that all inventions that may
be characterized as “mechanical” allow claiming a genus
based on disclosure of a single species.
As we noted in Ariad, there are no “bright-line rules
governing, for example, the number of species that must
be disclosed to describe a genus claim, as this number
necessarily changes with each invention, and it changes
with progress in a field.” Ariad, 598 F.3d at 1351. In-
deed, factual inquiries will, at times, create confounding
results. But, whatever inconsistencies may appear “to
exist in the application of the law, those inconsistencies
rest not with the legal standard but with the different
facts and arguments presented to the courts.” Id. at 1352.
That is precisely the situation here. After hearing all of
the testimony and evidence, the jury resolved the facts in
favor of SK and determined that it had met its burden of
proving by clear and convincing evidence that the ’270
patent did not satisfy the written description require-
ment. Again, we are not entitled to disturb that finding
when there was substantial evidence to support it.
2. Exceptional Case
Attorneys’ fees may be awarded to the prevailing
party in “exceptional cases.” 35 U.S.C. § 285. The excep-
tional nature of a case must be established by clear and
convincing evidence. Brooks Furniture Mfg., Inc. v. Du-
tailier, Int’l Inc., 393 F.3d 1378, 1382 (Fed. Cir. 2005).
Absent litigation misconduct, sanctions may be imposed
only if: (1) the litigation is brought in subjective bad faith,
and (2) the litigation is objectively baseless. Id. at 1381.
20 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
In deciding whether a case is exceptional, trial courts are
to consider the “totality of the circumstances” surrounding
not just the initial allegations of infringement, but the
maintenance of those claims throughout the litigation.
See MarcTec, LLC v. Johnson & Johnson, 664 F.3d 907,
915–19 (Fed. Cir. 2012). Thus, when information gleaned
from discovery or the court’s rulings make clear that the
continued pursuit of litigation is frivolous or vexatious,
fees may be warranted even where the filing of the initial
complaint was arguably justified. See id.SK contends that Synthes brought objectively base-
less allegations of infringement and validity and contin-
ued to push those claims in the face of facts and claim
construction rulings that made clear that Synthes’ claims
were unsupportable. SK alleges that Synthes engaged in
litigation misconduct by taking a number of baseless
positions on everything from its claim construction argu-
ments to its damages theory. SK contends that the dis-
trict court’s view of Synthes’ conduct was too myopic,
failing to examine the propriety of its conduct as a whole.
After an independent review of the record—in its entire-
ty—we agree with the district court that SK failed to
demonstrate with clear and convincing evidence that it is
entitled to attorney fees under § 285. See Synthes, ECF
No. 577 (N.D. Cal. Sept. 27, 2012).
III. CONCLUSION
Based on the foregoing, we affirm the district court’s
denial of JMOL that claims 29–31 of the ’270 patent are
invalid under 35 U.S.C. § 112, paragraph 1 for lacking an
adequate disclosure to support the “plurality of openings”
limitation. We also affirm the district court’s denial of
SK’s request for attorneys’ fees under 35 U.S.C. § 285.
Accordingly, we need not reach the other issues addressed
by the district court and addressed by the parties in the
briefing before this court.
AFFIRMED
United States Court of Appeals
for the Federal Circuit
______________________
SYNTHES USA, LLC (formerly known as Synthes
(U.S.A.)) AND DEPUY SYNTHES PRODUCTS, LLC,
Plaintiffs-Appellants,
v.
SPINAL KINETICS, INC.,
Defendant-Cross Appellant.
______________________
2013-1047, -1059
______________________
Appeals from the United States District Court for the
Northern District of California in No. 09-CV-1201, Senior
Judge Ronald M. Whyte.
______________________
TARANTO, Circuit Judge, dissenting.
