*1 AFFIRMED reference products. nasal With aqueous to art, is prior this there no evidence to party its own costs. Each shall bear of person that a support the conclusion ordinary expect a combination skill would alcohol, acid, benzyl phenylethyl
of citric a
alcohol, 80 to contain polysorbate
buffer, and sur- pH adjuster, preservative,
factant, or ex- absorption but enhancer no promote bioavailability. to
cipient Thus, acid” the “about 20.0 mM citric SCIENTIFIC, INC., STAR supports the district limitation alone Plaintiff-Appellant, summary non- grant judgment of court’s of absorption used as an obviousness. When v. was patent, the '116 citric acid enhancer COMPA- R.J. REYNOLDS TOBACCO KSR, fifty options. one of over See (A Corporation) NY North Carolina Further, 1727. 127 S.Ct. U.S. Company and R.J. Tobacco acid at about when the art used citric (A Jersey Corporation), New Defen- mM, patent, used as in the '315 it was dants-Appellees. genuine a There only as buffer. is no of fact that a of dispute material No. 2010-1183. liquid to attempting make a Appеals, States of United Court calcitonin composition to deliver salmon Circuit. Federal body through a adminis- into human nasal tration, using not have would considered Aug. narrowly 20 mM acid with about citric alcohol, benzyl phenyl- of claimed amounts alcohol, 80, because
ethyl polysorbate expected
the formulation would
perform properly specificity to meet the Thus, accept- pharmaceutical use. even
ing design there was need pressure develop pharmaceuti-
market bioequivalent
cal formulation that
Miacalcin®, no in the there is evidence
record claim 19 would be an obvious
solution to motivations. those
V. dis-
Accordingly, this court affirms the grant summary judgment
trict court’s Unigene, in favor of af-
nonobviousness court’s of sum-
firms the district denial obviousness, judgment
mary affirms crime- Apotex’s
district court’s denial motion, district
fraud and affirms the Apotex’s
court’s dismissal of new claims
and defenses. *3 infringement
Star’s JMOL of and the deni- al of Star’s motion for a new trial but reverses the district court’s denial of Star’s validity. JMOL I.
Star
is the exclusive licensee of the
patents,
which claim tobacco cur-
ing
Curing
methods.
dries
shipment
compa-
leaves before
to tobacco
*4
nies.
art curing
One
method—“air
curing” places tobacco
leaves
a barn to
—
dry
any
without
added heat.
In the Unit-
Austin, LLP,
Phillips, Sidley
Carter G.
States,
ed
curing
generally performed
is
DC,
Washington,
argued
plaintiff-
of
for
curing
heated
through
barns
a method
appellant. With him on the brief were
curing,”
called “flue
which
gas
uses diesel
Shumsky,
Eric A.
Michael D. Hatcher and
propane gas
or
heaters.
Quin M.
on
Sorenson. Of counsel
the brief
McMillan, Jr.,
Sup-
were Richard
Mark M.
1970s,
Until the
curing
most
occurred in
Ahdoot,
Jeffrey
ko and
D.
of Crowell & indirect-fired barns that heated and dried
LLP,
Moring,
Washington,
DC.
the tobacco in an
separated
environment
Brinks, Hoefer,
Addy,
Meredith Martin
gases
by
from the exhaust
released
Lione,
IL,
Chicago,
argued
Gilson &
for
1970s,
heaters.
In the
in an effort to save
defendants-appellees. On the brief were money, tobacco farmers switched to direct-
Gabric,
A. Kaplan, Ralph
Cyn-
Richard
J.
barns,
fired
which mixed the combustion
Homan,
thia A.
Phillip
Danielle Anne
and
exhaust with the curing tobacco. The
Julie L. Leichtman. Of Counsel was K.
gases
combustion
(including carbon mo-
Mrksich.
Shannon
noxide,
dioxide,
carbon
and water vapor)
anaerobic,
can
oxygen-free,
create an
RADER,
LINN,
Judge,
Before
Chief
environment. This anaerobic environment
DYK,
Judges.
Circuit
in direct-fired barns can lead to the forma-
family
compounds
tion of a
of chemical
Opinion
by
for the court filed Chief
tobacco-specific
called
nitrosamines
Judge
Opinion concurring-in-
RADER.
(“TSNAs”)
curing
tobacco leaves. To-
part
dissenting-in-part
by
filed
Circuit
TSNAs,
acquire
bacco can
four
Judge DYK.
varieties of
NNN, NNK,
known
the abbreviations
RADER,
Judge,
Chief
NAB, and NAT.
(“Star”)
Scientific,
Appellant Star
Inc.
