DCT
1:10-cv-00129
Latex Allergen Reduction LLC v. Dynarex Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Latex Allergen Reduction, LLC (Wisconsin)
- Defendant: Dynarex Corporation (New York)
- Plaintiff’s Counsel: DeWitt, Ross & Stevens, S.C.
- Case Identification: 1:10-cv-00129, N.D. Ill., 01/08/2010
- Venue Allegations: Venue is alleged based on substantial activities, distributions, and sales of the accused products by or on behalf of the Defendant within the Northern District of Illinois.
- Core Dispute: Plaintiff alleges that Defendant’s enzyme-treated natural rubber latex gloves, and the methods used to manufacture them, infringe a patent related to neutralizing protein allergens in latex.
- Technical Context: The technology addresses the widespread issue of allergic reactions to proteins in natural rubber latex, a significant health concern in the medical field and for consumers of products like gloves.
- Key Procedural History: The patent-in-suit was assigned from the original assignee, Allergen Reduction Inc., to Plaintiff Latex Allergen Reduction, LLC on April 30, 2008.
Case Timeline
| Date | Event |
|---|---|
| 1997-04-30 | '004 Patent Priority Date |
| 1998-07-07 | '004 Patent Issue Date |
| 2008-04-30 | '004 Patent assigned to Plaintiff |
| 2010-01-08 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 5,777,004 - "Method Of Neutralizing Protein Allergens In Natural Rubber Latex Product Formed Thereby"
- Patent Identification: U.S. Patent No. 5,777,004, “Method Of Neutralizing Protein Allergens In Natural Rubber Latex Product Formed Thereby,” issued July 7, 1998.
The Invention Explained
- Problem Addressed: The patent describes the problem of allergenic reactions to proteins naturally found in rubber latex products, an issue that gained prominence with increased latex glove use following universal precautions against pathogens like HIV (’004 Patent, col. 1:12-34). Existing methods to reduce allergens were either prohibitively expensive, such as wet-stripping or post-cure washing, or adversely affected the physical properties of the finished latex articles, such as through double centrifugation (’004 Patent, col. 1:53-2:15).
- The Patented Solution: The invention proposes a method of treating natural rubber latex with a combination of at least one protease enzyme and at least one peptidase enzyme (’004 Patent, Abstract). This dual-enzyme treatment is designed to enzymatically degrade the larger, allergenic proteins into smaller peptide fragments and amino acids that are too small to elicit an allergic reaction in humans, thereby neutralizing the allergenicity without compromising the latex's physical characteristics (’004 Patent, col. 2:22-34).
- Technical Importance: The invention provided an economically feasible way to create non-allergenic latex products that retained the physical properties of conventionally manufactured latex, addressing a significant need in the medical and consumer products industries (’004 Patent, col. 2:18-21).
Key Claims at a Glance
- The complaint asserts independent claims 1, 11, 24, 25, 26, and 28.
- Independent Claim 1 (Method):
- A method of neutralizing protein allergens in natural rubber latex
- comprising treating the natural rubber latex with a protease enzyme and a peptidase enzyme
- such that the protein allergens contained within the natural rubber latex are degraded to polypeptide fragments and amino acids which are non-allergenic to humans.
- Independent Claim 24 (Product-by-Process):
- A protein allergen-free natural rubber latex
- produced according to the method of claim 1.
- The complaint reserves the right to assert dependent claims, including claims 2, 3, 27, and 29 (Compl. ¶14).
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are "enzyme-treated natural rubber latex gloves," which the complaint notes are sometimes referred to as "Allotex" products (Compl. ¶¶8-9). The complaint also targets the method of manufacturing these gloves, alleging infringement under 35 U.S.C. § 271(g) for products made abroad and imported into the U.S. (Compl. ¶15).
Functionality and Market Context
- The complaint alleges, upon information and belief, that Dynarex uses a manufacturing facility near Beijing, China, to treat natural rubber latex with enzymes "for the purpose of reducing the allergy-causing content" (Compl. ¶12). It is further alleged that Dynarex markets these products with the claim that they "contain as much as 99 percent fewer allergy-causing components than untreated natural rubber latex" (Compl. ¶10). The accused gloves are allegedly sold and distributed to customers within the Northern District of Illinois (Compl. ¶11). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
'004 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of neutralizing protein allergens in natural rubber latex comprising treating the natural rubber latex with a protease enzyme and a peptidase enzyme | Defendant allegedly "treats natural rubber latex with enzymes...for the purpose of reducing the allergy-causing content of natural rubber latex to make gloves." | ¶12 | col. 11:46-49 |
| such that the protein allergens contained within the natural rubber latex are degraded to polypeptide fragments and amino acids which are non-allergenic to humans. | Defendant claims that its accused products "contain as much as 99 percent fewer allergy-causing components than untreated natural rubber latex." | ¶10 | col. 2:29-34 |
- Identified Points of Contention:
- Technical Questions: A primary question will be whether the "enzymes" allegedly used by the Defendant (Compl. ¶12) correspond to the specific combination of "a protease enzyme and a peptidase enzyme" required by the claim. The complaint does not specify the type or number of enzymes used in the accused process. The patent suggests that treatment with only a protease or only a peptidase is insufficient to eliminate allergens, raising the question of whether the specific combination is essential for infringement (’004 Patent, col. 11:24-34).
