Case 1:12-cv-01104-GMS Document 118 Filed 12/17/13 Page 1 of 15 PageID #: 1134

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

) ) ) ) ) ) ) ) ) ) ) )

SALIX PHARMACEUTICALS, INC. and DR. FALK PHARMA GmbH, Plaintiffs,

V.

Civil Action No. 12-1104-GMS

LUPIN LIMITED and LUPIN PHARMACEUTICALS, INC., Defendants.

________________________________ )

ORDER CONSTRUING THE TERMS OF U.S. PATENT NOS. 6,551,620; 7,547,451; 8,337,886; and 8,496,965
After having considered the submissions of the parties, and hearing oral argument on the matter, IT IS HEREBY ORDERED, ADJUDGED, and DECREED that, as used in the asserted claims of U.S. Patent Nos. 6,551,620 ("the '620 patent"), 7,547,451 ("the '451 patent"), 8,337,886 ("the '886 patent"), and 8,496,965 ("the '965 patent"): 1. The court adopts the parties' proposed construction for the term "pellet" to mean "small, free-flowing spherical or semi- spherical particles formed from an agglomeration of bulk drugs and excipients using wet mass extrusion/ spheronization." 1

The plaintiffs Salix Pharmaceuticals, Inc. ("Salix") and Dr. Falk Pharma GmbH ("Dr. Falk") (collectively, "plaintiffs") and the defendants Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively, "Lupin") agreed upon the construction of the term "pellet" in the Joint Claim Chart. (D.I. 84-1.) In the absence of a genuine dispute, the court will not construe this term. See 02 Micro International Ltd. v. Beyond Innovation Technology Co., Ltd., 521 F.3d 1351, 1360 (Fed. Cir. 2008); US. Surgical Corp. v. Ethicon, Inc., I 03 F .3d 1554, 1568 (Fed. Cir. 1997).

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2. The court adopts the parties' proposed construction for the term "mean maximal plasma concentration of the 5-aminosalicylic acid i'is reached at" to have its plain and ordinary meaning. 2 3. The term "matrix-forming polymer" is construed to mean "polymers, except pHsensitive enteric polymers, that are used to form the non gel-forming polymer matrix." At the Markman hearing, the plaintiffs clarified its position and stated that "matrixforming polymer or polymers are used in the creation of the polymer matrix," (Tr. 3 at 11:19-21 ), and that "the polymer matrix in the claims of the '965 patent is a non gel-forming polymer matrix," (id. at 68:1-10, 72:8-9). Plaintiffs also conceded the patentee disclaimed pH-sensitive enteric polymers during prosecution of the '620 patent. (See id. at 69:24- 70:6; JAllO.) Thus, the parties agree that the "matrix-forming polymer" means "polymers that are used to form the non gel-forming polymer matrix." (See Tr. at 69:22-24; D.I. 100 at 9.) But Lupin argues the specification and prosecution history of the patents-in-suit further limit the "matrix-forming polymer" to a member of the three specific polymers disclosed in the specification (Eudragit RS/RL/NE). (D.I. 100 at 5-9.) The court disagrees.
It is well established that courts "indulge a 'heavy presumption' that claim terms carry

their full ordinary and customary meaning unless the patentee unequivocally imparted a novel meaning to those terms or expressly relinquished claim scope during prosecution." Omega Eng 'g
Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003) (citations omitted). Additionally, the

"court will not limit broader claim language to [a] single [embodiment] 'unless the patentee has

After submission of claim construction briefing, but prior to oral argument, the parties reached agreement as to the meaning of this term. In the absence of a genuine dispute, the court will not construe this term. See 02 Micro Int'l., 521 F.3d at 1360; US. Surgical, 103 F.3d at I 568.
3

"Tr." refers to the Nov. 21, 2013 Markman Hearing Transcript. (0.1. 115.)

