Rowpar Pharmaceuticals Incorporated et al v. Lornamead Incorporated

Filing 93

ORDER re: 74 Brief (Non Appeal) filed by Lornamead Incorporated, 75 Brief - Opening filed by Micropure Incorporated, Rowpar Pharmaceuticals Incorporated. Signed by Judge David G Campbell on 3/25/2014. (DGC, nvo)

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1 WO 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT 7 FOR THE DISTRICT OF ARIZONA 8 9 Rowpar Pharmaceuticals Incorporated, et al., 10 Plaintiffs, 11 ORDER v. 12 No. CV-13-01071-PHX-DGC Lornamead Incorporated, 13 Defendant. 14 The Court held a Markman hearing on March 25, 2014. This order will set forth 15 16 the Court’s constructions of the disputed terms and phrases. 17 I. Background. 18 Plaintiffs Rowpar Pharmaceuticals, Inc. (“Rowpar”) and Micropure, Inc. 19 (“Micropure”) assert claims for misappropriation of trade secrets, breach of contract, and 20 patent infringement by Defendant Lornamead, Inc. (“Lornamead”). Doc. 1. 21 The United States Patent and Trademark Office issued United States Patent No. 22 6,017,554 (“the ’554 Patent”) on January 25, 2000. Dr. Perry Ratcliff, the founder of 23 Rowpar, is named as the inventor. Micropure is the assignee of the ’544 Patent. The 24 ’544 Patent teaches the use of chlorine dioxide in conjunction with a phosphate 25 compound. According to the specification, chlorine dioxide may be used to prevent and 26 treat fungal and bacterial infections of the rectal, vaginal, urethral, oral, nasal, ocular, and 27 auditory canal orifices, and other abnormal conditions of the epithelium. 28 dioxide is unstable in aqueous solutions at lower pH levels, which makes it difficult for Chlorine 1 use on areas of the human body. The phosphate compound has a dual role: it inhibits the 2 escape of chlorine dioxide at lower pH levels, and it acts as a surface tension reducing 3 agent. 4 Rowpar’s complaint alleges infringement of claims 2, 5, and 8-13 of the ’544 5 Patent by making, selling, and offering for sale a sulfate-free stabilized chlorine dioxide 6 toothpaste that was marketed and sold at Walgreens. Doc. 1, ¶¶ 47, 49. 7 II. Legal Standard. 8 A patent includes two basic components: (1) a written description of the invention, 9 which is referred to as the “specification” of the patent, and (2) the patent claims. The 10 claims of a patent define the scope of the invention to which the patentee is entitled. 11 Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005); see also Vitronics Corp. v. 12 Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Claim construction is a matter 13 of law exclusively within the province of the Court. Markman v. Westview Instruments, 14 Inc., 517 U.S. 370, 372 (1996). When construing a patent’s claims, the words of a claim 15 are generally given their ordinary and customary meaning. Phillips, 415 F.3d at 1312. 16 The ordinary and customary meaning of a claim term is the meaning that the term would 17 have to a person of ordinary skill in the art in question at the time of the invention, read 18 “not only in the context of the particular claim in which the disputed term appears, but in 19 the context of the entire patent, including the specification.” Id. at 1313. 20 When construing the claims, the Court should first look to the intrinsic evidence of 21 the patent, which includes the specification, file history, and patent prosecution. Id. The 22 specification is the primary basis for claim construction and the best source for 23 understanding a technical term in the proper context. Id. at 1315. In addition to the 24 specification and the claims themselves, the Court should also consider the patent’s 25 prosecution history. Id. at 1317; see also Graham v. John Deere Co., 383 U.S. 1, 33 26 (1966) (“[A]n invention is construed not only in the light of the claims, but also with 27 reference to . . . the prosecution history[.]”). 28 Extrinsic evidence may also be used to assist the Court’s claim construction. -2- 1 Extrinsic evidence consists of all evidence external to the patent and prosecution history, 2 including expert and inventor testimony, dictionaries, learned treaties, and other patents. 3 Phillips, 415 F.3d at 1317. Extrinsic evidence must not be used to vary or contradict 4 claim terms. Vitronics, 90 F.3d at 1584. 5 III. Construction of Disputed Terms. 