Claim Term Analysis and Secondary Considerations in Inter Partes Review Andrew P. Ritter Andrew P. Ritter is an associate at Sughrue Mion, prove “that a patent is invalid by a preponderance of the PLLC in Washington, DC. His practice focuses on evidence.” 3 patent prosecution, inter partes matters, and opinion In addition, to determine the validity of a patent dur- preparation on matters relating to infringement and ing an IPR, claim terms are construed using a “broadest validity in litigation. Mr. Ritter focuses on such reasonable construction” in view of the specification. 4 areas as computer systems, medical systems, medical Furthermore, factors relating to the validity of the devices, electrical and optical connectors, and claimed invention under 35 U.S.C. §§ 102 and 103 also other mechanical and electrical devices. The views must be investigated. expressed herein are solely those of the author. The “Broad But Reasonable” In a recent inter partes review (IPR), the Patent and Claim Term Trial Appeals Board (PTAB), in addressing two impor- tant concepts in construing and validating patent claims, The enactment of the AIA by Congress gave petition- found that only some of the grounds of patentability ers the ability to request that the PTAB cancel one or were sufficient to meet the “preponderance of the evi- more claims of a patent, by determining that the claim dence standard” for determining claims unpatentable. or claims are unpatentable under 35 U.S.C. §§ 102 or Specifically, the PTAB held that claim terms in an IPR 103, based on prior art consisting of patents and printed are construed in a broad but reasonable manner and that publications. 5 Unlike litigation in district courts, where secondary considerations, without any nexus between claims are presumed valid and claims are construed the evidence of the secondary considerations and the based on the narrower Phillips standard, 6 the PTAB uses claimed invention, are not enough to save claims from a the broadest reasonable construction standard during prima facie case of obviousness. 1 IPRs of unexpired patents. 7 Thus, the petitioner in an As the two-year anniversary of the implementation IPR has a greater opportunity to prove invalidity of one of the IPR approaches, a brief overview of the IPR is or more claims than an accused infringer in district court provided, while presenting an analysis of the claim term litigation. construction and the application of secondary consider- While IPR proceedings are still in their infancy, ations in IPR proceedings. the PTAB has made clear that the broadest reason- able interpretation standard will be applied in IPR proceedings. For example, the PTAB has applied the Inter Partes Review broadest reasonable interpretation standard in each of its decisions. The PTAB’s decision in Nuvasive, Inc. v. Background Warsaw Orthopedic, Inc. provides several examples of Inter partes review proceedings became available on the PTAB’s claim construction using the “broad but September 16, 2012, replacing the preexisting inter partes reasonable” standard. reexamination procedure. Under the American Invents Act (AIA), the change from inter partes reexamination Nuvasive, Inc. v. Warsaw to IPR “convert[ed] inter partes reexamination from Orthopedic, Inc. an examination to an adjudicative proceeding,” while also elevating the threshold for initiating IPRs, institut- During the Nuvasive IPR, six grounds of unpatentabil- ing estoppel provisions, and allowing the petitioner to ity were asserted against the patent at issue based on six challenge any and all patents, among other changes. 2 asserted prior art. In its decision, the PTAB reproduced The burden on the petitioner to prove invalidity in an claim 9 as illustrative of the claimed subject matter of IPR, however, remains unchanged from inter partes the patent. 8 Claim 9 is directed to methods of performing reexamination procedures, in which the petitioner must surgery along a lateral aspect of the spine by sequentially I P L i t i g a t o r SEPTEMBER/OCTOBER 2014 5
