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.