DCT

2:10-cv-00108

Gebauer Medizintechnik GmbH v. Krumeich

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Gebauer Medizintechnik GmbH v. Jorg H. Krumeich, 2:10-cv-00108, W.D. Wash., 01/18/2010
  • Venue Allegations: Venue is based on 35 U.S.C. § 293, which provides for jurisdiction and venue over foreign-domiciled patentees in the U.S. District Court for the District of Columbia, and the complaint asserts that venue is proper in the Western District of Washington because Defendants are subject to personal jurisdiction there.
  • Core Dispute: Plaintiffs seek a declaratory judgment that Defendant Krumeich's patent for an ophthalmic microkeratome is invalid for incorrect inventorship and anticipation by prior sale, and is unenforceable due to inequitable conduct before the USPTO.
  • Technical Context: The lawsuit concerns microkeratomes, which are precision surgical instruments used to create a thin, hinged flap in the cornea as a preparatory step for vision correction procedures such as LASIK.
  • Key Procedural History: The complaint outlines a protracted business and development history between Plaintiff Gebauer and Defendant Krumeich. Plaintiffs allege that they, along with other non-parties, invented key technologies—including a flexible drive mechanism and a detachable cutting head—which Defendant Krumeich then improperly patented in his own name. The complaint also references a prior license agreement between the parties and related litigation in Germany.

Case Timeline

Date Event
1986-01-01 Business relationship begins between Gebauer and Krumeich/Eyetech.
1997-01-14 Letter from Krumeich to Gebauer discussing development roles.
1997-01-31 Krumeich/Eyetech approach Gebauer to develop a motor-driven microkeratome.
1997-04-25 Priority Date: European patent application ('949.7) filed.
1997-05-29 Gebauer alleges constructive reduction to practice of the "steel band" drive mechanism.
1998-02-20 FDA 510(k) premarket notification submitted for the "Lasitome" microkeratome.
1998-04-27 U.S. application 09/067,146 (parent to the patent-in-suit) filed.
1998-07-16 Critical Date for on-sale bar for the '293 patent's CIP application.
1999-07-16 U.S. application 09/354,597 (which issued as the '293 patent) filed as a CIP.
2000-06-06 U.S. Patent 6,071,293 issues.
2002-10-01 A key customer (Summit's successor) ceases selling the Gebauer apparatus.
2003-01-01 Gebauer and Krumeich enter into a license agreement for the patent-in-suit.
2004-07-28 European counterpart patent '949.7 is granted.
2010-01-18 Complaint for Declaratory Judgment filed.

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

  • *U.S. Patent No. 6,071,293, "AUTOMATIC MICROKERATOME", issued June 6, 2000*

The Invention Explained

  • Problem Addressed: The patent describes prior art microkeratomes as having a large, integrated structure combining the suction ring (which holds the eye) and the drive mechanism. This unitary design is described as "difficult to handle," making it challenging for a surgeon to precisely position the device on a patient's cornea before beginning the cut (’293 Patent, col. 2:1-7).
  • The Patented Solution: The invention is a modular ophthalmic apparatus where the corneal suction ring is a separate component from the microkeratome's cutting head and actuator. This allows a surgeon to first position and secure the suction ring on the eye, and only then attach the cutting head assembly to perform the automated cut (’293 Patent, Abstract; col. 2:49-54). The patent also discloses specific improvements added in a continuation-in-part application, including a "flat, flexible steel band" as a "shift member" to drive the device and a detachable cutting head with a transparent applanation window to improve the surgeon's view (’293 Patent, col. 3:1-17).
  • Technical Importance: This modular approach sought to enhance the precision, control, and ease of use for surgeons performing corneal flap creation, a critical phase of LASIK surgery (’293 Patent, col. 2:7-11).

Key Claims at a Glance

  • The complaint seeks a declaration that the entire patent is invalid and unenforceable. The allegations of invalidity due to an on-sale bar are directed at new matter introduced in the CIP, which corresponds to dependent claims 6, 7, and 8 (Compl. ¶¶24, 33). The foundational independent claim is Claim 1.
  • Independent Claim 1, Essential Elements:
    • A corneal suction ring with microkeratome guide surfaces.
    • A microkeratome for executing a transverse cut, which includes a cutting head, a motor housing, and a motor for oscillating a cutting blade.
    • The cutting head has guide surfaces that are insertable for "mating engagement" with the guide surfaces on the suction ring.
    • An electronically controllable actuator to control relative movement between the suction ring and the cutting head.
    • The actuator includes a housing and a stepping motor to drive a "shift member."
    • The actuator housing is "rigidly connected to or combined with" the microkeratome's motor housing, and the shift member is "releasably connected" to the suction ring.

