DCT
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 Inc, INC. (Texas)
- Plaintiff’s Counsel: Jones Waldo Holbrook & McDonough
- Case Identification: 2:18-cv-00518, D. Utah, 06/28/2018
- Venue Allegations: Plaintiff alleges that venue is proper in the District of Utah pursuant to 28 U.S.C. §§ 1400 and 1391(b) and (c), without providing further specific factual support for this conclusion in the complaint.
- Core Dispute: Plaintiff alleges that Defendant’s sale of private-label nasal sprays containing xylitol infringes three patents related to methods and compositions for the nasal administration of xylitol to prevent or treat upper respiratory infections.
- Technical Context: The technology concerns the use of xylitol, a sugar alcohol, in saline-based nasal delivery systems as a non-antibiotic approach to reduce bacterial load in the nasopharynx and mitigate associated conditions like ear infections and sinusitis.
- Key Procedural History: The complaint states the inventor was motivated by personal family experience with recurring earaches, leading to the patented inventions. Plaintiff Xlear also alleges it has marked its own commercial products with the numbers of the ’143 and ’372 patents, which may be relevant to questions of notice and damages.
Case Timeline
| Date | Event |
|---|---|
| 1998-03-24 | Earliest Priority Date for '143 and '372 Patents |
| 1998-10-30 | Earliest Priority Date for '883 Patent |
| 2000-04-25 | '143 Patent Issued |
| 2001-07-10 | '372 Patent Issued |
| 2003-07-29 | '883 Patent Issued |
| 2018-06-28 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,054,143 - "Xylitol Delivery," Issued April 25, 2000
The Invention Explained
- Problem Addressed: The patent identifies the need for new approaches to prevent bacterial infections like otitis media and sinusitis, particularly in light of the "worldwide spread of penicillin-resistant strains of pneumocci" (ʼ143 Patent, col. 2:59-62). It also notes that the body’s natural immune response to respiratory irritants, nasal congestion, is often counteracted by traditional decongestants, and proposes a method to facilitate rather than suppress this "washing" action (ʼ143 Patent, col. 2:15-21).
- The Patented Solution: The invention is a method for delivering xylitol directly to the nasopharynx using a nasal spray containing a saline solution (ʼ143 Patent, col. 2:22-25). This approach is described as more efficient than oral delivery (e.g., chewing gum), which is subject to dilution through digestion and circulation (ʼ143 Patent, col. 2:25-28). The xylitol is said to reduce the adherence of pathogenic bacteria to nasal tissues, thereby cleaning the nasopharynx and reducing infection rates without directly killing the bacteria, which may help avoid resistance issues (ʼ143 Patent, col. 2:32-41).
- Technical Importance: The invention proposed an adjunctive or preventative therapy for common upper respiratory infections that leveraged a natural compound's anti-adherence properties, offering an alternative to antibiotics or symptom-suppressing medications (ʼ143 Patent, col. 2:35-49).
Key Claims at a Glance
- The complaint asserts one or more unspecified claims (Compl. ¶17). Independent claim 1 is representative of the patented method:
- 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," Issued July 10, 2001
The Invention Explained
- Problem Addressed: The ’372 Patent, a divisional of the application that led to the ’143 Patent, addresses the same problems of upper respiratory infections and the need for effective, non-antibiotic preventative treatments (ʼ372 Patent, col. 1:16-24).
- The Patented Solution: Rather than claiming a method, this patent claims a specific product: the aqueous solution itself. The invention is a composition for nasal use containing specific weight-based ratios of water, xylitol/xylose, and sodium chloride, designed for delivery as a nasal spray (’372 Patent, Abstract; col. 4:25-29). The formulation is described as a "pleasant nasal spray" that can deliver a therapeutic effect with a much smaller dose of xylitol than would be required orally (’372 Patent, col. 2:30-35).
- Technical Importance: This patent provides a concrete formulation for the method claimed in its parent patent, defining specific component ratios for a commercial nasal spray product (ʼ372 Patent, col. 4:25-29).
