By Donald Zuhn

USPTO SealOn the same day that the
Supreme Court handed down its decision in Association for Molecular
Pathology v. Myriad Genetics, Inc
.
, the U.S. Patent and Trademark Office issued a one-page memorandum to its Patent Examining Corps to provide
preliminary guidance on the decision. 
The memo from Andrew Hirshfeld, the Deputy Commissioner for Patent
Examination Policy, notes that in Myriad,
"the Supreme Court held that claims to isolated DNA are not
patent-eligible
under 35 U.S.C. § 101," and that the decision "significantly
changes the Office's examination policy regarding nucleic acid-related
technology" (emphasis in original). 
The memo advises the examining corps that:

As of today,
naturally occurring nucleic acids are not patent eligible merely because they have
been isolated.  Examiners should now
reject product claims drawn solely to naturally occurring nucleic acids or
fragments thereof, whether isolated or not,
as being ineligible subject
matter under 35 U.S.C. § 101.  Claims
clearly limited to non-naturally-occurring nucleic acids, such as a cDNA or a
nucleic acid in which the order of the naturally-occurring nucleotides has been
altered (e.g., a man-made variant sequence), remain eligible.  Other claims, including method claims, that
involve naturally occurring nucleic acids may give rise to eligibility issues
and should be examined under the existing guidance in MPEP 2106, Patent Subject Matter Eligibility.

(emphasis in original).

The memo concludes by
noting that "[t]he USPTO is closely reviewing the decision in Myriad and will issue more comprehensive
guidance on patent subject matter eligibility determinations, including the role
isolation plays in those determinations."

Patent Docs thanks Hal Wegner for alerting the patent community to the memorandum.

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One response to “USPTO Issues Memo on AMP v. Myriad to Examining Corps”

  1. Watson, Come Here Quickly! Avatar
    Watson, Come Here Quickly!

    Claims clearly limited to non-naturally-occurring nucleic acids, such as … a nucleic acid in which the order of the naturally-occurring nucleotides has been altered (e.g., a man-made variant sequence), remain eligible.
    Is this an accurate reading of Myriad? If I am the first to discover a particular gene (and discover a utility for it), and the gene doesn’t have introns, can I get a claim to all of the nucleotide sequences coding for that gene if I disclaim the “naturally occurring” sequence?
    Similarly, what happens if I discover a new, useful protein expressed by an organism, without any knowledge of the organism’s genome (its genome hasn’t been sequenced), and I want to claim a novel non-obvious DNA encoding that protein. I obtain the amino acid sequence of the protein directly from the protein.
    Assuming the organism does not have introns, do I have to first sequence the genome of the organism and disclaim the naturally-occuring sequence? Or can I just use the phrase “wherein the nucleic acid encoding the protein consisting of SEQ ID X does not include a nucleic acid sequence found in nature”?

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