DCT
2:23-cv-01544
Vertos Medical Inc v. Folsom Metal Products Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Vertos Medical, Inc. (Delaware)
- Defendant: Folsom Metal Products, Inc., aka Frontier Devices, and individual distributors (Alabama)
- Plaintiff’s Counsel: Stradling Yocca Carlson & Rauth PC; Balch & Bingham LLP
- Case Identification: 2:23-cv-01544, N.D. Ala., 11/14/2023
- Venue Allegations: Venue is asserted in the Northern District of Alabama on the basis that the primary corporate defendant, Folsom Metal Products, Inc., is located and incorporated in the district, and that a substantial part of the alleged infringing activities, including offers to sell and sales, occurred within the district.
- Core Dispute: Plaintiff alleges that Defendant’s Disposable Kerrison System (DKS) kit infringes multiple utility and design patents related to minimally invasive surgical procedures and instruments for treating lumbar spinal stenosis, and further alleges claims of false advertising and RICO violations.
- Technical Context: The technology concerns methods and devices for percutaneous, image-guided lumbar decompression, offering a minimally invasive alternative to traditional open spinal surgery for treating stenosis.
- Key Procedural History: The complaint alleges that in mid-December 2019, a Vertos officer provided Defendant Martin with pre-suit notice of Vertos' patents, specifically reading Claim 1 of U.S. Patent No. 8,734,477 and directing him to Vertos’ website listing its patents. This event is cited to support allegations of willful infringement and intent for induced infringement.
Case Timeline
| Date | Event |
|---|---|
| 2004-07-29 | Priority Date for ’879 Patent |
| 2005-07-29 | Priority Date for ’772 Patent |
| 2006-05-09 | Priority Date for ’830, ’762, and ’477 Patents |
| 2006 | Vertos receives first FDA 510(k) clearance for "mild"® kit |
| 2008-10-23 | Priority Date for multiple Bone Rongeur Design Patents |
| 2010 | Vertos receives second FDA 510(k) clearance for "mild"® kit |
| 2010-02-16 | Issue Date for ’259 Design Patent |
| 2010-03-02 | Issue Date for ’146 and ’939 Design Patents |
| 2010-07-06 | Issue Date for ’252 Design Patent |
| 2011-03-01 | Issue Date for ’879 Patent |
| 2011-04-05 | Issue Date for ’671 Design Patent |
| 2011-05-17 | Issue Date for ’830 Patent |
| 2011-07-06 | Issue Date for ’253 Design Patent |
| 2013-02-26 | Issue Date for ’964 Design Patent |
| 2013-12-17 | Issue Date for ’762 Patent |
| 2014-05-27 | Issue Date for ’477 Patent |
| 2014-11-11 | Issue Date for ’772 Patent |
| 2019-12 | Vertos provides pre-suit notice of patents to Defendant Martin |
| 2023-Summer | Alleged commercialization of accused DKS kit begins |
| 2023-11-14 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,896,879 - "Spinal Ligament Modification"
- Issued: March 1, 2011 (the “’879 Patent”)
The Invention Explained
- Problem Addressed: Traditional open surgery for spinal stenosis, known as a laminectomy, is highly invasive. It requires cutting through back muscles and supporting ligaments to expose the spinal column, which can lead to significant post-operative pain, long recovery times, and potential spinal instability (’879 Patent, col. 2:10-18).
- The Patented Solution: The invention provides a minimally invasive surgical method that avoids the need for open surgery. The method involves percutaneously injecting a fluid into the epidural space to gently compress the thecal sac (containing spinal nerves), thereby creating a protective “safety zone” between the nerves and the surgical site (’879 Patent, col. 6:52-59; Fig. 3). A surgeon can then insert a tool into a “working zone” within the thickened ligamentum flavum and use imaging to guide the removal of tissue, relieving the nerve compression that causes stenosis (’879 Patent, Abstract).