Key Claims at a Glance
- The complaint asserts one or more unspecified claims (Compl. ¶18). Independent claim 1 is representative of the patented composition:
- 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.
Multi-Patent Capsule
- Patent Identification: U.S. Patent No. 6599883, “Nasal Delivery of Xylitol,” Issued July 29, 2003 (Compl. ¶8).
- Technology Synopsis: This patent describes pharmaceutical compositions and methods for preventing or treating upper respiratory infections via nasal administration of xylitol. The specification emphasizes that nasal delivery is more proximal to the biological target area (the nasopharynx and openings to the eustachian tubes) than oral administration, enabling a more direct and effective treatment with potentially fewer side effects (’883 Patent, col. 4:22-38). The patent discloses formulations that may include various excipients such as buffers, thickening agents (e.g., methylcellulose), and humectants (e.g., glycerin) to create gels or more viscous solutions (’883 Patent, col. 2:21-31, col. 5: Table 5).
- Asserted Claims: The complaint asserts one or more unspecified claims (Compl. ¶19). Representative independent claims include claim 1 (a composition "consisting essentially of xylitol") and claim 13 (a method of "nasally delivering... an active agent consisting essentially of xylitol").
- Accused Features: The complaint alleges that Defendant's nasal sprays are pharmaceutical compositions containing xylitol and that Defendant's instructions direct users to perform an infringing method of administration (Compl. ¶¶19, 56, 65).
III. The Accused Instrumentality
Product Identification
- The accused products are "nasal sprays containing xylitol" sold by Defendant Whole Foods Market Inc (Compl. ¶16). The complaint specifically identifies a product listed for sale online as "365-nasal-mist-with-xylitol-2-ct" (Compl. ¶16).
Functionality and Market Context
- The complaint alleges the accused products are aqueous solutions containing xylitol, designed for administration as a nasal spray (Compl. ¶¶16, 18). It further alleges that the product packaging and associated websites "provide instruction on the method that users of its products should follow to nasally administer an effective amount of xylitol/xylose to the nasopharynx of a human" (Compl. ¶20). The complaint includes an exhibit with sales materials for the accused product, which allegedly provide instructions for nasal administration of the xylitol spray (Compl. ¶20, Ex. D). The complaint does not contain allegations regarding the product's specific market share or commercial significance beyond the fact that it is offered for sale by a national retailer.
IV. Analysis of Infringement Allegations
The complaint does not provide claim charts or detailed element-by-element infringement allegations. The following tables summarize the infringement theories as they can be inferred from the complaint's general 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 instructions allegedly direct users to perform a method of use that results in cleaning the nasopharynx. | ¶20 | col. 4:55-58 |
| which comprises nasally administering | The accused product is a nasal spray, and its instructions allegedly direct users to administer the product into the nose. | ¶¶16, 20 | col. 4:57-58 |
| an effective amount of xylitol/xylose in solution. | The accused product is a solution containing xylitol, and the instructions allegedly direct administration of an "effective amount." | ¶17 | col. 3:9-11 |
’372 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An aqueous solution for nasal use | The accused product is a "nasal mist" sold as a liquid spray. | ¶16 | col. 3:10-12 |
| comprising by weight 100 parts of water, | The complaint alleges the product is a nasal spray containing xylitol, implying an aqueous base, but provides no specific formulation details. | ¶18 | col. 4:25-26 |
| between 65 parts to 1 part of xylitol/xylose, | The complaint alleges the accused product contains xylitol in amounts that infringe one or more claims. | ¶18 | col. 4:26-27 |
| and between 0.95 and 0.45 parts of sodium chloride. | The complaint does not provide any specific factual allegations regarding the presence or concentration of sodium chloride in the accused product. | ¶18 | col. 4:27-29 |
- Identified Points of Contention:
- Scope Questions: A central question for the '143 Patent will be whether the act of spraying a xylitol solution into the nose, as allegedly instructed by Defendant, constitutes the claimed method of "cleaning the nasopharynx." This may depend on whether "cleaning" is construed to require a specific functional result or is inherently met by the administration itself.
