DCT
8:22-cv-00145
Omnia Medical LLC v. PainTEQ LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Omnia Medical, LLC (Ohio)
- Defendant: PainTEQ, LLC (Florida), Sean LaNeve, and Charles Girsch
- Plaintiff’s Counsel: Paskert Divers Thompson; Walter | Haverfield LLP
- Case Identification: 8:22-cv-00145, M.D. Fla., 01/18/2022
- Venue Allegations: Venue is asserted based on Defendant PainTEQ having its principal place of business in Tampa, Florida, which is within the Middle District of Florida.
- Core Dispute: Plaintiff alleges that Defendant’s LinQ™ SI Joint Stabilization System infringes a design patent and a utility patent related to sacroiliac joint surgical devices and methods.
- Technical Context: The technology concerns medical devices and methods for sacroiliac (SI) joint fixation and fusion, a surgical procedure intended to treat certain types of lower back pain by stabilizing the joint connecting the spine to the pelvis.
- Key Procedural History: The complaint notes that the patent infringement claims were previously part of a motion to amend in a separate pending case between the parties (Case No. 20-02805, M.D. Fla.), which the court denied, leading to the filing of this new action. Subsequent to the complaint's filing, both patents-in-suit underwent post-grant proceedings. U.S. Patent No. 11,083,511 was challenged in an Inter Partes Review (IPR2023-00451), resulting in the cancellation of all claims (1-23) as of February 14, 2024. U.S. Design Patent No. D922,568 was subject to an Ex Parte Reexamination (No. 90/019,474), which concluded on December 12, 2024, with the confirmation of the patentability of its single claim.
Case Timeline
| Date | Event |
|---|---|
| 2013-03-15 | Earliest Priority Date for '511 Patent |
| 2015-03-25 | Earliest Priority Date for D'568 Patent |
| 2016-12-01 | Approximate date discussions began between Omnia and PainTEQ |
| 2017-04-01 | Effective date of Stocking Agreement between parties |
| 2019-02-19 | PainTEQ terminates Stocking Agreement |
| 2021-06-15 | 'D568 Patent Issued |
| 2021-08-10 | '511 Patent Issued |
| 2022-01-18 | Complaint Filed |
| 2024-02-14 | IPR Certificate issued cancelling all claims of '511 Patent |
| 2024-12-12 | Reexamination Certificate issued confirming claim of D'568 Patent |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Design Patent No. D922,568 - "Surgical Cannula,"
- Patent Identification: U.S. Design Patent No. D922,568, "Surgical Cannula," Issued June 15, 2021 (Compl. ¶99).
The Invention Explained
- Problem Addressed: Design patents protect the ornamental appearance of an article of manufacture, not its utility. This patent secures rights to a specific, non-functional design for a surgical cannula (Compl. ¶101).
- The Patented Solution: The patent claims the ornamental design for a surgical cannula as depicted in its figures. The design features a generally cylindrical shaft with a flanged, circular proximal end and a forked, U-shaped distal end comprising two prongs ('D568 Patent, Figs. 1, 4, 9). The complaint highlights the "unique design features" covered by the patent (Compl. ¶101).
- Technical Importance: The design provides a distinct visual appearance for a surgical tool used in SI joint procedures, which can be a basis for product differentiation in the medical device market (Compl. ¶101).
Key Claims at a Glance
- Design patents contain a single claim. The asserted claim is for "The ornamental design for a surgical cannula, as shown and described" ('D568 Patent, Claim).
U.S. Patent No. 11,083,511 - "Method and Implant System for Sacroiliac Joint Fixation and Fusion,"
- Patent Identification: U.S. Patent No. 11,083,511, "Method and Implant System for Sacroiliac Joint Fixation and Fusion," Issued August 10, 2021 (Compl. ¶109).
The Invention Explained
- Problem Addressed: The patent's background section describes prior art SI joint treatments as potentially requiring "extensive surgical exposure and dissection" and using instruments not specifically designed for the purpose, which can lead to longer surgical times, patient pain, and risk of failed surgery (’511 Patent, col. 1:56 - col. 2:8).
- The Patented Solution: The invention provides an improved surgical method and system that uses a "posterior access approach" through a novel "exposure device" (a surgical channel tool) to deliver a fusion implant directly into the SI joint (’511 Patent, Abstract). This specialized tool is designed to guide instruments and the implant precisely, enabling mechanical fixation and promoting bone fusion in a minimally invasive manner (’511 Patent, col. 2:15-41).
- Technical Importance: This approach is presented as a way to create a "secure and consistent fusion construct" while potentially reducing the surgical footprint and associated complications common to older techniques (’511 Patent, col. 2:5-8).
Key Claims at a Glance
- The complaint asserts infringement of "at least one claim" without specifying which claims are asserted (Compl. ¶113). Independent method claim 10 is representative of the invention described.
- The essential elements of independent claim 10 include:
- creating a first incision proximal to the sacroiliac joint;
- inserting a surgical channel tool having two bilateral blunt tangs on a distal end;
- the surgical channel having a hollow barrel with an interior guidance slot;
- creating a void in the sacroiliac joint;
- inserting a fusion implant into the void using an inserter; and
- driving the fusion implant into the void so a protrusion on the implant engages with bone tissue, fixing the relative positions of the sacrum and ilium.
- The complaint does not explicitly reserve the right to assert dependent claims, but the broad allegation of infringing "one or more claims" leaves this possibility open (Compl. ¶2).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant's "LinQ™ SI Joint Stabilization System" (the "LinQ™ Products"), which includes products for use in surgical procedures for SI joint repair and fusion (Compl. ¶8).