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demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction,"' Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1288 (Fed. Cir. 2009)

(quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)).
Here, the common specification teaches: Suitable matrix-forming polymers are, for example, those polymers which are known in the prior art as coating lacquers for delayed release pharmaceuticals, such as,for example, (meth)acrylic ester copolymers. Among the polymers which are essentially insoluble in the intestinal tract and permeable to intestinal fluids and the active compound, those are preferred which are insoluble or particularly preferably water-insoluble in the intestinal tract. Methyl acrylate copolymers and ammoniometh-acrylatc copolymers of the type such as can be obtained under the tradename Eudragit RS/RL/NE are particularly preferred. (JA067 at col. 3, 11. 43-5 (emphasis added).) The court finds the patentee did not use "words or expressions of manifest exclusion or restriction" to limit the matrix-forming polymer to the "particularly preferred" embodiments. See Abbott Labs, 566 F.3d at 1288. Indeed, the patentee did the exact opposite by using the words "for example" and "among the polymers." Accordingly, the court will not limit "matrix-forming polymer" to the Eudragit RS/RL/NE preferred embodiments. Similarly, the court finds Lupin's prosecution disclaimer arguments are meritless. During the prosecution of the '620 patent, which is the only patent-in-suit that specifically limits the matrix-forming polymer to Eudragit RS/RL/NE, the examiner rejected the pending claims as unpatentable over Marvola in view of Heafield. (See JA103.) The examiner stated that Marvola teaches a composition containing the active compound and a pH-sensitive enteric polymer in the core, such as Eudragit S, to control the drug release. While the examiner

acknowledged that Marvola does not teach use of Eudragit RS/RL/NE expressly disclosed in 3

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the patentee's application, the exammer concluded that a skilled artisan would have been motivated to use any of the Eudragit polymers in the Marvola composition because Heafield teaches that those polymers are equivalent and could be used "interchangeably." (See JAI 0304.) In response, the patentee distinguished the chemical and physical properties of Eudragit RS/RL/NE from Eudragit S; argued that they are not all interchangeable or workable in Marvola; and argued that the examiner's hind-site analysis was therefore not a valid basis for making the combination. (See JAil I.) The examiner accepted the patentee's argument and issued a Notice of Allowability. (JA207.) Thus, the prosecution history establishes the patentee only disclaimed pH-sensitive enteric polymers (like the Eudragit S polymer in Marvola), and did not make an unambiguous broad disclaimer of all matrix--forming polymers except for Eudragit RS/RL/NE. See Omega Eng'g, 334 F.3d at 1325 (finding doctrine of prosecution disclaimer only applies where "the alleged disavowing statements [are] both so clear as to show reasonable clarity and deliberateness, and so unmistakable as to be unambiguous evidence of disclaimer."). Likewise, the court is not persuaded by Lupin's prosecution disclaimer arguments relating to the '451 and '886 patents over the prior art '744 patent. During the '451 patent prosecution, the patentee stated the copolymer disclosed in the '744 patent was recited in a '451 patent claim as an enteric coating, not a matrix-forming polymer. The patentee added that it was not a suitable matrix-forming polymer because it dissolved in intestinal fluid. (See JA124.) The court does not agree with Lupin that those statements clearly and unambiguously disavow all coating lacquers for delayed-release pharmaceuticals. Plaintiffs correctly stated at the Markman hearing that experts are better suited to address the question of whdher there are coating lacquers
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that are not pH sensitive and would be suitable matrix-forming polymers. (See Tr. 71:2-19.) Further, during the '886 patent prosecution the patentee distinguished the '744 patent based on how it functioned, not on a specific controlled release profile. The '744 patent discloses a

controlled release tablet containing a multiplicity of drug reservoirs in the matrix, whereas the present invention is a pharmaceutical pellet formulation with an active compound in a non gelforming polymer matrix core, which is then coated with an enteric coating. (See JA168-70.) Thus, the court finds the specification and prosecution history do not limit the matrixforming polymer to the Eudragit RS/RL/NE polymers disclosed in the specification. The court therefore construes the term "matrix-forming polymer" to mean "polymers, except pH-sensitive enteric polymers, that are used to form the non gel-forming polymer matrix." 4. The term "non gel-forming polymer matrix" is construed to mean "a polymeric material that does not become a gel when in contact with fluid, and can be used for incorporation of, and controlled release of, an active ag1;!nt." The parties dispute whether the court should construe "non gel-forming polymer matrix" in its entirety or separately in its two constituent parts -- "non-gel forming" and "polymer matrix." The four patents-in-suit descend from a common parent application and share a

