'401 and '649 claim drying tobacco in a "controlled environment" with sufficient air flow to prevent "an anaerobic condition" near the curing plant. Claim 4 of '649 is exemplary.

4. A process of substantially preventing the formation of at least one nitrosamine in a harvested tobacco plant, the process comprising:

drying at least a portion of the plant, while said portion is uncured, yellow, and in a state susceptible to having the formation of nitrosamines arrested, 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 airflow sufficient to substantially prevent an anaerobic condition around the vicinity of said plant portion; and

wherein said controlled environment is provided by controlling at least one of humidity, temperature, and airflow.

RJR asserted that "controlled environment" and "anaerobic condition" were indefinite, thus invalidating the claims. RJR pointed out that the disclosure failed to disclose how to manipulate humidity, temperature, or air flow so as to establish the requisite "controlled environment."

The United States Court of Appeals for the Federal Circuit has stated that "[t]he primary purpose of the definiteness requirement is to ensure that the claims are written in such away that they give notice to the public of the extent of the legal protection afforded by the patent, so that interested members of the public, e.g., competitors of the patent owner, can determine whether or not they infringe." All Dental Prodx LLC v. Advantage Dental Prods., 309 F.3d 774, 779-80 (Fed. Cir. 2002).

"The person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art." Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955,962 (Fed. Cir. 1986) (addressing obviousness and citing Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 454 (Fed. Cir. 1985)).

RJR presents a rather persuasive argument that the Patent does not inform those of ordinary skill in the art how to establish the claimed "controlled environment" or how to adjust the humidity, temperature, and airflow relative to each other and to other factors to affect the curing process. Indeed, Star itself seeks to present testimony from an expert witness, Mr. James Sturgill, that is highly supportive of RJR's position. Thus, the transcript of Sturgill's deposition includes:

Q: What is the amount of airflow used in conventional barns?

A: I don't know that I can give you a number for airflow used in conventional barns.

Q: Well, how the heck do you know where the accused barns have an airflow that was greater than what was conventionally used?

A. That's a good question.

Defs.’ Mem. in Supp. of Mo. Summ. J. [Paper 668], ex. 1 (Deposition of James Sturgill) at 111-12.

Star contented that "controlled environment" needed to be appreciated within the context of the term "anaerobic condition."

Essentially, Star takes the position that the "touchstone for proper airflow therefore must be tied to preventing anaerobicity around the plants." Pl.s’ Cross-Mo. for Summ. J. [ Paper 682] at 9. Thus, Star argues that the definiteness of "controlled environment" can be appreciated only in the context of "anaerobic condition." Therefore, the Court will proceed on the basis that RJR would not be entitled to summary judgment as to the indefiniteness of the term "controlled environment" if the term "anaerobic condition" would pass muster as sufficiently definite.

The only way to know that the curing successfully reduced nitrosamine, and thus infringed, was after the fact.

In sum, one can know that he has practiced the invention only by finding, after a curing operation, that he has obtained a low TSNA reading.

The testimony of the inventor himself establishes that one skilled in the art cannot know, from the patent, how to conduct a curing operation that will achieve the intended result in light of the many variables associated with curing. For example:

Q: So how could one know if its an oxygen deficient condition?

A: If you cure the tobacco and you create an anaerobic situation you'll know it by the levels of the TSNAs that you'll measure.

Defs.’ Mem. in Supp. of Mo. Summ. J. [Paper 668], ex. 11(Deposition of Jonnie Williams) at 50; see also id. at 51, 54-57,61-62.

The indefiniteness issue presented herein is analogous to that presented in Geneva Pharmaceuticals v. Glaxosmithkline PLC,349 F.3d 1373 (Fed. Cir. 2003), in which the court found the term "synergistically effective amount" to be fatally indefinite. Id. at 1383. In Geneva, as in the instant case, the limitation was defined in terms of the desired result, and there was insufficient guidance to enable the hypothetical artisan to determine the specific action to take without undue experimentation. Id. In the instant case, one skilled in the art would not know whether a particular curing operation arrangement was within the claim scope or not except after the fact. And, even when one knew that the result had been obtained so that the invention had been practiced, one could not know how to repeat the success in the next curing run. The Geneva court referred to such a claim limitation as "the epitome of indefiniteness." Id. at 1384.

Judge Marvin Garbis observed that the patents "do not teach how to control the environment to prevent an anaerobic condition that will substantially prevent the formation of a nitrosamine." The judge found "anaerobic condition... fatally indefinite and renders the claims at issue invalid."

Star vows to appeal.