Case 2:13-cv-00391-ES-JAD Document 407 Filed 11/06/17 Page 1 of 26 PageID: 7848
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`Not for Publication
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`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`Civil Action No. 13-0391 (ES) (JAD)
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`OPINION
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`JAZZ PHARMACEUTICALS, INC.,
`and JAZZ PHARMACEUTICALS
`IRELAND LIMITED,
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`Plaintiffs,
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`v.
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`AMNEAL PHARMACEUTICALS,
`LLC, et al.,
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`Defendants.
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`SALAS, DISTRICT JUDGE
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`Before the Court is the parties’ request for claim construction. The Court held a Markman
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`hearing on April 27, 2017. (D.E. No. 350). This Opinion sets forth the Court’s constructions of
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`the disputed terms.
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`I. Background1
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`Plaintiffs Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited (together,
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`“Jazz”) market the drug product XYREM®, which is used to treat patients with two of the most
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`prevalent symptoms of narcolepsy: excessive daytime sleepiness and cataplexy. Defendants2 filed
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`Abbreviated New Drug Applications with the FDA seeking approval to market generic versions
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`of XYREM®. Jazz sued Defendants for patent infringement under 35 U.S.C. § 100 et seq., alleging,
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`1
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`The Court draws these facts from the parties’ briefing and provides this background for contextual purposes
`only. Nothing in this section should be construed as a finding of fact by this Court.
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`2
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`The Defendants in this case are Amneal Pharmaceuticals, LLC (“Amneal”); Lupin Limited; Lupin
`Pharmaceuticals, Inc., Lupin Inc. (collectively, “Lupin”); Watson Laboratories, Inc. (“Watson”); and Par
`Pharmaceutical, Inc. (“Par”). Par did not participate in this Markman proceeding. (See D.E. No. 321 at 1 n.1; D.E.
`No. 315 at 2 n.1).
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`1
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`among other things, that Defendants’ proposed generic versions of XYREM® will infringe Jazz’s
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`patents.
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`XYREM® is sold as a concentrated oral solution that is diluted by the patient with water
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`prior to its use at bedtime. The active ingredient in XYREM® is sodium oxybate (also known as
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`gamma-hydroxybutyrate, or GHB). Under certain conditions, GHB may become chemically
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`unstable and break down. GHB solutions may also become prone to microbial contamination.
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`This Markman decision involves eleven patents stemming from two patent families: the
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`‘431 patent family and the ‘306 patent family.3 The ‘431 patent family covers pharmaceutical
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`compositions of GHB—and methods of making and using such pharmaceutical compositions—
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`that are chemically stable and microbial resistant, without the need for a preservative.
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`The ‘306 patent family (comprising what are known as “DDI”—or “drug-drug-
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`interaction”—patents) covers specific methods of treating sleep disorders in patients receiving
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`both GHB and valproate. Valproate (also known as divalproex sodium) is used as an
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`anticonvulsant and mood-stabilizing drug, primarily for treating epilepsy and bipolar disorder.
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`Significantly, valproate is involved in processes that can both raise and lower the levels of GHB
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`in a patient. So, the DDI patents claim methods for safely co-administering GHB and valproate to
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`treat patients with sleep disorders.
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`The parties submitted a Joint Claim Construction and Prehearing Statement identifying
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`seven disputed terms. (D.E. No. 315 (“Joint Stmt.”)). Following Markman briefing,4 the parties
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`3
`The ‘431 patent family comprises 9 patents: U.S. Patent Nos. 6,472,431 (“the ‘431 patent”); 6,780,889 (“the
`‘889 patent”); 7,262,219 (“the ‘219 patent”); 7,851,506 (“the ‘506 patent”); 8,263,650 (“the ‘650 patent”); 8,461,203
`(“the ‘203 patent”); 8,324,275 (“the ‘275 patent”); 8,859,619 (“the ‘619 patent”); and 8,952,062 (“the ‘062 patent”).
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`The ‘306 patent family comprises 2 patents: U.S. Patent Nos. 8,772,306 (“the ‘306 patent”) and 9,050,302
`(“the ‘302 patent”).
