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Latex Allergen Reduction, LLC v. Dynarex Corporation

April 21, 2011

LATEX ALLERGEN REDUCTION, LLC, PLAINTIFF/COUNTER-DEFENDANT,
v.
DYNAREX CORPORATION,
DEFENDANT/COUNTER-PLAINTIFF.



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

MEMORANDUM OPINION AND ORDER

Plaintiff Latex Allergen Reduction, LLC ("LAR") has brought this suit against defendant Dynarex Corporation ("Dynarex") for patent infringement of LAR's U.S. Patent 5,777,004 (the "'004 Patent"). The '004 Patent is directed to a method of neutralizing protein allergens found in natural rubber latex. '004 Patent, Col. 2, lines 24-25. The proteins in natural rubber latex that cause allergic reactions are made of chemical chains called "peptides," which are themselves chemical chains of amino acids. The patented invention relies on a protease enzyme and a peptidase enzyme to break down or degrade the protein allergens in the natural rubber latex so that the remaining particles are "too small to elicit an allergic reaction in humans." Id. at Col. 4, lines 1-3. The preferred method of the '004 Patent involves a two-step process for treating natural rubber latex. Id. at Col. 5, line 29 - Col. 6, line 46. In the first treatment step, a protease enzyme solution is applied to the latex. In a second step, a peptidase enzyme solution is introduced to continue the process of breaking down the proteins. Id. at Col. 6, lines 12-13. The patent explains that "[w]hen the protease treatment and the peptidase treatment yield the preferred [degree of chemical break down] the allergenicity of the latex is reduced below detectable levels." Id. at Col. 6, lines 41-46. The '004 Patent also states that the solutions of protease and peptidase enzymes can be simultaneously added in a single step. Id. at Col. 6, lines 49-54.

Because the parties disagree as to the meaning of certain terms and phrases used in the '004 Patent, this opinion construes those terms and phrases pursuant to Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995).

I.

"[T]he interpretation and construction of patent claims, which define the scope of the patentee's rights under the patent, is a matter of law exclusively for the court." Markman, 52 F.3d at 970-71. Claim terms "are generally given their ordinary and customary meaning," Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996), which is to say the meaning those words would have to a person of ordinary skill in the art at the time of the patent's effective filing date. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005). The so-called "intrinsic evidence," i.e., the claim language itself, the patent's specification, and its prosecution history, is of paramount significance in construing disputed terms. While "extrinsic evidence," i.e., everything else, may be helpful to understand the meaning of technical or scientific terms, such evidence is considerably less reliable than intrinsic evidence for determining "the legally operative meaning of claim language," id. at 1317.

Analysis of the intrinsic evidence always begins with the language of the claims. Vitronics, 90 F.3d at 1582. Next comes the patent specification, which "'is always highly relevant to the claim construction analysis.'" Phillips, 415 F.3d at 1314 (quoting Vitronics, 90 F.3d at 1582). Nevertheless, "limitations from the specification are not to be read into the claims." Golight, Inc. v. Wal-Mart Stores, Inc., 355 F.3d 1327, 1331 (Fed. Cir. 2004) (citations omitted). While a patentee is free to be his or her own lexicographer and ascribe a special definition to a given term, "any special definition given to a word must be clearly defined in the specification." Markman, 52 F.3d at 980. Like the specification, the prosecution history is considered reliable evidence of the meaning of claim terms, but it too "cannot 'enlarge, diminish, or vary'" the limitations in the claims. Id. (quoting Goodyear Dental Vulcanite Co. v. Davis, 102 U.S. 222, 227 (1880)).

With these general principles in mind, I turn to the claim terms in dispute.

II.

A. "non-allergenic to humans"

1. All Protein Allergens v. Two or More Protein Allergens

Claim 1 states:

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. '004 Patent, Col. 11, lines 40-45 (emphasis added). LAR begins by proposing that "non-allergenic to humans" means that only the protein allergens that are actually degraded are incapable of producing an allergic reaction in most humans. To get to this articulation, LAR first argues that I should look to the preamble*fn1 of Claim 1 to understand the antecedent basis for the phrase "the protein allergens." According to LAR, the use of the phrase "protein allergens" in the preamble*fn2 to Claim 1 means that the invention requires only that two or more protein molecules be "degraded," and that the latex itself need not be made non or less allergenic so long as two or more protein molecules are neutralized. LAR then uses this proposed understanding of "protein allergens" in the preamble to argue that "the protein allergens contained within the natural rubber latex" in Claim 1 is limited to two or more protein molecules. LAR goes on to explain that the clause "which are non-allergenic to humans" is plural and must modify "polypeptide fragments and amino acids" and not the singular noun, "latex." LAR suggests that "the prepositional phrase 'within the natural rubber latex' simply mirrors the language of the preamble and states where the protein allergens that are degraded are located." LAR Resp. at 15. LAR goes on to state that "the clear meaning of claim 1 is that those protein allergens that are degraded are degraded to polypeptide fragments and amino acids which are non-allergenic to humans." Id. (emphasis in original).

According to Dynarex, the claim language clearly "identifies which proteins need to be degraded: the protein allergens contained within the natural rubber latex." Dynarex Mem. at 10. The claim does not say "some protein allergens" or contain any other qualifier. Further, LAR's proposed construction should be rejected because it would deprive the invention of utility and render the claim invalid. According to Dynarex, "[d]egrading a small or limited quantity of the proteins contained with[in] the latex would clearly have no substantive effect on the allergenicity of the latex, and, thus, provide no utility." Id.

A preliminary issue I must address is whether Claim 1 requires that all the protein allergens contained within the natural rubber latex be degraded to a certain level (as advanced by Dynarex) or whether only two or more protein molecules must be degraded (as advanced by LAR). I conclude that the plain language of Claim 1 indicates that all the protein allergens contained within the latex must be degraded. The language of claim 1 expressly describes which protein allergens ("the" protein allergens contained within the natural rubber latex) must be degraded. Because I do not see any ambiguity in this language, I reject LAR's suggestion that I look to the preamble as an antecedent basis for the phrase "the protein allergens." See The United States Patent and Trademark Office Manual of Patent Examining Procedure 2173.05(e)(explaining that an antecedent basis is required in drafting a claim when the term is so vague or general that it would otherwise be invalid for indefiniteness); see also Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999) ("If the body of a claim fully and intrinsically sets forth the complete ...


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