DCT
1:20-cv-11807
Rasmussen Instruments LLC v. DePuy Synthes Products Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Rasmussen Instruments, LLC (Utah)
- Defendant: DePuy Synthes Products, Inc. (Delaware/Massachusetts); DePuy Synthes Sales, Inc. (Massachusetts); Medical Device Business Services, Inc. (Indiana)
- Plaintiff’s Counsel: Fish & Richardson P.C.
- Case Identification: 1:20-cv-11807, D. Mass., 01/28/2021
- Venue Allegations: Plaintiff alleges venue is proper in the District of Massachusetts because Defendants conduct regular business in the district and have committed the alleged acts of patent infringement there.
- Core Dispute: Plaintiff alleges that Defendant’s ATTUNE® Knee System, including its Intuition surgical instruments, infringes patents related to systems and methods for aligning and tensioning knee prostheses during arthroplasty surgery.
- Technical Context: The technology concerns orthopedic surgical instrumentation designed to improve the accuracy of bone resections and the balancing of ligament tension during knee replacement, which are critical factors for the long-term success and function of the implant.
- Key Procedural History: The complaint alleges a history of pre-suit interactions, including that the inventor, Dr. Rasmussen, engaged in licensing negotiations with DePuy from late 2012 to early 2014, during which he presented and demonstrated his patented invention. It further alleges that DePuy was aware of the inventor's patent publications as early as 2009 through their citation in Information Disclosure Statements during the prosecution of DePuy’s own patents. These negotiations did not result in a license.
Case Timeline
| Date | Event |
|---|---|
| 2005-02-08 | Priority Date for Asserted Patents (Provisional App. 60/651,102) |
| 2009-11-17 | DePuy allegedly identified Plaintiff's publications in an IDS |
| 2012-09-01 | Licensing discussions between Dr. Rasmussen and DePuy allegedly begin |
| 2014-01-31 | Licensing negotiations allegedly broke down (approx. "early 2014") |
| 2016-11-15 | U.S. Patent No. 9,492,180 Issued |
| 2019-12-31 | U.S. Patent No. 10,517,583 Issued |
| 2020-10-02 | Original Complaint Filed |
| 2021-01-28 | First Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,492,180 - “Arthroplasty Systems and Methods for Optimally Aligning and Tensioning a Knee Prosthesis,” issued November 15, 2016
The Invention Explained
- Problem Addressed: In conventional knee replacement surgery, achieving the correct alignment of prosthetic components and balancing the tension of surrounding ligaments can be difficult, and failure to do so can lead to post-operative pain, instability, and poor joint function (Compl. ¶14-15). The patent notes that preserving soft tissue can be challenging due to the need to firmly support resection guides during the procedure (’180 Patent, col. 1:49-54).
- The Patented Solution: The invention provides a system of surgical instruments that uses the patient's own anatomy, specifically intramedullary (IM) canals in the femur and tibia, as stable reference points (’180 Patent, Abstract). The system includes femoral and tibial components that are coupled by a tensioning apparatus, such as a threaded bolt, which allows a surgeon to distract the joint and apply a precise, measurable amount of tension to the ligaments before making bone cuts (’180 Patent, col. 9:30-45). This is intended to ensure the cuts are made in a way that achieves a balanced and physiologically optimal knee function post-implant.
- Technical Importance: The technology aims to improve surgical precision and patient outcomes by using the knee's own ligamentous structure to guide the placement of instrumentation and resection, particularly in the context of minimally invasive surgical approaches (Compl. ¶18).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 9 (Compl. ¶40).
- The essential elements of independent claim 9 are:
- A device for adjusting tension in a knee joint, comprising:
- a femoral component defining an opening, configured to extend into a femur;
- a tibial component configured to be seated at a proximal portion of a tibia;
- an elongated member configured to extend into the opening in the femoral component; and
- a threaded member coupled to the elongated member, configured to be turned to vary tension by changing the distance between the femoral and tibial components.
- The complaint reserves the right to assert other claims (Compl. ¶39).
U.S. Patent No. 10,517,583 - “Arthroplasty Systems and Methods for Optimally Aligning and Tensioning a Knee Prosthesis,” issued December 31, 2019
The Invention Explained
- Problem Addressed: As with the parent ’180 patent, this patent addresses the need for improved instrumentation to guide bone resections in knee arthroplasty that works well with minimally invasive techniques and helps balance forces for improved function (Compl. ¶16-17; ’583 Patent, col. 2:16-23).
- The Patented Solution: The invention provides a surgical apparatus that allows for both tensioning and alignment adjustment. It features an "elongated member" for insertion into the femur and a "tibial contact member" for placement on the tibia (’583 Patent, claim 7). These are connected by an "adjustable component" that critically allows the tibial member to be "rotatable about a longitudinal axis of the elongated member" when the knee is in a flexed position. This rotational degree of freedom is designed to allow the surgeon to adjust for the natural varus/valgus angle of the knee while the joint is under tension (’583 Patent, col. 13:4-10).
