DCT
4:23-cv-00887
Vitalte Lifesciences Inc v. Bonds Therap LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Vitalte Lifesciences Inc. (Delaware)
- Defendant: Bonds Therapeutics LLC d/b/a Trocar Supplies (Kentucky)
- Plaintiff’s Counsel: Greenberg Traurig, LLP
- Case Identification: 4:23-cv-00887, N.D. Ohio, 04/28/2023
- Venue Allegations: Venue is alleged to be proper in the Northern District of Ohio because Defendant has a regular and established place of business in the district and has allegedly committed acts of infringement there.
- Core Dispute: Plaintiff alleges that Defendant’s line of “Blunt Tip Atraumatic Trocars” infringes a patent related to medical devices for the subcutaneous implantation of hormone pellets.
- Technical Context: The technology concerns trocars—medical instruments used to place medication pellets under a patient's skin—designed to be "atraumatic" to reduce pain and tissue damage compared to traditional methods.
- Key Procedural History: The complaint alleges that the parties engaged in discussions regarding a potential manufacturing and distribution relationship for the patented technology in February 2020, which included entering into a Confidential Disclosure Agreement (CDA). Plaintiff alleges Defendant was made aware of the "patented blunt tip trocar technology" at that time.
Case Timeline
| Date | Event |
|---|---|
| 2018-02-21 | '806 Patent Priority Date (Application Filing) |
| 2020-02-18 | Parties allegedly entered a Confidential Disclosure Agreement |
| 2022-08-09 | U.S. Patent No. 11,406,806 Issued |
| 2023-04-28 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,406,806 - "Atraumatic Trocar Apparatus, System and Kit," issued August 9, 2022
The Invention Explained
- Problem Addressed: The patent’s background section describes prior art trocars used for hormone pellet therapy as having a beveled cutting edge that slices through tissue. This process is described as painful, causing significant scarring, bruising, risk of infection, and potential for the implanted pellets to be extruded from the body (’806 Patent, col. 2:23-44).
- The Patented Solution: The invention is a trocar system that avoids cutting tissue by using a “blunt cannula” in combination with an obturator that has a rounded tip (’806 Patent, col. 2:57-62; Abstract). Instead of slicing, this design is intended to gently push aside and slip past subcutaneous tissue, thereby delivering the pellets with minimal trauma, which is purported to reduce pain and complications (’806 Patent, col. 13:45-53).
- Technical Importance: This approach seeks to improve patient outcomes in hormone pellet therapy by providing a method of subcutaneous delivery that "causes little or no trauma to the subcutaneous tissue" (’806 Patent, col. 2:53-54).
Key Claims at a Glance
- The complaint alleges infringement of one or more claims, with a focus on independent claim 1 (Compl. ¶32).
- Independent Claim 1 requires:
- An atraumatic trocar apparatus comprising a blunt cannula and an obturator.
- The blunt cannula must have a tubular body with a smooth edge at its anterior end, a medication slot, a fixedly coupled handle, and a posterior end with a coupling element that includes a notch. The inner diameter must be at least 3 mm.
- The obturator must have an anterior rounded tip, a body that inserts into the cannula, a fixedly coupled handle, and a second coupling element that includes at least one tab.
- The apparatus must be structured such that the obturator’s rounded tip extends past the cannula's end when the notch and tab interface with one another.
III. The Accused Instrumentality
Product Identification
- Defendant’s “Blunt Tip Atraumatic Trocars,” also referred to as the “Accused Products” (Compl. ¶19).
Functionality and Market Context
- The complaint alleges the Accused Products are medical devices for delivering medication pellets to a subcutaneous insertion site (Compl. ¶22). The complaint uses annotated photographs to allege that the products possess the specific structural features of the patented invention, including a blunt cannula, a medication slot, and an obturator with a rounded tip designed to be inserted within the cannula (Compl. ¶¶23-29). One such photograph, an annotated view of the accused cannula, identifies the "Anterior end with smooth edge" (Compl. p. 6). The products are marketed and sold through Defendant's website (Compl. ¶19).