These TSNAs arise
anaerobic
because
appeals
judg-
the denial of its motion for
conditions stimulate microbes on tobacco
(“JMOL”)
ment as a matter of law
and in
plants
produce
enzyme,
nitrate re-
jury
the alternative a
trial after a
new
ductase, which converts nitrate to nitrite
invalidity
verdict of non-infringement and
and nitric oxide. Nitric oxide reacts with
(“'649
6,202,649
U.S. Patent Nos.
рrecursor
tobacco alkaloids
to form
ent”)
(“'401
(collec-
6,425,401
patent”)
TSNAs.
tively,
patents”).
“Williams
Star Scienti-
Because some TSNAs are known carcin-
fic,
Inc. v. R.J.
No.
Tobacco
(D.Md.
8:01-cv-1504,
ogens, tobacco companies
long sought
Dkt. No. 1146
Dec.
have
2009).
This court affirms the denial of
methods that minimize or eliminate
However,
Id. col.6 11.35-41.
the Williams
plants.
on cured tobacco
TSNA formation
that “one of
patents
cur-
elaborate
claim a tobacco
The Williams
curing would
in the art of tobacco
“substantially prevent[s]”
that
ing method
parameters of
during
the outer
of at least one TSNA
understand
the formation
invention,
in its broadest
employee
present
Jonnie
curing. Star
(“Williams”)
forms,
a certain extent
the named inventor.
are variable to
is
precise
on the
confluence
depending
patent appli-
provisional
first filed a
Star
any given
numerous
factors]
[these
Sep-
Septembеr
1998. On
cation on
Id. col.6 11.51-55.
harvest.”
15, 1999,
non-provision-
filed a
tember
Star
March
which issued on
application,
patents posit
al
the Williams
general,
In
application
patent.
as the '649
sustaining
an aerobic environment
a continuation
leading
patent
to the '401
during
prevent
will
TSNA
into the
that matured
application
of the
Id. col.7 11.53-55.
purposes
For
formation.
pro-
In
patent.
the time between
agreed that
infringement,
parties
non-provisional
and the
application
visional
4 and 12
elements of claims
the combined
developed the “Star-
application, Williams
representative.
were
*5
the commercial embodi-
process,
Cure”
Those claims recite:
J.A. at 46387-90.
parties agree
invention. The
ment of the
substantially prevent-
process
4. A
the best mode of
process
the StarCure
is
ing the formation of
at least one nitrosa-
claimed invention.
practicing the
plant,
in a harvested tobacco
mine
comprising:
process
with air cur-
patents
The Williams
work
flue
ing and both indirect and direct
plant,
drying
portion
at least a
11.53-66;
patent
methods.
col.2
eol.3
uncured, yellow,
portion
while said
is
method creates a “con-
11.1-24. Williams’
susceptible
having
in
to
and
a state
that controls “at least
trolled environment”
arrested,
in
formation
nitrosamines
humidity,
temperature
rate of
ex-
one of
environment and for
controlled
time
airflow,
temperature,
CO
change,
[carbon
substantially prevent
sufficient
to
level,
level,
[carbon dioxide]
monoxide]
of said at least one nitrosa-
formation
C02
level,
arrangement of the
[oxygen]
and
mine;
02
Id. at Abstract.
The
plant.”
tobacco
controlled
environment
wherein
said
“controlling the
patents define
Williams
air free of combustion exhaust
comprises
“determining
selecting
as
conditions”
to sub-
gases and an airflow sufficient
humidity,
tempera-
rate of
appropriate
an
stantially
condition
prevent
anaerobic
airflow,
exchange,
temperature,
CO
ture
vicinity
plant portion;
around the
of said
level,
level,
level,
arrangement
C02
prevent
of the tobacco leaves to
or reduce
environment
is
wherein said controlled
the formation of at least one TSNA.”
controlling
least one
provided by
at
11.65-68,
col.5
col.611.1-4. The Williams
humidity, temperature, and airflow.
tobacco
practice
ents teach that “the
(emphasis add-
patent
col.20 11.18-33
science,
art
curing is more of an
than
ed).
any given
during
because
conditions
4,
according to claim
process
12. The
adjusted
into ac-
cure must be
to take
the treatment
time is
wherein
from
Id. col.6
11.35-37.
many
count”
variables.
up
about 2 weeks.
about
hours
í8
in
Those variables
include “differences
added).
Id. col.2011.50-51
(emphasis
posi-
leaves harvested from various stalk
2001,
through
Star had
tions,
From 1998
among curing barns
difference
agreements with Brown & Williamson
they are used” and more.
terms of where
Co.,
using
8:01-cv-1504,
cure low-TSNA tobacco
Williams’ olds Tobacco
No.
Dkt.
712,
46,
No.
slip op.
method. Star made millions of
at
On shadowy one slide showed argument; 4,000 jury trial with 24 witnesses and over labeled figure holding piece paper this court’s transcript. Despite pages (“Burton his back “Burton Letter” behind I decision in Star that the Williams slide”): inequitable not unenforceable for were *7 (3) alleged public and an use at top”); at 43788.
