Up to now, the applicant’s duty to disclose information material being relevant to a US patent application to the USPTO has been handled strictly. In order to avoid providing a defense for infringers, applicants have submitted a great amount of information material.
According to the decision “Therasense Inc. vs. Becton” the court of appeal being competent for patent law decided that the requirements of the duty have been too strict. Infringers could only defend themselves with the help of the insufficiency of the information disclosure if the concealed information had impeded the grant of the patent or if the applicant has intended a thoroughly planned deception.
The conditions of an insufficient disclosure of the information material are:
Proof has to exist that the applicant has concealed the document with the intention to deceive. It is insufficient to prove that the applicant has known the document and its relevance.
Based on a reasonably broad interpretation of the claims the relevance of the document has to be such that its disclosure would reasonably have led to a refusal of the grant of the patent.
In case of serious misconduct by the applicant or his representative, relevance is not an issue. Examples for serious misconduct are perjury, forgery of proof or concealment of proof. Please note, that even a non-disclosure of a negative foreign office action may be a serious misconduct.
The USPTO has drafted an amendment of title 37 CFR § 1.56 in order to establish a uniform handling.
As consequence, according to the requirements mentioned above, the insufficiency of the disclosure has to be such that it can serve as a base for either a revocation action at court or instead a re-examination of the patent at the USPTO.