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Latex Allergen Reduction, LLC v. Dynarex Corporation

December 15, 2011


The opinion of the court was delivered by: Elaine E. Bucklo United States District Judge


Plaintiff Latex Allergen Reduction, LLC ("LAR") sued Dynarex Corporation ("Dynarex") alleging that Dynarex sells or offers for sale latex gloves which infringe Patent No. 5,777,004 (the "'004 Patent"). The '004 Patent is directed to one or more methods of using enzymes to eliminate allergy-causing proteins contained in natural rubber latex in order to make the latex non-allergenic to humans. LAR alleges that Dynarex sells latex gloves manufactured using the claimed method.

On April 21, 2011, I construed a number of contested claim terms. Now before me is Dynarex's motion for summary judgment on Claims 1 and 11. Because plaintiff has made clear that it cannot withstand summary judgment on Claim 11, I grant Dynarex's motion with respect to Claim 11. In addition, for all the reasons given below, I also grant Dynarex's motion for summary judgment on Claim 1 of the '004 Patent.


Summary judgment is appropriate if "the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). Once the moving party shows that there is no genuine issue of material fact, the burden of proof shifts to the nonmoving party to designate specific facts showing that there is a genuine issue for trial. Celotex Corp. v. Catrett, 477 U.S. 317, 330 (1986).

An infringement analysis involves two steps. See J&M Corp. v. Harley Davidson, Inc., 269 F.3d 1360, 1366 (Fed. Cir. 2001). First, a court must determine as a matter of law the scope and meaning of the claims through claim construction. Id. Second, the construed claims must be compared to the allegedly-infringing device or method. Id.

Having already construed the claims at issue, I turn now to the second step. "To prove infringement, the patentee must show that the accused [method] meets each claim limitation either literally or under the doctrine of equivalents." Catalina Mktg. Int'l, Inc. v., Inc., 289 F.3d 801, 812 (Fed Cir. 2002). LAR argues that Dynarex's method literally infringes the '004 Patent. "Summary judgment of no literal infringement is proper when, construing the facts in a manner most favorable to the non-movant, no reasonable jury could find that the accused [method] meets every limitation recited in the properly construed claim." Id.

Dynarex argues that it is entitled to summary judgment because two limitations of the '004 Patent are not present in the method utilized in making its gloves. First, it argues that its gloves are not "non-allergenic to humans" because its gloves have detectable levels of protein allergens.*fn1 Second, Dynarex maintains that LAR cannot prove that the method used by Dynarex to make gloves uses two separate and distinct enzymes, wherein one enzyme is a protease enzyme and the other enzyme is a peptidase enzyme, and the two enzymes are not the same. Because I conclude that LAR has failed to put forward evidence which shows that the method utilized by Dynarex results in gloves which are "non-allergenic to humans," I need not address the issue of the two separate enzymes.

Turning, then, to the phrase "non-allergenic to humans," I construed that phrase to mean "the protein allergens contained within the natural rubber latex are degraded such that the natural rubber latex is incapable of producing an allergic reaction in any human as demonstrated by having non-detectable levels of protein allergens." 4/21/11 Opin. at 10. Dynarex argues that LAR has no testing or other evidence to prove that Dynarex sold or offered for sale any latex gloves having "non-detectable" levels of protein allergens.*fn2

A bit of background is required to understand LAR's response. Dynarex sells enzyme-treated latex gloves under the trade name Allotex. Dynarex acquired the rights to make and sell Allotex gloves in 2003 from Tillotson Healthcare, which was then in Chapter 11 reorganization and has since been liquidated. Dynarex has never manufactured latex or latex gloves itself, but instead contracts with suppliers to manufacture the gloves using the Allotex process.

According to Dynarex, gloves that are manufactured for sale by Dynarex are periodically tested for protein allergens before being shipped to Dynarex. The Dynarex production gloves are tested using either the LEAP test or the ASTM D6499 ELISA Inhibition Test. The LEAP test and ASTM D6499 ELISA Inhibition test are recognized in the field as being appropriate tests for determining whether latex gloves have detectable levels of antigens. Dynarex markets its gloves only as having "reduced allergenicity."

In support of its claim of infringement, LAR points to testing done in 1999 by Tillotson Healthcare, performed four years before Dynarex acquired the Allotex process.*fn3 According to LAR, there were two batches of Tillotson Healthcare gloves which, when tested for the presence of allergens, recorded a "nd," or "non-detect" result for protein allergens. Without addressing the fact that the tests were done by Tillotson Healthcare, and not Dynarex, LAR relies on these two batches from 1999 to argue that Dynarex has sold gloves which are "non-allergenic to humans."

In reply, Dynarex maintains that LAR has failed to put forward evidence that Dynarex, as opposed to Tillotson Healthcare, sold or offered for sale any gloves made with non-allergenic latex. Importantly, Dynarex has put forward evidence that all the tests done on Dynarex gloves have uniformly shown that the gloves have detectible levels of protein allergens. While LAR attempts to refute this by pointing to the Tillotson Healthcare tests, LAR has not identified any test on Dynarex gloves which show nondetectable levels of protein allergens.

LAR points to two pages in a power point presentation. LAR provides no context for the document and the author and audience are unknown. Neither page supports LAR's position, as it is impossible to discern what values the chart and graph assigned to the enzyme-treated proteins. Finally, in a single sentence, LAR points to Exhibits 8,9 and 10 as support. LAR provides no argument, explanation or context for these documents. It is not appropriate for a party to merely cite to three highly technical exhibits and expect the court to do its work for it. As a result, I find LAR has waived any argument that Exhibits 8, 9, and 10 support its position that Dynarex ...

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