6 A. 7 Rowpar originally disputed Lornamead’s assertion that the preambles to the 8 independent claims are limiting. Doc. 75 at 6. Rowpar now agrees with Lornamead that 9 the preambles are limiting. Id. Preamble of the Asserted Claims. 10 B. 11 The term “epithelium” is found in the preamble of every independent claim of the 12 ’544 Patent. Rowpar asserts that “epithelium” should be construed as “tissue covering 13 internal and external surfaces of the body, including gingival tissue (gums).” 14 Lornamead asserts that “epithelium” should be construed as “tissue lining the surfaces of 15 body cavities.” Doc. 74 at 19. The Court will adopt the general definition of “tissue 16 covering internal and external surfaces of the body.” Epithelium. Id. 17 The parties agree that neither the claims nor the specification provide a definition 18 of “epithelium.” The claims and specification do, however, shed some light on the 19 proper construction. The preamble to each claim refers to the “epithelium of the rectal, 20 vaginal, urethral, oral, nasal, ocular, and auditory canal orifices.” See, e.g., U.S. Patent 21 No. 6,017,554 col.15 ll.41-42. Lornamead asserts that the construction of “epithelium” 22 should therefore be limited to tissue that is part of the orifices identified in the preamble. 23 Doc. 74 at 20. Lornamead also points to language at multiple locations in the ’544 Patent 24 in which the term “epithelium” is used in connection with the body cavities identified in 25 the claim preambles. Doc. 74 at 20. For example, the ’544 Patent indicates that the 26 composition treats “abnormal conditions of the epithelium of bodily orifices.” U.S. 27 Patent No. 6,017,554 col.1 ll.14-15. 28 It is important to note that the term being construed consists of a single word: -3- 1 “epithelium.” If that word, standing alone, was construed to mean “tissue lining the 2 surfaces of body cavities” as Lornamead suggests, then the remainder of the phrase in 3 which it appears repeatedly – “of the rectal, vaginal, urethral, oral, nasal, ocular, and 4 auditory canal orifices” – would be superfluous. 5 constructions that render other terms superfluous. See CAE Screenplates Inc. v. Heinrich 6 Fiedler GmbH & Co. KG, 224 F.3d 1308, 1317 (Fed. Cir. 2000) (“In the absence of any 7 evidence to the contrary, we must presume that the use of . . . different terms in the 8 claims connotes different meanings.”); Primos, Inc. v. Hunter’s Specialties, Inc., 451 9 F.3d 841, 848 (Fed. Cir. 2006) (rejecting overlapping constructions that would render one 10 Courts generally should avoid of several distinct claim terms superfluous). 11 The first part of Rowpar’s proposed construction is consistent with definitions of 12 “epithelium” in pertinent dictionaries. See Doc. 78-2 at 4 (defining “epithelium” as cells 13 constituting “the covering of internal and external surfaces of the body.”); Doc. 78-3 at 6 14 (defining “epithelium” as “[t]he nonvascular cellular layer that covers the internal and 15 external surfaces of the body.”); Doc. 78-4 at 5 (defining “epithelium” as “the covering of 16 the internal and the external organs of the body[.]”); Doc. 78-5 at 4 (defining 17 “epithelium” as “[t]he purely cellular avascular layer covering all the free surfaces[.]”). 18 The Court concludes that the proper construction of the single word “epithelium” 19 is “tissue covering internal and external surfaces of the body.” The Court need not 20 expressly state, as Rowpar suggests, that “epithelium” includes gingival (gum) tissue, as 21 that is inherent in this general meaning of “epithelium.” 22 C. 23 The phrase “topical composition” is found in the preamble of every independent 24 claim in the ’544 Patent. Rowpar asserts that no construction is necessary. Doc. 75 at 7. 25 Lornamead asserts that “topical composition” should be construed as “a pharmaceutical 26 mixture of active and inactive ingredients for the treatment of ailments on the surface 27 tissues of the body.” Doc. 74 at 21. 