Big defeat for UC/Berkeley in CRISPR war

The outcome was an affirmance that no interference-in-fact existed;
UC/Berkeley loses its appeal:


This case turns in its entirety on the substantial evidence
standard. The Board found a person of ordinary
skill in the art would not have had a reasonable expectation
of success in applying the CRISPR-Cas9 system in
eukaryotic cells. J.A. 48–49. Given the mixture of evidence
in the record, we hold that substantial evidence
supports the Board’s finding that there was not a reasonable
expectation of success, and we affirm. UC argues
that the Board: (1) improperly adopted a rigid test for
obviousness that required the prior art contain specific
instructions, and (2) erred in dismissing evidence of
simultaneous invention as irrelevant. For the reasons set
forth below, we hold the Board did not err in its analysis.



Statements made on the UC/Berkeley side were used
AGAINST UC/Berkeley:


The Board was also presented evidence of statements
by the UC inventors acknowledging doubts and frustrations
about engineering CRISPR-Cas9 systems to function
in eukaryotic cells and noting the significance of Broad’s
success. One of the named inventors, Dr. Jennifer Doudna,
acknowledged the “huge bottleneck” in making genetic
modifications in animals and humans, J.A. 5911, and
after the publication of the initial UC research, she stated
“[o]ur 2012 paper was a big success, but there was a
problem. We weren’t sure if CRISPR/Cas9 would work in
eukaryotes,” J.A. 5880. She also explained that she had
“many frustrations” in getting CRISPR-Cas9 to work in
human cells, and that she thought success in doing so
would be “a profound discovery.” J.A. 5908. Evidence in
the record also suggested her colleagues recognized
Broad’s development was significant. When a colleague
contacted Dr. Doudna to inform her of Broad’s success he
stated “I hope you’re sitting down,” “CRISPR is turning
out to be absolutely spectacular in [Broad researcher]
George Church’s hands.” J.A. 5908. The Board viewed
this evidence as indicating that an ordinarily skilled
artisan would have lacked a reasonable expectation of
success.3



Footnote 3:



UC also argues the Board erred in giving “near dispositive
weight” to statements by Dr. Doudna and Dr.
Carroll, which it claims were misinterpreted by the
Board. The Board considered a variety of statements
made by both Dr. Doudna and Dr. Carroll. In doing so, it
afforded the statements weight depending on the contexts
in which they were made and their relevance to its analysis.
See J.A. 14–23. To the extent UC argues the Board
erred in its reading of these statements in the contexts in
which they arose, we conclude substantial evidence supports
the Board’s interpretation.


Note text by the CAFC:


UC expended substantial time and effort to convince
this court that substantial evidence supports the view it
would like us to adopt, namely, that a person of ordinary
skill would have had a reasonable expectation of success
in implementing the CRISPR-Cas9 system in eukaryotes.
There is certainly evidence in the record that could support
this position. The prior art contained a number of
techniques that had been used for adapting prokaryotic
systems for use in eukaryotic cells, obstacles adopting
other prokaryotic systems had been overcome, and Dr.
Carroll suggested using those techniques to implement
CRISPR-Cas9 in eukaryotes. We are, however, an appellate
body. We do not reweigh the evidence. It is not our
role to ask whether substantial evidence supports factfindings
not made by the Board, but instead whether such
evidence supports the findings that were in fact made.
Here, we conclude that it does.



Of simultaneous invention:


Simultaneous invention may serve as evidence of obviousness
when considered in light of all of the circumstances.
Lindemann Maschinenfabrik GMBH v. Am.
Hoist & Derrick Co., 730 F.2d 1452, 1460 (Fed. Cir. 1984).
We have recognized that simultaneous invention may
bear upon the obviousness analysis in two ways. Monarch
Knitting Mach. Corp. v. Sulzer Morat GmbH, 139
F.3d 877, 883 (Fed. Cir. 1998). First, it is evidence of the
level of skill in the art. Id. Second, it constitutes objective
evidence that persons of ordinary skill in the art
understood the problem and a solution to that problem.
Id. Inherent in the existence of interference practice is
the principle that evidence of simultaneous invention
cannot alone show obviousness, otherwise any claims
involved in an interference would be unpatentable for
obviousness. Lindemann, 730 F.2d at 1460. The weight
of evidence of simultaneous invention must, therefore, be
carefully considered in light of all the circumstances. See
Monarch Knitting, 139 F.3d at 883.
In August 2012, the Jinek 2012 paper was published
explaining the CRISPR-Cas9 system and its use in vitro
using isolated components. There is no dispute that this
represented a breakthrough in the art. The fact that six
research groups succeeded in applying this technology in
eukaryotic cells within a short period of time after this is
certainly strong evidence that there was a motivation to
combine the prior art in this manner. The Board expressly
recognized UC’s evidence of simultaneous invention in
this context, and it concluded the evidence of simultaneous
invention was evidence of the motivation to combine
the prior art references but did not “necessarily” indicate
an expectation of success prior to the completion of the
experiments. J.A. 23.

UC would have the Board read more into this evidence
and infer that because several research teams
pursued a particular approach, and that approach was
ultimately successful, they must have expected that
approach to work. It argued to the Board that absent an
expectation of success, multiple groups “would not have
undertaken the use of UC’s Type-II CRISPR-Cas system
in eukaryotic cells.” J.A. 245. The Board rejected this
bright-line rule and instead determined in this instance
the evidence of simultaneous invention did not establish a
reasonable expectation of success given the “specific
context of the art at the time.” See J.A. 23–25. The Board
explained that “[e]ach case must be decided in its particular
context, including the characteristics of the science or
technology, its state of advance, the nature of the known
choices, the specificity or generality of the prior art, and
the predictability of results in the area of interest.”
J.A. 25 (quoting Abbott Labs. v. Sandoz, Inc., 544 F.3d
1341, 1352 (Fed. Cir. 2008)). We do not see any error in
this analysis. Contrary to UC’s claims, the Board recognized
that UC’s evidence of simultaneous invention is
relevant to the obviousness determination. We consider
Broad’s evidence of simultaneous invention, along with
evidence regarding the state of the art, the statements of
the inventors, failures involving similar technologies, and
the remainder of the record evidence, and conclude the
Board’s finding is supported by substantial evidence.



The conclusion:


For the foregoing reasons, we affirm the Board’s
judgment of no interference-in-fact. The Board performed
a thorough analysis of the factual evidence and considered
a variety of statements by experts for both parties and the
inventors, past failures and successes in the field, evidence
of simultaneous invention, and the extent to which
the art provided instructions for applying the CRISPRCas9
technology in a new environment. In light of this
exhaustive analysis and on this record, we conclude that
substantial evidence supports the Board’s finding that
there was not a reasonable expectation of success, and the
Board did not err in its determination that there is no
interference-in-fact.

We have considered UC’s remaining arguments and
find them unpersuasive. We note that this case is about
the scope of two sets of applied-for claims, and whether
those claims are patentably distinct. It is not a ruling on
the validity of either set of claims.




***Of relevance

UC’s Patent Application No. 13/842,859

Broad's U.S. Patent No. 8,697,359

PTAB 106,048