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Nucleonics Says USPTO Rejects All Claims for Fourth Time in Re-Exam of Benitecís Patent

Tuesday, April 22, 2008

Horsham, PA -- Nucleonics, Inc., a biotechnology company focused on the development of novel expressed RNA interference-based (eiRNA) therapeutics, announced today that the U.S. Patent and Trademark Office has issued a fourth rejection of all of the claims of Benitec’s U.S. Patent No. 6,573,099, which is the subject of litigation Benitec brought against Nucleonics in March 2004.

"Nucleonics remains confident in its freedom to operate and expects the final office action to be consistent with the patent office findings to date, namely that all of the claims of the Benitec patent are invalid," said Robert Towarnicki, Nucleonics President and Chief Executive Officer. "We continue to assert that the ‘099 patent and all its related patent applications, including numbers 10/346,853, 10/759,841, 10/821,726, 09/646,807, 10/646,070 and 10/821,710, suffer the same fatal flaws that have caused the USPTO to repeatedly reject all claims despite Benitec’s arguments and interviews."

Mr. Towarnicki noted that Benitec’s "pleasure" in having the USPTO modify its prior art rejection in view of the key Fire-Mello patent from an "anticipatory" to an "obviousness" rejection relates only to Benitec’s dual promoter constructs, having a promoter-sense sequence and a separate promoter-antisense sequence.

"Even if Benitec were able to successfully argue the non-obviousness of such constructs over Fire, which we believe is doubtful, it would not impact Nucleonics or likely anyone else as this type of construct is highly inefficient for the creation of siRNA and would never be utilized commercially," commented Mr. Towarnicki.

Nucleonics also said today that the company has learned that the U.S. Supreme Court will not grant Nucleonics’ petition for writ of certiorari in the Benitec v. Nucleonics litigation concerning the ‘099 patent. The case was dismissed at the district court level on Benitec’s motion, citing lack of jurisdiction. The Federal Circuit upheld the dismissal in a 2-1 decision and now the Supreme Court has declined to review the case. All that a denial of a petition for a writ of certiorari means is that fewer than four members of the Court thought it should be granted. The Supreme Court has rigorously insisted that such a denial carries with it no implication whatever regarding the Court’s views on the merits of a case that it has declined to review. In light of the recent USPTO action we are not overly concerned with this decision. With all remaining patent claims rejected yet again, the Court action may well prove irrelevant to Nucleonics.

About Nucleonics

Nucleonics, founded in January 2001, is an emerging biotechnology company focused on the development of novel RNA interference-based therapeutics for viral and other diseases. The company’s lead program, a gene silencing therapeutic against chronic hepatitis B infection, is currently in Phase 1 human safety studies and a second gene silencing therapeutic, for hepatitis C infection, is in late preclinical development. Privately owned, Nucleonics is headquartered in Horsham, Pennsylvania.

For more information on the company, please visit the Nucleonics website at Individuals interested in learning more about participating in the company’s clinical trials for hepatitis B should visit our web site at If you have further questions, please email

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