DCT
2:22-cv-00490
Treace Medical Concepts Inc v. Fusion Orthopedics LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Treace Medical Concepts, Inc. (Delaware)
- Defendant: Fusion Orthopedics, LLC (Arizona)
- Plaintiff’s Counsel: Osborn Maledon, P.A.; Fish & Richardson P.C.
- Case Identification: 2:22-cv-00490, D. Ariz., 07/11/2022
- Venue Allegations: Venue is alleged to be proper in the District of Arizona because Defendant is an Arizona limited liability company that conducts business in the district.
- Core Dispute: Plaintiff alleges that Defendant’s LapiLock 4D Bunion Correction System and associated surgical methods infringe five U.S. patents related to orthopedic surgery instruments and techniques for correcting bunion deformities.
- Technical Context: The technology concerns surgical methods and devices for treating hallux valgus, commonly known as bunions, by correcting the multi-planar alignment of the first metatarsal and medial cuneiform bones of the foot.
- Key Procedural History: The complaint details pre-suit correspondence beginning on February 16, 2022, when Plaintiff notified Defendant of alleged infringement of one patent. After an exchange of letters, Plaintiff sent a second notice letter on March 15, 2022, identifying four additional patents. The complaint alleges that following these communications, Defendant modified its surgical literature, for instance by changing the term "fulcrum" to "spacers," which may be relevant to the infringement analysis of certain claims.
Case Timeline
| Date | Event |
|---|---|
| 2015-01-07 | Priority Date for ’426 and ’335 Patents |
| 2015-08-14 | Priority Date for ’590 and ’670 Patents |
| 2015-01-01 | Treace Medical introduces its Lapiplasty procedure |
| 2017-04-03 | Priority Date for ’764 Patent |
| 2019-07-09 | U.S. Patent No. 10,342,590 Issues |
| 2020-02-18 | U.S. Patent No. 10,561,426 Issues |
| 2020-12-01 | U.S. Patent No. 10,849,670 Issues |
| 2021-01-12 | U.S. Patent No. 10,888,335 Issues |
| 2021-03-16 | U.S. Patent No. 10,945,764 Issues |
| 2022-02-16 | Treace sends first notice letter to Fusion regarding ’590 Patent |
| 2022-02-17 | Fusion acknowledges receipt of Treace's letter |
| 2022-03-02 | Fusion informs Treace of changes to its literature |
| 2022-03-15 | Treace sends second notice letter regarding five patents-in-suit |
| 2022-07-11 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,561,426 - "Bone Cutting Guide Systems and Methods"
- Patent Identification: U.S. Patent No. 10,561,426, titled "Bone Cutting Guide Systems and Methods," issued February 18, 2020 (Compl. ¶46).
The Invention Explained
- Problem Addressed: The patent background describes the general problem of anatomically misaligned bones, such as those in the foot, which may require surgical intervention to correct alignment and improve patient quality of life (’426 Patent, col. 1:19-24).
- The Patented Solution: The invention is a system and method for precisely cutting bones during orthopedic surgery. It features a bone cutting guide with a support that is fixed to a bone. A main guide member, which contains slots to guide a cutting tool (e.g., a saw blade), is mounted on a shaft that can be translated relative to the fixed support. This allows a surgeon to accurately position the guide member over the desired cut location on one or more bones (such as a metatarsal and cuneiform) before making precise, parallel, or otherwise controlled cuts to prepare the joint for fusion (’426 Patent, Abstract; col. 2:26-44).
- Technical Importance: The system provides a mechanism for reproducible and accurate bone preparation, which is a critical step in achieving a stable and correctly aligned bone fusion in bunion surgery (Compl. ¶¶13, 18).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶47).
- Essential elements of independent claim 1 include:
- positioning a first cutting slot of a bone cutting guide over a metatarsal;
- inserting a cutting member through the first cutting slot to remove a portion of the metatarsal;
- adjusting an alignment of the metatarsal relative to a cuneiform to establish a moved position;
- positioning a second cutting slot of the bone cutting guide over the cuneiform;
- inserting the cutting member through the second cutting slot to remove a portion of the cuneiform; and
- causing the metatarsal to fuse to the cuneiform in the moved position.
- The complaint reserves the right to assert other claims of the patent (Compl. ¶47).
