Andrew Melick | December 16, 2016
In Re: NuVasive, Inc.
November 9, 2016
Before Moore, Wallach and Taranto. Opinion by Taranto.
Medtronic filed two petitions for inter partes review (IPR) against U.S. Patent 8,187,334 to a spinal fusion implant owned by NuVasive. The claims of the ‘334 patent recite two size requirements: that the length of the implant is greater than 40 mm and that the length to width ratio is 2.5. In both petitions, Medtronic cited the combination of two references for teaching the size limitations. In the patent owner responses, NuVasive addressed the combination of references as in Medtronic’s petition. However, in Medtronic’s reply, Medtronic changed its reliance to just one of the cited references for teaching both of the size limitations citing a different portion of the reference. The PTAB ultimately relied on Medtronic’s changed position in its final decision. In one IPR, the CAFC held that NuVasive had an opportunity to respond because Medtronic’s petition was at least minimally sufficient to provide notice. However, in the second IPR, NuVasive was not given proper notice to respond.
NuVasive’s patent (US Patent No. 8,187,334) is to implants for spinal fusion surgery. Medtronics, Inc. filed two petitions for IPR against the patent. The Patent Trial and Appeal Board (“PTAB”) instituted the two IPRs as IPR2013-507 (IPR507) and IPR2013-508 (IPR508). Medtronics later settled with NuVasive and has withdrawn from the appeal. The PTO Director took over the appeal for Medtronics.
The relevant part of claim 1 in the patent is as follows:
1. A spinal fusion implant of non-bone construction positionable within an interbody space between a first vertebra and a second vertebra . . .
wherein said implant has a longitudinal length greater than 40 mm extending from a proximal end of said proximal wall to a distal end of said distal wall;
wherein a central region of said implant includes portions of the first and second sidewalls positioned generally centrally between the proximal wall and the distal wall, at least a portion of the central region defining a maximum lateral width of said implant extending from said first sidewall to said second sidewall, wherein said longitudinal length is at least two and half [sic] times greater than said maximum lateral width . . . .
In IPR507, Medtronic’s petition cited Frey (U.S. Patent Application Publication No. 2002/0165550) which teaches an implant having a length at least 2.5 times the width; and argued that it would have been obvious to modify Frey to have a length greater than 40 mm based on Michelson (U.S. Patent No. 5,860,973). Medtronic additionally cited another passage in Michelson for teaching other features of the claims. The additionally cited passage of Michelson discusses Figure 18 of Michelson.
In IPR508, Medtronic’s petition relied on Synthes Vertebral Spacer-PR Brochure (SVS-PR) and Telemon brochures (Telemon) which teach implants having lengths that are at least 2.5 times their widths. Medtronic argued that it would have been obvious to modify either SVS-PR or Telemon to have lengths greater than 40 mm as taught in Michelson. However, in the IPR508 petition, Medtronic did not include a citation to Michelson that discusses Figure 18.
In the patent owner response, NuVasive addressed Michelson’s Figures 16, 19 and 20 showing long and wide implants or narrow implants as opposed to long and narrow implants as in the claims, and NuVasive argued that it would not have been obvious to combine the implant length of Michelson with the primary references teaching the length to width ratio of 2.5 because the implant would be an unsuitable size for the intended insertion path of the primary references.
Medtronic then replied to NuVasive by specifically pointing to Figure 18 for teaching an implant having a length that was greater than 40 mm and satisfying the length to width ratio of 2.5.
NuVasive objected to Medtronic’s argument pointing to Figure 18 as being a new ground of invalidity asserted for the first time in the reply. NuVasive requested leave to file motions to strike or to file surreplies. The PTAB denied both requests.
At the oral argument, NuVasive again attempted to address the issue regarding the new ground of invalidity. However, the PTAB did not allow NuVasive to make substantive arguments. Medtronic provided arguments relating to Figure 18, and NuVasive objected again. However, the PTAB assured NuVasive that it understood NuVasive’s position and would consider the propriety of Medtronic’s arguments in its final decision.
In the final decisions for IPR507 and IPR508, the PTAB cancelled claims relying heavily on its findings that Michelson by itself discloses both the length and length to width requirements.
The CAFC explained the rules applied to this case. The PTAB is not limited to citing portions of the prior art specifically drawn to its attention. For example, the PTAB can cite additional material such as for reinforcing the meaning of another prior art reference or describing the state of the art at the time of the invention, and this is especially true if the additional material cited by the PTAB is not relied on for establishing claim limitations. However, under the Administrative Procedure Act (APA), when the additional material is an essential part of the obviousness determination, i.e., for identifying claim elements in the prior art, the patent owner is entitled to adequate opportunity to respond to the asserted facts. And this adequate opportunity to respond for the patent owner applies to additional material in an already cited reference if the material is in a newly cited portion of the reference.
The CAFC held that in IPR507, NuVasive had an opportunity to respond because Medtronic’s petition was at least minimally sufficient to apprise NuVasive of the assertion about Figure 18 of Michelson. Medtronic’s petition cited text in Michelson which referred to Figure 18 and stated that the text shows “longer than wide” implants. The CAFC acknowledged that this was not a clear or direct reference to the claimed 2.5 length to width ratio or that this feature is taught in Figure 18 of Michelson. But the CAFC said that this information in Medtronic’s petition should have put NuVasive on notice to address Figure 18 and its relationship to the length to width ratio claim limitation.
For IPR508, the CAFC held that NuVasive did not have an opportunity to respond to assertions about Figure 18 since Medtronic’s petition did not include the same citation to Michelson regarding Figure 18 or the same assertions regarding the passage in Michelson. The CAFC concluded that:
The [PTO] Director has furnished no persuasive basis on which we are prepared to hold that a (barely sufficient) notice in one proceeding constituted an obligation-triggering notice in the other proceeding in which a comparable notice was missing.
The PTO Director appears to have argued that since in IPR508, NuVasive discussed some of the text cited in the Michelson passage cited by Medtronic in IPR507, Medtronic was allowed to respond by discussing Figure 18 of Michelson. However, the CAFC said that satisfying the rule that “a reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response or patent owner response” 37 C.F.R. § 42.23(b), does not mean that pre-Response notice was sufficient.
The PTO Director also argued that NuVasive was permitted to cross-examine the relevant expert for Medtronic and file “observations” on the cross-examination. The CAFC said that while this vehicle may be used to protect against APA violations, the CAFC has never said that this vehicle is always sufficient to provide an opportunity to respond. In this case filing “observations” was not sufficient because new evidence cannot be submitted with observations. And in this case, the PTAB rejected portions of NuVasive’s observations for being too argumentative.
In IPR507, the CAFC affirmed the PTAB’s decision invalidating claims 1-5, 10, 11, 14, 15 and 19-28 and upholding claim 18. In IPR508, the CAFC vacated the PTAB’s decision and remanded for further proceedings regarding claims 16 and 17.
In an IPR, A patent owner should consider all citations made by petitioner to the prior art in the petition even if the petition does not directly or clearly discuss why or how such citations are relevant. If a patent owner does not address a certain citation that was merely mentioned in passing by the petitioner, the petitioner may later directly rely on such citation or to figures cited in such citation. However, if a petitioner in its reply relies on new citations to a prior art reference, patent owner should object to the argument as being a new ground of invalidity.