November 6, 2015

Farewell the ten sequences rule. The new MPEP disposes of the old §803.04 rule.

The latest MPEP revisions make a variety of changes. Most of the attention has focused on changes to examination procedures for 35 U.S.C. §101, for the obvious reason that this is an aspect of the law that has been in considerable flux of late. However, what first caught your humble blog scribe’s eye was the change to MPEP §803.04. Previously, this section had provided that “in most cases, up to ten independent and distinct nucleotide sequences will be examined in a single application without restriction…” (emphasis added).

This rule was added back in 1996, and in recent years it has become somewhat contentious. The complexity of nucleotides being discovered and claimed has increased since 1996. As a result, the PTO published a notice in the 27 March 2007 patent gazette that purported to rescind the 1996 rule. However, the MPEP was never updated to reflect this rescission, and right up until 29 October 2015, the MPEP continued to say that an applicant should ordinarily get ten sequences examined per application. Moreover, the MPEP provides that “Orders and Notices, or portions thereof, relating to the examiners’ duties and functions which have been omitted or not incorporated in the text may be considered obsolete.” Therefore, applicants could be forgiven for thinking that the 1996 rule was still in effect. The ambiguous status of the 2007 rescission notice has given rise to disagreements between applicants and examiners as to when election of species requirements are proper for SEQ ID NOs.

For better or worse, the new MPEP resolves this disagreement. The revised text makes clear that “[a]ll pending applications are subject to the 2007 OG notice… Claims to polynucleotide molecules will be considered for independence, relatedness, distinction and burden in the same manner as claims to any other type of molecule.” In other words, the “ten sequences” rule is no more.

However, while the 2007 OG notice is no doubt correct that the complexity of claimed SEQ ID NOs has increased since 1996, it should be noted that the sophistication of sequence search tools has also increased. It is not clear, therefore, that the Director’s reasoning in 1996 (“to further aid the biotechnology industry… without creating an undue burden on the Office, the Director has decided sua sponte to partially waive the requirements of 37 CFR 1.141 et seq. and permit a reasonable number of… nucleotide sequences to be claimed in a single application”) is actually obsolete.

The new §803.04 has the potential to do real harm to the biotechnology industry, which under the terms of the new rule could be required to file a separate application on every individual SEQ ID NO claimed. When and if the PTO solicits comments on the new MPEP revisions, interested stakeholders should urge the Director to reinstate the “ten sequences” rule.