What is pre-AIA 35 U.S.C. 103(b) and when does it apply?

Pre-AIA 35 U.S.C. 103(b) is a provision applicable to biotechnological processes. It precludes a rejection of process claims which involve the use or making of certain nonobvious biotechnological compositions of matter under pre-AIA 35 U.S.C. 103(a). This provision is only applicable to applications subject to pre-AIA 35 U.S.C. 102. As stated in the MPEP: Only…

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How has the Federal Circuit’s decisions in Ochiai and Brouwer affected the need for pre-AIA 35 U.S.C. 103(b)?

The Federal Circuit’s decisions in In re Ochiai and In re Brouwer have significantly impacted the need for relying on pre-AIA 35 U.S.C. 103(b). The MPEP notes: In view of the Federal Circuit’s decisions in Ochiai and Brouwer, an applicant’s need to rely upon pre-AIA 35 U.S.C. 103(b) should be rare. These cases addressed whether…

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What is considered a “biotechnological process” under pre-AIA 35 U.S.C. 103(b)?

Pre-AIA 35 U.S.C. 103(b) provides a specific definition for a “biotechnological process.” According to the statute, it includes: A process of genetically altering or inducing a single- or multi-celled organism to: Express an exogenous nucleotide sequence Inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence Express a specific physiological characteristic not naturally associated…

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