IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
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`
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`FRESENIUS KABI USA, LLC,
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`Plaintiff,
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`V.
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`WATSON LABO RA TORIES, INC. and
`ACT A VIS, INC.,
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`Defendants.
`
`)
`)
`)
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`) C.A. No. 14-161-RGA
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`FRESENIUS KABI USA, LLC,
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`)
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`) C.A. No. 14-160-RGA
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`DR. REDDY'S LABORATORIES, LTD. and
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`DR. REDDY'S LABO RA TORIES, INC.,
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`)
`)
`)
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`Plaintiff,
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`v.
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`Defendants.
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`PLAINTIFF FRESENIUS KABI USA, LLC'S
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`
`
`OPENING CLAIM CONSTRUCTION BRIEF
`
`Bass and Spangenberg
`v.
`Fresenius Kabi USA, LLC
`0
`U.S. Patent No. 8,476,01
`Exhibit 1023
`
`Exh. 1023
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`

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`Interactive Gffl Express, Inc. v. Compuserve, Inc, 256 F.3d 1323, 1333-34 (Fed. Cir. 2001)
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`(reversing claim constructions of district court for importing limitations from specification).
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`B.
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`Terms to be Construed
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`1.
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`“From About 0 to About 10% by Weight Solvent for Propofol”
`andfor “From About 0 to About 10% by Weight of the Solvent”
`Should be Construed According to Its/Their Plain and Ordinary
`Meaning
`
`Claim Term(s)
`
`Plaintiffs Proposed
`Construction
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`Defendants‘ Proposed
`Construction
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`“from about 0 to about 10%
`
`Plain and ordinary meaning,
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`“less than 10% by weight
`solvent for propofol, provided
`that the amount of solvent is
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`also less than any amount of
`solvent in any prior art
`Diprivan®”
`
`
`
`by weight solvent for
`propofol”
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`“from about 0 to about 10%
`by weight of the so1vent”2
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`The use of the term “from about 0 to about 10% by weight” to define the numeric range
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`ofthe amount of“solvent for propanol” as recited in claims 1-3, 5-15, 17, 20, 24-28, 33-3 5, 38,
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`43, 44, 46, 49 and 52-56 has a well—understood, plain and ordinary meaning in the art. See
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`Thorner v. Sony Computer Entm ’: Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012) (terms should
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`be given their ordinary and customary meaning unless one of two exceptions is present: “1)
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`when a patentee sets out a definition and acts as his own lexicographer, or 2) when the patentee
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`disavows the full scope of a claim term either in the specification or during prosecution”)
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`(citations omitted). Neither the ’010 patent specification nor its prosecution history deviates
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`from that well-understood meaning. Cf Marabella DecI., Ex. A (‘O10 patent) at 419-12 (“The
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`formulation is preferably comprised of an oil in water emulsion with a mean particle size of from
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`2 The parties have listed separately the two “from about 0 to about 10% by weight” terms
`because the language following “by weight” differs slightly in the two groups of claims (“solvent
`for propofol” vs. “of the solvent”)- The parties agree that the differences are immaterial.
`Therefore, the parties have each proposed a single construction for both terms. Every asserted
`claim includes one of the “from about 0 to about 10% by weight” terms.
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`Exh. 1023
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`

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`about 100 to about 300 nanometers in diameter .
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`.
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`. .”); 4:13-14 (“The composition preferably has
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`a pH in the range of from about pH 5 to about pH 8.”); 6:58-62 (“The mean size of the droplets
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`typically is in the range from about 20 nanometers to about 1000 nanometers, desirably from
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`about 50 nanometers to about 500 nanometers, and more desirably from about 100 to about 300
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`nanometers”).
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`Where, as here, the specification does not set forth a specific definition, courts routinely
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`hold that the term “about” requires no construction. See, e.g., Ferrirrg B V v. Watson Labs, Inc.,
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`764 F.3d 1382, 1389 (Fed. Cir. 2014) (‘“About’ is not defined either explicitly or by implication
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`by the specification. We think that the district court did not err in giving the term ‘about’ its
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`ordinary meaning and in refusing to give it a more specific construction”); Merck & ("0., Inc. v.
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`Teva Pharms. USA, Inc, 395 F.3d 1364, 1369-T0 (Fed. Cir. 2005) (holding that the term “about”
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`should be given its ordinary and accepted meaning of “approxirnately” unless the patentee
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`clearly redefines “about” in the specification).
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`The issue here is Whether compositions with e.ractr'y 10% by weight of solvent infringe.
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`Defendants’ blatantly results-oriented construction would, in essence, exclude any composition
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`with 10% or more by weight of the solvent from the scope of the asserted claims. But there is no
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`support in the intrinsic record for Defendants’ complicated, multi-pronged construction of the
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`term. Indeed, inserting the limitation “less than 10% by weight” into the construction of “from
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`about 0 to about 10% by weight” plainly flies in the face of the plain meaning of the term(s) as
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`used in the specification, The ’0l 0 parent specification clearly distinguishes the use of the term
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`“about 0% to about 10% by weight” from the term “less than 10% by weight” to describe
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`examples of different amounts of various components that can be present in formulations of the
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`invention. Compare e.g. Marabella Decl., Ex. A (’0l 0 patent) at 5:36-38 (“The water miscible
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`Exh . 1023
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`

