3D bioprinting combines emerging 3D printing technologies with synthetic biology. The promise of 3D bioprinting technology is to fabricate organs for transplantation, treat burn victims with in vivo skin repair, and create wearable microbiomes. 3D bioprinting can successively build, repair, or reproduce living human cells. This capability challenges eligible subject matter doctrine in U.S. patent law because the law has no brightline standard for patent eligibility for nature-based products. As 3D bioprinting technologies mature, U.S. patent law will need to respond to situations where living and nonliving worlds merge. This Article proposes a "Mixed-Scanned-Transformed" standard to supplement U.S. patent law's "markedly different characteristics" examination of nature-based products. The markedly different standard arose from the Chakrabarty case in 1980 and is most recently informed by the Myriad case in 2013, but neither case involved merging living and nonliving worlds. By applying this newly proposed standard, 3D bioprinted materials would likely be upheld as patentable subject matter. The proposed "Mixed-Scanned-Transformed" standard and proposed clarity on what is not a "human organism" will allow U.S. patent law to become more bright-line towards 3D bioprinting inventions.
41 Seattle University Law Review 1 (2017)