Earlier, the USPTO published an Official Gazette notice in November of 1996 providing a partial waiver of the requirements for restriction and for unity of invention determinations. The 1996 Notice permitted examination of a reasonable number (reasonable being normally up to ten, independent and distinct molecules).
Now, in their quest to reduce patent application pendency times without hiring examiners, the USPTO has reconsidered the policy “in view of changes in the complexity of applications filed” (their words), the types of inventions claimed and the state of the prior art in this technology since that time. Apparently the changes in the complexity of searching tools does not factor into the equation.
The USPTO claims that because of these unsubstantiated changes in the art, the search and examination of up to ten molecules described by their nucleotide sequence often consumes a disproportionate amount of Office resources. Consequently, a new Notice published in the gazette rescinds the partial waiver for restriction practice in national applications and for unity of invention determinations in both PCT international applications and the resulting national stage applications.
As part of the rationale, the office claims that in 1996, polynucleotide molecules were often claimed by simple reference to a nucleotide sequence. In contrast, the USPTO contends that:
polynucleotide molecules are now often claimed in a single application in a variety of complex formats, some of which may embrace multiple inventions, such as by reference to: the amino acid sequence of the protein encoded; the ATCC number of a deposited plasmid containing the polynucleotide molecule; arbitrary laboratory designations; function of the nucleic acid alone or in combination with a partial linear nucleotide sequence; a genus described in terms of homology, percent identity, or hybridization; a genus (or subgenus) described by nucleic acid sequence with variable positions specified within the sequence listing; single nucleotide polymorphisms (SNPs); antisense; or interfering RNA.
Interestingly, a quick search of the patent database shows patents that issued in 1996 claiming multiple sequences (US 5,589,582 [1]), claiming polynucleotides by referencing ATCC numbers of plasmids (US 5,589,582 [1]), claiming a polynucleotide having a certain percent identity (US 5,556,767 [2]), claiming antisense oligonucleotides (US 5,571,903 [3]) and so forth.
This change — and the resulting immense price hike for all biotech inventions — is effective immediately and is applicable to all pending applications. Note, however, that supplemental restriction requirements will not be advanced in applications that have already received an action on their merits in the absence of extenuating circumstances.
For regular U.S. applications, claims to polynucleotide molecules will be considered for independence, relatedness, distinction and burden as for claims to any other type of molecule.
For International applications and national stage filings of international applications, unity of invention will exist when the polynucleotide molecules, as claimed, share a general inventive concept, i.e., share a technical feature which makes a contribution over the prior art.
Examination of Patent Applications Containing Nucleotide Sequences (PDF) [4]