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Changes To Implement the First Inventor To File Provisions of the Leahy-Smith America Invents Act, Final Rule, 78 Fed. Reg. 11023, Feb. 14, 2103
The rule revises the rules of practice in title 37 of the Code of Federal Regulations to implement, and to address the examination issues raised by, section 3 of the Leahy-Smith America Invents Act (AIA), which, inter alia, converted the U.S. patent system from a “first to invent” to a “first inventor to file” system. These changes in section 3 of the AIA are effective on March 16, 2013.
Examination Guidelines for Implementing the First Inventor To File Provisions of the Leahy-Smith America Invents Act, 78 Fed. Reg. 11059, Feb. 14, 2103
The USPTO is providing the examination guidelines to assist in the implementation of the “first inventor to file” provisions of the Leahy-Smith America Invents Act (AIA), and to clarify certain aspects of the law in response to public comment. The guidelines will be effective as of March 16, 2013.
Feb. 22, 2013 Office of Science and Technology Policy memo directing each Federal Agency with over $100 million in annual conduct of research to develop a plan to support increased public access to the results of this research.
Notice of Proposed U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, 78 Fed. Reg. 12369, Feb. 22, 2013
The Office of Science and Technology Policy is asking for comments on the proposed U.S. policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. The purpose of the policy is to protect against misuse of certain select agents and toxins that could post a threat to public health, agriculture, the environment or national security. This is a close the gap policy to deal with "dual use" research not specifically addressed under existing federal regulations. Dual Use Research of Concern is research that can be reasonably anticipated to provide knowledge, information, products or technologies that could be misapplied to pose a significant threat to public health and other areas as referenced above. The covered agents and toxins are listed in section 6.2.1 of the Policy and are as follows:
a) Avian influenza virus (highly pathogenic) b) Bacillus anthracis c) Botulinum neurotoxin d) Burkholderia mallei e) Burkholderia pseudomallei f) Ebola virus g) Foot-and-mouth disease virus h) Francisella tularensis i) Marburg virus j) Reconstructed 1918 Influenza virus k) Rinderpest virus l) Toxin-producing strains of Clostridium botulinum m) Variola major virus n) Variola minor virus and o) Yersinia pestis.
The categories of experiments are
a) Enhances the harmful consequences of the agent or toxin;
b) Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification;
c) Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies;
d) Increases the stability, transmissibility, or the ability to disseminate the agent or toxin;
e) Alters the host range or tropism of the agent or toxin;
f) Enhances the susceptibility of a host population to the agent or toxin; or
g) Generates or reconstitutes an eradicated or extinct agent or toxin listed in 6.2.1, above.
Under the proposal, if the University works with any of the agents in the manner described, the Principal Investigator has to refer any research involving those agents to an institutional dual use review entity, which will then determine if any of the listed effects might be produced, and if yes, the review entity would weigh the benefits and risks of the research and develop a risk management plan. Comments are due by April 23, 2013. For more on this topic see the Boston University Research Compliance web page on Dual Use Research of Concern.