Opinion ID: 183656
Heading Depth: 3
Heading Rank: 1

Heading: We focus first on the two broadest claims, which

Text: are most vulnerable to Globus’s invalidity challenge. Those claims, claim 45 of the ’929 patent and claim 42 of the ’422 patent, are reproduced below: 45. A minimally invasive surgical device, comprising: at least a pair of anchors positionable within a body of a patient; a connecting element positionable within the body; and an instrument associated with the con- necting element, the instrument being operable to percutaneously place the connecting element in a WARSAW ORTHOPEDIC v. GLOBUS MEDICAL 8 predetermined location relative to the pair of anchors. 42. A minimally invasive surgical method, comprising: positioning at least a pair of anchors within a body of a patient; contacting a connecting element with an in- sertion instrument; referencing a position of the connecting ele- ment relative to a position of the pair of anchors; and percutaneously inserting the connecting ele- ment into a desired subcutaneous position relative to the pair of anchors. On appeal, Globus argues that the claims as con- strued are anticipated by an endoscopic surgery performed in the mid-1990’s by its expert witness, Dr. Paul McAfee. 1 A videotape of that surgery was played for the jury, and the procedure was described at length by Dr. McAfee as well as by Dr. Scott Tromanhauser, Warsaw’s expert witness. Assisted by an endoscopic camera, Dr. McAfee inserted two screws into the patient’s spine. Using a grasping instrument, Dr. McAfee inserted a 1 Globus relies on two references on appeal, the McAfee surgery and U.S. Patent No. 4,448,191 (the ’191 patent). The ’191 patent discloses a surgical technique requiring incisions that Globus’s expert admitted were “significant.” All of the asserted claims require a “percutaneous” insertion procedure. The district court construed “percutaneous” to mean “through a small incision or small puncture in the skin.” In light of this distinction, we decline to set aside the jury’s finding that the ’191 patent does not anticipate the asserted claims. 9 WARSAW ORTHOPEDIC v. GLOBUS MEDICAL connecting rod through a small hole in the patient’s back and guided the rod into holes in the two screwheads. Warsaw’s expert, Dr. Tromanhauser, conceded that the McAfee procedure discloses most of the elements of claims 45 and 42, including a pair of anchors and the connecting element. As part of Warsaw’s infringement case, he also explained to the jury that the “predetermined location” limitation in claim 45 is met when the surgeon inserts both screws, dictating the placement of the connecting rod. As to the validity of claim 45 of the ’929 patent, the only issue on appeal is whether the McAfee procedure discloses the final element, “operable to percutaneously place the connecting element in a predetermined location relative to the pair of anchors.” As to the validity of claim 42 of the ’422 patent, the only issue on appeal is whether the McAfee procedure discloses the step of “referencing a position of the connecting element relative to a position of the pair of anchors.” Globus’s position is that the claims, as construed, require only that the instrument assist the surgeon in positioning the connecting element so that it connects the first and second screws. Warsaw’s position is that the claims require that the instrument be able to place the connecting element into the first and second screws without guidance from the surgeon. It is true, as Warsaw argues, that the Sextant places the connecting rod in the proper orientation without the need for the surgeon to guide the rod between the two screws. Once the surgeon has placed the anchors in the vertebrae and properly aligned the inserter, the Sextant will always place the connector between the holes machined in the anchors. The critical question for purposes of the validity inquiry is whether the claims require that the instrument, rather WARSAW ORTHOPEDIC v. GLOBUS MEDICAL 10 than the surgeon, perform the function of directing the connecting element along the path between the first and second screws. Warsaw contends that none of the asserted claims read on a method or a device in which the surgeon uses an ordinary surgical tool to manually insert a rod into the two screws. At trial, Warsaw’s expert, Dr. Tromanhauser, distinguished the invention from the McAfee procedure as follows: The way I see this is the instrument has an opera- tion and [the claim is] talking about the capability of the instrument, not the capability of the sur- geon. Dr. McAfee’s capability is to grab this rod with this general purpose instrument and watch it go into place. That’s not a capability of the in- strument, that’s a capability of the surgeon. So the instrument is not operated—the instrument doesn’t have an operation that places the rod, the surgeon does. Warsaw’s position reflects the way the Sextant works, but it is inconsistent with the limitations in claims 45 and 42, as construed. At Warsaw’s behest, the court construed the final limitation of claim 45 to mean “the instrument can be operated to guide the connecting element, through a small incision or small puncture in the skin, into a location that is determined in advance.” That construction does not require the instrument itself to define the path followed by the rod; under that construction, the surgeon can use the instrument to guide the rod by sight or feel from the first screw to the “location that is determined in advance,” i.e., the second screw. That is precisely what the McAfee surgery discloses. The McAfee 11 WARSAW ORTHOPEDIC v. GLOBUS MEDICAL procedure therefore anticipates claim 45 of the ’929 patent under the trial court’s construction. The McAfee procedure anticipates claim 42 of the ’422 patent for similar reasons. Warsaw argues that the “referencing” limitation requires that “the instrument establishes the position of the rod relative to the screws.” But that argument is inconsistent with the trial court’s construction of the phrase “referencing a position of the connecting element relative to a position of the pair of anchors.” At Warsaw’s urging, the trial court construed that limitation to mean “establishing the position of the connecting element relative to the position of the pair of anchors.” Nothing about the court’s construction of any of the steps of method claim 42 requires that the “referencing” or “inserting” step be performed by an instrument with little to no input or guidance from the surgeon, as opposed to by a surgeon who uses a general purpose tool to guide the connecting element by sight or feel. Thus, because the court’s construction allows the referencing step to be performed either by the surgeon, as in the McAfee procedure, or by an instrument that is aligned by the surgeon, as in a procedure in which the Sextant is used, the McAfee procedure satisfies that limitation and therefore anticipates claim 42 of the ’422 patent. 2 2 At closing argument, counsel for Warsaw argued that claim 45 of the ’929 patent refers “to a capability of the instrument,” and that the “instrument itself serves as a guide.” Counsel argued that the “referencing element” of claim 42 of the ’422 patent “requires some sort of mechanical capability to get the rod . . . in the right place.” While those remarks suggest a narrower construction of those claims, we cannot substitute counsel’s argument for the broader construction given by the court and provided to the jury to guide its deliberations. WARSAW ORTHOPEDIC v. GLOBUS MEDICAL 12 Warsaw argues that the referencing step must be performed by the instrument or the final “insertion” step would be redundant. That is not the case. As construed by the court, the referencing step requires that someone or something—the surgeon or the instrument—establish the desired position of the connecting element by reference to the two anchors. The insertion step requires placement of the anchor through a small hole in the patient’s skin and into the desired position. It is therefore distinct from the referencing step. Because the McAfee procedure discloses all elements of claim 45 of the ’929 patent and claim 42 of the ’422 patent, we reverse the district court’s denial of Globus’s JMOL for invalidity on the basis of anticipation.