DCT

1:17-cv-11039

DR Jennifer White v. Boston Scientific Corp

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-11039, D. Mass., 06/06/2017
  • Venue Allegations: Venue is alleged to be proper in the District of Massachusetts because Defendant Boston Scientific Corporation has its principal place of business there, and the predecessor in interest (Sadra, Inc.) met with the Plaintiff in Massachusetts to discuss the technology at issue.
  • Core Dispute: Plaintiff seeks correction of inventorship under 35 U.S.C. § 256, alleging she is an uncredited co-inventor of Defendants' patent and related patent application for a transcatheter heart valve, having contributed key inventive concepts.
  • Technical Context: The technology concerns minimally invasive devices and methods for replacing a diseased heart valve, specifically a transcatheter heart valve (THV) system designed to improve sealing and anchoring.
  • Key Procedural History: The complaint notes that the patent-in-suit is the subject of a separate infringement lawsuit brought by Boston Scientific against Edwards Lifesciences. An Inter Partes Review (IPR) was subsequently filed against U.S. Patent No. 8,992,608. The IPR resulted in the cancellation of claims 1-4 of the patent, which are among the claims for which Plaintiff asserts co-inventorship.

Case Timeline

Date Event
2003-08-01 Dr. White first meets with Sadra founder to discuss THV design.
2003-10-01 Dr. White attends brainstorming meetings and allegedly discloses key concepts.
2004-06-16 Earliest priority date for '608 Patent.
2009-06-26 Application for '608 Patent filed.
2015-03-31 U.S. Patent No. 8,992,608 issues.
2015-10-02 '462 patent application filed.
2016-10-12 IPR against '608 Patent filed (No. IPR2017-00060).
2017-04-24 Notice of Allowance for '462 patent application issues.
2017-06-06 Complaint for correction of inventorship filed.
2021-02-09 IPR Certificate issues, cancelling claims 1-4 of the '608 Patent.

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,992,608 - “Everting Heart Valve,” issued March 31, 2015

The Invention Explained

  • Problem Addressed: The patent describes drawbacks of prior art endovascular heart valve replacement systems, including a lack of sufficient radial strength to anchor the device, poor deployment accuracy, and the inability to visualize the new valve's function before final, irreversible deployment (U.S. Patent No. 8,992,608, col. 2:11-34). These issues can lead to improper sealing (paravalvular leaks), device migration, or obstruction of coronary arteries (U.S. Patent No. 8,992,608, col. 2:1-4).
  • The Patented Solution: The invention is a heart valve replacement system comprising an expandable anchor and a separate replacement valve. The system is designed to be repositionable and even retrievable after initial expansion but before being permanently locked in place (U.S. Patent No. 8,992,608, col. 6:3-9). A key feature is a "fabric seal" that is initially wrapped over the anchor and, upon deployment, bunches up to form flaps or "pockets" that use blood backflow pressure to create a better seal against the native tissue, preventing leaks (U.S. Patent No. 8,992,608, col. 14:24-34; Fig. 32-34). The anchor can be actively "foreshortened" to increase its diameter and radial strength after placement, enhancing stability (U.S. Patent No. 8,992,608, col. 5:60-65).
  • Technical Importance: This approach aims to provide surgeons with more control and precision during minimally invasive valve replacement, addressing critical failure modes like leakage and migration that limited earlier-generation devices (U.S. Patent No. 8,992,608, col. 2:20-34).

Key Claims at a Glance

  • The complaint asserts co-inventorship of claims 1 through 9 (Compl. ¶37). Independent claim 1 is central.
  • Essential elements of independent claim 1 include:
    • An expandable anchor with a collapsed delivery configuration and an expanded configuration.
    • A replacement valve commissure support element attached to the expandable anchor.
    • A commissure portion of a replacement valve leaflet attached to the support element.
    • A fabric seal at least partially disposed around an exterior portion of the expandable anchor.
    • The fabric seal has an undeployed state where it extends from the distal end of the valve and back proximally over the anchor.
    • The fabric seal has a deployed state where it comprises flaps that extend into spaces formed by native valve leaflets.
    • The fabric seal is adapted to prevent blood from flowing between the seal and heart tissue.
  • The complaint reserves the right to assert co-inventorship of other claims, including those in the related '462 application (Compl. ¶¶ 37, 46).

U.S. Patent Application No. 14/873,462 - “Everting Heart Valve”

  • Identification: U.S. Patent Application No. 14/873,462, titled “Everting Heart Valve” (the “’462 patent application”) (Compl. ¶9).
  • Technology Synopsis: The application is a continuation related to the '608 patent and claims a medical device intended to solve problems associated with paravalvular leakage (Compl. ¶33). It describes a "sealing element between the replacement valve and a patient's native valve" (Compl. ¶33, Ex. D, at page 2).
  • Asserted Claims: Plaintiff alleges she is a co-inventor of allowed claims 2 through 10 (Compl. ¶46).
  • Accused Features: The complaint alleges that Dr. White's contribution of the "sealing element" concept is a significant part of the claimed inventions in the '462 application (Compl. ¶47).

III. The Accused Instrumentality

No probative visual evidence provided in complaint.

This action does not concern an infringing product. The dispute centers on the inventorship of U.S. Patent No. 8,992,608 and the related '462 patent application, which are owned by or licensed to the Defendants (Compl. ¶¶ 6-7). The core allegation is that these patent instruments improperly omit Dr. White as a co-inventor (Compl. ¶¶ 31, 35).

