When is a document a “Printed Publication” under 102(b)?

The Federal Circuit held that there was an insufficient record to qualify the reference “IsoMed Constant-Flow Infusion System (“IsoMed”) as publicly accessible and therefore a printed publication under 35 U.S.C §102(b), and remanded for additional fact finding in C.R. Bard, Inc., Bard Peripheral Vascular, Inc., v. Angiodynamics, Incorporated(Fed. Cir. Sept. 28, 2018.)

The patents at issue were U.S. Patent Nos. 7,785,3027,947,022, and 7,959,615. The Patent Trial and Appeal PTAB held the claims unpatentable in part in aninter partesreview. Both parties appealed various aspects of the PTAB’s rulings.

Relevant Law

A reference qualifies as a printed publication under §102(b) if the reference was “sufficiently accessible to the public interested in the art.” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016). “A reference is considered publicly accessible if it was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009).

Analysis

Bard, the patent owner,  argued that the PTAB erred in concluding thatIsomedqualifies as a “printed publication” under 35 U.S.C. §102(b). Isomedis a clinical reference guide developed by a third-party, Medtronic, Inc., for physicians and allied professionals who care for patients using Medtronic’s implantable reciprocating IsoMedpump device. The reference bears a 2000 copyright date.

The PTAB’s found that the guide was “publicly accessible.” The guide was prepared “for distribution to physicians and allied professionals,” and not restricted to use with Medtronic. A declaration from Hank La Force, a sales representative, stated that he “personally distributed numerous copies of the . . . publication to interested medical professionals, including doctors, nurses, surgeons, radiologists, oncologists, and other medical clinicians,” and that there were no restrictions or limitations on distribution . . .”

The Federal Circuit disagreed that the guide was “publicly accessible.” The court found some indicia that the document was a public-facing document. For example, it included lists of contact phone numbers for Medtronic service departments and various offices suggesting that the document may be used for healthcare professionals outside of Medtronics. On the other hand, the La Force declaration did little to establish public accessibility. La Force failed to identify how many copies of the document were distributed, when they were distributed or to whom they were distributed.

Further, the PTAB’s findings regarding the declaration were ambiguous. The PTAB did not expressly find that La Force distributed the documents, but rather focused on the inference that Isomedwas available to any member of the relevant public who requested a copy. The court found unclear, however, to what extent the PTAB relied on Bard’s testimony regarding distribution. It was further unclear whether the public would have had a reason to request the document.

This case stands in contrast to In re Enhanced Security Research LLC, 739 F.3d 1347 (Fed. Cir. 2014). In this case, a declaration explained that the manual at issue was associated with a software product “sold to or installed for approximately a dozen customer.” There was additional evidence of the advertisements for the software product. This provided a sufficient basis to conclude that consumers would have had a reason to reach out and request it.

 Lessons for Practice

Insist on evidence showing public accessibility for a reference alleged to be a printed publication – or provide it, if you are the challenger.  Isomedwas a document maintained by Medtronic. In determining whether the document qualified as a printed publication, the court placed weight not only on whether the document was available to the public, but also on whether the public would have had reason to request the document. The court was looking for evidence that (1) the document was distributed with Medtronic devices and (2) that the devices were advertised, increasing the likelihood that the public would be aware of the document.

 

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