The FDA issued a direct rule, along with a proposed rule, that would ban medical products containing ozone-depleting substances (ODSs), including chlorofluorocarbons. Some medical devices, combination products and drug delivery systems using such substances have been exempted from the ban, but the agency said that exemption is no longer necessary because alternatives that don't use ODSs are now available. Comments are due by Dec. 25.

The U.S. Patent and Trademark Office (PTO) is seeking comment on an international effort to revise the World Intellectual Property Organization (WIPO) standard for presenting nucleotide and amino acid sequences and sequencing changes in XML in patent applications. The Committee on WIPO Standards adopted an interim version of the revisions in March but has yet to implement it, according to a PTO notice in Thursday's Federal Register. One of the efforts since then to finalize and improve the effectiveness of WIPO Standard ST.26 is a proposed guidance annex that would include a variety of sequence disclosure examples. The PTO is particularly interested in comments on the comprehensiveness and clarity of the revised standard and the proposed annex, as well as the proposed authoring/validation tool for creating the sequence listing in XML. Comments are due by Dec. 26.

The U.S. Patent and Trademark Office is also proposing revisions to two rules – one on the materiality standard for the duty to disclose information in patent applications and reexamination proceedings and the other on petitions for the revival or reinstatement of abandoned applications and canceled or expired registrations. The duty to disclose rule would bring the agency's regulations in line with a 2011 Federal Circuit Court decision. The PTO first proposed the changes in 2011, but given the passage of time since the comment period ended five years ago, the agency decided to open it to further comment before finalizing the rule. The rules were slated for publication in last Friday's Federal Register. Comments on both rules are due by Dec. 27.