DCT
2:16-cv-00172
Xlear v. Renewal Science
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Xlear, Inc. (Utah)
- Defendant: Renewal Science, LLC (Pennsylvania)
- Plaintiff’s Counsel: JONES WALDO HOLBROOK & McDONOUGH PC
- Case Identification: 2:16-cv-00172, D. Utah, 03/02/2016
- Venue Allegations: Plaintiff alleges venue is proper in the District of Utah pursuant to 28 U.S.C. §§ 1400 and 1391(b) and (c), without pleading specific facts supporting this conclusion.
- Core Dispute: Plaintiff alleges that Defendant’s nasal sprays containing xylitol infringe a patent covering methods for cleaning the nasopharynx through the nasal administration of a xylitol solution.
- Technical Context: The technology involves pharmaceutical formulations, specifically using xylitol, a sugar alcohol, in nasal sprays to prevent or treat upper respiratory infections by reducing bacterial adherence in the nasal passages.
- Key Procedural History: The complaint alleges that Plaintiff marks its own nasal spray products with the asserted patent number, a fact that may be relevant to issues of notice and damages.
Case Timeline
| Date | Event |
|---|---|
| 1998-03-24 | U.S. Patent No. 6,054,143 Priority Date |
| 2000-04-25 | U.S. Patent No. 6,054,143 Issued |
| 2016-02-29 | Complaint Filed (Dated Feb 29, filed Mar 2) |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,054,143 - “Xylitol Delivery”
- Patent Identification: U.S. Patent No. 6,054,143, “Xylitol Delivery,” issued April 25, 2000 (the “’143 Patent”).
The Invention Explained
- Problem Addressed: The patent identifies the need for new approaches to prevent upper respiratory bacterial infections, such as otitis and sinusitis, particularly given the worldwide spread of penicillin-resistant bacteria (’143 Patent, col. 2:13-18, 61-64). It notes that bacteria adhering to tissues in the nasopharynx are a primary cause of such infections (’143 Patent, col. 2:40-42).
- The Patented Solution: The invention is a method for delivering xylitol directly to the nasopharynx via a nasal spray or drops in a saline solution (’143 Patent, Abstract; col. 2:21-24). This nasal delivery is described as more efficient than oral administration, as it avoids dilution through digestion and circulation, and works by reducing the adherence of pathogenic bacteria to nasal tissues, thereby facilitating the "washing" of the nasal cavity (’143 Patent, col. 2:24-31; col. 3:24-26).
- Technical Importance: The patented method purports to offer a non-antibiotic approach to preventing common infections by leveraging a naturally occurring substance, and to do so more efficiently than prior art methods like oral administration, making it suitable for infants who cannot chew gum (’143 Patent, col. 2:45-48).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" without specifying which ones (Compl. ¶14). Independent claim 1 is the broadest method claim.
- Independent Claim 1:
- A method of cleaning the nasopharynx in a human in need of said method
- which comprises nasally administering an effective amount of xylitol/xylose in solution.
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are "nasal sprays containing xylitol" that are sold, or offered for sale, by Defendant (Compl. ¶13).
Functionality and Market Context
- The complaint alleges that Defendant’s products are sold through multiple websites, including its own and an Amazon.com account (Compl. ¶13). The core functionality is alleged to be the delivery of xylitol to the nasal passages. The complaint further alleges that the products, packaging, and associated websites provide instructions on how users should nasally administer the xylitol solution (Compl. ¶15). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’143 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of cleaning the nasopharynx in a human in need of said method | The complaint alleges Defendant provides instructions that induce users to perform a method that infringes the patent, which is described as cleaning the nasopharynx by reducing the population of resident pathogenic bacteria. | ¶14, ¶15, ¶28 | col. 2:11-13, 50-53 |
| which comprises nasally administering an effective amount of xylitol/xylose in solution. | Defendant is alleged to sell "nasal sprays containing xylitol" and to provide instructions to "nasally administer an effective amount of xylitol/xylose to the nasopharynx," thereby inducing users to perform the claimed administration step. | ¶13, ¶14, ¶28 | col. 3:55-58 |
- Identified Points of Contention:
- Scope Questions: The complaint’s infringement theory rests heavily on inducement. A central question will be whether Defendant’s instructions direct users to perform every step of the claimed method, including for the purpose of "cleaning the nasopharynx," or if the product is promoted for a different, non-infringing purpose (e.g., simple moisturization).