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`4
`(See D.E. No. 321 (“Jazz Open. Br.”); D.E. No. 323 (“Def. Open. Br.”); D.E. No. 333 (“Def. Resp. Br.”); &
`D.E. No. 334 (“Jazz Resp. Br.”)).
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`2
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`submitted an Amended Joint Claim Construction and Prehearing Statement reducing the number
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`of disputed terms to five. (D.E. No. 348 (“Am. Joint Stmt.”)).
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`II. Legal Standard
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`A. Basics of Claim Construction
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`A patent claim is that “portion of the patent document that defines the scope of the
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`patentee’s rights.” Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 835 (2015).5 When
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`the parties in a patent infringement action “present a fundamental dispute regarding the scope of a
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`claim term, it is the court’s duty to resolve it.” O2 Micro Int’l Ltd. v. Beyond Innovation Tech.
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`Co., 521 F.3d 1351, 1362 (Fed. Cir. 2008).
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`The words of a claim are generally given their ordinary and customary meaning, which is
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`“the meaning that the term would have to a person of ordinary skill in the art [(a “POSA”)] in
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`question at the time of the invention, i.e., as of the effective filing date of the patent application.”
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`Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005). To determine the ordinary and
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`customary meaning of a disputed term, the court must look to “those sources available to the public
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`that show what a [POSA] would have understood [the] disputed claim language to mean.” Id. at
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`1314.
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`B. Intrinsic and Extrinsic Evidence
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`“In determining the proper construction of a claim, the court has numerous sources that it
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`may properly utilize for guidance. These sources . . . include both intrinsic evidence (e.g., the
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`patent specification and file history) and extrinsic evidence (e.g., expert testimony).” Vitronics
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`Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
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`5
`Unless otherwise indicated, all internal citations and quotation marks are omitted, and all emphasis is added.
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`With respect to intrinsic evidence, “the claims themselves provide substantial guidance as
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`to the meaning of particular claim terms.” Phillips, 415 F.3d at 1314. Indeed, “the context in
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`which a term is used in the asserted claim can be highly instructive.” Id. Similarly, “[o]ther claims
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`of the patent in question, both asserted and unasserted, can also be valuable sources of
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`enlightenment as to the meaning of a claim term.” Id.
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`Importantly, the specification “is always highly relevant to the claim construction analysis”
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`and “is the single best guide to the meaning of a disputed term.” Id. at 1315 (quoting Vitronics,
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`90 F.3d at 1582). “[T]he specification may reveal a special definition given to a claim term by the
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`patentee” or “may reveal an intentional disclaimer, or disavowal, of claim scope by the inventor.”
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`Id. at 1316. Thus, “the specification necessarily informs the proper construction of the claims,”
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`and it is “entirely appropriate for a court, when conducting claim construction, to rely heavily on
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`the written description for guidance as to the meaning of the claims.” Id. at 1316-17. Notably,
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`however, the court may “not read limitations from the specification into claims.” Thorner v. Sony
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`Computer Entm’t Am. LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012). In particular, the Federal Circuit
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`has “repeatedly warned against confining the claims to . . . embodiments” described in the
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`specification. Phillips, 415 F.3d at 1323.
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`The court must also consider the patent’s prosecution history, i.e., “the complete record of
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`the proceedings before the PTO . . . includ[ing] the prior art cited during the examination of the
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`patent.” Id. at 1317. Although the prosecution history “often lacks the clarity of the specification
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`and thus is less useful for claim construction purposes,” it can nevertheless “inform the meaning
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`of the claim language by demonstrating how the inventor understood the invention and whether
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`the inventor limited the invention in the course of prosecution, making the claim scope narrower
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`than it would otherwise be.” Id.
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`The court may also rely on extrinsic evidence, i.e., “all evidence external to the patent and
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`prosecution history, including expert and inventor testimony, dictionaries, and learned treatises.”
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`Id. But, extrinsic evidence “is unlikely to result in a reliable interpretation of patent claim scope
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`unless considered in the context of the intrinsic evidence.” Id. at 1319.
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`C. Indefiniteness at the Markman Stage
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`Patent claims must “inform those skilled in the art about the scope of the invention with
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`reasonable certainty,” when read in light of the specification and prosecution history. Nautilus,
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`Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2129 (2014). A patent claim that fails to so inform
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`a POSA is indefinite. Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1340-41 (Fed. Cir.
