1. “In finding these claims invalid as obvious, the district court relied on a press release (“the RFIB2001 Press Release”), which quotes a named inventor and reports some results of a study that is discussed at length in the IBS-D Patents. Did the district court err by relying on the RFIB2001 Press Release as prior art under pre-AIA Section 102(a) without evidence that it reported work by ‘others’?”
2. “Even considering the RFIB2001 Press Release, the highest dosage for which the district court found prior art reported successful results in treating IBS-D was 1,200 mg per day. Did the district court err in applying this Court’s ‘prior-artrange’ cases to find a reasonable expectation of success in treating IBS-D using the claimed dosage (1,650 mg per day) because it was ‘within the known range’? Issue Concerning Polymorph Patents: Two patents claim rifaximin in a form labeled ‘polymorphic form β.’”
3. “At the time of the patent filing, it was unknown whether rifaximin was even polymorphic, much less whether form β existed. Did the district court err in finding that a skilled artisan would have had a motivation and reasonable expectation of success in preparing the claimed rifaximin form β?”