The subject patent discloses a transcatheter heart valve (THV) system designed for endovascular replacement of a patient's heart valve (U.S. Patent No. 8,992,608, Abstract). The system includes an expandable anchor and a replacement valve with a fabric seal. The commercial importance of the patent is highlighted by the complaint's reference to a separate patent infringement lawsuit where Defendants have accused the Edwards Lifesciences Sapien 3 Transcatheter Heart Valve of infringing the '608 patent (Compl. ¶8). Plaintiff alleges that her omission as an inventor has damaged her by preventing her from benefiting from ownership rights, such as licensing the patent (Compl. ¶43).

IV. Analysis of Inventorship Allegations

The complaint does not allege product infringement but instead alleges that Plaintiff contributed to the conception of the claimed invention. The following table maps the elements of the patent's claims to the specific inventive concepts Plaintiff alleges she disclosed to Defendants' predecessor, Sadra, Inc.

'608 Patent Inventorship Allegations

Claim Element (from Independent Claim 1 and dependent Claim 2) Plaintiff's Alleged Contribution Complaint Citation Patent Citation
a fabric seal at least partially disposed around an exterior portion of the expandable anchor ... wherein in the deployed state the fabric seal comprises flaps that extend into spaces formed by native valve leaflets Plaintiff "disclosed and taught the Sadra group ... about using backflow blood to help create a seal, including 'pockets' to stop paravalvular leaks." ¶23 col. 21:35-43
The system of claim 1, wherein, in the deployed state, the fabric seal defines a plurality of pockets. Plaintiff alleges that before her disclosures, the named inventors "did not possess the concept of using backflow blood to help create a seal, or 'pockets' to stop paravalvular leak." ¶24 col. 22:42-44
a replacement valve commissure support element attached to the expandable anchor Plaintiff "disclosed and taught the Sadra group ... about using a 'commissure support element' attached to an expandable anchor." ¶25 col. 22:25-27
a commissure portion of a replacement valve leaflet attached to the commissure support element Plaintiff alleges she spent a day with a named inventor "designing development prototypes of new THVs with improved sealing mechanisms including her contributions of ... a 'commissure support element' attached to an expandable anchor." ¶27 col. 22:28-30

Identified Points of Contention

  • Contribution vs. Conception: A central question for the court will be whether Dr. White’s alleged contributions of "pockets" and a "commissure support element" rise to the level of contributing to the "conception" of the invention as defined by law. The court will need to determine if she contributed to "the formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice."
  • Corroboration: To succeed, a claim of co-inventorship requires corroborating evidence beyond the claimant's own testimony. A key factual question will be what evidence (e.g., lab notebooks, emails, prototypes, or witness testimony from the 2003 meetings) can be produced to support the allegations that Dr. White disclosed these specific concepts to the named inventors (Compl. ¶¶ 23-27).
  • Significance of Contribution: The court will have to measure Dr. White's alleged contributions "against the full scope of the inventions" (Compl. ¶38). This raises the question of whether her ideas were merely explanations of well-known concepts or were instead a significant contribution to the novel features of the claimed combination.

V. Key Claim Terms for Construction

The construction of terms will be critical to determining the scope of the invention and, therefore, the significance of Dr. White's alleged contributions.

The Term: "fabric seal"

  • Context and Importance: This term is central to the dispute, as Dr. White claims she conceived of the concept of using "pockets" to create a seal, a feature the patent attributes to the "fabric seal" (Compl. ¶23; U.S. Patent No. 8,992,608, cl. 2). The scope of this term will be pivotal in assessing whether her contribution was to a key element of the claimed invention. Practitioners may focus on this term because its definition links directly to the primary allegation of uncredited invention.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the seal in functional terms, stating it "bunches up to create fabric flaps and pockets that extend into spaces formed by the native valve leaflets" (U.S. Patent No. 8,992,608, col. 14:25-29), suggesting any structure that performs this function could be covered.
    • Evidence for a Narrower Interpretation: The specification also provides a specific embodiment where the "fabric seal 380 extends from the distal end of valve 20 and back proximally over anchor 30 during delivery" (U.S. Patent No. 8,992,608, col. 14:24-27; Fig. 32). Defendants may argue the invention is limited to this specific structural arrangement, potentially diminishing the role of a more general "pockets" concept.

The Term: "commissure support element"

  • Context and Importance: This is the second key concept Dr. White claims to have contributed (Compl. ¶25). Its definition is important for establishing whether her idea corresponds to what is actually claimed.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Claim 1 recites the element broadly as a "support element attached to the expandable anchor." This general language could encompass any structure that supports the valve commissures.
    • Evidence for a Narrower Interpretation: The detailed description consistently illustrates this element as physical "posts 38a, 38b and 38c" to which the valve leaflets are coupled (U.S. Patent No. 8,992,608, col. 5:36-40; Fig. 1A). An argument could be made that the invention is limited to this post-like structure, requiring Dr. White to prove she conceived of that specific implementation.

VI. Other Allegations

  • Conversion: The complaint includes a state law claim for conversion under California law (Count III). It alleges that Defendants, through their predecessor Sadra, "improperly and wrongfully exercised dominion" over Dr. White's intellectual property by using her disclosed ideas to obtain the '608 patent and file the '462 application without her authorization or credit (Compl. ¶55).

VII. Analyst’s Conclusion: Key Questions for the Case

The resolution of this inventorship dispute will likely depend on the answers to two central questions for the court:

  • A core legal and factual question will be one of inventive contribution: Does the evidence show that Dr. White’s alleged disclosures of "pockets" and a "commissure support element" constituted a significant contribution to the conception of the invention as recited in the patent's claims, or were they merely the presentation of abstract ideas or well-known principles?
  • A key evidentiary question will be one of corroboration: Under the high standard required to correct inventorship of an issued patent, what tangible, non-testimonial evidence can Plaintiff produce from the nearly 14-year period between the alleged disclosures and the filing of the complaint to independently corroborate her claim of having conceived and communicated these specific inventive features to the named inventors?