J.A. farm, a tobacco farm un- Hassel Brown’s Dr. primary invalidity expert, RJR’s with RJR. der contract (“Dr. Otten”), opined that Lambert Otten light obvious in patents the Williams were that the argued RJR also Williams by of combination of a review article by the Dr. Supported were indefinite. ents al., Air- Anna Wiеrnik et titled “Effect of testimony, argued RJR that one Otten’s Curing Composition on the of Chemical in art would not understand a skilled the (“Wiernik”) reviewing Japanese Tobacco” and Patent environment” after “controlled 51-144535, Curing patents. Accordingly, titled “Method for RJR No. the Williams Leaves,” patents the were indefi- argued Domestic Tobacco with the Williams (“Toh- skill would Hideyuki inventor Tohno nite because one named no”). be- that unable to determine the difference Dr. Otten further testified and the processes” “conventional prior anticipate art references the tween three (1) by the method; required “controlled environment” patents: the Peele Williams (2) to several pointed RJR Spindletop patents. at the Williams alleged public use where values patents of the Facility by (“Spindle- parts Williams Research used RJR case, humidity argument in- After oral this for the the temperature Office, values overlap аssigned parte an ex light vention Patent reex- processes.” Star, “conventional request by amination confirmed that patents claims of the the Williams deserve infringement expert was primary Star’s priority provisional applica- the date Lee”). (“Dr. Dr. Lee Dr. Lee’s Richard tion, September 1998. namely The oxygen testimony focused on levels 4, 12, Patent found that claims Office also resulting curing barns and RJR’s and 20 of and claim 41 patent, the '649 levels, low TSNA show- tobacco had cured Tohno, patent, the '401 obvious over were ing anaerobic conditions that lead that the Wiernik, other “substantially prevent- had been and several references as- TSNA by ed.” at 45775-77. serted RJR. Because of earlier date, filing effective the Patent Office did verdict, special A based on June not consider the Peele reference as priority date as- September art. I, signed the court in Star found RJR’s non-infringing to be and the curing process II. anticipated, invalid as ob- patents mode, vious, best failing to disclose Priority A. Date J.A. at 30-33. The district indefinite. This reviews the court first district denied Star’s motion for JMOL. court later summary judgment ruling court’s that the Star, 1-12. 1146 at The district Dkt. No. asserted the Williams claims of are upheld and order court’s memorandum provisional application not entitled to the Peele
jury’s that the method did verdict Star, priority date. Dkt. No. 703 at 1-12. patents. at 4. infringe not the Williams Id. This court both the district reviews court’s further that the court noted district summary grant judgment determi- jury likely certainly did and “most should priority nation of date without deference. expert testimony. Dr. Lee’s rejected have” Carp. Research Techs. Inc. v. Microsoft that, court The district elaborated at 5. Corp., 627 F.3d testimony Dr. Lee’s was not moot- even if verdict, ed the district court would by the provisional ap Claims deserve grant non-infringement and ex- JMOL as filing long date so plication’s earlier testimony as meeting Dr. Lee’s clude written application adequate contains de Id. In Daubert standard. addition § scription Trading under 35 U.S.C. infringement, finding no direct the court Inc., 595 eSpeed Techs. Intl. Inc. v. F.3d also motion for denied Star’s JMOL 1340,1350 (Fed.Cir.2010). Consistent with *8 Further, infringement. court indirect ¶ 1, descrip § 35 U.S.C. 112 the written appeal evidentiary rulings denied Star’s application tion of provisional must juror. a Id. The excusing at 5-7. ordinary one skill in the art enable motion court denied Star’s for JMOL claimed in the practice the invention non- jury’s findings of indefinite- reverse the New provisional application. Railhead mode, ness, disclose best antici- failure to Mfg., Mfg. 298 F.3d L.L.C. v. Vermeer pation, on the basis that and obviousness 1290,1294 (Fed.Cir.2002). jury ample “the had evidence on which to case, In this the asserted claims proven, by find had clear and that RJR 15, September priority 1998 deserve the evidence, that the convincing Patents-in- application. The provisional date ap- Id. at This Suit were invalid.” 7-8. provisional application’s descrip written court has peal jurisdiction This followed. 1295(a)(1). air minimum flow § tion discloses that the under 28 U.S.C. 1372 28,000