- Scope Questions: The complaint alleges the accused products have "99 percent fewer allergy-causing components" (Compl. ¶10). A central issue will be whether this alleged reduction meets the claim limitation that allergens are "degraded to polypeptide fragments and amino acids which are non-allergenic to humans." The patent specification provides a more specific definition, suggesting this means degradation to peptides of "seven or fewer amino acid residues" (’004 Patent, col. 3:9-12). The court will need to determine if the alleged 99% reduction satisfies this functional and structural outcome.
V. Key Claim Terms for Construction
The Term: "a protease enzyme and a peptidase enzyme"
Context and Importance: This phrase is the core of the claimed method. The infringement analysis will depend on whether the Defendant's process, which allegedly uses "enzymes" (Compl. ¶12), uses this specific combination. Practitioners may focus on this term because the patent's own examples distinguish between the ineffective results of using these enzymes singly versus the effective result of using them in combination (’004 Patent, Table 7, col. 11).
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The complaint does not provide sufficient detail for analysis of this element.
- Evidence for a Narrower Interpretation: The patent consistently discusses proteases and peptidases as distinct categories of enzymes required for the invention (’004 Patent, col. 2:25-29). The specification presents a two-step preferred embodiment where the latex is first treated with a protease and then separately with a peptidase, reinforcing their distinct roles (’004 Patent, col. 2:39-47). Table 7 explicitly shows that using an alkaline protease alone (Sample B) or an amino peptidase alone (Sample C) failed to eliminate allergens, whereas their combined use (Sample A) was successful, which may support a construction requiring two distinct enzyme types (’004 Patent, col. 11:24-34).
The Term: "non-allergenic to humans"
Context and Importance: This term defines the required outcome of the treatment and sets the standard for infringement. Its definition will be critical in determining whether the accused products, alleged to have "99 percent fewer allergy-causing components" (Compl. ¶10), actually meet the claim limitation.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term itself is functional. A party might argue that any process that renders the final product non-allergenic by a commercially or medically accepted standard meets this limitation.
- Evidence for a Narrower Interpretation: The specification provides a more concrete, structural definition, stating that the invention works by degrading proteins into "small peptides and amino acids which then are not capable of causing Type-I allergenicity in humans" (’004 Patent, col. 2:62-65). It further quantifies this, noting "hydrolysis products produced by the present method have an average molecular weight which is lower than what is required to cause an allergenic reaction in humans, generally on the order of seven or fewer amino acid residues" (’004 Patent, col. 3:7-12). This language could support a narrower construction requiring proof of degradation to a specific molecular size.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that the Defendant’s acts of infringement "were and continue to be done with Dynarex's knowledge that the process utilized...is covered by LAR's 004 Patent" (Compl. ¶16). This allegation of knowledge could be used to support a claim for induced infringement, although one is not explicitly pleaded as a separate count. The complaint also pleads infringement under 35 U.S.C. § 271(g), alleging the knowing importation and sale of gloves manufactured abroad using the patented process (Compl. ¶15).
- Willful Infringement: Plaintiff explicitly prays for a finding that Dynarex has "willfully and deliberately infringed" (Compl., Prayer for Relief ¶B). This allegation is supported by the same assertion of "knowledge" of the ’004 Patent (Compl. ¶16).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of process identification: what specific enzyme or combination of enzymes does the accused Dynarex process actually use? The case may turn on whether discovery reveals the use of both a protease and a peptidase, as distinguished from a single enzyme or a different combination of enzymes.
- A key question of claim construction and infringement will be one of functional outcome: does the accused product's alleged "99 percent fewer allergy-causing components" satisfy the claim requirement that protein allergens are degraded into "non-allergenic" fragments? The resolution will depend on whether this limitation is construed as a general reduction in allergenicity or as a more specific requirement for degradation to a particular molecular size, as suggested by the patent's specification.