DCT

1:20-cv-01786

Barry v. OrthoPediatrics Corp

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-01786, D. Del., 12/30/2020
  • Venue Allegations: Venue is asserted in the District of Delaware on the basis that Defendant is a Delaware corporation and therefore resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s RESPONSE Spine System, a set of surgical instruments, infringes five U.S. patents directed to systems and methods for correcting spinal deformities.
  • Technical Context: The technology relates to orthopedic surgical devices used to correct complex spinal curvatures, such as scoliosis, by simultaneously derotating multiple vertebrae.
  • Key Procedural History: The complaint notes that the two earliest patents-in-suit ('358 and '121) were previously litigated against Medtronic, resulting in a jury verdict of willful infringement that was affirmed on appeal. The same two patents also survived unsuccessful inter partes review (IPR) proceedings initiated by Medtronic. The complaint further alleges that Defendant had notice of some of the patents-in-suit as early as January 2016 via a subpoena in the Medtronic case, and received a direct notice letter regarding other patents-in-suit in August 2017.

Case Timeline

Date Event
2004-12-30 Earliest Priority Date for all Asserted Patents
2010-03-02 Issue Date for U.S. Patent No. 7,670,358
2013-01-29 Issue Date for U.S. Patent No. 8,361,121
2014-01-01 Plaintiff files suit against Medtronic, Inc. (approximate date)
2016-01-25 Defendant allegedly receives subpoena regarding '358 & '121 patents
2016-05-17 Issue Date for U.S. Patent No. 9,339,301
2017-06-06 Issue Date for U.S. Patent No. 9,668,787
2017-06-06 Issue Date for U.S. Patent No. 9,668,788
2017-08-28 Plaintiff allegedly sends notice letter to Defendant
2020-12-30 Complaint Filed

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

U.S. Patent No. 7,670,358 (the ’358 Patent) - "System and Method for Aligning Vertebrae in the Amelioration of Aberrant Spinal Column Deviation Conditions," Issued March 2, 2010

The Invention Explained

  • Problem Addressed: The patent describes conventional methods for correcting severe spinal deformities like scoliosis as inadequate. These prior methods are characterized as focusing on correcting vertebrae one-by-one (seriatim) or achieving only two-dimensional straightening, which limits the degree of correction and risks vertebral fracture from focused forces ('358 Patent, col. 2:42-62).
  • The Patented Solution: The invention proposes a system and method for manipulating an entire segment of the spinal column "substantially as a whole" ('358 Patent, col. 2:63-68). This is achieved using a "pedicle screw cluster derotation tool" that simultaneously engages pedicle screws implanted in multiple vertebrae. By linking the engagement members, a surgeon can apply a manipulative force that is dispersed across the entire vertebral cluster, allowing for a safer and more complete three-dimensional correction (en bloc derotation) ('358 Patent, Abstract; col. 3:46-68).
  • Technical Importance: This approach represented a shift from sequential, single-vertebra adjustments to a holistic, multi-vertebra correction, aiming to achieve a full 3D realignment that was previously considered unattainable ('358 Patent, col. 2:51-57).

Key Claims at a Glance

  • The complaint asserts method claim 4, which depends from independent method claim 1 (Compl. ¶52).
  • Independent Claim 1 requires:
    • Selecting a first set of pedicle screws.
    • Selecting a "first pedicle screw cluster derotation tool" having "handle means" and a group of "pedicle screw engagement members" that are "mechanically linked."
    • Implanting the pedicle screws into a first group of multiple vertebrae.
    • Engaging the engagement members with the heads of the implanted pedicle screws.
    • Applying a manipulative force to the handle means to, "in a single motion simultaneously rotat[e]" the vertebrae.