- Technical Questions: For the '372 Patent, the dispute will likely focus on the product's actual chemical composition. A key evidentiary question will be whether the accused nasal mist contains not only xylitol but also sodium chloride within the specific weight ratios required by claim 1. The complaint's lack of any allegation regarding the presence of sodium chloride raises the question of whether the infringement claim is sufficiently pleaded.
V. Key Claim Terms for Construction
The Term: "effective amount" (from '143 Patent, claim 1)
Context and Importance: This term is central to the scope of the method claim. Its definition will determine the dosage and/or concentration of xylitol required to infringe. Practitioners may focus on this term because its construction could either broaden the claim to cover any non-trivial amount of xylitol or narrow it to require a specific, clinically proven quantity.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests that "As little as 1% xylitol/xylose in solution appears to be the effective minimum strength" ('143 Patent, col. 3:9-11), potentially supporting a broad definition.
- Evidence for a Narrower Interpretation: A defendant could argue the term is tied to achieving the specific results described in the patent's background, such as the "two-thirds" reduction in bacterial adherence observed in a study cited by the inventor ('143 Patent, col. 2:54-56).
The Term: "comprising by weight" (from '372 Patent, claim 1)
Context and Importance: The infringement analysis for the composition claim hinges entirely on whether the accused product meets the specific weight ratios of water, xylitol, and sodium chloride. The construction of this term will dictate how those ratios are calculated and the precision required.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The use of the open-ended transition word "comprising" indicates that the presence of other ingredients (such as the preservatives mentioned in dependent claim 2) does not preclude infringement, so long as the claimed components are present in the specified ratios.
- Evidence for a Narrower Interpretation: The patent provides a specific formulation example: "5 grams of xylitol/xylose mixed with 45 cubic centimeters of 'Ocean' nasal spray manufactured by the Fleming Company... [which] contains 0.65% sodium chloride" ('372 Patent, col. 3:30-35). A party could argue that this example helps define the specific proportionalities intended by the claim language, anchoring the "by weight" calculation to a concrete embodiment.
VI. Other Allegations
- Indirect Infringement: The complaint pleads inducement to infringe all three patents-in-suit. The allegations are based on Defendant providing product packaging and website materials that "actively instruct purchasers" to use the nasal sprays in a manner that allegedly infringes the patents' method claims (Compl. ¶¶33, 65). The complaint further alleges Defendant has knowledge of the patents and intends for its users to perform the infringing acts (Compl. ¶¶34, 49, 66).
- Willful Infringement: The complaint alleges that Defendant's infringement has been willful and deliberate (Compl. ¶¶28, 43, 58). The factual basis asserted for this claim is that Defendant had "actual or constructive knowledge" of the patents at the time of the infringing conduct (Compl. ¶¶27, 42, 57). The complaint does not allege specific facts supporting pre-suit knowledge, such as a prior notice letter.
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this case may turn on the following central questions:
A primary issue will be one of compositional evidence: Can the Plaintiff establish through discovery and product testing that Defendant's "365" brand nasal spray contains not only xylitol but also sodium chloride within the specific weight-ratio ranges recited in the '372 Patent's asserted claims? The absence of factual allegations on this point in the complaint suggests this will be a critical area of dispute.
A second core issue will be one of functional claim scope: Can the term "cleaning the nasopharynx" in the '143 Patent be construed to cover the simple act of nasal spraying as allegedly instructed by Defendant, or will it be construed to require proof of a more specific biological or mechanical result?
Finally, a key procedural question is one of pleading sufficiency: Does the complaint's general allegation that the accused product contains xylitol "in amounts that infringe" provide sufficient factual matter to state a plausible claim for relief under the Iqbal/Twombly standard, especially for the '372 Patent, which requires a specific ratio of multiple components?