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`2015). “A party challenging the validity of a patent must establish invalidity by clear and
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`convincing evidence.” Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283, 1294 (Fed. Cir.
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`2015) (citing Microsoft Corp. v. i4i Ltd. P’ship, 131 S. Ct. 2238, 2242 (2011)). “Of course, claims
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`are not indefinite merely because they present a difficult task of claim construction.” Halliburton
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`Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1249-50 (Fed. Cir. 2008). Rather, “if the meaning
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`of the claim is discernible, even though the task may be formidable and the conclusion may be one
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`over which reasonable persons will disagree,” the claim is sufficiently clear to avoid invalidity on
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`indefiniteness grounds. See id.
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`Claim indefiniteness presents a question of law, and district courts may find claims
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`indefinite at the Markman stage. See, e.g., Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364,
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`1368-74 (Fed. Cir. 2014) (affirming the district court’s indefiniteness ruling at claim construction
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`post-Nautilus); Mycone Dental Supply Co. v. Creative Nail Design, Inc., No. 11-4380, 2014 WL
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`3362364, at *4 (D.N.J. July 9, 2014) (“[I]ndefiniteness is a significant issue to be adjudicated at
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`claim construction . . . .”).6
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`III. Construction of Disputed Claim Terms
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`A. The ‘431 Patent Family
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`1. “Third Container Means”
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`Claim 17 of the ‘650 patent: “The set of claim 15, comprising a third container means capable
`of retaining a first container means, a second container means, and one or more delivery vehicles
`capable of administering the pharmaceutical composition to the patient.”7
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`Jazz
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`Defendants
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`The Court
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`“a container distinct from a
`first and second container”
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`This is a means-plus-function
`term under 35 U.S.C. § 112
`¶ 6; and it is indefinite.
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`This is a means-plus-function
`term under 35 U.S.C. § 112
`¶ 6; and it is indefinite.
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`i.
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`“Third Container Means” is a Means-Plus-Function Limitation
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`As a threshold matter, the parties dispute whether “third container means” is a means-plus-
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`function limitation. “A means-plus-function limitation recites a function to be performed rather
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`than definite structure or materials for performing that function.” Lockheed Martin Corp. v. Space
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`Systems/Loral, Inc., 324 F.3d 1308, 1318 (Fed. Cir. 2003). The relevant statutory language
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`provides that
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`[a]n element in a claim for a combination may be expressed as a means or step for
`performing a specified function without the recital of structure, material, or acts in
`support thereof, and such claim shall be construed to cover the corresponding
`structure, materials, or acts described in the specification and equivalents thereof.
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`6
`To be sure, courts often “decline to address indefiniteness arguments in claim construction because they are
`potentially dispositive, require a high burden of proof, and may more profitably be considered in connection with
`patent validity. Fresenius Kabi USA, LLC v. Fera Pharms, LLC, No. 15-3654, 2016 WL 5109142, at *9 (D.N.J. Sept.
`20, 2016) (collecting cases); see also Int’l Dev. LLC v. Richmond, No. 09-2495, 2010 WL 4703779, at *7 (D.N.J.
`Nov. 12, 2010) (“It may be true that determining indefiniteness of claim language is a question of law that is drawn
`from the court’s performance of its duty as the construer of patent claims, which is the same duty that gives rise to the
`Markman hearing . . . . However, this does not outweigh the practical considerations that militate against determining
`indefiniteness prior to the end of all discovery.”).
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`“Third container means” also appears in claim 18 of the ‘650 patent and claim 16 of the ‘619 patent.
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`6
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`35 U.S.C. § 112, ¶ 6.8
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`Use of the word “means” in claim language creates a presumption that § 112, ¶ 6 applies.
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`TriMed, Inc. v. Stryker Corp., 514 F.3d 1256, 1259 (Fed. Cir. 2008). This presumption, however,
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`can be rebutted in two ways. Sage Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1427 (Fed.
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`Cir. 1997). First, “where a claim uses the word ‘means,’ but specifies no function for the ‘means,’
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`it does not implicate section 112.” Id. Second, “where a claim recites a function, but then goes
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`on to elaborate sufficient structure, material, or acts within the claim itself to perform entirely the
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`recited function, the claim is not in means-plus-function format.” Id. at 1427-28. The second
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`scenario applies here.