- Technical Importance: This method introduced a way to decompress the spinal canal percutaneously under local anesthesia, offering a treatment option with potentially fewer risks and a faster recovery compared to traditional open spinal surgery (’879 Patent, col. 2:19-24).
Key Claims at a Glance
- The complaint asserts at least Claim 1 (Compl. ¶147).
- Essential elements of independent claim 1 include:
- A method for treating stenosis in a spine comprising the steps of:
- a) compressing the thecal sac in the region of interest by injecting a fluid into the epidural space to form a modified epidural space and a safety zone and establish a working zone…;
- b) inserting a tool into tissue in the working zone without breaching an anterior surface of the ligamentum flavum;
- c) using the tool to percutaneously reduce the stenosis by excising a portion of tissue in the working zone; and
- d) utilizing imaging to visualize the position of the tool during at least a part of step c).
U.S. Patent No. 7,942,830 - "Ipsilateral Approach To Minimally Invasive Ligament Decompression Procedure"
- Issued: May 17, 2011 (the “’830 Patent”)
The Invention Explained
- Problem Addressed: As with the ’879 Patent, the invention addresses the drawbacks of open spinal surgery (’830 Patent, col. 2:3-20). It further addresses the challenge of obtaining a clear view of the surgical site during a minimally invasive procedure, which can be obstructed by the patient’s vertebrae (’830 Patent, col. 10:59-65).
- The Patented Solution: The ’830 Patent refines the surgical method by teaching a specific ipsilateral tool trajectory. After creating a safety zone via fluid injection, the surgeon percutaneously accesses the target tissue from one side of the patient’s spine (a "lateral side of the median plane") and removes tissue on that same side (’830 Patent, Abstract). This specific approach is designed to parallel the surface of the laminae, providing the surgeon with a less obstructed view under imaging guidance (’830 Patent, col. 11:15-24).
- Technical Importance: By defining a specific surgical pathway, the invention aimed to improve the safety and efficacy of percutaneous decompression by giving surgeons a clearer, more direct line of sight to the interlaminar space during the procedure (’830 Patent, col. 11:15-24).
Key Claims at a Glance
- The complaint asserts at least Claim 1 (Compl. ¶147).
- Essential elements of independent claim 1 include:
- A method for treating stenosis in a spine of a patient comprising the steps of:
- a) generating at least one view of a portion of the spinal canal…;
- b) compressing the dural sac…by injecting a fluid to form a safety zone…;
- c) percutaneously accessing the region of interest on a first lateral side of the median plane via a tool trajectory that passes generally between a lamina of a superior first vertebra and a lamina of an inferior second vertebra…;
- d) inserting a tissue removal tool into tissue in the working zone on the first lateral side of the median plane via the tool trajectory;
- e) using the tissue removal tool to percutaneously reduce the stenosis on the first lateral side…; and
- f) utilizing the at least one view to position the tissue removal tool…
Multi-Patent Capsule: Additional Utility Patents (’762, ’477, ’772)
- Patent Identification: U.S. Patent Nos. 8,608,762; 8,734,477; and 8,882,772 (Compl. ¶¶80, 83, 86).
- Technology Synopsis: These patents claim further variations and refinements of the methods for percutaneously treating spinal stenosis. They describe specific tool trajectories relative to the spine’s anatomy, such as advancing a tool parallel to the long axis of the interlaminar space, and methods involving the use of a first instrument to create an access channel for a second instrument (Compl. ¶¶82, 85, 88).
- Asserted Claims: At least Claim 1 of each patent (Compl. ¶147).
- Accused Features: The complaint alleges that Defendant’s instructions for the DKS kit induce physicians to perform these patented methods (Compl. ¶147).
Multi-Patent Capsule: Bone Rongeur Design Patents (’253, ’964, ’259, ’252, ’146, ’939, ’671)
- Patent Identification: U.S. Design Patent Nos. D619,253; D676,964; D610,259; D619,252; D611,146; D621,939; and D635,671 (Compl. ¶137).