U.S. Patent No. 10,849,670 - "Bone Positioning and Preparing Guide Systems and Methods"
- Patent Identification: U.S. Patent No. 10,849,670, titled "Bone Positioning and Preparing Guide Systems and Methods," issued December 1, 2020 (Compl. ¶81).
The Invention Explained
- Problem Addressed: The patent addresses the need for methods to correct bone deformities, specifically bunions, which involve misalignment of the first metatarsal relative to other foot bones (’670 Patent, col. 2:40-42).
- The Patented Solution: The patent claims a surgical method where the misaligned bones (first metatarsal and medial cuneiform) are first moved into a corrected anatomical alignment across at least two planes (frontal and transverse). Crucially, only after this multi-planar correction is achieved are the ends of the bones prepared (e.g., cut) for fusion. The bones are then fixed in this corrected position (’670 Patent, Abstract; col. 2:40-52). This "correct-before-you-cut" sequence is a key aspect of the patented method.
- Technical Importance: This approach allows the surgeon to achieve and verify the desired three-dimensional correction of the deformity before committing to irreversible bone cuts, which is intended to improve surgical outcomes (Compl. ¶18).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶82).
- Essential elements of independent claim 1 include:
- making an incision on a foot to provide access to a tarsal-metatarsal joint;
- performing a soft tissue release to mobilize the joint;
- moving a first metatarsal relative to a medial cuneiform in at least two planes, including a frontal plane and a transverse plane, to establish a moved position;
- after moving the first metatarsal, preparing an end of the first metatarsal;
- after moving the first metatarsal, preparing an end of the medial cuneiform; and
- fixing the moved position by inserting a fixation device across the tarsal-metatarsal joint.
- The complaint reserves the right to assert other claims of the patent (Compl. ¶82).
U.S. Patent No. 10,888,335 - "Bone Cutting Guide Systems and Methods"
- Patent Identification: U.S. Patent No. 10,888,335, "Bone Cutting Guide Systems and Methods," issued January 12, 2021 (Compl. ¶116).
- Technology Synopsis: The patent claims a method for correcting bone alignment using a bone cutting guide. The method involves positioning cutting slots of the guide over a metatarsal and a cuneiform, inserting fixation pins through the guide into the bones, and then using a cutting member in the slots to remove portions of the bones (Compl. ¶117; ’335 Patent, Claim 1).
- Asserted Claims: Independent claim 1 (Compl. ¶117).
- Accused Features: The complaint alleges that Fusion's LapiLock Brochure and LapiLock Video instruct and encourage surgeons to perform the claimed method using the Accused Products (Compl. ¶117).
U.S. Patent No. 10,945,764 - "Tarsal-Metatarsal Joint procedure Utilizing Fulcrum"
- Patent Identification: U.S. Patent No. 10,945,764, "Tarsal-Metatarsal Joint procedure Utilizing Fulcrum," issued March 16, 2021 (Compl. ¶151).
- Technology Synopsis: The patent claims a surgical method for bunion correction. The method includes aligning a bone cutting guide with the joint between the metatarsal and cuneiform, establishing the moved position of the metatarsal, and then using a guide feature of the bone cutting tool to remove portions of both bones (’764 Patent, Claim 1).
- Asserted Claims: Independent claim 1 (Compl. ¶152).
- Accused Features: The complaint alleges that Fusion’s instructional materials for its LapiLock system describe the performance of the claimed steps using the Accused Products (Compl. ¶152).
U.S. Patent No. 10,342,590 - "Tarsal-Metatarsal Joint Procedure Utilizing Fulcrum"
- Patent Identification: U.S. Patent No. 10,342,590, "Tarsal-Metatarsal Joint Procedure Utilizing Fulcrum," issued July 9, 2019 (Compl. ¶186).
- Technology Synopsis: The patent claims a surgical method for correcting a bunion by inserting a "fulcrum" between the first and second metatarsals. A distal portion of the first metatarsal is then moved toward the second, pivoting the proximal portion about the fulcrum to reduce the intermetatarsal angle, after which the bone ends are prepared (’590 Patent, Claim 1).
- Asserted Claims: Independent claim 1 (Compl. ¶188).
- Accused Features: The complaint alleges that Fusion's original LapiLock surgical procedure instructed the use of a "fulcrum" (later renamed "spacer") in a manner that practices the claimed method (Compl. ¶¶37, 188, 254).
