Pac. Biosciences of Cal., Inc. v. Pers. Genomics Taiwan, Inc

Authored by: Jeremy J. Gustrowsky

A recent decision from the Federal Circuit has provided important guidance on what it means for a patented device to be “capable of identifying a single biomolecule.” The case centered around U.S. Patent No. 7,767,441, which describes an apparatus designed to identify individual biomolecules—such as DNA or proteins—using optical detection methods. The dispute arose between Pacific Biosciences of California, Inc. (PacBio) and Personal Genomics Taiwan, Inc. (PGI), with both parties challenging the Patent Trial and Appeal Board’s (PTAB) interpretations and findings regarding the patent’s claims.

The heart of the matter was the meaning of the phrase “identifying a single biomolecule.” PacBio argued that the patent should cover devices that can identify a biomolecule by making copies and analyzing the group, not just by examining the original molecule alone. However, the court sided with the PTAB’s interpretation, holding that the patent requires the apparatus to be capable of determining the identity of just one biomolecule by examining that molecule itself, not by analyzing a collection of copies. The court emphasized that the word “single” in the claim was key, and the patent’s description repeatedly highlighted the importance of single-molecule sensitivity as a way to avoid problems seen in methods that rely on analyzing groups of molecules.

The court also reviewed whether certain prior art references anticipated or made obvious the claimed invention. In one instance, the court agreed with the PTAB that a reference called Hassibi did not teach the ability to identify a single biomolecule, because its detection methods were not sensitive enough to examine just one molecule. On the other hand, the court found that another reference, Choumane, did disclose technology capable of detecting and identifying individual biomolecules, supporting the PTAB’s finding that some claims of the patent were not valid in light of this prior art.

In the end, the Federal Circuit affirmed the PTAB’s decisions, upholding the interpretation that the patent covers only those devices capable of identifying a single biomolecule by direct examination. This decision provides valuable clarity for inventors and companies working in the field of molecular detection, highlighting the importance of precise claim language and the need for true single-molecule sensitivity in such patents.