DCT

8:14-cv-00087

Applied Medical Resources Corp v. Covidien LP

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Applied Medical Resources Corporation v. Covidien LP, 8:14-cv-00087, C.D. Cal., 01/17/2014
  • Venue Allegations: Plaintiff alleges venue is proper because it resides in the district and has been injured there, or alternatively, because Defendants reside outside the district and committed the majority of their infringing acts outside the district.
  • Core Dispute: Plaintiff alleges that Defendant’s SILS Port surgical access devices infringe a patent related to a surgical access apparatus and method.
  • Technical Context: The technology concerns surgical access ports used in minimally invasive (laparoscopic) procedures to provide a sealed pathway for instruments into a body cavity, such as a gas-pressurized abdomen.
  • Key Procedural History: The complaint does not mention any prior litigation, licensing history, or other significant procedural events related to the patent-in-suit.

Case Timeline

Date Event
2000-10-19 U.S. Patent No. 8,496,581 Priority Date
2013-07-30 U.S. Patent No. 8,496,581 Issue Date
2014-01-17 Complaint Filing Date

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

U.S. Patent No. 8,496,581 - SURGICAL ACCESS APPARATUS AND METHOD

  • Patent Identification: U.S. Patent No. 8496581, “SURGICAL ACCESS APPARATUS AND METHOD,” issued July 30, 2013.

The Invention Explained

  • Problem Addressed: The patent describes that prior art surgical access devices, such as trocars, relied on complex, multi-part seal structures that could only accommodate a narrow range of instrument sizes. This made them cumbersome and often required multiple different devices for a single surgery, particularly for hand-assisted procedures. (’581 Patent, col. 1:46-67).
  • The Patented Solution: The invention is a surgical access port, preferably made from a very soft, elastic gel-like material ("ultragel"), that is "monolithically formed" into a single piece with proximal and distal flanges. (’581 Patent, col. 2:13-20; col. 6:7-9). This simplified, single-valve structure is designed to form a seal with the surgical incision and also to conform around a wide variety of instrument sizes—from a thin guidewire to a surgeon's hand—to prevent gas from leaking out of the body cavity. When no instrument is present, the opening is designed to self-seal. (’581 Patent, Abstract; col. 2:22-29).
  • Technical Importance: This design aimed to simplify the construction and enhance the versatility of surgical access ports, allowing a single device to serve multiple functions that previously required several specialized and complex instruments. (’581 Patent, col. 2:9-12).

Key Claims at a Glance

  • The complaint asserts "one or more claims" of the ’581 patent without specifying which ones (Compl. ¶9). The patent contains three independent claims (1, 12, and 21).
  • Independent Claim 1 recites a surgical access device comprising:
    • A non-inflatable access port sized to span an abdominal wall.
    • The port includes a proximal portion, a distal portion, and an intermediate portion, which are "monolithically formed of an elastomeric material."
    • The proximal portion has a proximal flange with a surface that "at least partially defines a concave area."
    • The distal portion has a distal flange.
    • The port is adapted to be placed within an incision, forming a perimeter seal with the abdominal wall and a separate seal with a surgical instrument (a trocar) passing through it.
  • Independent Claim 12 is similar but specifies the material is a "thermoplastic elastomer" and that the port creates a seal by exerting "a force on the incision."
  • Independent Claim 21 is a system claim for the access device in combination with an instrument (a trocar).
  • The complaint does not explicitly reserve the right to assert dependent claims, but the broad allegation of infringing "one or more claims" leaves this possibility open. (Compl. ¶9).

III. The Accused Instrumentality

Product Identification

  • The complaint identifies "products marketed by Defendants under the name SILS Port" and related products promoted for use in "SILS Procedures." (Compl. ¶9).

Functionality and Market Context

  • The complaint alleges that these products are used for surgical access but does not provide any specific details about their structure, materials, or method of operation. (Compl. ¶9). No allegations regarding the products' commercial importance are made.
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed infringement theory or a claim chart. It makes a general allegation that the SILS Port products infringe the ’581 patent. (Compl. ¶9). The following table outlines the elements of a representative independent claim against which infringement will be measured, but the complaint provides no specific facts to populate the "Alleged Infringing Functionality" column beyond the general accusation.

