Trilateral Project 24.1-Biotechnology 096

The answer depends on what the invention actually is. For example, if the invention is a probe for a particular plasmid, even a low rate of identity might be useful for an initial screening using low stringency hybridization to different plasmid constructs. Similarly, with the well known degeneracy of the genetic code, the third position of the codon may assume a large number of different nucleotides and still code for the same amino acid. Consequently, DNAs with only 66.6% identity might encode exactly the same amino acid sequence. Addition of introns and highly variable nontranslated sequences at the three prime end of the message could easily result in DNAs of far less than 50% identity that would encode the same amino acid sequence. It is important to permit applicants to draft their claims in a manner that permits adequate protection of their invention in order to spur rapid development in this area --as in all areas-- of technology.

To be enabling under 35 U.S.C. Sec. 112, a patent must contain a description that enables one skilled in the art to make and use the claimed invention without undue experimentation. This requirement means the applicant must enable one skilled in the art to carry out the claimed invention commensurate with the scope or breadth of the claims.

For DNA sequences as well as amino acid sequences, "that means disclosing how to make and use enough sequences to justify grant of the claims sought." Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200-18 USPQ2d 1016, 1027 (Fed. Cir. 1991). A disclosure of Protein X and a modifications of Protein X might enable a generic claim encompassing these and similar modifications but may represents inadequate support for all proteins or DNAs with a particular function. There may be countless other types of protein sequences --as well as the DNAs encoding such sequences-- that would result in a particular function. An appellant that has described how to make and use only a few of them is not entitled to claim those that are not placed in the hands of one skilled in the art. Although enablement is a legal determination, it is based on underlying factual determinations regarding what one of skill in the relevant art knows as well as what is found in the specification. Consequently, each application must be reviewed and few per se rules can be articulated.