DCT

1:18-cv-00324

Applied Medical Technology Inc v. Corpak Medsystems Inc

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-00324, N.D. Ohio, 08/31/2016
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant transacts business, sells the accused product, maintains a distribution network, and has committed acts of infringement within the Northern District of Ohio.
  • Core Dispute: Plaintiff alleges that Defendant’s nasal tube retention system, when used as instructed, infringes a patent related to a method for placing and securing nasal tubes using a magnetic bridle system.
  • Technical Context: The technology concerns medical devices for securing nasoenteral feeding tubes, which are prone to accidental dislodgement, aiming to provide a more secure and less traumatic placement method than prior techniques.
  • Key Procedural History: The complaint alleges that Plaintiff is the exclusive licensee of the patent-in-suit. It further alleges Defendant had pre-suit knowledge of the patent as early as 2011, stemming from a review of Plaintiff's competing product and from Defendant's disclosure of the patent in an Information Disclosure Statement (IDS) filed with the U.S. Patent and Trademark Office.

Case Timeline

Date Event
2000-09-01 ’715 Patent Priority Date
2003-10-14 ’715 Patent Issue Date
2011-01-01 Approximate Date of Defendant's Alleged Knowledge of Patent
2014-03-01 Approximate Launch of Accused CORGRIP System
2016-08-31 Complaint Filing Date

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

U.S. Patent No. 6,631,715 - "Magnetic Nasal Tube Bridle System and Related Method"

  • Patent Identification: U.S. Patent No. 6,631,715, "Magnetic Nasal Tube Bridle System and Related Method," issued October 14, 2003. (Compl. ¶1; ’715 Patent, cover).

The Invention Explained

  • Problem Addressed: The patent identifies shortcomings with prior methods for securing nasal feeding tubes, noting they can be uncomfortable, lose adhesion over time, cause skin injury, or involve difficult and time-consuming procedures that risk patient discomfort and mandibular dislocation. (’715 Patent, col. 1:44-68, col. 2:1-7).
  • The Patented Solution: The invention describes a system and method that uses magnetism to simplify the placement of a securing "bridle." A flexible member with a magnet on its tip is inserted into one nostril, while a magnetic probe is inserted into the other nostril. The magnets attract behind the nasal septum, allowing the probe to capture and pull the flexible member's tip out through the second nostril, thereby looping the bridle. A separate "receiver" component then secures both the nasal tube and the ends of the flexible member externally via channels. (’715 Patent, Abstract; col. 4:15-38, col. 6:20-48).
  • Technical Importance: The described magnetic coupling method was intended to provide a "rapid, easy" way to loop a bridle around the posterior nasal septum with "minimal patient discomfort." (’715 Patent, col. 2:10-13).

Key Claims at a Glance

  • The complaint asserts independent claim 18. (Compl. ¶11, ¶14).
  • The essential elements of Claim 18 are:
    • A method of placing and securing at least one tube through a nose into a patient comprising:
    • inserting the at least one tube into a first or second nare of the nose;
    • inserting an end portion of a flexible member having a magnet attached thereto into a first nare of the nose;
    • inserting a magnetic probe into a second nare of the nose for attracting said magnet and said end portion of said flexible member;
    • removing said probe from the second nare of the nose thereby retrieving said end portion of said flexible member through the second nare of the nose; and
    • snapping the at least one tube into a channel formed in a receiver.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the "CORGRIP NG/NI Tube Retention System" (the "Corgrip System"). (Compl. ¶12).

Functionality and Market Context

The complaint identifies the Corgrip System as a device for "nasogastric/nasointestinal tube retention." (Compl. ¶12). It is alleged that Defendant provides an instruction manual and product literature that provide "detailed instructions" for the use of the Corgrip System, and that these instructions direct medical care providers to use the device in an infringing manner. (Compl. ¶12, ¶14). The complaint alleges that Defendant sells the Corgrip System to customers in Ohio and elsewhere in the United States. (Compl. ¶6, ¶12).