III. The Accused Instrumentality

Product Identification

  • The complaint concerns the microkeratome apparatus designed, manufactured, and sold by Plaintiff Gebauer (Compl. ¶¶7, 18-19). As this is a declaratory judgment action, the Plaintiff's product is the instrumentality at issue.

Functionality and Market Context

  • The complaint alleges that Gebauer developed the subject microkeratome over several years, initially at the request of Defendant Krumeich (Compl. ¶11). The device is described as evolving from an earlier model that required manual advancement to a fully motor-driven apparatus (Compl. ¶¶10-11).
  • The complaint alleges that key features corresponding to the '293 patent claims were invented not by the named inventor, Krumeich, but by Gebauer's own personnel (Detlev Paul Gebauer) and third parties (Mr. Knuelle). These allegedly include the "steering rod" drive transmission, its replacement with a flexible "steel band" (also referred to as a "shift member"), a redesigned detachable head with a large applanation window, and the use of a stepping motor (Compl. ¶¶13, 16, 18, 23).
  • The complaint includes a diagram from a user manual for the "Mikrokeratom Typ VAR-III," which depicts the main components including the cutting head assembly (12), the drive unit (11), and the control console (Compl. Ex. F, p. 54). This diagram provides an overview of the system's architecture.

IV. Analysis of Infringement Allegations

As a declaratory judgment action, the complaint asserts non-infringement. The analysis below outlines the potential infringement claims by Defendant Krumeich that give rise to the controversy, based on the complaint's description of the Plaintiff's technology. The core of the complaint is that even if the product reads on the claims, the patent is invalid and/or unenforceable.

  • '293 Patent Infringement Allegations
Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a corneal suction ring comprising a cornea engaging surface on one side thereof and microkeratome guide surfaces at the opposite side thereof... The Gebauer device utilizes a suction ring to hold the eye and guide the cutting head, a system which the complaint alleges was part of the initial development project (Compl. ¶11). ¶11, ¶18 col. 4:51-57
a microkeratome to execute at least a partial transverse cut... said microkeratome comprising a cutting head, a motor housing and a motor for oscillating movement of a cutting blade guided in said cutting head... The complaint describes Gebauer's development of a "redesigned head for the microkeratome apparatus" with a blade slot and means to be "clicked" on to the motor flange (Compl. ¶18). An engineering drawing allegedly shows this redesigned head (Compl. Ex. G, p. 68). ¶18 col. 4:58-61
whereby said cutting head is provided with guide surfaces insertable for mating engagement into the guide surfaces of said suction ring... The complaint alleges that Gebauer developed the motor-driven solution, which required the cutting head to engage with the suction ring for automated advancement (Compl. ¶11). ¶11, ¶18 col. 4:62-65
and an electronically controllable actuator... comprising an actuator housing and a stepping motor within this housing to drive a shift member... whereby the actuator housing is rigidly connected to... the motor housing of said microkeratome and said shift member is releasably connected to said suction ring. The complaint alleges that the concepts for the drive mechanism—first a stiff "steering rod" and later a flexible "steel band" shift member—were conceived and reduced to practice by Gebauer personnel (Compl. ¶¶13, 16). The complaint includes what it purports to be early design drawings of both the "steering rod" (Compl. Ex. B) and the "steel band" (Compl. Ex. D). ¶13, ¶16 col. 4:66-col. 5:1
  • Identified Points of Contention:
    • Inventorship and Ownership: The central dispute is not over claim scope but over the patent's validity. The complaint raises the fundamental question of who actually invented the claimed subject matter. Does the evidence, including the alleged early design drawings (Compl. Ex. B, Ex. D), support the plaintiff's claim that its own personnel and associates, not the named inventor, conceived of the core technical advancements?
    • On-Sale Bar: The complaint raises a question of statutory invalidity under 35 U.S.C. § 102. Did the commercial sale or offer for sale of the Gebauer microkeratome in the U.S. through EVI, which the complaint alleges occurred before July 16, 1998, place the new subject matter added in the CIP application (e.g., the flexible steel band) in the public domain more than one year before the application's filing date (Compl. ¶¶19, 24)?

