DCT
1:20-cv-06821
OsteoMed LLC v. Stryker Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: OsteoMed LLC (Delaware)
- Defendant: Stryker Corporation (Michigan)
- Plaintiff’s Counsel: K&L GATES LLP
- Case Identification: 1:20-cv-06821, N.D. Ill., 11/17/2020
- Venue Allegations: Venue is based on Defendant Stryker maintaining a regular and established place of business in the Northern District of Illinois, from which it allegedly commits acts of infringement.
- Core Dispute: Plaintiff alleges that Defendant’s Anchorage CP, Anchorage 2 CP, and VariAx 2 orthopedic plating systems infringe four patents related to bone plates that use a transfixation screw to fuse joints.
- Technical Context: The technology concerns orthopedic surgical implants, specifically plates and screws used in foot and ankle surgery to fuse bones across a damaged or arthritic joint.
- Key Procedural History: The four patents-in-suit are part of a single family and share a common priority claim to an application filed in 2009. This common origin suggests the patents likely share a substantially similar specification, which may lead to related claim construction arguments across all asserted patents.
Case Timeline
| Date | Event |
|---|---|
| 2009-04-28 | Earliest Priority Date for all Patents-in-Suit |
| 2013-09-10 | ’608 Patent Issued |
| 2016-05-31 | ’776 Patent Issued |
| 2017-09-19 | ’716 Patent Issued |
| 2019-04-02 | ’085 Patent Issued |
| 2020-09-02 | Alleged date of Stryker's awareness of infringement |
| 2020-11-17 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,529,608 - "BONE PLATE WITH A TRANSFIXATION SCREW HOLE," Issued September 10, 2013
The Invention Explained
- Problem Addressed: The patent’s background describes how conventional bone plates used for joint fusion surgery can bend or break when placed under load (e.g., when a patient puts weight on their foot), which can cause the bones to move out of alignment and result in a failed fusion, or "non-union" (Compl. ¶17; ’608 Patent, col. 4:1-11).
- The Patented Solution: The invention is a bone plate featuring a "transfixation screw hole" that allows a screw to be inserted through the plate and across the joint, engaging both bones. This transfixation screw is designed to absorb some of the mechanical stress that would otherwise be placed solely on the plate, thereby increasing the construct's overall reliability and durability while also holding the bones in "tight approximation" to improve the likelihood of a successful fusion (Compl. ¶19; ’608 Patent, col. 4:12-25). The specification further explains this creates a "tension band" construct that counteracts forces that would pull the joint apart (Compl. ¶35; ’608 Patent, col. 6:11-24).
- Technical Importance: This design provides a more robust method for joint fixation compared to a simple plate, aiming to reduce implant failure rates in orthopedic procedures (Compl. ¶18).
Key Claims at a Glance
- The complaint asserts independent claim 11 (Compl. ¶35).
- The complaint does not explicitly reserve the right to assert other claims, though this remains a possibility.
- Essential elements of independent claim 11 include:
- A plate for securing two discrete bones together across an intermediate joint.
- The plate comprises an elongate spine with a first end, a second end, and a bridge portion to span the joint.
- A transfixation screw hole is disposed along the spine, with an inner surface configured to direct a transfixation screw alongside the bridge portion and through both bones.
- The configuration enables the screw to absorb tensile load when the second bone is loaded, permitting transfer of that load through the screw into the bridge.
- A portion of the bridge and the transfixation screw hole has a thickness greater than a portion of the first and second ends.
U.S. Patent No. 9,351,776 - "BONE PLATE WITH A TRANSFIXATION SCREW HOLE," Issued May 31, 2016
The Invention Explained
- Problem Addressed: As a continuation of the application leading to the ’608 Patent, the ’776 Patent addresses the same technical problem of potential failure in conventional joint-fixation plates under mechanical load (Compl. ¶¶ 16-17; ’776 Patent, col. 4:1-11).
- The Patented Solution: The patented solution is a system that includes not only the specialized bone plate but also the transfixation screw itself. The claim elements define the interaction between the screw head, the screw hole, and the plate's bridge portion to absorb tensile load and transfer it into the plate, thereby stabilizing the joint (Compl. ¶52; ’776 Patent, Abstract, col. 4:12-25).
- Technical Importance: By claiming the plate and screw as a system, the patent covers the entire functional construct as used in surgery, aiming to protect the inventive concept of how these components work together to improve patient outcomes (Compl. ¶18).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶55).
- Essential elements of independent claim 1 include:
- A system for securing two discrete bones across a joint.
- The system comprises a plate with an elongate spine, first and second ends, and a bridge portion.
- At least a portion of the bridge has a depth greater than the depth of either the first or second end.
- The plate has a transfixation screw hole configured to direct a screw through the bones.
- The system also comprises a transfixation screw with a head configured to abut the inner surface of the screw hole and a shaft that extends through the bones.
