DCT
2:17-cv-04703
Puget Bioventures LLC v. Stryker Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Puget BioVentures, LLC (Washington)
- Defendant: Stryker Corporation (Michigan) and Howmedica Osteonics Corp. (New Jersey)
- Plaintiff’s Counsel: Robins Kaplan LLP
- Case Identification: 2:17-cv-04703, D.N.J., 06/26/2017
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Howmedica Osteonics Corp. resides there, and Defendant Stryker Corporation has allegedly committed acts of infringement and maintains a regular and established place of business in the district.
- Core Dispute: Plaintiff alleges that Defendant’s knee arthroplasty systems and associated surgical instruments infringe a patent related to methods for performing minimally invasive total knee replacement surgery using a specialized cutting guide.
- Technical Context: The technology concerns surgical instrumentation for total knee arthroplasty, a common orthopedic procedure to replace the weight-bearing surfaces of the knee joint to relieve pain and disability.
- Key Procedural History: The complaint notes that the patent-in-suit, the '822 patent, was the subject of an inter partes reexamination where the Patent Trial and Appeal Board (PTAB) confirmed the validity of several original claims, including those asserted in this case. Plaintiff also alleges that its predecessor-in-interest provided Defendant with notice of the '822 patent in July 2011. The provided patent documents also include a reexamination certificate indicating that all claims of the '822 patent were disclaimed by the assignee in December 2018, subsequent to the filing of this complaint.
Case Timeline
| Date | Event |
|---|---|
| 1995-06-07 | '822 Patent Priority Date |
| 2004-01-01 | Accused Triathlon Knee System Launch |
| 2011-06-28 | '822 Patent Issue Date |
| 2011-07-13 | Plaintiff Alleges Notifying Stryker of the '822 Patent |
| 2012-09-07 | Inter Partes Reexamination of '822 Patent Requested |
| 2016-12-16 | PTAB Confirms Validity of Asserted '822 Patent Claims |
| 2017-06-26 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 7,967,822, Methods and Apparatus for Orthopedic Implants, issued June 28, 2011 (the "’822 Patent").
The Invention Explained
- Problem Addressed: The patent’s background section identifies limitations in conventional total knee arthroplasty (TKA) instrumentation. These include inaccuracies from the deflection of guide pins and oscillating saw blades, as well as "tolerance stacking" from multiple instruments, which can lead to poor implant fit and alignment, requiring significant manual skill from the surgeon to overcome (’822 Patent, col. 2:3-33).
- The Patented Solution: The invention provides methods and apparatus to improve the accuracy and reproducibility of bone resections in TKA (’822 Patent, Abstract). A central feature is a surgical method where a cutting guide, positioned on only one side of a bone (e.g., the medial side), is used to guide an oscillating saw blade to create a cut surface across the entire end of the bone, including the opposite (e.g., lateral) side. The guide itself is described as being substantially smaller than the total width of the cut it enables, a key aspect of its minimally invasive design (’822 Patent, col. 35:36-56; Compl. ¶38).
- Technical Importance: This approach was designed to facilitate minimally invasive surgery by reducing the size of the required instrumentation, while seeking to create more consistent and accurate results with less reliance on a surgeon's manual skill (Compl. ¶15; ’822 Patent, col. 2:40-48).
Key Claims at a Glance
- The complaint asserts direct infringement of one or more claims, inducement of infringement of claims 1, 5, and 14, and contributory infringement of claims arising from the use of the accused tibial resection guide (Compl. ¶¶41, 43, 53-56). The infringement analysis in the complaint focuses on independent method claim 5.
- Independent Claim 5 Elements:
- A method for performing a total knee arthroplasty procedure on a knee joint in a patient's body comprising:
- positioning a cutting guide having at least one guide surface adapted to guide an oscillating saw blade proximate an end portion of one long bone of the knee joint, the cutting guide having opposite medial and lateral ends which are spaced apart by a first distance;
- moving the oscillating saw blade into engagement with the one long bone at the knee joint;
- cutting the one long bone at the knee joint with the oscillating saw blade by moving the oscillating saw blade along the guide surface on the cutting guide and cutting bone to form a cut surface which extends across the end portion of the one long bone a maximum of a second distance in a generally mediolateral direction parallel to a longitudinal central axis of the guide surface which is more than half again as long as the first distance of the cutting guide between the opposite medial and lateral ends; and
- positioning a total knee arthroplasty implant into engagement with the cut surface.
- The complaint reserves the right to assert dependent claims (Compl. ¶¶41, 43).
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities include the Triathlon Total Knee System, Triathlon Titanium Knee, the Triathlon Surgical Technique Instruments, and the MIS Surgical Technique Instruments, among others (Compl. ¶41). The allegations center on the use of the system's instrumentation, particularly the tibial resection guide, to perform knee arthroplasty procedures (Compl. ¶¶47-48).
Functionality and Market Context
- The accused products are systems used by orthopedic surgeons for performing TKA (Compl. ¶46). The complaint alleges that Stryker provides surgeons with instructional materials, including a "Triathlon® Knee System MIS Surgical Protocol," that direct the use of the products in an infringing manner (Compl. ¶¶44, 46).
