Star Scientific, Inc. v. R.J. Reynolds Tobacco Co.

United States Court of Appeals
for the Federal Circuit
__________________________
STAR SCIENTIFIC, INC.,
Plaintiff-Appellant,
v.
R.J. REYNOLDS TOBACCO COMPANY (A NORTH
CAROLINA CORPORATION)
AND R.J. REYNOLDS TOBACCO COMPANY (A
NEW JERSEY CORPORATION),
Defendants-Appellees.
__________________________
2010-1183
__________________________
Appeal from the United States District Court for the
District of Maryland in consolidated case nos. 01-CV-1504
and 02-CV-2504, Senior Judge Marvin J. Garbis.
___________________________
Decided: August 26, 2011
___________________________
CARTER G. PHILLIPS, Sidley Austin, LLP, of Washing-
ton, DC, argued for plaintiff-appellant. With him on the
brief were ERIC A. SHUMSKY, MICHAEL D. HATCHER and
QUIN M. SORENSON. Of counsel on the brief were RICHARD
MCMILLAN, JR., MARK M. SUPKO and JEFFREY D. AHDOOT,
of Crowell & Moring, LLP, of Washington, DC.
STAR SCIENTIFIC v. RJ REYNOLDS 2
MEREDITH MARTIN ADDY, Brinks, Hoefer, Gilson & Li-
one, of Chicago, Illinois, argued for defendants-appellees.
On the brief were RICHARD A. KAPLAN, RALPH J. GABRIC,
CYNTHIA A. HOMAN, DANIELLE ANNE PHILLIP and JULIE L.
LEICHTMAN. Of counsel was K. SHANNON MRKSICH.
__________________________
Before RADER, Chief Judge, LINN, and DYK Circuit
Judges.
Opinion for the court filed by Chief Judge RADER. Opin-
ion concurring-in-part and dissenting-in-part filed by
Circuit Judge DYK.
RADER, Chief Judge,
Appellant Star Scientific, Inc. (“Star”) appeals the de-
nial of its motion for judgment as a matter of law
(“JMOL”) and in the alternative a new trial after a jury
verdict of non-infringement and invalidity of U.S. Patent
Nos. 6,202,649 (“’649 patent”) and 6,425,401 (“’401 pat-
ent”) (collectively, “Williams patents”). Star Scientific,
Inc. v. R.J. Reynolds Tobacco Co., No. 8:01-cv-1504, Dkt.
No. 1146 (D. Md. Dec. 21, 2009). This court affirms the
denial of Star’s JMOL of infringement and the denial of
Star’s motion for a new trial but reverses the district
court’s denial of Star’s JMOL on validity.
I.
Star is the exclusive licensee of the Williams patents,
which claim tobacco curing methods. Curing dries the
tobacco leaves before shipment to tobacco companies. One
prior art curing method—“air curing"—places tobacco
leaves in a barn to dry without any added heat. In the
United States, curing is generally performed in heated
curing barns through a method called “flue curing,” which
uses diesel gas or propane gas heaters.
3 STAR SCIENTIFIC v. RJ REYNOLDS
Until the 1970s, most curing occurred in indirect-fired
barns that heated and dried the tobacco in an environ-
ment separated from the exhaust gases released by the
heaters. In the 1970s, in an effort to save money, tobacco
farmers switched to direct-fired barns, which mixed the
combustion exhaust with the curing tobacco. The com-
bustion gases (including carbon monoxide, carbon dioxide,
and water vapor) can create an anaerobic, or oxygen-free,
environment. This anaerobic environment in direct-fired
barns can lead to the formation of a family of chemical
compounds called tobacco-specific nitrosamines (“TSNAs”)
on curing tobacco leaves. Tobacco can acquire four varie-
ties of TSNAs, known by the abbreviations NNN, NNK,
NAB, and NAT.
These TSNAs arise because anaerobic conditions
stimulate microbes on tobacco plants to produce the
enzyme, nitrate reductase, which converts nitrate to
nitrite and nitric oxide. Nitric oxide reacts with precursor
tobacco alkaloids to form TSNAs.
Because some TSNAs are known carcinogens, tobacco
companies have long sought curing methods that mini-
mize or eliminate TSNA formation on cured tobacco
plants. The Williams patents claim a tobacco curing
method that “substantially prevent[s]” the formation of at
least one TSNA during curing. Star employee Jonnie
Williams (“Williams”) is the named inventor.
Star first filed a provisional patent application on
September 15, 1998. On September 15, 1999, Star filed a
non-provisional application, which issued on March 20,
2001 as the ’649 patent. The application leading to the
’401 patent is a continuation of the application that
matured into the ’649 patent. In the time between the
provisional application and the non-provisional applica-
tion, Williams developed the “StarCure” process, the
commercial embodiment of the invention. The parties
STAR SCIENTIFIC v. RJ REYNOLDS 4
agree the StarCure process is the best mode of practicing
the claimed invention.
The Williams patents work with air curing and both
indirect and direct flue curing methods. ’649 patent col.2
ll.53-66; col.3 ll.1-24. Williams’ method creates a “con-
trolled environment” that controls “at least one of humid-
ity, rate of temperature exchange, temperature, airflow,
CO [carbon monoxide] level, CO2 [carbon dioxide] level, O2
[oxygen] level, and arrangement of the tobacco plant.”
Id. at Abstract. The Williams patents define “controlling
the conditions” as “determining and selecting an appro-
priate humidity, rate of temperature exchange, tempera-
ture, airflow, CO level, CO2 level, O2 level, and
arrangement of the tobacco leaves to prevent or reduce
the formation of at least one TSNA.” Id. col.5 ll.65-68,
col.6 ll.1-4. The Williams patents teach that “the practice
of tobacco curing is more of an art than a science, because
curing conditions during any given cure must be adjusted
to take into account” many variables. Id. col.6 ll.35-37.
Those variables include “differences in leaves harvested
from various stalk positions, difference among curing
barns in terms of where they are used” and more. Id.
col.6 ll.35-41. However, the Williams patents elaborate
that “one of ordinary skill in the art of tobacco curing
would understand that the outer parameters of the pre-
sent invention, in its broadest forms, are variable to a
certain extent depending on the precise confluence of
[these numerous factors] for any given harvest.” Id. col.6
ll.51-55.