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`The Federal Circuit has explained that “[s]ufficient structure exists when the claim
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`language specifies the exact structure that performs the functions in question without need to resort
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`to other portions of the specification or extrinsic evidence for an adequate understanding of the
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`structure.” TriMed, Inc., 514 F.3d at 1259-60. Courts “decide on an element-by-element basis,
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`based upon the patent and its prosecution history, whether § 112, ¶ 6 applies.” Cole v. Kimberly-
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`Clark Corp., 102 F.3d 524, 531 (Fed. Cir. 1996).
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`Jazz argues that “third container means” is not a means-plus-function limitation because
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`the claims containing that term recite sufficient structure. (Jazz Open. Br. at 5-8; Jazz Resp. Br.
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`at 6-9). Specifically, Jazz contends that the claims “describe[] a structure—a container—that is
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`used to hold other structures such as a first and second container and delivery vehicles.” (Jazz
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`Open. Br. at 8). According to Jazz, “Defendants recognize that the terms ‘first container means’
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`and ‘second container means’ recite sufficient structure because Defendants do not contend that
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`these terms fall under § 112, ¶ 6.” (Id.). And Jazz asserts that the claims’ functional description
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`8
`The applicable pre-AIA statute—35 U.S.C. § 112, ¶ 6—is identical to current 35 U.S.C. § 112(f).
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`for “third container means”—i.e., that the “third container means” is “capable of” performing a
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`function—does not convert the term into a means-plus-function limitation. (Id.).
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`Defendants counter that, as an initial matter, “third container means” is presumed to be a
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`means-plus-function limitation because the claim contains the word “means.” (Def. Open. Br. at
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`13; Def. Resp. Br. at 8). Defendants then argue that there is no evidence to rebut this presumption,
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`as the “claims plainly recite three functions for the ‘third container means’ and do not describe any
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`contemplated structure to perform those functions.” (Def. Open. Br. at 13). In fact, according to
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`Defendants, “there is no explicit structure at all recited for the ‘third container means.’” (Id. at
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`14) (emphasis in original). Rather, Defendants argue that “the word ‘container’ conveys the
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`general function of containing, not a specific structure.” (Id. at 15). Defendants further argue that
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`“even if ‘container’ could reasonably refer to some endless category of structures, it is far from
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`sufficient to rebut the means-plus-function presumption here.” (Id.). This is especially true,
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`Defendants submit, where “the same modifier is used for the distinct ‘first’ and ‘second’ means as
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`well.” (Def. Resp. Br. at 9) (emphasis in original).
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`The Court concludes that “third container means” is a means-plus-function limitation. At
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`the outset, the Court presumes that “third container means” invokes § 112, ¶ 6. This is because
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`the claims containing “third container means” use the term “means” to describe a limitation:
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`“capable of retaining a first container means, a second container means, and one or more delivery
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`vehicles.” See Biomedino, LLC v. Waters Tech. Corp., 490 F.3d 946, 950 (Fed. Cir. 2007). To be
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`sure, this presumption applies even though the claims recite “means” and not “means for.” See,
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`e.g., id. (“When a claim uses the term ‘means’ to describe a limitation, a presumption inheres that
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`the inventor used the term to invoke § 112, ¶ 6.”); Altiris, Inc. v. Symantec Corp., 318 F.3d 1363,
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`1375 (Fed. Cir. 2003) (same); Personalized Media Commc’ns, LLC v. Int’l Trade Comm’n, 161
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`F.3d 696, 703 (Fed. Cir. 1998) (same).
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`Next, to determine if this presumption is rebutted, the Court must assess whether the claims
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`specify the “exact structure that performs the functions in question without need to resort to other
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`portions of the specification or extrinsic evidence for an adequate understanding of the structure.”
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`TriMed, 514 F.3d at 1259-60. If the claims recite sufficient structure, then the presumption falls
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`and the term does not invoke § 112, ¶ 6. See id. Here, Jazz argues that “container” constitutes
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`sufficient structure to rebut the means-plus-function presumption. (Jazz Open. Br. at 5-8; Jazz
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`Resp. Br. at 6-9). The Court disagrees.
