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NIH inventors have developed the first known method of producing Regulatory B-cells (Bregs) ex-vivo. There is a great need to supplement the low population of Bregs in a patient suffering from an autoimmune disease where Breg levels are severely reduced, such as uveitis. This method involves
In Merck KGaA v. Integra Lifesciences I, Ltd., 125 S. Ct. 2372 (Jun. 13, 2005), the Supreme Court considered the scope of the exemption from patent infringement embodied in 35 U.S.C. § 271(e)(1). Under §271(e)(1), also referred to as the safe harbor provision, "[i]t shall not be an act of