In general, the Williams patents posit that sustaining
an aerobic environment during tobacco curing will pre-
vent TSNA formation. Id. col.7 ll.53-55. For purposes of
infringement, the parties agreed that the combined ele-
ments of claims 4 and 12 of the ’649 patent were repre-
sentative. J.A. at 46387-90. Those claims recite:
5 STAR SCIENTIFIC v. RJ REYNOLDS
4. A process of substantially preventing the forma-
tion of at least one nitrosamine in a harvested to-
bacco plant, the process comprising:
drying at least a portion of the plant, while said
portion is uncured, yellow, and in a state suscep-
tible to having the formation of nitrosamines ar-
rested, in a controlled environment and for a time
sufficient to substantially prevent the formation of
said at least one nitrosamine;
wherein said controlled environment comprises
air free of combustion exhaust gases and an air-
flow sufficient to substantially prevent an anaero-
bic condition around the vicinity of said plant
portion; and
wherein said controlled environment is provided
by controlling at least one of humidity, tempera-
ture, and airflow.
’649 patent col.20 ll.18-33 (emphasis added).
12. The process according to claim 4, wherein the
treatment time is from about 48 hours up to about
2 weeks.
Id. col.20 ll.50-51 (emphasis added).
From 1998 through 2001, Star had agreements with
Brown & Williamson to cure low-TSNA tobacco using
Williams’ patented method. Star made millions of dollars
in licensing fees for rights to the Williams patents. How-
ever, defendants-appellees R.J. Reynolds Tobacco Com-
pany (“RJR”) terminated those agreements with Star
upon acquisition of Brown & Williamson.
RJR conducted its own research to develop curing
methods to minimize TSNA formation on cured tobacco.
One RJR researcher, David Peele (“Peele”), filed a patent
STAR SCIENTIFIC v. RJ REYNOLDS 6
application in April of 1999, which issued as U.S. Patent
No. 6,805,134 (“Peele patent” or “’134 patent”) on October
19, 2004.
The Peele patent claims a method of reducing TSNA
formation by using “a heating source that is not a direct-
fire heating source” to “avoid contact with, or exposure to,
tobacco being subjected to flue-curing processing steps
with nitric oxide gases.” ’134 patent col.3 ll.37-47. To
reduce exposure of curing tobacco leaves to nitric oxide
gases, Peele provides a method of retrofitting direct-fire
flue curing barns with heat exchangers to effectively turn
them into indirect-fire flue curing barns (“Peele method”).
By 2000, RJR required every farmer in its chain to retro-
fit their barns in accordance with the Peele method.
On May 23, 2001, Star filed a complaint against RJR,
alleging infringement of the ’649 patent, and subse-
quently filed an amended complaint further alleging
infringement of the ’401 patent. RJR denied infringement
and claimed both patents were unenforceable for inequi-
table conduct, and invalid for anticipation, obviousness,
indefiniteness, and failure to disclose the inventor’s best
mode.
After a bench trial, the district court held the Wil-
liams patents unenforceable for inequitable conduct and
granted summary judgment of invalidity for indefinite-
ness. Star Scientific, Inc. v. R.J. Reynolds Tobacco Co.,
No. 8:01-cv-1504, Dkt. No. 712, slip op. at 46 (D. Md. June
26, 2007) (finding the Williams patents unenforceable for
inequitable conduct based on the nondisclosure of a
document (“Burton letter”)); Star Scientific, Inc. v. R.J.
Reynolds Tobacco Co., No. 8:01-cv-1504, Dkt. No. 711, slip
op. at 12-14 (D. Md. June 22, 2007) (finding the Williams
patents invalid for indefiniteness). Additionally, the
district court granted summary judgment to RJR on the
filing date question. Star Scientific, Inc., v. R.J. Reynolds
7 STAR SCIENTIFIC v. RJ REYNOLDS
Tobacco Co., No. 8:01-cv-1504, Dkt. No. 703, slip op. at 1-
12 (D. Md. Jan. 19, 2007). The district court found new
matter in Star’s non-provisional application and held that
the Williams patents were entitled to the September 15,
1999 non-provisional filing date and not the September
15, 1998 priority date of the provisional application. Id.Because the non-provisional application includes a new
example calling for “air flow of approximately 25,000
CFM,” but the provisional application disclosed a mini-
mum airflow of “at least 28,000 CFM,” id. at 11, the court
found that no reasonable fact finder could find that the
25,000 CFM airflow rate in the non-provisional applica-
tion had been disclosed in the provisional application. Id.
at 12.
On appeal, this court reversed the findings of unen-
forceability and invalidity. Star Scientific, Inc., v. R.J.
Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cir. 2008)
(reh’g en banc denied Oct. 22, 2008) (“Star I”). This court
held that the claim term “anaerobic condition” was not
indefinite and consequently reversed the district court’s
grant of summary judgment of invalidity. Id. at 1371.
This court also found that the Williams patents were not
unenforceable for inequitable conduct. Id. at 1365. In
reversing the district court’s inequitable conduct finding,
this court held that RJR failed to show the withheld prior
art, including the Burton letter, renders either of the
Williams patents unenforceable. Id. At that time, this
court did not review the district court’s priority date
determination. This court also did not address anticipa-
tion and best mode because the trial court denied RJR's
summary judgment motions on those grounds. Id. at
1365 n.6. Therefore, this court remanded this case to the
district court for proceedings on infringement (“Star II”).
Id. at 1373.
STAR SCIENTIFIC v. RJ REYNOLDS 8
On remand, Star II featured a 20-day jury trial with
24 witnesses and over 4,000 pages of transcript. Despite
this court’s decision in Star I that the Williams patents
were not unenforceable for inequitable conduct, RJR’s
attorneys continually argued, particularly during closing
argument, that Star’s failure to produce the Burton letter
to the United States Patent and Trademark Office (“Pat-
ent Office”) was significant evidence in support of invalid-
ity. J.A. at 46806-07 (“The Burton letter is again from an
invalidity standpoint. . . . The important point here is
this was information the Patent Office did not have in
front of it.”). RJR projected a slide show for the jury
during its closing argument; one slide showed a shadowy
figure holding a piece of paper labeled “Burton Letter”
behind his back (“Burton slide”):
J.A. at 43788.