“may be about at 1” static This court CFM reviews a district barn,” pressure typical curing in a but court’s decision to exclude evidence under may vary the “minimum flow of air ac- the law of the regional Valley circuit. Del. cording may to conditions and deter- Nets, LLC, Grp., Floral Inc. v. Shaw Rose a mined on routine basis.” at 62198 (Fed.Cir.2010). 1374, 597 F.3d 1379 The added). (emphasis provi- Claim 3 of the Fourth Circuit reviews a district court’s application sional further clarifies decision to admit or exclude evidence for claimed invention covers a “flow ... suffi- an abuse of Buckley discretion. v. Muka prevent cient to an anaerobic condition” (4th Cir.2008). 306, sey, 538 F.3d around the tobacco. J.A. 62205. an evidentiary Even if ruling constitutes provisional Because the application teaches discretion, оnly abuse of it is reversible ordinary one of skill that a minimum air party’s when it affects a rights. substantive “may vary,” flow one of would know that the in a curing conditions The district court not did commit revers- 25,000 barn could an air demand flow of ible error in evidentiary its rulings. Be- CFM. The district court’s spe- reliance on inequitable cause conduct was at issue cifically disclosed air flow improperly rates trial, in the presenta- this court finds the scope provisional narrowed the ap- tion of the troubling. Burton slide The plication based on an example added in the slide, Burton showing shadowy figure non-provisional later-filed application that conspicuously holding piece paper be- a process discloses using an “air back, hind his does not support any claim 25,000 approximately flow of CFM.” In- issue this case. a practical As mat- deed, the Patent Office’s recent reexami- ter, however, Star did not pres- show the 15, nation September confirms that 1998 is entation of the Burton slide affected its proper priority date. rights. substantive Accordingly, this court September priority date detects no abuse of discretion in the trial significant has several implications on this evidentiary court’s decisions. First, appeal. reference, the Peele with an 26, 1999, effective filing April date of is not III. Second, art. because the StarCure This court reviews the denial of process developed by was Williams after JMOL without deference under the same September failure to disclose this applied by standard the trial court. Lu process cannot constitute a failure to dis- Techs., cent Inc. v. Gateway, 580 F.3d close the best mode of in- practicing the The Fourth Star, vention. Dkt. No. 703 at 11.
Circuit reviews a motion for JMOL with Evidentiary Objections B. out light deference most favorable to nonmoving Hand, party. A Helping Star contends that the trial court com- Cnty., LLC v. Baltimore mitted numerous evidentiary reversible er- (4th Cir.2008). “Judgment as a matter of rors. Star seeks reversal and remand for proper law is only if can ‘there be but one new trial based on the court’s exclusion *9 ” data, reasonable conclusion as to proffered the verdict.’ failure to exclude the slide, Prods., Inc., above, Burton Ocheltree v. Scollon reproduced failure to 335 F.3d (4th Cir.2003) (en 325, banc). arguments exclude by made 331 RJR about A denial failure to produce the Burton of a motion letter to the for a new trial is reviewed for Office, Patent and other arguments an abuse of made discretion. Verizon Servs. during RJR trial. Va., Inc., Corp. v. Cox Fibemet 602 F.3d
1373 This court reverses the dis- (Fed.Cir.2010) quirement. Fourth 1325, (applying 1331 law). pat- in the that the granted finding is trict court’s A new trial Circuit there is conduct only when the Fourth Circuit invalid for failure to disclose ents are the trial rendered as to have grievous “so inven- practicing the claimed best mode оf unfair.” Id. tion. court’s the district reverses This court B. Indefiniteness on issues for JMOL motion
denial Star’s validity of the Williams involving the legal purely is a Indefiniteness the district affirms This court ents. reviews without defer issue that this court for JMOL motion court’s denial of Star’s Serv., v. Bancorp LLC ence. Hartford This court infringement. regard to (Fed.Cir. Co., 1367,1372 Ins. 359 F.3d Life indefiniteness, mode, obvi- best evaluates 2004). only finds claims “not This court ousness, infringement anticipation, “insolubly to construction” or amenable turn. Datamize, indefinite. ambiguous” be Software, 417 F.3d LLC v. Plumtree A. Best Mode (Fed.Cir.2005) (citations 1342, omit 1347 con requirement mode The best ted). Thus, can in a construed claim First, the court must tains two elements. if construction remains insolu definite the possessed inventor whether the