advancing surgical instruments through a lateral aspect extended beyond a central region of the vertebral body of the spine, using each preceding surgical instrument as or overlapped onto an apophyseal ring. 18 However, the a guide, to place a spinal implant in a disc space of the PTAB found that Brantigan disclosed an implant “sized spine. 9 In its decision, the PTAB determined claims 17-23 to conform with the disc spaced between adjoining were prima facie obvious under 35 U.S.C. § 103(a) over vertebrae.” 19 prior art references to Jacobson, Leu, and Brantigan, in In construing the term “disc space,” as recited in claim view of a broad but reasonable construction of the claim 17, the PTAB determined that a broad but reasonable terms. construction, in light of the specification, would “include a space between adjacent vertebral bodies.” 20 However, the patent owner relied on expert testimony from the What Is “Lateral”? inventor of the patent at issue to provide an anatomical During the IPR, the patent owner, Warsaw, argued definition of a “vertebral body” as: that the feature “a path having an axis lying in a coronal plane,” as recited in Claim 17, must lie in a direct lateral [Containing] a vertebral endplate that “is typi- path to the spine. 10 However, the PTAB determined that cally vascular,” an “apophyseal ring” “anatomically Jacobson, which depicts passing a cannula laterally to an distinct from the vertebral endplate” and “almost intervertebral space, was sufficient to teach this feature entirely avascular” located “[t]oward the vertebral of Claim 17. 11 In its argument, the patent owner alleged periphery,” and a “cortical rim” “distinct from the that “lateral” as recited in Claim 17 actually meant a apophyseal ring” located “[a]t the very edge of the direct lateral approach to the spine ( i.e. , a 90 degree lat- vertebral body.” 21 eral approach), while the disclosure of Jacobson only disclosed a posterolateral approach . 12 To rebut the patent The PTAB determined that, regardless of whether or owner’s argument, the petitioner, Nuvasive, presented not the expert’s anatomical definitions were correct, the expert testimony that one of ordinary skill in the art patent owner did not provide sufficient evidence to show would understand that “lateral” meant just that—a lat- that the implant as claimed extended outside the disc eral approach to the spine. 13 space. 22 Thus, in agreeing with the petitioner, the PTAB In agreeing with the petitioner, the PTAB stated that determined that an implant sized to conform to the “disc “[w]e credit [the expert’s] testimony that one of ordi- space,” which includes the space between adjacent verte- nary skill in the art would have understood the term bral bodies, would have been obvious to one of ordinary “lateral … to mean ‘lateral’ … at least because it would skill in the art. For example, an “implant being sized to have been reasonable for one of ordinary skill in the art occupy substantially the full transverse widths of the to have construed [the] term with a common, accepted vertebral bodies” would necessarily include an implant definition.” 14 Furthermore, the PTAB also stated that the “sized to conform with the disc spaced between adjoin- failure of Claim 17 to recite “direct lateral” supports that ing vertebrae,” as disclosed by Brantigan. 23 Accordingly, the determination that a person of ordinary skill in the the PTAB determined that the feature of claim 17 was art would not have construed the term lateral to mean prima facie obvious in view of Brantigan’s disclosure and “direct lateral.” 15 In other words, the PTAB construed the broad but reasonable interpretation of the feature the term at its most common definition, which was the “disc space.” most reasonable interpretation of the term. Inclusion by Failing to Exclude Defining an Implantable Space The patent owner also argued that the “graft con- The PTAB also determined whether the feature glomerate” disclosed in Leu did not teach “an interbody “implant being sized to occupy substantially the full intraspinal implant,” as recited in claim 17. The patent transverse widths of the vertebral bodies,” as recited in owner again provided expert testimony from the inventor claim 17, was prima facie obvious in view of Brantigan. that the graft conglomerate of Leu contains “impacted In construing the above-recited feature of claim 17, the bone” and “soft cancellous bone,” which the patent PTAB agreed with the petitioner that Brantigan discloses owner asserted a person of ordinary skill in the art would an “implant that is both shaped and sized with regard to understand is not provided in an interbody intraspinal the disc space.” 16 However, the patent owner argued that implant. 24 However, the patent owner failed to provide Brantigan discloses an implant designed to sit within an an explanation for restricting bone types and the speci- apophyseal ring and to sit in a central region of adja- fication did not explicitly state that such bone type must cent vertebral bodies. 17 In other words, the patent owner not be present, i.e. , be excluded, in an interbody intra- asserted that Brantigan failed to disclose an implant that spinal implant. Thus, in broadly construing the feature I P L i t i g a t o r 6 SEPTEMBER/OCTOBER 2014
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