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In an inter partes review (“IPR”) proceeding, a patent owner should submit any relevant evidence that might lead to a nonobviousness determination.  Relevant evidence may include secondary indicators of nonobviousness such as (1) commercial success, (2) long-felt but unsolved needs, and (3) failure of others. See Graham v. John Deere Co., 383 U.S. 1 at 18.  However, “[t]o be given substantial weight in the determination of obviousness or non-obviousness, evidence of secondary considerations must be relevant to the subject matter as claimed, and therefore the examiner must determine whether there is a nexus between the merits of the claimed invention and the evidence of secondary considerations.” (MPEP 716.01(b) citing Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 305 n.42 (Fed. Cir. 1985)).

Establishing a nexus between commercial success and the patented technology

In order to demonstrate commercial success in the context of secondary considerations of non-obviousness, an expert must establish a nexus between that commercial success and the patented technology. Cot’n Wash, Inc. v. Henkel Corp., No. CV 12-650-SLR, 2014 WL 4245871, at *15 (D. Del. Aug. 26, 2014).  However, if the marketed product embodies the claimed features, and is coextensive with them, then a nexus is presumed and the burden shifts to the party asserting obviousness to present evidence to rebut the presumed nexus.  Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000).

NuVasive’s petition for IPR

In NuVasive v. Warsaw Orthopedic (IPR2013-00395), NuVasive petitioned the Patent Trial and Appeal Board (“PTAB”) to invalidate claims 1 to 6 of U.S. Patent 8,444,696 (FIG. 7A above) on the grounds that the claims were obvious in view of several prior art references (Paper No. 5).  Patent owner, Warsaw, chose not to file a Preliminary Response and the PTAB instituted the IPR on December 20, 2013 (Paper No. 12).

U.S. Patent 8,444,696 – Spinal Fusion Implant

The ‘696 patent relates to an interbody-spinal-fusion implant that is “configured to restore and maintain two adjacent vertebrae of the spine in correct anatomical angular relationship.” (US 8,444,696 at 1:20-23).  The spinal implants are sized to fit within the disc space that is created when the disc material between two adjacent vertebrae is removed, and conform “wholly or in part to the disc space created.” (Id. at 1:61-64).

Warsaw’s response to petition

In its response to NuVasive’s petition, Warsaw argued in part that the claims are nonobvious in view of the industry’s widespread adoption of Dr. Gary K. Michelson’s (inventor of ‘696 patent) spinal fusion implants and the commercial success of products that are covered by claims 1 and 4 of ‘696 patent (Paper No. 24 at 24).

In particular, Warsaw argued that the claims are nonobvious because:

  1. the spinal fusion implants developed by Dr. Michelson  have changed the practice of spinal surgery, and are the preferred implants for many surgeons (Id., citing Ex. 2005, ¶ 24, Declaration of Dr. Charles Branch);
  2. NuVasive’s expert, Dr. Brantigan, agrees that there has been a significant adoption of spinal fusion implants that appear to fall within the scope of the ‘696 patent (Id., citing Ex. 2009, 172:15 to 173:2, Deposition of Dr. John Brantigan); and
  3. sales of spinal fusion implants by Medtronic (e.g. CLYDESDALE® Spinal System) that are covered by claims 1 and 4 have totaled more than $80 million since inception (Id., citing Ex. 2010, Declaration of Lori Ferrell, accountant at Medtronic).

NuVasive’s reply

In reply, NuVasive countered that Warsaw did not satisfy its burden of showing that the commercially successful product embodies and is coextensive with the claimed features of the patent (Paper No. 25 at 14).  Even if the Clydesdale implant is covered by the claims of the ‘696 patent, NuVasive argues that there is no nexus between the features claimed and the commercial success of the Clydesdale implant (Id. at 14-15).  For example, Warsaw made no attempt to show why the alleged success is not a result of promotion, advertising, or other business events (Id.).

PTAB decision

The PTAB largely agreed with NuVasive and held that Warsaw “has not attempted to establish a nexus between the claims of the ‘696 and the CLYDESDALE® Spinal System.” (Paper No. 36 at 13-14).  Therefore, the PTAB held that Warsaw’s “arguments and evidence as to commercial success are entitled to little or no weight. (Id.).

Conclusion

In this instance, the PTAB found Warsaw’s explanation of the nexus between commercial success and the patented technology inadequate.  The natural question:  what is required to establish a nexus?

At a minimum, which NuVasive pointed out was lacking here (Paper No. 35 at 17), you should provide a claim-by-claim analysis indicating which claims cover the commercially successful product.  Without a claim-by-claim analysis, it is difficult to establish a nexus between the claimed features and the commercial success of the product.

Furthermore, you should clearly explain why the claimed features are what led to the success of the product, rather than other factors such as promotion, advertising, or other business events.

In any event, one thing is clear.  When you are aware of secondary considerations that may lead to a nonobvious determination, you should take special care to establish the nexus between the merits of the claimed invention and the evidence of secondary considerations, thereby shifting the burden to the other party.