UNITED STATES DISTRICT COURT
`FOR THE CENTRAL DISTRICT OF CALIFORNIA
`
`CASE NO. SACV 13-1436 AG (JPRx)
`
`CLAIM CONSTRUCTION ORDER
`
`)))))))))))))))
`
`ALLERGAN USA, INC. and
`ALLERGAN INDUSTRIE, SAS,
`
`Plaintiffs,
`
`v.
`
`MEDICIS AESTHETICS, INC., et al.
`
`Defendants.
`_________________________________
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`Exhibit 1027
`Prollenium v. Allergan
`
`

`

`BACKGROUND
`
`Plaintiffs Allergan USA, Inc. and Allergan Industrie, SAS (“Plaintiffs”) own or
`exclusively license United States Patent Nos. 8,450,475 (“‘475 Patent”) and 8,357,795 (“‘795
`Patent”). The patents claim injectable soft tissue fillers used to compensate for the effects of
`aging, and methods of preparing such fillers. Plaintiffs allege that Defendants Medicis
`Aesthetics, Inc., Medicis Pharmaceutical Corporation, Valeant Pharmaceuticals North America
`LLC, Valeant Pharmaceuticals International, and Valeant Pharmaceuticals International, Inc.
`(“Defendants”) infringe both patents. The parties dispute the meaning of three groups of claim
`terms and have agreed to the meaning of seven claim terms. (Jt. Claim Construction and
`Prehearing Statement, Dkt. No. 52.)
`
`LEGAL STANDARD
`
`Claim construction is an interpretive issue “exclusively within the province of the court.”
`Markman v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996). It begins with an analysis of
`the claim language itself, Interactive Gift Express, Inc. v. Compuserve, Inc., 256 F.3d 1323,
`1331 (Fed. Cir. 2001), since the claims define the scope of the patent right. Phillips v. AWH
`Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005). In construing the claim language, the Court begins
`with the principle that “the words of a claim are generally given their ordinary and customary
`meaning.” Id. (internal quotation marks omitted).
`“The ordinary and customary meaning is the meaning that the [claim] term would have to
`a person of ordinary skill in the art in question at the time of the invention.” Id. at 1313. “[T]he
`person of ordinary skill in the art is deemed to read the claim term not only in the context of the
`particular claim in which the disputed term appears, but in the context of the entire patent,
`including the specification.” Id. Where the patent itself does not make clear the meaning of a
`claim term, courts may look to “those sources available to the public that show what a person of
`skill in the art would have understood the disputed claim language to mean,” including the
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`prosecution history and “extrinsic evidence concerning relevant scientific principles, the
`meaning of technical terms, and the state of the art.” Id. 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.” Id. “In such circumstances general purpose dictionaries may be helpful.”
`Id. In other cases, claim terms will not be given their ordinary meaning because the
`specification defines the term to mean something else. Novartis Pharms. Corp. v. Abbott Labs.,
`375 F.3d 1328, 1334 (Fed. Cir. 2004); Kumar v. Ovonic Battery Co., Inc., 351 F.3d 1364, 1368
`(Fed. Cir. 2003). For the specification to define a term to mean something other than its
`ordinary meaning, it must set out its definition in a manner sufficient to provide notice of that
`meaning to a person of ordinary skill in the art. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
`1994).
`
`ANALYSIS
`
`1.
`
`TECHNOLOGY OVERVIEW
`
`For its understanding of the technology at issue, the Court relies on the intrinsic and
`extrinsic evidence submitted by the parties. Both patents relate to “injectable soft tissue fillers”
`and more specifically to “hyaluronic acid-based dermal and subdermal fillers including an
`anesthetic agent.” (‘475 Patent 1:16-19; ‘795 Patent 1:16-19.) Such fillers are injected into the
`face to temporarily fill wrinkles and lines that result from aging and environmental factors.
