Neurovision Med. Prods., Inc. v. Medtronic Pub. Ltd.

• Decision Date: 27 October 2016
• Docket Number: Case No. 2:16-cv-127-JRG-RSP
• Parties: Neurovision Medical Products, Inc., Plaintiff, v. Medtronic Public Limited Company, et al., Defendants.
• Court: U.S. District Court — Eastern District of Texas

Neurovision Medical Products, Inc., Plaintiff,
v.
Medtronic Public Limited Company, et al., Defendants.

Case No. 2:16-cv-127-JRG-RSP

UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS MARSHALL DIVISION

October 27, 2016

CLAIM CONSTRUCTION MEMORANDUM OPINION AND ORDER

Before the Court is the opening claim construction brief of Neurovision Medical Products, Inc. ("Plaintiff") (Dkt. No. 70, filed under seal on September 6, 2016),¹ the response of Medtronic Xomed, Inc., Medtronic, Inc., Medtronic PLC, HCA Holdings, Inc., and Healthtrust Purchasing Group, L.P. (collectively "Defendants") (Dkt. No. 76, filed on September 20, 2016), and the reply of Plaintiff (Dkt. No. 82, filed on September 27, 2016). The Court held a hearing on the issues of claim construction and claim definiteness on October 17, 2016. Having considered the arguments and evidence presented by the parties at the hearing and in their briefing, the Court issues this Order.

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Table of Contents

I. BACKGROUND ............................................................................................................... 3

II. LEGAL PRINCIPLES ..................................................................................................... 7

A. Claim Construction ................................................................................................. 7

B. Departing from the Ordinary Meaning of a Claim Term ...................................... 10

C. Functional Claiming and 35 U.S.C. § 112, ¶ 6 (pre-AIA) / § 112(f) (AIA) ......... 11

D. Definiteness Under 35 U.S.C. § 112, ¶ 2 (pre-AIA) / § 112(b) (AIA) ................. 13

III. CONSTRUCTION OF DISPUTED TERMS ............................................................... 14

A. "electrode," "electrode plate" ............................................................................... 14

B. "positioned to contact ..." ..................................................................................... 19

C. "[located] further proximal thereof," "[located] proximal [of said first electrode plate]," "[located at said same predetermined distance or] further proximal [thereof]" ............................................................................................... 26

D. "trace" ................................................................................................................... 30

E. "applied [...] directly to the surface of the tube," "applied [...] directly to the tube surface" ................................................................................................... 35

F. "electrical leads" ................................................................................................... 38

G. "trachea" ............................................................................................................... 41

H. Preambles of '844 Patent Claims 1, 4 and '894 Patent Claims 1, 4, 10, 14 ......... 45

IV. CONCLUSION ............................................................................................................... 49

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I. BACKGROUND

Plaintiff alleges infringement of two U.S. Patents: No. 8,467,844 (the "'844 Patent) and No. 8,634,894 (the "'894 Patent) (collectively, the "Asserted Patents"). The Asserted Patents are each entitled "Electrode for Prolonged Monitoring of Laryngeal Electromyography." The application leading to the '844 Patent was filed on September 21, 2010 and the patent issued on June 18, 2013. The application leading to the '894 Patent was filed on June 4, 2013 and the patent issued on January 21, 2014. The '894 Patent purports to have issued from a division of the '844 Patent's application. Each Asserted Patent claims priority to a provisional application filed on September 21, 2009.

Image materials not available for display.

FIG. 8

In general, the Asserted Patents are directed to technology for monitoring electrical signals during laryngeal electromyography. The technology can be generally understood with reference to Figures 7 and 8 of the Asserted Patents, reproduced below and annotated by the Court. The patent teaches that an endotracheal tube (12) may be used to support a patient's respiration. These tubes may include electrodes that are used to collect electrical signals from anatomical tissue (e.g., from the muscles of larynx). These signals are called electromyographic signals. The tube is placed through the patient's mouth and down into the trachea. Electrodes (62, in blue; 64, in purple) are positioned along the length of the tube to

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pick up electromyographic signals from, for example, the vocal cords and tongue. The signals collected by the electrodes are conducted up the tube (to the proximal end, 18, at the patient's mouth) and from there are sent to monitoring equipment. The prior-art approaches purportedly have two main failings: (1) adding the electrodes and their electrical connections to the tracheal tubes results in raised portions on the tube that can cause injury to the patient during the procedure, and (2) the electrodes and their connections require the addition of material to the tube that is less flexible than the tube and, therefore, placing the electrode-laden tube in the patient may be more difficult than placing the tube alone.

