USPTO Issues Memo on AMP v. Myriad to Examining Corps

By Donald Zuhn --

On 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.

Comments

[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"?