`(‘475 Patent 1:23-34.) Ideally, fillers should cause minimal discomfort upon injection, be long-
`lasting to require fewer injections, and not induce allergic responses. (‘475 Patent 1:35-41.) The
`FDA regulates fillers as medical devices. (See ‘475 Patent 1:42-45, 54-65.)
`Today, many dermal fillers use hyaluronic acid (“HA”) as a base. (Kablik et al.,
`Comparative Physical Properties of Hyaluronic Acid Dermal Fillers, 35 Dermatol. Surg. 302
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`(2009) (“Kablik”), Decl. of Elizabeth Flanagan in Supp. of Pls.’ Responsive Claim Construction
`Br., Dkt. No. 65-1, Ex. G 302.) HA is a water soluble polysaccharide made by the body that can
`bind to large amounts of water, adding volume to soft tissue such as skin. (‘475 Patent 1:66-2:6;
`Kablik 303.) HA also does not induce allergic responses, making it an excellent candidate for
`filler use. (‘475 Patent 2:2-6; Tezel and Fredrickson, The science of hyaluronic acid dermal
`fillers, 10 J. Cosmetic and Laser Therapy 35 (2008) (“Tezel”), Decl. of William F. Cavanaugh in
`Supp. of Defs.’ Claim Construction Br. (“Cavanaugh Decl.”), Ex. 1, Dkt. No. 54-1 36.)
`But in its natural state, HA degrades rapidly once injected, requiring frequent injections to
`keep wrinkles at bay. (Kablik 303-04; Tezel 37.) One way to address this problem is to link HA
`polymers—chains of HA—together using a chemical compound called a crosslinking agent.
`(‘475 Patent 2:15-19; Tezel 37.) As shown in the below figure, when uncrosslinked HA (image
`A) reacts with a crosslinking agent, the crosslinking agent may connect to one HA strand by
`bonding on one end and forming a pendant group (image C), or to two HA strands, linking them
`(image B):
`
`(Kablik 304.) “Whether chemical modification results in formation of a cross-link (a bond
`between two strands of HA) or a pendant group [a crosslinking agent bonded to only one strand
`of HA] is a function of the reaction conditions used by different manufacturers of HA fillers.”
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`(Kablik 304.) The crosslinking agent, such as 1,4-butanediol diglycidal ether (“BDDE”), forms
`a covalent bond with the HA polymer chain:
`
`(Tezel, Fig. 5 (“BDDE . . . crosslinking agent used to bind HA polymer chains to each other,
`transforming liquid HA solutions into gels. Both the primary hydroxyl site (-CH2OH) and
`secondary hydroxyl sites (-CHOH) within the HA monomeric unit are possible target sites for
`reactions with BDDE.”).)
`A crosslinked HA gel can be visualized as follows:
`
`(Pls.’ Opening Claim Construction Br. 3.) Scientists and clinicians often use the “degree of
`crosslinking” as a measure of the hardness of a crosslinked HA gel, because as the number of
`crosslinkages increase, the gel’s flexibility decreases. (Tezel 38.) The parties agree that “degree
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`of crosslinking” should be construed as “the percent weight ratio of crosslinking agent to HA
`monomeric units (HA disaccharide units) within the crosslinked portion of the HA based
`composition (i.e., (total mass of crosslinking agent / total mass of monomeric units) * 100)).” (Jt.
`Claim Construction and Prehearing Statement 3.) This is slightly different from the literature
`definition, which is based on counts, not weights: “to say that a dermal filler has a degree of
`crosslinking of 4% means that, on average, there are four crosslinker molecules for every 100
`disaccharide monomeric units of HA.” (Tezel 38.)
`Uncrosslinked HA is a liquid, but crosslinked HA is an insoluble gel that resists
`degradation. (Kablik 304-05; Tezel 36.) But crosslinked HA can be too viscous to inject into
`the skin through a fine gauge needle. (‘475 Patent 2:7-14.) To make the crosslinked HA gel
`easier to inject, some manufacturers add liquid uncrosslinked HA as a soluble fluid component,
`helping the filler move through small needles. (Kablik 305; Tezel 39.) But because
`uncrosslinked HA degrades quickly, the appropriate balance must be struck between cross-
`linked HA and uncrosslinked HA. (Kablik 305.)