- Technology Synopsis: These patents protect the ornamental designs for the “mild® Bone Rongeur,” a surgical instrument used in the decompression procedure. Each patent claims the unique visual appearance of the tool or its components, as shown in its figures (Compl. ¶¶91, 94, 97, 100, 103, 106, 109). The complaint includes a drawing from the ’253 Patent as an example of the claimed design (Compl. p. 38, FIG. 4).
- Asserted Claims: Claim 1 of each patent (Compl. ¶138).
- Accused Features: The complaint alleges that the "knock-off bone rongeur" included in the DKS kit is "substantially the same" in appearance as the designs claimed in these patents (Compl. ¶138).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the “Disposable Kerrison System” or “DKS,” a kit of surgical instruments (Compl. ¶2).
Functionality and Market Context
- The complaint alleges the DKS kit is a “knock-off” of Plaintiff’s "mild"® kit, designed and marketed as a cheaper substitute for performing Percutaneous Image-guided Lumbar Decompression (PILD) procedures (Compl. ¶¶2, 37). A photograph provided in the complaint shows the DKS kit contains several surgical tools, including what appear to be Kerrison rongeurs, arranged in a sterile package (Compl. p. 14, at ¶34). The complaint alleges the DKS kit is marketed covertly through a network of distributors and lacks key safety components found in the "mild"® kit, such as a specialized Tissue Sculpter and a Depth Guide to mitigate the risk of over-penetration (Compl. ¶¶5, 70-71).
IV. Analysis of Infringement Allegations
’879 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a) compressing the thecal sac in the region of interest by injecting a fluid into the epidural space to form a modified epidural space and a safety zone... | The accused instructions allegedly direct users to "Perform an epidural gram," which involves injecting fluid into the epidural space, and to note changes in the "Epidurogram" that "reveals space estoration [sic]." | ¶147 | col. 6:47-59 |
| b) inserting a tool into tissue in the working zone without breaching an anterior surface of the ligamentum flavum; | The accused instructions direct users to "Place the device from lateral to medial to the central part of the laminar window." | ¶147 | col. 8:1-8 |
| c) using the tool to percutaneously reduce the stenosis by excising a portion of tissue in the working zone; and | The accused instructions direct users to "Perform your bone and ligament resection," "Work from central medial to lateral," and "Resect the Superior and inferior lamina." | ¶147 | col. 4:42-45 |
| d) utilizing imaging to visualize the position of the tool during at least a part of step c). | The accused instructions direct the procedure to be performed "under a contralateral view," which necessitates the use of imaging. | ¶147 | col. 3:12-18 |
’830 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| b) compressing the dural sac in the region of interest by injecting a fluid to form a safety zone... | The accused instructions allegedly direct users to "Perform an epidural gram," which injects fluid into the epidural space, and to note changes revealing "space estoration [sic]." | ¶147 | col. 10:25-30 |
| c) percutaneously accessing the region of interest on a first lateral side of the median plane via a tool trajectory that passes generally between a lamina of a superior first vertebra and a lamina of an inferior second vertebra... | The accused instructions direct users to "Place the device from lateral to medial to the central part of the laminar window," allegedly teaching the patented ipsilateral approach. | ¶147 | col. 11:4-24 |
| e) using the tissue removal tool to percutaneously reduce the stenosis on the first lateral side of the median plane; and | The accused instructions direct users to perform "bone and ligament resection" from "central medial to lateral," which allegedly constitutes reduction of stenosis on the same side as the tool insertion. | ¶147 | col. 3:42-46 |
| f) utilizing the at least one view to position the tissue removal tool... | The accused instructions direct the procedure to be performed "under a contralateral view," which requires imaging to position the tool. | ¶147 | col. 11:15-24 |
Identified Points of Contention
- Scope Questions: A central question may be whether the instruction to "Perform an epidural gram," a procedure often used for diagnosis, meets the claim limitation of "compressing the thecal sac...to form a...safety zone." The patent specifications describe the safety zone as a specific, functional barrier created to protect the spinal cord, which may suggest a purpose and effect beyond that of a standard epidurogram (’879 Patent, col. 6:52-59).