common specification. In the common specification, "polymer matrix" is always modified by "non-gel forming." The entire disputed term appears in the '620, '451, and '886 patent claims, while "polymer matrix" appears without the "non-gel forming" qualifier in the '965 patent claims. Lupin argues that the disputed term should be separated into its constituent parts to ensure that "polymer matrix" is construed consistently across all four closely-related patents. (D.I. 94 at 11.) The plaintiffs similarly argue that "non gel-ft)rming polymer matrix" and

"polymer matrix" should be construed consistently with each other according to their plain and
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ordinary meaning. (D.I. 102 at 1.) But the plaintiffs offer different constructions for the two terms. The plaintiffs propose "non gel-forming polymer matrix" should be construed as "a polymer or a composite of polymers that does not become a gel when in contact with fluid," (D.I. 92 at 8), while "polymer matrix," as used in the '965 patent, should be construed more broadly as "a polymeric material that can be used for incorporation of an active agent," (id. at 10). However, as noted above, the plaintiffs reconciled the discrepancy at the Markman hearing by conceding that "the polymer matrix in the claims of the '965 patent is a non gel-forming polymer matrix," (Tr. at 68:1-10, 72:8-9). The court shall begin with Lupin's proposed "polymer matrix" construction-- "a uniform mixture formed from mixing an active compound with a matrix-forming polymer, wherein the matrix-forming polymer controls the release of the active compound." (D.I. 94 at 11.) To support its "uniform mixture" limitation, Lupin argues the specification discloses that the "active compound" is "preferably homogeneously dispersed in the [polymer] matrix," and that the pellet cores are prepared by "intensively knead[ing]" a mixture including the active compound and matrix-forming polymer. (!d. at 17.) Lupin then cites extrinsic evidence and argues "[a] skilled artisan would understand that the purpose and effect of this 'intensive[] knead[ing]' is to ensure a uniform mixture of the active compound in the matrix forming polymer." (!d.) The court is not persuaded and agrees with the plaintiffs that the "uniform mixture" limitation is not supported by the specification. The specification does disclose a

preference for a homogeneous dispersion of the active ingredient in the polymer matrix, (JA067 at col.3, 11. 10-11 ), but "uniform mixture" does not appear in the specification. (See generally JA066-JA070.) As such, the specification does not contain any evidence that the patentee
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intended to redefine or disclaim the plain and ordinary meaning of "homogeneously dispersed."

See Omega Eng'g, 334 F.3d at 1323 (holding that courts "indulge a 'heavy presumption' that
claim terms carry their full ordinary and customary meaning unless the patentee unequivocally imparted a novel meaning to those terms or expressly relinquished claim scope during prosecution.") Accordingly, the court rejects Lupin's attempt to narrow the broad claim scope of "homogeneously dispersed" to mean "uniformly mixed." See Finjan, Inc. v. Secure Computing

Corp., 626 F.3d 1197, 1206 (Fed. Cir. 2010) (accepting the district court's rejection of a
construction that "would unjustifiably narrow the term's broad scope, which was not explicitly limited or redefined by the specification."). Similarly, the court finds Lupin's "formed from mixing an active compound with a matrix-forming polymer" limitation is improper. The specification teaches that [t]he pellet formulations according to the invention can be prepared according to conventional processes known to the person skilled in th~~ art. For example, the matrix material is first mixed with the active compound and, if appropriate, the further pharmaceutically tolerable additives and shaped to give pellets. (JA068 at col.4, 1. 66- col. 5, 1. 4.) Here again, the patentee did not use "words or expressions of manifest exclusion or restriction" to limit how the pellets are f01med. Accordingly, the court rejects Lupin's proposed limitation to narrow the scope of "polymer matrix." See Abbott Labs, 566 F.3d at 1288 (quoting Liebel-Flarsheim, 358 F.3d at 906) ("[C]ourt[s] will not limit broader claim language to [a] single [embodiment] 'unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction.'"). Finally, the court disagrees with Lupin that it
IS

the "matrix-forming polymer" that

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"controls the release of the active compound."