IV. Analysis of Infringement Allegations
'806 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a blunt cannula with a tubular cannula body, wherein a surface of an anterior end of the tubular cannula body includes a smooth edge | Defendant's product is alleged to have a blunt cannula with a tubular body and a smooth-edged anterior end. An annotated image is provided to show this feature. | ¶23; p. 6 | col. 6:35-37 |
| wherein the blunt cannula is formed with a medication slot disposed along the tubular cannula body at a location more proximate to a posterior end... | The complaint alleges the accused cannula has a medication slot located toward its posterior end. | ¶24 | col. 6:46-52 |
| and a cannula handle fixedly coupled to the tubular cannula body | The accused cannula is alleged to include a fixedly coupled handle. | ¶25 | col. 6:62-63 |
| wherein the posterior end of the tubular cannula body includes a first coupling element... wherein the first coupling element includes a notch | The posterior end of the accused cannula is alleged to include a notch that functions as a coupling element. | ¶26 | col. 7:14-18 |
| and wherein an inner diameter of the tubular cannula is at least 3 millimeters (mm) | The complaint alleges the inner diameter of the accused cannula is at least 3 mm, citing to a product variant on Defendant's website. | ¶27 | col. 6:58-62 |
| an obturator that includes an anterior rounded tip, an obturator body that is inserted within the tubular cannula body, an obturator handle fixedly coupled... and a second coupling element that includes at least one tab | Defendant's product is alleged to include an obturator with a rounded tip, a body, a handle, and a tab. An annotated photograph displays these components. | ¶28; p. 8 | col. 8:10-24 |
| wherein the obturator extends through the tubular cannula body so that the anterior rounded tip of the obturator extends past the anterior end... when the notch and the at least one tab interface with one another | The complaint alleges that when assembled, the accused obturator's tip extends past the cannula's end when the notch and tab interface. | ¶29 | col. 8:53-59 |
- Identified Points of Contention:
- Scope Questions: A central question may be the construction of "blunt" and "smooth edge." The patent defines these terms primarily by contrasting them with the "beveled cutting edge" of the prior art (’806 Patent, col. 2:5-8). The dispute may turn on whether the accused product's design, whatever its specific geometry, falls within the scope of a non-cutting device as contemplated by the patent.
- Technical Questions: The complaint alleges a functional relationship where the obturator tip extends past the cannula end "when the notch and the at least one tab interface" (Compl. ¶29). A key factual question will be whether the accused product's notch and tab actually "interface" in a way that performs the orienting function described in the patent (e.g., preventing rotation, per ’806 Patent, col. 3:63-65), or if their physical correspondence is incidental and functionally different.
V. Key Claim Terms for Construction
The Term: "blunt cannula"
- Context and Importance: This term is at the heart of the invention's "atraumatic" nature and is the primary feature distinguishing it from the prior art. The definition of "blunt" will likely be dispositive for infringement.
- Intrinsic Evidence for a Broader Interpretation: The specification repeatedly contrasts the invention with prior art that has a "beveled cutting edge" (’806 Patent, col. 2:5-8), suggesting "blunt" could be broadly construed as "not sharp" or "non-cutting."
- Intrinsic Evidence for a Narrower Interpretation: The specification describes the cannula as having a "blunt or rounded cylindrical end" (’806 Patent, col. 6:35-37) and shows specific embodiments in figures like FIG. 2A. A defendant could argue these embodiments limit the term to a specific rounded geometry.
The Term: "interface with one another"
- Context and Importance: This phrase defines the required interaction between the cannula's notch and the obturator's tab. Proving infringement requires showing not just the presence of a notch and tab, but that they interact as claimed. Practitioners may focus on this term because it links the structure of the components to their function when assembled.
- Intrinsic Evidence for a Broader Interpretation: The claim language itself does not specify the type of interface, potentially allowing for any physical contact that occurs when the parts are in the claimed orientation.
- Intrinsic Evidence for a Narrower Interpretation: The specification provides a functional purpose for the interface: "to prevent the insertion obturator from rotating about the cannula" (’806 Patent, col. 3:63-65). A court could determine that "interface" requires this specific anti-rotation function, not just incidental contact.
VI. Other Allegations
- Willful Infringement: The complaint alleges willful infringement based on pre-suit knowledge of the technology (Compl. ¶36). The specific facts alleged to support this claim are a February 2020 communication with Defendant about the inventor's "patented blunt tip trocar technology" and the execution of a Confidential Disclosure Agreement to evaluate a potential business relationship concerning the technology (Compl. ¶¶17-18).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "blunt cannula", defined in the patent by its contrast to sharp, cutting trocars, be construed to read on the specific design of the accused product? The case may depend on whether "blunt" is interpreted broadly as "non-cutting" or is limited to the specific rounded embodiments shown in the patent.
- A key evidentiary question will be functional: does the interaction between the notch on the accused cannula and the tab on the accused obturator constitute an "interface" that performs the stabilizing function described in the patent, or is the feature structurally present but functionally distinct from what the claim requires?
- A central question for damages will be the effect of the alleged pre-suit business discussions on willfulness. The court will have to determine if Defendant's alleged knowledge from the 2020 CDA and related talks rises to the level of egregious conduct necessary to support enhanced damages.