DCT
1:18-cv-00217
Minerva Surgical Inc v. Hologic Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Minerva Surgical, Inc. (Delaware)
- Defendant: Hologic, Inc. (Delaware); CYTYC Surgical Products, LLC (Massachusetts)
- Plaintiff’s Counsel: Wilson Sonsini Goodrich & Rosati PC
- Case Identification: 5:17-cv-02013, N.D. Cal., 04/11/2017
- Venue Allegations: Venue is alleged based on Defendants' continuous and systematic contacts with the Northern District of California, including regular business transactions and prior litigation activity within the district.
- Core Dispute: Plaintiff alleges that Defendant’s NovaSure ADVANCED endometrial ablation system infringes a patent related to medical devices designed to treat abnormal uterine bleeding.
- Technical Context: The technology is in the field of electrosurgical medical devices for endometrial ablation, a procedure that removes the uterine lining to treat menorrhagia (heavy menstrual bleeding).
- Key Procedural History: The complaint alleges that Defendants have had knowledge of the patent-in-suit since at least February 8, 2016, a date preceding the accused product's launch and the filing of the complaint, which may form the basis for the willfulness allegation.
Case Timeline
| Date | Event |
|---|---|
| 2010-10-19 | '208 Patent Priority Date |
| 2015-11-17 | '208 Patent Issue Date |
| 2016-02-08 | Alleged date of Defendant's knowledge of '208 Patent |
| 2017-02-02 | Accused Product (NovaSure ADVANCED) Launch Date |
| 2017-04-11 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,186,208 - "Systems for Endometrial Ablation"
- Issued: November 17, 2015
The Invention Explained
- Problem Addressed: The patent's background section notes that prior radiofrequency ablation devices suffered from deficiencies including "incomplete treatments, non-uniform ablation depths, and risk of injury to adjacent organs" (’208 Patent, col. 1:36-40).
- The Patented Solution: The patent describes an endometrial ablation device with an expandable frame that carries a compliant energy-delivery surface (’208 Patent, Abstract). The frame is designed to expand into a triangular shape to conform to the uterine cavity. A key aspect of the invention is the use of frame elements with "dissimilar material properties"; specifically, the inner frame elements are designed to be stiffer than the outer frame elements, which allegedly produces a more optimal, triangular expanded shape (’208 Patent, col. 19:24-54).
- Technical Importance: This design, using dissimilar materials, is presented as a method to "increase the total surface area of the dielectric in contact with tissue when compared with a shape which has more deeply bowed outer frame elements," potentially leading to more complete ablation (’208 Patent, col. 19:50-54).
Key Claims at a Glance
- The complaint asserts independent claim 13 of the '208 Patent.
- The essential elements of independent claim 13 are:
- A system for endometrial ablation comprising an elongated shaft with a working end.
- The working end includes a compliant energy-delivery surface actuated by an interior expandable-contractable frame.
- The surface is expandable to a selected planar triangular shape to engage the uterine walls.
- The frame has flexible outer elements in lateral contact with the surface and flexible inner elements not in lateral contact with the surface.
- The inner and outer elements have "substantially dissimilar material properties."
- The prayer for relief seeks judgment on "one or more claims of the ’208 patent," preserving the right to assert other claims (Compl. p. 8, ¶A).
III. The Accused Instrumentality
Product Identification
- The accused product is the "NovaSure® ADVANCED Impedance Controlled Endometrial Ablation System" ("NovaSure ADVANCED") (Compl. ¶7).
Functionality and Market Context
- The NovaSure ADVANCED is a system for endometrial ablation, comprising an "elongated shaft with a working end" (Compl. ¶17).
- The working end features a "compliant energy-delivery surface" that is "expandable to a selected planar triangular shape" to engage the uterine walls (Compl. ¶17). A diagram from the product's manual, included in the complaint, illustrates the device deployed in a triangular shape inside a uterus (Compl. ¶17, p. 5, Ex. C at 14).
- The complaint alleges the device's expandable frame has "flexible outer elements" and "flexible inner elements" (Compl. ¶19). A screenshot from the defendant's website, also included in the complaint, is annotated to identify these alleged components (Compl. ¶19, p. 6).
- The product is positioned as a direct competitor to the plaintiff's own Minerva EAS product (Compl. ¶16).
