Ex parte Grillo-López

In ex parte examination, where the examiner shows that a reference was made sufficiently accessible to interested persons ordinarily skilled in the art, the Board may find a prima facie case that the reference is a "printed publication" under § 102(b), and the burden of production shifts to the applicant to rebut it. The IPR framework under which a petitioner must show reasonable likelihood of prevailing (Hulu) does not apply to examination, so prior IPR decisions finding the same document not a printed publication do not control. No prior precedent directly addressed this issue in the text; the Board distinguished earlier IPR decisions (Celltrion v. Biogen) that found the same FDA transcript was not shown to be a printed publication, and held the Hulu framework for IPR does not apply to examination. For the examiner, a prima facie showing of public accessibility suffices to shift the burden, and the Board may rely on facts beyond the Answer through a new ground of rejection under 37 C.F.R. § 41.50(b). For the applicant, it is not enough to point to inconsistent IPR outcomes or argue lack of evidence; the applicant must come forward with rebuttal evidence or argument, such as disputing the skilled artisan's qualifications. The Board relied on Federal Circuit and CCPA burden-shifting authority such as In re Jung, In re Antor Media, In re Rijckaert, In re Best, and on In re Wyer for deciding each printed publication case on its own facts. LEGAL TEST OR STANDARD: The Board applied the printed publication inquiry of whether the document was made sufficiently accessible to the public interested in the art, within a burden-shifting framework in which the USPTO sets out a prima facie case and the applicant must come forward with rebuttal evidence or argument. The Board stated that the IPR framework, where a petitioner must present evidence sufficient to show it is reasonably likely to prevail, does not apply to examination, and that each printed publication case is decided on its own facts (In re Wyer). TRIGGERING FACTS: An FDA advisory committee meeting on rituximab was noticed in the Federal Register, was open to the public and attended by a public member who spoke, and the Federal Advisory Committee Act required a transcript to be created and made publicly available. The skilled artisan was an oncologist or medical researcher of average experience, which the appellant did not dispute. Earlier IPR petitioners had not cited the Federal Register notice, attendance, or FACA requirements. The affirmance was designated a new ground of rejection under 37 C.F.R. § 41.50(b). KEY QUOTE: "Given the different legal frameworks and burdens for establishing a reference as prior art in IPR proceedings and examination, the Decision is not contrary to the Board decisions finding that a petitioner failed to meet its burden of showing that the FDA transcript is a printed publication." (p. 3) PRIOR PRECEDENT AFFECTED: Distinguishes Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019) (precedential), as inapplicable to examination. Distinguishes the IPR decisions in Celltrion, Inc. v. Biogen, Inc., IPR2017-01094, IPR2017-01230, IPR2017-01227, and IPR2017-01229. Follows Ex Parte Albert, 18 USPQ2d 1325 (BPAI 1984), on the applicant's burden. PRACTICE TIP: Do not rely on prior IPR rulings that the same document was not a printed publication; in examination, expect the burden of production to shift after a prima facie case, and come forward with specific rebuttal evidence on public accessibility, including a challenge to the artisan's qualifications, rather than only attacking the sufficiency of the examiner's showing.