BIO recently sent Director Kappos 13 pages of comments on the PTO’s proposed revisions to 37 C.F.R. §1.56(b). (A copy of the comments is available at the end of this post.) BIO clearly is struggling to reconcile the differing views  of its members, and mostly succeeds. The comments give a good background on the development of the PTO’s duty of disclosure and the role of the judiciary in developing the inequitable conduct defense:

“Paradoxically, the development of the [IC] doctrine was driven, at least initially, by the well-intentioned belief that the judicial enforcement of applicant disclosure obligations in private actions to which the USPTO is not a party would nevertheless help the USPTO in getting its job done.”

This has obviously not occurred, and the comments note that in Therasense, the Fed. Cir. “declined to adopt the USPTO’s  definition of materiality as the judicial standard, recognizing that its prior efforts to enforce the USPTO’s materiality standards had actually contributed to the problems that led the court to take up this case in the first place.”

Despite this inherent tension, the comments go on to conclude:

“The USPTO proposes a literal importation of the judicial materiality standard into its Rule 56…There is good reason to believe, however, that the Therasense standard, in the course of judicial interpretation, will be subject to drift in the courts over time….thereby inviting creep and uncertainty in the operation of Rule 56….In short, most BIO members do not agree that administration of a judicial standard that is sure to evolve – and likely to erode – over time is the approach that will most benefit the USPTO and the applicant community.”

Responding to member input that there are few types of prior art that are not readily available to Examiners, and that the AIA pre- and post-issuance procedures will provide even more relevant information to Examiners, the comments get to the heart of the question and put a stake through it:

“The USPTO has not provided a clear explanation of why it continues to need Rule 56. If the  PTO wants only the Therasense standard ["hard" but-for materiality and specific intent to deceive], then there would seem to be no need for the rule – it is already the law. If the intention is to prevent fraud, lying, falsification, perjury and the like, federal statutes such as Section 1001  of Title 18 of the U.S. Code provide the applicable standard and the appropriate reach. The USPTO should affirm that it seeks nothing more.” 

Not just pretty words!

BIO Comments