As stated in "matrix-forming polymer"

construction analysis above, the parties agree that the matrix-forming polymer forms the non gelforming polymer matrix. At the Markman hearing the plaintiffs stated "[t]he matrix-forming polymers do impart the controlled release properties. But the release is actually controlled by the non gel-forming polymer matrix. [It] impart[s] those properties into the dosage form. That is certain. We do agree with that." (Tr. At 17:13-17.) The plaintiffs' position is supported by the '620 patent prosecution history where the patentee distinguished how the present invention functioned from Marvola. The present invention provides controlled release formulations based on a matrix copolymer which is pH insensitive and essentially insoluble in the gastrointestinal tract. The matrix copolymers of the present invention impart controlled release properties to the dosage form by virtue of the form's permeability to intestinal fluids into the dosage form and the diffusion of the active compound out of the dosage form rather than a slow degradation of matrix polymers as in Marvola. (JA111 (emphasis added).) The plaintiffs more accurately characterize the prosecution history. The court therefore finds the pellet core -- the non gel-forming polymer matrix -- controls the release ofthe active compound. Next, the court addresses Lupin's proposed "non-gel forming" construction. Lupin

proposes "non-gel forming" should be construed as "hydrophobic and essentially insoluble" because the patentee disavowed hydrophilic and/or soluble polymer matrices in the specification and prosecution history. (D.I. 94 at 9.) Plaintiffs counter that Lupin's proposed "hydrophobic" construction imports a limitation that is not found in the intrinsic record, adds ambiguity, and excludes preferred embodiments. Further, plaintiffs charge the "essentially insoluble" limitation is unnecessary and redundant language already found in the claims. (D .I. 102 at 3-5.)

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Here, the common specification reveals that the patentee disclaimed gel-forming polymers, but he did not redefine "non-gel forming" to mean "hydrophobic." The pertinent specification language identifies and distinguishes a prior art French patent application: FR-A 2 692 484 discloses a tablet for the controlled release of [the active compound] in a hydrophilic matrix which consists of swellable polymers forming a gel barrier, and having an enteric coating. After dissolution of the coating, the matrix swells and forms a gel barrier through which the active compound diffuses out. (JA066 at col. 1, 11. 51-55 (emphasis added).) The patentee then distinguished the present invention from the prior art and disclaimed only gel-forming polymer matrices. The use of a swellable, gel-forming matrix such as described inFR-A 2 692 484 is not suitable for pellets having a diameter of [:S] 3mm, since on account of the small diameter the polymer is very rapidly penetrated by the water, eroded as a result, and the active compound would thus be released virtually immediately (about 30 min). In the context of the present invention, however, it has surprisingly been found that, if the active compound is present in the pellet core in a non gel-forming polymer matrix which is essentially insoluble and permeable to intestinal fluids and the active compound, a markedly reduced release of the active compound into the blood, with simultaneously increased local concentration of the active compound at the site of the disorder in the intestine, is guaranteed in comparison with aminosalicylic acid formulations already known in the prior art.
(!d. at col. 2, 11. 52-67 (emphasis added).)

The court finds that the patentee did not "clearly express an intent to redefine" "gelforming" as "hydrophilic" or "non-gel forming" as "hydrophobic." See Thorner v. Sony Camp.

Entm 'tAm. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012) ("A patentee must clearly set forth a
definition of the disputed claim term other than its plain and ordinary meaning . . . It is not enough for a patentee to simply disclose a single embodiment or use a word in the same manner in all embodiments, the patentee must clearly express an intent to redefine the term.") In