28 Topical Composition. Neither the claims nor the specification provides a definition of “topical -4- 1 composition.” Lornamead points to uses of the phrase “topical composition” in the 2 preamble that are coupled with “[for] treating conditions of the epithelium” to argue that 3 “topical compositions” refers only to compositions for the treatment of ailments of the 4 surface tissues of the body. Doc. 74 at 22. Lornamead also argues that the term 5 “composition” refers to a pharmaceutical mixture for a therapeutic effect that contains 6 both active and inactive ingredients. Id. 7 The word “composition” is a general term in patent law that simply suggests a 8 mixture or combination. See 35 U.S.C. § 101 (“Whoever invents or discovers any new 9 and useful process, machine, manufacture, or composition of matter . . .”). Nothing in the 10 patent suggests that the single word “composition” is limited to a mixture of active and 11 inactive ingredients. Although some of the examples include such ingredients, the patent 12 never suggests that “composition” is intended to be limited by them. The Court agrees 13 with Rowpar that the patent’s use of the term “composition” imposes no limitations on 14 any of the claims and does not need to be construed. See Abbot Laboratories v. Bayer 15 HealthCare LLC, No. 09-40002-FDS, 2010 WL 4340565, at *4-5 (D. Mass. Oct. 25, 16 2010) (declining to construe “composition,” which “is a term of art in patent law, and is 17 not a term that normally requires interpretation.”). 18 Rowpar asserts that “topical” should be construed as “local application to part(s) 19 of the body” because in every instance where a “topical” composition or preparation is 20 used it is applied locally to a part of the body. Doc. 75 at 9-10. Lornamead argues that 21 “topical” means “for the treatment of ailments on the surface tissues of the body.” 22 Doc. 74 at 20. Lornamead’s definition does not require application of the composition 23 directly to the treated area of the body. An oral medication would satisfy its definition, 24 contrary to the descriptions contained throughout the patent. The Court largely adopts 25 Rowpar’s proposed construction of “topical.” The Court construes “topical” to mean “to 26 be applied locally to a part of the body.” 27 D. 28 The phrase “topical preparation” is found in every independent claim of the ’544 Topical Preparation. -5- 1 Patent. Rowpar asserts that the term should be construed as “a composition ready for 2 local application to part(s) of the body.” Doc. 75 at 8. Lornamead asserts that the term 3 should be construed as “a pharmaceutical mixture of active and inactive ingredients for 4 the treatment of ailments on the surface tissues of the body” – the same construction that 5 Lornamead proposes for “topical composition.” Doc. 74 at 25. Because the Court 6 construed the term “topical” above, it need only address “preparation.” 7 The parties agree that the claims provide a list of “preparation[s],” including 8 “liquid solutions, suspensions, semi-solids, salves, creams, and suppositories.” See U.S. 9 Patent No. 6,017,554 col.15 ll.48-50. Lornamead’s suggestion that “preparation” must be 10 construed to include active and inactive ingredients improperly attempts to impose 11 narrowing limitations on the claims that have no basis in the claim language. Nothing in 12 the patent suggests that “preparation” is limited to a mixture of active and inactive 13 ingredients. Although some of the examples include such ingredients, the patent does not 14 suggest that “preparation” is intended to be limited by such examples. The Court will not 15 impose narrowing constructions without support from the claim language. 16 Honeywell Int’l Inc. v. Universal Avionics Sys. Corp., 488 F.3d 982, 992-93 (Fed. Cir. 17 2007) (rejecting construction that imposed additional, narrowing limitations not found in 18 the claim language). See 19 Rowpar’s proposed construction of “topical preparation” accords more naturally 20 with the intrinsic and extrinsic evidence. The ’544 Patent uses the term “preparation” to 21 refer to nine compositions that “may be prepared” for a particular use. See, e.g., U.S. 22 Patent No. 6,017,554 col.12 l. 1 through col.14 l.62 (“Hypothetically, the following 23 composition may be prepared . . .); see also Id. at col. 7 ll.3-13 (detailing how a test 24 solution was “prepared.”). 25 something ready for a particular use. See Doc. 78-2 at 6 (“[A] medicine made ready for 26 use[.]”); Doc. 78-3 at 7 (“A substance, such as medicine, prepared for a particular 27 purpose.”); Doc. 78-5 at 8 (“[S]omething made ready, as a medicinal or other 28 mixture[.]”). Pertinent dictionaries also define a “preparation” as The Court concludes that “preparation” means “a composition for -6- 1 treatment.” Thus, “topical preparation” means “a composition for treatment to be applied 2 locally to a part of the body.” 3 E. 4 The phrase “total preparation” is found in claim 7 of the ’544 Patent. Rowpar 5 asserts that the phrase should be construed as “topical preparation” as construed above. 