The First Application of Myriad by the USPTO

In a Memorandum from Andrew H. Hirshfeld, the Deputy Commissioner for Patent Examination ‎and Policy, addressed to all USPTO Examiners, the Deputy Commissioner instructed the ‎rejection of all naturally occurring nucleic acids, isolated or not, based on the Supreme Court ‎decision Association for Molecular Pathology v. Myriad Genetics, Inc., because "naturally ‎occurring nucleic acids are not patent eligible merely because they have been ‎isolated." According to the Memorandum, which appears to be the only USPTO guidance on the ‎issue to date, "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." According to Dr. ‎Simmons of Sughrue Mion, "it is uncertain how narrowly or broadly the USPTO will apply this ‎decision, although the Memorandum is very narrowly tailored." The Memorandum does not ‎indicate that any other subject matter that occurs naturally but is claimed in isolated form should ‎be rejected based on Myriad. A copy of the Memorandum is available here.‎