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USPTO rescinds partial waiver of restriction requirements for nucleotide inventions
March 13, 2007
In a news release yesterday, the USPTO has rescinded its partial waiver of the requirements of 37 C.F.R. §§ 1.141 and 1.475 et seq. Under the former policy, a "reasonable number" of nucleotide inventions, typically up to ten, would be considered in a single application without a restriction requirement or issues regarding unity of invention. This requirement extends to all new and pending applications, although if a substantive office action has been sent, the notice indicates that a supplemental restriction requirement will only be issued in "extenuating circumstances." The result is that nucleotide inventions are now subject to the same unity of invention requirements as all other inventions. The USPTO states that this was done in an effort to shorten the pendency of applications, although a sure side effect will be an increase in separate applications that will need to be filed, and as a result, more fees to the USPTO. Click through to read the USPTO's summary of the release and for the examination guidelines provided.Here is the summary:
The United States Patent and Trademark Office (Office) published an Official Gazette notice in November of 1996 providing a partial waiver of the requirements for restriction pursuant to 37 CFR 1.141 et seq. and for unity of invention determinations pursuant to 37 CFR 1.475 et seq. See Examination of Patent Applications Containing Nucleotide Sequences, 1192 Off. Gaz. Pat. Office 68 (Nov. 19, 1996) (1996 Notice). The 1996 Notice permitted examination of a reasonable number, normally up to ten, independent and distinct molecules described by their nucleotide sequence in a single patent application. The Office has reconsidered the policy set forth in the 1996 Notice in view of changes in the complexity of applications filed, the types of inventions claimed and the state of the prior art in this technology since that time. Because of these changes, the search and examination of up to ten molecules described by their nucleotide sequence often consumes a disproportionate amount of Office resources over that expended in 1996. Consequently, with this Notice the Office rescinds the partial waiver of 37 CFR 1.141 et seq. for restriction practice in national applications filed under 35 U.S.C. 111(a), and 37 CFR 1.475 et seq. for unity of invention determinations in both PCT international applications and the resulting national stage applications under 35 U.S.C. 371. This Notice 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.
Relevant examination guidelines:
For National applications filed under 35 U.S.C. 111(a), polynucleotide inventions will be considered for restriction, rejoinder and examination practice in accordance with the standards set forth in MPEP Chapter 800 (except for MPEP 803.04 which is superceded by this Notice). 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 under 35 U.S.C. 371, unity of invention determination will be made in view of PCT Rule 13.2, 37 CFR 1.475 and Chapter 10 of the ISPE Guidelines. 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.
The full release is available here. Hat tip to the Patent Prospector.
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