6 Lornamead asserts that the claim language and prosecution history provide “a strong 7 indication that ‘total preparation’ is a typographic error” and that the phrase should be 8 construed in the same manner as “topical preparation.” Doc. 74 at 36. Because the 9 parties agree that the phrase “total preparation” should be construed in the same manner 10 as “topical preparation,” the Court will adopt its construction of “topical” and 11 “preparation” above. Total Preparation. 12 F. 13 The phrase “retard escape” is found in every independent claim of the ’544 Patent. 14 Rowpar asserts that the phrase should be construed as “slow emission.” Doc. 75 at 11. 15 Lornamead asserts that it should be construed as “slow the production of chlorine dioxide 16 breakdown products during product storage.” 17 Rowpar’s proposed construction for three reasons. Retard Escape. Doc. 74 at 27. The Court prefers 18 First, Lornamead’s proposed construction introduces a limitation – “during 19 product storage” – which does not follow from the phrase’s ordinary meaning. Nor does 20 it follow from the use of the phrase in the patent, which uses this language: “retard escape 21 of the chlorine dioxide from said topical preparation.” 22 6,017,554 col.15 ll.55-56. Nothing in this phrase suggests that “retard escape” is limited 23 to the storage of the topical preparation, and the Court declines to add an unnecessary 24 limitation. See Aria Diagnostics, Inc. v. Sequenom, Inc., 726 F.3d 1296, 1300-01 (Fed. 25 Cir. 2013) (it is improper to introduce narrowing limitations not found in the claim 26 language). See, e.g., U.S. Patent No. 27 Second, the specification mentions “retard escape” only once, stating that “[t]he 28 addition of activating inhibitor phosphates to the stabilized chlorine dioxide reduces -7- 1 surface tension and retards the rapid escape of chlorine dioxide gas at the pH range of 6.5 2 to 7.0 typical of the orifices of the body.” U.S. Patent No. 6,017,554 col.15 ll.52-56. 3 Lornamead’s construction overlooks the fact that “retard escape” is used in connection 4 with retarding the escape of chlorine dioxide when the topical preparation is applied to 5 bodily orifices, not only when storing the preparation. 6 Third, after excluding the words “during product storage” from Lornamead’s 7 construction, it appears that the parties’ constructions are substantially the same. The 8 Court construes “retard escape” as “slow emission.” 9 G. Liquid Solution. 10 The phrase “liquid solution” is found in every independent claim of the ’544 11 Patent. Each of the independent claims requires that the claimed topical preparation be 12 “selected from the group consisting of liquid solutions, suspensions, semi-solids, salves, 13 creams, and suppositories.” See, e.g., U.S. Patent No. 6,017,554 col.15 ll.48-50. Rowpar 14 asserts that the phrase should be given its plain and ordinary meaning or, if it must be 15 construed, should be defined as “a dissolved mixture in liquid form of a solute and 16 solvent.” Doc. 75 at 12. Lornamead asserts that the phrase should be construed as “a 17 mixture of liquid ingredients and solid ingredients dissolved in the liquid ingredients.” 18 Doc. 74 at 28. 19 Neither the claims nor specification shed much light on the meaning of “liquid 20 solution.” The only intrinsic evidence is that “liquid solution” is an embodiment of a 21 “topical preparation.” Pertinent dictionaries do provide definitions of the term “solution” 22 that aid the Court’s analysis. See Doc. 78-2 at 7 (defining “solution” as “a homogenous 23 mixture of one or more substances (solutes) dispersed molecularly in a sufficient quantity 24 of dissolving medium (solvent). The solute may be a gas, liquid, or solid; the solvent is 25 usually liquid, but may be solid[.]”); Doc. 78-5 at 9 (defining “solution” as “[t]he 26 incorporation of a solid, a liquid, or a gas in a liquid or noncrystalline solid resulting in a 27 homogenous single phase.”). 