- The screw functions to absorb tensile load and transfer it from the second bone, through the screw, into the screw's head and the plate's bridge portion.
U.S. Patent No. 9,763,716 - "BONE PLATE WITH A TRANSFIXATION SCREW HOLE," Issued September 19, 2017
- Technology Synopsis: The patent, part of the same family, describes a system for orthopedic joint fusion. This system uses a bone plate with a specific hole for a "transfixation screw" that passes through the plate and across the joint, creating a stable construct to resist bending forces and promote bone healing (Compl. ¶72; ’716 Patent, Abstract).
- Asserted Claims: Independent claim 1 (Compl. ¶75).
- Accused Features: The complaint alleges Stryker's Anchorage CP plating systems, which include both a plate and a transfixation screw, infringe by providing the complete claimed system for joint fusion (Compl. ¶¶ 73-74, 76).
U.S. Patent No. 10,245,085 - "BONE PLATE WITH A TRANSFIXATION SCREW HOLE," Issued April 2, 2019
- Technology Synopsis: The patent discloses a system for securing bones across a joint, comprising a plate with a "thickened portion" in the bridge area. This thickened portion contains an aperture for a transfixation screw, with the added thickness intended to increase strength and help direct the screw's trajectory for improved surgical stability (Compl. ¶92; ’085 Patent, Abstract, cl. 1).
- Asserted Claims: Independent claim 1 (Compl. ¶95).
- Accused Features: The Anchorage CP plating systems are accused of infringing by incorporating a plate with a thickened bridge portion and an aperture for a transfixation screw, allegedly matching the claimed system (Compl. ¶¶ 93-94, 96).
III. The Accused Instrumentality
Product Identification
- The accused products are Stryker’s Anchorage® CP, Anchorage® 2 CP, and VariAx® 2 plating systems (collectively, "Anchorage CP plating systems") (Compl. ¶6).
Functionality and Market Context
- The Anchorage CP plating systems are used for foot and ankle surgery, specifically to fuse the first metatarso-phalangeal joint by securing the first metatarsal and proximal phalanx bones (Compl. ¶29). The complaint alleges these systems function by using a plate affixed to both bones and a separate "transfixation screw" that passes through the plate and across the joint to hold the bones together (Compl. ¶29). An image in the complaint depicts a multi-step surgical technique for implanting the system, showing the placement of the plate and insertion of the transfixation screw (Compl. ¶29, Ex. H at 27). The complaint positions these products within Stryker's broader portfolio of implantable devices for foot and ankle surgery, sold by a "global medical device company" (Compl. ¶¶ 27-28).
IV. Analysis of Infringement Allegations
'608 Patent Infringement Allegations
| Claim Element (from Independent Claim 11) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A plate for securing two discrete bones together across an intermediate joint... | The Anchorage CP plating system is identified as "a plate for securing two discrete bones together across an intermediate joint." An accompanying image shows a plate spanning a joint between a "1st bone" and "2nd bone" (Compl. ¶36). | ¶36 | col. 8:8-11 |
| ...an elongate spine having...a bridge portion disposed between the first end and the second end, the bridge portion configured to span across the joint... | The complaint provides annotated images identifying the "Elongate spine," "1st end," "2nd end," and "Bridge portion" on the accused plate (Compl. ¶¶37, 40). | ¶¶37, 40 | col. 7:47-53 |
| ...a transfixation screw hole...comprising an inner surface configured to direct a transfixation screw...at a trajectory configured to pass through a first position on the first bone and a second position on the second bone once the plate is placed across the joint... | An annotated diagram illustrates the "Transfixation screw hole," its "Inner surface," and the "Transfixation screw hole trajectory" extending from the first bone to the second bone (Compl. ¶41). | ¶41 | col. 8:12-23 |
| ...enabling said screw to absorb tensile load when the second bone is loaded permitting transfer of the tensile load through said screw into said bridge... | A cut-away diagram alleges that an "Upward load puts tensile load from 2nd bone through screw into screw and bridge" (Compl. ¶41). | ¶41 | col. 8:23-27 |
| ...wherein at least a portion of said bridge portion and said transfixation screw hole has a thickness greater than at least a portion of said first and second ends. | The complaint includes an image of the accused plate with a callout stating "A greater depth than 1st and 2nd ends," intended to show the greater thickness of the bridge portion (Compl. ¶42). | ¶42 | col. 8:27-31 |
'776 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A system for securing two discrete bones together across a joint...comprising: an elongate spine having...a bridge portion...at least a portion of said bridge portion having a depth greater than at least a portion of the depth of either the first end or the second end... | The Anchorage CP plating system is identified as the infringing "system" (Compl. ¶56). An image with callouts purports to show the accused plate has "A greater depth than 1st and 2nd ends" in its bridge portion (Compl. ¶60). | ¶¶56, 60 | col. 12:5-13 |
| ...a transfixation screw hole disposed along the spine...configured to direct the transfixation screw...at a trajectory configured to pass through a first position on the first discrete bone, a portion of the joint, and a second position on the second discrete bone... | An annotated diagram shows the "Transfixation screw hole" and its alleged trajectory passing from the first bone to the second (Compl. ¶61). | ¶61 | col. 12:14-23 |
| ...and a transfixation screw comprising a head configured to abut the inner surface of the transfixation screw hole and a shaft... | A cut-away diagram labels the "Head" of the screw shown abutting the "Inner surface" of the screw hole, as well as the screw's "Shaft" (Compl. ¶62). | ¶62 | col. 12:24-27 |
| ...to absorb tensile load...thereby transferring the tensile load from the second discrete bone, through the screw into said head and said bridge portion. | A diagram with a labeled arrow alleges that an "Upward load puts tensile load from 2nd bone through screw into head and bridge" (Compl. ¶62). | ¶62 | col. 12:28-33 |
Identified Points of Contention
- Scope Questions: The claims in both patents use the term "substantially conform with a geometry of the...bone." This raises the question of how closely the accused plates must match the patient's anatomy to infringe. A court will need to determine whether this requires a patient-specific or joint-specific custom fit, or if a more generic, off-the-shelf shape is sufficient.
