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Nuvasive, Inc. v. Warsaw Orthopedic, Inc. (IPR2013-00206, Paper No. 65, July 10, 2014)

In a recent inter partes review (IPR), the Patent and Trial Appeals Board (PTAB) found that only some of the grounds of unpatentability were sufficient to meet the “preponderance of the evidence standard” for determining claims unpatentable.  In its decision, the PTAB held that secondary considerations, without any nexus between the evidence of the secondary considerations and the claimed invention, were not enough to save claims 17-23 of U.S. Patent No. 8,251,997 B2 (“the ’997 patent”) from being unpatentable.  However, Claims 9-16 and 24-30 were determined to be patentable.  Id. at 27.

In the IPR, six grounds of unpatentability were asserted against the ’997 patent based on six asserted prior art.  In its decision, the PTAB reproduced Claim 9 as illustrative of the claimed subject matter of the ’997 patent.  Id. at 3.  Specifically, the ’997 patent is directed to methods of performing surgery along a lateral aspect of the spine by sequentially advancing surgical instruments through a lateral aspect of the spine, using each preceding surgical instrument as a guide in order to place a spinal implant in a disc space of the spine.  Id. at 3-4.

The PTAB determined claims 17-23 were unpatentable under 35 U.S.C. § 103(a) as being obvious over prior art references to Jacobson, Leu, and Brantigan.

Jacobson

In its decision, the patent owner, Warsaw, argued that the feature “a path having an axis lying in a coronal plane,” as recited in Claim 17, must lie in a direct lateral path to the spine.  Id. at 7.  However, the PTAB determined that Jacobson, which depicts passing a cannula laterally to an intervertebral space, was sufficient to teach this feature of Claim 17.  Id.at 8.  In its argument, the patent owner argued that “lateral” as recited in Claim 17 actually meant a direct lateral approach to the spine (i.e., a 90 degree lateral approach), while the disclosure of Jacobson only disclosed a posterolateralapproach.  To rebut the patent owner’s argument, the petitioner, Nuvasive, presented expert testimony that one of ordinary skill in the art would understand that “lateral” meant just that — a lateral approach to the spine.  Id.  The PTAB agreed with the petitioner, stating that the failure of Claim 17 to recite “direct lateral” further supporting the petitioner’s  argument.

The patent owner also argued that the figures of Jacobson were two-dimensional, so even though these figures may appear to show a direct lateral path, the figures do not show the actual surgical approach, which could be posterolateral or anterolateral.  The PTAB discounted this argument, finding that, regardless of whether or not surgeons are taught to orient instruments by taking images of a patient’s body, which could provide a more accurate surgical approach than the figures of Jacobson, the patent owner still did not demonstrate that the two-dimensional figures of Jacobson teaches inserting instruments in any way other than in a lateral direction.  Id. at 11.

Furthermore, the patent owner attempted to argue that the different procedures taught by Jacobson would not be performed by a person of ordinary skill in the art using a lateral approach, because the procedures taught by Jacobson could cause surgical complications, even relying on expert testimony to support this arguments.  See e.g., Id. at 12-15.  However, the PTAB notes that Jacobson addresses the potential surgical risks, and the surgery is not performed if there is a chance of harming the patient.  Accordingly, the PTAB determined that absent a specific requirement of a “direct lateral” approach, a person of ordinary skill would understand that the lateral approach disclosed in Jacobson meets the “lateral” approach as recited in Claim 17.  Id. at 15.

Brantigan

The PTAB also determined  whether the feature “implant being sized to occupy substantially the full transverse widths of the vertebral bodies,” as recited in Claim 17, was taught by Brantigan.  In its decision, the PTAB held that Brantigan’s disclosure of implants “generally shaped and sized to conform with the disc space” teaches this feature.

