United States: Distribution Of Certain Materials To Groups Of People Without Restriction May Render Such Materials Printed Publications Under § 102(B)

Last Updated: August 7 2018
Article by Marina I. Miller

The Federal Circuit affirmed in-part and vacated in-part the PTAB's (the Board) decision that the petitioner, Medtronic, Inc., had not proven that the challenged patent claims were unpatentable. The Court affirmed the Board's determination that challenged claims were not obvious over two prior art references, but vacated and remanded the Board's determination that other references, a video "Thoracic Pedicle Screws for Idiopathic Scoliosis" and slides "Free Hand Thoracic Screw Placement and Clinical Use in Scoliosis and Kyphosis Surgery," were not "publicly accessible" under 35 U.S.C. § 102(b) and therefore were not prior art.  "The Board did not fully consider all the factors for determining whether the Video and Slides were publicly accessible."

Medtronic manufactures surgical systems and tools. Dr. Mark Barry sued Medtronic for patent infringement alleging that Medtronic's products infringed Dr. Barry's patents, including U.S. Patent Nos. 7,670,358 and 7,776,072. Medtronic then petitioned for, and the Board instituted, IPR proceedings for all claims in both patents. The challenged claims of the '358 and the '072 patents are directed to a method and a system, respectively, for aligning vertebrae in the amelioration of aberrant spinal column deviation conditions. The issues raised in Medtronic's appeal concern the "Simultaneously Rotating" and "Derotation Tool" limitations. Appellant petitioner Medtronic argued that the asserted claims were obvious over a patent application (U.S. 2005/0245928), in light of a book chapter (Masters Techniques in Orthopaedic Surgery:The Spine, (2d ed.) (MTOS)), and also introduced the Video and related Slides, illustrating the use of pedicle screws in derotation surgery.

The '928 Application discloses how a surgeon makes small incisions in the skin that are just large enough to insert the portions of the '928 device that engage pedicle screws implanted in the vertebrae.  Unlike the '358 or the '072 Patents, the surgical technique described in the '928 Application does not involve a large incision between the vertebrae that exposes substantial portions of the spine.  Medtronic argued that the '928 Application alone made it obvious for a spine surgeon to use its displacement device to rotate multiple vertebrae simultaneously. The Board, however, found that the '928 Application failed to disclose the "Simultaneously Rotating" limitation because the operation of the '928 device requires multiple motions, as opposed to a single motion, and results in compression or distraction of the vertebrae, as opposed to derotation. The Court agreed with the Board that this claimed step is missing from the reference. The Board considered opinions of Medtronic and Dr. Barry's experts, and credited the testimony of Dr. Barry's expert who opined that any amount of rotation would be minimal and that using the '928 device to rotate vertebrae as claimed would likely introduce, rather than correct, spinal deformities. The Court discerned no error in the Board's determination.

MTOS describes using pedicle screws in the thoracic and lumbar spine and performing multiple "apical vertebral derotation" (AVD) maneuvers to derotate the spine but does not explicitly disclose manipulating multiple posts simultaneously as part of the AVD maneuvers. Medtronic argued that MTOS disclosed the "Simultaneously Rotating" limitation and that one of

ordinary skill in the art would have been motivated to combine the teachings of the '928 Application with MTOS. The Court, however, agreed with the PTAB that MTOS does not describe "the simultaneous application of manipulative force" and identified significant differences between the '928 Application and MTOS that undercut Medtronic's arguments that the references were readily combinable. "The Board also reasonably found that neither reference discloses or suggests a device or system with a 'handle means' that performs the simultaneous rotational functions as recited by the challenged claims." The Court supported the Board's conclusion.

The Court further opined on whether the Board erred in concluding that the Video and Slides were not accessible to the public.  A CD containing the Video had been distributed to participants at three separate programs in 2003, and binders containing relevant portions of the Slides had been also distributed at two of the three meetings. One of the 2003 meetings was limited to about 20 SDSG members ("experts voted into membership by an executive board based on their qualifications and ability to conduct research"), while the other two programs were open to other surgeons with about 75 surgeons total attending the programs.

Often the issue of a reference's public accessibility arises in the context of references stored in libraries. In such cases, courts generally inquire whether the reference was sufficiently indexed or cataloged. Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016). In Suffolk Techs., the Court has stated that "a printed publication need not be easily searchable after publication if it was sufficiently disseminated at the time of its publication."  Suffolk Techs., LLC v. AOL Inc., 752 F.3d 1358, 1364 (Fed. Cir. 2014).  In Medtronic, "the question becomes whether such materials were sufficiently disseminated at the time of their distribution at the conferences."

The Court's review of previous cases involving distribution of materials at meetings provided factors relevant to this case. "[T]he size and nature of the meetings and whether they are open to people interested in the subject matter of the material disclosed are important considerations. Another factor is whether there is an expectation of confidentiality between the distributor and the recipients of the materials. Even if there is no formal, legal obligation of confidentiality, it still may be relevant to determine whether any policies or practices associated with a particular group meeting would give rise to an expectation that disclosures would remain confidential."

The Court considered all of the relevant factors and found that the Board did not address the potentially-critical difference between the SDSG meeting and the other two programs, which were not limited to members of the SDSG and the materials were distributed without restrictions.

Although the Board found that the disclosure to a small group of experts at the SDSG meeting was insufficient to find that the Video and Slides were publicly available, the Court determined that "its analysis was silent on the distribution that occurred in the two non-SDSG programs." The Board did not address "whether the disclosures would remain confidential."  Although the SDSG members were experts voted into the membership, "the relatively exclusive nature of the SDSG membership is only one factor in the public accessibility analysis. It may be relevant, for example, to consider the purpose of the meetings and to determine whether the SDSG members were expected to maintain the confidentiality of received materials or would be permitted to share or even publicize the insights gained and materials collected at the meetings."

The target audience can be a factor in determining public accessibility. See In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir.2004). "But this factor alone is not dispositive of the inquiry. Distributing materials to a group of experts, does not, without further basis, render those materials publicly accessible or inaccessible, simply by virtue of the relative expertise of the recipients. The nature of those meetings, as well as any restrictions on public disclosures, expectations of confidentiality, or, alternatively, expectations of sharing the information gained, can bear important weight in the overall inquiry."

Companies, individuals and attorneys should consider presentation and distribution of information in any setting with the utmost care when contemplating to pursue subject matter intended for dissemination in a patent application.  Also, the factors referred to by the Court in Medtronic should be considered when petitioners evaluate "public accessibility" of a reference for reliance in IPRs. The issues of "public accessibility" of a reference and "printed publication" are especially relevant in life science related proceedings, as prior art in this field more commonly includes more than just U.S patents and published applications.

Medtronic, Inc. v. Mark A. Barry, Case No. 2017-1169 (Fed. Cir., June 11, 2018).

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