“When the subject matter is a DNA segment, conception requires possession and appreciation of the DNA segment that is claimed.” This does not, however, necessarily require the full and correct nucleotide sequence, as long as the identified information is sufficient “to distinguish it from other materials, and to define how to obtain it.”
Background / Facts: The interference proceeding on appeal here concerns the protein-encoding portion of the complementary DNA (“cDNA”) for the human interleukin-13 receptor binding chain (“IL-13bc”). Both Sanofi and Pfizer were conducting research in this field of scientific endeavor, for therapeutic and diagnostic purposes, and both Sanofi and Pfizer discovered and filed patent applications directed to the polynucleotide encoding the relevant IL-13 binding chain. Pfizer, as the junior party, presented documentary and testimonial evidence that it had isolated and identified the desired cDNA before the Sanofi benefit date. However, due to sequencing errors, Pfizer did not then have a completely accurate analysis of the entire nucleotide sequence.
Issue(s): Whether conception for a DNA segment requires the full and correct nucleotide sequence.
Holding(s): No. “We conclude that the Board correctly based conception and reduction to practice on the possession of the isolated DNA segment that was shown to have the desired properties. When the subject matter is a DNA segment, conception requires possession and appreciation of the DNA segment that is claimed. … The Board found that Pfizer had successfully searched for and isolated the IL-13bc DNA segment, and possessed and appreciated the isolated IL- 13bc DNA before the Sanofi benefit date.” Although “[f]or proteins and polynucleotide species, a sequence is the gold standard for identifying species with precision , … [i]t does not, however, thereby follow that a sequence is the only way to identify the composition precisely. … Upon selecting, isolating and characterizing clone 11 Pfizer was able to define [the IL-13bc] so as to distinguish it from other materials, and to define how to obtain it.”