“Labcorp failed to ‘provide persuasive argument or evidence to explain why creating holes in the cell membranes . . . would have been seen by the [person of ordinary skill in the art] as acceptable.’”- Federal Circuit opinion
The U.S, Court of Appeals for the Federal Circuit (CAFC) on Monday, January 6, rejected Laboratory Corporation of America Holdings’ (Labcorp) argument that, among other issues, the Patent Trial and Appeal Board (PTAB) erred in its motivation to combine analysis and ultimate determination that Labcorp had not proven Ravgen, Inc.’s patent claims to be obvious. The opinion was authored by Judge Lourie.
Ravgen owns U.S. Patent 7,332,277, which covers “non-invasive methods for sampling DNA and detecting genetic disorders in a fetus.” Labcorp challenged various claims of the patent in two separate inter partes review (IPR) petitions but the Board held that the claims had not been shown to be unpatentable. On appeal, Labcorp said the PTAB “(1) required a heightened and untenable standard for proving a motivation to combine, (2) did not adhere to precedents that require reading each reference as a whole, and (3) in effect engaged in post hoc claim construction to read additional limitations into the claims,” according to the CAFC’s opinion. Labcorp additionally argued that the Board’s factual findings were not supported by substantial evidence.
Labcorp first maintained that a person of ordinary skill in the art would have been motivated to combine methods disclosed in three prior art references but the Board disagreed, finding that Ravgen’s reasoning on the motivation to combine analysis outweighed Labcorp’s. Specifically, one of the proposed prior art combinations included the use of paraformaldehyde, which has the potential to “create gaps in the cell membranes, providing a means for maternal DNA to escape into the sample,” according to the PTAB’s decision. And another combination using the reference incorporating paraformaldehyde would not have been obvious because “formaldehyde was known to damage nucleic acids,” said the Board.
On appeal, Labcorp charged that the PTAB “erroneously required Labcorp’s proposed combinations to be perfect, rather than merely desirable, which is all the case law requires,” but the CAFC said the Board reached its determination by reviewing the expert testimony and analyzing the prior art teachings, and that it did not apply an improperly heightened standard. “[R]ather, it found that Labcorp failed to ‘provide persuasive argument or evidence to explain why creating holes in the cell membranes . . . would have been seen by the [person of ordinary skill in the art] as acceptable,’” wrote the CAFC.
The court further rejected Labcorp’s attempt to “recast factual issues as legal ones” by arguing that the Board “improperly relied on generic concerns of DNA damage, failed to consider if a person of ordinary skill in the art would have pursued the invention despite those concerns, and did not follow […] precedent on what constitutes teaching away.” The concerns relied upon by the Board were specific to the invention at hand, said the CAFC, and focused on the specific combination of references. The opinion also found that the Board did not ignore the court’s precedent on teaching away but instead “found that, on the balance of the evidence, ‘the literature would have dissuaded a [person of ordinary skill in the art] from using formaldehyde or paraformaldehyde in the…modified method.”
As to Labcorp’s argument that the Board failed to consider everything two of the prior art references teach, the CAFC disagreed, citing explicit references to the relevant teachings, but also noting that “even if the Board’s consideration of these teachings were not so clear, ‘we have said numerous times, failure to explicitly discuss every fleeting reference or minor argument does not alone establish that the Board did not consider it.’”
Finally, the CAFC dismissed Labcorp’s argument that the Board engaged in “post hoc” claim construction, explaining that neither party identified a need for claim construction during the proceedings and the Board did not construe any terms itself, either explicitly or implicitly, and also said Labcorp had “failed to identify any factual finding by the Board that was not reasonably supported by substantial evidence.” The court therefore affirmed both IPR decisions.
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