`To mitigate injection discomfort, anaesthetic agents such as lidocaine are used. (‘475
`Patent 2:20-23.)
`
`2.
`
`OVERVIEW OF THE ‘475 AND ‘795 PATENTS
`
`The ‘475 Patent concerns HA-based soft tissue fillers that include at least one anesthetic
`agent. (‘475 Patent 2:36-41.) The HA-based compositions described in the patent have “an
`enhanced stability, relative to conventional HA-based compositions including, for example,
`lidocaine, when subjected to high temperatures and pressures.” (‘475 Patent 5:32-38.) The ‘475
`Patent claims compositions comprising (1) HA crosslinked with BDDE, (2) uncrosslinked HA,
`and (3) an anesthetic agent such as lidocaine. (‘475 Patent 16:40-18:59.) The specifications
`describe the concentration of HA in the compositions as between about 10 mg/mL and 40
`mg/mL. (‘475 Patent 5:51-58.) The specifications also describe the concentration of lidocaine
`as between about 0.1% and about 5% by weight of the composition. (‘475 Patent 6:13-16.)
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`An objective of the ‘475 Patent was to avoid the “partial or almost complete degradation
`prior to injection” that tended to occur in HA-based compositions that incorporated lidocaine.
`(‘475 Patent 2:15-32.) The ‘475 Patent teaches that such compositions were especially prone to
`degradation “during high temperature sterilization steps and/or when placed in storage for any
`significant length of time.” (‘475 Patent 2:27-28.) The specifications describe sterilization as
`“any method known in the art to effectively kill or eliminate transmissible agents” and an
`important step in making the HA-based compositions. (‘475 Patent 11:14-17.) Autoclaving is
`“[o]ne preferable method of sterilization of the filled syringes” that “can be accomplished by
`applying a mixture of heat, pressure and moisture to a sample in need of sterilization.” (‘475
`Patent 11:18-21.) Disinfectant gas and irradiation can also be used to sterilize dermal fillers.
`(See ‘475 Patent 11:29-44.)
`The ‘795 Patent also relates to HA-based soft tissue fillers that include at least one
`anesthetic agent. (‘795 Patent 2:36-41.) The ‘795 Patent is very similar to the ‘475 Patent, but
`discloses another experimental example, and contains a different set of claims. (‘795 Patent
`15:21-17:2, 19:20-22:27.)
`
`3.
`
`AGREED TERMS
`
`The Parties agree upon the following constructions:
`
`sterile
`(claims 1, 18, 27, 34)
`degree of crosslinking
`(claims 5-7, 18, 27, 31, 37)
`
`‘475 Patent
`substantially free of detectable, viable
`microorganisms
`the percent weight ratio of crosslinking agent
`to HA monomeric units (HA disaccharide
`units) within the crosslinked portion of the
`HA based composition (i.e., (total mass of
`crosslinking agent/ total mass of monomeric
`units)*100))
`The “crosslinked portion of the HA based
`composition” as used herein has the same
`construction as the other terms referring to
`“crosslinked HA,” as construed by the Court.
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`[X]% uncrosslinked HA by volume
`(claims 1, 2, 33, 36)
`
`[X]% free HA by volume
`(claim 27)
`
`sterile
`(claim 1)
`lidocaine is freely released in vivo
`(claim 1)
`extrusion force
`(claim 41)
`
`the percent weight ratio of uncrosslinked HA
`in a filler composition (i.e., ((mass of
`uncrosslinked HA in the composition/mass of
`total HA in the composition)*100)
`Uncrosslinked HA as used herein has the
`same construction as the “uncrosslinked HA”
`term, as construed by the Court.
