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The preamble of a patent claim is an introductory statement that defines the environment in which the claimed invention is to be used or operated. Whether a preamble is construed to be a part of the claim can be crucial to the outcome of a biotechnology patent infringement or interference case, as recent opinions by the U.S. Court of Appeals for the Federal Circuit illustrate. It has long been the case that if the preamble is “necessary to give life, meaning, and vitality” to the claim, then it should be construed as a claim limitation. See, e.g., Kropa v. Robie, 187 F.2d 150, 152 (CCPA 1951). If, on the other hand, the preamble merely states the intended use of the invention, then the preamble cannot be said to constitute or explain a claim limitation and is of no significance to claim construction. See, e.g., Pitney Bowes Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999). In the past year, the Federal Circuit has construed preambles in three biotechnology cases. All three cases involved method claims having one or more manipulative steps. Bristol-Myers Squibb Co. v. Ben Venue, 246 F.3d 1368 (Fed. Cir. 2001), an infringement action, involved two patents related to a method of administering the anti-tumor drug paclitaxel (Taxol) during a three-hour period. Representative claims of the two patents are: – “A method for reducing hematologic toxicity in a cancer patient undergoing Taxol treatment comprising parenterally administering to said patient an antineoplastically effective amount of about 135-175 mg/m2 taxol over a period of about three hours.” U.S. Patent No. 5,641,803. – “A method for treating a cancer patient to effect regression of a taxol-sensitive tumor, said method being associated with reduced hematologic toxicity, said method comprising: (i) premedicating said patient with a medicament that reduces or eliminates hypersensitivity reactions; and (ii) parenterally administering to said patient an antineoplastically effective amount of about 135-175 mg/m2 taxol over a period of about three hours.” U.S. Patent No. 5,670,537. The preamble of each claim is the language before the word “comprising.” The defendants argued to the district court that the claims were invalid due to anticipation by a published research study. The study described treating cancer patients with three-hour infusions of paclitaxel within the claimed dosage ranges, though without success. The court held that the study anticipated the claims and granted summary judgment to the defendants. On appeal, Bristol-Myers argued that the failure to treat the preamble as a necessary limitation constituted reversible error. The Federal Circuit disagreed. It noted that the steps of the three-hour infusion method are performed in the same way, regardless of whether the patient experiences a reduction of hematologic toxicity. Language such as “for reducing hematologic toxicity” and “to effect regression of a taxol-sensitive tumor, said method being associated with reduced hematologic toxicity” is, according to the Federal Circuit, “only a statement of purpose and intended result.” Id. at 1376. The Federal Circuit concluded that since the preamble phrases at issue did not result in a manipulative difference in the steps of the claim, they were not claim limitations and could be ignored for purposes of construing the claim and determining anticipation. According to the court, the claims required no particular result from carrying out the claimed steps. Therefore, the claims were held to be anticipated by the published study describing the performance of the manipulative steps, even though the study had not met with success. OPPOSITE FINDING IN ‘RAPOPORT’ Two months later, the Federal Circuit appeared to reach the opposite result in Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir. 2001), finding that the preamble in a method of treatment claim was a necessary limitation. Rapoportinvolved an appeal of an award of priority in a patent interference. The interference count related t “A method for treatment of sleep apneas [transient cessation of breathing during sleep] comprising administration of a therapeutically effective amount of a Formula I azapirone compound … to a patient in need of such treatment.” 254 F.3d at 1056. The azapirone compound of Formula I included the drug buspirone. On appeal, David M. Rapoport did not contest the award of priority to William C. Dement by the Board of Patent Appeals and Interferences, but instead argued that the board erred in not finding Dement’s claims anticipated by a published study. The study involved administering buspirone to treat anxiety in patients suffering from sleep apnea, but did not describe administering buspirone to treat sleep apnea itself. The patients included people requiring the use of a nocturnal ventilator, as well as normal volunteers. Neither the parties nor the board disputed that the preamble should be construed as a claim limitation. Rather, Rapoport had argued to the board that the preamble “method for treatment of sleep apneas” in the interference count should be interpreted broadly to include both treatment of anxiety secondary to sleep apnea, and treatment of the underlying sleep disorder itself. The board, however, had interpreted this phrase as being limited to the underlying disorder itself. The board found that Dement’s claims were not anticipated by the study. The Federal Circuit affirmed the board, finding that substantial evidence supported the conclusion that the study did not disclose administration of buspirone to treat sleep apnea itself. The court