Zimmer Biomet Spine Inc v. Jackson Roger P

1. Case Identification

• Case #: IPR2023-01431
• Patent #: 10,548,641
• Filed: September 22, 2023
• Petitioner(s): Zimvie, Inc. and Zimmer Biomet Spine, Inc.
• Patent Owner(s): Roger P. Jackson
• Challenged Claims: 1-28

2. Patent Overview

• Title: Medical Implant Receivers Having Dual Lead in Closure Mating Thread Forms
• Brief Description: The ’641 patent is directed to threaded closures, or setscrews, for spinal implant systems. The patent purports to solve problems associated with single-start threads by disclosing a "double-start" closure with two helically wound thread forms, each having a specific start structure for simultaneously engaging a U-shaped receiver to capture a spinal rod.

3. Grounds for Unpatentability

Ground 1: Obviousness over ’477 and Boschert - Claims 1, 3-19, and 21-28 are obvious over the ’477 Publication in view of Boschert.

• Prior Art Relied Upon: ’477 Publication (Application # 2005/0267477) and Boschert (Patent 7,857,834).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the ’477 Publication discloses a spinal closure with all the key thread geometry claimed in the ’641 patent, including a single thread with a truncated start structure, a curvate leading face (with both concave and convex surfaces), and a beveled lower surface. However, ’477 teaches a single-start thread. Petitioner asserted that Boschert explicitly teaches that designing a setscrew with a "double lead" (i.e., dual-start) thread is advantageous to "start more easily than with a single lead." The combination of Boschert's dual-start thread configuration with the specific thread geometry from the ’477 Publication allegedly renders the independent claims obvious.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine the references to achieve the known benefits taught by each. A POSA would modify the closure of the ’477 Publication with the dual-start threads taught by Boschert to gain the advantage of more reliable and easier threading into the receiver, a benefit expressly taught by Boschert.
  • Expectation of Success: A POSA would have a reasonable expectation of success because dual-start threads were well-known components in spinal closures and the manufacturing techniques were well within the skill of the art. The combination would yield the predictable result of an easier-to-start closure with the favorable thread-entry characteristics of the ’477 design.

Ground 2: Obviousness over ’477, Boschert, and ’391 - Claim 2 is obvious over the ’477 Publication in view of Boschert and the ’391 Publication.

• Prior Art Relied Upon: ’477 Publication (Application # 2005/0267477), Boschert (Patent 7,857,834), and the ’391 Publication (Application # 2006/0069391).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground builds on the combination in Ground 1 to address the limitations of dependent claim 2, which adds a "guide tool having a first guide arm and a second guide arm detachably attached to the receiver." Petitioner argued the ’391 Publication teaches exactly this feature: a detachable guide tool for use with spinal implant receivers that allows for minimally invasive surgery. The guide tool in ’391 has internal threads that align with the receiver threads to allow a closure to be passed through the tool and into the receiver.
  • Motivation to Combine: A POSA building the spinal implant system of ’477 and Boschert would be motivated to incorporate the detachable guide tool from ’391 to achieve the well-known benefits of minimally invasive surgery. As Boschert contemplates the use of various instruments with its receiver, it would have been obvious for a POSA to look to known tools like the one taught in ’391.
  • Expectation of Success: Combining a known detachable guide tool with a spinal screw system was a familiar and predictable integration for a POSA.

Ground 3: Obviousness over ’477, Boschert, and Johnson - Claim 20 is obvious over the ’477 Publication in view of Boschert and Johnson.

• Prior Art Relied Upon: ’477 Publication (Application # 2005/0267477), Boschert (Patent 7,857,834), and Johnson (Application # 2007/0088357).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground adds Johnson to the base combination of Ground 1 to address dependent claim 20, which recites that the receiver arms "each include a breakoff extension." Petitioner asserted that Johnson explicitly discloses a spinal receiver with an upper portion that functions as a break-off extension arm, which "may be cut or sheared off" after a compression member is tightened, leaving a low-profile implant.
  • Motivation to Combine: A POSA would be motivated to add the break-off extensions from Johnson to the receiver design to gain the recognized benefits of easier rod delivery and alignment without needing special reduction tools, a key advantage taught by Johnson.
  • Expectation of Success: The techniques for designing and machining break-off extensions for spinal implants were well-known, and a POSA would have reasonably expected success in incorporating this feature into the combined ’477/Boschert receiver.

4. Key Claim Construction Positions

• "leading face surface" (Claims 1, 21, 26): Petitioner proposed this term be construed as the forward-most surface of the thread in the direction of rotation. This construction is based on the patent’s figures, particularly Figure 5, which show this surface as having the claimed curvate (concave and convex) profile at the start of the thread.
• "bottom beveled surface" (Claim 13): Petitioner argued this term refers to the sloped lower surface of the thread’s start structure. This is where the thread has been truncated and has not yet reached its full profile, as depicted in the patent’s figures, a feature also shown in the prior art ’477 Publication.
• "concave surface is adjacent the root and the convex surface is adjacent the crest" (Claims 11, 27): Petitioner asserted a POSA would understand these terms according to their plain meaning and the patent's Figure 5. The construction defines the S-shaped curve of the leading face relative to the innermost (root) and outermost (crest) portions of the thread helix.

5. Arguments Regarding Discretionary Denial

• §325(d) - Same or Substantially Same Art/Arguments: Petitioner argued that discretionary denial under 35 U.S.C. §325(d) is inappropriate because the core prior art (’477 Publication, ’391 Publication, Johnson) and the specific combinations asserted in the petition were never presented to or considered by the patent examiner during prosecution. While Boschert was of record, its key teaching on dual-start threads was allegedly overlooked.
• Fintiv Factors: Petitioner argued that denial under Fintiv is not warranted because the petition presents compelling evidence of unpatentability. Furthermore, Petitioner stipulated that if the IPR is instituted, it will not pursue in the parallel district court litigation any invalidity grounds that were raised or could have reasonably been raised in the petition.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-28 of the ’641 patent as unpatentable.