DCT

0:20-cv-00595

BioNebicine Corp v. Smiths Medical ASD Inc

I. Executive Summary and Procedural Information

Parties & Counsel:
- Plaintiff: BioNebicine Corp. and BN Intellectual Properties, Inc. (Nevada)
- Defendant: Smiths Medical ASD, Inc. dba Smiths Medical (Delaware)
- Plaintiff’s Counsel: Carlson, Caspers, Vandenburgh, & Lindquist P.A.
Case Identification: 0:20-cv-00595, D. Minn., 02/25/2020
Venue Allegations: Venue is alleged to be proper in the District of Minnesota on the basis that Defendant maintains its principal place of business in the state, developed the accused product in the state, and conducts substantial business there, including sales of the accused products.
Core Dispute: Plaintiff alleges that Defendant’s Portex® brand endotracheal tubes infringe a patent related to an improved endotracheal tube design featuring a specialized cuff for positioning the tube and managing patient secretions.
Technical Context: The technology concerns medical devices for patient ventilation, specifically endotracheal tubes designed to prevent kinking and reduce the risk of ventilator-associated pneumonia by pooling and enabling the suction of secretions.
Key Procedural History: The complaint alleges that the inventor contacted Defendant in late 2009, prior to the patent’s issuance, to discuss a potential license and provided the patent application, which allegedly put Defendant on notice of the technology. The provided patent documents also include a Reexamination Certificate issued in April 2023, post-dating the complaint, which cancelled the originally asserted claims (1-9) and added new claims (10-16). This post-filing development fundamentally alters the asserted patent rights and may require the Plaintiff to amend its pleadings to proceed with the case.

Case Timeline

Date	Event
2009-09-28	'795 Patent Application Filing Date
Late 2009	Alleged pre-suit contact with Defendant to license invention
2012-07-24	'795 Patent Issue Date
2020-02-25	Complaint Filing Date

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

U.S. Patent No. 8,225,795 - “Kink resistant endotracheal tube”

Issued: July 24, 2012.

The Invention Explained

Problem Addressed: The patent’s background section identifies two primary problems with conventional endotracheal tubes: they can kink or collapse at body temperature, restricting airflow, and they allow secretions to accumulate above the inflatable cuff, creating a risk of aspiration pneumonia if those secretions enter the lungs (ʼ795 Patent, col. 1:15-49).
The Patented Solution: The invention claims to solve these problems through a tube design that includes a specialized inflatable cuff. A key feature is that an upper portion of the cuff is "folded over upon itself" to create a "concave surface for accumulating secretions" ('795 Patent, col. 3:32-36). This structure is intended to form a basin that pools fluids above the cuff, allowing them to be suctioned away through a dedicated channel, thereby preventing them from entering the patient’s lungs ('795 Patent, col. 3:40-45, Abstract). The patent also describes features to resist kinking, such as specific materials and reinforced wall sections ('795 Patent, col. 4:43-58).
Technical Importance: The design attempts to enhance patient safety during mechanical ventilation by maintaining a clear airway and actively managing secretions that can cause serious secondary infections ('795 Patent, col. 1:45-49).

Key Claims at a Glance

The complaint asserts independent claim 1 and dependent claim 2 (Compl. ¶35).
The essential elements of independent claim 1 include:
- A flexible elongated tubular member with specific features (distal/proximal ends, beveled tip, curved portion) defining a central passageway for ventilation.
- A first minor passageway and an inflatable cuff made of a gas impervious material, secured to the tube’s exterior surface.
- The inflatable cuff is "folded over upon itself at said upper portion to form a concave area for pooling secretions above said cuff."
- The inflatable cuff is "folded over upon itself for a distance of about ¼ inch at said upper portion."
The complaint reserves the right to assert additional claims of the ’795 Patent (Compl. ¶51).

III. The Accused Instrumentality

Product Identification

The complaint names a line of Defendant’s Portex® endotracheal tubes as the "Accused Products," using the "Portex® SACETT™ Suction Above Cuff Endotracheal Tube" as the representative example for its infringement allegations (Compl. ¶36, ¶37).

Functionality and Market Context

The complaint alleges the Portex® SACETT™ tube is a kink-resistant endotracheal tube comprising a flexible tubular member, a beveled tip, a curved portion, and a central passageway for ventilation (Compl. ¶41, ¶42).
The accused tube includes an inflatable cuff and a "first minor passageway" (Compl. ¶43). An annotated image provided in the complaint identifies this passageway as a channel for managing secretions (Compl. ¶43, p. 12).
The central infringement allegation is that the accused tube's inflatable cuff is "folded over upon itself at said upper portion to form a concave area for pooling secretions above said cuff" for a distance of approximately ¼ inch (Compl. ¶44). The complaint provides a photograph purporting to show this feature being measured with a ruler (Compl. ¶44, p. 13).
The complaint alleges that Defendant enjoys substantial income from the sale of these products throughout the United States (Compl. ¶16).

