ÿ ÿÿ
`
`Defendants.
`
`
`RAVGEN,INC.,
`
`Plaintiff,
`
`V.
`
`MYRIAD GENETICS,INC., and
`MYRIAD WOMEN’S HEALTH,INC.,
`
`Defendants.
`
`RAVGEN,INC.,
`
`Plaintiff,
`
`Vv.
`
`BIORA THERAPEUTICS,INC.,
`
`C.A. No. 20-cv-1730-RGA-JLH
`
`JURY TRIAL DEMANDED
`
`C.A. No. 20-cv-1734-RGA-JLH
`
`JURY TRIAL DEMANDED
`
`Defendant.
`
`DEFENDANTS’ OBJECTIONS TO REPORT AND RECOMMENDATION
`REGARDING CLAIM CONSTRUCTION
`
`Case 1:20-cv-01730-RGA-JLH Document 143 Filed 07/12/23 Page 1 of 17 PageID #: 11540
`Case 1:20-cv-01730-RGA-JLH Document 143 Filed 07/12/23 Page 1 of 17 PagelD #: 11540
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`RAVGEN,INC.,
`
`Plaintiff,
`
`V.
`
`C.A. No. 20-cv-1646-RGA-JLH
`
`JURY TRIAL DEMANDED
`
`ARIOSA DIAGNOSTICS,INC.,
`ROCHE SEQUENCING SOLUTIONS,INC.,
`ROCHE MOLECULAR SYSTEMS,INC., and
`FOUNDATION MEDICINE,INC.,
`
` ÿÿ ÿ
` ÿ
`
`Defendants.
`
`
`RAVGEN,INC.,
`
`Plaintiff,
`
`V.
`
`MYRIAD GENETICS,INC., and
`MYRIAD WOMEN’S HEALTH,INC.,
`
`Defendants.
`
`RAVGEN,INC.,
`
`Plaintiff,
`
`Vv.
`
`BIORA THERAPEUTICS,INC.,
`
`C.A. No. 20-cv-1730-RGA-JLH
`
`JURY TRIAL DEMANDED
`
`C.A. No. 20-cv-1734-RGA-JLH
`
`JURY TRIAL DEMANDED
`
`Defendant.
`
`DEFENDANTS’ OBJECTIONS TO REPORT AND RECOMMENDATION
`REGARDING CLAIM CONSTRUCTION
`
`Case 1:20-cv-01730-RGA-JLH Document 143 Filed 07/12/23 Page 1 of 17 PageID #: 11540
`Case 1:20-cv-01730-RGA-JLH Document 143 Filed 07/12/23 Page 1 of 17 PagelD #: 11540
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`RAVGEN,INC.,
`
`Plaintiff,
`
`V.
`
`C.A. No. 20-cv-1646-RGA-JLH
`
`JURY TRIAL DEMANDED
`
`ARIOSA DIAGNOSTICS,INC.,
`ROCHE SEQUENCING SOLUTIONS,INC.,
`ROCHE MOLECULAR SYSTEMS,INC., and
`FOUNDATION MEDICINE,INC.,
`
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`Case 1:20-cv-01730-RGA-JLH Document 143 Filed 07/12/23 Page 2 of 17 PageID #: 11541
`Case 1:20-cv-01730-RGA-JLH Document 143 Filed 07/12/23 Page 2 of 17 PagelD #: 11541
`
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES0.00... cccccccccescesceeeseeeceeeseescacsaeseesceaeeesseesececsaesecacaeseeaceaeeesaeeeteeeeeeseatees ii
`
`L.
`
`IL.
`
`INTRODUCTION.00o.eecececesseseeeseeesseeseeeceaesceacsaeseesesseseeseseeesaeseeaeaeeeeeeaeeesseeaeeeseateeeaeeateeses 1
`
`“AGENT” LIMITATION...0. ce ccecceseeseeseeceeeseeeceaeseeseeeeeeseeeseceesaeseeaeaeeeceeeaeeesetaeeaseatseeaeeateeees 1
`
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`6. .ÿ)& 7 *-4$ÿ ,))-*ÿ7'ÿ '*'4+ )'/ÿ8 *&ÿ',.-),75'ÿ '4*, )*6ÿ !ÿ
` ÿ&'ÿ(')*ÿ + *,* -)ÿ'1 *'.ÿ)/'0 ) *'ÿ2)1* -),5ÿ'4+.ÿ-0ÿ '(4''ÿ 9ÿ
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`ÿ
`ÿ
`
`A.
`
`B.
`
`C.
`
`D.
`
`The Agent Limitation is Indefinite Because the Scope of the Term “Cell
`Lysis Inhibitor” Cannot be Determined with Reasonable Certainty .............ee 1
`
`The Agent Limitation Recites Indefinite Functional Terms of Degree................0. 5
`
`EDTAIs Not Excluded From The Agent Limitation ............cccsscssecsseeesseeesneeesneees 8
`
`Endogenous Substances Are Not Excluded From The Agent Limitation...............9
`
`Tl.
`
`“ISOLATED” / “ISOLATING” TERMS ..0...ccccccccccceseeeeeeeseeeeeeeseeeeeeeseceseateeceeeaeeeeetaneetsees 10
`
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`
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`ÿ
`ÿ
`
`A.
`
`B.
`
`C.
`
`D.
`
`The Agent Limitation is Indefinite Because the Scope of the Term “Cell
`Lysis Inhibitor” Cannot be Determined with Reasonable Certainty .............ee 1
`
`The Agent Limitation Recites Indefinite Functional Terms of Degree................0. 5
`
`EDTAIs Not Excluded From The Agent Limitation ............cccsscssecsseeesseeesneeesneees 8
`
`Endogenous Substances Are Not Excluded From The Agent Limitation...............9
`
`Tl.