determine meaning provide it fails to bly ambiguous, in the claimed practicing a best mode of the bounds of the clarity sufficient about filing time of at the vention I, art. 537 claim to one skilled Star Enter., v. Edge LLC application. Green (citations omitted). at 1371 Absolute F.3d 1287, Etc., LLC, F.3d Mulch 620 Rubber claim clarity required is not to find a term step This is sub first 1296 that a claim This court has held definite. pref on the inventor’s jective and focuses discerning may be definite even when term practicing for a best mode erence meaning [task] is a “formidable application’s at the time of the invention which rea may the conclusion be one over Ltd. v. (citing N. Telecom filing date. Id. disagree.” Source persons sonable will Co., 1281, 1286 Samsung Elecs. 215 F.3d LLC, Tech., LendingTree, LLC v. Search (Fed.Cir.2000)). step is an The second (Fed.Cir.2009) 1063, (citing F.3d 1076 whether the objective inquiry to determine Eng’g Co. v. United Exxon Research & the best public concealed from the inventor (Fed.Cir.2001)). States, 1371,1375 265 F.3d (cit the invention. practicing mode of Carp., Indus. Carp. v. Arco ing Chemcast construed the claim The district court (Fed.Cir.1990)). 923, to mean “controlled environment” term humidity, more of “controlling one or had that Williams RJR concedes airflow in the temperaturе mode as of yet contemplated best barn, from conven- in a manner different Br. at 26. Appellee September substantially pre- curing, tional order above, September As discussed Star Sci- vent the formation of TSNAs.” for the asserted proper priority date v. Tobacco entific, Inc. R.J. Therefore, patents. claims of Williams 8:01-cv01504, slip op. at Dkt. No. No. shows no filing, at the time of the record 2004). (D.Md. parties do March evidence mode violation. Without best ordinarily skilled arti- that an not contest of a best possession had that Williams of the term “con- meaning san knows invention the claimed practicing mode of environment,” they dispute but trolled cannot the record filing, at the time of would whether a best mode re- invalidity under the support *10 know how to establish a controlled envi tobacco manufacture. The manner of perform ronment to the claimed method. Virginia which tobacco grown, hаr Here, requires showing indefiniteness vested, and processed is well known. person ordinary that a skill would find Moreover, patent '134 col.4 11.3-8. the rec insolubly “controlled environment” to be curing ord demonstrates that tobacco vari ambiguous. ables are well known in the tobacco indus context, perspective, try. this record In that the term “controlled
From present does not grounds reasonable environment” falls well within the' bounds showing that “controlled environment” is ordinary Thus, in skill the art. this jury’s indefinite. The verdict assumes insolubly term is not ambiguous and is not person that a of skill in the art would not indefinite.
recognize a “controlled environment” be
C. Obviousness
cause the Williams
do
give
exact
measuring humidity,
numbers
temp
103(a),
§
Under 35
a pat
U.S.C.
erature, and airflow in a
cur
conventional
ent is invalid “if the differences between
However,
ing barn.
repeatedly
record
subject matter
...
[claimed]
and the
person
shows that a
of skill in the art of prior art
subject
are such that the
matter
tobacco curing
possess
would
un
adequate
aas whole would
been
have
obvious at the
derstanding to manipulate these variables
time the invention was made
person
to a
to create a controlled environment.
In
having ordinary
in
the art to which
deed,
curing
because conventional
varies
subject
said
pertains.”
matter
Obvious
depending
cure,
on the conditions for each
ness is a determination of law based on
specific numerical values are not needed
underlying determinations of fact.
M.
Geo
for one
in
skilled
the art
to implement
Int’l,
Martin
Sys.
Co. v. Alliance Mach.
conventional curing. As described in the
These
patent:
factual determinations
scope
include the
practice of
curing
[T]he
tobacco
is more
art,
prior
content of the
the level of
science,
of an art than a
because
art,
ordinary skill in the
the differences
during any
conditions
given cure must
between the claimed
pri-
invention and the
adjusted
be
to take into account such
art,
secondary
considerations of
differences,
factors as varietal
differ
nonobviousness.
Teleflex,
KSR Int’l Co. v.
ences
leaves harvested from various
398, 406,
550 U.S.
127 S.Ct.
positions,
stalk
among
differences
(2007)
L.Ed.2d 705
(citing Graham v. John
used,
they
barns
terms of where
are
1, 17-18,
Deere
383 U.S.
86 S.Ct.
and environmental variations.
(1966)).
