Issue(s): Was the district court correct in denial of Appellant’s Star Scientific, Inc. (“Star”) 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 patent”) (collectively, “Williams patents”)?
STAR SCIENTIFIC, INC., Plaintiff-Appellant, v. R.J. REYNOLDS TOBACCO COMPANY, 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); Before RADER(Author), LINN, and DYK (dissenting-in-part),
Facts: 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. Until the 1970s, most curing occurred in indirect-fired barns that heated and dried the tobacco in an environment 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 combustion 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 varieties 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 minimize 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. Williams developed the “StarCure” process, the commercial embodiment of the invention. The parties 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. In general, the Williams patents posit that sustaining an aerobic environment during tobacco curing will prevent TSNA formation. For purposes of infringement, the parties agreed that the combined elements of claims 4 and 12 of the ’649 patent were representative.
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. However, defendants-appellees R.J. Reynolds Tobacco Company (“RJR”) terminated those agreements with Star upon acquisition of Brown & Williamson.
On May 23, 2001, Star filed a complaint against RJR, alleging infringement of the ’649 patent, and subsequently filed an amended complaint further alleging infringement of the ’401 patent. RJR denied infringement and claimed both patents were unenforceable for inequitable conduct, and invalid for anticipation, obviousness, indefiniteness, and failure to disclose the inventor’s best mode.
Lower Court’s Decision: After a bench trial, the district court held the Williams patents unenforceable for inequitable conduct and granted summary judgment of invalidity for indefiniteness. Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., (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., (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.
On appeal, this court reversed the findings of unenforceability 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. court also found that the Williams patents were not unenforceable for inequitable conduct. 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. At that time, this court did not review the district court’s priority date determination. This court also did not address anticipation and best mode because the trial court denied RJR’s summary judgment motions on those grounds. Therefore, this court remanded this case to the district court for proceedings on infringement (“Star II”).
A June 16, 2009 special verdict, based on the September 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. After oral argument in this case, the Patent Office, in light of an ex parte reexamination request by Star, confirmed that the claims of the Williams patents deserve the priority date of the provisional application, namely September 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.
Findings on Appeal: 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, In this case, the asserted claims deserve the September 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.” 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. 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 reexamination confirms that September 15, 1998 is the proper priority date.
Star contends that the trial court committed numerous 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, reproduced 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. 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.
A. Best Mode: RJR concedes that Williams had not yet contemplated a best mode as of September 15, 1998. 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: 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. The district court construed the claim term “controlled 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.”
Here, indefiniteness 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 environment” 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 environment. Indeed, because conventional curing varies depending on the conditions for each cure, specific numerical values are not needed for one skilled in the art to implement conventional curing.
C. Obviousness: Whether prior art invalidates a patent claim as obvious is determined from the perspective of one of ordinary skill in the art.
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 ordinary skill in the art would combine Wiernik’s teaching (that TSNAs form from high humidity, optimal temperature, and anoxia) with Tohno’s teaching (that an increased airflow helps avoid an oxygen deficient condition) to generate the claimed curing methods.
Even if the record showed some motivation or suggestion 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.
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 render 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.
Moreover, the record contains many secondary considerations that support nonobviousness. The record shows a substantial need in the industry for curing methods 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 longfelt industry need. To that end, the record showed decades of unsuccessful attempts at reducing TSNA levels to the extent achieved by the Williams patents.
D. Anticipation: The jury verdict did not identify which prior art reference supplied clear and convincing evidence to anticipate the Williams patents. Because Dr. Otten testified 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 Spindletop and Brown.
A jury could not reasonably find by clear and convincing evidence that Brown’s method of curing met the claim limitation “substantially prevent the formation of . . . at least one nitrosamine,” ’649 patent, more than a year before the Williams patents’ September 15, 1998 priority date.
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 Williams 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.
Star’s expert testimony was dispositive in this case. The record shows that Star presented Dr. Lee as its “primary evidence of infringement[.]”. 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. Indeed, the district court remarked that the jury “as it most certainly should have, rejected Dr. Lee’s opinion altogether.” 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.”
Star advances several arguments for a new trial. However, Star’s arguments need not be addressed because 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 substantial 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 evidence presented.”(citations omitted)). It was not an abuse of discretion for the district court to deny Star’s motion for a new trial.
DYK, Circuit Judge, concurring-in-part and dissenting-in-part: Although I agree with the majority with respect to infringement, I would find the patents-at-issue invalid for indefiniteness, and respectfully dissent from the majority’s contrary holding. Because I would hold the patents invalid for indefiniteness, I find it unnecessary to reach any of the other invalidity challenges. Here, the district court construed the term “controlled 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.”
The specifications elsewhere directly contradict the majority’s conclusion, explaining that the claimed “controlled environment” is something different from conventional 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.” In sum, the patents describe the claimed “controlled environment” as something different from conventional curing methods, but fail to explain those differences in a 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 definiteness, such circularity is insufficient to inform skilled artisans of the bounds of the claims.
Allen’s Observations: Thank goodness someone figured out how to reduce those pesky carcinogens introduced during the tobacco curing processes. Anyway, there is not much here that can be generalized, with one exception. The best mode was not known at the time the provisional was filed, but later found during development. This should help inventors rest easy when filing. It makes sense that more testing might be required after a provisional is filed. While technically it would be better to disclose at least a subjective belief as to the best mode, not venturing to guess what it might be is not going to be punished.