`the percent weight ratio of free HA in a filler
`composition (i.e., ((mass of free HA in the
`composition / mass of total HA in the
`composition)*100)
`Free HA as used herein has the same
`construction as the “free HA” term, as
`construed by the Court.
`‘795 Patent
`substantially free of detectable, viable
`microorganisms
`plain and ordinary meaning
`
`the force that one must apply to expel a soft
`tissue filler composition through the needle in
`its assembled, intended delivery system
`
`(Jt. Claim Construction and Prehearing Statement, Dkt. No. 52.) These constructions will bind
`the parties. See MyMail, Ltd. v. Am. Online, Inc., 476 F.3d 1372, 1377-78 (Fed. Cir. 2007)
`(rejecting appellate challenge to claim construction agreed to by party in district court). But the
`Court makes one change. Ceteris paribus (other things being equal), the Court prefers to give
`the jury claim constructions in English. So, while a person of ordinary skill in the art would
`readily understand the Latin term “in vivo,” the Court construes “lidocaine is freely released in
`vivo” to mean “lidocaine is freely released in a patient’s body.”
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`4.
`
`CONSTRUCTION OF THE DISPUTED TERMS
`
`4.1
`
`“stable”
`
`Term
`stable
`(‘475 Patent
`claims 1, 18,
`27, 31, 34)
`
`Plaintiffs’ Proposed Construction Defendants’ Proposed Construction
`resists chemical and physical
`A sterile composition that maintains
`decomposition
`one of the following aspects:
`transparent appearance, pH, extrusion
`force and/or rheological characteristics,
`hyaluronic acid (HA) concentration,
`sterility, osmolarity, and lidocaine
`concentration, after being stored at
`about 25C for about two months
`
`‘475 Patent claim 1 is reproduced here for context with the disputed term in bold:
`
`1. A stable, sterile soft tissue filler comprising:
`a hyaluronic acid (HA) component comprising HA crosslinked with 1,4 butanediol
`diglycidyl ether (BDDE), and uncrosslinked HA, wherein the HA
`component comprises greater than about 10% uncrosslinked HA by volume,
`and
`lidocaine combined with said crosslinked component.
`
`(‘475 Patent 16:40-46.)
`Defendants agreed in their responsive brief to drop their request that the construction
`include the term “sterile composition,” the 25ºC storage temperature, and the two-month storage
`period. (Defs.’ Answering Claim Construction Br. 3.) The resulting proposed construction is
`“maintains one of the following aspects: transparent appearance, pH, extrusion force and/or
`rheological characteristics, hyaluronic acid (HA) concentration, sterility, osmolarity, and
`lidocaine concentration.” (S.P.R. 3.5.1 Chart of Proposed Constructions.)
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`Defendants argue that their construction relies on the definition of “stable” in the ‘475
`Patent, which Defendants argue is used throughout the patent to measure stability. (Defs.’
`Opening Claim Construction Br. 7-8.) But Plaintiffs respond that Defendants’ proposal comes
`from the ‘475 Patent’s definition of “autoclave stable,” and that the more general term, “stable,”
`should not be so limited. (Pls.’ Opening Claim Construction Br. 7-11.)
`While Plaintiffs argue that a person of ordinary skill in the art would understand their
`construction to be the plain and ordinary meaning of “stable,” they only support this argument
`with two dictionary definitions. (See Pls.’ Opening Claim Construction Br. 7-8.) Such “heavy
`reliance on the dictionary divorced from the intrinsic evidence risks transforming the meaning of
`the claim term to the artisan into the meaning of the term in the abstract.” Phillips, 415 F.3d at
`1321.
