Courtesy of Benzinga.
BioDelivery Sciences International, Inc. (Nasdaq: BDSI) has been informed by the United States Patent & Trademark Office (USPTO) that it has rejected all claims of US Patent No. 7,824,588 (the ‘588 Patent) which is currently being asserted against BDSI by MonoSol RX, LLC (MonoSol). The USPTO’s action follows BDSI’s September 2011 request for reexamination of the ‘588 Patent by the USPTO.
The USPTO’s action is a significant and positive development for BDSI as the ‘588 Patent is a key element of claims first asserted in a litigation filed by MonoSol in November 2010 against BDSI and its commercial partners for BDSI’s ONSOLIS. In its action, MonoSol claimed that BDSI’s confidential, proprietary manufacturing process for ONSOLIS infringes on the thin film manufacturing process claimed in the ‘588 Patent.
BDSI has defended the case on the grounds of non-infringement and invalidity of the ‘588 Patent. In September 2011, BDSI filed an Inter Partes Request for Reexamation of the ‘588 Patent with the USPTO based on a number of prior art references that anticipate and/or render obvious (and thus unpatentable and invalid) all of the claims of the ‘588 Patent. The recent action by the USPTO supports BDSI’s position on this matter. The USPTO granted BDSI’s request for the reexamination, because it found substantial new questions of patentability affecting all 191 claims of the ‘588 Patent, and it issued an official action rejecting all 191 claims as unpatentable over a number of prior art references. MonoSol has two months to respond to this action, after which BDSI may comment to the USPTO on MonoSol’s response.
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