The U.S. Court of Appeals for the Federal Circuit affirmed a summary judgment of invalidity of method claims relating to nutritional supplements under 35 U.S.C. §102(b) in view of a printed advertisement published a year before the patent’s priority date. Iovate Health Sciences, Inc. v. Bio-Engineered Supplements & Nutrition, Inc., Case No. 09-1018 (Fed. Cir., Nov. 19, 2009) (Lourie, J.; Mayer, J., concurring).

Independent claim 1 of the patent-in-suit’s recited “[a] method for enhancing muscle performance or recovery from fatigue wherein said method comprises administering a composition comprising a keto acid and an amino acid where in said amino acid is cationic or dibasic.” All the remaining asserted claims depended from claim 1. The court previously construed the claim phrases “enhancing muscle performance” and “recovery from fatigue,” the later meaning “increasing muscle performance after muscle performance has been decreased by exercise.”

The asserted art was published in FLEX magazine and included the following information: the composition of a supplement; the timing, method, and an amount to be administered; how the product was made; sales price; purchase locations; and a rebate offer with a coupon and redemption deadline. The advertisement indicated that the supplement was “to help muscles recuperate faster after exercise; and to ‘decrease[] the breakdown of muscle proteins’ to ‘provide[] greater potential for post-workout recovery.’” The Court found that the printed publication was “accessible to persons interested and ordinarily skilled in the subject matter to which the advertisements relate.” Iovate appealed.

On appeal, Iovate argued that the advertisement did not meet the “recovery from fatigue” limitation as construed because the ad was directed to “recovery from one workout to the next.” The Court disagreed and held that the plaintiffs’ proffered “conclusory expert testimony and attempts to increase the specificity of the language used in the claims’ preamble … borders on the frivolous.” In support, the Court cited the patent specification and the plaintiffs’ own allegations of infringement. The plaintiffs also provided expert testimony that skilled artisans do not rely on magazine advertisements to prove effectiveness of nutritional supplements.

The defendants argued that the plaintiff's evidence was irrelevant since claim 1 did not specify a functional or effective result; i.e., the claim is directed to a method for (not of) enhancement; an amount or concentration of the composition’s ingredients; or a step for assessing the intended result.

Iovate argued that the advertisement did not include enabling disclosure, as is required for anticipatory prior art, because it did not teach a skilled artisan how to make a composition effective for enhancing due to the lack of guidance on ingredient dosages.

The Federal Circuit made short work of Iovate’s argument, echoing the defendant’s argument that the claim did not recite language requiring an effect or result, as well as that the article does provide sufficient dosage information to enable a skilled artisan to administer an effective amount. The Court also noted that dosing information was already known in the art, as evidenced by prior art references described in the asserted patent.

Judge Mayer also agreed with the district court that the claims were also invalid under the on-sale bar of § 102(b).