In re Crish (Fed. Cir. 2004).
Identification of nucleotide sequence for known plasmid does not render nucleotide sequence novel.
by Donald Zuhn
In an appeal from a decision of the PTO Board, the Federal Circuit affirmed the rejection of claims directed to purified DNA molecules having promoter activity for the human involucrin gene (hINV) as unpatentable under 35 U.S.C. § 102(b).
After isolating and sequencing the promoter sequence for hINV in the plasmid pSP64lI-3 H6B, Appellants pursued claims directed to specific portions of the promoter sequence having promoter activity. The claims were rejected under § 102(b) as being anticipated by one of Appellants’ own publications, disclosing the approximate size and structure – but not the sequence – of the hINV promoter, and by a second publication, disclosing protein-binding sites on the hINV promoter. In Appellants’ own publication the plasmid pSP64lI-3 H6B was used to determine the structure of the hINV promoter, while in the second publication the plasmid pSP64lI-3 H/Hc was used to identify protein-binding sites on the hINV promoter. Appellants appealed the Examiner’s final rejection to the Board.
Appellants first asserted that even if the publications cited against their application used plasmids containing the same hINV promoter region, other workers had sequenced the hINV promoter region in the plasmid pSP64lI-3 H6B, and had obtained a sequence that differed significantly from the promoter sequence described in Appellants’ application. In addition, Appellants asserted that because neither prior art publication specifically disclosed the nucleotide sequence recited in their application, neither publication could anticipate their application. The Board affirmed the Examiner’s final rejection, concluding that Appellants had failed to demonstrate that the plasmids used in the prior art publications possessed hINV promoter sequences that differed from the sequence described in Appellants’ application. The Board also determined that although neither prior art publication disclosed the hINV promoter sequence, the plasmids described in each publication necessarily possessed an hINV promoter sequence that was identical to the sequence described in Appellants’ application.
In affirming the Board’s decision, the Court determined that the Board had reasonably concluded that the plasmids used in Appellants’ prior publication and in Appellants’ application were identical. The Court next concluded, in addressing Appellants’ first assertion, that it was irrelevant whether other workers had obtained a different sequence for the promoter region of hINV since Appellants could not rely upon the inability of another worker to correctly sequence the promoter region of the hINV gene from plasmid pSP64lI-3 H6B when they had accurately sequenced the promoter region themselves. Finally, with regard to Appellants’ second assertion, the Court determined that “[Appellants’] characterization that the pending claims cover a novel DNA sequence having promoter activity, whereas the references disclose only the starting material plasmid, is unsound,” since “[t]he starting material plasmid necessarily contains the gene of interest, including the promoter region.”
NOTE: This post was written by patent attorney Donald Zuhn, PhD. Don is a true expert in cutting edge biotech patent law and practices both prosecution and litigation at McDonnell Boehnen Hulbert & Berghoff LLP in Chicago. [Brief Biography].