IV. Analysis of Infringement Allegations

The complaint alleges that Corpak induces infringement of Claim 18 of the ’715 Patent by providing instructions that direct medical care providers to use the Corgrip System to perform each step of the claimed method (Compl. ¶14, ¶15). The complaint references a claim chart, attached as Exhibit D, which is not included in the filed complaint document. The core of the infringement theory is that the instructions provided with the Corgrip System map directly onto the steps of Claim 18, and that medical professionals who follow these instructions directly infringe the patent. (Compl. ¶14, ¶16).

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Technical Questions: A central factual question will be whether the steps detailed in the Corgrip System's instruction manual correspond to every limitation of Claim 18. The analysis will depend on a step-by-step comparison of the accused method (as instructed) with the claimed method, particularly whether the accused securing component functions by "snapping the at least one tube into a channel formed in a receiver."

V. Key Claim Terms for Construction

  • The Term: "snapping the at least one tube into a channel formed in a receiver"

    • Context and Importance: This final step of the method claim defines the securing action. The word "snapping" suggests a specific mechanical action and fit. The infringement analysis may turn on whether the Corgrip System's receiver secures the tube via a "snapping" action or through a different mechanism, such as pure friction, clamping, or adhesion.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification's stated goal is to "firmly grasp[] the exterior of the nasal tube T₁ to prevent dislodgement," which could arguably be achieved by means other than a strict snap-fit. (’715 Patent, col. 5:33-35).
      • Evidence for a Narrower Interpretation: The specification repeatedly uses language suggesting a specific type of fit. The abstract describes receiving the nasal tube in a "snap-fit manner," and the detailed description notes that "the size of the axial opening allows the nasal tube T₁ to be snapped into place." (’715 Patent, Abstract; col. 5:28-30). The claim itself uses the specific gerund "snapping."

  • The Term: "magnet attached thereto"

    • Context and Importance: This term appears in the second step of the method and defines the relationship between the magnet and the flexible member. Practitioners may focus on this term to determine if the specific manner of attachment used in the Corgrip System falls within the scope of the claim as interpreted in light of the patent's disclosure.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification states that "other methods of securing the magnet... such as adhesives, tapes, etc. may be utilized," suggesting the term "attached" is not limited to a single embodiment. (’715 Patent, col. 4:33-38).
      • Evidence for a Narrower Interpretation: The preferred embodiments describe the magnet as being "substantially within the end portion" of the flexible tube or "molded around the magnet," which could support an argument that "attached" requires a more integrated or enveloped configuration than simple surface adhesion. (’715 Patent, col. 4:26-32).

VI. Other Allegations

  • Indirect Infringement: The complaint's sole count is for induced infringement under 35 U.S.C. § 271(b). It alleges that Defendant instructs and encourages medical care providers to infringe Claim 18 by providing the Corgrip System with a detailed instruction manual that specifically directs users to perform the patented method. (Compl. ¶14, ¶15).
  • Willful Infringement: The complaint alleges that Defendant's infringement was and is willful. (Compl. ¶20). The factual basis for this allegation is Defendant's purported actual knowledge of the ’715 patent "at least as early as 2011," which Plaintiff alleges arose from Defendant's review of Plaintiff's patent-marked product and from Defendant's own inclusion of the ’715 patent in an Information Disclosure Statement during the prosecution of one of its own patent applications. (Compl. ¶13).

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

  • A primary issue will be one of induced infringement: Can the plaintiff establish, through evidence such as Defendant's instruction manual, that Corpak's affirmative acts specifically directed and intended for medical professionals to perform every step of the method recited in Claim 18?
  • A key question will be one of claim construction and factual correspondence: Will the term "snapping," which defines the final securing step of the claimed method, be construed to require a specific snap-fit mechanism, and does the accused Corgrip System's receiver function in a way that meets that definition?
  • A central evidentiary question for willfulness and potential damages enhancement will be the extent of Defendant's pre-suit knowledge: What evidence will demonstrate that Defendant's alleged 2011 review of a competitor's product and its IDS filing establish knowledge of the patent and its relevance to the accused Corgrip System?