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Notebook Entries Fail to Show Possession of DNA Construct

January 29, 2003
Burwell, L. Scott

Decision icon Decision

Last Month at the Federal Circuit - February 2003

Judges: Lourie (author), Friedman, and Prost

In Singh v. Brake, No. 01-1621 (Fed. Cir. Jan. 29, 2003), the Federal Circuit affirmed the Board’s decision awarding judgment in an interference to Anthony Brake. The Board had held that Brake’s parent application adequately described and enabled the invention of the count, thereby entitling Brake to the filing date of that application. The Board had further held that Arjun Singh had not met his burden of proving conception prior to the filing date of Brake’s parent application and that Singh also had not met his burden of demonstrating diligence between conception and reduction to practice. The Federal Circuit affirmed these rulings.

The count at issue in the interference was directed to a DNA construct for use in expressing and secreting foreign proteins in yeast. Brake’s parent application disclosing the subject matter of the count was filed on January 12, 1983, and the patent issuing from a continuation-in-part of that application was assigned to Chiron Corporation. Singh, whose application was assigned to Genentech, Inc., alleged that he conceived the subject matter of the count in late 1982.

Singh’s attempts to develop the DNA construct of the count began in October 1982, when he was informed that the protein he was trying to express from that construct contained eight additional amino acids not present in the natural protein. Singh then devised a plan to redesign the construct to remove the nucleotides encoding the extra amino acids and testified that in November 1982 he had ordered a nucleotide sequence for use in an experiment designed to delete the extra amino acids. That order was canceled on the same day and, a week later, a different nucleotide sequence was ordered for the deletion experiment.

Singh argued on appeal that the Board had failed to consider the totality of the corroborative evidence that he had offered to establish his 1982 conception, namely, three laboratory-notebook entries that he asserted should be read together. The Federal Circuit rejected that argument, concluding that the November notebook entry recording the first order of the nucleotide sequence for use in the deletion experiment merely expressed the problem to be solved, but did not provide a solution. The Court also noted that the nature of the sequence ordered in November cast doubt on the accuracy of Singh’s testimony that he had ordered that sequence for use in a deletion experiment.

The Federal Circuit also agreed with the Board that nothing in Singh’s notebook corroborated his testimony that the three laboratory-notebook entries were meant to be read together. Even assuming that they were, the Federal Circuit ruled that the totality of the evidence was insufficient to prove by a preponderance of the evidence that Singh had a definite and permanent idea of an operative method for making the DNA construct prior to Brake’s filing date. The Court agreed with the Board that the notebook entries did not provide any protocol or outline of the deletion experiment, and that the entries at best stated a goal that Singh hoped to achieve. The Federal Circuit also concluded that Singh had failed to prove reasonable diligence toward reduction to practice by a preponderance of the evidence, as the laboratory-notebook pages relied on by Singh were unexplained as to content and relevance as well as being uncorroborated.

Singh also appealed the Board’s determination that Brake was entitled to the January 12, 1983, filing date of his parent application. Singh asserted that Brake did not provide an adequate written description of the invention of the count in that parent application because the application disclosed a large genus of over 9000 species, whereas the count was directed to only two species, and that the parent application did not provide adequate direction to lead a person of ordinary skill in the art to the subgenus of the count. The Federal Circuit rejected that argument, disagreeing with Singh’s calculation of the total number of species disclosed in the priority application and concluding that the parent application disclosed at most seventeen species, only two of which were meaningful embodiments. The Federal Circuit also noted that the disclosure of one of the original claims of the parent application provided a clear blaze mark providing in ipsis verbis support for the subject matter of the count.

Finally, the Federal Circuit held that the Board had not abused its discretion by returning the parties’ briefs without consideration because Singh’s briefs contained new arguments that were not raised at the outset of the interference.