`
`To link their construction to the intrinsic record, Plaintiffs point to passages in the ‘475
`Patent discussing the conditions under which the compositions should be stable. (Pls.’ Opening
`Claim Construction Br. 8.) These passages do use “stable” without reciting the list of metrics
`that appears elsewhere in the specification, but they do not specifically address the meaning of
`the term. (See ‘475 Patent 2:7-17; 2:42-48.) Nothing in the specification suggests that “stable”
`carries a meaning divorced from the specific metrics discussed, and “[t]he claims of a patent are
`always to be read or interpreted in light of its specifications.” Phillips, 415 F.3d at 1316
`(quoting Schriber–Schroth Co. v. Cleveland Trust Co., 311 U.S. 211, 217 (1940).)
`Nor, as Plaintiffs argue, does the absence of discussion about the term in the prosecution
`history support a dictionary-based construction. (Pls.’ Opening Claim Construction Br. 9-10.)
`While the prosecution history does not contain a disclaimer of the scope of the term, it also
`contains nothing showing that the applicant or examiner understood the term to be as broad as
`Plaintiff’s proposed definition.
`Because it lacks a standard for measuring resistance to physical and chemical
`decomposition, Plaintiffs’ construction would frustrate a comparison of the patented invention to
`the allegedly infringing invention. “Courts construe claim terms in order to assign a fixed,
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`unambiguous, legally operative meaning to the claim.” Chimie v. PPG Industries, Inc., 402 F.3d
`1371, 1377 (Fed. Cir. 2005). Plaintiff’s construction is too vague to provide such a meaning.
`And, contrary to Plaintiffs’ argument, Defendants’ construction is not solely based on the
`patent’s definition of “autoclave stable.” The specification lists ways to measure the stability of
`the disclosed compositions: “The stable compositions maintain at least one of, or all of, the
`following aspects after effective autoclave sterilization and/or prolonged storage: transparent
`appearance, pH for use in a patient, extrusion force and/or rheological characteristics, HA
`concentration, sterility, osmolarity, and lidocaine concentration.” (‘475 Patent 5:39-44
`(emphasis added).)
`These metrics were not limited to stability during autoclaving. The specification again
`lists measures of stability that apply in circumstances beyond autoclaving: “the compositions
`maintain their integrity in terms of rheology, viscosity, appearance and other characteristics even
`when stored for a lengthy period of time . . . and even after being subjected to sterilization
`procedures, for example, autoclaving.” (‘475 Patent 6:49-54 (emphasis added).) These
`measures of stability apply to both sterilization and storage, thus linking Defendants’
`construction to all the disclosed types of stability.
`Defendants’ construction thus appropriately walks the “fine line between reading a claim
`in light of the specification, and reading a limitation into the claim from the specification.”
`Phillips, 415 F.3d at 1323 (quoting Comark Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182,
`1186–87 (Fed. Cir. 1998).) But Defendants’ construction says “one of” rather than “at least one
`of” as in the specification, and Defendant did not explain the change. The Court will therefore
`use the “at lease one of” language. Defendants’ construction, as thus modified, “stays true to the
`claim language and most naturally aligns with the patent’s description of the invention,”
`Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998).
`The Court therefore construes “stable” as “maintains at least one of the following aspects:
`transparent appearance, pH, extrusion force and/or rheological characteristics, hyaluronic acid
`(HA) concentration, sterility, osmolarity, and lidocaine concentration.”
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`4.2
`
`The “Crosslinked HA” Terms
`
`Term(s)
`
`HA crosslinked with 1, 4-
`butanediol diglycidyl ether
`(BDDE)
`(‘475 Patent claims 1, 31, 34)
`hyaluronic acid (HA)
`component crosslinked with 1,
`4 butanediol diglycidyl ether
`(BDDE)
`(‘475 Patent claim 18)
`(BDDE)-crosslinked
`hyaluronic acid
`(‘475 Patent claim 27)
`hyaluronic acid (HA)
`component crosslinked with a
`crosslinking agent
`(‘795 Patent claim 1)
`
`Plaintiffs’ Proposed
`Construction
`HA that forms a
`macromolecular structure
`resulting from chemical
`linking of HA by BDDE
`
`Defendants’ Proposed
`Construction
`HA that has been covalently
`modified with BDDE to form
`a macromolecular structure
`that is water-insoluble, such
`that the degree of
`crosslinking is at least about
`2% and is up to about 20%
`
`HA that forms a
`macromolecular structure
`resulting from chemical
`linking of HA by a
`crosslinking agent
`
`HA that has been covalently
`modified with a crosslinking
`agent to form a
`macromolecular structure
`that is water-insoluble, such
`that the degree of
`crosslinking is at least about
`2% and is up to about 20%
`
`The only difference between the ‘475 Patent crosslinked-HA terms and the ‘795 Patent
`crosslinked-HA term is that the ‘475 Patent’s claims specify BDDE as the crosslinking agent.
