Lederer v. Nine Eighteen Medical Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Wayne Lederer (New York)
  • Defendant: Nine Eighteen Medical, Inc. (California)
  • Plaintiff’s Counsel: Fish & Richardson P.C.
• Case Identification: 2:10-cv-00271, E.D.N.Y., 02/01/2013
• Venue Allegations: Venue is alleged based on the defendant conducting substantial, systematic, and continuous business in the judicial district, including offering to sell and selling goods.
• Core Dispute: Plaintiff alleges that Defendant’s noise-attenuating headsets, designed for use in medical imaging environments, infringe a patent related to technology for providing audio to a user while protecting them from loud magnetic fields.
• Technical Context: The technology addresses the need for safe and effective communication headsets in high-noise environments like Magnetic Resonance Imaging (MRI) machines, which require non-magnetic components to prevent image distortion and safety risks.
• Key Procedural History: This action is an Amended Complaint. The original defendant, Newmatic Sound Systems, Inc., allegedly ceased operations and sold its assets to the current defendant, Nine Eighteen Medical, Inc., which shares the same president and continues to sell the accused products. The patent originally asserted, U.S. Patent No. 7,609,844, was later reissued as U.S. Reissue Patent No. RE43,595, which is the patent now asserted in this Amended Complaint. The complaint alleges pre-suit communications between the inventor and the defendant's president concerning the patented technology.

Case Timeline

Date	Event
2003-10-27	’595 Patent Priority Date
2009-03-01	Pre-suit contact between Plaintiff and Defendant's President
2009-10-27	Original U.S. Patent No. 7,609,844 Issue Date
2012-08-21	U.S. Reissue Patent No. RE43,595 Issue Date
2013-02-01	Amended Complaint Filing Date

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

• Patent Identification: U.S. Reissue Patent No. RE43,595, "Noise Attenuating Headset," issued August 21, 2012.

The Invention Explained

• Problem Addressed: Magnetic Resonance Imaging (MRI) systems generate extremely loud noises due to the drive pulses applied to their gradient coils, creating a need to provide sound protection for patients and personnel (RE43,595 Patent, col. 1:24-30).
• The Patented Solution: The invention is a "magnetically inert" headset that uses a compressible ear insert, similar to a foam earplug, to physically block sound by conforming to the user's ear canal. A "pneumatic port," or hollow tube, runs through the center of this ear insert to deliver desired audio (e.g., music or instructions) from an external, non-magnetic sound transducer via air tubes. This design allows for both passive noise attenuation and active audio delivery without using metallic components that would be hazardous in a high-magnetic-field environment (RE43,595 Patent, Abstract; col. 2:49-61; Fig. 1B).
• Technical Importance: The technology provides a method for patients undergoing MRI scans to be protected from hazardous noise levels while still being able to receive communications from the MRI technologist (RE43,595 Patent, col. 2:28-35).

Key Claims at a Glance

• The complaint asserts "one or more claims of the ’595 patent, including at least claim 10" (Compl. ¶14). Independent claim 10, as amended by the Ex Parte Reexamination Certificate RE43,595 C1, is analyzed below.
• Amended Independent Claim 10:
  • A magnetically inert, noise-attenuating headset comprising:
  • an ear insert having a through-hole and adapted to fit into an ear canal;
  • a pneumatic port disposed in the hole in the ear insert to receive audible sound waves and couple the sound waves to the ear canal,
  • wherein the ear insert substantially conforms to the shape of the ear canal and is sized and composed of a compressible material to attenuate noise from an MRI system, and further wherein the ear insert "provides the only means in the headset that serves as a barrier for attenuating the noise";
  • a headset assembly including pneumatic tubing acoustically coupled to both the pneumatic port and a non-magnetic transducer to deliver audio.
• The complaint states that Plaintiff may assert other claims in the future (Compl. ¶14).

III. The Accused Instrumentality

Product Identification

• The accused products are identified as "Newmatic's Coil Headsets," with one specific product referenced as "item CHS29" (Compl. ¶12-13).

Functionality and Market Context

• The complaint describes the accused products as "noise attenuating headsets" (Compl. ¶14). It alleges these products were originally sold by Newmatic Sound Systems, Inc. and that sales were continued by Nine Eighteen Medical, Inc. after Newmatic ceased operations (Compl. ¶2-3, ¶13). The complaint does not provide specific technical details on the operation, materials, or construction of the accused headsets.