28 Lornamead’s proposed construction requires the solute to originate as a solid, but -8- 1 none of the dictionaries consulted by the Court suggest that limited meaning. To the 2 contrary, some specifically state that the solute may be gas, liquid, or solid. In addition, 3 nothing in the claim language or specification suggests that the solute must be solid. See, 4 e.g., U.S. Patent No. 6,017,554 col.5 ll.60-67 (describing liquid solution prepared by 5 combining liquid solute with liquid solvent). Because the phrase “liquid solution” has a 6 plain and ordinary meaning that accords with the intrinsic evidence and relevant 7 dictionary definitions, the Court will construe is as “a dissolved mixture in liquid form of 8 a solute and solvent.” 9 H. Suspensions. 10 The term “suspensions” is found in every independent claim of the ’544 Patent. 11 Rowpar asserts that the term should be given its plain and ordinary meaning or, if it must 12 be construed, should be defined as “a dispersed mixture of particles in a liquid medium.” 13 Doc. 75 at 13. Lornamead asserts that the term should be construed as “a mixture of 14 liquid ingredients and solid ingredients that are reversibly dispersed in a liquid.” Doc. 74 15 at 28. The Court will adopt Rowpar’s proposed construction. 16 The intrinsic record does not significantly inform the meaning of the term 17 “suspension.” 18 Doc. 78-5 at 10 (defining “suspension” as “[c]oarse dispersion; the dispersion through a 19 liquid of a solid in finely divided particles of a size large enough to be detected by purely 20 optical means[.]”); Doc. 78-8 at 4 (defining “suspension” as “[a] system in which very 21 small particles (solid, semi-solid, or liquid) are more or less uniformly dispersed in a 22 liquid or gaseous medium.”). The dictionary definitions differ from one another. The 23 Federal Circuit has instructed, however, that “consulting dictionary definitions is simply 24 a first step in the claim construction analysis and is another reason why resort must 25 always be made to [the intrinsic evidence].” Brookhill-Wilk 1, LLC. v. Intuitive Surgical, 26 Inc., 334 F.3d 1294, 1300 (Fed. Cir. 2003). Pertinent dictionaries do provide definitions of “suspension.” See 27 The Court finds no basis in the intrinsic or extrinsic evidence for the portion of 28 Lornamead’s construction requiring that suspension components be “reversibly -9- 1 dispersed.” The Court will adopt Rowpar’s construction because it is broader than 2 Lornamead’s and comports with both dictionary definitions. 3 I. 4 The term “semi-solids” is found in every independent claim of the ’544 Patent. 5 Rowpar asserts that the term should be given its plain and ordinary meaning or, if it must 6 be construed, should be defined as “forms used for topical application that are not fully 7 solid, such as creams, gels, pastes, and lotions.” Doc. 75 at 14. Lornamead asserts that 8 the term should be construed as “a mixture that is neither solid nor liquid.” Doc. 74 at 9 28. The Court will adopt Rowpar’s proposed construction. Semi-Solids. 10 Several dictionary definitions shed light on the meaning of the term “semi-solid.” 11 See Doc. 78-9 at 4 (defining “semi-solid” as “having the qualities of both a solid and a 12 liquid: highly viscous[.]”); Doc. 78-10 at 4 (defining “semi-solid” as “[i]ntermediate in 13 properties, esp. in rigidity, between solids and liquids” or “[a] semisolid substance, such 14 as a stiff dough or firm gel.”). The Court rejects Lornamead’s proposed construction 15 because it is ambiguous. It would include a gas since gases are neither “solid nor liquid,” 16 but gases clearly are not “semi-solid.” 17 construction because it is consistent with the dictionary definitions and the specification 18 provides examples of semi-solid preparations including toothpaste, gels, gel mixtures, 19 and lotions. See, e.g., U.S. Patent No. 6,017,554 col.11 ll.61-67 (describing a toothpaste 20 preparation). The Court will adopt Rowpar’s proposed 21 J. 22 The term “salves” is found in every independent claim of the ’544 Patent. Rowpar 23 asserts that the term should be given its plain and ordinary meaning or, if it must be 24 construed, should be defined as “ointment.” Doc. 75 at 14. Lornamead asserts that the 25 term should be construed as “an ointment.” Doc. 74 at 28. The Court prefers Rowpar’s 26 construction only because it is not singular. Lornamead’s proposed construction of “an 27 ointment” is inconsistent with the plural “salves. 