In its Final Written Decision, the Board held that Petitioner demonstrated by a preponderance of the evidence that all of the challenged claims, claims 1-12, of the ’535 patent are unpatentable. The ’535 patent generally “relates to techniques employing medical devices for spinal surgery.”
Addressing claim construction, the Board had construed two claim terms in its Decision on Institution, and neither party disputed the constructions in the PO Response or Reply. Accordingly, the Board maintained the same constructions for the Final Written Decision.
Also, in the Decision to Institute, the Board determined that the challenged claims of the ’535 patent are not entitled to the benefit of the ’424 provisional’s filing date. Patent Owner did not dispute this determination, and the Board maintained this position for the Final Written Decision.
Petitioner moved to exclude certain exhibits. Petitioner argued that one set of exhibits were irrelevant, as they were not cited to by Patent Owner. The Board dismissed this portion of the motion as moot, because neither the parties nor the Board relied on those exhibits. Petitioner further argued that another set of exhibits should be excluded as hearsay. The Board agreed with Patent Owner that they were offered for non-hearsay purposes (showing declarants’ states of mind), and thus the motion was denied with respect to those exhibits. Petitioner further argued that yet another set of exhibits should be excluded as hearsay. Again the Board agreed with Patent Owner that they were offered for non-hearsay purposes (showing industry praise and the states of minds of the declarants). The Board also agreed with Patent Owner that whether the authors of those exhibits are skilled artisans goes to the weight of the evidence, not its admissibility. Thus, the Board denied the motion with respect to these exhibits as well.
Turning to the prior art, the Board addressed each of the obviousness grounds of unpatentability. First, the Board addressed disputes over the level of ordinary skill in the art. Petitioner contends that a POSITA would have knowledge of both neurophysiology and spine surgery, and that Patent Owner’s declarants are merely spine surgeons without expertise in neurophysiology. Patent Owner argued that a POSITA would have been a spine surgeon, and that Petitioner’s declarant has expertise in neuromonitoring, but not spine surgery. The Board agreed with Petitioner on the level of ordinary skill in the art, and considered the respective expertise of each declarant in weighing their testimony.
The Board then analyzed the specific obviousness grounds. The parties disputed whether a skilled artisan would have had reason to combine the teachings of Foley, Marino, Obenchain, and NIM Guide. Petitioner argued that there would have been a reason to combine the references, because the nerve detection techniques of Marino and NIM Guide are specifically intended to make the surgical procedures of Foley and Obenchain safer. Patent Owner argued that a POSITA would not have combined the references because of the conventional wisdom of the dangers of traversing the psoas muscle. The Board agreed with Petitioner and found that Patent Owner’s descriptions of the cited art were too restrictive.
Patent Owner also asserted several objective indicia to show non-obviousness. The Board explained that while it is Patent Owner’s burden to introduce evidence supporting objective indicia, the ultimate burden of persuasion never shifts to Patent Owner. Instead, the objective indicia are considered along with all of the other evidence in making the obviousness determination. Patent Owner’s objective indicia included arguments “that the conventional wisdom among spine surgeons was that a lateral approach to the spine through the nerve-rich portion of the psoas muscle was dangerous and that surgeons were skeptical of procedures using that approach; nevertheless, there was a long-felt need for such an approach to avoid the disadvantages of other approaches; against this backdrop, Patent Owner developed a successful technique for traversing the psoas muscle; and, as a result, Patent Owner received extensive praise, created a new market, and ultimately achieved commercial success.” The objective evidence was centered on praise for, and success of, its “eXtreme Lateral Interbody Fusion” (XLIF) systems and methods. The Board found that Patent Owner had not adequately established what XLIF is or whether it is encompassed by the claims of the ’535 patent, because it referred to features of the technique with a high degree of generality. Also, the term “XLIF” appears to be a marketing term, and the Board found that Patent Owner had not fully clarified whether it was referring to a method or a group of products, thus leaving it to the Board to determine what it is referring to in each situation that the term “XLIF” is used.
Medtronic, Inc. v. NuVasive, Inc., IPR2014-00081
Paper 44: Final Written Decision
Dated: April 3, 2015
Patent: 8,005,535 B2
Before: Francisco C. Prats, Scott E. Kamholz, and David C. McKone
Written by: McKone
Related Proceedings: IPR2014-00087 (8,005,535); IPR2014-00034 (8,000,782); IPR2014-00073 (8,192,356); IPR2014-00074 (8,192,356); IPR2014-00075 (8,016,767)