Wiernik by stan- in tobacco cured observed conducted over a summarizes studies *12 curing techniques. gen- dard bulk Tohno the drawback smoking property.” of J.A. erally by attributes the bad odor caused 60771-72. Wiernik also fails to teach the other techniques to abundance of “un- gases need eliminate combustion necessary gases” and claims a method to therefore lacks any disclosure for “air free “unnecessary exclude those gases” “pro- gases.” Instead, of combustion exhaust enzyme the of mote] activation the con- Wiernik concludes “the intricate and com- leaves, tained in the tobacco achieving thus plex of [curing] fully mechanisms are not a curing.” short-term J.A. 60771-72. understood[,] deeper insight [a] into these Tohno does not mention and does TSNAs reactions would an optimization enable of provide oxygen a link the between curing procedure.” J.A. 64565. (inherent flow) increasing levels air Moreover, the record many contains sec- precursor or alkaloids the activa- ondary support considerations that nonоb- tion or inhibition of nitrate reductase— viousness. The record a shows substantial targets both critical of the Williams need in industry curing for methods ents. that minimized or eliminated formation general Wiernik’s teachings produce also of TSNAs. The record also nu- contains little to render the Williams obvi- merous scientific counseling articles ous. speculates that microorgan- Wiernik eliminating minimizing or carcinogens in by isms are influenced environmental fac- tobacco has a long-felt industry been need. during tors the end of yellowing or the end, To that the record showed decades of beginning browning of the stage curing attempts reducing unsuccessful at TSNA potentially facilitate the production of by levels to the extent achieved TSNAs. speculative Wiernik’s and tenta- (tes- patents. Williams See J.A. 45521-23 tive disclosure of “might” “may” what timony that RJR had “Nitrosamine task- lead to nitrite production and TSNA does from force” around 1990 until about 1995 not sufficiently direct or instruct one of with a mission to “understand nitrosa- skill in this art. See Abbott Labs. v. Andrx apply mines and that understanding Pharm., (Fed. competitive advantage”). The record also Cir.2006) (stating that a unexpected evinced long results that met a skill possesses the “understandings and industry trial, felt example, need. For at art”). knowledge reflected the prior Williams testified that after presenting his Further, before, as noted the record con- products low-TSNA tobacco at an industry tains no evidence suggesting a motivation “everyone conference wanted to get ac- to combine an article on remedying a foul quainted,” including “all major to- odor in summary tobacco with a of studies companies.” bacco Finally, 45326. as sum, about TSNA formation. In this rec- evidenced Brown & Williamson’s licens- ord shows no clear convincing evi- es, dollars, which cost millions of Williams’ prima dence of a facie case obviousness. invention had achieved considerable mar- Both Wiernik and Tohno fail to teach acceptance ket and commercial success. the claim limitation of with “air free of combustion gases.” '649 patent col.20 Anticipation D. 11.27-28.Tohno nowhere expel- discusses jury ling gases identify verdict did not from the which curing chamber. In- stead, prior art supplied Tohno reference clear and describes method of estab- con- lishing vincing “sufficient anticipate ventilation” to evidence to “supply in order to patents. “shorten the period, J.A. 33. Because Dr. Otten tes- 02” prevent action, a fast curing and eliminate tified that pieces prior three art antici- day, the sixth the end patents, “[o]n this court con-
pated Williams
after
art
references:
those
yellowing,
siders
the tobacco was removed from
alleged public uses
method and the
Peele
quick-dried[.]”
the bam and
J.A. 44679
and Brown. J.A.
Spindletop
addеd). Spindletop does not
(emphases
*13
prior public
use
qualify
anticipatory
as
102(b), pat
§
a
35 U.S.C.
Under
in Spindletop’s
cured
because
if
claimed invention
may not issue
ent
uncured,
not
controlled environment was
country more than
public
use in this
was
required by
patents.
as
the Williams
critical date.
year
patent’s
before the
one
IP,
See,
Hyundai
v.
Mo
LLC
e.g., Orion
reasonably
by
juryA
could not
find
Am.,
967,
605 F.3d
974
tor
convincing evidence that Brown’s
clear and
above,
Here,
fil
as discussed
the effective
the claim limitation
method
met
15,
Because
September
1998.
ing date
...
“substantially prevent the formation of
method
shows that
the Peele
the record
nitrosamine,”
patent
at
least one
before
year
more than one
was not used
11.24-25,
year
more than a
before the
col.20
date,
does
filing
this reference
the effective
15,
patents’ September
pri-
1998
anticipatory prior art. Be
qualify
not
as
jury
by
ority
could find
dаte. The district court construed
no reasonable
cause
that either
convincing
evidence
“substantially
clear
the formation of ...
prevent
were anti
or Brown farms
Spindletop
at least one nitrosamine” to mean “the
uses, this court reverses
cipatory public
level of at least one of the nitrosamines
motion
district court’s denial
Star’s
than
following ranges:
falls within the
less
on the basis of
anticipation
for
for JMOL
NNN,
for
less
jucg/g
ppm]
[0.05
about 0.05
Peele.
ppm] for NAT
pg/g [0.10
than about 0.10
NAB,
pg/g
0.05
plus
and less than about
102(b)
public
A
use under Section
Be-
ppm] for NNK.” J.A. 13053.
[0.05
in
any public use of the claimed
includes
Mr. Brown had retrofitted
by
other than the inven
cause
2002
vention
restriction,
limitation,
no
tor who is “under
the Peele
his barns
accordance with
secrecy to the inventor.”
obligation
or
method,
TSNA data was
proffered
RJR’s
Spring,
Wrapmaster,
L.P. v.
Clock
collected
pre-retrofit
between
data
divided
(Fed.Cir.2009)
1317,
(quot
1325
post-retrofit
data
in 1996 and 1998
OrthoArm, Inc., 501
ing Adenta GmbH v.
64018. RJR’s
collected in 2002. See J.A.
(Fed.Cir.2007)).