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or provide a detailed narrative mapping specific features of the accused products to the limitations of the asserted claims. The infringement allegation is made in a conclusory fashion, stating that by making, using, and selling its noise attenuating headsets, the defendant infringes at least claim 10 of the ’595 patent (Compl. ¶14). Without specific factual allegations detailing how the accused headsets meet each element of the asserted claim, a tabular analysis is not possible based on the complaint's contents.

Identified Points of Contention

• Scope Questions: A central dispute may arise over the claim limitation, added during reexamination, requiring that the ear insert "provides the only means in the headset that serves as a barrier for attenuating the noise" (RE43,595 C1, col. 2:10-14). The question will be whether the accused headsets contain any other components, such as padded earcups, that also serve as a noise-attenuating barrier, which could place them outside the scope of this limitation.
• Technical Questions: The litigation will likely require factual determinations of whether the accused headsets are "magnetically inert" and use a "non-magnetic transducer" as required by the claim (RE43,595 C1, col. 2:22-26). Further, evidence will be needed to establish if the ear inserts of the accused products are made of a "compressible material" that "substantially conforms to the shape of the ear canal" in the manner claimed (RE43,595 C1, col. 2:1-4).

V. Key Claim Terms for Construction

The Term: "wherein the ear insert provides the only means in the headset that serves as a barrier for attenuating the noise" (emphasis added)

• Context and Importance: This limitation was added to claim 10 during reexamination and is likely to be the most critical term for determining infringement. Its interpretation will define whether headsets with multiple noise-blocking components (e.g., an insert and an earcup) can infringe. Practitioners may focus on this term because its absolute language ("only means") creates a significant potential for a non-infringement defense if any other part of the accused device contributes to noise attenuation.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A plaintiff might argue that the term should be read in context to mean the sole dedicated or primary means, and that incidental sound-blocking from a structural earcup does not constitute a second "means... that serves as a barrier."
  • Evidence for a Narrower Interpretation: The plain language suggests an absolute condition. A defendant could argue that if its product includes any other component that provides measurable noise attenuation, such as the foam padding (316) within an earcup (310) shown in the patent's own Figure 3, then the ear insert is not the "only means," and the claim is not infringed.

The Term: "compressible material"

• Context and Importance: The definition of this term determines the range of materials from which the noise-attenuating ear insert can be made. The dispute will center on whether the material used in the accused product falls within the scope of this term as understood from the patent.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification provides a list of potential materials, stating the ear insert "can conform to the shape of the ear canal upon insertion therein such as compressible foam, vinyl, plastic or rubber" (RE43,595 Patent, col. 2:54-56).
  • Evidence for a Narrower Interpretation: A party could argue that the function of attenuating loud MRI noise implies a high degree of compressibility and expansion, potentially limiting the term to materials like memory foam that create a near-hermetic seal, as opposed to less-conforming plastics or rubbers.

VI. Other Allegations

Indirect Infringement

• The complaint does not include a formal count for indirect infringement, nor does it allege specific facts to support a claim of inducement or contributory infringement, such as detailing how the defendant instructs its customers to use the product in an infringing manner.

Willful Infringement

• The complaint alleges that the defendant’s infringement has been "willful and deliberate" (Compl. ¶16). This allegation is supported by claims of pre-suit knowledge, based on communications in March 2009 between the plaintiff and the defendant's president, Elias Husary. The complaint alleges these discussions concerned the plaintiff's patent rights and product development, and quotes Mr. Husary as stating, "it really pisses me off when people try to find workarounds for patents" (Compl. ¶10-11).

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

• A core issue will be one of claim scope post-reexamination: Can the phrase "the only means... that serves as a barrier," which was added to claim 10 during reexamination, be interpreted to read on a headset that includes both an attenuating ear insert and an outer earcup that also blocks noise? The resolution of this question will likely depend heavily on the prosecution history that led to the amendment.
• A key evidentiary question will be one of factual proof: As the complaint lacks technical specifics, the case will depend on the evidence produced during discovery. Can the plaintiff demonstrate that the accused "Newmatic's Coil Headsets" are in fact "magnetically inert" and possess all other structural and material properties recited in the asserted claim?
• The viability of the willfulness claim will present a central question. Do the alleged pre-suit communications between the parties, particularly the quoted email from the defendant’s president, rise to the level of establishing egregious conduct and a deliberate disregard for the plaintiff's patent rights sufficient to justify enhanced damages?