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The U.S. Patent and Trademark Office on Dec. 21, 1999, issued for public notice and comment its second round of examination guidelines for compliance with the written-description requirement of 35 U.S.C. 112, 1. Revised Interim Guidelines for Examination of Patent Applications Under the 35 U.S.C. Sec. 112, para. 1 “Written Description” Requirement, 64 Fed. Reg. 71427 (Dec. 21, 1999). The deadline for submission of comments to the PTO is March 22.

The first set of written-description examination guidelines, issued in June 1998, was widely criticized by the biotechnology industry, bar organizations and academics; many commentators questioned the propriety of issuing comprehensive guidelines in response to a single, controversial decision by the U.S. Court of Appeals for the Federal Circuit, Regents of the University of California v. Eli Lilly and Co., 119 F.3d 1559 (Fed. Cir. 1997) (originally filed claims directed to recombinant production of insulin held invalid as not complying with written-description requirement). Critics also charged that requiring examiners to focus on written-description issues would detract them from the more important effort of determining novelty and nonobviousness.

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