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), claiming polynucleotides by referencing ATCC numbers of plasmids (US 5,589,582), claiming a polynucleotide having a certain percent identity (US 5,556,767), claiming antisense oligonucleotides (US 5,571,903) 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)

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  1. Seems to me that this new notice is simply an admission of current restriction practices in the USPTO. Lately, I can’t get the Examiner to examine different splice variants of the same chromosomal gene in a single application! And since petition practice is the only mechanism to fight these overly narrow restrictions, my clients don’t fight them as often as I’d like. So, I find it sort of quaint and honest that the USPTO admits what appears to have been standing policy. I don’t imagine that it will have much, if any, effect on the number of applications I have to submit to get a reasonable number of sequences examined.

  2. The PTO doesn’t hate you, they just want to find as many ways as possible to keep your clients shelling out the duckets. I worked for a bioinformatics company where you could search 10, 50 or 100 or more sequences AT THE SAME TIME, notwithstanding the fact their algorithm is better than Smith-Waterman. The CIPO and EPO use this search platform. With the right system in place there is really no good (non-monetary) reason not to be able to search all splice variants of a given gene. Aaron Dubberley’s clients are getting screwed because the PTO insists on sticking with Compugen and not upgrading their search platform like the EPO and CIPO. It is kind of like the same reason you don’t see those easy-to-make lightbulbs that last forever on the shelves. You buy the cheap ones that last a few months, then you’re spending money to buy new ones. And I believe 10 is an arbitrary number of sequences to permit for a given application. Moreover, I disagree with the notion that it will create excessive art and undue burden to examine splice variants of a given gene. Labs and universities that study a gene STUDY a gene. If a gene has 5 splice variants it is not going to produce five times the references as if you searched only one of the splice variants.. or a gene without splice variants. Odds are you are going to uncover the same references, the same research teams and the same names over and over. If this restriction issue is remedied you can be sure another can or worms will be opened. And it will look a little like this newly proposed CON practice.