就近期美国联邦最高法院Mayo v. Prometheus一案的判决,对美国《专利法》第101条"专利适格标的"产生的影响进行了研究。对Mayo基本案情进行介绍后,梳理了近年来美国《专利法》第101条专利适格标的范围及其检测标准的变化,指...就近期美国联邦最高法院Mayo v. Prometheus一案的判决,对美国《专利法》第101条"专利适格标的"产生的影响进行了研究。对Mayo基本案情进行介绍后,梳理了近年来美国《专利法》第101条专利适格标的范围及其检测标准的变化,指出美国专利标的物范围一直缺乏清晰、明确的界定;专利适格标的检测方法虽历经多次变革,但始终无法形成一个统一、清晰的检测标准。从法律功能、专利效力、产业发展等角度,分析了Mayo案件判决产生的影响,并就企业创新成果的保护、专利申请提出了建议。展开更多
AIM： To evaluate whether treatment with the Prometheus system significantly affects cytokines, coagulation factors and other plasma proteins. METHODS： We studied nine patients with acute-onchronic liver failure and ...AIM： To evaluate whether treatment with the Prometheus system significantly affects cytokines, coagulation factors and other plasma proteins. METHODS： We studied nine patients with acute-onchronic liver failure and accompanying renal failure. Prometheus therapy was performed on 2 consecutive days for up to 6 h in all patients. Several biochemical parameters and blood counts were assessed at regular time points during Prometheus treatment. RESULTS： We observed a significant decrease of both protein-bound （e.g. bile acids） and water-soluble （e.g. ammonia） substances after Prometheus therapy. Even though leukocytes increased during treatment （P〈 0.01）, we found no significant changes of C-reactive protein, interleukin-6, and tumor necrosis factor-o plasma levels （all P 〉 0.5）. Further, antithrombin 3, factor II and factor V plasma levels did not decrease during Prometheus therapy （all P 〉0.5）, and the INR remained unchanged （P = 0.4）. Plasma levels of total protein, albumin, and fibrinogen were also not altered during Prometheus treatment （all P 〉 0.5）. Finally, platelet count did not change significantly during therapy （P= 0.6）. CONCLUSION： Despite significant removal of protein- bound and water-soluble substances, Prometheus therapy did not affect the level of cytokines, coagulation factors or other plasma proteins. Thus, the filters and adsorbers used in the system are highly effective and specific for water-soluble substances and toxins bound to the albumin fraction.展开更多
AIM： To evaluate treatment safety and hemodynamic changes during a single 6-h treatment with the PrometheusTM liver assist system in a randomized, controlled study. METHODS： Twenty-four patients were randomized to e...AIM： To evaluate treatment safety and hemodynamic changes during a single 6-h treatment with the PrometheusTM liver assist system in a randomized, controlled study. METHODS： Twenty-four patients were randomized to either the study group or to one of two control groups： Fractionated Plasma Separation Adsorption and Dialysis, PrometheusTM system （Study group; n = 8）; Molecular Adsorbent Recirculation System （MARS）TM （Control group 1, n = 8）; or hemodialysis （Control group 2; n = 8）. All patients included in the study had decompensated cirrhosis at the time of the inclusion into the study. Circulatory changes were monitored with a Swan-Ganz catheter and bilirubin and creatinine were monitored as measures of protein-bound and water-soluble toxins. RESULTS： Systemic hemodynamics did not differ between treatment and control groups apart from an increase in arterial pressure in the MARS group （P = 0.008）. No adverse effects were observed in any of the groups. Creatinine levels significantly decreased in the MARS group （P = 0.03） and hemodialysis group （P = 0.04）. Platelet count deceased in the Prometheus group （P = 0.04）.CONCLUSION： Extra-corporal liver support with Prometheus is proven to be safe in patients with endstage liver disease but does not exert the beneficial effects on arterial pressure as seen in the MARS group,展开更多
文摘就近期美国联邦最高法院Mayo v. Prometheus一案的判决,对美国《专利法》第101条"专利适格标的"产生的影响进行了研究。对Mayo基本案情进行介绍后,梳理了近年来美国《专利法》第101条专利适格标的范围及其检测标准的变化,指出美国专利标的物范围一直缺乏清晰、明确的界定;专利适格标的检测方法虽历经多次变革,但始终无法形成一个统一、清晰的检测标准。从法律功能、专利效力、产业发展等角度,分析了Mayo案件判决产生的影响,并就企业创新成果的保护、专利申请提出了建议。
文摘AIM： To evaluate whether treatment with the Prometheus system significantly affects cytokines, coagulation factors and other plasma proteins. METHODS： We studied nine patients with acute-onchronic liver failure and accompanying renal failure. Prometheus therapy was performed on 2 consecutive days for up to 6 h in all patients. Several biochemical parameters and blood counts were assessed at regular time points during Prometheus treatment. RESULTS： We observed a significant decrease of both protein-bound （e.g. bile acids） and water-soluble （e.g. ammonia） substances after Prometheus therapy. Even though leukocytes increased during treatment （P〈 0.01）, we found no significant changes of C-reactive protein, interleukin-6, and tumor necrosis factor-o plasma levels （all P 〉 0.5）. Further, antithrombin 3, factor II and factor V plasma levels did not decrease during Prometheus therapy （all P 〉0.5）, and the INR remained unchanged （P = 0.4）. Plasma levels of total protein, albumin, and fibrinogen were also not altered during Prometheus treatment （all P 〉 0.5）. Finally, platelet count did not change significantly during therapy （P= 0.6）. CONCLUSION： Despite significant removal of protein- bound and water-soluble substances, Prometheus therapy did not affect the level of cytokines, coagulation factors or other plasma proteins. Thus, the filters and adsorbers used in the system are highly effective and specific for water-soluble substances and toxins bound to the albumin fraction.
基金The NOVO Nordic Foundation, Savvrksejer Jeppe & Ovita Mindelegat, Fabricant Vilhelm Pedersen & Wifes Mindelegat, A.P. Moller Scientific Foundation, the Danish Medical Association Research Fund and the Laerdal Foundation for Acute Medicine, and by an unrestricted grant from the Fresenius Medical Care GmBH
文摘AIM： To evaluate treatment safety and hemodynamic changes during a single 6-h treatment with the PrometheusTM liver assist system in a randomized, controlled study. METHODS： Twenty-four patients were randomized to either the study group or to one of two control groups： Fractionated Plasma Separation Adsorption and Dialysis, PrometheusTM system （Study group; n = 8）; Molecular Adsorbent Recirculation System （MARS）TM （Control group 1, n = 8）; or hemodialysis （Control group 2; n = 8）. All patients included in the study had decompensated cirrhosis at the time of the inclusion into the study. Circulatory changes were monitored with a Swan-Ganz catheter and bilirubin and creatinine were monitored as measures of protein-bound and water-soluble toxins. RESULTS： Systemic hemodynamics did not differ between treatment and control groups apart from an increase in arterial pressure in the MARS group （P = 0.008）. No adverse effects were observed in any of the groups. Creatinine levels significantly decreased in the MARS group （P = 0.03） and hemodialysis group （P = 0.04）. Platelet count deceased in the Prometheus group （P = 0.04）.CONCLUSION： Extra-corporal liver support with Prometheus is proven to be safe in patients with endstage liver disease but does not exert the beneficial effects on arterial pressure as seen in the MARS group,