’581 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A surgical access device, comprising: a non-inflatable access port sized to span a thickness of an abdominal wall of a patient... The complaint alleges that the SILS Port is a surgical access device that infringes the ’581 patent. ¶9 col. 16:21-25
wherein the access port comprises a proximal portion, a distal portion, and an intermediate portion... The complaint does not describe the specific components of the SILS Port. ¶9 col. 16:26-29
wherein the proximal portion comprises a proximal flange... wherein the proximal surface portion at least partially defines a concave area... The complaint does not describe the specific geometry of the SILS Port. ¶9 col. 16:35-39
wherein the distal portion comprises a distal flange having a distal flange diameter... The complaint does not describe the specific geometry of the SILS Port. ¶9 col. 16:40-41
wherein the proximal flange, the distal flange, and the intermediate portion are monolithically formed of an elastomeric material... The complaint does not specify the materials or manufacturing process of the SILS Port. ¶9 col. 16:42-45
wherein the access port is ... adapted to form a seal with the surgical instrument positioned through the access port... The complaint alleges the SILS Port is used for surgical procedures but provides no detail on its sealing mechanism. ¶9 col. 16:55-63

Identified Points of Contention

  • Evidentiary Questions: As the complaint lacks specific factual allegations, the central dispute will be evidentiary. Discovery will be required to determine if the accused SILS Port product actually possesses the features required by the claims. For example, what evidence will show that the SILS Port is "monolithically formed," has a "concave area" on its proximal surface, and is made of the type of "elastomeric material" described in the patent?
  • Technical Questions: A key technical question will be whether the operational principle of the accused SILS Port matches the claimed function. For instance, does the SILS Port form a seal by conforming to an instrument's surface in the manner described and claimed in the ’581 patent, or does it operate via a different sealing mechanism?

V. Key Claim Terms for Construction

  • The Term: "monolithically formed"

  • Context and Importance: This term appears in all independent claims and is central to the claimed invention's structure. The infringement analysis will depend on whether the accused SILS Port is constructed as a single, seamless piece or is assembled from separate components. Practitioners may focus on this term because it distinguishes the invention from prior art devices that were often assemblies of multiple parts.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent does not provide an explicit definition that deviates from the term's plain meaning, which could allow for some interpretation.
    • Evidence for a Narrower Interpretation: The specification repeatedly describes the structure as a single, unitary part, for example, stating "the access pad with flanges is formed monolithically" and illustrating it with a continuous cross-section in Figure 8. (’581 Patent, col. 6:7-9; Fig. 8). This suggests the term implies formation as a single, unibody structure without seams or bonding of separate pieces.
  • The Term: "concave area"

  • Context and Importance: This geometric limitation on the proximal flange is recited in independent claims 1, 12, and 21. A defendant may argue its product lacks this specific feature. The definition of how much of the surface must be concave, and to what degree, will be important.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim language "at least partially defines a concave area" suggests that the entire surface need not be concave and that even a slight or incidental curvature could meet the limitation. (’581 Patent, col. 16:38-39).
    • Evidence for a Narrower Interpretation: The drawings, such as Figure 6, depict a distinct and deliberate bowl-like shape for the proximal flange (54a), which could support an argument that the term requires a functionally significant, rather than merely incidental, concavity.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement based on Defendants' marketing and selling of the SILS Port products with the knowledge and intent that customers would use them to infringe. (Compl. ¶12). It alleges contributory infringement on the grounds that the SILS Port is not a staple article of commerce, is especially made to be used in an infringing manner, and is known by Defendants to be so adapted. (Compl. ¶13).
  • Willful Infringement: The complaint alleges willful infringement based on Defendants having "actual knowledge of the '581 patent" and continuing to infringe after gaining this knowledge. (Compl. ¶¶11, 15).

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

  • A central issue will be one of evidentiary proof: Given the complaint's lack of specific factual allegations, the case will hinge on whether discovery reveals that the accused SILS Port products actually contain the specific combination of structural and material limitations recited in the asserted claims, such as being "monolithically formed" from an "elastomeric material" with a "concave" proximal surface.
  • A key legal question will be one of claim construction: The viability of the infringement case may depend on how the court construes the term "monolithically formed." A narrow construction requiring a single, seamless molded part could present a higher bar for the Plaintiff to prove infringement compared to a broader definition that might permit certain types of assembly or bonding.