RJR’s primary invalidity expert, Dr. Lambert Otten
(“Dr. Otten”), opined that the Williams patents were
obvious in light of the combination of a review article by
Anna Wiernik et al., titled “Effect of Air-Curing on the
Chemical Composition of Tobacco” (“Wiernik”) and Japa-
nese Patent No. 51-144535, titled “Method for Curing
Domestic Tobacco Leaves,” with the named inventor
Hideyuki Tohno (“Tohno”). Dr. Otten further testified
9 STAR SCIENTIFIC v. RJ REYNOLDS
that three prior art references anticipate the Williams
patents: (1) the Peele method; (2) an alleged public use at
the Spindletop Research Facility used by RJR (“Spindle-
top”); and (3) an alleged public use at Hassel Brown’s
farm, a tobacco farm under contract with RJR.
RJR also argued that the Williams patents were in-
definite. Supported by Dr. Otten’s testimony, RJR argued
that one skilled in the art would not understand a “con-
trolled environment” after reviewing the Williams pat-
ents. Accordingly, RJR argued the Williams patents were
indefinite because one of ordinary skill would be unable to
determine the difference between “conventional proc-
esses” and the “controlled environment” required by the
Williams patents. RJR pointed to several parts of the
Williams patents where values for temperature and
humidity for the invention overlap with values assigned
to “conventional processes.”
Star’s primary infringement expert was Dr. Richard
Lee (“Dr. Lee”). Dr. Lee’s testimony focused on the oxy-
gen levels in RJR’s curing barns and that the resulting
cured tobacco had low TSNA levels, showing that the
anaerobic conditions that lead to TSNA had been “sub-
stantially prevented.” J.A. at 45775-77.
A June 16, 2009 special verdict, based on the Septem-
ber 15, 1999 priority date assigned by the court in Star I,
found RJR’s curing process to be non-infringing and the
Williams patents invalid as anticipated, obvious, failing to
disclose best mode, and indefinite. J.A. at 30-33. The
district court later denied Star’s motion for JMOL. Star,
Dkt. No. 1146 at 1-12. The district court’s memorandum
and order upheld the jury's verdict that the Peele method
did not infringe the Williams patents. Id. at 4. The
district court further noted that the jury likely did and
“most certainly should have” rejected Dr. Lee’s expert
testimony. Id. at 5. The district court elaborated that,
STAR SCIENTIFIC v. RJ REYNOLDS 10
even if Dr. Lee’s testimony was not mooted by the verdict,
the district court would grant JMOL of non-infringement
and exclude Dr. Lee’s testimony as not meeting the
Daubert standard. Id. In addition to finding no direct
infringement, the court also denied Star’s motion for
JMOL on indirect infringement. Further, the court
denied Star’s appeal of evidentiary rulings and excusing a
juror. Id. at 5-7. The court denied Star’s motion for
JMOL to reverse the jury’s findings of indefiniteness,
failure to disclose best mode, anticipation, and obvious-
ness on the basis that “the jury had ample evidence on
which to find that RJR had proven, by clear and convinc-
ing evidence, that the Patents-in-Suit were invalid.” Id.
at 7-8. This appeal followed. This court has jurisdiction
under 28 U.S.C. § 1295(a)(1).
After oral argument in this case, the Patent Office, in
light of an ex parte reexamination request by Star, con-
firmed that the claims of the Williams patents deserve the
priority date of the provisional application, namely Sep-
tember 15, 1998. The Patent Office also found that claims
4, 12, and 20 of the ’649 patent, and claim 41 of the ’401
patent, were obvious over Tohno, Wiernik, and several
other references asserted by RJR. Because of the earlier
effective filing date, the Patent Office did not consider the
Peele reference as prior art.
II.
A. Priority Date
This court first reviews the district court’s summary
judgment ruling that the asserted claims of the Williams
patents are not entitled to the provisional application
priority date. Star, Dkt. No. 703 at 1-12. This court
reviews both the district court’s grant of summary judg-
ment and determination of priority date without defer-
11 STAR SCIENTIFIC v. RJ REYNOLDS
ence. Research Corp. Techs. Inc. v. Microsoft Corp., 627
F.3d 859, 867 (Fed. Cir. 2010).
Claims deserve the provisional application’s earlier
filing date so long as that application contains adequate
written description under 35 U.S.C. § 112. Trading
Techs. Int’l. Inc. v. Espeed Inc., 595 F.3d 1340, 1350 (Fed.
Cir. 2010). Consistent with 35 U.S.C. § 112 ¶ 1, the
written description of the provisional application must
enable one of ordinary skill in the art to practice the
invention claimed in the non-provisional application.
New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d
1290, 1294 (Fed. Cir. 2002).
In this case, the asserted claims deserve the Septem-
ber 15, 1998 priority date of the provisional application.
The provisional application’s written description discloses
that the minimum air flow “may be about 28,000 CFM at
1” static pressure in a typical curing barn,” but that the
“minimum flow of air may vary according to conditions
and may be determined on a routine basis.” J.A. at 62198
(emphasis added). Claim 3 of the provisional application
further clarifies that the claimed invention covers a “flow .
. . sufficient to prevent an anaerobic condition” around the
curing tobacco. J.A. 62205. Because the provisional
application teaches one of ordinary skill that a minimum
air flow “may vary,” one of ordinary skill would know that
the conditions in a curing barn could demand an air flow
of 25,000 CFM. The district court’s reliance on specifically
disclosed air flow rates improperly narrowed the scope of
the provisional application based on an added example in
the later-filed non-provisional application that discloses a
process for curing using an “air flow of approximately
25,000 CFM.” Indeed, the Patent Office’s recent reexami-
nation confirms that September 15, 1998 is the proper
priority date.
STAR SCIENTIFIC v. RJ REYNOLDS 12
The September 15, 1998 priority date has several sig-
nificant implications on this appeal. First, the Peele
reference, with an effective filing date of April 26, 1999, is
not prior art. Second, because the StarCure process was
developed by Williams after September of 1998, failure to
disclose this process cannot constitute a failure to disclose
the best mode of practicing the invention. Star, Dkt. No.
703 at 11.
