Public FDA hearing is a printed publication, Hulu IPR decision does not apply to examination

Ex parte Antonio J. Grillo-Lopez
Appeal 2018-006082 (Appln. No. 13/524,837)
Precedential (designated April 7, 2020)

Brief Summary: Public FDA hearing held to be printed publication and “the framework set forth in the Hulu decision for IPR proceedings does not apply to examination” (burden on petitioner vs. “burden-shifting framework”).

Summary: The Appellant requested rehearing of a prior Board decision affirming the Examiner’s rejections as obvious, which was denied in this decision. The Board concluded that an FDA Transcript of the July 25, 1997 meeting of FDA’s Biological Response Modifiers Advisory Committee was a printed publication. The Appellant argued that the Board “conflat[es] the concept of the hearing itself being public with the question of whether the FDA Transcript is a printed publication”, “does not articulate any reason that an ordinary skilled person would have read the Federal Register”, “notice of a public hearing is not evidence that a later printed publication was made sufficiently available to an ordinarily skilled person exercising reasonable diligence”, and “attendance at the oral hearing by an ‘interested member of the public’ is not evidence that a later printed publication was made sufficiently available”. The Board was not persuaded, finding “a prima facie case exists that an interested artisan would have been aware of the notice of meeting published in the Federal Register” (e.g., “once an ordinarily skilled artisan is aware of the meeting regarding rituximab, he or she also would have known of the existence of the transcript and been able to obtain a copy with the exercise of reasonable diligence”; Bayer, CCPA 1978; SRI Int’l, FC 2008). FN4 explains that “the advisory committee meeting, without more, transforms the transcript of the meeting into a printed publication”. The Board also explained that in an IPR “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” (Hulu, PTAB Dec. 20, 2019, precedential), but “[i]n contrast, the examination context involves a burden-shifting framework under which the USPTO can shift the burden to the application to come forward with rebuttal evidence or argument to overcome a prima facie case” (Ex Parte Albert, BPAI 1984). Thus, the Board concluded that “the framework set forth in the Hulu decision for IPR proceedings does not apply to examination.”