Knowledge of the reference and knowledge of materiality alone are insufficient after Therasense to show an intent to deceive. Moreover, it is not enough to argue “carelessness, lack of attention, poor docketing or cross-referencing, or anything else that might be considered negligent or even grossly negligent.” To sustain a charge of inequitable conduct, “clear and convincing evidence must show that the applicant made a deliberate decision to withhold a known material reference.” While this does not change any best practices with regard to IDS submissions, it perhaps offers a little comfort and protection in the event that an occasional oversight may occur.
Background / Facts: The district court found that during prosecution of the patent at issue the inventor and his attorney withheld from the PTO three material references and information about PTO rejections in two related prosecutions, thereby committing inequitable conduct and rendering the patent unenforceable.
Issue(s): Whether, under the Therasense standard, an applicant’s knowledge of a reference’s materiality can by itself prove that a subsequent non-disclosure was based on a “deliberate decision” to withhold the references from the PTO.
Holding(s): No. The district court clearly erred in relying on the patentee’s inability to offer a good faith explanation as a basis to infer a deliberate decision to withhold references. Ultimately, for all of the references, the evidence supports only that the inventor and his attorney (1) knew of the references, (2) may have known they were material (which the court did not reach), and (3) did not inform the PTO of them. That is not enough. As Therasense made clear, a defendant must prove that an applicant (1) “knew of the reference,” (2) “knew it was material,” and (3) “made a deliberate decision to withhold it.” Whatever one might conclude about their conduct and interactions relating to the references, or the busy nature of the attorney’s practice at the relevant time, an applicant’s knowledge of a reference’s materiality cannot by itself prove, let alone clearly and convincingly prove, that any subsequent non-disclosure was based on a “deliberate decision.” Otherwise, the third element in Therasense’s intent to deceive analysis would be satisfied in any case in which the second element was satisfied.