The invention of the Asserted Patents addresses the purported failures of the prior-art devices by creating electrodes (62, in blue; 64, in purple), conductive traces (20, in green; 66, in green), and conductive pads (22, in red) directly on the surface of the tube by applying a conductive ink or paint to the surface. In this way, the detrimental effects of the wires, metallic plates, and adhesives of the prior-art devices are eliminated. That is, the invention reduces the threat of injury by minimizing raised surfaces and increases the ease of placement in the patient by minimizing the decrease in the tube's flexibility due to the electrodes and their connections.

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FIG. 7

Image materials not available for display.

The abstracts of the Asserted Patents are identical and provide:

Laryngeal surface electrodes are devices designed to hold a conductive surface against the vocal cords in order to pick up small electrical signals from the muscle known as electromyographic signals. Several embodiments of a laryngeal electromyography tube include a conductive electrode surface that is painted, screen printed or otherwise applied directly onto the body of an endotracheal tube, such that the final device has no raised surfaces which can injure the vocal cords. These endotracheal tube with integral laryngeal surface electrodes can be safely used placed for prolonged, continuous monitoring during surgery, after surgery and during intensive care treatment intubation without a need to remove and replace the tube at these various stages of treatment. In one embodiment, one electrode contacts the vocal cords and a second electrode contacts the tongue.

Claim 4 of the '844 Patent, Claim 10 of the '894 Patent and Claim 14 of the '894 Patent, exemplary formation-method, device, and use-method system claims respectively, recite as follows:

'844 Patent

4. A method of forming an electrode bearing endotracheal tube for laryngeal electromyography comprising:
providing an endotracheal tube having a retaining balloon at a distal end thereof,

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forming on an exterior surface of the endotracheal tube one or more electrode plates, at least one trace attached to each of the one or more electrode plates and a conductive pad attached to a proximal end of the traces, a first of said electrode plates located at the distal end of the endotracheal tube proximal of the retaining balloon, the conductive pad or pads located at a proximal end of the endotracheal tube,
the electrode plates, traces and electrode pads formed by applying a conductive ink in a liquid carrier to the exterior surface of the endotracheal tube,
evaporating the liquid carrier to provide an electrically conductive path from the electrode plates to the endotracheal tube proximal end, and
forming an insulating barrier over the traces, the barrier extending from a point of connection of the traces to the electrode plates to a point of connection of the traces to the electrode pads
wherein a second electrode plate is located proximal of said first electrode plate, the first electrode plate positioned to contact the vocal cords and the second electrode plate positioned to contact the tongue when properly positioned for performing laryngeal electromyography.

'894 Patent

10. A method of conducting monitoring of electrical signals during laryngeal electromyography for a period of time in excess of 8 hours without injury to the trachea comprising:
providing an endotracheal tube having a retention balloon at or adjacent a distal end thereof,
forming on the outer surface of said tube
a) one or more electrically conductive electrodes applied proximal of the balloon directly to the surface of the tube, without the inclusion of a carrier film between the tube surface and the electrodes,
b) electrically conductive traces connected to or integral with the electrodes, the traces applied directly to the tube surface and running along the length of the endotracheal tube to a proximal portion thereof,
c) connection points connected to or integral with the conductive traces applied directly to the tube surface at a proximal end of the traces, and
d) electrical leads attached to the connection points, said leads adapted for connection to monitoring equipment,
e) the electrically conductive traces covered by an insulating material along their length from a point adjacent the electrodes to a point adjacent the proximal ends of the traces,
wherein said electrically conductive electrodes, traces and connection points comprise a conductive paint or printing ink,
placing the endotracheal tube in the trachea with at least one electrode in contact with the vocal cords, and
monitoring electrical signals with the at least one electrode, said monitored

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