IV. Analysis of Infringement Allegations

'795 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a flexible elongated tubular member having distal and proximal open ends, a beveled tip at said distal end and a curved portion between said distal and proximal ends, and said tubular member defining a central major passageway for ventilation of a patient	The complaint alleges the Portex® SACETT™ tube contains a flexible elongated tubular member with these exact features. A product image with annotations for the "Distal End with Beveled Tip," "Proximal End," and "Curved Portion" is provided as support (Compl. p. 11).	¶42	col. 4:21-25
a first minor passageway and an inflatable cuff for centering said tubular member in a patient's trachea and for accumulating secretions above said cuff and wherein said inflatable cuff is of a gas impervious material secured to an exterior surface of said tubular member	The accused tube is alleged to contain a "first minor passageway and an inflatable cuff" for these purposes, with the cuff secured to the exterior surface. An annotated image highlights the "First Minor Passageway" and "Inflatable cuff" (Compl. p. 12).	¶43	col. 3:25-32
wherein said inflatable cuff is folded over upon itself at said upper portion to form a concave area for pooling secretions above said cuff	The complaint alleges the accused tube's cuff is "folded over upon itself" at its upper portion, creating a concave area to pool secretions.	¶44	col. 6:39-43
wherein said inflatable cuff is folded over upon itself for a distance of about ¼ inch at said upper portion to form a concave area for pooling secretions above said cuff	The complaint alleges the cuff is folded for a distance of "about ¼ inch." A close-up photograph with a ruler placed next to the cuff is provided to evidence this specific dimension (Compl. p. 13).	¶44	col. 5:50-51

Identified Points of Contention

Scope Questions: A primary dispute may concern the construction of "folded over upon itself." The question is whether this term requires a specific manufacturing process or permanent structure, versus a shape the accused cuff assumes when deployed. The complaint's photographic evidence, which purports to measure the "fold," suggests Plaintiff anticipates this dispute and is presenting its interpretation of the product's structure (Compl. p. 13).
Technical Questions: A key factual question will be whether the accused product’s cuff functions as claimed to create a "concave area for pooling secretions." The infringement theory relies on interpreting the physical shape of the accused device, as shown in product photos, as meeting this functional limitation.

V. Key Claim Terms for Construction

The Term: "folded over upon itself"
- Context and Importance: This phrase describes the core structural innovation of the patent’s secretion management system. The outcome of the infringement analysis will likely depend on whether the physical configuration of the accused product's cuff falls within the court's construction of this term.
- Intrinsic Evidence for a Broader Interpretation: The patent does not provide an explicit definition, which may support a construction that encompasses any structure where the cuff material turns back on itself to form a recess for pooling secretions (ʼ795 Patent, col. 3:32-36).
- Intrinsic Evidence for a Narrower Interpretation: The patent figures, particularly Figure 2, depict a distinct and pronounced fold. A party could argue the term is limited to this specific illustrated embodiment. Furthermore, the claim's recitation of a specific dimension ("about ¼ inch") may suggest that "folded over" refers to a discrete, measurable structural feature rather than a general shape ('795 Patent, col. 6:43-46).
The Term: "kink resistant"
- Context and Importance: This term appears in the preamble of the asserted claim and is a central theme of the patent. Practitioners may focus on this term because its construction will determine whether it is a positive limitation on the claim and, if so, what objective standard a product must meet to be considered "kink resistant."
- Intrinsic Evidence for a Broader Interpretation: The specification contrasts the invention with prior art tubes that "kink when subjected to normal body temperature," suggesting "kink resistant" could mean any improvement over that baseline without requiring a specific quantitative metric ('795 Patent, col. 1:20-23).
- Intrinsic Evidence for a Narrower Interpretation: The specification links the "kink resistant" property to specific material characteristics (e.g., "hardness of about 80 durometers") and structural elements like a "thickened wall portion" or a "D-shaped reinforcement" ('795 Patent, col. 4:43-58; col. 5:63-67). A party may argue that the term should be limited to tubes incorporating these disclosed features.

VI. Other Allegations

Indirect Infringement: The complaint does not include a separate count for indirect infringement. However, it alleges facts that could form the basis for such a claim, stating that Defendant "distributes, sells, and/or imports" the tubes and that "medical professionals" use them in Minnesota and throughout the United States (Compl. ¶7, ¶13).
Willful Infringement: The complaint alleges willful infringement based on pre-suit knowledge. The central allegation is that in late 2009, the inventor contacted Defendant to license the technology, provided the pending patent application, and specifically noted that Defendant’s Portex® products would infringe upon issuance of the patent (Compl. ¶31). This alleged direct notice forms the primary basis for the willfulness claim (Compl. ¶32, ¶53).

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

A threshold issue for the case is one of procedural viability: given that the asserted claims 1 and 2 were cancelled during a reexamination that concluded after the complaint was filed, can the plaintiff continue the lawsuit? This will likely require an amendment to the complaint to assert the new, patentable claims, and the prosecution history of that reexamination will be critical in construing their scope.
Assuming the case proceeds, a core issue will be one of definitional scope: can the term "folded over upon itself," which describes the creation of a secretion-pooling basin, be construed to read on the physical structure of the accused Portex® cuff, or does a technical distinction in their construction place the accused products outside the claims?
A central evidentiary question will concern willfulness: what evidence exists to corroborate the complaint's allegation of a "late 2009" meeting where the inventor allegedly put the Defendant on notice of its future infringement? The outcome of this factual dispute will be determinative for any potential enhancement of damages.