CAFC: Claim language first, specification second, prosecution history third…

Iowa State and Vanderbilt v. Wiley (Fed. Cir. March 7, 2005, NONPRECEDENTIAL)

By John Smith, PhD < ?xml:namespace prefix ="" o /> 

Iowa State University Research Foundation, Inc. (ISURF), Vanderbilt University, et al. appealed a Judgment as a Matter of Law granted by the District Court for the Southern District of Iowa that U.S. patent No. 5,348,979 was not infringed by Wiley Organics. 

ISURF sought injunctive relief and damages for Wiley’s allegedly contributory infringement and inducement of infringement for producing ß-hydroxy-ß-methylbutyric acid, or HMB.  Wiley supplied HMB to < ?xml:namespace prefix ="" st1 />MTI exclusively from 1995 to 2000.  In 2000, Wiley began to distribute the compound to other companies.  At issue on appeal was the construction of the claim terms “subject” and “patient.”  Claim 1 of the patent was considered to be representative:

1. The method of protein sparing, comprising orally or intravenously administering to a human subject an effective amount of ß-hydroxy-ß-methylbutyric acid (HMB) for increasing the retention of nitrogen, said HMB being in an edible or intravenously-administrable form selected from (i) its free acid form, (ii) its sodium, potassium, or calcium salt, (iii) its methyl or ethyl ester, or (iv) its lactone, and continuing the said administration of HMB until the amount of nitrogen in the patient’s urine has substantially decreased.  (Col. 6, ll. 7-16.)

The ISURF argued that the terms encompassed healthy individuals as well as those in need of treatment with HMB.  The District Court, however, had construed the claims in Wiley’s favor, ruling that the claims did not encompass healthy individuals, but only those with a “negative nitrogen balance” (in need of HMB treatment).

In the appellate decision, the Federal Circuit began with the claim language.  It noted that the terms “subject” and “patient” are used interchangeably in the patent, with no qualifications, other than that the individuals are human; the Court noted that there is no language indicating the sick or elderly are the only individuals contemplated to be within the scope of the claims.  The claim language also indicated that a relative change in nitrogen levels was all that was required by the claims; any decrease in nitrogen levels was within the scope of the claims.

The Court then proceeded to examine the specification.  It noted that the only experimental example in the specification had normal, healthy individuals as subjects.  The Court also noted that other language in the specification described the treatment of normal, healthy subjects.

Last, the Court examined the prosecution history.  It concluded that interpretations of the claim language by the examiner was not important, as the prosecution history revealed that the rejection by the examiner was based on the examiner’s interpretation of the prior art, not whether the claims were limited to treatment of sick individuals.

The order granting JMOL was vacated and the case remanded for further proceedings consistent with the Federal Circuit’s claim construction.

John Smith is an attorney at MBHB LLP in Chicago.  He earned both his JD and PhD (inorganic chemistry) from Vanderbilt University. He has co-authored numerous articles and served as a faculty member in the Chemistry Department of Lipscomb University in Nashville, Tennessee.