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describing the prior art, the patentee identified that the hydrophilic polymer matrix swells and forms a gel barrier. That does not amount to a declaration that every gel-forming polymer matrix is hydrophilic and every non gel-forming polymer matrix is hydrophobic. Further, the court finds that the specification does not contain any words or expressions of restriction that clearly disavow the broad claim scope of "non-gel forming" to restrict the claims to "hydrophobic" polymer matrices. See Abbott Labs, 566 F.3d at1288. The court's finding is bolstered by the fact that Lupin's "hydrophobic" construction would improperly exclude two of the three preferred matrix-fomting polymers disclosed in the specification, Eudragit RS and RL, which are also expressly claimed in claim 1 of the '620 patent. (See JA067 col. 3, 11. 52-54; JA070 col. 9, 11. 30-44; D.I. 103-2 at 140 (stating Eudragit RS and RL are hydrophilic).) The Federal Circuit has repeatedly held "[a] claim interpretation that excludes a preferred embodiment from the scope of the claim 'is rarely, if ever, correct."'

Globetrotter Software, Inc. v. Elan Computer Grp., Inc., 362 F.3d 1367, 1381 (Fed. Cir. 2004)
(quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996)). Moreover, the court agrees with the plaintiffs that construing "non gel-forming" as "hydrophobic" would introduce ambiguity because hydrophobic and hydrophilic are interrelated and relative terms. While polymer matrices may have varying degrees of hydrophobicity or hydrophilicity, in the context of the instant claims and inventions, a polymer matrix either forms a gel surface barrier (as described in FR-A 2 692 484) or it does not (as in the claimed invention). The court therefore it rejects Lupin's proposed "hydrophobic" limitation because it is not found in the specification, would exclude preferred embodiments, and would introduce 10

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ambiguity. However, Lupin's proposed "essentially insoluble" limitation does appear throughout the specification and in the prosecution history. As noted above, the specification discloses that "[i]n the context of the present invention ... the active compound is present in the pellet core in a non gel-forming polymer matrix which is essentially insoluble and permeable to intestinal fluids and the active compound ...." (JA066 at col. 2, ll. 58-62.) Indeed, the specification

repeatedly emphasizes that the non gel-forming polymer matrix/matrix-forming, non gel-forming polymer in the pellet core is "essentially insoluble in the intestinal tract and permeable to intestinal fluids and the active compound." (JA067 at col. 3, ll. 9-11, 41-43, 48-50.) The Federal Circuit has recognized, "there is sometimes a fine line between reading a claim in light of the specification, and reading a limitation into the claim from the specification."
Comark

Commc'ns, Inc. v. Harris Corp., 156 F.3d 1182,1186 (Fed. Cir. 1998). And "court[s] look[] to

whether the specification refers to a limitation only as a part of less than all possible embodiments or whether the specification read as a whole suggests that the very character of the invention requires the limitation be a part of every embodiment." Alloc, Inc. v. fTC, 342 F.3d 1361, 13 70 (Fed. Cir. 2003 ). The "essentially insoluble in the intestinal tract" specification statements strike the court as an example of the latter. Moreover, the patentee argued that the "essentially insoluble in the intestinal tract" property of the present invention polymer matrix distinguished it from a prior art patent to overcome an obviousness rejection during the prosecution of the '451 and '886 patents. (See JA123-24 ("The matrix of the '744 patent ... dissolves, disintegrates, degrades, hydrolyzes, solubilizes, is digested or undergoes like changes [in the intestines] .... Thus, contrary to the 11

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present application, the matrix of the '744 patent is destroyed in the intestinal fluid .... "); JA131 (same); JA156-57 (same); JA169-70 (same); and JA184 (same).) The court therefore finds the specification and prosecution history require the polymer matrix to be "essentially insoluble in the intestinal tract." Nevertheless, the "essentially insoluble in the intestinal tract" limitation is expressly identified in every independent claim of the four patents-in-suit. The court therefore sees no reason to impose it as a redundant limitation to the plain and ordinary meaning of "non-gel forming." See Advanced Med. Optics, Inc. v. Alcon Inc., 361 F. Supp. 2d 370, 380 (D. Del. 2005) (rejecting proposed construction as unduly repetitive and unnecessary because the construction "would have the claim language read 'corresponding to the [restriction of fluid flow through the handpiece] of the handpiece'").) In sum, "non gel-forming polymer matrix" and "polymer matrix" are construed consistently. The court rejects Lupin's "polymer matrix" limitations-- "uniform mixture formed from mixing an active compound with a matrix-forming polymer, wherein the matrix-forming polymer controls the release of the active compound." In addition, the court rejects Lupin's "non-gel forming" limitations- "hydrophobic and essentially insoluble." The court will impose a limitation regarding controlled release properties based on the prosecution history. The court

