Background
10x Genomics appealed three Patent Trial and Appeal Board final written decisions in inter partes reviews brought by Parse Biosciences. The patents—U.S. Patent Nos. 10,155,981, 10,240,197, and 10,697,013—claim methods for analyzing and counting nucleic acids from single cells by using identifying tag sequences.
The Board determined that all claims of the three patents were unpatentable as obvious. It relied principally on the combination of Linnarsson and McCloskey, and for certain claims also relied on McCloskey II. On appeal, 10x challenged the Board’s motivation-to-combine findings, its conclusion that the prior art disclosed the ’981 patent’s “correlate” limitations, and its finding that a skilled artisan would have used ligation to add a second tag.
The Court’s Holding
The Federal Circuit affirmed. For the ’013 patent, the court rejected 10x’s contention that the Board failed to make the necessary motivation-to-combine finding, explaining that the Board addressed the arguments 10x had presented and that 10x had not shown harmful error.
The court held that substantial evidence supported the Board’s findings that combining Linnarsson and McCloskey would reduce amplification bias, that McCloskey was not limited to seven-nucleotide barcodes, and that the rationale did not require tagging every mRNA molecule in a cell. It also upheld the findings that Linnarsson disclosed the cell-specific correlation limitation and that using ligation to introduce a second tag was an obvious design choice offering flexibility in when the tag could be added.
Key Takeaways
- The Federal Circuit affirmed the PTAB’s determinations that the challenged claims were unpatentable as obvious.
- Substantial evidence supported a motivation to combine the references to reduce amplification bias, independently of the Board’s alternative design-choice rationale for certain grounds.
- The record supported using ligation as one of two known ways to add a second tag and as a method providing flexibility in the tagging process.
Why It Matters
The nonprecedential decision illustrates the importance of presenting motivation-to-combine objections fully before the PTAB and showing harmful error on appeal. It also demonstrates that an obviousness rationale need not depend on a prior-art reference’s particular working example when the reference teaches how that example can be varied.
For biotechnology patent disputes, the decision confirms that conventional molecular techniques and expert testimony can provide substantial evidence for combining known tagging methods, including where the proposed combination addresses amplification bias in single-cell nucleic-acid analysis.