2:18-cv-00518
Xlear v. Whole Foods Market
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Xlear, Inc. (Utah)
- Defendant: Whole Foods Market IP, LP. (Delaware)
- Plaintiff’s Counsel: JONES WALDO HOLBROOK & McDONOUGH PC
- Case Identification: 2:18-cv-00518, D. Utah, 09/26/2018
- Venue Allegations: Plaintiff alleges venue is proper pursuant to 28 U.S.C. §§ 1400 and 1391(b) and (c).
- Core Dispute: Plaintiff alleges that Defendant’s xylitol-containing nasal sprays infringe patents related to compositions and methods for the nasal administration of xylitol to prevent or treat upper respiratory infections.
- Technical Context: The technology involves using xylitol, a sugar alcohol, in saline-based nasal formulations to reduce pathogenic bacteria in the nasopharynx, thereby addressing conditions like otitis media and sinusitis.
- Key Procedural History: The complaint states that the inventor, Dr. Alonzo H. Jones, developed the technology after researching the anti-bacterial effects of xylitol. Plaintiff Xlear alleges it has marked its own products with the numbers of the ’143 and ’372 patents.
Case Timeline
| Date | Event |
|---|---|
| 1998-03-24 | Patent Priority Date (’143 and ’372 Patents) |
| 1998-10-30 | Patent Priority Date (’883 Patent) |
| 2000-04-25 | U.S. Patent No. 6,054,143 Issues |
| 2001-07-10 | U.S. Patent No. 6,258,372 Issues |
| 2003-07-29 | U.S. Patent No. 6,599,883 Issues |
| 2018-09-26 | First Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,054,143 - Xylitol Delivery
The Invention Explained
- Problem Addressed: The patent background describes the need for new approaches to prevent bacterial infections in the nasopharynx, such as otitis and sinusitis, particularly given the worldwide spread of penicillin-resistant bacteria (’143 Patent, col. 2:57-64).
- The Patented Solution: The invention proposes a method of cleaning the nasopharynx by nasally administering a solution containing xylitol (’143 Patent, Abstract). The patent explains that this direct nasal delivery is more efficient than oral administration because it avoids dilution from ingestion and metabolism, thereby delivering the active agent directly to the affected area (’143 Patent, col. 2:21-34). The xylitol is purported to reduce the adherence of bacteria, while a saline carrier helps to wash them away.
- Technical Importance: The invention provides a non-antibiotic method for reducing bacterial load that is particularly suitable for infants who cannot use other xylitol delivery methods, such as chewing gum (’143 Patent, col. 2:45-48).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" (Compl. ¶17). Independent claim 1 is a method claim.
- 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.
U.S. Patent No. 6,258,372 - Xylitol Nose Spray
The Invention Explained
- Problem Addressed: As a divisional of the application leading to the ’143 Patent, the ’372 Patent addresses the same problem of reducing bacteria in the nasopharynx to prevent upper respiratory infections (’372 Patent, col. 1:16-23).
- The Patented Solution: This patent claims the pharmaceutical composition itself, rather than the method of use. The invention is an aqueous solution formulated for nasal use that comprises specific weight ratios of water, xylitol, and sodium chloride (’372 Patent, col. 3:24-27). The formulation is described as a slightly hypotonic saline solution designed to facilitate the washing effect (’372 Patent, col. 3:19-22).
- Technical Importance: The patent defines a specific product formulation for carrying out the therapeutic method, providing a stable and effective composition for nasal delivery of xylitol (’372 Patent, col. 3:1-4).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" (Compl. ¶18). Independent claims 1, 5, 9, and 11 are composition claims.
- Claim 1:
- An aqueous solution for nasal use comprising by weight
- 100 parts of water,
- between 65 parts to 1 part of xylitol/xylose, and
- between 0.95 and 0.45 parts of sodium chloride.
U.S. Patent No. 6,599,883 - Nasal Delivery of Xylitol
Technology Synopsis
The ’883 Patent discloses a pharmaceutical composition and method for treating upper respiratory infections via nasal delivery of xylitol (’883 Patent, Abstract). The invention focuses on formulations that may include additional pharmaceutically acceptable carriers such as buffers, thickening agents (e.g., methylcellulose), and humectants (e.g., glycerin), which can create more viscous compositions like gels intended for prolonged contact with the nasal mucosa (’883 Patent, col. 2:21-39).
Asserted Claims
The complaint alleges infringement of "one or more claims" (Compl. ¶19). Independent claims include composition claim 1 and method claim 13.
Accused Features
The complaint alleges that Defendant’s nasal sprays contain a pharmaceutical composition that infringes the patent (Compl. ¶19).
III. The Accused Instrumentality
Product Identification
The accused products are "nasal sprays containing xylitol" sold by Defendant through its stores and website (Compl. ¶16). A specific product, "365 nasal mist with xylitol," is identified via a URL (Compl. ¶16).