`The parties dispute (1) whether “chemical” or “covalently” should describe the bond formed by
`the crosslinking agent, (2) whether “linking” or “modified” should describe how HA and the
`crosslinking agent form a macromolecular structure, (3) whether “water-insoluble” needs to be
`included, and (4) whether the “degree of crosslinking” needs to be included.
`
`4.2.1 “Chemical” vs. “Covalent”
`
`Plaintiffs argue that “the plain meaning of ‘crosslink’ suggests that one material—a
`crosslinking agent—chemically connects two materials together.” (Pls.’ Opening Claim
`Construction Br. 13-14.) Plaintiffs cite the Random House Dictionary definition of “crosslink”:
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`“a bond, atom, or group linking the chains of atoms in a polymer or other complex organic
`molecule.” (Id.) Defendants argue that “covalently modified” more accurately describes the
`cross linkages and that Plaintiffs’ construction is too broad and vague. (Defs.’ Opening Claim
`Construction Br. 9.) Plaintiffs do not contest that the linkages connecting the HA strands to the
`BDDE molecules are covalent bonds. (Pls.’ Opening Claim Construction Br. 15, “[c]rosslinking
`agents are capable of forming two covalent bonds with HA.”) But Plaintiffs argue that using the
`technically accurate term “covalent” to describe the cross linkages will confuse the fact-finder.
`(Pls.’ Responsive Claim Construction Br. 3.)
`The specter of confusion is no excuse for imprecision. Chemical bonds include ionic
`bonds and covalent bonds. Volhardt and Schore, Organic Chemistry 7 (1997). An article
`Plaintiffs submitted with their briefs states: “[a] gel with a lower number of cross-links (covalent
`bonds) has a greater length of the HA molecule between links.” (Kablik 306 (emphasis added).)
`The same article specifically distinguishes between gels held together by (covalent) cross-
`linking and those more weakly held together by hydrogen bonding: “The HA modified with
`predominantly pendant groups forms gels that are held together by physical entanglement due to
`interchain hydrogen bonding. These gels are not as strong as the ones produced by creating a
`covalently cross-linked network.” (Kablik 310.)
`Thus, including “covalently” in the construction would give an appropriate level of
`precision to “resolve disputed meanings and technical scope in order to aid the fact-finder.” Bd.
`of Trs. of Leland Stanford Junior Univ. v. Roche Molecular Sys., Inc. 528 F. Supp. 2d 967, 982
`(Fed. Cir. 2009) (citing United States Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed.
`Cir. 1997)). The Court therefore includes “covalently” in the construction.
`
`4.2.2 “Linking” vs. “Modified”
`
`Defendants’ proposed construction omits an important concept by using “modified” in
`place of Plaintiffs’ “linked.” To be cross-linked, HA is not just modified with crosslinkers to
`create modified but unlinked HA. To the contrary, crosslinked HA has “intermolecular
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`junctions joining the individual HA polymer molecules, or monomer chains, into a permanent
`structure.” (‘475 Patent 4:62-65; ‘795 Patent 5:43-46 (emphasis added).) If the cross-linking
`agent bonds only on one of its ends, connecting to only one strand of HA, the HA polymer
`molecules are not joined. (See Kablik 304.) Defendants’ construction does not require the
`cross-linking agent to connect to HA strands on both ends, thus allowing modification without
`cross-linkage. Defendants argue that the rest of its construction—“to form a macromolecular
`structure that is water-insoluble”—precludes such an interpretation. (Defs.’ Answering Claim
`Construction Br. 4). But there is no reason to introduce the ambiguity, just as ambiguity should
`be avoided on the chemical vs. covalent issue.