In my view, Spinal Kinetics failed as a matter of law
to show, by clear and convincing evidence, that asserted
claims 29-31 of Patent No. 7,429,270 are invalid for
inadequacy of the written description. In particular,
Spinal Kinetics offered no clear and convincing proof that
the difference between the “openings” of the claims and
the grooves of the written description is one that (in the
eyes of skilled artisans) has any effect, let alone an effect
that is difficult to predict, on fulfillment of the identified
purposes of the claims at issue. Nor is there any basis for
finding the written description inadequate to support the
“flexible core” limitation (or one other limitation for which
2 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
the district court itself rejected Spinal Kinetics’s written-
description challenge). I therefore respectfully dissent
from the majority’s affirmance of the judgment that the
patent claims are invalid.
Regarding the judgment of noninfringement, which
must be addressed if the invalidity judgment is reversed,
I conclude that the district court relied on an erroneous
construction of the claim term “fiber system.” That error
cannot be disregarded as one we can be confident had no
effect on the verdict of noninfringement, for the usual
simple reasons. The jury did not specify that it found
noninfringement on a basis other than the incorrectly
construed limitation; there is ample (perhaps conclusive)
evidence that this limitation is met under the proper
construction; and there is sufficient evidence to have
allowed the jury to find that the other limitations are met.
The jury verdict of noninfringement therefore must be
vacated. Accordingly, I would remand the case for a
determination, presumably through a new trial, of wheth-
er the accused products infringe under the proper claim
construction.
I
A
The written-description challenge in this case is to
structural claim language that is broader than the specific
embodiments disclosed in the written description. This is
not a case—such as some cases involving genetic or chem-
ical inventions—in which the claim language at issue is
functional rather than an identifier of structure. See, e.g.,
Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1349-50 (Fed. Cir. 2010); Regents of University of
California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed.
Cir. 1997). Nor is it a case in which the claim language
includes details that do not appear in the written descrip-
tion. See, e.g., Purdue Pharma L.P. v. Faulding Inc., 230
F.3d 1320, 1327 (Fed. Cir. 2000). The written-description
SYNTHES USA, LLC v. SPINAL KINETICS, INC. 3
question here is the familiar one involving whether the
claim language is simply too broad given the disclosure—
notwithstanding that claim language may be and com-
monly is broader than described embodiments, as it
identifies what aspects of the disclosed embodiments
matter. See In re Rasmussen, 650 F.2d 1212, 1215 (CCPA
1981) (“[T]hat a claim may be broader than the specific
embodiment disclosed in a specification is in itself of no
moment.”); Ronald Slusky, Invention Analysis and Claim-
ing: A Patent Lawyer’s Guide at 32-33 (2007) (discussing
claim drafting process of identifying what features of
embodiment matter).
In a case like this one, the written-description re-
quirement must focus on whether the way in which the
(broader) claim term differs from the (narrower) disclo-
sure is pertinent to fulfilling the identified purposes of the
claims at issue. More specifically, for a challenger to
prove insufficiency of the written description to support
the claim language, the challenger must identify the
respect in which the claim language differs from the
disclosed embodiments. At a minimum, the challenger
must then demonstrate that, in the eyes of a relevant
skilled artisan, that particular difference has a material
effect on whether the product or process would achieve
the aims of the claims at issue, with materiality of the
effect not the same as non-obviousness but related to
predictability (this case requiring no further definition of
that relation). See Ariad, 598 F.3d at 1351, 1352; Bilstad
v. Wakalopulos, 386 F.3d 1116, 1124-25 (Fed. Cir. 2004)
(inquiry into whether skilled artisans “would not readily
discern that other members of the genus would perform
similarly to the disclosed members, i.e., if the art is un-
predictable”); In re Curtis, 354 F.3d 1347, 1355, 1358
(Fed. Cir. 2004) (inquiry into whether skilled artisan
“could not predict the operability in the invention of any
species other than the one disclosed”; focus on “unpredict-
ability in performance”); Rasmussen, 650 F.2d at 1215
4 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
(inquiry into whether difference from described embodi-
ment is “unimportant” to operability). 1
It is commonly true, of course, that a skilled artisan
has to make some judgments when seeking to implement
the patent, whether it is the described embodiments or an
undescribed embodiment of the broader claim that the
artisan is proceeding to make and use. If those judgments
are sufficiently unguided by the written description,
unknown to a skilled artisan, or uncertain (requiring
undue experimentation), at least an enablement problem
may arise—though there is no enablement challenge here.