The patent owner relied on expert testimony from the inventor of the ’997 patent to provide an anatomical definition of a “vertebral body” as:

[Containing] a ‘vertebral endplate that ‘is typically vascular,’ an ‘apophyseal ring’ ‘anatomically distinct from the vertebral endplate’ and ‘almost entirely avascular’ located ‘[t]oward the vertebral periphery,’ and a ‘cortical rim’ ‘distinct from the apophyseal ring’ located ‘[a]t the very edge of the vertebral body.

Id at 18The PTAB determined that, regardless of whether or not the expert’s anatomical definitions were correct, the patent owner did not provide sufficient evidence to show that the feature of Claim 17 was not prima facie obvious in view Brantigan’s implant “sized to conform with the disc space.”  Id.  The patent owner also argued  that a person of ordinary skill in the art would not have found the claim term obvious in view of the various disclosures of implants in Brantigan.  However, the PTAB again determined that the claim terms as properly construed will be “broadly but reasonably [construed] in light of the [s]pecification.”  Id. at 17.

The patent owner found that, in view of this construction, the “implant being sized to occupy substantially the full transverse widths of the vertebral bodies,” as recited in Claim 17, was met by Brantigan.

Leu

The patent owner argued that the “graft conglomerate” disclosed in Leu did not teach “an interbody intraspinal implant,” as recited in Claim 17.  Specifically, patent owner again provided expert testimony from the inventor that the graft conglomerate of Leu contains “impacted bone” and soft cancellous bone,” which a person of ordinary skill in the art would understand is not provided in an interbody intraspinal implant.  Id. at 21.  In its decision, the PTAB held that patent owner provided no reason why an interbody intraspinal implant could not contain these bone types, and found that Leu taught “an interbody intraspinal implant,” as recited in Claim 17.

Furthermore, in citing KSR Int’l Co. v. Teleflex, Inc., the PTAB found that combining known elements for inserting instruments into a disc space, as disclosed in Jacobson, with devices used in a spinal fusion procedure, as disclosed in Leu and Brantigan, “is likely to be obvious when it does no more than yield predictable results.”  500 U.S. 398, 416 (2007).

The patent owner further argued that secondary considerations of commercial success, industry praise or, copying of the ’997 patent renders Claims 17-23 non-obvious.  However, the PTAB found that, even if the patent owner’s evidence of commercial success, industry praise, and copying was valid, no nexus was shown between the evidence and the claimed invention, as required for a finding of non-obviousness based on secondary considerations.  Nuvasive, Inc. at 25.

Claims 9-16 and 24-30

The PTAB did not invalidate all of the claims of the ’997, however.  Independent Claim 9 of the ’997 patent recites that a length of an implant is sized to occupy substantially the full transverse width of the vertebral bodies of the two adjacent vertebrae.  Independent Claim 24 recites that the length of an implant is sized to occupy the full transverse width of the vertebral bodies of the two adjacent vertebrae.  Id. at 31.

The petitioner argued that these features were obvious over a prior art reference to Michelson, which disclosed an artificial fusion implant placed in an intervertebral space, where the drill only penetrates 28 millimeters past the end of the drill sleeve and the implant can be at most 26 millimeters in length, and that the implant may be made smaller to enhance the safety.  Id. at 31-32.  However, the PTAB found that Michelson makes no disclosure of the relation of the length of the implant or the length of the drill opening in relation to the size of the vertebral body.  Id. at 32.  Therefore, the PTAB found that the Michelson did not teach or suggest for a surgeon to size an implant to occupy the full transverse width or even substantially the full transverse width of the vertebral bodies of the two adjacent vertebrae, as recited in Claims 24 and 9, respectively.  Thus, the PTAB found Claim 9 and 24, and Claims 10-16 and 25-30 for their respective dependencies, were nonobvious over the combination of Jacobson, Leu, and Michelson.  Id. at 22.

Throughout the IPR, the patent owner attempted to limit the breadth of certain claim terms or cast the terms in a different light to prevent a finding of obviousness of Claims 17-23.  However, it is clear that the PTAB will continue to broadly, but reasonably, construe claim terms, while strictly applying the Federal Circuit’s secondary consideration factors in determining obviousness.