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`solvent or the water-immiscible solvent is present in an amount that is preferably from 0 to 10%
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`by weight of the composition .
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`.
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`. .”) with id. at 25:44-46 (“[A]n inert closure material was
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`essential for formulations containing less than 10% oil.”). Nowhere in the specification is it
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`disclosed that “less than 10% by weight” is necessary for the solvent for propofol in the claimed
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`invention. In fact, the specification states that “[t]he
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`the water-immiscible solvent [i.e.
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`solvent for propofol] is present in an amount that is preferably ‘ffrom 0 to 10% by weight ofthe
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`e0mpost'tion”, which contradicts the “less than 10% by weight solvent for propofol” limitation
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`proposed by Defendants.
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`Additionally, construing “from about 0 to about 10% by weight .
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`. .” as necessitating that
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`the solvent for propofol be present in an amount “less than 10% by weight solvent for propofol”
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`violates the principle of claim differentiation by making claim 1 directly conflict with or be
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`redundant of the language of other claims in the same patent. See Phfflips, 415 F.3d at 1324-25
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`(“The inclusion of such a specific limitation on the term ‘baffles’ in claim 2 makes it likely that
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`the patentee did not contemplate that the term ‘baffles’ [as recited in claim 1] already contained
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`that limitation”). For example, whereas claim 1 does recite compositions comprising “from
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`about 0 to about 10% by weight solvent for propofol”, claim 29 — which depends from claim 1 —
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`recites compositions comprising, inter alia, “less than about 0.5% by weight solvent for
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`propofol” See Marabella Decl., Ex. A (’0l0 patent) at 27:55-28:3; 29:55-57. The specific
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`inclusion of the “less than about 0.5% by weight” limitation for the “solvent for propofol” in
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`claim 29 means that the patentee knew how to claim “less than” a desired weight for the “solvent
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`for propofol” where it was applicable, and further, that the patentee did not contemplate that the
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`term “about 0 to 10% by Weight” for the “solvent for propofol”, as recited in independent claim
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`1, should be limited to “less than 10% by weight.” See PhiHip.s', 415 F.3d at 1324-25.
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`Exh. 1023
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`

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`Furthermore, during prosecution of the "K09 application the patentee expressly amended
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`the term “less than 10% by weight solvent for propofol” to “from about 0 to about 10% by
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`weight solvent for propofol.” See Marabella Decl., Ex. B (April 30, 2013 Applicant-Initiated
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`Interview Summary) at WPROP00l8388 — WPROP00l8402. That change is reflected in an
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`“Examiner’s Amendment” and a Notice of Allowance that allowed claim 1 (and all other
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`pending claims) that issued as the ‘01 0 patent. Marabella Decl., Ex. C (Notice of Allowance) at
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`WPROPOOI 8403 — WPROPOOI 8410. By proposing a construction that seeks to limit the “from
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`about 0 to about 10%” to mean “less than 10%,” Defendants ignore the express amendment to
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`that term entered by the Examiner and reflected in the Notice for Allowance. Defendants’
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`construction of this term plainly contradicts the intrinsic evidence in the prosecution history and,
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`thus, the Court should reject it.
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`Finally, Defendants’ proposal to include the limitation “less than any amount of solvent
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`in any prior art Diprivan®” lacks any support in the intrinsic evidence. The ‘O1 0 patent
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`specification never uses this phrase or even comes close to stating that this criterion is necessary
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`for the solvent for propofol in the claimed invention. Moreover, there is no precision in
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`Defendants’ proposed construction since it is silent as to what amounts are excluded by the
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`“prior art Diprivan®.”
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`Exh. 1023
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`

`
`FARNAN LLP
`
`/s/ Brian E, Farnan
`
`Brian E. Farnan (Bar No. 4089)
`919 North Market Street
`12th Floor
`
`Wilmington, DE 19801
`Phone: 302-777-0300
`
`Fax: 302-777-0301
`
`bfaman@famanlaw.com
`
`Founsel’for Pfamrfff
`Fre.s‘eni1r.s‘ Kabf USA, LLC
`
`Of Counsel’:
`
`Daryl L. Wiesen
`John T. Bennett
`
`Sundar Subramanyam
`Samuel Sherry
`Srikanth K, Reddy
`Todd Marabella
`
`Jennifer L, Ford
`GOODWIN PROCTER LLP
`
`Exchange Place
`53 State Street
`
`Boston, MA 02109
`(617) 570-1000:1617) 523-1231 (fax)
`DWiesen@goodwinprocter.com
`JBennett@goodwinprocter.com
`SSubramanyam@goodwinprocter.com
`SSherry@goodwinprocter.com
`SReddy@goodwinprocter.com
`TMarabella@goodwinprocter.com
`.lFord@goodwinprocter_com
`
`Dated: January 23, 2014
`
`Exh. 1023