Holding: For conception, an idea must be in sufficiently final form such that only exercise of ordinary skill remains to reduce the idea to practice without extensive research or experimentation. Evidence of both the inventor’s experimentation and third-party experimentation should be considered to determine whether the idea was able to be reduced to practice using only routine skill and methods.
This case is an appeal of the PTAB’s finding that Broad was entitled to priority over Regents in an interference proceeding regarding the use of CRISPR technology to edit eukaryotic DNA. The PTAB found that Regents failed to prove conception of the invention prior to Broad’s actual reduction to practice.
CRISPR Type II systems use an RNA sequence, called crRNA, to guide a protein to a particular DNA sequence. These systems include three components that form a CRISPR-Cas9 complex: mature tracrRNA, mature crRNA, and a protein called Cas9. Regents claimed to have simplified this process by linking the mature tracrRNA and mature crRNA sequences in the CRISPR-Cas9 system into a single-molecule called chimera A.
Regents scientists started planning experiments using their CRISPR-Cas9 system in March 2012 including two methods of editing eukaryotic DNA, microinjection and expression vectors. Regents filed a first provisional application describing these techniques on May 25, 2012. In June 2012, Regents scientists presented their new system at a conference presentation and in an article in Science. After this presentation, scientists from other laboratories, including Broad, attempted to use Regents’ disclosed system to edit DNA in eukaryotic DNA. Dr. Zhang from Broad had a successful result on July 20, 2012 and was able to replicate the experiment on July 31, 2012. Dr. Zhang submitted his results to Science on October 5, 2012, and the article was published on January 3, 2013.
In the meantime, in July 2012, Regents began performing microinjection tests on fish and expression vector tests in human cells. Although promising results were initially found in the expression vector tests in August 2012, subsequent experiments showed no evidence of editing. Email between Regents scientists on October 10, 2012 expressed disappointment with the results and doubts about whether the process could properly edit DNA. However, Regents filed a second provisional application on October 19, 2012, and had evidence of successful editing on October 29, 2012.
During the course of their experiments, both Regents and Broad filed patent applications related to the CRISPR technology, initiating the interference under appeal. Count 1 of the interference recites claim 18 of US Patent No. 8,697,359 owned by Broad and US Patent Application No. 15/981,807, owned by Regents. The relevant claims were each directed to guide RNA, which the PTAB construed to mean only a single-molecule RNA. Broad argued that the term guide RNA should not be limited to a single or dual molecule RNA configuration.
Regents moved to be given the benefit of the May 2012 filing date of the P1 provisional application, or in the alternative, at least the October 2012 filing date of the P2 provisional application or the January 2013 filing date of the P3 provisional application. The PTAB determined that neither the first Regents provisional application filed in May 2012 nor the second Regents provisional application filed in October 2102 were a constructive reduction to practice of Count 1. Therefore, Regents’ first constructive reduction to practice was at the filing date of its third provisional application filed in January 2013. The PTAB found that Broad reduced it claimed system to practice by October 5, 2012, when Dr. Zhang submitted his manuscript to Science. Based on this finding, the PTAB designated Broad the senior party and Regents the junior party.
There are three stages to the inventive process: (1) conception, (2) reasonable diligence, and (3) reduction to practice. The PTAB found that Regents had not proven conception of the invention prior to Broad’s reduction to practice, since Regents did not know that their CRISPR-Cas9 system would produce the effects on genes in a eukaryotic cell that were recited in Count 1. The PTAB largely came to this conclusion based on Regents’ scientists’ uncertainty conveyed in the emails discussing failed experiments and suggesting modifications to their CRISPR-Cas9 system.
To complete the conception stage, an inventor does not need to know that their invention will work. Knowledge that the invention will work rests only at the reduction to practice stage. Some general uncertainty is allowed. What matters for conception is whether the inventors had a definite and permanent idea of the operative invention such that the no prolonged period of extensive research, experiment, and modification followed the alleged time of conception. Therefore, the Federal Circuit found that the PTAB erred by not considering whether Regents’ emails led to modifications in their experiments that would have substantively changed the original idea.
The key question is when Regents had formed the idea of the use of the CRISPR-Cas9 system to edit eukaryotic DNA in sufficiently final form such that only exercise of ordinary skill remained to reduce the idea to practice without extensive research or experimentation. To answer this question, evidence of experimental success using routine skill or methods by either the inventor or a third party should be considered. Therefore, the PTAB should have considered both the experimentation by Regents and by Broad to determine if Regents had conceived the claimed invention as of the filling date of one of the earlier provisional applications. Instead, the PTAB considered neither and only focused on Regents’ scientists’ statements about experimental difficulties and doubts of success. For this reason, the PTAB’s decision was vacated and remanded to decide on conception using the proper inquiry.
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