New Amsterdam LLC v. Osteopore Intl Pte Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: New Amsterdam, LLC (Delaware)
  • Defendant: Osteopore International Pte Ltd. (Singapore)
  • Plaintiff’s Counsel: Garteiser Honea, PLLC
• Case Identification: 2:23-cv-00034, E.D. Tex., 01/27/2023
• Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Texas because Defendant is a foreign entity that maintains a regular and established business presence in the United States, including through a distribution and sales contract for the accused products in Texas.
• Core Dispute: Plaintiff alleges that Defendant’s bioresorbable surgical strip fasteners, marketed as Osteostrip™, infringe a patent related to devices for reattaching a skull flap to the cranium following a craniotomy.
• Technical Context: The technology concerns medical implants used in neurosurgery to provide a stable, cosmetically acceptable, and bone-growth-promoting closure for openings in the skull created during surgical procedures.
• Key Procedural History: The complaint details the patent's chain of title, from the inventors to BioDynamics, LLC in 2006, then to First Commerce Bank in June 2021, and finally to Plaintiff New Amsterdam, LLC in September 2021.

Case Timeline

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

U.S. Patent No. 7,833,253 - "Craniotomy Closures and Plugs," issued November 16, 2010

The Invention Explained

• Problem Addressed: The patent’s background section describes the drawbacks of then-current methods for reattaching a skull flap after a craniotomy (Compl. ¶18). Methods using sutures or wires could result in a cosmetically undesirable "depressed area," while titanium plates were described as relatively expensive, did not ensure bone fusion, and left permanent foreign bodies in the patient (’253 Patent, col. 2:9-28).
• The Patented Solution: The invention proposes a flexible "strip fastener" that can be shaped to follow the perimeter of the skull opening, restoring the skull's original contour (Compl. ¶19; ’253 Patent, col. 2:53-60). The fastener includes tabs that are disposed over the skull and the re-positioned skull flap, bridging the gap between them. Embodiments describe a multi-part assembly where brackets holding the tabs are affixed to a flexible strip, which is then secured to the bone (’253 Patent, Fig. 3; col. 10:1-14).
• Technical Importance: The technology aimed to provide a craniotomy closure method that was more cosmetically acceptable than sutures, less expensive than titanium plates, and was designed to enhance bone growth for healing across the surgical cut (’253 Patent, col. 2:45-50).

Key Claims at a Glance

• The complaint asserts independent claims 1 and 12 (Compl. ¶25, ¶31).
• Independent Claim 1 requires, in part:
  • A flexible strip with sufficient flexibility to be formed lengthwise around the perimeter of a skull flap.
  • A plurality of tabs spaced along the strip's length.
  • At least one tab extending in a direction opposite at least one other tab.
  • The tabs are "affixed to the flexible strip by way of brackets."
  • An "attachment means selected from the group consisting of screws, tacks and staples" for securing the device.
• Independent Claim 12 is similar to Claim 1, but instead of requiring "screws, tacks and staples," it requires "adhesive means for securing the tabs to either the skull flap or the skull."
• The complaint reserves the right to assert additional claims (Compl. ¶25).

III. The Accused Instrumentality

Product Identification

• The complaint identifies the "Osteoplug in strip craniotomy format" as an Accused Instrumentality (Compl. ¶24). Product marketing materials also refer to the product as Osteostrip™ (Compl. ¶27).

Functionality and Market Context

• The accused products are described as strip fasteners intended for use in the "repair of bone void resulting from trauma or surgical procedure" (Compl. ¶27). The complaint alleges these products are used for reattaching a skull flap removed during brain surgery (Compl. ¶23). A product description included in the complaint states the devices are "3D printed with patented interconnected porous microarchitecture to enable natural tissue regeneration" (Compl. ¶27, p. 10). A visual from an instructional video shows the accused strip fastener being placed over a craniotomy cut to bridge the skull and the skull flap. This screenshot from the "Osteo Video" shows a strip fastener being secured with a screw-like implement to bridge a skull and a detached skull flap (Compl. ¶27).

IV. Analysis of Infringement Allegations

'253 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: The central dispute may turn on the construction of the claim phrase "tabs are affixed to the flexible strip by way of brackets." The patent figures and description depict a multi-component assembly of a strip and separate brackets (’253 Patent, Fig. 3). The accused product, as shown in a product image, appears to be a single, unitary 3D-printed component (Compl. ¶28, p. 11). This raises the question of whether a unitary, integrally formed structure can be construed as meeting a claim limitation that recites a multi-part assembly.
  • Technical Questions: The complaint does not provide evidence detailing how the accused 3D-printed structure is manufactured or functions at a component level. A key technical question for the court will be whether the integrated tab-like features of the accused product can be considered distinct "tabs" that are "affixed" to a "strip" via structures that function as "brackets," or if the product is a fundamentally different, non-infringing design.

V. Key Claim Terms for Construction

• The Term: "tabs are affixed to the flexible strip by way of brackets" (Claim 1)
• Context and Importance: This term appears to be the primary distinction between the claimed invention's described embodiments and the accused product's apparent structure. The outcome of the case could depend on whether this term is construed to require separate, physically distinct components that are joined together, or if it can read on a single, integrally formed piece where different portions serve the functions of a strip, tabs, and brackets. Practitioners may focus on this term because the accused product's unitary 3D-printed nature creates a direct challenge to this element of the claim.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party could argue that the essence of the invention is the final geometry and function, not the method of assembly. The patent's summary focuses on the result: a "strip fastener... provided with tabs or flanges which are disposed over and adjacent to the skull flap and the skull" (’253 Patent, col. 2:64-67), suggesting that "by way of brackets" could be interpreted as a functional description of the connecting structures rather than a strict manufacturing requirement.
  • Evidence for a Narrower Interpretation: A party could point to the patent’s explicit disclosure and figures, which consistently show a multi-component construction. For example, Figure 3 shows distinct brackets (32) and a strip (31), and the specification states, "Brackets 32 may be adhered to the strip fastener 30 by adhesives, spot welding or other means" (’253 Patent, col. 10:1-3). This language explicitly describes the joining of separate parts, which could support a narrower construction limited to non-unitary assemblies.

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement of infringement based on Defendant's creation and distribution of materials such as an instructional "Osteo Video," brochures, and manuals that allegedly instruct surgeons on how to use the accused products in an infringing manner (Compl. ¶32). It also alleges contributory infringement, stating the accused products are not staple articles of commerce and are especially adapted for infringing use (Compl. ¶33).
• Willful Infringement: The complaint alleges that Defendant has been on actual notice of the ’253 Patent since the date it received service of the complaint, and that any subsequent infringement is therefore willful (Compl. ¶34).

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

The resolution of this dispute will likely depend on the court’s determination of a few central issues:

• A core issue will be one of claim construction and structural scope: Can the claim phrase "tabs are affixed to the flexible strip by way of brackets," which textually suggests a multi-component assembly, be construed to read on the accused product's apparently unitary, 3D-printed structure?
• A key evidentiary question will be one of component identity: Can the plaintiff provide sufficient evidence to persuade the court that, despite its unitary appearance, the accused product contains distinct structural portions that function as and meet the definitions of a "strip," "tabs," and "brackets" as separate limitations within the claim?