Wednesday, December 07, 2016

Oral argument in CRISPR interference on December 6, 2016

The Scientist discussed the hearing of December 6, 2016 in the CRISPR interference battle.

Jeff Akst wrote

Just after 10:00 a.m., three USPTO judges entered and took their seats in front of the packed room. A few minutes later, Steve Trybus of law firm Jenner & Block in Chicago began his arguments on behalf of the Broad. He emphasized that it’s not obvious how to take a pathway from prokaryotes and plug it into eukaryotic cells—that there was strong motivation for doing so, but no reasonable expectation of success. He said that it seemed Doudna herself didn’t think this extension was obvious, quoting from a 2012 interview, in which she stated that she wasn’t sure if it would work in eukaryotic cells, which have a nucleus, and that she had experienced “many frustrations” in getting CRISPR to work in human cells. Despite having first filed its provisional patent in May 2012, Doudna’s group didn’t succeed in getting the gene editor to work in eukaryotic cells until October 2012, Trybus said. That’s “the antithesis of something that would have been obvious,” he told the judges.

In the obviousness analysis, the focus seems to be on how predictable the outcome of going from prokaryotes to eukaryotes:

It’s clear that the real issue here is about the “obviousness,” Mark Rohrbaugh, the National Institutes of Health’s special advisor for technology transfer, said at a panel discussion held at the American University Washington College of Law following the hearing. “Was this the system that just happened to successfully easily move from a prokaryotic to eukaryotic system? Were they just lucky in that? Or was it predictable and obvious based on the prior art that it could move from one system to the other?”

The O'Farrell case had been a milepost for "reasonable expectation of success" and included discussion of what would not be obvious:

when what was ‘obvious to try’ was to explore a new
technology or general approach that seemed to be a
promising field of experimentation, where the prior art gave
only general guidance as to the particular form of the
claimed invention or how to achieve it. Id. (citing O’Farrell,
853 F.2d at 903).”

KSR had noted to find obviousness:

“there is a recognized problem or need in the art; there are a finite number of identified, predictable
solutions to the recognized need or problem; and one of ordinary skill in the art could have pursued these known
potential solutions with a reasonable expectation of success.”


Post a Comment

<< Home