28 “ointment.” Salves. - 10 - The Court construes “salves” as 1 K. 2 The term “creams” is found in every independent claim of the ’544 Patent. 3 Rowpar asserts that the term should be given its plain and ordinary meaning or, if it must 4 be construed, should be defined as “any fluid mixture of thick consistency.” Doc. 75 at 5 15. 6 pharmaceutical emulsion, made of oil and water, for the treatment of body surfaces.” 7 Doc. 74 at 29. The Court will adopt Rowpar’s proposed construction. Creams. Lornamead asserts that the term should be construed more narrowly as “a 8 Lornamead’s proposed construction would limit “creams” to “emulsions” made of 9 oil and water. Doc. 75 at 15. The specification and claims are silent as to the meaning of 10 the term “cream,” and the intrinsic record provides no reason to conclude that “creams” 11 are limited as Lornamead suggests. The Court will not impose narrowing constructions 12 without support from the claim language. Honeywell Int’l Inc., 488 F.3d at 992-93. 13 L. 14 The term “suppositories” is found in every independent claim of the ’544 Patent. 15 Rowpar asserts that the term should be given its plain and ordinary meaning or, if it must 16 be construed, should be defined as “a medicated solid body intended for introduction into 17 an orifice of the body.” Doc. 75 at 15. Lornamead asserts that the term should be 18 construed more narrowly as “a solid pharmaceutical preparation designed for insertion 19 into the rectum, vagina or urethra.” Doc. 74 at 29. The Court will adopt Rowpar’s 20 proposed construction. Suppositories. 21 Both parties suggest that suppository means a solid body or preparation, but 22 Lornamead’s proposed construction would require that it be designed for insertion “into 23 the rectum, vagina, or urethra.” This limitation is not found in the intrinsic record. 24 Although Lornamead’s proffered dictionary definition lists the rectum, urethra, and 25 vagina as orifices suitable for suppositories, it does not suggest that the list is exhaustive. 26 Because the intrinsic evidence does not suggest Lornamead’s limitation, the Court will 27 not adopt it. Honeywell Int’l Inc., 488 F.3d at 992-93. 28 - 11 - 1 M. 2 The phrase “shelf life” is found in every independent claim of the ’544 Patent. 3 Rowpar asserts that the phrase should be construed as “stability over time of chlorine 4 dioxide at a pH in the range of about 6.0 to 7.4.” Doc. 75 at 16. Lornamead asserts that 5 the phrase should be construed as “the storage period of a product, during which it has 6 full pharmacological or cosmetic effect as defined by the manufacturer’s product 7 specifications.” Doc. 75 at 33. The Court will adopt Rowpar’s construction. Shelf Life. 8 Lornamead asserts that its proposed construction is derived from the claim 9 language and specification. Doc. 74 at 33. As Lornamead indicates, the phrase “shelf 10 11 12 13 14 life” is embedded in each independent claim: “. . . wherein the concentration of phosphate compound is in a range . . . to retard escape of the chlorine dioxide from said topical preparation, said topical preparation being at a pH in the range of about 6.0 to about 7.4, thereby increasing the shelf life and efficacy of said topical preparation.” 15 See, e.g., U.S. Patent No. 6,017,554 col.15 ll.54-59. Lornamead argues that “the claim 16 language clearly links the concentration of the phosphate compound with the pH range to 17 increase the product’s shelf life.” Doc. 74 at 33. Because the specification teaches that 18 the escape of chlorine dioxide can be inhibited by addition of a phosphate compound, 19 Lornamead argues that the construction of “shelf life” must reflect a measure of 20 continued potency. Id. But this definition would render unnecessary the word “efficacy” 21 which appears immediately after “shelf life” in the patent language quoted above. By 22 defining “shelf life” to include “full pharmacological or cosmetic effect,” Lornamead’s 23 definition would leave no need for the term “efficacy.” 