`“Linking” from Plaintiffs’ construction is consistent with the patents’ use of “crosslinked
`HA” and avoids describing modified but unlinked HA. The Court therefore includes “linking”
`in the construction.
`
`4.2.3 “Water Insoluble”
`
`Plaintiffs argue that there is no basis in the intrinsic record to construe “crosslinked HA”
`as “water insoluble,” but offer no evidence supporting the idea that crosslinked HA is water
`soluble. (Pls.’ Opening Claim Construction Br. 16.) And the prior art cited in the patents
`confirms that crosslinked HA is water insoluble. (See, e.g., Cavanaugh Decl., Dkt. No. 54-4, Ex.
`4, U.S. Patent No. 8,124,120 1:20-23; 2:6-8.) “[P]rior art cited in a patent or cited in the
`prosecution history of the patent constitutes intrinsic evidence.” Powell v. Home Depot U.S.A.,
`Inc., 663 F.3d 1221, 1231 (Fed. Cir. 2011) (citations omitted).
`The specifications of both patents also support construing “crosslinked HA” as “water
`insoluble.” (See, e.g., ‘475 Patent 3:65-67, 7:4-9, 7:29-35, 9:49-54, 12:37-39, 13:9-11; ‘795
`Patent 3:66-4:1.) Nothing in the specifications suggests that crosslinked HA is water soluble.
`The extrinsic evidence cited by Plaintiffs also supports the notion that crosslinked HA is water
`insoluble: “Thus, a network of cross-linked HA retains its structure until sufficient degradation
`has occurred at the gel surface to form soluble oligosaccharides that can be metabolized and
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`cleared from the body” (Kablik 304); “The total HA concentration consists of insoluble HA gel
`and soluble-free HA.” (Kablik 305.)
`Further, failing to include “water insoluble” in the construction could allow lightly
`crosslinked HA, which the parties and both patents classify as free or uncrosslinked HA, to be
`classified as “crosslinked HA” as well. (See ‘475 Patent 3:10-13, 5:5-13; ‘795 Patent 5:53-61.)
`The extrinsic evidence also suggests that would be inaccurate:
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`This fluid component contains unmodified and modified soluble HA that is
`generated during the manufacturing process when HA fragments are formed as a
`side-product of the chemical modification. These soluble fluids are easily
`metabolized and do not contribute to the extended duration and effectiveness of the
`product. Only the cross-linked HA resists enzymatic and radical degradation and
`therefore extends the filler’s presence in the dermis, contributing to its
`effectiveness.
`
`(Kablik 305.) The Court therefore includes “water-insoluble” in the construction to prevent
`overlap with “uncrosslinked HA.”
`
`4.2.4 “Degree of Crosslinking Between 2% and 20%”
`
`Defendants’ construction requires the degree of crosslinking to be between 2% and 20%.
`The specification states that “[t]he degree of crosslinking in the HA component of the present
`compositions is at least about 2% and is up to about 20%.” (‘475 Patent 9:31-33.) The question
`is whether this reference to “the present compositions” is enough to limit the claims, or whether
`that language merely refers to nonlimiting preferred embodiments.
`
`It is true that, in some circumstances, a patentee’s consistent reference to a certain
`limitation or a preferred embodiment as ‘this invention’ or the ‘present invention’
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`can serve to limit the scope of the entire invention, particularly where no other
`intrinsic evidence suggests otherwise. . . . On the other hand, we have found that
`use of the phrase ‘present invention’ or ‘this invention’ is not always so limiting,
`such as where the references to a certain limitation as being the ‘invention’ are not
`uniform, or where other portions of the intrinsic evidence do not support applying
`the limitation to the entire patent.