therefore adopts a modified version of plaintiffs' proposed plain and ordinary meaning and construes "non gel-forming polymer matrix" to mean "a polymeric material that does not become a gel when in contact with fluid, and can be used for incorporation of, and controlled release of, an active agent." 5. The term "polymer matrix" as used in the '965 patent is construed to mean "a polymeric material that does not become a gel when in contact with fluid, and can be 12

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used for incorporation of, and controlled release of, an active agent." 4 6. The term "homogeneously dispersed" is construed meamng.
1:0

have its plain and ordinary

Both parties agree that the term should be given its plain and ordinary meaning. (D.I. 92 at 17; D.I. 94 at 17.) But Lupin argues the plain and ordinary meaning of the term to a skilled artisan is "uniformly mixed." (D.I. 94 and 17.) The Court rejects Lupin's attempt to narrow the broad claim scope of "homogeneously dispersed" to "uniformly mixed" consistent with the analysis above, where the court rejected Lupin's "uniform mixtme" limitation on the "polymer matrix." See Finjan, 626 F.3d at 1206 (accepting the district court's rejection of a construction that "would unjustifiably narrow the term's broad scope, which was not explicitly limited or redefined by the specification."). 7. The term "about 4 hours" is construed to have its plain and ordinary meaning. The court rejects Lupin's proposed construction of"approximately 4 hours." (D.I. at 1819.) Lupin's rationale for the construction is that the "plaintiffs repeatedly relied upon the specific release profile of the claimed formulations to overcome prior art during the prosecution of the patent-in-suit." (!d. at 19.) The court finds, however, the mere substitution of the word "approximately" for "about" does not add any clarity to the scope of the claim.
See US.

Surgical, 103 F.3d at 1568 ("Claim construction is a matter ofresolution of disputed meanings

and technical scope, to clarify and when necessary to explain what the patentee covered by the

At the Markman hearing, plaintiffs stated "the polymer matrix in the claims of the '965 patent is a non gel-forming polymer matrix." (Tr. at 68:1-10, 72:8-9). Therefore, consistent with the extensive discussion regarding the "non gel-forming polymer matrix" above, the court construes "polymer matrix" as used in the '965 patent to mean "a polymeric material that does not become a gel when in contact with fluid, and can be used for incorporation of, and controlled release of, an active agent."

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claims, for use in the determination of infringement. It is not an obligatory exercise m redundancy."). Further, the Federal Circuit has observed that "it is rarely feasible to attach a precise limit to 'about,"' and that such qualifying language generally must "be understood in light of the technology embodied in the invention." Modine Mfg. Co. v. United States fTC, 75 F.3d 1545, 1554 (Fed. Cir. 1996), abrogated in nonrelevant part by Festa Corp. v. Shoketsu
Kinzoku Kogyo Kabushiki Co., 234 F.3d 558 (Fed. Cir. 2000) (en bane).

Accordingly, "[w]hen the claims are applied to an accm,ed device, it is a question of technologic fact whether the accused device meets a reasonable meaning of 'about' in the particular circumstances." !d.; see also Acumed LLC v. Stryker Corp., 483 F.3d 800, 806 (Fed. Cir. 2007) ("[A] sound claim construction need not always purge every shred of ambiguity. The resolution of some line-drawing problems ... is properly left to the trier of fact."); PPG Indus. v.
Guardian Indus. Corp., 156 F.3d 1351, 1355 (Fed. Cir. 1998) ("[A]fter the court has defined the

claim with whatever specificity and precision is warranted by the language of the claim and the evidence bearing on the proper construction, the task of determining whether the construed claim reads on the accused product is for the finder of fact."). The court therefore finds the term "about 4 hours" should be given its plain and ordinary meaning. See Phillips, 415 F.3d at 1314 ("In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words.").

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Dated: December 11 , 2013

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