24 Lornamead argues that Rowpar’s construction is “misleading because it relies 25 solely on the pH of the topical composition, whereas the specification clearly teaches that 26 it is the phosphate compounds that improve the stability of the chlorine dioxide” at a 27 given pH. Doc. 74 at 33-34. Lornamead also argues that Rowpar’s construction “implies 28 that ‘shelf life’ is solely related to chlorine dioxide and pH, when the specification and - 12 - 1 claims indicate that it is also related to the ‘phosphate compound[.]’” Id. at 34. The 2 Court does not agree. When read within the context of the claim, Rowpar’s construction 3 of “shelf life” accounts for the central feature of the claim – improved stability of 4 chlorine dioxide at a lower pH – without disregarding the fact that the stability is 5 achieved by the addition of a phosphate compound. 6 N. 7 The term “efficacy” is found in every independent claim of the ’544 Patent. 8 Rowpar asserts that the proper construction of “efficacy” is “effectiveness in said 9 treatment of [conditions] of the epithelium.” Doc. 75 at 17. Lornamead asserts that the 10 proper construction is “product’s ability to produce the desired effect when used 11 topically.” Doc. 74 at 34. Efficacy. 12 Lornamead identifies evidence in the claim language and specification that links 13 the term “efficacy” to the “shelf life” of the topical preparation. Taken together, these 14 terms indicate that the term “efficacy” is intended to reflect the ability of stabilized 15 chlorine dioxide to produce a beneficial result. 16 Lornamead’s proposed construction. Doc. 82-3 at 7 (defining “efficacy” as “[t]he extent 17 to which a specific intervention, procedure, regimen, or service produces a beneficial 18 result under ideal conditions.”). A dictionary definition buttresses 19 Rowpar asserts that the “preamble explicitly identifies the specific effect by which 20 efficacy is to be judged.” Doc. 75 at 17. For example, the topical preparation in claim 11 21 must be effective “for treating the epithelium of the rectal, vaginal, oral, anal, ocular, and 22 auditory canal orifices by reducing the occurrence of leukoplakia in the orifices.” U.S. 23 Patent No. 6,017,554 col.17 ll.44-47. The specification also teaches that the claimed 24 compositions can be used to treat specific bodily orifice maladies “by reducing the 25 presence of fungal and bacterial infections and leukoplakia[.]” Id. at col.4 ll.14-21. 26 Rowpar asserts that the proper construction of “efficacy” must focus on the capacity of an 27 accused product to produce a particular result and not on its intended or actual use. 28 Doc. 75 at 17; see Revolution Eyewear, Inc. v. Aspex Eyewear, Inc., 563 F.3d 1358, - 13 - 1 1369-70 (Fed. Cir. 2009) (finding that claim term required only that accused product had 2 a capacity to perform a function regardless of whether the accused product is actually 3 used to perform that function) (citing Intel Corp. v. United States Int’l Trade Comm’n, 4 946 F.2d 821 (Fed. Cir. 1991)). 5 The Court will adopt Rowpar’s construction. The words “desired effect” in 6 Lornamead’s proposed interpretation are ambiguous and appear to focus on the intent of 7 the manufacturer or users of the accused product, which is improper during claim 8 construction. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1353 (Fed. 9 Cir. 2001) (“We are not prepared to assign a meaning to a patent claim that depends on 10 the state of mind of the accused infringer.”). Rowpar’s proposed construction refers to 11 treatment of the specific conditions described in the patent. Contrary to Lornamead’s 12 assertion, Rowpar’s proposed construction is not misleading because it clearly ties 13 “efficacy” to “said treatment,” which entails treatments involving chlorine dioxide. 14 15 O. Chlorine Dioxide in a Concentration in the Range of About 0.005% to About 2.0%. 16 The phrase “chlorine dioxide in a concentration in the range of about .005% to 17 about 2.0%” is contained in independent claims 1, 2, 7, 8, 10, and 12 of the ’544 Patent. 18 Rowpar asserts that the phrase should be construed consistent with its plain and ordinary 19 meaning. Doc. 75 at 18. Lornamead argues that it should be construed as “chlorine 20 dioxide is present in a concentration from exactly .005% to 2.0%.” Doc. 75 at 14. 