U.S. Patent No. 8,361,121 (the ’121 Patent) - "System and Method for Aligning Vertebrae in the Amelioration of Aberrant Spinal Column Deviation Conditions," Issued January 29, 2013

The Invention Explained

  • Problem Addressed: The '121 Patent addresses the same technical problem as its parent '358 Patent: the limitations and risks associated with prior art methods for correcting complex, three-dimensional spinal deformities ('121 Patent, col. 2:46-67).
  • The Patented Solution: The patent describes a system for achieving en bloc derotation using two opposing "pedicle screw cluster derotation tools," one on each side of the spinal column, that are connected by a "cross-linking member." This construct allows a surgeon to apply coordinated forces across the spine, simultaneously derotating multiple vertebrae to correct the deformity ('121 Patent, cl. 2). The specification explains this allows for correction in three dimensions, including the "roll axis" ('121 Patent, col. 6:63-65).
  • Technical Importance: The invention refines the en bloc derotation concept by explicitly claiming a bilateral system with a cross-linking member, designed to provide greater control and stability during the complex rotational maneuver.

Key Claims at a Glance

  • The complaint asserts independent system claim 2 (Compl. ¶66).
  • Independent Claim 2 requires:
    • A first set of pedicle screws.
    • A "first pedicle screw cluster derotation tool" with a handle means and a group of "three or more" mechanically linked engagement members.
    • A second set of pedicle screws.
    • A "second pedicle screw cluster derotation tool" with similar features.
    • A "cross-linking member" that links the first and second handle means.

U.S. Patent No. 9,339,301 (the ’301 Patent) - "System and Method for Aligning Vertebrae…," Issued May 17, 2016

  • Technology Synopsis: This patent claims a system for aligning human vertebrae comprising two sets of at least three pedicle screws and two corresponding "pedicle screw cluster derotation tools." The tools each have at least three engagement members interconnected by a linking member, and the two tools are interconnected by a cross-linking member to facilitate simultaneous rotation of the vertebrae (Compl. ¶78; ’301 Patent, cl. 1).
  • Asserted Claims: Independent system claim 1 is asserted (Compl. ¶76).
  • Accused Features: The complaint alleges that the RESPONSE Spine System, when assembled in a three-by-three configuration with a cross-link, infringes this patent (Compl. ¶78).

U.S. Patent No. 9,668,787 (the ’787 Patent)

  • Technology Synopsis: This patent claims a method for applying manipulative force to the spine. The method involves implanting pedicle screws, temporarily engaging them with "elongated levers," linking the levers together so they move in unison, and then moving the linked levers to simultaneously rotate the vertebrae (Compl. ¶88; ’787 Patent, cl. 6).
  • Asserted Claims: Independent method claim 6 is asserted (Compl. ¶86).
  • Accused Features: The complaint alleges that surgeons are induced to infringe when they use the RESPONSE Spine System's levers, link them together, and manipulate the construct to derotate the spine as instructed (Compl. ¶¶88, 91).

U.S. Patent No. 9,668,788 (the ’788 Patent)

  • Technology Synopsis: This patent claims a system for applying a manipulative force, comprising pedicle screws, "elongated levers" to engage the screws, and both axial and transverse linking members to connect the levers. The assembled system permits an operator to move the levers in unison to rotate the pedicle screws about a spinal roll axis (’788 Patent, cl. 1).
  • Asserted Claims: Independent system claim 1 is asserted (Compl. ¶98).
  • Accused Features: The infringement theory mirrors that for the ’787 patent, focusing on the assembly of the RESPONSE Spine System's levers and linking members to form the claimed infringing system (Compl. ¶¶98, 87-92).

III. The Accused Instrumentality

Product Identification

  • The "OrthoPediatrics Products," more specifically identified as the OrthoPediatrics RESPONSE Spine System (Compl. ¶44).