An anti
F.3d
pre-retrofit
the 1996 and 1998
data from
102(b)
§
must
cipatory public use under
any
under
reason-
provide
barns does not
limitations.
Id. at
exhibit all of the claim
convincing
interpretation clear and
able
case,
not
In this
the record does
1325.
limitation was met.
evidence that this claim
at
any
at
that the methods used
point
show
See, e.g., J.A. 60670.
limitation that
Spindletop included the
in a con
placed
crop
“uncured” tobacco was
sample
One
from Brown’s
trolled environment.
See
crop
Brown’s 1998
samples
seventeen
from
col.201.23.
for each of the four
and were tested
TSNAs, resulting
sixty-eight
individual
meth
Dr. Otten testified that the
Thirty-
for 1998.
64009.
readings
J.A.
Spindletop
included transfer
od used
tests came
sixty-eight
four of the
at least five
ring
spent
stalks that had
id.,
reading,
which was
back with
0.00
days
in “air
barns” into the con
being “below the
only explained by RJR as
rapid drying
environment of
trolled
J.A.
detection limit” of
test.
opposi
46551-52.
chamber.
J.A.
RJR’s
returned
The lone 1996 test
clarifies 3438:10-11.
motion for JMOL
tion to Star’s
readings
practical cases” there would be no case of
with “ND” or non-detectable
Indeed,
each TSNA. J.A. 60670.
infringement.
J.A. 36950.
jury
district court remarked that the
“as it
Dr.
testified that
the detection
Otten
have,
certainly
rejected Dr.
most
should
No
ppm.
limit was 0.15
J.A. 46555-56.
opinion altogether.”
Lee’s
In
juror
reasonable
could conclude that a ser-
fact,
that,
court
the district
indicated
had
year
ies of tests from
less than a
Lee,
jury not
discredited Dr.
the court
date,
patents’ priority
to the
let alone
testimony
“would now exclude Dr. Lee’s
as
readings
one test from
“ND”
meeting
the Daubert standard.”
can
convincing
“0.00”
serve as clear and
curing techniques
evidence
Brown’s
*14
Dr.
Otten testified that farmers
anticipate
patents,
the
which re-
Williams
infringe
tobacco for RJR did not
the
quire
ppm
TSNA levels below 0.05
or 0.10
in
patents.
Williams
Included
his testimо-
ppm,
only
where a “0.00” or “ND” result
ny were test results from 200 barns of 57
provides that the concentration of TSNAs
growing
farmers
tobacco used
RJR.
ppm
is below the 0.15
detection threshold.
45779,
jury
J.A.
45868-69. The
heard Dr.
Accordingly,
court
that
this
finds
no rea-
testify
Otten
the farmers had not
juror
sonable
could find the Williams
substantially prevented anaerobic condi-
anticipated.
ents
tions and Dr. Otten showed them that
TSNA levels measured from the farmers’
Infringement
E.
were
barns
above the levels claimed
jury
The
returned a special verdict find-
patents.
Williams
J.A. 46328-29.
ing
infringement
that Star did not show
jury
is entitled to credit or discredit
patents by
preponderance
Williams
testimony
situation,
before it.
In this
of the evidence. The district court denied
expert testimony
where
was needed
es-
and,
Star’s motions for JMOL
in the alter-
tablish
it
infringement, was not unreason-
native, a
trial.
new
jury
able for the
testimony
discredit the
prove infringement,
To
a plaintiff
expert
of Star’s
and find that the
prove
must
presence
every
of each and
Verizon,
infringed.
were not
See
claim
equivalent
element or its
in the ac
(denying
36951. In
advances several
the court’s threat to
Star
?
However,
conditionally limit or
Dr.
for a new trial.
argu
exclude
Lee’s
Star’s
testimony, Star conceded that “for all ments neеd not be addressed because this
infringement
Because this court affirms the district
is liable for direct
under 35
jury
271(g)
§
court’s denial of JMOL on the
verdict of
U.S.C.
are not addressed in this
noninfringement,
arguments
opinion.
Star’s
that RJR
In
validity
moots 265 F.3d
grant of JMOL
court’s
validity.
words,
pertaining to
“if reasonable efforts at claim
any alleged errors
other
any
notes that correction of
in a
This court
construction result
definition
does
changed
would not have
alleged
particularity
error
provide
sufficient
was sub-
in this case because there
result
clarity to inform
artisans of the
skilled
jury
before the
stantial untainted evidence
claim,
insolubly
the claim is
bounds
non-infringement.
support
a verdict
ambiguous and invalid for indefiniteness.”