21 Lornamead asserts that because the claim language does not provide any guidance 22 on the amount of variability permitted in the claimed range, the range should be 23 construed “as being exact and non-variable.” Doc. 74 at 14. Because nothing in the 24 specification, prosecution history, or claim language identifies a concentration outside 25 this range, Lornamead argues that its “exact and non-variable” proposed construction is 26 suitable notwithstanding the use of the word “about” in the patent. See Pall Corp. v. 27 Micron Separations, Inc., 66 F.3d 1211, 1217 (Fed. Cir. 1995) (“[T]he word ‘about’ does 28 not have a universal meaning in patent claims, and the meaning depends on the - 14 - 1 technological facts of the particular case.”); Conopco, Inc. v. May Dept. Stores Co., 46 2 F.3d 1556, 1561 (Fed. Cir. 1994) (finding that the term “about” provides less flexibility 3 for the boundaries of a claimed range where the patent teaches that a specific value is 4 critical to the invention). Lornamead notes that the specification’s examples include a 5 maximum concentration of 0.2%, and indicate that the preferred concentration for most 6 patients of chlorine dioxide is between 0.005% and 0.5%. U.S. Patent No. 6,017,554 7 col.4 ll.35-36. In extreme cases, the specification indicates that the concentration could be 8 increased to 1.0-2.0%. Given this intrinsic evidence, Lornamead argues, the phrase 9 “chlorine dioxide in a concentration range of about 0.005% to about 2.0%” should be 10 narrowly construed. Doc. 74 at 16. 11 In Conopco, the patent claimed a range of relative weight ratios from “about 40:1 12 to 1:1.” 46 F.3d at 1561. The patent taught that adherence to the range was responsible 13 for the efficacy of the patented composition. Id. The claimant also emphasized the 14 importance of adhering to the range in the prosecution history. Id. The trial court 15 considered a ratio of 162.9:1 to be within the literal scope of the range, in part because 16 “about” allows a range to extend as far as the prior art would allow. Id. The Federal 17 Circuit rejected this conclusion and held that a person of ordinary skill in the art would 18 not have read “about” to encompass a fourfold increase in the specified numerical range. 19 The Court will not adopt Lornamead’s rigid construction. Conopco rejected a 20 claim construction in which “about” meant a fourfold increase in the claimed numerical 21 range, but it did not hold that the term “about” should be effectively deleted and the 22 claimed range strictly enforced. The Court concludes that “about” should be given its 23 plain and ordinary meaning. “About” does not ordinarily mean “exactly,” and the Court 24 cannot conclude that Lornamead’s narrow construction is warranted when the patent 25 itself uses “about” and does not require strict adherence to the range. If the Court is 26 required to apply the patent to specific facts, it may need to make a determination as to 27 the reasonable scope of “about,” as was required in Conopco. But the Court cannot now 28 conclude that “about” means “exactly.” - 15 - 1 P. 2 The phrase “at least 0.1% chlorine dioxide” is found in independent claims 5, 9, 3 11, and 13 of the ’544 Patent. Rowpar asserts that the term should be given its plain and 4 ordinary meaning. Doc. 75 at 19. Lornamead asserts that it should be construed to mean 5 that “chlorine dioxide is present in a concentration from 0.1% to no more than 2.0%.” 6 Doc. 75 at 17. The Court will adopt Rowpar’s construction. At Least 0.1% Chlorine Dioxide. 7 The phrase “at least” has been construed by the Federal Circuit to mean a range 8 with a defined lower limit. See Quantum Corp. v. Rodime, PLC, 65 F.3d 1577, 1582 9 (Fed. Cir. 1995). Lornamead asserts that because the examples in the specification teach 10 a maximum concentration of 2.0% chlorine dioxide, the Court should impose an upper 11 limit of 2.0%. Doc. 74 at 18. But Lornamead’s arguments for strictly limiting the top of 12 the range to 2.0% have been rejected above. Moreover, the ordinary meaning of “at 13 least” sets a lower limit on the claimed range but says nothing about the upper limit, and 14 Lornamead has not presented intrinsic evidence that the patentee intended the claims 15 using “at least” to have an upper bound. See 3M Innovative Prop. Co. v Tredegar Corp., 16 725 F.3d 1315, 1329-32 (Fed. Cir. 2013) (rejecting a “narrower construction” of a 17 claim’s plain language unless “required by the specification or prosecution history.”). 18 The Court concludes that the phrase should be given its plain and ordinary meaning, 19 which does not have a defined upper boundary. 20 Dated this 25th day of March, 2014. 21 22 23 24 25 26 27 28 - 16 -

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