Pacific Biosciences of California, Inc. v. Personal Genomics Taiwan, Inc., Appeal Nos. 2022-1410, -1554 (Fed. Cir. January 9, 2024)

In this week’s Case of the Week, the Federal Circuit affirmed two inter partes review (“IPR”) decisions by the Patent Trial and Appeal Board (“Board”) based on claim construction of the phrase “an apparatus for identifying a single biomolecule.” 

Pacific Biosciences of California, Inc. (“PacBio”) filed the IPR petitions against claims of US Patent No. 7,767,441, owned by Personal Genomics Taiwan, Inc. (“PGI”).  In one IPR, PacBio argued that claims 1-2, 6-7, 10-22, 24, and 27-36 were unpatentable as either anticipated or obvious over the Hassibi reference.  The Board did not agree with PacBio’s arguments and did not find the challenged claims unpatentable.  In the second IPR, PacBio argued that claims 1-6, 9, and 43-58, were unpatentable as either anticipated or obvious over the Choumane reference.  Here, the Board agreed with PacBio and found the challenged claims unpatentable.  Both parties appealed and the Federal Circuit affirmed the Board’s decision in both cases.

The ’441 patent discloses and claims an apparatus for identifying biomolecules.  The apparatus employs an optical detector capable of recognizing and measuring a biomolecule linked to a probe, fluorophore, or other molecular label.  The main question in both IPRs was whether the claim phrase “an apparatus for identifying a single biomolecule” meant that the apparatus was capable of identifying a biomolecule based on the detection of one individual biomolecule, or whether the claim language meant that identification required multiple copies of the biomolecule in order to identify the biomolecule. 

The Board concluded the claim language indicated that the apparatus needed only one individual biomolecule in order to identify the single biomolecule.  The Board ultimately found that the Hassibi reference did not teach the limitation of “identifying a single biomolecule,” but that the Choumane reference did.

In finding that the Hassibi reference did not teach the limitation of “identifying a single biomolecule,” the Board relied on expert witness testimony that the Hassibi disclosure related to biomolecule detection methods that require at least 60,000 biomolecules.  This was based on the methods in the Hassibi reference being described as having “a sensitivity of detection as low as 0.1 attomoles.”

By comparison, the Board found that the Choumane reference did disclose identifying a single biomolecule, due to description of the Choumane including “very small openings … of a dimension less than the wavelength of light emitted by chromaphores,” where “these openings delimit very small observation volumes … for the detection and observation of individual chromophores.”  

In affirming the Board’s decisions, the Federal Circuit considered the dictionary definition of the term “identify,” the presence of the term “single” in the claim language, and the disclosure of the ’441 patent specification.  Based on the analysis of these factors, the Federal Circuit agreed that the claim construction of the ’441 patent apparatus being able to identify a single individual biomolecule was consistent with the ordinary meaning of the phrase in the context of the disclosure.  The Federal Circuit highlighted that the inclusion of the term “single” in the claim language significantly supported the Board’s interpretation, since there would be no reason to include the term “single” if the apparatus required multiple copies of a biomolecule in order to identify it.

The Federal Circuit also relied heavily on the ’441 patent specification, noting that the Board’s claim construction was supported by the specification in multiple locations.  Specifically, the Federal Circuit noted the specification disclosed that “[e]ach optical detection apparatus may sense the existence of a fluorophore on the single molecule by detecting photons emitted from the fluorophore.”  Further, the specification also discussed that the claimed devices should be capable of sequencing single molecules to avoid the known difficulty of asynchrony in both the amplification and sequencing steps of clustered sequencing methods.  Thus, the Federal Circuit found the Board’s claim constructions convincing. 

The opinion can be found here.

By Ann C. Bernert

This article summarizes aspects of the law and does not constitute legal advice. For legal advice for your situation, you should contact an attorney.