On April 7, 2020, the Patent Trial and Appeal Board (“PTAB”) designated one decision as precedential and four decisions as informative, all relating to the topic of prior-art status.  Overall, the precedential decision clarifies the different standards for establishing a reference as a printed publication in IPRs versus patent examination, and the informative decisions provide examples of factual scenarios meeting and failing to meet the “threshold showing” for printed-publication status at the IPR institution stage.  A summary of each decision is below.

Appellant requested rehearing of the PTAB’s decision affirming an obviousness rejection that was based, in part, on a transcript of an FDA meeting.  The PTAB had found that the FDA transcript was made sufficiently accessible to constitute a printed publication, but Appellant argued the PTAB’s decision conflicted with previous PTAB treatment of the same transcript.

The PTAB disagreed, first noting the different evidentiary standards in patent examination versus IPR proceedings, where the PTAB had previously addressed the FDA transcript.  Decision at 2–3.  IPR proceedings require a petitioner to present evidence sufficient to show a reasonable likelihood it will succeed on unpatentability, while patent examination involves burden shifting to require an applicant to produce evidence to overcome a prima facie case, including a prima facie case that a reference is printed publication.  Id.

As a factual matter, the IPR petitioners that unsuccessfully attempted to use the FDA transcript had not put forth certain evidence that the Examiner had produced, such as publication in the Federal Register and attendance details.  Id. at 3.  Here, the Appellant failed to rebut a prima facie case that the FDA transcript was publicly accessible.  Id. at 3–8.

Petitioner Sandoz challenged claims to methods for treating disorders related to tumor necrosis factor α (TNF-α), such as Crohn’s disease.  Paper 11, 3–4.  The asserted ground of obviousness relied on a package insert for the drug Humira®Id. at 5.  Although IPR was not instituted, the PTAB determined that the petitioner made a sufficient threshold showing at the institution stage that the package insert constituted a printed publication.  Id. at 8–13.

The PTAB first contrasted the showing required at the institution stage as compared to the final decision stage.  It clarified that “[f]or institution purposes, Petitioner has the burden to establish a reasonable likelihood that it will prevail on the merits,” which includes showing that the reference qualifies as a printed publication.  Id. at 8–9.  As to the proof required at institution, the PTAB explained that “the Petition must include argument and direct us to evidence sufficient to show that Petitioner would establish such public accessibility by a preponderance of the evidence during the course of the trial.”  Id. at 9.  The PTAB explained that this “threshold showing” was not a lower standard of proof, but instead an analysis of whether the preponderance of the evidence standard is reasonably likely to be met at a later time.  Id. at 12.

As to the specific facts, the PTAB weighed evidence consisting of an Internet Archive (aka Wayback Machine) screenshot of the FDA webpage with an associated affidavit from the Internet Archive, along with expert testimony about how ordinarily skilled artisans could have accessed drug package inserts on the FDA website during the relevant time period.  Id. at 10–13.  The PTAB found this evidence sufficient to meet the threshold showing required at the institution stage.

Petitioner Argentum (“Petitioner”) challenged claims to compounds such as lacosamide, and methods of using these compounds to treat disorders such as epilepsy.  Paper 19, 4–5.  Certain grounds included a thesis as one of the references.  Although the PTAB instituted IPR on other grounds, the PTAB determined the Petitioner did not put forth sufficient evidence to make a threshold showing of public availability necessary to institute IPR on grounds including the thesis.  Id. at 3, 12.

The PTAB rejected Petitioner’s evidence, reasoning that it did not relate to whether the thesis itself was publicly accessible in the relevant time period.  Id. at 12.  Specifically, the PTAB rejected Petitioner’s argument that an uncontested fact in an unrelated litigation admitting public accessibility of the thesis was probative of the inquiry here, because there may have been other strategic, litigation-specific reasons for the stipulation.  Id. at 10–11.  The PTAB also refused to give Petitioner a rebuttable presumption of public accessibility due to Petitioner’s difficulty in getting the library housing the thesis to provide accessibility information to the Petitioner.  Id. at 11.  Finally, the PTAB did not find probative several publications that referenced other theses at the same university, because the publications were all written by either the thesis authors or their advisors, who would have had personal knowledge of the theses’ existence.  Id. at 11–12.

Petitioner Seabery challenged claims to a system for tracking and analyzing welding activity.  Paper 11, 2–4.  All grounds relied upon a Ph.D. dissertation, and the PTAB determined that the Petitioner put forth sufficient evidence to make a threshold showing of public availability.  Id. at 5–8.

With its Petition, Petitioner submitted an expert declaration from the advisor of the Ph.D. student who authored the dissertation in question.  The declaration attested that the dissertation was deposited in a library and indexed, and it also included copyright and publication details of dissertation excerpt reprints.  Id. at 7.  The PTAB found this testimony sufficient to meet the threshold showing required at the institution stage.  Id. at 7–8.

Petitioners In-Depth Geophysical and In-Depth Compressive Seismic (“Petitioners”) challenged claims to a computerized sensing method for interpreting seismic data.  Paper 14, 2.  All grounds in the petition included a paper from an annual conference, and the PTAB found that Petitioners did not make a threshold showing that the reference was a printed publication.  Id. at 3–13.

The PTAB weighed two types of evidence: (1) a Researchgate website printout, and (2) the use of the reference during prosecution of a related European patent application.  Id. at 5–13.  The PTAB found the Researchgate printout insufficient because although the printout did list a date before the priority date, it did not include any information explaining what that date represented (e.g., submission date vs. publication date).  Id. at 9–10.  Further, Patent Owner pointed to a download date on the reference itself that was after the priority date, and Patent Owner’s expert opined that the reference was likely only published at or after the conference—which occurred after the priority date.  Id. at 10–12.

Regarding the use of the reference during the European patent application’s prosecution, the PTAB did not find the examiner’s consideration of the paper relevant because European patent laws do not include a 1-year grace period, so publication of the reference during a range of dates after the U.S. priority date would have nevertheless been sufficient for use in the European prosecution.  Id. at 13.

Ultimately, the PTAB found that Petitioner’s evidence was not sufficient to make a threshold showing of public accessibility and denied institution.  Id. at 13–14.


Be sure to check out our blog’s previous posts on this topic: March 3, 2020; Dec. 27, 2019; Dec. 2, 2019; Nov. 13, 2018; and Sept. 25, 2018.

[1] The stamp on the PDF of the decision appears to incorrectly reference that the decision was designated informative as to § II.C.1, but the PTAB website indicates the decision was designated informative as to § III.C.1.