Two Points
It is of interest to review the sequence of events between the landmark publication in Nature and the subsequent filing and issue of a US Patent covering this subject matter. The manuscript for the paper was received by Nature on Sep 16, 1997 and was accepted for publication on November 24, 1997. This seminal paper was published by Nature on Feb 19, 1998 with the title "Potent and specific genetic interference by double-stranded RNA in Caenorhabditis elegans". A patent on this subject matter was not filed till Dec 18, 1998 almost 10 months after the initial publication. My guess is that someone at the technology transfer office at Carnegie Institution of Washington was not quite sure about the application of such fundamental scientific discovery.
Genetic inhibition by double-stranded RNA US Patent 6,506,559
Abstract:
A process is provided of introducing an RNA into a living cell to inhibit gene expression of a target gene in that cell. The process may be practiced ex vivo or in vivo. The RNA has a region with double-stranded structure. Inhibition is sequence-specific in that the nucleotide sequences of the duplex region of the RNA and of a portion of the target gene are identical. The present invention is distinguished from prior art interference in gene expression by antisense or triple-strand methods.
The above patent abstract written in 1998 succinctly and elegantly defined the essence of the technology. This patent was filed in December 18, 1998 and only issued in January of 2003. What happened? Why does it take four years for the patent to be issued? Although patent are public document, you will not find the background information on the process that lead to the issue of this patent. To find this information you will have to look at the "File Wrapper". The folder in which the U.S. Patent and Trademark Office maintains the application papers is referred to as a file wrapper. In it contains the "office action" notifications and responses from the patent attorney amongst other documents. I view the patent application exercise as a bargaining process between the patent attorney and the examiner. Your patent attorney drafts the specifications of the patent according to information supplied by you. His responsibility include drafting claims that are as broad as possible consistent with the specifications. In addition making sure that the patent application meets all statutory requirements, the patent examiner has to ensure that the claims are not overly broad beyond what the specifications can support. In critical cases of due diligence for freedom to operate, it is also essential to review the file wrapper.
Patent Application Information Retrieval (PAIR) is an electronic service provided by USPTO for information on issued or published patent application status. Also available at PAIR are file wrapper document images. For convenience, the electronic copies of file wrappers can also be ordered from USPTO. Other commercial suppliers include Advanced Patent Services and Access Patent Group. In the software (WizPatent Manager and WizPatent Express) that we have developed and knowing the importance of information from file wrapper, we have provided links to PAIR all US Patents downloaded. This makes looking up file wrapper information on PAIR a breeze.
However the PAIR portal is far from perfect. Not infrequently the portal is down. In other cases, the images are not available and you have to order them commercially. This usually cost about a $100 and the average size of the file wrapper is between 50 to a 100 pages.