B. Evidentiary Objections
Star contends that the trial court committed numer-
ous reversible evidentiary errors. Star seeks reversal and
remand for a new trial based on the court’s exclusion of
proffered data, failure to exclude the Burton slide, repro-
duced above, failure to exclude arguments made by RJR
about failure to produce the Burton letter to the Patent
Office, and other arguments made by RJR during trial.
This court reviews a district court’s decision to ex-
clude evidence under the law of the regional circuit. Del.
Valley Floral Grp., Inc. v. Shaw Rose Nets, LLC, 597 F.3d
1374, 1379 (Fed. Cir. 2010). The Fourth Circuit reviews a
district court’s decision to admit or exclude evidence for
an abuse of discretion. Buckley v. Mukasey, 538 F.3d 306,
317 (4th Cir. 2008). Even if an evidentiary ruling consti-
tutes an abuse of discretion, it is only reversible when it
affects a party’s substantive rights. Id.The district court did not commit reversible error in
its evidentiary rulings. Because inequitable conduct was
not at issue in the trial, this court finds the presentation
of the Burton slide troubling. The Burton slide, showing a
shadowy figure conspicuously holding a piece of paper
behind his back, does not support any claim at issue in
this case. As a practical matter, however, Star did not
show the presentation of the Burton slide affected its
substantive rights. Accordingly, this court detects no
13 STAR SCIENTIFIC v. RJ REYNOLDS
abuse of discretion in the trial court’s evidentiary deci-
sions.
III.
This court reviews the denial of JMOL without defer-
ence under the same standard applied by the trial court.
Lucent Techs, Inc. v. Gateway, Inc., 580 F.3d 1301, 1309
(Fed. Cir. 2009). The Fourth Circuit reviews a motion for
JMOL without deference in the light most favorable to the
nonmoving party. A Helping Hand, LLC v. Baltimore
Cnty., 515 F.3d 356, 365 (4th Cir. 2008). “Judgment as a
matter of law is proper only if ‘there can be but one rea-
sonable conclusion as to the verdict.’” Ocheltree v. Scollon
Prods., Inc., 335 F.3d 325, 331 (4th Cir. 2003) (en banc).
A denial of a motion for a new trial is reviewed for an
abuse of discretion. Verizon Servs. Corp. v. Cox Fibernet
Va., Inc., 602 F.3d 1325, 1331 (Fed. Cir. 2010) (applying
Fourth Circuit law). A new trial is granted in the Fourth
Circuit only when there is conduct “so grievous as to have
rendered the trial unfair.” Id.This court reverses the district court’s denial of Star’s
motion for JMOL on issues involving the validity of the
Williams patents. This court affirms the district court’s
denial of Star’s motion for JMOL with regard to infringe-
ment. This court evaluates best mode, indefiniteness,
obviousness, anticipation, and infringement in turn.
A. Best Mode
The best mode requirement contains two elements.
First, the court must determine whether the inventor
possessed a best mode of practicing the claimed invention
at the time of filing the patent application. Green Edge
Enter., LLC v. Rubber Mulch Etc., LLC, 620 F.3d 1287,
1296 (Fed. Cir. 2010). This first step is subjective and
focuses on the inventor’s preference for a best mode of
practicing the invention at the time of the application’s
STAR SCIENTIFIC v. RJ REYNOLDS 14
filing date. Id. (citing N. Telecom Ltd. v. Samsung Elecs.
Co., 215 F.3d 1281, 1286 (Fed. Cir. 2000)). The second
step is an objective inquiry to determine whether the
inventor concealed from the public the best mode of
practicing the invention. Id. (citing Chemcast Corp. v.
Arco Indus. Corp., 913 F.2d 923, 928 (Fed. Cir. 1990)).
RJR concedes that Williams had not yet contemplated
a best mode as of September 15, 1998. Appellee Br. at 26.
As discussed above, September 15, 1998 is the proper
priority date for the asserted claims of the Williams
patents. Therefore, at the time of filing, the record shows
no best mode violation. Without evidence that Williams
had possession of a best mode of practicing the claimed
invention at the time of filing, the record cannot support
invalidity under the best mode requirement. This court
reverses the district court’s finding that the Williams
patents are invalid for failure to disclose the best mode of
practicing the claimed invention.
B. Indefiniteness
Indefiniteness is a purely legal issue that this court
reviews without deference. Bancorp Serv., LLC v. Hart-
ford Life Ins. Co., 359 F.3d 1367, 1372 (Fed. Cir. 2004).
This court only finds claims “not amenable to construc-
tion” or “insolubly ambiguous” to be indefinite. Datamize,
LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1347 (Fed.
Cir. 2005) (citations omitted). Thus, a construed claim
can be indefinite if the construction remains insolubly
ambiguous, meaning it fails to provide sufficient clarity
about the bounds of the claim to one skilled in the art.
Star I, 537 F.3d at 1371 (citations omitted). Absolute
clarity is not required to find a claim term definite. This
court has held that a claim term may be definite even
when discerning the meaning is a “formidable [task] and
the conclusion may be one over which reasonable persons
will disagree.” Source Search Tech., LLC v. Lendingtree,
15 STAR SCIENTIFIC v. RJ REYNOLDS
LLC, 588 F.3d 1063, 1076 (Fed. Cir. 2009) (citing Exxon
Research & Eng’g Co. v. United States, 265 F.3d 1371,
1375 (Fed. Cir. 2001)).
The district court construed the claim term “con-
trolled environment” to mean “controlling one or more of
humidity, temperature and airflow in the curing barn, in
a manner different from conventional curing, in order to
substantially prevent the formation of TSNAs.” Star
Scientific, Inc. v. R.J. Reynolds Tobacco Co., No. 8:01-cv-
01504, Dkt. No. 458, slip op. at 2 (D. Md. March 31, 2004).
The parties do not contest that an ordinarily skilled
artisan knows the meaning of the term “controlled envi-
ronment,” but they dispute whether a person of ordinary
skill would know how to establish a controlled environ-
ment to perform the claimed method. Here, indefinite-
ness requires a showing that a person of ordinary skill
would find “controlled environment” to be insolubly
ambiguous.
