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USPTO Orders Re-Examination of Benitec s US Patent Based on Nucleonics Request

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The US Patent and Trademark Office earlier this month ordered a re-examination of Benitec’s US patent • numbered 6,573,099 and entitled “Genetic Constructs for Delaying or Repressing the Expression of a Target Gene” • pursuant to a request made by Nucleonics as part of a broader intellectual property dispute between the companies.

On Oct. 4, Nucleonics asked the USPTO to re-examine 22 claims in the Benitec patent, which covers the company’s core DNA-directed RNAi technology, based on examples of prior art that allegedly render the patent invalid. The patent’s abstract states that the invention comprises “synthetic genes [used] for modifying endogenous gene expression in a cell, tissue, or organ of a transgenic organism, in particular a transgenic animal or plant. More particularly, the … invention provides novel synthetic genes and genetic constructs which are capable of repressing delaying or otherwise reducing the expression of an endogenous gene or a target gene in an organism when introduced thereto.”

According to a USPTO document, Nucleonics’ request was granted on Dec. 7, triggering a two-month waiting period for Benitec to respond before a full re-examination is conducted. Benitec Chairman and CEO John McKinley said he had no comment on the situation.

Should the USPTO go ahead with the re-examination, a review of the IP will be conducted based on the prior art examples cited by Nucleonics. On average, the patent office completes a re-examination within 21 months. The patent holder, and in some cases the initiating third party, can then rebut the examiner’s finding.

“We’re pleased that the USPTO examined the prior art submitted by us and determined that each and every claim is the subject of a re-exam,” Robert Towarnicki, Nucleonics’ CEO, told RNAi News this week. “We couldn’t have asked for anything more at this stage than to get each claim of the patent re-examined.”

Although encouraged by the patent office’s action, Towarnicki pointed out that an order for re-examination is a very small victory and a far cry from the actual invalidation of a patent. Indeed, of the less than 400 requests for re-examination the USPTO received last year, all were granted. In almost two-thirds of cases, at least one of the claims was changed, usually narrowed. In almost a third of the re-examinations, all of the claims were upheld, and in 10 percent of cases, all the claims were canceled.

Nucleonics request to the USPTO was made as part of its ongoing intellectual property dispute with Benitec. Earlier this year, Benitec filed a lawsuit alleging that Nucleonics, Ambion, and GenScript infringed its US patent. While GenScript and Ambion have settled with Benitec through licensing deals, Nucleonics has decided to fight it out: Aside from its request to the USPTO, Nucleonics also asked the patent and trademark officials in Australia to review two other Benitec patents issued in that country. As reported by RNAi News, the Australian patent office recently said it was poised to begin proceedings to revoke two of Benitec’s Australian patents based on the re-examinations (see RNAi News, 12/3/2004).

• DM