noted that the disputed phrase “treatment of sleep apneas” was technically a part of the preamble, but found that it should be treated as a necessary claim limitation. The reason provided by the Rapoport court for treating the preamble as a necessary limitation was that without it, the phrase “a patient in need of such treatment” would be meaningless. Id. at 1059. ‘GRIFFIN’ ALSO FINDS A LIMITATION Most recently, the Federal Circuit held that the preamble in a method-of-diagnosis claim functioned as a claim limitation. The case, Griffin v. Bertina, 285 F.3d 1029 (Fed. Cir. 2002), appears to be the first in which the court has construed a claim involving a method for diagnosing a disease. Like Rapoport, Griffininvolved the appeal of an award of priority in a patent interference. In Griffin, the invention was directed to a method of diagnosing thrombosis. The count comprised a number of manipulative steps. Specifically, the count was: “A method for diagnosing an increased risk for thrombosis or a genetic defect causing thrombosis comprising the steps of: (A) obtaining, from a test subject, test nucleic acid comprising codon 506 within EXON 10 of the human Factor V gene; and (B) assaying for the presence of a point mutation in the nucleotides of codon 506 within EXON 10 of the human factor V gene…wherein the presence of said point mutation in said test nucleic acid indicates an increased risk for thrombosis or a genetic defect causing thrombosis.” 285 F.3d at 1031. The diagnostic test is based on the finding that a mutation in the human factor V gene found in patients with a specific blood coagulation disorder is associated with an increased risk of thrombosis. During the interference, John H. Griffin alleged that he was the first to invent, on the basis of sequencing gels that showed a mutation in a person with the blood coagulation disorder. The board, however, construed the count as requiring an appreciation of the significance of the identified point mutation to the diagnosis of an increased risk of thrombosis due to a genetic defect. Because Griffin’s evidence failed to demonstrate this appreciation, the board awarded priority to Rogier M. Bertina. On appeal, Griffin argued that the count should not be limited by the preamble “for diagnosing an increased risk of thrombosis or a genetic defect causing thrombosis” or by the “wherein” clause in the body of the count that specifies the correlation with increased risk. Those clauses, according to Griffin, merely state the inherent result of performing the manipulative steps of the count. Griffin argued the count should be construed as limited only to its manipulative steps. The Federal Circuit disagreed. The court noted that diagnosis is the essence of the invention and “its appearance in the count gives ‘life and meaning’ to the manipulative steps.” Id. at 1033. The manipulative steps — that is, obtaining nucleic acid and assaying for a point mutation — “have little meaning or utility unless they are placed within the context of the diagnosis of an increased risk of developing thrombosis, recited in the preamble and ‘wherein’ clauses.” Id. The Federal Circuit concluded that the preamble and the “wherein” clause had limiting effect, and affirmed the board’s judgment of priority to Bertina. FINDING THE COMMON THREAD All three of these cases involved method claims with one or more manipulative steps. In Bristol-Myers, the phrases at issue were construed not to be a further limitation of the manipulative steps in the body of the claim. In contrast, in Rapoportand Griffin, the preamble was construed to be a necessary limitation. As a consequence, to meet the limitations of the claims required something more than just performing the manipulative steps. When exactly is the preamble of a biotechnology-method claim necessary to give “life, meaning, and vitality” to the claim? In other words, when will it be construed to be a limitation? The preambles of the claims at issue in all three cases expressed the overarching purpose of performing the manipulative steps recited in the claims, namely, treatment of cancer, treatment of sleep apnea and diagnosis of an increased risk of thrombosis. The preambles in the Bristol-Myers patents, however, also included statements of inherent results, such as efficacy or reduction of hematologic toxicity. The court concluded that the disputed claims did no more than claim a result, namely, the efficacy and reduced toxicity of three-hour infusions in cancer patients. According to the court, the purpose of the claimed method — treating cancer — was no different from the purpose described in the published study. The overarching purpose of treating patients in the disputed claims in Rapoport– treatment of sleep apnea — differed from that in the study – treatment of symptoms associated with sleep apnea. Similarly, the preamble in the Griffinclaims recited the purpose of performing the manipulative steps — diagnosis of an increased risk of thrombosis. Thus, an analysis of these three cases suggests that preamble language in a method-of-treating or a method-of-diagnosing claim is more likely to be treated as a limitation when it states the purpose for performing the claimed method, and to be dismissed as surplus verbiage when it describes an inherent result. Karen Bl�chlinger and W. David Shenk are associates at Seattle’s Christensen O’Connor Johnson & Kindness, http://www.cojk.com . Bl�chlinger has a Ph.D. in molecular biology and prosecutes biotechnology patent applications. Shenk is a litigator with experience in patent interferences.

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