Functionality and Market Context
The accused products are saline-based nasal sprays containing xylitol (Compl. ¶16, ¶18). The complaint alleges that the products, packaging, and associated websites provide instructions for users to "nasally administer an effective amount of xylitol/xylose to the nasopharynx of a human" (Compl. ¶20). These instructions form the primary basis for the inducement of infringement allegations.
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 | Defendant's products, packaging, and websites instruct users on a method of nasally administering the xylitol spray, which allegedly performs the function of cleaning the nasopharynx. | ¶20 | col. 3:55-58 |
| which comprises nasally administering an effective amount of xylitol/xylose in solution. | Defendant's nasal sprays contain xylitol in solution, and the instructions allegedly direct users to nasally administer an "effective amount" of this solution. | ¶17, ¶20 | col. 3:57-58 |
Identified Points of Contention
- Scope Questions: A central issue may be whether the instructions provided with the accused product direct users to perform a method for the purpose of "cleaning the nasopharynx," as required by the claim preamble, or if the product is marketed for a different purpose (e.g., simple moisturizing). The definition of "effective amount" will also be critical; the complaint does not specify the amount of xylitol delivered by the accused product.
- Technical Questions: For the inducement claim, a key question will be whether Defendant’s instructions, when followed, necessarily result in the performance of every step of the claimed method.
’372 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An aqueous solution for nasal use comprising by weight 100 parts of water, | The accused product is an aqueous nasal spray. | ¶16, ¶18 | col. 3:24-27 |
| between 65 parts to 1 part of xylitol/xylose, | The complaint alleges that the accused nasal sprays contain xylitol in amounts that meet the claimed weight-part ratio. | ¶18 | col. 3:25-26 |
| and between 0.95 and 0.45 parts of sodium chloride. | The complaint alleges the accused product's formulation infringes, implying its sodium chloride concentration meets this limitation. | ¶18 | col. 3:27 |
Identified Points of Contention
- Scope Questions: The infringement analysis for this composition patent appears to be primarily a factual inquiry. The complaint does not provide specific data on the accused product's formulation.
- Technical Questions: The dispute will likely depend on a quantitative chemical analysis of the accused product to determine if the precise weight-part ratios of xylitol and sodium chloride relative to water fall within the ranges specified in the claim.
V. Key Claim Terms for Construction
The Term: "effective amount" (’143 Patent, Claim 1)
Context and Importance
This term defines the dosage required for infringement of the method claim. Its construction will determine the threshold for what constitutes an infringing act of administration. Practitioners may focus on this term because the complaint alleges administration of an "effective amount" without providing quantitative support.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The specification states that "As little as 1% xylitol/xylose in solution appears to be the effective minimum strength" (’143 Patent, col. 3:9–11), which could support an argument that any clinically relevant dose from such a solution is "effective."
- Evidence for a Narrower Interpretation: The specification also provides specific dosage examples, such as "approximately 70 milligrams per day" for infants (’143 Patent, col. 3:35–36). This could support an argument that the term requires a specific daily dosage shown to achieve the results described in the patent.
The Term: "cleaning the nasopharynx" (’143 Patent, Claim 1)
Context and Importance
This phrase in the preamble defines the purpose and function of the claimed method. Whether the accused method performs this function is essential for a finding of infringement.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent links "cleaning" to a "reduction of the bacteria count in the nasopharynx" (’143 Patent, col. 2:32–34). Plaintiff could argue any method that achieves this bacterial reduction effect meets the limitation.
- Evidence for a Narrower Interpretation: The detailed description explains a mechanism where the solution "loosens the bacterial attachment and washes the nasal cavity" (’143 Patent, col. 3:25–26). A defendant could argue that "cleaning" requires both a biochemical anti-adherence effect and a physical "washing" action.
VI. Other Allegations
Indirect Infringement
The complaint pleads inducement to infringe all three patents-in-suit (Compl. ¶¶31-37, 46-52, 61-69). The allegations are based on Defendant’s instructions on product packaging and websites, which allegedly direct and encourage users to perform the patented methods and use the patented compositions (Compl. ¶20, ¶33, ¶35). The complaint alleges that Defendant has knowledge of the patents and intends for its customers to infringe (Compl. ¶32, ¶34).
Willful Infringement
Willfulness is alleged for all three patents, based on Defendant having "actual or constructive knowledge" of the patents while engaging in infringing conduct (Compl. ¶27-28, ¶42-43, ¶57-58). The complaint does not specify the factual basis for the alleged pre-suit knowledge.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central factual question will be one of compositional identity: does laboratory analysis of the accused "365 nasal mist with xylitol" reveal concentrations of xylitol and sodium chloride that fall within the specific weight-part ratios claimed in the ’372 patent? The resolution of this issue will likely rely on expert discovery and testing.
- A core issue for the method claims will be one of functional scope: can the act of using the accused spray as directed by Defendant's marketing and instructions be construed as "cleaning the nasopharynx" by administering an "effective amount," as those terms are defined within the ’143 patent?
- A key question for the indirect infringement allegations will be one of specific intent: does the evidence demonstrate that Defendant, by providing user instructions, knew of the patents and specifically intended for consumers to perform acts that constitute infringement of the claimed methods?