Somewhat of a moot point going forward in view of the new AIA supplemental examination procedures, the takeaway here is simply that a reissue application is permissible for an unintentional failure to file an IDS, and that “deceptive intent” in the reissue statute requires the same high standard of proof as “deceptive intent” in connection with charges of inequitable conduct, where “negligence – even gross negligence – is insufficient to establish deceptive intent.”
Background / Facts: The drug product here was the “statin” having the brand name Crestor, which is federally approved for use in control of cholesterol and for treatment of atherosclerosis. After failing to submit an IDS during initial prosecution, and in particular failing to bring two notably material references to the PTO’s attention, a corresponding reissue application was filed to cure the “defect” of nondisclosure of the these references.
Issue(s): Whether an unintentional failure to file an IDS is a recognizable defect justifying the reissuance of an application.
Holding(s): Yes. Precedent establishes that for reissue purposes “error is established where there is no evidence that the appellant intentionally omitted or abandoned the claimed subject matter.” Here, the court found as fact that there was error in failing to file an IDS citing the two material references, but that there was not sufficient evidence of deceptive intent. Rather, the court found that the evidence as a whole “paints a more innocent explanation of [in-house counsel] Mr. Shibata as a new and inexperienced manager attempting to handle an understaffed and overworked Patent Department.” As with inequitable conduct, due to the “complexity of patent prosecution, negligence – even gross negligence – is insufficient to establish deceptive intent.”