From that perspective, this record does not present
reasonable grounds for showing that “controlled environ-
ment” is indefinite. The jury’s verdict assumes that a
person of skill in the art would not recognize a “controlled
environment” because the Williams patents do not give
exact numbers measuring humidity, temperature, and
airflow in a conventional curing barn. However, the
record repeatedly shows that a person of skill in the art of
tobacco curing would possess adequate understanding to
manipulate these variables to create a controlled envi-
ronment. Indeed, because conventional curing varies
depending on the conditions for each cure, specific nu-
merical values are not needed for one skilled in the art to
implement conventional curing. As described in the ’649
patent:
[T]he practice of tobacco curing is more of an art
than a science, because curing conditions during
STAR SCIENTIFIC v. RJ REYNOLDS 16
any given cure must be adjusted to take into ac-
count such factors as varietal differences, differ-
ences in leaves harvested from various stalk
positions, differences among curing barns in terms
of where they are used, and environmental varia-
tions
’649 patent col.6 ll.35-41. The ’649 patent further ex-
plains that “the controlled conditions described herein
[are] according to conventional methods commonly and
commercially used in the U.S.” Id. col.6 ll.16-18. The
later-filed Peele patent, assigned to RJR, confirms that:
[V]arieties of Virginia tobacco that can be grown
and cured in accordance with [the Peele method]
will be readily apparent to those skilled in the art
of tobacco growing, harvesting, and processing,
and tobacco manufacture. The manner of which
Virginia tobacco is grown, harvested, and proc-
essed is well known.
’134 patent col.4 ll.3-8. Moreover, the record demon-
strates that tobacco curing variables are well known in
the tobacco industry. In that context, the term “controlled
environment” falls well within the bounds of ordinary
skill in the art. Thus, this term is not insolubly ambigu-
ous and is not indefinite.
C. Obviousness
Under 35 U.S.C. § 103(a), a patent is invalid “if the
differences between the [claimed] subject matter . . . and
the prior art are such that the subject matter as a whole
would have been obvious at the time the invention was
made to a person having ordinary skill in the art to which
said subject matter pertains.” Obviousness is a determi-
nation of law based on underlying determinations of fact.
Geo M. Martin Co. v. Alliance Mach. Sys. Int’l, 618 F.3d
1294, 1300 (Fed. Cir. 2010). These factual determinations
17 STAR SCIENTIFIC v. RJ REYNOLDS
include the scope and content of the prior art, the level of
ordinary skill in the art, the differences between the
claimed invention and the prior art, and secondary con-
siderations of nonobviousness. KSR Int’l Co. v. Teleflex,
Inc., 550 U.S. 398, 406 (2007) (citing Graham v. John
Deere Co., 383 U.S. 1, 17-18 (1966)).
Whether prior art invalidates a patent claim as obvi-
ous is determined from the perspective of one of ordinary
skill in the art. Id. at 420 (“The question is not whether
the combination was obvious to the patentee but whether
the combination was obvious to a person with ordinary
skill in the art.”). Through the lens of one of ordinary
skill in the art, even when all claim limitations are found
in prior art references, the fact-finder must not only
determine what the prior art teaches, but whether prior
art teaches away from the claimed invention and whether
there is a motivation to combine teachings from separate
references. See Dystar Textilfarben GMBH & Co.
Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360
(Fed. Cir. 2006) (citing In re Fulton, 391 F.3d 1195, 1199-
1200 (Fed. Cir. 2004)). Ultimately, obviousness requires
careful judgment and analysis in light of technical facts.
KSR, 383 U.S. at 419; see also Motorola, Inc. v. Interdigi-
tal Tech. Corp., 121 F.3d 1461, 1472 (Fed. Cir. 1997)
(“[T]here is no requirement that the prior art contain an
express suggestion to combine known elements to achieve
the claimed invention. Rather, the suggestion to combine
may come from the prior art, as filtered through the
knowledge of one skilled in the art.”).
Importantly, the great challenge of the obviousness
judgment is proceeding without any hint of hindsight. See
ATD Corp. v. Lydall, Inc., 159 F.3d 534, 546 (Fed. Cir.
1998) (observing that obviousness “cannot be based on the
hindsight combination of components selectively culled
from the prior art to fit the parameters of the patented
STAR SCIENTIFIC v. RJ REYNOLDS 18
invention”). Further, secondary considerations “may
often be the most probative and cogent evidence [of non-
obviousness] in the record.” Stratoflex, Inc. v. Aeroquip
Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983).
Dr. Otten testified that a combination of two prior art
references, Tohno and Wiernik, rendered the ’649 patent
obvious. Specifically, he testified that a person of ordi-
nary skill in the art would combine Wiernik’s teaching
(that TSNAs form from high humidity, optimal tempera-
ture, and anoxia) with Tohno’s teaching (that an in-
creased airflow helps avoid an oxygen deficient condition)
to generate the claimed curing methods.
Wiernik is a literature survey from 1995 that summa-
rizes studies conducted over a decade that primarily
“concentrate[] on the formation of tobacco-specific ni-
trosamines.” J.A. 64530. Wiernik teaches that artisans
in tobacco curing “recognized” the role of microbial medi-
ated reduction of nitrate to nitrite and “verified” that
nitrite has a key limiting role in TSNA formation. J.A.
64531. Wiernik tentatively proposes conditions that could
lead to TSNA formation on curing tobacco leaves “after
the end of yellowing when the leaves turn brown.” Id.Wiernik observes that “it seems that microorganisms . . .
have little chance to produce nitrite and TSNA.” J.A.
64545 (emphasis added). However, Wiernik adds that
when nutrients are made available to microorganisms
through cell death, nitrite “may” be produced under
“favourable [sic] conditions, i.e. high humidity, optimal
temperature and anoxia.” Id. (emphasis added).
Tohno is a Japanese patent application from 1978.
J.A. 60769-60772. Tohno teaches a method to “shorten
the curing period, prevent a fast curing action, and elimi-
nate the drawback of [having a ‘nasty odor’ in a tobacco
product].” J.A. 60772. Tohno teaches a method involving
manipulation of air flow, humidity, and temperature to
19 STAR SCIENTIFIC v. RJ REYNOLDS
“achiev[e] short-term curing.” Id. Tohno touts its pre-
scribed environment as “promoting the browning action”
that leads to accelerated curing. Id. Tohno does not
mention TSNAs and does not associate its increased air
flow with TSNA formation or cell death.
