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Only One Single Biomolecule in the Preamble

Posted by James Juo | Jan 16, 2024 | 0 Comments

The preamble of a patent claim typically is not given much weight, but that is not always the case.

In Pacific BioSciences of California, Inc.  v. Personal Genomics Taiwan, Inc., No. 22-1410, — F.4th — (Fed. Cir. Jan. 9, 2023), the preamble for the claims in U.S. Patent No. 7767441 included the phrase, “for identifying a single biomolecule.” See ParkerVision, Inc. v. Qualcomm Inc., 903 F.3d 1354, 1361–62 (Fed. Cir. 2018) (explaining that capability is one meaning of “for” language).

The [“identifying a single biomolecule”] language refers to (a) ascertaining the identity of a biomolecule, i.e., what that biomolecule is, and (b) doing so by examining just that one biomolecule, not others (even copies).


            We agree with the Board that this identifying-by-examining-one-alone meaning is the ordinary meaning of the phrase in context. The striking feature of the phrase is its inclusion of the word “single.” There is no apparent reason for the inclusion of the word “single” in the phrase except to indicate that the capability required is to identify a molecule with just that one molecule in view

The Federal Circuit found that, “in explaining the claimed bioassay system's single-molecule sensitivity, the specification differentiates, on one hand, “identifying a single biomolecule” by examining that individual biomolecule from, on the other, detecting a population-level signal from an ensemble or cluster of amplified or copied biomolecules.”

The patent specification explained that the known difficulty of asynchrony in both the amplification (e.g., drift between the sequences of ideally clonal templates) and sequencing (e.g., dephasing of the stepwise sequencing reactions amongst the sequencing templates) steps of clustered sequencing methods—was avoided by an apparatus with single-molecule detection sensitivity, enabling single-molecule examination for identification.

When the patent illustrates optical detection apparatuses “identifying a single biomolecule,” it depicts examination of one individual biomolecule, not an ensemble or cluster consisting of multiple biomolecules.

The Federal Circuit affirmed the PTAB's claim construction of the “identifying a single biomolecule” phrase that “contemplates running myriad optical detection apparatuses in parallel to detect a single or individual biomolecule in each such apparatus” where this construction requires that the apparatus have the capability to characterize (determine the identity of) a biomolecule by examining that biomolecule alone, with no copies created to form an ensemble for examination.

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About the Author

James Juo

James Juo is an experienced intellectual property attorney. He has successfully litigated various intellectual property disputes involving patents, trademarks, copyrights, and trade secrets. He also has counseled clients on the scope and validity of patent and trademark rights.


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