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are Defendant Fusion Orthopedics, LLC's "LapiLock 4D Bunion Correction System," its associated medical instruments ("Accused Products"), and the surgical method taught for its use (Compl. ¶¶21, 41).
Functionality and Market Context
- The LapiLock system provides surgeons with instruments and a technique to perform bunion correction surgery (Compl. ¶21). An image from the LapiLock Brochure shows a tray of the Accused Products, including the LapiLock Jig, Cutting Blocks, and Spacers (Compl. ¶41, p. 18). The complaint alleges the associated surgical method involves preparing bone ends, aligning the bones, compressing them, inserting a fulcrum or spacer, and fixing the bones in the corrected position (Compl. ¶18). Plaintiff alleges that Defendant targets surgeons already trained on Plaintiff's competing LAPIPLASTY® procedure, thereby seeking to capitalize on Plaintiff's technology and training efforts (Compl. ¶¶26, 77).
IV. Analysis of Infringement Allegations
’426 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| positioning a first cutting slot of a bone cutting guide over a metatarsal | Fusion’s LapiLock Brochure and Video allegedly instruct surgeons to perform this step using the Accused Products. | ¶47 | col. 2:28-30 |
| inserting a cutting member through the first cutting slot to remove a portion of the metatarsal | Fusion’s LapiLock Brochure and Video allegedly instruct surgeons to perform this step using the Accused Products. | ¶47 | col. 2:31-33 |
| adjusting an alignment of the metatarsal relative to a cuneiform separated from the metatarsal by a joint to establish a moved position of the metatarsal | Fusion’s LapiLock Brochure and Video allegedly instruct surgeons to perform this step using the Accused Products, such as the LapiLock Jig. | ¶47 | col. 5:9-24 |
| positioning a second cutting slot of the bone cutting guide over the cuneiform | Fusion’s LapiLock Brochure and Video allegedly instruct surgeons to perform this step using the Accused Products. | ¶47 | col. 2:34-36 |
| inserting the cutting member through the second cutting slot to remove a portion of the cuneiform | Fusion’s LapiLock Brochure and Video allegedly instruct surgeons to perform this step using the Accused Products. | ¶47 | col. 2:37-39 |
| causing the metatarsal to fuse to the cuneiform in the moved position | Fusion’s LapiLock Brochure and Video allegedly instruct surgeons to perform fixation steps that result in fusion. The complaint provides an image of four key surgical steps from Fusion's marketing materials, including "4. Fixate," which allegedly achieves this claimed step (Compl. ¶18, p. 6). | ¶47 | col. 2:40-42 |
’670 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| moving a first metatarsal relative to a medial cuneiform in at least two planes, including a frontal plane and a transverse plane, to establish a moved position of the first metatarsal | Fusion’s LapiLock Brochure and Video allegedly instruct surgeons to use the LapiLock Jig to achieve multi-planar correction of the metatarsal before making bone cuts. | ¶82 | col. 2:42-47 |
| after moving the first metatarsal, preparing an end of the first metatarsal | Fusion’s LapiLock Brochure and Video allegedly instruct surgeons to prepare the joint surfaces of the first metatarsal after the alignment has been corrected. The complaint provides a side-by-side comparison of "Pre-Complaint" and "Post-Complaint" surgical videos from Fusion, alleging the original video showed steps corresponding to the claimed method (Compl. ¶265, p. 48). | ¶82 | col. 2:48-49 |
| after moving the first metatarsal, preparing an end of the medial cuneiform opposing the end of the first metatarsal | Fusion’s LapiLock Brochure and Video allegedly instruct surgeons to prepare the joint surfaces of the medial cuneiform after the alignment has been corrected. | ¶82 | col. 2:50-52 |
| fixing the moved position of the first metatarsal relative to the medial cuneiform by inserting a fixation device across the tarsal-metatarsal joint | Fusion’s LapiLock Brochure and Video allegedly instruct surgeons to apply fixation, such as plates and screws, to permanently secure the corrected alignment. | ¶82 | col. 2:53-56 |
Identified Points of Contention
- Scope Questions: A primary dispute may concern the term "fulcrum" in the ’590 Patent. The complaint alleges that after receiving notice, Fusion changed the term to "spacer" in its instructional materials (Compl. ¶37). This raises the question of whether Fusion’s "spacer" performs the same function in the same way to achieve the same result as the claimed "fulcrum", and whether the change was a legally effective design-around or merely a nominal change.
