New Therasense Guidelines to Invite Extrinsic Evidence Abuse?

As discussed yesterday, the USPTO has proposed to modify asepcts of Rule 1.56(b) and Rule 1.555(b) to comport to the materiality standard of the recent Therasense decision of the CAFC. In doing so, the Office has proposed a definition of “but for-plus” materiality standard defined by acts of omission (duty of disclosure) together with affirmative acts relating to willful false statements and misrepresentations (duty of candor and good faith).

Rule 56 is an ethical guidepost that pertains only to Patent Applicants. As such, aside from a rare protest under Rule 1.291 or 1.99, third parties do not submit prior art materials to the USPTO under this Rule (of course patent reform will provide more opportunities for pre-grant submissions). Instead, Rule 56 compliance is litigated as an element of an inequitable conduct defense to patent infringement. Charges of inequitable conduct are not substantively considered in patent reexamination as the Office is a less than ideal arbiter of questions of “intent.” 

Currently, the USPTO is proposing to define, by Rule, a materiality standard in terms of “bad acts.” Consequently, has the USPTO now undermined established practice (MPEP) by encouraging new 1.555(b)(2) submissions for consideration of such information in patent reexamination?

Section (c) of Rule 1.555 provides that:

The responsibility for compliance with this section rests upon the individuals designated in paragraph (a) of this section and no evaluation will be made by the Office in the reexamination proceeding as to compliance with this section. If questions of compliance with this section are raised by the patent owner or the third party requester during a reexamination proceeding, they will be noted as unresolved questions in accordance with § 1.552(c). (emphasis added)

In view of the language of 555(c), which remains unchanged by the proposal, it is clear that submissions by third parties in patent reexamination that address matters of compliance with Rule 555 cannot be considered in the reexamination proceeding. This section does not preclude retrospective compliance arguments relating to the original prosecution (Rule 56 compliance challenges).  

On the other hand, MPEP 2216 cautions that conduct of parties should not be included in a Request for reexamination as such will not be considered. Further, Rule 1.552(c), (mentioned above in 1.555 (c)) provides that issues outside of patents and printed publications will not be considered, but merely noted on the record in the next Office Action.

The problem with the proposed changes is that Rule 555(b)(2) defines a materiality determination in terms of an analysis of affirmative acts relating to willful false statements and misrepresentations. The proposed changes to Rule 555(b) also replace the previous language that helped refined patent reexamination materiality in terms of patents and printed publications–it is unclear why this language was removed.

Assuming the USPTO finalizes the current proposal, the Office may have a difficult time refusing extrinsic information in patent reexamination as to the “plus” aspect of the proposed materiality standard. That is to say, the proposed Rule provides a “but for-plus” standard in ascertaining materiality of a reference, but the “plus” component is essentially off limits to Third Parties in arguing materiality of a given reference before the Office. 

Can the Office rightfully refuse extrinsic evidence explaining previous misleading submissions to the Office? Would such information not provide “new light” as to the materiality of previously considered art under the Proposed Rules? 

A more manageable solution is to modify the proposal to add back in “patents and printed publications” to 555(b)(1) and to drop (b)(2) altogether. As written yesterday, safeguards against fraudulent conduct already exist, there is no need to muddy the waters of materiality.

With enhanced pre-grant submission rights being expanded by Patent Reform, and Inter Partes Review and Post Grant Review providing new, litigation style dispute formats, the USPTO could very well find themselves policing past conduct under the current proposal.