IV. Analysis of Infringement Allegations
'208 Patent Infringement Allegations
| Claim Element (from Independent Claim 13) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A system for endometrial ablation comprising: an elongated shaft with a working end having an axis... | The NovaSure ADVANCED system is described as comprising an "elongated shaft with a working end." | ¶17 | Abstract |
| ...and comprising a compliant energy-delivery surface actuatable by an interior expandable-contractable frame... | The NovaSure ADVANCED is alleged to have a "compliant energy-delivery surface" that is "actuatable by an interior expandable-contractable frame." | ¶¶17-18 | col. 2:10-13 |
| ...the surface expandable to a selected planar triangular shape configured for deployment to engage the walls of a patient's uterine cavity... | The complaint alleges the energy-delivery surface is "expandable to a selected planar triangular shape configured for deployment to engage the walls of a patient's uterine cavity." | ¶17 | col. 8:39-44 |
| ...wherein the frame has flexible outer elements in lateral contact with the compliant surface and flexible inner elements not in said lateral contact... | The complaint alleges, based on a website demonstration, that the frame has "flexible outer elements in lateral contact with the compliant surface and flexible inner elements" not in contact. | ¶19 | col. 19:24-34 |
| ...wherein the inner and outer elements have substantially dissimilar material properties. | The complaint alleges "On information and belief, the inner and outer elements have substantially dissimilar material properties." | ¶19 | col. 19:35-41 |
Identified Points of Contention
- Technical Question: The complaint's allegation that the accused device's frame elements have "substantially dissimilar material properties" is made "on information and belief" (Compl. ¶19). A central evidentiary question will be what proof the plaintiff can obtain and present to demonstrate this alleged factual condition in the accused product. This will likely require technical discovery, product teardowns, and expert analysis.
- Scope Questions: The case will likely require the court to construe the meaning of "substantially dissimilar material properties." The question will be whether this term requires a specific type of material difference (e.g., in composition, thickness, or spring constant, as described in patent embodiments) or if it can be satisfied by any difference that results in the functional outcome of creating a more triangular shape.
V. Key Claim Terms for Construction
- The Term: "substantially dissimilar material properties"
- Context and Importance: This term appears to be the central point of novelty in claim 13 and is critical to the infringement analysis. The outcome of the case may depend heavily on how this term is defined, as the other elements of the claim appear to describe more conventional features of such devices, which the complaint alleges are readily observable in the accused product's marketing materials.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue that the term should be interpreted functionally, pointing to specification language that the goal of the dissimilar materials is to create a "more triangular shape" to "increase the total surface area of the dielectric in contact with tissue" (’208 Patent, col. 19:50-54). Under this view, any material property difference that achieves this functional objective could be considered "substantially dissimilar."
- Evidence for a Narrower Interpretation: A party could argue for a narrower definition based on specific examples in the patent. The specification describes an embodiment where the inner frame elements are made of "NanoFlex® material" and are thicker, while the outer elements are made of "304 SS or 316 SS" and are thinner (’208 Patent, col. 19:41-49). This suggests "dissimilar" could be limited to differences in material composition, precipitation hardenability, spring constant, or plastic deformation range, as explicitly discussed (’208 Patent, col. 19:41-49, col. 20:6-9).
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement to infringe, asserting that Defendants' "marketing, sales, support, and distribution" and associated "Instructions for Use and Controller Operator's Manual" instruct and encourage customers to use the NovaSure ADVANCED system in an infringing manner (Compl. ¶¶17, 26).
- Willful Infringement: The complaint alleges that infringement has been willful. This allegation is based on purported pre-suit knowledge, stating that Defendants "had knowledge of the '208 patent since at least February 8, 2016," which is approximately one year before the accused product's launch (Compl. ¶24).
VII. Analyst’s Conclusion: Key Questions for the Case
The dispute as framed in the complaint appears to center on two pivotal questions for the court:
- A key evidentiary question will be one of material composition: What evidence will Plaintiff produce to support its "information and belief" allegation that the inner and outer frame elements of the accused NovaSure ADVANCED device are, in fact, constructed from materials with "substantially dissimilar" properties?
- A core issue will be one of definitional scope: How will the court construe the claim term "substantially dissimilar material properties"? Will the construction require a specific type of metallurgical or mechanical difference as exemplified in the patent's embodiments, or will a broader, functional definition based on the resulting shape of the device suffice?