What is critical for present written-description purposes
is this: if there is materially the same range of implemen-
tation judgments for the described embodiments and the
broader claim—such as, here, how many openings/grooves
to have, their shape, how close to the center and far from
the periphery they would locate the fibers passing
through—the need for such judgments is irrelevant to the
written-description question. What matters is only the
particular difference between the narrower embodiments
and broader claims.
Recognizing the burden of proof carried by the chal-
lenger, this approach implements the Ariad formulations:
whether the inventor “possessed the claimed invention,”
or “actually invented the invention claimed.” 598 F.3d at
1351, 1355-56. If the challenger does not make the show-
ing identified above, the relevant skilled artisan will
understand that, by expressly describing certain embodi-
1 A patent’s written description may describe more
than one purpose or problem to be solved, and a particu-
lar claim may not address all of them. See, e.g., Phillips v.
AWH Corp., 415 F.3d 1303, 1327 (Fed. Cir. 2005) (en
banc). The written-description analysis of a particular
claim must focus on the purposes and problems relevant
to that particular claim.
SYNTHES USA, LLC v. SPINAL KINETICS, INC. 5
ments, the inventor possessed the more broadly claimed
invention, because the differences are immaterial to what
the inventor invented. See In re Peters, 723 F.2d 891, 893
(CCPA 1983) (reversing claim rejections that were based
on a difference between the broader claim terms and the
narrower disclosure, because “[m]ost importantly, one
skilled in the art would readily understand that in prac-
ticing the invention [the difference] is unimportant”). If
the challenger has made the identified showing, the
relevant skilled artisan will understand that the inventor
had not (based on the disclosure) addressed issues of
consequence to fulfilling the invention’s purpose, and so
did not possess in full the broadly claimed invention. See
Ariad, 598 F.3d at 1353 (“Requiring a written description
of the invention limits patent protection to those who
actually perform the difficult work of ‘invention’—that is,
conceive of the complete and final invention with all its
claimed limitations.”).
At the same time, this approach aligns with a critical
role of the written-description requirement in a case
involving a question of breadth. In such a case, the
requirement serves to prevent an inventor from acquiring
exclusivity rights over potential products or processes
that present problems in achieving the invention’s aims
that he or she has not solved. See Fiers v. Revel, 984 F.2d
1164, 1171 (Fed. Cir. 1993) (“attempt[s] to preempt the
future before it has arrived” are “not in compliance with
the description requirement”). It thus confines patents to
the problems the inventor solved and leaves to other
people the solutions they identify that the inventor did
not.
B
In this case, Spinal Kinetics failed to present the proof
required to show an insufficient written description. The
difference between the claimed “openings” and the dis-
closed “grooves” is simply that, for a groove, the space
6 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
remains open at the perimeter whereas, for an “opening,”
it need not be: “opening” covers slots wholly interior to the
outer boundary of the plate. But Spinal Kinetics did not
prove that that difference—potential closure at the pe-
rimeter—had any effect on the ability of the invented
implants to fulfill their purpose.
The evident role of the grooves is to prevent sideways
movement of the fibers, along the perimeter of the plate,
as they hold the components of the implant together. See
’270 patent at col. 3, lines 27-30 (“By guiding the fibres in
the grooves the fibre system can be so anchored on the
cover plates, that in the case of tensile forces acting on the
fibres no slipping of the fibres on the lateral sides is possi-
ble.”) (emphasis added). Nothing in Spinal Kinetics’s
proof showed that closing the space at the perimeter
affects that function (let alone in an unpredictable way).
