Holding: Enablement analysis under Section 112 is distinct from enablement analysis for a prior art reference under Section 102. Non-working examples may be sufficient to enable a prior art reference as long as undue experimentation would not have been required to disclose the claimed feature.
Synthego filed IPRs against US Patent No. 10,337,001 and US Patent No. 10,900,034, each owned by Agilent. The ‘001 Patent and the ‘034 patent relate to CRISPR-Cas systems for gene editing. The CRISPR-Cas system includes guide RNA (gRNA) bound with Cas protein to form a single complex. The gRNA guides the complex to a targeted DNA sequence and binds with the target DNA, and the Cas protein cleaves the DNA at that location.
The ’001 Patent claims a synthetic guide RNA that has “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to a target polynucleotide.” Likewise, the ‘034 Patent claims a synthetic guide RNA that has “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to the target sequence.”
In the IPRs, the PTAB found all claims of the ‘001 Patent and the ‘034 Patent to be unpatentable. The key prior art was PCT Application No. WO 2015/026885 to Pioneer Hi-Bred. Pioneer Hi-Bred discloses compositions and methods for using a guide polynucleotide/Cas endonuclease system for genome modification of, gene editing, and for inserting a polynucleotide into the genome of a cell or organism. The specification of Pioneer Hi-Bred states that the guide polynucleotide may solely comprise ribonucleic acids and be referred to as guide RNA. Further, the specification of Pioneer Hi-Bred discloses several examples that were relevant in the IPRs. These examples describe modifying nucleic acid components to a guide polynucleotide/Cas endonuclease system to increase cleavage activity and specificity.
The PTAB ruled that Pioneer Hi-Bred expressly disclosed the functional features of the gRNA that was claimed in the ‘001 Patent and the ‘034 Patent. Pioneer Hi-Bred taught guide polynucleotides that could form a complex with a Cas endonuclease and then enable the endonuclease to recognize a DNA target site. Agilent argued that certain data in the Pioneer Hi-Bred reference showed that there was not cleavage for some particular modified gRNA. However, the PTAB found that the disclosure of some non-functional examples does not undermine the disclosure of other functional examples. The Federal Circuit sided with the PTAB, finding that substantial evidence supported its finding that Pioneer Hi-Bred expressly disclosed the functional features of the claimed gRNA.
Agilent alternatively argued that even if Pioneer Hi-Bred does show gRNA functionality it was not enabling. The PTAB ruled that Pioneer Hi-Bred was enabling and the Federal Circuit upheld this decision. Anticipation does not require the actual creation or reduction of practice of the prior art subject matter, but only requires that the disclosure be enabling. Enablement requires that the reference teach a skilled artisan to make or carry out what is disclosed in the reference without undue experimentation. A prior art reference does not need to enable the challenged claim in its entirety, but only needs to enable a single embodiment of the challenged claim.
To determine whether Pioneer Hi-Bred was enabling, the PTAB considered the Wands factors and found that a person of ordinary skill in the art could practice the disclosure in Pioneer Hi-Bred that anticipated the claims of the ‘001 Patent and the ‘034 Patent. Even though some of the examples disclosed in Pioneer Hi-Bred that were relied upon to show anticipation may not have been working examples, this does not undermine the presumption that Pioneer Hi-Bred was enabled. The CRISPR/Cas system was still somewhat new at the time of filing of the ‘001 Patent and the ‘034 Patent, but a person of skill in the art at the time would have had a general idea of the role of gRNA and the types of chemical modification that could be used to reduce RNA degradation. Therefore, undue experimentation would not have been required to make the gRNA claimed in the ‘001 Patent and the ‘034 Patent.
Agilent argued that Pioneer Hi-Bred was similar to Amgen v. Sanofi, 598 U.S. 594 (2023), in which the Supreme Court found claims that were entirely functionally defined to not be enabled when the claims of the patent sought to monopolize an entire genus of antibodies based on their function. However, the Federal Circuit pointed out that in Amgen, the issue was whether the asserted claims were sufficiently enabled under 35 U.S.C. §112. In this case, the question was whether the Pioneer Hi-Bred prior art reference was enabled to support anticipation. These are separate questions. For a Section 112 inquiry, the specification of a patent must enable one skilled in the art to use the invention. In contrast, for anticipatory disclosures, Section 102 does not include this same requirement.
Federal Circuit Precedential 
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