As previously reported here, the U.S.P.T.O. issued guidance to its examiners on how to apply the Supreme Court’s recent decisions in which certain diagnostic methods and isolated DNA were held ineligible for patenting. In response to an invitation for comments on its guidance, the P.T.O. received substantial pushback from the patent-holding community, and from those in the biomedical and biotechnological fields in particular, who felt that the guidance went broader in limiting patent eligibility than required by the Supreme Court, failed to provide much-needed, usefully clear instruction on the bounds between eligibility and ineligibility, and imposed new, stringent standards on applicants that were ultimately unlikely to withstand scrutiny on review by the courts yet would require applicants to expend needless time and resources to challenge on appeal, among other faults.
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On May 9, 2014, the P.T.O. held a public forum to discuss its rationale for the rules and attempt to explain them better. A replay on the May 9 forum can be found on a webpage the P.T.O. has established to advise the public on developments related to its patent-eligibility guidance, here. During the forum, in which attendees and presenters from public advocacy groups (such as the Biotechnology Industry Organization (BIO), the American Intellectual Property Law Association, and the Intellectual Property Law Section of the American Bar Association) continued to express displeasure with the guidance and dissatisfaction with the P.T.O.’s defenses and explanations thereof, the P.T.O. announced that it would be updating its guidance and invited further public comment. Initially, the deadline for further written public comment was June 30, 2014. But subsequently, the deadline was extended, to July 31, 2014. Comments can be send to the P.T.O.’s “Guidance Mailbox” here: email@example.com.
Furthermore, on June 27, at the 2014 BIO International Convention, the P.T.O. presented additional “sample” claims for which it seeks public comment as to whether they should be considered patent eligible, and also invited the public to suggest additional examples of claims “for use by the Office to create a more complete picture of the impact of Supreme Court precedent on subject matter eligibility, and to provide comments on the subject matter eligibility of particular claims.” Members of the public who support applications of Supreme Court precedent on subject matter eligibility that differ from the P.T.O.’s guidance “to submit written comments presenting their alternative approach and the legal rationale for the alternative.”
The P.T.O.’s apparent responsiveness to public input on this issue is a welcome indication that some of the worst fears elicited by its guidance when first issued may be assuaged in time, and presents a potentially effective mechanism for public influence.