More generally, nothing in Spinal Kinetics’s proof showed
that the difference between grooves and interior openings
was material to the working of the claimed device. The
two witnesses on which Spinal Kinetics relies for its
written-description challenge are its expert, Dr. Lee, and
its Research and Development Manager, Mr. Koske.
Neither they, nor the documents on which they relied,
showed (by clear and convincing evidence) how the way in
which “openings” differ from “grooves” makes any materi-
al difference to the working of the claimed device.
Dr. Lee’s key testimony was his statement that “the
stress or strain on the fibers” is affected by whether the
fibers pass through the plate near the center or near the
perimeter. See J.A. 20853 (Tr. 2456:11-2458:11). But,
decisively, the distance from the center (or perimeter) is
not the respect in which “openings” differ from “grooves.”
Whether the space at the perimeter remains open (as with
grooves) or closed (as with openings) plays no role in
determining how far from (or near to) the center the fibers
pass through the plate: if a groove extends deep toward
the center, the fibers will pass through the plate there,
SYNTHES USA, LLC v. SPINAL KINETICS, INC. 7
just as they will if openings are placed at that location.
Dr. Lee’s testimony, not addressing the difference be-
tween openings and grooves, is irrelevant to the analysis.
Nothing else Dr. Lee said makes up for the irrele-
vance of the foregoing testimony. He testified that he
could not find the word “openings” in the specification, see
Joint App. 20852 (Tr. 2453:1-13), but that is itself of no
importance: the written-description requirement is about
support in substance, not about labels. Kao Corp. v.
Unilever U.S., Inc., 441 F.3d 963, 967–68 (Fed. Cir. 2006).
Dr. Lee also stated that there was a “significant difference
. . . in biomechanical properties” between the broader
claim term and the narrower disclosure. See Joint App.
20853 (Tr. 2456:11-2458:11). But without the eventual
identification of what difference in properties he meant,
that sentence is entirely a conclusory opinion, which is
insufficient to meet a burden of proving facts by clear and
convincing evidence. See, e.g., Active Video Networks, Inc.
v. Verizon Comm’ns, Inc., 694 F.3d 1312, 1327, 1330-31
(Fed. Cir. 2012); Krippelz v. Ford Motor Co., 667 F.3d
1261, 1269 (Fed. Cir. 2012); Ashland Oil, Inc. v. Delta
Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir.
1985). It was only the distance-from-center testimony
discussed just above that gave any concrete factual con-
tent to the otherwise-conclusory assertion, but that basis,
as shown, is irrelevant to the required analysis.
Mr. Koske likewise did not present the required proof,
either through his testimony or through the exhibits
about which he testified. That evidence established that,
at one point, Spinal Kinetics had one or more prototypes
with grooves (and many other features) and that it even-
tually settled on a design that had interior openings (and
many other features). But nowhere did Mr. Koske testify,
and nowhere do the exhibits show, that the earlier proto-
types were rejected because they had grooves as opposed
to interior openings or that the Spinal Kinetics product-
development process focused on that difference. See J.A.
8 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
20757–78 (Tr. 2076:21–2081:13). The evidence identifies
“technical hurdles” involving whether to use fibers or
adhesive to anchor the fiber system to the cover plates, see
J.A. 20736 (Tr. 1991:15-1993:3), and concerns about what
shape the interior openings should be to preserve disc
strength, J.A. 20737 (Tr. 1996:10-1997:12), but none of
the evidence addresses the differences between grooves
and interior openings in relation to those or any other
issues. In none of the testimony of Mr. Koske or the
documents cited by Spinal Kinetics, Brief for Appellee at
51-52, or the evidence cited by the majority opinion (at 15-
16) is there any indication about how much if any experi-
mentation or study Spinal Kinetics did to choose between
interior openings and grooves or about any material
challenges encountered when considering use of interior
openings versus grooves (there can be a plurality of ei-
ther, and each can cause the fiber location to be almost
anywhere in the plate). In my view, this is not clear and
convincing evidence.