- Technical Questions: A key factual dispute will be whether the amount of xylitol delivered by the accused product constitutes an "effective amount" for "cleaning the nasopharynx" as contemplated by the patent. The complaint does not provide specific details regarding the formulation of Defendant’s product or the specific instructions for its use.
V. Key Claim Terms for Construction
The Term: "effective amount"
- Context and Importance: This term of degree is central to the scope of infringement. Its definition will determine the concentration or dosage of xylitol required for a product's use to be infringing. Practitioners may focus on this term because the dispute will likely involve comparing the dosage delivered by the accused product against the threshold required by the claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent states that "As little as 1% xylitol/xylose in solution appears to be the effective minimum strength," which could support a broad definition encompassing any product meeting or exceeding this low threshold (’143 Patent, col. 3:9-10).
- Evidence for a Narrower Interpretation: The patent provides specific examples of dosages, such as "approximately 70 milligrams per day" for infants, and formulations like "5 grams of xylitol/xylose mixed with 45 cubic centimeters of 'Ocean' nasal spray" (’143 Patent, col. 3:27-28, 38-39). A defendant could argue these examples limit the term to more substantial quantities necessary to achieve the patent's stated therapeutic goals.
The Term: "cleaning the nasopharynx"
- Context and Importance: This phrase defines the goal and utility of the claimed method. Whether the use of the accused product achieves "cleaning" as understood in the patent will be a critical infringement question.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term could be construed broadly to mean any washing of the nasal cavity, as the specification states that the nasal application "washes the nasal cavity" (’143 Patent, col. 3:25-26).
- Evidence for a Narrower Interpretation: The patent repeatedly links "cleaning" to a specific biological mechanism: "reducing the number of bacteria resident there" and a "reduction of the population of resident pathogenic strep pneumonia" (’143 Patent, col. 2:12-13; col. 3:48-50). A defendant may argue that "cleaning" requires proof of a significant reduction in bacterial load, not just a simple saline flush.
VI. Other Allegations
- Indirect Infringement: The complaint explicitly pleads induced infringement, alleging that Defendant has knowledge of the ’143 Patent and "actively instructs purchasers" on how to use its xylitol nasal sprays in an infringing manner via product packaging and websites (Compl. ¶¶ 27-30). The intent element is supported by the allegation that Defendant knows and intends that users will follow these instructions to administer xylitol to the nasopharynx (Compl. ¶29).
- Willful Infringement: Willfulness is alleged based on Defendant’s purported "actual or constructive knowledge of the ’143 Patent" at the time of its infringing conduct (Compl. ¶22, ¶23). The complaint does not plead specific facts detailing how or when Defendant acquired this knowledge.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of claim construction: how much xylitol constitutes an "effective amount," and what level of biological activity is required to meet the "cleaning the nasopharynx" limitation? The answers will define the threshold for infringement.
- A key evidentiary question for the inducement claim will be: do Defendant's product instructions specifically direct users to perform all steps of the patented method for the claimed purpose? The case may depend on whether Plaintiff can prove that Defendant’s marketing and instructions cross the line from describing a product's general use to actively encouraging infringement of the specific method claimed in the ’143 Patent.
- The outcome may also turn on a question of proof: given the complaint's lack of specific factual detail about the accused product's formulation and recommended dosage, a primary challenge for the Plaintiff will be to gather and present evidence demonstrating that the use of Defendant's product, as instructed, necessarily meets the limitations of the asserted claims.