Functionality and Market Context

  • The RESPONSE Spine System is a set of surgical instruments for performing spinal correction procedures, including "versatile rod reduction and coupled derotation options" (Compl. ¶46). The system includes pedicle screws, instruments referred to as "Rod Reducers" and "Rod Reduction Towers" that act as levers, handles for manipulation, a "multi segment rotation pin" to link the handles, and a "comb-shaped cross-connector device" (Compl. ¶¶48, 57). The complaint alleges that Defendant's surgical technique guides and marketing materials instruct surgeons to assemble these components into a construct and then "[d]erotate the spine by manipulating the construct" (Compl. ¶57). An image from a product overview shows instructions for "Coupled Derotation" (Compl. p. 12, image at ¶57). The complaint also alleges the RESPONSE system was designed to compete with and was copied from a product licensed by the Plaintiff, the Biomet Trivium Derotation System (Compl. ¶41). A side-by-side photographic comparison of the two systems is provided to support this allegation (Compl. p. 7, image at ¶41).

IV. Analysis of Infringement Allegations

’358 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
selecting a first pedicle screw cluster derotation tool, said first pedicle screw cluster derotation tool having first handle means and a first group of pedicle screw engagement members which are mechanically linked with said first handle means... The RESPONSE Spine System's "Rod Reducers" or "Rod Reduction Towers" allegedly function as the engagement members, which are linked to handles and connected via a "multi segment rotation pin" to form the derotation tool. ¶¶55, 57 col. 5:1-7
implanting a each pedicle screw in a pedicle region of each of a first group of multiple vertebrae... Surgeons are instructed to implant the RESPONSE pedicle screws into the vertebrae that are to be derotated. A collage of RESPONSE system components, including pedicle screws, is shown in the complaint (Compl. p. 10). ¶54 col. 6:21-25
engaging each pedicle screw engagement member respectively with said head segment of each pedicle screw... The "Rod Reducers" and "Rod Reduction Towers" are allegedly taught to be attached to each implanted pedicle screw. ¶57 col. 6:26-29
applying manipulative force to said first handle means in a manner for simultaneously engaging said first group of pedicle screw engagement members and first set of pedicle screws and thereby in a single motion simultaneously rotating said vertebrae... to achieve an amelioration... Defendant's product literature allegedly instructs surgeons to "[d]erotate the spine by manipulating the construct" as a whole, which applies force through the handles to simultaneously rotate the engaged vertebrae. An instructional graphic for "Coupled Derotation" is provided (Compl. p. 12). ¶¶56, 57, 58 col. 6:30-38

’121 Patent Infringement Allegations

Claim Element (from Independent Claim 2) Alleged Infringing Functionality Complaint Citation Patent Citation
a first pedicle screw cluster derotation tool... having... a first group of three or more pedicle screw engagement members which are mechanically linked... The complaint alleges that surgeons assemble the RESPONSE system's handles and levers/towers to form a derotation tool. An image in the complaint depicts a construct with at least three levers on each side (Compl. p. 8). ¶68 col. 8:3-13
a second pedicle screw cluster derotation tool... having... a second group of three or more pedicle screw engagement members... The complaint alleges that surgeons are instructed to use two such tools, one on each side of the spine, to perform the derotation. ¶68 col. 8:14-19
a cross-linking member that links the first handle means to the second handle means. The complaint alleges the RESPONSE system includes a "comb-shaped cross-connector device" that connects the handles transversely across the spine. An image provided in the complaint shows the system assembled with four rods and a cross-connector (Compl. p. 9). ¶¶48, 68 col. 8:20-22

Identified Points of Contention:

  • Scope Questions: A primary question may be whether the accused RESPONSE system, which is assembled from individual components like towers, handles, and pins during surgery, constitutes a "pedicle screw cluster derotation tool" with "mechanically linked" members as contemplated by the patents. The defense may argue the claims require a more integrated, pre-linked tool, as depicted in certain patent figures, rather than a modular construct.
  • Technical Questions: The infringement analysis will depend on the specific function of the "multi segment rotation pin" and the "comb-shaped cross-connector device" in the accused system. A key question for the court will be whether these components function to "mechanically link" the levers and handles in the manner required by the claims, enabling the "single motion" rotation of the entire construct.