Spinal Kinetics thus failed to establish the im-
portance of the openings/grooves difference. And that
conclusion is reinforced indirectly by the patent itself—
specifically, by the fact that the written description is not
actually limited to using grooves for the fibers. The
majority states that the specification “discloses a series of
examples of how the fiber system may be anchored on the
cover plates” and that “[a]ll of these examples employ
‘grooves,’ not slots or openings on the plates.” Maj. Op. at
13. But the specification, while reciting grooves in some
of the examples it gives for how “anchoring of the fibres
on the cover plates can be carried out,” includes other
examples that are described without any mention of
grooves at all. ’270 patent at col. 3, lines 22-62. One
separately stated example simply calls for “adhering the
fibre system on the cover plates,” while another calls for
join the plates “in a form-locking manner.” Id. at lines 35
SYNTHES USA, LLC v. SPINAL KINETICS, INC. 9
& 42-44. Thus, grooves are not part of all of the anchor-
ing embodiments disclosed in the ’270 patent.
C
The jury verdict of insufficient written description for
the claim at issue cannot be supported on any other
ground. On appeal, Spinal Kinetics argues that substan-
tial evidence supports finding that two other claim limita-
tions—“substantially rigid bone contacting plate” and
“flexible core”—lack adequate written-description sup-
port. The district court rejected the first contention but
accepted the second. Both contentions are meritless.
Spinal Kinetics did not prove that the specification,
which discloses “closing plates” that “are made from
titanium or a titanium alloy,” ’270 patent, col. 6, lines 4-5,
fails to adequately describe the claimed “substantially
rigid bone contacting plate.” The cover plates, as stated
in the specification, are “anchor[ed to] the fibre system” in
order to ensure “the intervertebral implant remains
stable even under the greatest loads and the fibre system
is capable to withstand even considerable tensile forces.”
’270 patent, col. 2, lines 35-37.
Spinal Kinetics argues that the written description is
inadequate because nowhere but the claims does the
specification use the terms “rigid” or “substantially rigid.”
But the “disclosure as originally filed does not . . . have to
provide in haec verba support for the claimed subject
matter at issue,” Cordis Corp. v. Medtronic AVE, Inc., 339
F.3d 1352, 1364 (Fed. Cir. 2003), and Spinal Kinetics
failed to present any evidence, much less clear and con-
vincing evidence, either (1) that the titanium closing
plates described by the specification and depicted in
Figures 3 and 4 were not “substantially rigid” or (2) that a
skilled artisan, reading the description of the properties
and functions of the closing plates (i.e., titanium closing
plates used to stabilize the intervertebral implant), would
not reliably predict that “substantially rigid” closing
10 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
plates achieve the desired properties of the claimed de-
vice. See In re Smythe, 480 F.2d 1376, 1383 (CCPA 1973)
(“[T]he specification clearly conveys to one skilled in the
art that in this invention the characteristics of a fluid are
what make the segmentizing medium work in this inven-
tion.”).
For the “flexible core” limitation, Spinal Kinetics rests
its challenge on the claim term’s purported incompatibil-
ity with the disclosure of “an elastically deformable
formed body . . . with an incompressible core, preferably a
liquid core.” ’270 patent, col. 5, lines 15-17. This argu-
ment, though the district court accepted it, is plainly
incorrect. An “incompressible core” is in no way irrecon-
cilable with a “flexible core.” Incompressible and flexible
simply do not conflict: a squeezed balloon that readily
deforms while maintaining a constant volume is simulta-
neously flexible and incompressible. Thus, the jury could
not have reasonably concluded that, because the patent
specifically discloses an “incompressible core,” the inven-
tion could not also include a “flexible” core.
Accordingly, I conclude that there has been no clear
and convincing evidence that the written description
inadequately describes the claimed inventions. I would
reverse the district court’s denial of judgment as a matter
of law that Spinal Kinetics failed to prove invalidity.
II
As to the judgment of noninfringement, I conclude
that it relies on an incorrect construction of the claim
term “fiber system.” The error could well have been the
basis for the jury verdict, which therefore must be vacat-
ed. The case should be remanded for further proceedings
on whether the accused products infringe under the
proper claim construction.
