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Establishing that a prior art reference inherently anticipates claims of a patent application requires more than “speculative assumptions” about what the reference teaches, the Federal Circuit has held. David M. Rapoport v. William C. Dement, No. 00-1451, Fed. Cir. In its June 28 ruling, the Federal Circuit said that under its precedent, inherency “may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” A panel of the court upheld the Board of Patent Appeals and Interferences, which in an interference awarded priority in favor of William C. Dement and related parties over David M. Rapoport and further ordered that Dement was entitled to a patent containing the limitations at issue and that Rapoport is not. The subject matter claimed in the applications of the respective parties relates to treatment of sleep apnea, the transient cessation of breathing during sleep whose side effects can include anxiety. SLEEP APNEA The count in the interference relates to the treatment of sleep apnea by administering certain azapirone compounds such as buspirone. After the interference was declared, Dement was accorded the benefit of the filing date of parent applications and designated the senior party. Rapoport then alleged that the subject matter was not patentable to Dement on the grounds that it was anticipated and/or rendered obvious by a prior art reference authored by Rapoport, known as the FPR Publication. The board awarded priority of invention to Dement after concluding that Dement was entitled to an earlier date of conception than was Rapoport and that Dement’s conception inured to the benefit of the application involving his associated parties. On appeal, Rapoport did not contest the priority determination but argued that the board erred in finding the Dement claims not anticipated or obvious in light of the FPR Publication. Rapoport argued that the claimed “method for treatment of sleep apneas” in the interference count should include both the treatment of the sleep disorder and treatment of anxiety secondary to sleep apnea. Dement contended that the board correctly found that in the context of the interference, treatment of the underlying disorder is distinct from treatment of secondary symptoms. EVERY LIMITATION The Federal Circuit noted that to anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, expressly or inherently. The court agreed with the board’s construction, finding that the plain language of the interference count unambiguously refers to the treatment of sleep apneas narrowly defined and does not also include treatment of associated symptoms. The written description of the Dement application explicitly defines the “sleep apneas” at issue as the sleeping disorders themselves, the court added. Further, the summary of the invention in the Dement application describes administrations of doses that are consistent with treatment of the underlying disorder and inconsistent with treatment of secondary conditions, it said. Similarly, it said, the detailed description of the invention discloses treatment only for the underlying disorder. LIMITED DISCLOSURE The appeals panel further agreed that the disclosure of the FPR Publication was limited to treatment of anxiety in patients suffering from sleep apnea with buspirone and did not address treatment of the underlying sleep apnea disorder. The publication does not disclose tests in which buspirone was administered to patients with the intent to cure the underlying condition, it said, adding that even the proposed testing in the publication is limited to the treatment of patients suffering from anxiety, not from sleep apnea. The publication does not show administering buspirone in any specific amounts to patients suffering from sleep apnea, it added, in contrast to the Dement application, which discloses dosages to be administered at bedtime to patients suffering from sleep apnea. Rapoport further argued that the publication inherently anticipated the count, saying the publication discloses dosages of buspirone three times a day. The court noted that the publication explicitly states that the dosages were for the treatment of anxiety, not sleep apnea, and said that “Rapoport’s argument is based on at least two speculative assumptions: (1) that a treatment regimen of three doses a day would necessarily include an administration ‘at the time of sleep;’ and (2) that administering two 10 mg [milligram] doses of buspirone at unspecified times throughout the day in conjunction with a 10 mg dose of buspirone at bedtime would necessarily result in a ‘therapeutically effective amount’ of buspirone treatment for the purpose of treating the underlying sleep apnea disorder.” FAILED TO MEET BURDEN The court found that Rapoport failed to meet his burden of proving by a preponderance of the evidence that the proposed dosage treatment in the publication would result in a therapeutically effective amount but instead presented only argument that the range described in the Dement application of 20-40 mg does not rule out the thrice-daily 10 mg doses discussed in the publication. Rapoport is represented by Roger L. Browdy of Browdy and Neimark in Washington, D.C. Dement is represented by David S. Abrams of Roylance, Abrams, Berdo & Goodman in Washington. �; Copyright 2001 Mealey Publications, Inc.

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