- Technical Questions: A primary technical question is whether the accused Anchorage CP systems actually perform the functions of absorbing and transferring tensile load "into said bridge" as required by the claims. The complaint's allegations are supported by illustrative diagrams (e.g., Compl. ¶¶ 41, 62), not finite element analysis or other engineering data. The defense may argue that these are marketing simplifications and that the actual biomechanical function of their product is different from the specific load-transfer mechanism claimed.
V. Key Claim Terms for Construction
The Term: "substantially conform with a geometry of the...bone" (appears in claim 11 of the ’608 Patent and claim 1 of the ’776 Patent)
- Context and Importance: This term is critical for defining the required closeness of fit between the plate and the bone. The scope of this term will determine whether generic, multi-use plates can infringe, or if the claims are limited to plates with a more customized, anatomically precise shape.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discusses the invention in general terms, stating it relates to a device for securing bones and may be adapted for "virtually any joint...in the body" (’608 Patent, col. 5:57-59). This language could support an interpretation where "substantially conform" means a general, non-specific fit suitable for a class of joints.
- Evidence for a Narrower Interpretation: The specification also describes specific embodiments with very particular geometric features, such as "a rise...that fits over the head on the dorsal section of metatarsal," a "dorsiflexion angle," and a "valgus angle" to mimic natural anatomy (’608 Patent, col. 5:24-45). This could support a narrower construction requiring the plate to have these or similar specific, conforming geometric features.
The Term: "transferring the tensile load from the second discrete bone, through the screw into said head and said bridge portion" (appears in claim 1 of the ’776 Patent)
- Context and Importance: This functional limitation is at the core of the asserted invention. Infringement requires proving not just the presence of a plate and screw, but that they interact in this specific biomechanical way. Practitioners may focus on this term because proving this precise load path will likely require complex expert testimony and engineering evidence.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The abstract and background broadly describe the invention as absorbing "some of the stress that would otherwise be exerted on the plate" (’776 Patent, col. 4:15-18). A plaintiff might argue this supports a broader reading where any significant load sharing between the screw and plate meets the limitation.
- Evidence for a Narrower Interpretation: The specification details the creation of a "tension band" construct by placing the screw across the joint's "neutral bending axis" (’776 Patent, col. 6:11-24). A defendant could argue that "transferring the tensile load...into said...bridge portion" is not just any load sharing, but specifically refers to the function of this tension band, requiring proof that the accused system creates and relies on this specific biomechanical principle.
VI. Other Allegations
- Willful Infringement: The complaint alleges that Stryker's infringement has been and continues to be willful. The factual basis provided is the allegation that Stryker has been aware that it infringes each of the patents-in-suit "since at least September 2, 2020," which is prior to the filing of the complaint (Compl. ¶¶ 48, 68, 88, 106).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of claim construction and function: Can the functional limitation requiring the "transfer" of "tensile load...into said bridge" be met by a general load-sharing arrangement, or does it require proof that the accused system creates the specific "tension band" construct described in the patent's specification? The answer will determine the level of technical evidence OsteoMed must provide.
- A key evidentiary question will be one of proof of operation: Assuming a construction is adopted, does the accused Anchorage CP system actually operate in the claimed manner? The case may turn on a battle of experts analyzing the biomechanics of the accused products to determine if they indeed transfer load into the bridge portion of the plate as claimed, or if they achieve joint stability through a different, non-infringing technical mechanism.