- Technical Questions: The infringement analysis for the ’830 Patent will depend on whether the general instruction to "Place the device from lateral to medial" is specific enough to teach the detailed, multi-part ipsilateral trajectory required by claim 1(c). Evidence from the "DKS Product Common Uses" document or other instructional materials will be critical to determine if the specific path between adjacent vertebrae is taught as claimed.
V. Key Claim Terms for Construction
The Term: "safety zone" (’879 Patent, Claim 1; ’830 Patent, Claim 1)
- Context and Importance: This term is critical because the creation of the "safety zone" is a foundational step in the asserted method claims. The dispute may turn on whether the result of the allegedly instructed "epidural gram" creates what the patent defines as a "safety zone."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states that the safety zone is created by injecting fluid that "gently compresses and displaces the dural sleeve" (’879 Patent, col. 6:53-56). This language could support an argument that any fluid injection achieving this result creates the claimed zone.
- Evidence for a Narrower Interpretation: The patent attributes a specific protective function to the zone, explaining that its presence "ensures that the thecal sac will not be damaged even if the tool breaks through the anterior surface of ligament 26" (’879 Patent, col. 8:5-8). This may support an interpretation that requires a deliberate and sufficient compression to achieve this protective function, rather than incidental displacement.
The Term: "percutaneously accessing the region of interest on a first lateral side of the median plane via a tool trajectory" (’830 Patent, Claim 1)
- Context and Importance: This term defines the specific surgical approach claimed in the ’830 Patent. For induced infringement, Plaintiff must show that Defendant’s instructions teach this particular pathway. Practitioners may focus on this term because the complaint’s quoted instruction, "Place the device from lateral to medial," is general and may not describe the full, specific trajectory claimed.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim uses the word "generally" when describing the path "between a lamina of a superior first vertebra and a lamina of an inferior second vertebra," which may suggest that the trajectory does not need to be exact to fall within the claim scope.
- Evidence for a Narrower Interpretation: The specification describes this "ipsilateral approach" as providing a less obstructed view, which is a stated advantage of the invention (’830 Patent, col. 11:4-24). Figures 6-8 of the patent depict the specific angular relationships of this trajectory. This could support a narrower construction requiring the taught method to achieve this specific functional advantage.
VI. Other Allegations
Indirect Infringement
- The complaint’s primary theory for the utility patents is induced infringement under 35 U.S.C. § 271(b). It alleges Folsom instructs and encourages physicians to perform the patented methods by providing the DKS kits along with instructional documents, specifically the "DKS IFU" and the "DKS Product Common Uses" document, which allegedly detail the infringing steps (Compl. ¶¶147-148).
Willful Infringement
- Willfulness is alleged for both direct infringement of the design patents and induced infringement of the utility patents. The allegation is based on pre-suit knowledge stemming from a December 2019 phone call in which a Vertos executive allegedly informed Defendant Martin of Vertos’ patents, read a claim aloud, and directed him to a website listing the patents (Compl. ¶¶30-31, 144, 151). The complaint alleges that Defendants continued their activities despite this notice.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of functional equivalence: does the accused instruction to "Perform an epidural gram," a common diagnostic procedure, create the specific, protective "safety zone" described and claimed in the patents, or is there a fundamental mismatch in technical function and purpose?
- A key evidentiary question will be one of instructional specificity: do Defendant's instructional materials for the DKS kit direct users to perform the precise, multi-part surgical trajectories required by the asserted method claims, particularly the ipsilateral approach of the '830 Patent, or are the instructions too generic to map to the claimed steps?
- For the design patents, the dispute will center on the ordinary observer test: would an ordinary observer, familiar with the prior art for surgical bone rongeurs, be deceived into thinking the ornamental design of the accused DKS rongeur is the same as the designs claimed in Vertos' patents?