V. Key Claim Terms for Construction

  • The Term: "pedicle screw cluster derotation tool"

    • Context and Importance: This term is the heart of the invention recited in the '358 and '121 patents. Its construction is critical because the infringement case depends on whether the combination of the accused system's handles, levers/towers, and linking pins meets this definition. Practitioners may focus on whether "tool" implies a single, integrated apparatus or can encompass a collection of components assembled in situ to perform the claimed function.
    • Intrinsic Evidence for a Broader Interpretation: The specification describes the object of the tool as facilitating the "simultaneous application of manipulative forces to multiple pedicle screws" ('358 Patent, col. 5:25-28). This functional language could support an interpretation that covers any assembly that achieves this result.
    • Intrinsic Evidence for a Narrower Interpretation: The preferred embodiment describes the tool as being "configured from a grouping of pedicle screw wrenches 32, joined together by pedicle screw wrench linking members 42 to act in unison" ('358 Patent, col. 5:1-5). This language, along with Figure 1, could support a narrower construction requiring a more permanent or pre-assembled linkage of wrench-like structures.

  • The Term: "mechanically linked"

    • Context and Importance: This term defines the required relationship between the engagement members (and handles) of the derotation tool. The infringement allegation hinges on whether the accused system's use of a "multi segment rotation pin" passing through "slots in the handles" (Compl. ¶57) constitutes a "mechanical link."
    • Intrinsic Evidence for a Broader Interpretation: The term itself is general. The specification does not appear to provide an explicit definition, which may support giving the term its plain and ordinary meaning, covering any physical connection that constrains the parts to move together.
    • Intrinsic Evidence for a Narrower Interpretation: The patent figures depict the linking members (40, 42) as rigid components that directly connect the bodies of the wrenches or tools ('358 Patent, Fig. 1). A defendant may argue this implies a more rigid and direct connection than a pin-in-slot mechanism, which could allow for some relative movement.

VI. Other Allegations

  • Indirect Infringement: The complaint exclusively pleads induced infringement for all counts. It alleges Defendant provides extensive instruction, education, and encouragement to surgeons on how to assemble and use the RESPONSE Spine System in a manner that directly infringes the method claims and results in the assembly of the infringing systems (Compl. ¶¶53, 56-57, 67, 77, 87, 99). The basis for these allegations includes surgical technique guides, product overviews, and other instructional materials (Compl. ¶¶54, 57).
  • Willful Infringement: Willfulness is alleged for all five counts. The complaint asserts that Defendant had pre-suit knowledge of the patents and the alleged infringement based on several grounds: (1) monitoring the competitive landscape, including Plaintiff's licensed product; (2) awareness of the prior, highly-publicized litigation against Medtronic involving the '358 and '121 patents; (3) direct notice of the '358 and '121 patents via a subpoena served on January 25, 2016; and (4) a direct notice letter regarding the '301, '787, and '788 patents sent around August 28, 2017 (Compl. ¶¶32-40). The complaint also makes a specific allegation of copying, supported by a side-by-side visual comparison of the accused product and the licensed Biomet product (Compl. ¶41).

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

  • A central issue will be one of structural and functional equivalence: Does the accused RESPONSE system—which is assembled during surgery from separate towers, handles, and connecting pins—fall within the scope of the claimed "pedicle screw cluster derotation tool" with "mechanically linked" members, or do the patents require a more integrated, pre-linked apparatus? The resolution will likely depend on claim construction and a detailed factual analysis of how the accused system operates.
  • A second key question will concern willfulness and damages: Given the extensive allegations of pre-suit knowledge from prior litigation, direct notice, and alleged copying, a significant focus of the case will be on the defendant’s state of mind. Should infringement be found, the court will need to determine if Defendant's conduct was egregious enough to warrant enhanced damages under 35 U.S.C. § 284.
  • An underlying strategic question will be the impact of the prior art and litigation history: With the two earliest patents having survived both a jury trial and IPRs, the Defendant may face a significant challenge in raising invalidity defenses against them. This history could shift the case's focus heavily toward non-infringement arguments and the scope of the claims for all five patents in the family.