Even if the record showed some motivation or sugges-
tion to combine these references, the combination of
Tohno and Wiernik would still not present a clear and
convincing instance of obviousness. Tohno describes an
alternative quick bulk curing method with increased air
flow that ameliorates abnormal “smoking properties,” J.A.
60770, including a “nasty odor,” J.A. 60771, observed in
tobacco cured by standard bulk curing techniques. Tohno
generally attributes the bad odor caused by other tech-
niques to an abundance of “unnecessary gases” and claims
a method to exclude those “unnecessary gases” to “pro-
mot[e] the activation of the enzyme contained in the
tobacco leaves, thus achieving a short-term curing.” J.A.
60771-72. Tohno does not mention TSNAs and does not
provide a link between the oxygen levels (inherent in
increasing air flow) and precursor tobacco alkaloids or the
activation or inhibition of nitrate reductase—both critical
targets of the Williams patents.
Wiernik’s general teachings also produce little to ren-
der the Williams patents obvious. Wiernik speculates
that microorganisms are influenced by environmental
factors during the end of yellowing or the beginning of the
browning stage of curing to potentially facilitate the
production of TSNAs. Wiernik’s speculative and tentative
disclosure of what “might” or “may” lead to nitrite and
TSNA production does not sufficiently direct or instruct
one of skill in this art. See Abbott Labs. v. Andrx Pharm.,
Inc., 452 F.3d 1331, 1336 (Fed. Cir. 2006) (stating that a
person of ordinary skill possesses the “understandings
and knowledge reflected in the prior art”). Further, as
STAR SCIENTIFIC v. RJ REYNOLDS 20
noted before, the record contains no evidence suggesting a
motivation to combine an article on remedying a foul odor
in tobacco with a summary of studies about TSNA forma-
tion. In sum, this record shows no clear and convincing
evidence of a prima facie case of obviousness.
Both Wiernik and Tohno fail to teach the claim limi-
tation of curing with “air free of combustion gases.” ’649
patent col.20 ll.27-28. Tohno nowhere discusses expelling
gases from the curing chamber. Instead, Tohno describes
a method of establishing “sufficient ventilation” to “supply
O2” in order to “shorten the curing period, prevent a fast
curing action, and eliminate the drawback of smoking
property.” J.A. 60771-72. Wiernik also fails to teach the
need to eliminate combustion gases and therefore lacks
any disclosure for “air free of combustion exhaust gases.”
Instead, Wiernik concludes “the intricate and complex
mechanisms of [curing] are not fully understood[,] [a]
deeper insight into these reactions would enable an
optimization of the curing procedure.” J.A. 64565.
Moreover, the record contains many secondary con-
siderations that support nonobviousness. The record
shows a substantial need in the industry for curing meth-
ods that minimized or eliminated the formation of TSNAs.
The record also contains numerous scientific articles
counseling that eliminating or minimizing carcinogens in
tobacco has been a long-felt industry need. To that end,
the record showed decades of unsuccessful attempts at
reducing TSNA levels to the extent achieved by the Wil-
liams patents. See J.A. 45521-23 (testimony that RJR
had a “Nitrosamine taskforce” from around 1990 until
about 1995 with a mission to “understand nitrosamines
and apply that understanding for a competitive advan-
tage”). The record also evinced unexpected results that
met a long felt industry need. For example, at trial,
Williams testified that after presenting his low-TSNA
21 STAR SCIENTIFIC v. RJ REYNOLDS
tobacco products at an industry conference “everyone
wanted to get acquainted,” including “all of the major
tobacco companies.” J.A. 45326. Finally, as evidenced by
Brown & Williamson’s licenses, which cost millions of
dollars, Williams’ invention had achieved considerable
market acceptance and commercial success.
D. Anticipation
The jury verdict did not identify which prior art refer-
ence supplied clear and convincing evidence to anticipate
the Williams patents. J.A. 33. Because Dr. Otten testi-
fied that three pieces of prior art anticipated the Williams
patents, this court considers those prior art references:
the Peele method and the alleged public uses at Spindle-
top and Brown. J.A. 60664.
Under 35 U.S.C. § 102(b), a patent may not issue if
the claimed invention was in public use in this country
more than one year before the patent’s critical date. See,
e.g., Orion IP, LLC v. Hyundai Motor Am., 605 F.3d 967,
974 (Fed. Cir. 2010). Here, as discussed above, the effec-
tive filing date is September 15, 1998. Because the record
shows that the Peele method was not used more than one
year before the effective filing date, this reference does
not qualify as anticipatory prior art. Because no reason-
able jury could find by clear and convincing evidence that
either the Spindletop or Brown farms were anticipatory
public uses, this court reverses the district court’s denial
of Star’s motion for JMOL for anticipation on the basis of
Peele.
A public use under Section 102(b) includes any public
use of the claimed invention by a person other than the
inventor who is “under no limitation, restriction, or obli-
gation of secrecy to the inventor.” Clock Spring, L.P. v.
Wrapmaster, Inc., 560 F.3d 1317, 1325 (Fed. Cir. 2009)
(quoting Adenta GmbH v. OrthoArm, Inc., 501 F.3d 1364,
STAR SCIENTIFIC v. RJ REYNOLDS 22
1371 (Fed. Cir. 2007)). An anticipatory public use under §
102(b) must exhibit all of the claim limitations. Id. at
1325. In this case, the record does not show at any point
that the methods used at Spindletop included the limita-
tion that “uncured” tobacco was placed in a controlled
environment. See ’649 patent col.20 l.23.
Dr. Otten testified that the method used at Spindletop
included transferring stalks that had spent at least five
days in “air curing barns” into the controlled environ-
ment of a rapid drying chamber. J.A. 46551-52. RJR’s
opposition to Star’s motion for JMOL clarifies that “[o]n
the sixth day, after the end of yellowing, the tobacco was
removed from the barn and quick-dried[.]” J.A. 44679
(emphases added). Spindletop does not qualify as an
anticipatory prior public use because the tobacco cured in
Spindletop’s controlled environment was not uncured, as
required by the Williams patents.
