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

Speculative and Tentative Disclosures in the Prior Art May Not Sufficiently Direct or Instruct a Skilled Artisan


August 26, 2011

Sommers Ph.D., Erin M.


Last Month at the Federal Circuit - September 2011

Judges: Rader (author), Linn, Dyk (concurring-in-part and dissenting-in-part)

[Appealed from: D. Md., Senior Judge Garbis]

In Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., No. 10-1183 (Fed. Cir. Aug. 26, 2011), the Federal Circuit affirmed the district court’s denial of Star Scientific, Inc.’s (“Star”) JMOL of infringement and denial of Star’s motion for a new trial, but reversed the district court’s denial of Star’s JMOL on validity.

Star is the exclusive licensee of U.S. Patent Nos. 6,202,649 (“the ’649 patent”) and 6,425,401 (“the ’401 patent”) (collectively “the Williams patents”), which claim methods for curing (drying) tobacco leaves. Since the 1970s, tobacco has been cured in direct-fired barns that heat and dry the tobacco in the presence of the combustion exhaust gases released by the heaters. The combustion gases can create an anaerobic, or oxygen-free, environment that can lead to the formation of a family of chemical compounds called tobacco-specific nitrosamines (“TSNAs”), known carcinogens, on curing tobacco leaves.

The Williams patents claim tobacco-curing methods that “substantially prevent” the formation of at least one TSNA during curing by creating a “controlled environment.” Star filed a provisional patent application, and a year later filed a nonprovisional application, which issued as the ’649 patent. The ’401 patent issued from an application that was a continuation of the application that matured into the ’649 patent.

Star sued R.J. Reynolds Tobacco Company (“RJR”) for infringement of the Williams patents. RJR denied infringement and claimed that the patents were unenforceable for inequitable conduct and invalid for anticipation, obviousness, indefiniteness, and failure to disclose the inventor’s best mode. After a bench trial, the district court found the patents unenforceable for inequitable conduct, granted SJ of invalidity for indefiniteness, and granted RJR’s SJ motion that Star was not entitled to rely on the provisional application’s priority date because the nonprovisional application contained new matter. Star appealed to the Federal Circuit. In an earlier decision, the Court reversed the findings of unenforceability and invalidity, and remanded for proceedings on infringement. Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cir. 2008).

On remand, the jury, via special verdict, found the Williams patents invalid as anticipated, as obvious, for failing to disclose the best mode, and indefinite, and that RJR’s curing process did not infringe. The district court subsequently denied Star’s motions for JMOL on direct and indirect infringement, and for JMOL to reverse the jury’s findings of invalidity, and similarly denied Star’s appeal of evidentiary rulings.

In the current appeal, the Federal Circuit first addressed and reversed the district court’s SJ ruling that the Williams patents were not entitled to the provisional application filing date because the nonprovisional application added new matter in the form of a new example requiring “air flow of approximately 25,000 CFM.” The Court found that the district court’s reliance on specifically disclosed air flow rates in the written description of the provisional application (e.g., the provisional application disclosed that the minimum air flow “may be about 28,000 CFM”) “improperly narrowed the scope of the provisional application” “[b]ecause the provisional application teaches one of ordinary skill that a minimum air flow ‘may vary’ . . . [such that] the conditions in a curing barn could demand an air flow of 25,000 CFM.” Slip op. at 11. The Court thus concluded that the new example did not add new matter, and, therefore, the claims were entitled to the provisional application’s priority date. The Court also noted that the PTO recently concluded an ex parte reexamination, requested by Star, which confirmed that the Williams patents were entitled to the provisional application’s priority date.

Second, the Federal Circuit rejected Star’s challenges to the district court’s evidentiary rulings, finding that the district court did not commit reversible error because Star failed to show that any of the rulings affected its substantive rights.

Third, the Court reversed the district court’s denial of Star’s motion for JMOL on the issues involving the validity of the Williams patents. With respect to best mode, the Court reversed the district court’s finding of invalidity because (1) the Williams patents were entitled to the priority date of the provisional application, and (2) RJR conceded that Williams had not contemplated a best mode as of that date.

With respect to indefiniteness, the Federal Circuit held that the disputed claim term, “controlled environment,” was not “insolubly ambiguous.” The Court found that even in the absence of “exact numbers” measuring humidity, temperature, and airflow in a conventional curing barn, “a person of skill in the art of tobacco curing would possess adequate understanding to manipulate these variables to create a controlled environment.” Id. at 15. Specifically, “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.” Id. Further, the ’649 patent specification disclosed that “the controlled conditions described herein [are] according to conventional methods commonly and commercially used in the U.S.” Id. at 16 (alteration in original) (citation omitted). Thus, because tobacco-curing variables were well known in the tobacco industry, the term “controlled environment” was well within the bounds of ordinary skill in the art and, hence, not insolubly ambiguous and indefinite.

The Federal Circuit next reversed the district court’s determination of obviousness in light of two prior art references, Wiernik and Tohno. First, the Court concluded that “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 the art.” Id. at 19. Second, “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.” Id. Third, there was no evidence suggesting a motivation to combine an article on remedying a foul odor in tobacco (“Tohno”) with a summary of studies about TSNA formation (“Wiernik”). Fourth, neither reference taught the “air free of combustion gases” claim limitation of the Williams patents. Finally, many secondary considerations supported nonobviousness, including long-felt industry need for a curing method that minimized or eliminated the formation of TSNAs, decades of unsuccessful attempts at reducing TSNA levels to the extent achieved by the Williams patents, unexpected results, and commercial success evidenced by licenses worth millions of dollars.

Lastly, with respect to validity, the Federal Circuit found that the Williams patents were not anticipated by an RJR curing method and two alleged public uses. First, the RJR method was not used in the United States more than one year before the patent’s critical date, in light of the Court’s determination of priority. Second, the alleged first public use was not anticipatory because the tobacco cured in that instance was not uncured, as required by the claims. Third, the second alleged public use was not anticipatory because the threshold detection level of the test used to detect the TSNAs (0.15 ppm) was not able to accurately determine whether the TSNA levels were below 0.05 ppm or 0.10 ppm as required by the claims.

Fourth, with respect to infringement, the Federal Circuit agreed with the district court’s denial of Star’s JMOL, finding that it was not unreasonable for the jury to discredit Star’s expert’s testimony (Star’s primary evidence of infringement) in light of RJR’s conflicting expert testimony.

Finally, the Court found that the district court did not abuse its discretion in denying Star’s motion for a new trial because (1) the Court’s decision on validity moots any alleged errors pertaining to validity, and (2) the correction of any alleged errors with respect to infringement would not have changed the result because there was substantial untainted evidence before the jury to support a verdict of noninfringement.

Accordingly, the Federal Circuit affirmed the district court’s denial of JMOL on noninfringement and reversed the district court’s denial of JMOL on invalidity.

Judge Dyk concurred-in-part and dissented-in-part. He agreed with the majority with respect to noninfringement, but would have found the “controlled environment” term indefinite. In particular, Judge Dyk believed that the majority misinterpreted the specifications of the Williams patents and that, contrary to the majority’s interpretation, “controlled environment” was not equated with conventional curing. Judge Dyk would have credited RJR’s expert and found that the Williams 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 claim.

Summary authored by Erin M. Sommers, Ph.D., Esq.