The district court construed “fiber system” as “a col-
lection of fiber strands joined to the third and fourth
SYNTHES USA, LLC v. SPINAL KINETICS, INC. 11
plates and capable of absorbing tensile forces and con-
straining radial expansion of the flexible core.” Synthes
USA, LLC v. Spinal Kinetics, Inc., No. C-09-01201, 2010
WL 2573379, at *7 (N.D. Cal. June 23, 2010). That im-
portation of functional requirements is incorrect, because
the term “fiber system” is entirely a structural one.
“Where a claim uses clear structural language, it is gen-
erally improper to interpret it as having functional re-
quirements.” Schwing GmbH v. Putzmeister
Aktiengesellschaft, 305 F.3d 1318, 1324 (Fed. Cir. 2002);
accord Toro Co. v. White Consol. Indus., Inc., 266 F.3d
1367, 1371 (Fed. Cir. 2001) (“An invention claimed in
purely structural terms generally resists functional
limitation.”). Spinal Kinetics offers no convincing reason
to deviate from the general rule in this case.
Spinal Kinetics notes (correctly) that the specification
ascribes functions to the “fiber system,” including to
constrain the radial expansion of the core that it sur-
rounds, see, e.g., ’270 patent, col. 1, lines 26-34, but that is
not a reason to add those functions to the simple, clear
“fiber system” of the claim. Where the claim’s structural
definition of a term leaves ambiguities, such as an un-
addressed question of degree, this court has said that “it
is ‘entirely proper to consider the functions of an inven-
tion in seeking to determine the meaning of particular
claim language.’” ICU Med., Inc. v. Alaris Med. Sys., Inc.,
558 F.3d 1368, 1375 (Fed. Cir. 2009) (quoting Medrad,
Inc. v. MRI Devices Corp., 401 F.3d 1313, 1319 (Fed. Cir.
2005)). No such ambiguity exists here. Claim 29 requires
that the “fiber system” (1) “at least partially surround[]
the core,” (2) “is at least partially received within the
plurality of openings formed in the third and fourth plates
so that the fiber system is joined to the third and fourth
plates,” and (3) is “at least partially surround[ed]” by “an
elastic sheathing body.” ’270 patent, col. 8, lines 41-47.
Spinal Kinetics points to no open questions for which the
claim itself “does not suggest” an answer. See ICU Med.,
12 SYNTHES USA, LLC v. SPINAL KINETICS, INC.
558 F.3d at 1375-76. The term “a fiber system” is a
straightforward structural limitation that needs no fur-
ther construction, much less the addition of functional
qualifiers. See O2 Micro Int’l Ltd. v. Beyond Innovation
Tech. Co., Ltd., 521 F.3d 1351, 1362 (Fed. Cir. 2008).
Because the jury was given a flawed claim construc-
tion, and there was no separate jury finding of nonin-
fringement on another ground and the jury could easily
have found the “fiber system” element satisfied under the
correct construction, the verdict of noninfringement must
be vacated. See August Tech. Corp. v. Camtek, Ltd., 655
F.3d 1278, 1286 (Fed. Cir. 2011). At the same time,
Synthes has not shown that it is entitled to judgment of
infringement, i.e., that no jury could now reasonably find
noninfringement, considering all of the claim limitations
at issue, under proper instructions.
Therefore, the judgment of noninfringement should be
vacated and the case remanded to the district court. I
would not further constrain the district court’s discretion
about how to proceed on remand, including what might be
decided on new summary judgment motions and whether
to reconsider any evidentiary rulings that might be seen
in a different light in any new trial. And, regarding the
cross-appeal filed by Spinal Kinetics to challenge the
district court’s denial of its motion for attorney’s fees, it
suffices to say that my view of Synthes’s appeal would
mean that Spinal Kinetics would no longer meet even the
threshold condition of being a prevailing party.