A jury could not reasonably find by clear and convinc-
ing evidence that Brown’s method of curing met the claim
limitation “substantially prevent the formation of . . . at
least one nitrosamine,” ’649 patent col.20 ll.24-25, more
than a year before the Williams patents’ September 15,
1998 priority date. The district court construed “substan-
tially prevent the formation of . . . at least one nitrosa-
mine” to mean “the level of at least one of the
nitrosamines falls within the following ranges: less than
about 0.05 µg/g [0.05 ppm] for NNN, less than about 0.10
µg/g [0.10 ppm] for NAT plus NAB, and less than about
0.05 µg/g [0.05 ppm] for NNK.” J.A. 13053. Because by
2002 Mr. Brown had retrofitted his barns in accordance
with the Peele method, RJR’s proffered TSNA data was
divided between pre-retrofit data collected in 1996
and1998 and post-retrofit data collected in 2002. See J.A.
64018. RJR’s data from the 1996 and 1998 pre-retrofit
barns does not provide under any reasonable interpreta-
23 STAR SCIENTIFIC v. RJ REYNOLDS
tion clear and convincing evidence that this claim limita-
tion was met. See, e.g., J.A. 60670.
One sample from Brown’s 1996 crop and seventeen
samples from Brown’s 1998 crop and were tested for each
of the four TSNAs, resulting in sixty-eight individual
readings for 1998. J.A. 64009. Thirty-four of the sixty-
eight 1998 tests came back with a 0.00 reading, id., which
was only explained by RJR as being “below the detection
limit” of the test. J.A. 46556, 3438:10-11. The lone 1996
test returned with “ND” or non-detectable readings for
each TSNA. J.A. 60670.
Dr. Otten testified that the detection limit was 0.15
ppm. J.A. 46555-56. No reasonable juror could conclude
that a series of tests from 1998, less than a year prior to
the patents’ priority date, let alone one test from 1996,
with readings of “ND” or “0.00” can serve as clear and
convincing evidence that Brown’s curing techniques
anticipate the Williams patents, which require TSNA
levels below 0.05 ppm or 0.10 ppm, where a “0.00” or “ND”
result only provides that the concentration of TSNAs is
below the 0.15 ppm detection threshold. Accordingly, this
court finds that no reasonable juror could find the Wil-
liams patents anticipated.
E. Infringement
The jury returned a special verdict finding that Star
did not show infringement of the Williams patents by a
preponderance of the evidence. The district court denied
Star’s motions for JMOL and, in the alternative, a new
trial.
To prove infringement, a plaintiff must prove the
presence of each and every claim element or its equivalent
in the accused method or device. Uniloc USA, Inc. v.
Microsoft Corp., 632 F.3d 1292, 1301 (Fed. Cir. 2011).
Infringement is a question of fact reviewed for substantial
STAR SCIENTIFIC v. RJ REYNOLDS 24
evidence. Id. (citing Finisar Corp. v. DirecTV Group,
Inc., 523 F.3d 1323, 1332 (Fed. Cir. 2008)).
Star’s expert testimony was dispositive in this case.
The record shows that Star presented Dr. Lee as its
“primary evidence of infringement[.]” J.A. 36951. In fact,
upon the court’s threat to conditionally limit or exclude
Dr. Lee’s testimony, Star conceded that “for all practical
cases” there would be no case of infringement. J.A.
36950. Indeed, the district court remarked that the jury
“as it most certainly should have, rejected Dr. Lee’s
opinion altogether.” J.A. 52. In fact, the district court
indicated that, had the jury not discredited Dr. Lee, the
court “would now exclude Dr. Lee’s testimony as not
meeting the Daubert standard.” Id.Dr. Otten testified that farmers curing tobacco for
RJR did not infringe the Williams patents. Included in
his testimony were test results from 200 barns of 57
farmers growing tobacco used by RJR. J.A. 45779, 45868-
69. The jury heard Dr. Otten testify that the famers had
not substantially prevented anaerobic conditions and Dr.
Otten showed them that TSNA levels measured from the
farmers’ barns were above the levels claimed in the Wil-
liams patents. J.A. 46328-29.
The jury is entitled to credit or discredit testimony be-
fore it. In this situation, where expert testimony was
needed to establish infringement, it was not unreasonable
for the jury to discredit the testimony of Star’s expert and
find that the Williams patents were not infringed. See
Verizon, 602 F.3d at 1341 (denying motion for JMOL
when jury found noninfringement after weighing conflict-
ing expert testimony); see also Kinetic Concepts, Inc. v.
Blue Sky Med. Group, Inc., 554 F.3d 1010, 1024 (Fed. Cir.
2009) (finding that a jury can accept the testimony it finds
most persuasive). In light of Star’s heavy reliance on Dr.
25 STAR SCIENTIFIC v. RJ REYNOLDS
Lee’s testimony, this court affirms the district court’s
denial of Star’s motion for JMOL. 1
Star advances several arguments for a new trial.
However, Star’s arguments need not be addressed be-
cause this court’s grant of JMOL of validity moots any
alleged errors pertaining to validity. This court notes
that correction of any alleged error would not have
changed the result in this case because there was sub-
stantial untainted evidence before the jury to support a
verdict of non-infringement. See Verizon, 602 F.3d at
1342 (“We may affirm the jury’s findings on infringement
if substantial evidence in the record appears in the record
supporting the jury’s verdict and if correction of alleged
errors would not have changed the result given the evi-
dence presented.”(citations omitted)). It was not an abuse
of discretion for the district court to deny Star’s motion for
a new trial.
IV.
Accordingly, this court affirms the district court’s de-
nial of JMOL on noninfringement and reverses the dis-
trict court’s denial of JMOL on invalidity.
AFFIRMED-IN-PART AND REVERSED-IN-PART
Each party shall bear its own costs.
1 Because this court affirms the district court’s de-
nial of JMOL on the jury verdict of noninfringement,
Star’s arguments that RJR is liable for direct infringe-
ment under 35 U.S.C. § 271(g) are not addressed in this
opinion.
United States Court of Appeals
for the Federal Circuit
__________________________
STAR SCIENTIFIC, INC.,
Plaintiff-Appellant,
v.
R.J. REYNOLDS TOBACCO COMPANY (A NORTH
CAROLINA CORPORATION)
AND R.J. REYNOLDS TOBACCO COMPANY (A
NEW JERSEY CORPORATION),
Defendants-Appellees.