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`To start, the Court must look to the claims themselves to assess whether they recite
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`sufficient structure. So, what do the claims say about “third container means”? Only that it must
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`be capable of retaining a “first container means,” a “second container means,” and “one or more
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`delivery vehicles.” In other words, to the extent “container” refers to structure, the “third container
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`means” is “the only recitation of structure with the remainder [of the claim] pertaining solely to
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`the function of the means limitation.” See Unidynamics Corp. v. Automatic Prods. Int’l., Ltd., 157
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`F.3d 1311, 1319 (Fed. Cir. 1998).
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`For instance, the claims do not recite any information about how big the “third container
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`means” must be to carry out its functions, or what materials must comprise the “third container
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`means” so that it can carry out its functions. Cf. Cole, 102 F.3d at 531 (“An element with such a
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`detailed recitation of its structure, as opposed to its function, cannot meet the requirements of the
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`statute.”). And the other claimed items (“first container means,” “second container means,” and
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`“one or more delivery vehicles”) do not inform anything about the “third container means” because
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`they, too, have no description in the claims; one must consult the specification to learn what those
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`containers are. Thus, a POSA would not know, without consulting at least the specification, what
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`kind of container could or could not carry out the claimed functions. See TriMed, 514 F.3d at
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`1259-60. Accordingly, the presumption that “third container means” invokes § 112, ¶ 6 stands.
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`See id.
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`The absence of a detailed and specific structure distinguishes “third container means” from
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`two cases Jazz cites. (See, e.g., Jazz Open. Br. at 8). The first case, Cole, involved a patent for
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`disposable briefs used during toilet training. 103 F.3d at 526. Among other features, the briefs
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`contained separate absorbent layers that could easily be torn open and thrown away. Id. On appeal,
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`the Federal Circuit considered whether the term “perforation means” invoked § 112, ¶ 6. Id. at
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`530. Claim 1 in relevant part stated: “perforation means extending from the leg band means to the
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`waist band means through the outer impermeable layer means for tearing the outer impermeable
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`layer means for removing the training brief in case of an accident by the user.” Id. at 530. The
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`Federal Circuit found that the claim recited sufficient structure to rebut the means-plus-function
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`presumption. Id. at 531. In doing so, the Federal Circuit relied on the claims’ detailed description
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`of the structure, reasoning that “[t]he claim describes not only the structure that supports the tearing
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`function, but also its location (extending from the leg band to the waist band) and extent (extending
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`through the outer impermeable layer).” Id. The Federal Circuit concluded: “[a]n element with
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`such a detailed recitation of its structure, as opposed to its function, cannot meet the requirements
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`of the statute.” Id.
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`The second case, Envirco Corp. v. Clestra Cleanroom, Inc., involved a patent for a
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`centrifugal fan and filter assembly for clean-room environments. 209 F.3d 1360, 1361 (Fed. Cir.
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`2000). At issue during claim construction was the term “second baffle means.” Claim 1 stated in
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`relevant part:
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`second baffle means disposed radially outwardly of said centrifugal fan means and
`said first baffle means, said second baffle means having inner surfaces for directing
`the airflow from said centrifugal fan means inwardly of said primary housing and
`between said first baffle means and said filter means whereby air being introduced
`into said housing by said centrifugal fan means will be directed radially outwardly
`of said centrifugal fan means and guided by said first baffle means towards said
`second baffle means and thereafter by said second baffle means between said first
`baffle means and said air filter means.
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`Id. at 1363. The district court construed “second baffle means” as a means-plus-function
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`limitation. Id. On appeal, the Federal Circuit reversed, holding that “second baffle means” was
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`not a means-plus-function limitation because the claim recited sufficient structure for performing
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`the claimed function. Id. at 1364-65. The court observed that the term “baffle” itself is a structural
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`term and that the “dictionary definition of the word ‘baffle’ is a device (as a plate, wall or screen)
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`to deflect, check, or regulate flow.” Id. at 1365 (citing Webster’s Ninth New Collegiate Dictionary
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`124 (1990)).