`
`Absolute Software, Inc. v. Stealth Signal, Inc., 659 F.3d 1121, 1136-37 (Fed. Cir. 2011) (citing
`Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1308 (Fed. Cir. 2007)); see also
`Voda v. Cordis Corp., 536 F.3d 1311, 1320–22 (Fed. Cir. 2008) (declining to import the
`limitation where parts of the specification referred to a certain embodiment as the “present
`invention,” but the specification did not uniformly refer to the invention as being so limited, and
`the prosecution history did not reveal such a limitation).
`While the Court ultimately reaches the contrary conclusion, the 2%-20% statement is
`given in a context that suggests that it relates to the “invention,” and not just a preferred
`embodiment:
`
`Degree of crosslinking for purposes of the present disclosure is defined
`as the percent weight ratio of the crosslinking agent to HA-monomeric units within
`the crosslinked portion of the HA based composition. It is measured by the weight
`ratio of HA monomers to crosslinker (HA monomers: crosslinker).
`The degree of crosslinking in the HA component of the present
`compositions is at least about 2% and is up to about 20%.
`In some embodiments, the degree of crosslinking is between about 4% to
`about 12%. In some embodiments, the degree of crosslinking is less than about
`6%, for example, is less than about 5%.
`In other embodiments, the degree of crosslinking is greater than 5%,
`for example, is about 6% to about 8%.
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`(‘475 Patent 9:25-39 (emphasis added).) Thus, the specification introduces the 2%-20% range
`immediately after providing a definition that applies to all claims, using “the present
`compositions” language, and then proceeds to give more specific examples within the 2%-20%
`range.
`
`But the specification never again refers to a 2%-20% limitation. (See ‘475 Patent.) Also,
`the patent itself uses phrases such as “the present compositions” and “present description” in a
`slightly inconsistent manner, at times using “the present description” to refer to what is clearly
`only an example. (See ‘475 Patent 14:30-36.) The specification therefore does not show a
`uniform intention to limit the invention to a degree of crosslinking of about 2%-20%. (See ‘475
`Patent 9:34-45.) Claims 5, 6, and 7 require the HA component to have a degree of crosslinking
`less than about 6%, less than about 5%, and about 2%, respectively. (See ‘475 Patent 16:56-61.)
`Some claims containing the “crosslinked HA” terms do not specify a numerical value for the
`degree of crosslinking, merely claiming “HA crosslinked with . . . (BDDE).” (See ‘475 Patent
`Claims 1, 34.)
`“[W]hen a claim term is expressed in general descriptive words, we will not ordinarily
`limit the term to a numerical range that may appear in the written description or in other claims.”
`Renishaw, 158 F.3d at 1249; see also Conoco, Inc. v. Energy & Envtl. Int’l, L.C., 460 F.3d 1349,
`1357–58 (Fed. Cir. 2006). And, independent Claim 27 expressly requires a degree of
`crosslinking of “about 2% to about 20%.” (‘475 Patent 18:16-18.) Defendants’ proposed
`limitation would render that language superfluous. While “[c]laim differentiation is a guide, not
`a rigid rule,” because differently worded claims can define the exact same subject matter, “claim
`differentiation takes on relevance in the context of a claim construction that would render
`additional, or different, language in another independent claim superfluous.” Curtiss-Wright
`Flow Control Corp. v. Velan, Inc., 438 F.3d 1374, 1381 (Fed. Cir. 2006).
`Further, the prosecution history contains no suggestion that the 2% to 20% range was
`included in the specification in order to avoid prior art. (See Certified File History for U.S.
`Patent No. 8,450,475, 2011-05-31 Non-Final Rejection; 2011-11-09 Amendment/Req.
`Reconsideration After Non-Final Rejection; 2012-