Embryos as Patients? Medical Provider Duties in the Age of CRISPR/Cas9

By: G. Edward Powell III

The CRISPR/Cas9 genome engineering platform is the first method of gene editing that could potentially be used to treat genetic disorders in human embryos. No past therapies, genetic or otherwise, have been intended or used to treat disorders in existent embryos. Past procedures performed on embryos have exclusively involved creation and implantation (e.g., in-vitro fertilization) or screening and selection of already-healthy embryos (e.g., preimplantation genetic diagnosis). A CRISPR/Cas9 treatment would evade medical malpractice law due to the early stage of the intervention and the fact that it is not a treatment for the mother. In most jurisdictions, medical professionals owe no duty to pre-viable fetuses or embryos as such, but will be held liable for negligent treatment of the mother if the treatment causes injury to a born-alive child. This issue brief discusses the science of CRISPR/Cas9, the background legal status of human embryos, and the case for considering genetically engineered embryos as patients for purposes of medical malpractice law.
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Cite: 15 Duke L. & Tech. Rev. 344

Mitochondrial Replacement Therapy and the Regulation of Reproductive Genetic Technologies in the United States

By: Bob Zhao

The ability to alter the genes of future generations no longer belongs in the realm of science fiction. The genetic modification capabilities of modern science are advancing rapidly. Mitochondrial replacement therapy (MRT) represents the first crossing of the germline barrier in humans, and as of February 2015, it is the first procedure of its kind to be legalized in the Western world. How Congress decides to regulate MRT will influence future regulation of all genetic manipulation technologies. This brief argues that the current patchwork regulatory framework established in the United States is insufficient to deal with the complex issues MRT presents. As such, the creation of a new regulatory agency specifically focused on the oversight of reproductive and genetic biotechnologies may be necessary to balance the goals of ensuring the safety of research participants, promoting public debate, and stimulating continued scientific progress.

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Cite: 15 Duke L. & Tech. Rev. 121

Understanding the Backlog Problems Associated with Requests for Continued Examination Practice

By: Sean Tu

One of the greatest problems facing the current patent administration is a long patent pendency period. This study focuses on Request for Continued Examination (RCE) practice, and its effects on the current patent application backlog problem. RCEs are used to continue prosecution after a patent examiner has issued a final rejection. However, now that RCEs are placed on an examiner’s special docket, some examiners may pick up prosecution one to two years after the last action. Accordingly, there are great inefficiencies that may be created by this delay, such as relearning issues and questions from the previous action, diminished value of examiner interviews, and a higher likelihood of transfer to a new examiner. This study suggests that the RCE problem may be much worse for some art units compared to others. Specifically, the RCE problem is unevenly distributed between certain art units with technology center 1600 (biotechnology and organic chemistry) suffering the most from unexamined RCEs, while technology center 2800 (semiconductors, electrical and optical systems and components) remain unaffected. This RCE backlog can result in a delay of approximately three years for some art units. Possible solutions to the RCE problem include creating a two-track examiner specialization program: one track focusing on drafting office actions and a second track focusing on finding relevant prior art.