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`But the Federal Circuit did not stop there. It also relied on the claims’ detailed recitation
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`of “second baffle means.” In the very next sentence, the Federal Circuit explained that
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`the claims describe the particular structure of this particular baffle (“having inner
`surfaces for directing airflow . . . radially outward . . . and thereafter . . . between
`said first baffle means and said air filter means”). This recital of structure conflicts
`with the statutory requirement that means-plus-function claim elements state a
`function “without the recital of structure.”
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`Id. (quoting 35 U.S.C. § 112, ¶ 6). Indeed, the Federal Circuit concluded that “the second baffle
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`limitation is not a means-plus-function claim element” because “the claims recite sufficient
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`structure, including details about the location and formational details about the second baffle.”
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`Id. Here, the claims do not recite anything about “third container means” other than what it must
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`be capable of doing. Consequently, a POSA would “need to resort to other portions of the
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`specification or extrinsic evidence for an adequate understanding of the structure.” TriMed, 514
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`F.3d at 1260.
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`Jazz also relies on Greenberg v. Ethicon Endo-Surgery, Inc., 91 F.3d 1580, 1583 (Fed. Cir.
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`1996). (Jazz Open. Br. at 8). In that case, the Federal Circuit called the term “container” a
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`“commonplace structural term[].” As Defendants correctly point out, however, the claim term at
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`issue in Greenberg did not recite “means” and was thus governed by the opposite presumption:
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`that means-plus-function requirements did not apply. (Def. Resp. Br. at 8-9 n.4); see Advanced
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`Ground Info. Sys., Inc. v. Life360, Inc., 830 F.3d 1341, 1347 (Fed. Cir. 2016) (“The failure to use
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`the word ‘means’ also creates a rebuttable presumption . . . that § 112, para. 6 does not apply.”).
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`And as discussed above, even if “container” is itself a structural term, the claims lack sufficient
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`information about “third container means” for a POSA to know, without consulting the
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`specification, what kind of container can perform the claimed functions.
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`ii.
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`“Third Container Means” is Indefinite
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`Because the Court finds that “third container means” is a means-plus-function limitation,
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`it must engage in a two-step process to construe the term. Asyst Techs., Inc. v. Empak, Inc., 268
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`F.3d 1364, 1369 (Fed. Cir. 2001). The first step “is to identify the function explicitly recited in
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`the claim.” Id. The second step “is to identify the corresponding structure set forth in the written
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`description that performs the particular function set forth in the claim.” Id. “Under this second
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`step, structure disclosed in the specification is ‘corresponding’ structure only if the specification
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`or prosecution history clearly links or associates that structure to the function recited in the claim.”
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`Med. Instrumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1210 (Fed. Cir. 2003).
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`“If the patentee fails to disclose adequate corresponding structure, the claim is indefinite.”
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`Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1352 (Fed. Cir. 2015); see also EON Corp. IP
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`Holdings, LLC v. AT&T Mobility LLC, 785 F.3d 616, 621 (Fed. Cir. 2015) (“Means-plus-function
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`claim limitations under § 112, ¶ 6 must satisfy the definiteness requirement of § 112, ¶ 2.”).
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`Case 2:13-cv-00391-ES-JAD Document 407 Filed 11/06/17 Page 13 of 26 PageID: 7860
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`First, the Court must identify the functions “third container means” performs. As noted
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`above, those functions are “retaining a first container means, a second container means, and one
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`or more delivery vehicles capable of administering the pharmaceutical composition to the patient.”
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`Second, the Court must determine whether the specification discloses sufficient structure
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`that corresponds to the claimed functions. Williamson, 792 F.3d at 1351. Where there are multiple
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`claimed functions, “the patentee must disclose adequate corresponding structure to perform all of
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`the claimed functions.” Id. at 1351-52.
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`Jazz argues that the specification “describes various container means.” (Jazz Open. Br. at
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`9) (citing ‘650 patent at col. 16, l. 1-38). And according to Jazz, the specification “provides a
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`structure for the third container means”—a container. (Id.) (citing ‘650 patent at col. 10, l. 3-6 and
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`col. 16, l. 2-7). In particular, Jazz asserts that the “third container means” can be an injection or
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`blow-molded plastic container. (Id.) (citing ‘650 patent at col. 16, l. 29-32). Jazz also asserts that
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`the “third container means” could be other “structures explicitly listed” in the specification, such
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`as a bottle or flask. (Jazz. Resp. Br. at 10). Jazz further contends that the specification includes
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`“other suitable storage means” that are “able to retain the structures recited in the claims.” (Id.).
