By Christopher P. Singer —

The USPTO published a pre-OG notice regarding its new position on restriction practice in pending applications that relate to nucleic acid sequences.  Prior to this notice, the PTO had been officially operating under the direction of an Official Gazette notice dated November 19, 1996.  The old notice allowed for a partial waiver of requirements for restriction and unity of invention for applications relating to nucleotide sequences by permitting examination of a "reasonable" number — typically up to ten — independent and distinct molecules described by their nucleotide sequences in a single patent application.  This newly published notice effectively rescinds the 1996 notice, and requires that claims to polynucleotide sequences "be considered for independence, relatedness, distinction and burden as for claims to any other type of molecule."  Effectively, this means that applicants will be allowed to claim only a single polynucleotide sequence per patent application.

The notice lists a number of factors that motivated the change, the most interesting of which (to me) is the 54-fold increase in the number of nucleic acid sequences in the GenBank® database (and a 91-fold increase in the number of nucleotides) between 1996 and February 2006.  Further, the Office believes that this change will provide applicants with a more focused and consistent course of examination, as a result of the decrease in the search and examination burdens. 

This notice provides an official change in the PTO’s policy regarding the treatment of inventions relating to polynucleotide sequences.  However, this change likely will have little to no effect on the day-to-day practice of biotech restriction practice, as this notice seems to postdate what has already become common practice at the PTO.