The U.S. Patent and Trademark Office (USPTO) announced that it is proactively seeking public comments on the Leahy-Smith America Invents Act (AIA), H.R. 1249, passed by the U.S. House of Representatives on June 23, 2011, and currently pending before the U.S. Senate.  The AIA requires the USPTO to undertake a series of rulemakings to implement the Act.  Because several provisions of the AIA require implementation within a period of one year from enactment, the USPTO is anticipating that expeditious rulemaking proceedings will be required.

A website has been established to provide information to stakeholders and the public on the legislation and USPTO’s actions to implement the provisions of the AIA.  Updates will be provided on this site throughout the implementation process.  The USPTO announced that while any comments provided on the site are considered informal and not treated as part of a formal request for comments or a rulemaking, the organization intends to review and consider comments provided on the site.  Assuming the legislation is enacted, the USPTO indicated that it plans to issue formal notices of proposed rulemaking and will respond to comments received through that formal process. 

Comments on the following topic areas are requested:

  • Patents
  • Board of Patent Appeals and Interferences (BPAI)
  • Congressionally-Directed Studies and Reports
  • Fees and Budgetary Issues
  • Miscellaneous

In an earlier post we noted that under Section 27 of the AIA, the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent Office (Director) shall report to Committee of the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives on effective ways to conduct independent confirmatory genetic tests (second opinions) of genetic diagnostic tests covered by patents that are exclusively licensed. 

The Director’s report must include at least 4 items:

1. The impact of the current lack of independent second opinion testing on the ability to provide the highest level of medical care and on inhibiting innovation to existing testing and on inhibiting innovation to existing testing and diagnosis;

2. The effect that providing independent second opinion testing would have on the existing patent and license holders of the exclusive genetic test;

3. The impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine, such as the interpretation of testing results and performance of testing procedures;

4. The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.

Those wishing to comment on this section shall submit comments to , marked to the attention of Janet Gongola, Associate Solicitor, Office of the Solicitor.

Comments may also be mailed to Mail Stop Comments-Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Hiram Bernstein.  Comments will be posted on the USPTO website.  It is recommended that information intended to remain private, such as an address or phone number, not be included.