Ex parte Grillo-Lopez, Appeal No. 2018-006082 (Jan. 31, 2020)
On April 7, 2020, the PTAB designated its January decision in Ex parte Grillo-Lopez (“the Decision”) as precedential. In the Decision, the Board held that patent examination and IPR proceedings have different standards for establishing a prior art printed publication, with the petitioner in an IPR facing a higher burden of showing that a reference was publicly accessible. Having been designated as precedential, the Decision is now binding authority in all USPTO ex parte proceedings.
At issue in the Decision was whether the transcript of the July 25, 1997 meeting of the FDA’s Biological Response Modifiers Advisory Committee was sufficiently accessible to the public interested in the art so as to render it a printed publication. On August 28, 2019, the Board had affirmed the examiner’s rejections of certain patent claims as obvious over the prior art, and the appellant/applicant requested rehearing of that decision.
In arguing for rehearing, the appellant contended that the August 2019 decision was contrary to the Board’s earlier findings. Whereas in the August decision the Board determined that the FDA transcript was a printed publication within the meaning of 35 U.S.C. § 102(b), in previous decisions, the Board had found that the very same transcript was not a printed publication.
In the Decision, the Board held that these results were not inconsistent because its previous decisions involving the FDA transcript were in IPR proceedings, and the legal frameworks and burdens for establishing a reference as prior art in IPRs are different from those in ex parte patent examination.
In IPR proceedings, a petitioner is required to present evidence and arguments sufficient to show that it is reasonably likely that it will prevail in showing the unpatentability of the challenged claims. Thus, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.
The framework for IPR proceedings does not apply to patent examination, however. Instead, the examination context involves a burden-shifting framework under which the USPTO, once it sets forth a nominal publication date, can shift the burden to the applicant to disprove that publication date.
In the Decision, the Board went on to note that each printed publication case must be decided on the basis of its own facts. The Board explained that, in this case, the examiner considered various evidence that had not been cited in the IPR petition. For example, the IPR petitioner “did not cite to publication of the Notice of Hearing in the Federal Register, attendance of the hearing by an interested member of the public pursuant to the notice, or the requirements of FACA [Federal Advisory Committee Act] in support of the public accessibility of the FDA transcript.”
Thus, according to the Board, based on the different legal frameworks for examination and IPRs it is possible for the same FDA transcript to be considered a printed publication in one context but not the other.
Implications for Patent Law Litigation
Noting the contextual differences between IPR proceedings and patent examinations along with factual differences (the IPR petitioner’s failure to cite certain evidence), this decision highlights the case-by-case considerations in determining whether a printed document qualifies as a printed publication. The existence of evidence/quality of evidence demonstrating that a publication was publicly accessible is an important consideration when a non-patent publication is asserted as prior art in an IPR.