__________________________
2010-1183
__________________________
Appeal from the United States District Court for the
District of Maryland in consolidated case nos. 01-CV-1504
and 02-CV-2504, Senior Judge Marvin J. Garbis.
__________________________
DYK, Circuit Judge, concurring-in-part and dissenting-in-
part.
Although I agree with the majority with respect to in-
fringement, I would find the patents-at-issue invalid for
indefiniteness, and respectfully dissent from the major-
ity’s contrary holding. Because I would hold the patents
invalid for indefiniteness, I find it unnecessary to reach
any of the other invalidity challenges.
The Patent Act requires that claims “particularly
point[ ] out and distinctly claim[ ] the subject matter
STAR SCIENTIFIC v. RJ REYNOLDS 2
which the applicant regards as his invention.” 35 U.S.C. §
112. A claim term is not indefinite simply because “it
poses a difficult issue of claim construction”; rather, the
claims are indefinite “only if reasonable efforts at claim
construction prove futile.” Exxon Research & Eng’g Co. v.
United States, 265 F.3d 1371, 1375 (Fed. Cir. 2001). In
other words, “if reasonable efforts at claim construction
result in a definition that does not provide sufficient
particularity and clarity to inform skilled artisans of the
bounds of the claim, the claim is insolubly ambiguous and
invalid for indefiniteness.” Star Scientific, Inc. v. R.J.
Reynolds Tobacco Co., 537 F.3d 1357, 1371 (citing Halli-
burton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244,
1249–51 (Fed. Cir. 2008).
Here, the district court construed the term “controlled
environment” to mean “controlling one or more of humid-
ity, temperature, and airflow in the curing barn, in a
manner different from conventional curing, in order to
substantially prevent the formation of TSNAs.” See Star
Scientific, Inc. v. R.J. Reynolds Tobacco Co., No. 8:01-cv-
0154-MJG, slip op. at 2 (D. Md. Mar. 31, 2004). The
majority concludes that “a person of skill in the art of
tobacco curing would possess adequate understanding to
manipulate these variables to create a controlled envi-
ronment” because “tobacco curing variables are well
known to the tobacco industry.” Maj. op. at 16–17.
The majority characterizes the patents as “ex-
plain[ing] that ‘the controlled conditions described herein
[are] according to conventional methods commonly and
commercially used in the U.S.’” Id. at 16 (quoting ’649
patent, col.6 ll.16–18). But that is the opposite of what
the patents actually state. The patents state:
In this disclosure, tobacco that has been “con-
ventionally cured” is tobacco that has been air-
3 STAR SCIENTIFIC v. RJ REYNOLDS
cured or flue-cured, without the controlled condi-
tions described herein, according to conventional
methods commonly and commercially used in the
U.S.
’649 patent, col.6 ll.14–18; ’401 patent, col.6 ll.19–23.
Thus, far from equating the claimed “controlled environ-
ment” to conventional curing, the patents make clear that
conventional curing is conducted “without the controlled
conditions described herein.” Id. (emphasis added).
The specifications elsewhere directly contradict the
majority’s conclusion, explaining that the claimed “con-
trolled environment” is something different from conven-
tional curing methods. The specifications criticize
conventional curing processes on the ground that they “do
not provide suitable conditions (e.g., adequate oxygen
flow) and fail to prevent an anaerobic condition in the
vicinity of the tobacco leaves.” ’649 patent, col.7 ll.65–67;
’401 patent, col.8 ll.2–4. Specifically, the specifications
characterize the conventional air curing process as “sub-
jecting the [tobacco] to air curing without controlling the
ambient conditions (e.g., air flow through the barn, tem-
perature, humidity, and the like).” ’649 patent, col.3
ll.20–24; ’401 patent, col.3 ll.24–28. Indeed, the patents
teach that “the practice of tobacco curing is more of an art
than a science, because curing conditions during any
given cure must be adjusted to take into account” many
variables. ’649 patent, col.6 ll.35–37; ’401 patent, col.6
ll.39–41.
To determine whether a claim is invalid for indefi-
niteness, a court must determine “whether those skilled
in the art would understand what is claimed when the
claim is read in light of the specification.” Orthokinetics,
Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1576
(Fed. Cir. 1986). Expert testimony may be helpful in
STAR SCIENTIFIC v. RJ REYNOLDS 4
making this determination. See Datamize, LLC v. Plum-
tree Software, Inc., 417 F.3d 1342, 1348 (Fed. Cir. 2005)
(holding that a court may “rely on extrinsic evidence, such
as expert testimony,” to determine whether the claims are
indefinite) (internal quotation marks and citation omit-
ted); Seattle Box Co., Inc. v. Indus. Crating & Packing,
Inc., 731 F.2d 818, 826 (Fed. Cir. 1984) (stating that, in
making legal determinations, the court may rely on
expert testimony to aid in understanding the patent).
Here, R.J. Reynolds’ expert testified that a person of
ordinary skill in the art would be unable to draw the line
between conventional curing methods and the “controlled
environment” required by the claims. J.A. 46543–45.
Specifically, he noted that one of ordinary skill in the art
would understand the “controlled environment” limitation
to require the “control [of] humidity, temperature, and
airflow in a way that’s different from [conventional curing
processes], and with the objective and the purpose of
substantially preventing the formation of TSNAs.” J.A.
46543. He noted, however, that the patents do not pro-
vide sufficient guidance for one of skill in the art to de-
termine the ranges of temperature, humidity, and airflow
“covered by the [term] controlled environment that are
also not covered by the conventional curing processes.”
J.A. 46545. Further, when pressed on the issue, Star’s
expert could not provide any guidance regarding the
difference between the airflow in a conventional curing
process and that required in a “controlled environment,”
noting that it would be impossible to pinpoint values for
the temperature, airflow, and humidity required by the
claims because barn conditions are continually changing.
J.A. 45680.
In sum, the patents describe the claimed “controlled
environment” as something different from conventional
curing methods, but fail to explain those differences in a
5 STAR SCIENTIFIC v. RJ REYNOLDS
way that would permit a skilled artisan to determine the
bounds of the claims. To add to the confusion, the patents
define conventional curing methods as air-curing or flue-
curing “without the controlled conditions” required by the
claims. Under this court’s established test for definite-
ness, such circularity is insufficient to inform skilled
artisans of the bounds of the claims.