RSB Spine, LLC has filed a lawsuit against Orthofix Medical, Inc., SeaSpine Holdings Corporation, SeaSpine, Inc., and SeaSpine Orthopedics Corporation alleging patent infringement.
RSB Spine Sues Orthofix and SeaSpine for Patent Infringement

The litigation involves U.S. Patent No. 9,713,537 (the ‘537 patent). Robert S. Bray, Jr., M.D. is the sole inventor named on the patent. Dr. Bray is one of two founders of RSB Spine.
The ‘537 patent describes a bone stabilization plate system that includes, quoting directly from the patent document, “a base plate configured to fit primarily between an anterior portion of a first bone’s lip osteophyte and an anterior portion of a second, adjacent bone’s lip osteophyte.” The system includes “a plurality of bone screws configured to fit in respective bone screw holes in the base plate to secure the base plate.”
RSB Spine is claiming that the following products infringe the ‘537 patent: Orthofix’s LoneStar Cervical Stand Alone (CSA) System; SeaSpine’s Complete Cervical Intervertebral Body Fusion Device (IBD) System; and SeaSpine’s Shoreline® ACS.
RSB Spine claims the alleged infringing products have “no substantial non-infringing uses” notably because the alleged infringing products are purportedly “bone stabilization plate systems, containing all the structural elements claimed in the asserted patent, specifically designed for spinal fusion procedures.”
RSB Spine further asserts that the alleged infringing products “provide all the components and features that perform the claimed system of the ’537 Patent.” RSB Spine asserts that the alleged infringing products contain “a base plate, plurality of bone screw holes, and plurality of bone screws, and are designed for spinal insertion wherein the base plate bears weight of the vertebral bones for fusion.”
RSB Spine is demanding a jury trial. RSB Spine is seeking a ruling of patent infringement, compensatory damages, treble damages, and attorneys’ fees.
This is not the first time that RSB Spine has filed a patent infringement lawsuit for the ‘537 patent. According to RSB Spine’s complaint, RSB Spine has filed complaints against Xtant Medical Holdings, Inc.; Precision Spine, Inc.; Medacta USA, Inc.; Life Spine, Inc.; DePuy Synthes Sales, Inc.; and DePuy Synthes Inc.
For OTW’s coverage of these other suits, see Spine Patent Infringement Costs DePuy Synthes $12M.

Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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