V. Key Claim Terms for Construction

While the case centers on invalidity and unenforceability, the construction of certain terms may still be relevant to determining what, precisely, was allegedly invented by whom and when.

  • The Term: "shift member"

  • Context and Importance: This term is critical because the complaint alleges the original "stiff 'steering rod'" was replaced by an improved "flexible 'steel band'," and that this latter feature—explicitly added to the patent via the CIP application and recited in claim 6—was invented by a Gebauer employee (Compl. ¶¶16, 23). The court's interpretation of "shift member" will be relevant to the arguments about what subject matter is covered by the parent application versus the CIP, which is central to the on-sale bar analysis.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The Summary of the Invention broadly describes the term's function as forming a "releasably locked interconnection between the output of the stepping motor and a corneal suction ring" (’293 Patent, col. 2:15-19).
    • Evidence for a Narrower Interpretation: The detailed description explicitly introduces the "flat flexible steel band" as an "alternative embodiment" (’293 Patent, col. 3:1-4). This distinction may suggest the original term was not envisioned to cover this flexible embodiment, which was added as new matter in the CIP.

  • The Term: "cutting head"

  • Context and Importance: The complaint alleges that a "redesigned head" that was "detachable from the motor housing" was conceived by Gebauer (Compl. ¶18). Claim 7 requires the "cutting head" to be "detachably mounted." Practitioners may focus on this term because the definition of what constitutes the "cutting head" and what it means to be "detachably mounted" is central to the inventorship dispute over this feature.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claims describe the cutting head functionally as the component containing the oscillating blade and having guide surfaces (’293 Patent, col. 4:58-65).
    • Evidence for a Narrower Interpretation: The specification and Figure 4 distinguish the "cutting head" (40) from the "housing" (42) of the motor (36) (’293 Patent, col. 3:66-col. 4:3). The specific manner of attachment shown in the figures could be argued to limit the scope of "detachably mounted."

VI. Allegations of Invalidity and Unenforceability

  • Incorrect Inventorship: The complaint's primary cause of action is based on the allegation that Defendant Krumeich is not the sole and proper inventor. It specifically alleges that the use of a stepping motor was proposed by a Mr. Knuelle and that the key drive transmissions (both the "steering rod" and the flexible "steel band") and a redesigned, detachable cutting head were conceived and reduced to practice by Detlev Paul Gebauer (Compl. ¶¶13, 16, 18, 20, 38).
  • Inequitable Conduct: Plaintiff alleges that the '293 patent is unenforceable due to inequitable conduct. The bases for this allegation are that Defendant Krumeich (a) intentionally failed to identify the "real inventive entity" to the USPTO and (b) withheld material prior art during prosecution, thereby breaching the duty of candor and good faith (Compl. ¶38).
  • Invalidity under § 102 (On-Sale Bar): The complaint alleges that claims covering the new matter added in the 1999 CIP application—specifically the flexible shift member and detachable head—are invalid. It asserts that a microkeratome embodying these features was "offered for sale, sold and/or used in the United States" through an entity named EVI more than one year before the CIP's July 16, 1999 filing date (Compl. ¶¶24, 33). The complaint points to an FDA 510(k) submission from February 1998 as evidence of this activity (Compl. ¶19; Ex. H).

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

  • A central factual question will be one of inventorship: What evidence, such as lab notebooks, dated drawings, and witness testimony, will be presented to establish who conceived of the key claimed elements, particularly the flexible "steel band" shift member and the detachable cutting head that were added in the continuation-in-part application?
  • A dispositive issue may be the on-sale bar: Can the Plaintiff prove by clear and convincing evidence that a product embodying the novel features claimed in the CIP was the subject of a commercial offer for sale in the United States before the critical date of July 16, 1998, which would invalidate those claims?
  • A key legal and equitable question will be one of inequitable conduct: If incorrect inventorship or failure to cite material art is established, can Plaintiff further prove that the omissions or misrepresentations were made with the specific intent to deceive the USPTO, rendering the entire patent unenforceable?