- Technical Importance: This technology provides a mechanism for surgeons to independently adjust for rotational alignment while simultaneously controlling and maintaining ligament tension, aiming for a more anatomically correct placement of the final prosthesis (’583 Patent, col. 2:48-54).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 7 (Compl. ¶66).
- The essential elements of independent claim 7 are:
- An apparatus for adjusting tension and/or alignment of a knee joint, comprising:
- an elongated member configured to extend into a distal end of a femur;
- a tibial contact member configured to contact a proximal end of a tibia; and
- an adjustable component connecting the two, such that the tibial contact member is rotatable about a longitudinal axis of the elongated member when the apparatus is seated, fixed to the femur, and the knee is flexed.
- The complaint reserves the right to assert other claims (Compl. ¶65).
III. The Accused Instrumentality
Product Identification
- The complaint identifies the "ATTUNE® Knee System," and specifically the "Intuition Instruments" and its "Balanced Sizer" and associated components, as the Accused Products (Compl. ¶9-10, ¶38). These components include parts referred to by Defendant as the "Tapered Plug," "IM Rod," "CR Foot," "PS Foot," and "Balanced Sizer Distractor" (Compl. ¶41, ¶43, ¶45, ¶47).
Functionality and Market Context
- The Accused Products are a system of surgical tools used by orthopedic surgeons during knee replacement surgery (Compl. ¶10). Based on the complaint's allegations and supporting visuals, the system is assembled in situ during surgery. An "IM Rod" is inserted into the femur, a "Foot" is placed on the tibia, and a "Balanced Sizer Distractor" mechanism connects them. This assembly is allegedly used to adjust the spacing and tension between the femur and tibia to guide the surgeon in making bone cuts for the ATTUNE implant (Compl. ¶40, ¶50). The complaint characterizes DePuy as a "large medical device conglomerate" but provides no further market context for the accused system (Compl. ¶5).
IV. Analysis of Infringement Allegations
'180 Patent Infringement Allegations
| Claim Element (from Independent Claim 9) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a femoral component defining an opening, wherein a portion of the femoral component and a portion of the opening are both configured to extend into a femur... | The Accused Products include a "Tapered Plug," which the complaint alleges is the claimed "femoral component." A supporting visual shows this plug being seated in the distal portion of a femur (Compl. ¶41-42). | ¶41, ¶42 | col. 8:30-32 |
| a tibial component configured to be seated at a proximal portion of a tibia | The Accused Products include a "Foot" (in CR or PS versions), which the complaint alleges is the claimed "tibial component." A visual depicts the Foot seated on the proximal portion of the tibia (Compl. ¶43-44). | ¶43, ¶44 | col. 9:4-6 |
| an elongated member that is configured to extend into the opening in the femoral component | The Accused Products include an "IM Rod," which the complaint alleges is the "elongated member." A diagram shows the IM Rod extending into the opening of the "Tapered Plug" (femoral component) (Compl. ¶45-46). | ¶45, ¶46 | col. 8:16-20 |
| a threaded member that is configured to be coupled to the elongated member such that the threaded member is configured to be turned to vary tension in the knee joint... | The "Balanced Sizer Distractor" is alleged to be the "threaded member." The complaint provides visuals of its male and female threads and alleges it is turned to vary knee joint tension by changing the distance between the femoral and tibial components (Compl. ¶47-50). A diagram shows the fully assembled device, with the threaded member configured to change the distance between the other components (Compl. ¶50). | ¶47-50 | col. 9:22-26 |
'583 Patent Infringement Allegations
| Claim Element (from Independent Claim 7) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an elongated member that is configured to extend into a distal end of a femur | The Accused Products include an "IM Rod," which the complaint alleges is the claimed "elongated member." A visual depicts the IM Rod extending into the distal end of the femur (Compl. ¶67-68). | ¶67, ¶68 | col. 8:12-14 |
| a tibial contact member that is configured to contact a proximal end of a tibia | The Accused Products include a "Foot," which the complaint alleges is the "tibial contact member." A visual depicts this component contacting the proximal end of the tibia (Compl. ¶69-70). | ¶69, ¶70 | col. 9:10-12 |
| an adjustable component that connects the elongated member with the tibial contact member such that the tibial contact member is rotatable about a longitudinal axis of the elongated member... when the knee joint is in a flexed position. | The "Balanced Sizer Distractor" is alleged to be the "adjustable component" that connects the IM Rod and the Foot (Compl. ¶71). The complaint alleges this configuration allows the tibial contact member (Foot) to rotate about the longitudinal axis of the elongated member (IM Rod) when the knee is flexed (Compl. ¶72). A key visual with annotations illustrates this alleged rotational capability, depicting the longitudinal axis of the IM rod and the asserted rotation of the tibial and adjustable components around it (Compl. ¶72). | ¶71, ¶72 | col. 24:3-8 |
Identified Points of Contention
- Scope Questions: A central issue may be whether the term "component" (e.g., "femoral component," "tibial component" in the ’180 patent) can be construed to read on temporary surgical instruments as alleged by the Plaintiff. The patent specifications discuss both surgical instruments and permanent knee implants. A defendant may argue that in the context of knee arthroplasty, these terms refer unambiguously to the final prosthesis parts, not the disposable or reusable tools used to install them, raising a question of a scope mismatch.