Functionality and Market Context
- The LinQ™ system is alleged to be composed of "unlicensed and unauthorized copies or near copies" of Plaintiff's own PsiF™ System tools (Compl. ¶8). The complaint alleges that PainTEQ provides "bioskills training" and a "Surgical Technique Guide" to customers, instructing them on how to use the LinQ™ system to perform SI joint procedures (Compl. ¶9).
IV. Analysis of Infringement Allegations
The infringement theory for the design patent is based on visual similarity. The complaint provides a side-by-side comparison of the patented design and the accused product. A side-by-side comparison shows Figure 6 of the 'D568 Patent next to a photograph of the accused "PainTEQ Surgical Cannula" (Compl. p. 33). This visual evidence is central to the allegation that the accused cannula is "substantially similar" to the claimed design, such that an ordinary observer would be deceived (Compl. ¶102).
- Identified Points of Contention: The core question for the design patent will be whether the accused PainTEQ cannula's ornamental design is substantially the same as the claimed design. A court will assess if an ordinary observer would find the two designs confusingly similar, considering the overall appearance, including the cylindrical shaft and U-shaped distal prongs, while also accounting for any differences, such as the shape of the proximal flange and the presence of the "PAIN TEQ" text on the accused product.
'511 Patent Infringement Allegations
| Claim Element (from Independent Claim 10) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| b. inserting a surgical channel tool into said first incision... said surgical channel tool having two bilateral blunt tangs on a distal end thereof that are inserted between the articular surfaces of an ilium and a sacrum... | PainTEQ's customers are instructed via its Surgical Technique Guide to perform a method that includes using the LinQ™ products, which allegedly include a surgical cannula that meets these limitations. | ¶¶113, 114 | col. 15:27-40 |
| ...said surgical channel including a hollow barrel having an interior guidance slot in an interior diameter of said hollow barrel for controlling the depth of advancement... | The complaint alleges that the accused LinQ™ products and instructed method infringe, which suggests the accused cannula contains the claimed features. | ¶¶113, 114 | col. 13:61-65 |
| c. creating a void in said sacroiliac joint; | The accused method, as taught in PainTEQ's Surgical Technique Guide, allegedly includes the step of creating a void in the patient's SI joint. | ¶¶113, 114 | col. 35:38-44 |
| d. inserting a fusion implant into said void through said hollow barrel... said fusion implant having at least one protrusion for engagement with bone tissue... | The accused method allegedly instructs users to insert a fusion implant, as part of the LinQ™ system, into the created void. | ¶¶113, 114 | col. 23:20-30 |
| e. driving said fusion implant into said void such that said at least one protrusion engages with said bone tissue preventing pullout of the fusion implant... | The accused method allegedly instructs users to drive the implant into place to engage bone and achieve fixation. | ¶¶113, 114 | col. 20:20-24 |
- Identified Points of Contention:
- Scope Questions: A central dispute would have concerned whether the specific surgical cannula in the LinQ™ system meets the definition of a "surgical channel tool" that includes both "two bilateral blunt tangs" and an "interior guidance slot" as required by the claim.
- Technical Questions: An evidentiary question would be whether the step-by-step instructions in PainTEQ's Surgical Technique Guide teach a user to perform every limitation of the asserted method claim. Any deviation in the instructed procedure from the claimed method could be a basis for a non-infringement defense.
V. Key Claim Terms for Construction
- The Term: "interior guidance slot" ('511 Patent, Claim 10)
- Context and Importance: This term defines a key feature of the claimed surgical tool. Its construction would be critical for determining whether the accused PainTEQ cannula infringes, as the presence or absence of a structure meeting this definition could be dispositive.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the feature as a "timing feature" that "arrests the progress of a surgical implement" and also ensures it remains "properly oriented" (’511 Patent, col. 14:45-59). A party could argue the term covers any internal channel feature that guides an instrument and/or limits its depth.
- Evidence for a Narrower Interpretation: The figures depict a specific physical notch (146 in FIG. 29) that performs this function. A party could argue the term should be limited to a structure that is a discrete slot or notch, as opposed to a more general guiding shape of the barrel itself.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that PainTEQ indirectly infringes the '511 Patent by inducing its customers to infringe (Compl. ¶¶113, 116). The basis for this allegation is PainTEQ's provision of its "Surgical Technique Guide," which allegedly provides "step-by-step instructions" for performing the patented method, with knowledge that following these instructions would constitute infringement (Compl. ¶¶113-115).
- Willful Infringement: Willfulness is alleged for the '511 Patent based on the infringement being "in disregard for the '511 patent, without any reasonable basis for believing that it had a right to engage in the infringing conduct" (Compl. ¶119). The complaint alleges that during business negotiations, Omnia disclosed its IP holdings, including "the subject matter of the application that matured into the '511 Patent," which may be used to argue pre-suit knowledge (Compl. ¶30).
VII. Analyst’s Conclusion: Key Questions for the Case
The post-filing invalidation of the '511 Patent and confirmation of the 'D568 Patent fundamentally reshapes the dispute. The central questions for the case are now:
A core issue will be one of visual similarity: for the surviving 'D568 design patent, is the overall ornamental appearance of the accused PainTEQ surgical cannula substantially the same as the patented design in the eyes of an ordinary observer, sufficient to support a finding of infringement?
A key question will be a dispositive procedural issue: given the cancellation of all claims of the '511 utility patent in a post-grant review proceeding, what, if any, legal basis remains for this infringement claim? The litigation will likely focus on the preclusive effect of the IPR and whether any damages that may have accrued before the claims' cancellation can be recovered.