- The complaint highlights that the accused instrumentation is designed for "Minimally Invasive" surgery (Compl. p. 8). A key visual from the complaint depicts the "Tibial Resection Guide" being assembled for use in a surgical procedure (Compl. p. 9, Assembly 1D).
IV. Analysis of Infringement Allegations
'822 Patent Infringement Allegations
| Claim Element (from Independent Claim 5) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| positioning a cutting guide having at least one guide surface adapted to guide an oscillating saw blade proximate an end portion of one long bone of the knee joint... | Surgeons, following Stryker's instructions, use the Triathlon® Knee System and MIS Surgical Technique Instruments to position a tibial resection guide proximate the tibia. | ¶47 | col. 13:35-44 |
| ...the cutting guide having opposite medial and lateral ends which are spaced apart by a first distance; | The accused tibial resection guide has opposite medial and lateral ends. The complaint includes an annotated diagram identifying this "first distance." | ¶49 | col. 12:46-64 |
| moving the oscillating saw blade into engagement with the one long bone at the knee joint; | Surgeons are instructed to bring an oscillating saw blade into contact with the tibia to begin the resection. The complaint provides an annotated visual showing the "saw blade in engagement with tibia." | ¶50 | col. 2:27-28 |
| cutting the one long bone...to form a cut surface which extends...a second distance...which is more than half again as long as the first distance... | Following instructions, surgeons use the saw and guide to create a cut surface on the tibia that is wider than the guide itself. The complaint provides a diagram illustrating the proportional relationship between the guide's "first distance" and the resulting "cut surface." | ¶51 | col. 35:48-55 |
| positioning a total knee arthroplasty implant into engagement with the cut surface. | After the cut is made, surgeons position a Stryker knee implant onto the resected tibial surface. The complaint provides a screenshot from a surgical video showing the implant in situ. | ¶52 | col. 2:50-54 |
Identified Points of Contention
- Technical Questions: The infringement theory hinges on the allegation that Stryker instructs surgeons to use a small guide, placed on one side of the knee, to make a much wider cut across the entire bone. The complaint provides screenshots from a surgical video showing a blade positioned medially to resect the lateral tibia (Compl. p. 13). A central question will be whether Stryker’s official instructions require this specific technique, or merely provide tools that enable it at a surgeon's discretion.
- Scope Questions: The construction of the phrase "more than half again as long as the first distance" will be pivotal. The parties may dispute how to measure the "first distance" (e.g., the full physical width of the guide vs. the length of the guide slot) and the "second distance" (the resulting cut), which would directly impact whether the accused procedure meets this proportional limitation.
V. Key Claim Terms for Construction
- The Term: "a cut surface which extends... a maximum of a second distance... which is more than half again as long as the first distance of the cutting guide"
- Context and Importance: This limitation is the technical core of the asserted method claim, defining the specific geometry of the minimally invasive cut. The infringement case rests on whether the accused surgical method, as taught by Stryker, satisfies this precise proportional relationship. Practitioners may focus on this term because it quantifies the novel surgical technique claimed by the patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party arguing for a broader scope may contend that the term should be given its plain and ordinary meaning, emphasizing the patent's stated goal of enabling less invasive surgery. The description of the invention's objects, such as providing a method that "minimizes the skill necessary," could be cited to support a construction that covers any technique using a small guide to make a large cut (’822 Patent, col. 5:12-15).
- Evidence for a Narrower Interpretation: A party arguing for a narrower scope might point to specific embodiments in the specification, such as the detailed descriptions of "pattern plates" and "cutting slots," to argue that the "first distance" must be measured in a particular way related to those structures (’822 Patent, col. 12:46-64, col. 17:15-24). The specificity of the ratio ("more than half again as long") may suggest the patentee intended a precise, rather than general, meaning.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on allegations that Stryker acted with specific intent by providing surgeons with manuals, training, and surgical protocols that instruct on the performance of the patented method (Compl. ¶¶43-44). Contributory infringement is based on the sale of the tibial resection guide, which is alleged to be a material component of the invention, not a staple article of commerce, and sold with knowledge of the '822 patent (Compl. ¶¶55-56).
- Willful Infringement: The willfulness allegation is based on alleged pre-suit knowledge of the '822 patent. The complaint states that Stryker was notified of the patent via a letter on July 13, 2011, nearly six years before the suit was filed, and continued its alleged infringement despite this notice (Compl. ¶¶58-61).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core evidentiary issue will be one of instruction versus capability: Does Stryker’s official surgical protocol instruct surgeons to perform the patented method—using a narrow, single-sided guide to make a cut "more than half again as long"—or does it merely provide tools that can be used in this manner, leaving the specific technique to the surgeon’s discretion?
- A key legal question will be one of claim construction: How are the "first distance" (guide width) and "second distance" (cut width) to be measured? The resolution of this issue will determine whether the proportional relationship required by claim 5 is met by the accused surgical procedure.
- A dispositive issue for the litigation as a whole will be the effect of the patent's post-filing history: Given that all claims of the '822 patent were disclaimed in December 2018, a central question is what, if any, damages are recoverable for the period of alleged infringement between Stryker's notice in 2011 and the date the patent rights were extinguished.