- Technical Questions: For the ’583 patent, the infringement allegation hinges on a specific kinematic relationship: whether the accused tibial "Foot" is "rotatable about a longitudinal axis of the elongated member" when assembled. The complaint provides a diagram supporting this theory (Compl. ¶72). A key factual question for the court will be whether the Accused Product actually operates with this specific degree of freedom, or if its motion is more constrained or fundamentally different from the claimed rotation.
V. Key Claim Terms for Construction
The Term: "femoral component" / "tibial component" (’180 Patent, cl. 9)
Context and Importance: The infringement case for the ’180 patent depends on these terms covering the temporary surgical instruments (the "Tapered Plug" and "Foot") that are part of the Accused Products. Practitioners may focus on this term because if it is construed to mean only the permanent prosthetic implants, the infringement allegations against the surgical tools would fail.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent abstract distinguishes between a "first assembly for guiding resection" and a "second assembly including femoral and tibial knee components," suggesting the term "component" can refer to parts of either assembly (’180 Patent, Abstract). The specification also refers to parts of the instrumentation as "selectively lockable components" (’180 Patent, col. 3:4-5), which may support reading the term broadly to include instrumentation parts.
- Evidence for a Narrower Interpretation: The specification repeatedly uses "femoral and tibial knee components" when referring to the final implant, distinguishing these from the "instrumentation," "assembly," or "guides" used for resection (’180 Patent, col. 2:14-16). A defendant could argue this consistent distinction implies that "femoral component" and "tibial component," standing alone, carry their ordinary meaning in the art as the permanent implant parts.
The Term: "rotatable about a longitudinal axis of the elongated member" (’583 Patent, cl. 7)
Context and Importance: This limitation defines the precise mechanical action that enables alignment adjustment. The infringement allegation for the ’583 patent requires the accused "Balanced Sizer" to perform this specific rotation. The viability of this claim may depend entirely on whether the accused device is found to operate in this manner.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent claims an "apparatus for adjusting ... an alignment of a knee joint" where the adjustable component allows for "adjustment of an angle between the tibia and the femur" (’583 Patent, col. 23:1-8). This broader statement of purpose could be used to argue that any mechanism allowing rotational adjustment satisfies the claim's intent.
- Evidence for a Narrower Interpretation: The claim language is highly specific, requiring rotation "about a longitudinal axis," not just any rotational adjustment. The specification describes allowing the instrument to accommodate the "natural physiology of the patient's knee" and shows specific mechanical embodiments (e.g., ’583 Patent, Fig. 19-21). This could support a narrower construction requiring a true, relatively unconstrained pivot around the defined axis, rather than a more complex or limited motion.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. It asserts inducement by alleging DePuy provides instructions, tutorials, and marketing materials that lead surgeons and hospitals to use the Accused Products in an infringing manner (Compl. ¶53-54, ¶75-76). It asserts contributory infringement by alleging DePuy sells the various components (e.g., IM Rod, Foots, Distractor), knowing they are specially made for an infringing use and are not staple articles of commerce (Compl. ¶55-56, ¶77-78).
- Willful Infringement: The complaint alleges willfulness based on both pre- and post-suit knowledge. It alleges DePuy had pre-suit knowledge of the patented technology through its own patent prosecution activities (citing the technology in IDSs as early as 2009) and through direct licensing negotiations with the inventor between 2012 and 2014 (Compl. ¶20-28). The complaint alleges DePuy learned of the issued patents shortly after their issuance or, at the latest, upon the filing of the original complaint (Compl. ¶32).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can claim terms such as "femoral component" and "tibial component," which are rooted in the field of permanent orthopedic implants, be construed to cover the temporary surgical instruments that comprise the Accused Products? The outcome of this claim construction dispute may be dispositive for the allegations concerning the ’180 patent.
- A key evidentiary question will be one of kinematic function: does the accused "Balanced Sizer" assembly, when used in surgery, actually permit the "tibial contact member" to be "rotatable about a longitudinal axis of the elongated member" as required by claim 7 of the ’583 patent, or is there a fundamental mismatch between the accused device's actual mechanical operation and the specific motion claimed in the patent?