“Knowledge of the goal does not render its achievement obvious.” Obviousness generally requires that a skilled artisan have reasonably expected success in achieving that goal, and that goal in particular, not a different goal that may be a less challenging but also less worthwhile pursuit. This requirement derives from KSR, asking if there is “a design need or market pressure to solve” a problem and if that same problem is one having “identified, predictable solutions.”
Background / Facts: The patents on appeal from inter partes reexamination here are directed to methods and tools for the site-directed insertion of genes into eukaryotic chromosomes. More specifically, the claims recite GIIE endonucleases and methods of using them to insert DNA at a targeted location in an organism’s DNA. In rejecting the claims as obvious, the PTO founded its analysis on two articles from scientific journals – the Quirk and Bell-Pedersen references – that disclosed using a GIIE endonuclease to transfer DNA from a plasmid to non-chromosomal DNA in bacterial (i.e., prokaryotic) cells.
Issue(s): Whether the relevant skilled artisan – after reading Quirk’s and Bell-Pedersen’s disclosure that a GIIE endonuclease can promote targeted gene transfer into non-chromosomal DNA in prokaryotic cells – would have expected that a GIIE endonuclease would successfully promote targeted gene transfer into the chromosomal DNA of eukaryotic cells, and thus had good reason to pursue that possibility.
Holding(s): No. “[W]e conclude that one of ordinary skill in the art would not have reasonably predicted the successful adaptation of Quirk and Bell-Pedersen to target chromosomal DNA in eukaryotic cells.” While the prior art recognized that “[i]t would be a great advance if such alterations could be engineered into copies of a chosen gene in situ within the chromosomes of a living animal cell,” it also warns that using current techniques to introduce a GIIE endonuclease could be “highly toxic” to the cell, which might not be able to repair double-stranded breaks in the chromosome using homologous recombination. “In short, the prior art confirmed the great potential payoff of a method that produced a particular result. The desire for that payoff could motivate pursuit of the method, but ‘knowledge of the goal does not render its achievement obvious,’ … and obviousness generally requires that a skilled artisan have reasonably expected success in achieving that goal. Importantly, without a sound explanation for doing otherwise, which is not present here, the expectation-of-success analysis must match the highly desired goal, not switch to a different goal that may be a less challenging but also less worthwhile pursuit.”