In re Peter Droge, et al.

Docket No. 2011-1600

September 21, 2012

Brief summary: Use of modified recombination proteins in eukaryotic cells found obvious in view of prior art showing use in prokaryotic cells in the absence of prokaryotic accessory factors (“[o]bviousness does not require absolute predictability of success”).

Summary: The inventors appealed the BPAI decision that their claims relating to “methods of sequence specific recombination of DNA in a eukaryotic cell” using bacteriophage lambda integrase Int-h or Int-h/218 (modified Int proteins) obvious. The inventors argued that the disclosure of the use of modified Int proteins “in prokaryotic cells would not lead a skilled artisan to expect that these integrases would also work in eukaryotic cells” (e.g., by inventor declaration) due to differences in DNA structure (e.g., the DNA of prokaryotes is negatively supercoiled). However, the FC panel agreed with the Board, finding that one of the references taught that the wild type Int could be used in “any type of host cell…yeasts, animal cells, plant cells”. It found that another reference taught that the modified Int proteins and provided a motivation to use the same in eukaryotic cells as it showed prokaryotic accessory factors were not required. A third reference was found to provide a reasonable expectation of success by teaching that “in the absence of IHF, Int-h recombines supercoiled and nonsupercoiled [DNA] identically” thereby “directly contradicting” the inventor declaration. The FC panel noted that “[o]bviousness does not require absolute predictability of success…all that is required is a reasonable expectation of success” (citing In re Kubin (FC 2009)). It therefore concluded that the Board’s conclusions were supported by substantial evidence, and affirmed the decision.

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