Surgalign Spine Technologies, Inc. et al. v. LifeNet Health

Docket No. 2021-1117-18, -1236 (IPR2019-00569, -00570) ( (Non-Precedential)


April 11, 2022

Brief Summary:   IPR obviousness decision reversed, claim construction affirmed, other no obviousness decision affirmed.

Summary:  Surgalign appealed USPTO (“Board”) IPR decision finding it failed to prove the invalidity of certain of LifeNet’s claims, and LifeNet cross-appealed the determination that others were proven unpatentable.  The patents at issue are US 8,182,532 and US 6,458,158 have “substantially identical specifications” and relating to composite bone grafts for use in spinal fusion.  “Pertinent to Surgalign’s appeal, independent claim 4 of the ’532 patent recites a composite bone graft that includes two cortical bone portions that are ‘plate-like’” (cortical bone is stronger and “less receptive to cellular growth” while “[c]ancellous bone is soft, spongy, and has properties that promote the formation of bone, such as osteoconductivity”) and “‘bone pins… generally made of allogenic cortical bone” (the latter being shared by the independent claims of the ‘158 patent).  LifeNet’s cross-appeal includes ‘532 independent claim 12 that “recites that “one or more osteoconductive substances are disposed between [a] first cortical bone portion and [a] second cortical bone portion.”  The relevant references describe “‘[a]n implant composed substantially of cortical bone’ that is machined to form a ‘substantially ‘D’-shaped’ implant that has ‘a canal running therethrough’ that may be filled with osteogenic, osteoinductive, or osteoconductive material” (Grooms), “an ‘allogenic intervertebral implant for fusing vertebrae’ having ‘top and bottom surfaces [that] can be flat planar surfaces’” (Paul), and “a ‘composite corticospongial block’ made of two or three pieces of autologous iliac crest bone, fastened together with a metal screw” (Wolter).

The Board construed “‘plate-like’ in the ‘532 patent to mean ‘generally flat’” (as requested by Surgalign) that it found were not disclosed by Grooms and Paul resulting in its conclusion that Surgalign had not shown ‘532 claim 4 and its dependents unpatentable.  The FC panel disagreed with the Board’s construction and obviousness analysis as it “did not consider the flatness of the bone portions as they extend in the horizontal direction” and “the proper construction should consider the ‘overall shape’ of the cortical bone portion”, and therefore reversed the Board on this point.  Judge Newman dissented from this point arguing that “[t]he Board’s findings are supported by substantial evidence”, e.g., “the Grooms and Paul grafts are explicitly not plate-like, and cannot be so viewed.”

The Board also “construed the term ‘disposed between,’ as recited in claim 12 of the ’532 patent, not to require that the first and second cortical bone portions be completely separated throughout the graft” and that Grooms rendered ‘532 claims 12-21 obvious (e.g., ““[i]f ‘disposed between’ required complete separation . . . there would be no need for claims 1 and 2”, citing Columbia, FC 2019 and Stumbo, FC 2007).  In this appeal, LifeNet argued the Board “erred by giving too much weight to the language of the claims of the ’158 patent without properly analyzing the specification”.  The FC panel found no error with the Board’s construction since “unlike in Abbott [FC 2012 (“the patent ‘repeatedly, consistently, and exclusively’ depicted an electrochemical sensor without external cables or wires and disparaged sensors with external cables or wires”] and Groove [FC 2020 (“patent’s Field of the Invention described the ‘present invention’ as ‘delivering and serving local content and advertisements’”], there is both an uncontested ordinary meaning that is not limited as LifeNet urges and evidence in the form of the claims”.

The Board also concluded Wolter and combinations therewith did not render the claims unpatentable, a “conclusion hinged on its determination” of a lack of motivation “to modify Wolter in the proposed manner” (e.g., “would run counter to Wolter’s goal”, “‘technical difficulties’ in making the proposed substitution”).  In this appeal, Surgalign argued “the Board erred because it did not frame its obviousness analysis in terms of what a person of ordinary skill in the art would have been motivated to do at the time of the invention in 1999, and instead focused on Wolter’s 1987 statements” and “erroneously focused its motivation to combine analysis on whether making a Wolter-type graft from allogenic bone would have been the preferred solution”.  The FC panel found that while the Board may have “improperly analyzed [the] motivation to combine”, substantial evidence supported its conclusion of no reasonable expectation of success (Intell. Bio-Sys., FC 2016).

Patrick Halloran

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel…

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel approaches for gene therapy of melanoma. Pat has been an attorney (IL) since 1999 after graduating from Chicago-Kent College of Law, which was recently ranked as one of the top five law schools for Intellectual Property in the U.S. (U.S. News and World Report link). Pat also has a B.A. in Biology from Augustana College (Rock Island, IL; 1989) where he was on two NCAA Division III National Championship football teams (1985, 1986). He currently resides in Center Valley, PA.