(“We
Verizon,
may
IV. vent the formation of TSNAs.” See Star Accordingly, this court affirms the dis- Scientific, Inc. v. R.J. Tobacco on nonin- trict court’s denial of JMOL 8:01-cv0154-MJG, slip op. No. at reverses the district fringement and (D.Md. 2004). majority Mar. The con- invalidity. court’s denial of JMOL on person cludes that “a of skill in the art of AFFIRMED-IN-PART AND RE- possess adequate would un- curing tobacco VERSED-IN-PART derstanding manipulate these variables its costs. party Each shall bear own to create a controlled environment” be- curing cause “tobacco variables are well DYK, Judge, concurring-in-part Circuit industry.” Maj. op. known to the tobacco dissenting-in-part. and at 1374. majority I with Although agree with the majority patents The characterizes the I would find the respect infringement, “explaining] as that ‘the controlled condi- indefiniteness, invalid for patents-at-issue according tions herein [are] described majori- respectfully and dissent from the commonly conventional methods and com- ty’s contrary holding. Because I would ” mercially in at used the U.S.’ indefiniteness, patents hold the invalid for 11.16-18). (quoting patent, col.6 But '649 unnecessary any I find it to reach patents that is the of what the opposite invalidity challenges. other actually patents state. The state: requires The Patent Act that claims disclosure, In that this has distinctly and “particularly point[ out ] “conventionally cured” is tobacco been subject appli- the matter which the claim[ ] flue-cured, that has been air-cured or regards cant as his invention.” U.S.C. without the controlled conditions de- § A sim- claim term is not indefinite herein, according to conventional scribed poses because “it a difficult issue of ply commonly commercially methods construction”; rather, the claims are claim in used the U.S. “only if indefinite reasonable efforts 11.14-18; patent, patent, '649 col.6 '401 prove claim construction futile.” Exxon States, Thus, equating far from the Eng’g Research & Co. v. col.6 11.19-23. United that, in (stating making legal environment” to con- determina- claimed “controlled the make clear curing, patents tions, ventional may rely expert the court testi- curing is conducted that conventional mony understanding patent). to aid in the the controlled conditions de- “without Here, Reynolds’ expert R.J. testified that a added). (emphasis herein.” Id. scribed in art ordinary the would be directly specifications elsewhere unable to draw the line between conven- conclusion, majority’s ex- contradict the curing tional methods and the “controlled the claimed “controlled envi- plaining that required by environment” the claims. J.A. something ronment” is different from Specifically, 46543-45. he noted that one speci- methods. The conventional skill in the art would under- curing pro- fications criticize conventional stand the “controlled environment” limita- ground they on the “do not cesses require humidity, tion to the “control [of] provide (e.g., adequate conditions suitable temperature, way and airflow a that’s flow) oxygen prevent and fail to an an- curing pro- different from [conventional vicinity aerobic condition the of the to- cesses], objective the and the 11.65-67; patent, bacco leaves.” '649 col.7 purpose substantially preventing the patent, Specifically, col.8 11.2—4. the formation of TSNAs.” J.A. 46543. He specifications characterize convention- noted, however, do not al air curing process “subjeсting as provide guidance sufficient for one of skill controlling to air without [tobacco] art ranges temp- to determine the (e.g., the ambient conditions air flow erature, humidity, and airflow “covered barn, through temperature, humidity, controlled environment that are [term] like).” 11.20-24; patent, col.3 *16 also not covered the conventional cur- Indeed, patent, col.3 11.24-28. Further, ing processes.” 46545. patents practice teach that “the of tobac- issue, pressed expert when on the Star’s curing co of an than a is more art sci- provide any could not guidance regarding ence, curing during because conditions the difference between the airflow in a any given adjusted cure must be to take curing process conventional many into account” re- variables. ent, 11.35-37; environment,” '401 patent, quired eol.6 col.6 11.39— in a “controlled not- ing impossible that it would pinpoint be airflow, values for the tempеrature,
To determine whether a claim is invalid humidity required by the claims because indefiniteness, a court must determine continually changing. barn conditions are “whether those skilled in art would J.A. 45680. understand what is claimed when the claim light specification.” is read in Or- sum, In patents describe the claimed thokinetics, Chairs, Safety Inc. v. Travel something “controlled environment” as dif- Inc., 806 F.2d methods, ferent from conventional Expert testimony may helpful in mak- explain but fail to those differences in a Datamize, ing this determination. See way permit that would a skilled artisan to Inc., Software, LLC v. Plumtree 417 F.3d determine the bounds of the To claims. (Fed.Cir.2005) (holding that a confusion, add to the define evidence, may “rely court on extrinsic such air-curing conventional methods as expert testimony,” as to determine wheth- flue-curing “without the controlled con- indefinite) (internal er the claims are quo- required by ditions” the claims. Under omitted); tation marks citation Seattle this court’s for definite- established test Crating Packing, Box Inc. v. Indus. & (Fed.Cir.1984) ness, in- circularity such is insufficient to artisans of the bounds of the form skilled
claims.