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IP Alert: Federal Circuit Reaffirms Full Scope of Claims Should Be Enabled

May 17, 2021

On May 11, in Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc., the Federal Circuit issued a decision that should caution patent applicants to disclose enough information to enable the full scope of their claims. The court upheld a jury verdict of invalidity under 35 U.S.C. § 112 for lack of enablement, after determining there was sufficient evidence to support a finding that the full scope of the claims had not been enabled.

Pacific Biosciences (“PacBio”) sued Oxford, asserting Oxford infringed two patents. Both patents related to methods for sequencing a nucleic acid using nanopore technology. The Federal Circuit generally described these methods for sequencing using nanopore technology in which “nucleic acids are drawn through nanometer-sized holes formed in a substrate, and while they transit the holes, their sequences of nucleotides are identified or characterized based on changes in electric current passing through the substrate.”

A jury found the claims to be infringed but also determined that they were invalid for lack of enablement. The district court denied PacBio’s motion for judgment as a matter of law and for a new trial on the issue of enablement, upholding the jury’s invalidity determination.

On appeal, the Federal Circuit affirmed. Initially, the court stated that “it is not enough for enablement here that relevant artisans knew how to perform some ‘nanopore sequencing’ before the priority date” of the patents in 2009. Instead, the full scope of the claims should be enabled. In this regard, the court stated that the claims recited “methods of ‘determining the sequence of the template nucleic acid,’ without limiting the character of that ‘template nucleic acid.’” PacBio conceded that the two patents did not distinguish between any specific types of DNA.

PacBio argued that in testimony at trial, Oxford’s expert acknowledged that one of ordinary skill in the art would have been able to perform the claimed method in view of an NIH grant application that was available as of the priority date in 2009. The Federal Circuit found that the jury was not required to give the expert’s testimony broad meaning. The jury could have understood the expert to be stating that the method could be performed on the group of nucleic acids specifically discussed in the NIH grant application, which were a type of synthesized nucleic acids. In view of evidence regarding the disparity between this type of synthesized nucleic acids and biological DNA, the jury could have understood the answer as limited to the specific question and not as an acknowledgment that one of ordinary skill in the art “could make and use the full scope of the invention.”

According to the Federal Circuit, other evidence supported the jury determination of non-enablement as of 2009. Oxford’s expert also testified that the claims lacked enablement based on a claim element that involved determining the number of nucleotides affecting current measurement. The author of the NIH grant application testified that his research was limited to the specific type of synthesized nucleic acids he addressed and, to the best of his knowledge, nanopore sequencing of biological DNA did not occur until 2011. An Oxford witness also testified he was not aware of anyone using nanopore sequencing with biological DNA until 2011. In addition, Oxford presented evidence that it announced its success in nanopore sequencing with biological DNA in 2012 and that this announcement was regarded as a major advance. Further, PacBio did not present evidence of actual reduction to practice that would have rebutted Oxford’s evidence of non-enablement and conceded that its reduction to practice had been constructive.

This decision should serve as a caution to applicants when preparing their applications and drafting the scope of their claims. It is not sufficient for enablement that one of ordinary skill in the art be able to perform a limited scope of the claimed subject matter. Rather, the full scope of the claims should be enabled. Therefore, applicants should take care in how broadly they draft their claims in view of the disclosure. In addition, depending on the circumstances, applicants may want to make sure to include claims of different scope or may consider whether a slight delay in filing is warranted for additional testing to provide additional disclosure in the application.

For more information on this topic, please contact Fitch Even attorney Rudy I. Kratz, author of this alert.

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