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`Defendants first argue that “the specification and prosecution history lack any
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`corresponding structure clearly linked to the claimed “third container means.” (Def. Open. Br. at
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`16) (emphasis in original). Defendants note that the specification “not once mentions explicitly a
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`‘third container means’ of the invention.” (Id.). While Defendants acknowledge that the
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`specification refers generally to “container means,” they assert that the specification does so either
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`“in terms of pure function” or by listing “structures not tied in any way to the claimed ‘third
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`container means’ or its functions.” (Id. at 16-17) (emphasis in original). Rather, Defendants
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`contend that those structures are tied “to the first or second container means or delivery vehicle
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`Case 2:13-cv-00391-ES-JAD Document 407 Filed 11/06/17 Page 14 of 26 PageID: 7861
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`elements.” (Id. at 17) (citing ‘650 patent at col. 16, l. 12-14 (“the container means may itself be a
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`syringe, pipette, vial, ampule or other such like apparatus”); id. at col. 16, l. 22-25 (“The container
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`means will generally include at least one vial, test tube, flask, bottle, pouch syringe or other
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`container means.”); id. at col. 16, l. 35-36 (“Such an instrument may be a drinking cup, syringe,
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`pipette, or any such medically approved delivery vehicle.”)). According to Defendants, “[n]o one
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`would confuse these disclosed structures (e.g., syringe, pipette, vial) as corresponding to the
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`claimed ‘third container means.’” (Def. Open. Br. at 17). Alternatively, Defendants argue that, to
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`the extent the specification adequately links structure to “third container means,” “there is no
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`structure disclosed to achieve all three functions of ‘retaining’ the first and second container means
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`as well as one or more delivery vehicles.” (Id.).
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`The Court concludes that the specification lacks a corresponding structure for “third
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`container means.” First, the Court agrees with Defendants that the specification does not explicitly
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`link any structure to “third container means.” Jazz does not point the Court to any explicit
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`reference in the specification to a “third container means” of the invention.
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`The Court also concludes that the specification does not implicitly link any structure to
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`“third container means.” Jazz’s argument that the “third container means” can be a container is
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`unavailing because, under Federal Circuit law, the specification must identify the particular
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`structure that is used to carry out the claimed function. See Blackboard, Inc. v. Desire2Learn, Inc.,
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`574 F.3d 1371, 1385 (Fed. Cir. 2009) (“That ordinarily skilled artisans could carry out the recited
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`function in a variety of ways is precisely why claims written in ‘means-plus-function’ form must
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`disclose the particular structure that is used to perform the recited function.”). In other words, a
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`“patentee cannot avoid providing specificity as to structure simply because someone of ordinary
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`skill in the art would be able to devise a means to perform the claimed function.” Id.
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`Case 2:13-cv-00391-ES-JAD Document 407 Filed 11/06/17 Page 15 of 26 PageID: 7862
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`Although Jazz argues that the “third container means” could be “injection or blow-molded
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`plastic containers,” the specification suggests that those containers perform one function:
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`“containing the vials in close confinement for commercial sale.” See ‘650 patent at col. 16, l. 28-
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`31. The specification does not say anything about those containers retaining a “first container
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`means,” a “second container means,” and “one or more delivery vehicles”—functions the “third
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`container means” must be capable of doing. See Media Rights Techs., Inc., 800 F.3d at 1374-75
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`(finding the means-plus-function term “compliance mechanism” indefinite because the
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`specification did not recite any specific structure to perform all four claimed functions). The same
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`is true for the other structures listed in the specification, such as a bottle or flask. Accordingly, the
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`term “third container means” is indefinite under § 112, ¶ 2, and the claims reciting that term (claims
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`17 and 18 in the ‘650 patent and claim 16 in the ‘619 patent) are invalid. See Biomedino, 490 F.3d
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`at 950 (“If there is no structure in the specification corresponding to the means-plus-function
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`limitation in the claims, the claims will be found invalid as indefinite.”).
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`2. “the components are admixed sequentially” & “the com