- Technical Questions: A key factual question for the ’670 Patent will be the sequence of operations in the accused LapiLock method. Infringement requires that the bone preparation steps occur after the multi-planar alignment is established. The complaint alleges that Fusion has altered its instructional videos, which may create a dispute over what surgical sequence is actually taught, encouraged, and performed by surgeons using the LapiLock system (Compl. ¶¶37, 265).
V. Key Claim Terms for Construction
The Term: "fulcrum" (’590 Patent, Claim 1)
- Context and Importance: This term is central because infringement of the ’590 Patent hinges on whether the accused method involves "inserting a fulcrum." Practitioners may focus on this term because the Defendant allegedly replaced this exact word with "spacer" in its marketing materials post-notice, suggesting the term's meaning is a point of dispute (Compl. ¶¶37, 255). The construction will determine whether Fusion’s renamed component falls within the claim's scope.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims and specification describe the fulcrum functionally as an object about which the first metatarsal is pivoted to reduce the intermetatarsal angle (’590 Patent, col. 2:47-52). This functional language could support a construction that covers any instrument, regardless of its name or specific shape, that serves as the pivot point for the claimed realignment.
- Evidence for a Narrower Interpretation: The specification discloses specific embodiments of a "multidimensional fulcrum" with particular shapes, textures, and dimensions (e.g., ’590 Patent, Figs. 32-33, 39A-B). A party could argue that these specific disclosures limit the term "fulcrum" to the structures shown or described, rather than any object that can be used as a pivot.
The Term: "after moving the first metatarsal, preparing an end" (’670 Patent, Claim 1)
- Context and Importance: The temporal relationship defined by "after" is a critical limitation of this method claim. Practitioners may focus on this term because infringement depends on establishing a specific sequence of surgical events: correction first, bone-cutting second. Defendant may argue its method does not follow this strict sequence, or that the steps are performed concurrently.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification's general description of the method may not impose a requirement that the "moving" step is 100% complete and locked before any "preparing" begins. A party could argue "after" means that the substantive correction is achieved, even if minor adjustments occur during or after preparation begins.
- Evidence for a Narrower Interpretation: The plain language of the claim recites a clear, sequential order of operations. The patent abstract and summary emphasize moving the bone into alignment and then preparing the ends (’670 Patent, Abstract). This could support a construction requiring the "moving" step to be finalized before the "preparing" step commences.
VI. Other Allegations
Indirect Infringement
- The complaint alleges both induced and contributory infringement for all five patents. Inducement is predicated on allegations that Fusion actively and knowingly encourages surgeons to perform the patented methods by distributing instructional materials, including the "LapiLock Brochure" and "LapiLock Video," which allegedly detail the infringing steps (e.g., Compl. ¶¶63-69 for the ’426 Patent). Contributory infringement is based on allegations that components of the Accused Products, such as the "LapiLock Jig, Cutting Blocks and Joint Seeker," are material components of the patented inventions, are not staple articles of commerce, are specially made for an infringing use, and lack substantial non-infringing uses (e.g., Compl. ¶¶53-62 for the ’426 Patent).
Willful Infringement
- Willfulness is alleged for all five asserted patents. The claims are based on alleged pre-suit knowledge stemming from notice letters sent by Treace to Fusion on February 16, 2022 (regarding the ’590 patent) and March 15, 2022 (regarding all five patents-in-suit). The complaint alleges that Fusion continued its infringing conduct despite this knowledge of the patents and the infringement allegations (e.g., Compl. ¶¶32, 39, 70-74).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "fulcrum," as claimed in the ’590 patent, be construed to read on the component Fusion now calls a "spacer" in its LapiLock system, especially given the alleged change in terminology after notice of infringement?
- A key evidentiary question will be one of operational sequence: does the LapiLock surgical method, as actually taught and performed by surgeons, require the bone preparation steps to occur strictly after the multi-planar alignment is established, as mandated by the ’670 patent, or does the procedure deviate from this claimed order?
- A central question for damages will be one of intent: did Fusion’s modifications to its instructional materials following Plaintiff's notice letters constitute a good-faith attempt to design around the asserted patents, or do these actions represent an ongoing, willful infringement of Plaintiff's intellectual property rights?