`
`“ISOLATED” / “ISOLATING” TERMS ..0...ccccccccccceseeeeeeeseeeeeeeseeeeeeeseceseateeceeeaeeeeetaneetsees 10
`
`ÿÿ
`
` ÿ
`
`
`
`Case 1:20-cv-01730-RGA-JLH Document 143 Filed 07/12/23 Page 3 of 17 PageID #: 11542
`Case 1:20-cv-01730-RGA-JLH Document 143 Filed 07/12/23 Page 3 of 17 PagelD #: 11542
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`ÿ
` ÿ ÿ
`
ÿ
`ÿÿ
`ÿÿ !"#ÿ$%ÿ&& ÿ'()%*ÿ
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`,2Bÿ./01ÿ27BBÿ3.41/ÿ5 6/ÿ788+://////////////////////////////////////////////////////////////////////////////////////////////////-ÿ
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`72ÿ./B[\ÿ+82ÿ3.41/ÿ5 6/ÿ7872:ÿ////////////////////////////////////////////////////////////////////////////////////////////////////7ÿ
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`O? ^ ÿ$%ÿI " (ÿ_<*ÿ
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`7-,ÿ./ÿ`EVV/ÿ01ÿB,Bÿ3a/ÿa4b/ÿ7829:ÿ///////////////////////////////////////////////////////////////////////////////////////////+ÿ
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` J ?cÿ'()%ÿ$%ÿ;?!?>ÿ'( "T ( *ÿ
`,97ÿd/`/ÿ+C+ÿ3782B:ÿ///////////////////////////////////////////////////////////////////////////////////////////////////////////////////7ÿ
` ÿ
`ÿÿ
`
`GE Lighting v. AgiLight,
`750 F.3d 1304 (Fed. Cir, 2014)... ccccccssesccseeseceeeseceaeeeeseeceeeaecaeeeeceaeeeceaeeeeeaeeaeeeecaeeeeseaseeeeaeeaees 10
`
`Cases
`
`Aylus Networks v. Apple Inc.,
`856 F.3d 1353 (Fed. Cir. 2017).....ccceccccccceeesceseceeeeeeeceaeceeeeaeeenceseeaecaeeaaeeaeeeeeeeeeaeeeaeeaeeeaeeeeeeeees 8
`
`BASFv. Ingevity,
`2023 WL 4115908 (Fed. Cir. June 22, 2023) oo. ceccsccscssseseeseceeeeceeeeecsaeeeeeaecaeeaeceeeeseaeeeeeaeeneeaes 8
`
`BASF y. Johnson Matthey,
`875 F.3d 1360 (Fed. Cir, 2017).....ccccccccccseeseceseceeeeeseceaecaeeeacesaceseeeaesaeeaaeeaeeeeeeeeeaeeeaeeaeeeeeeeeeeeeees 6
`
`Blackbird Tech v. ELB Elecs.,
`895 F.3d 1374 (Fed. Cir. 2018)......ccccccccsceceeeseceseeeseceaecaeeeaeeaeeseeeaeceaeeaaeeaeeeeeeseeeaeseaeeaeeaeeeeeeeeees9
`
`Canopy Growth v. GWPharma,
`2023 WL 3048243 (Fed. Cir. Apr. 24, 2023) .......ccccsccsscsscesessecseecseeseeseeeseesseeseesseesseeaes2, 3,4,5
`
`Dow Chem. v. Nova Chem.,
`803 F.3d 620 (Fed. Cir, 2015)... ecccccccccscesceceeeeeeeeeceeceaeceaeeaeeeaceaeeseeeaaeeaeeeeeeeeeaeseaeeaeeaeeeeeeeeees7
`
`Halliburton v. M-I LLC,
`514 F.3d 1244 (Fed. Cir, 2008).......ccccccccsccsccseseceaeeeeeeeceeeecaeeecaeeeceaeeaeeaeeaeeaecaeeeseeeeeseaeeeeeaeenees 6
`
`Intel v. Qualcomm,
`21 F.4th 801 (Fed. Cir, 2021) ...ceccccccccscescssecseeeecseeeeceesecsaeeeceaecaeeaecaeesecaaeeeceaeeaeceeeeseaeeeeeaeeneeaes2
`
`Interval Licensing v. AOL,
`766 F.3d 1364 (Fed. Cir. 2014)... ccccccsssccssesecseeeeceaeceesaeceeesecaeesecaeseeceaeeaecaeeaeeaecaeeeeseaeeeceaeenseaes7
`
`Littelfuse v. Mersen USA,
`29 F.4th 1376 (Fed. Cir, 2022) oo... cccccccscesccsseseceeeeeceaeceesaecaeesecaeeeeceaeeecsaeeeeeaecaeeaeceeeeeeaseneeaeeas 3,4
`
`In re Mobile Telecomms.,
`265 F. Supp. 3d 454 (D. Del. 2017)... ccccccsscsccsseseceaeeeesaeceeeaecaeeseceeeeceaeeaeeaeeaeeaecaeeeeseaeeeeeaeeneeaes 8
`
`Multilayer Stretch Cling Film v. Berry Plastics,
`831 F.3d 1350 (Fed. Cir, 2016).......ccccccccceseecsseceeeeeceeeseceeeeeceeeeeceaeeaeeaeeaeeaecaeeeeseaeeeseaeeneeaeenees2,3
`
`Nautilus, Inc. v. Biosig Instruments,
`572 U.S. 898 (2014) ce ceccccccecceseceeeceeeeeeeeeeseeeaeesaecsaeeaeeaeeseeeaessaecaaeeaeeeaeeeeeaeseaeseaeeaeeeeeeeeeeeeeeaeeaaes2
`
`ii
`
`
`ÿÿ
`ÿÿ !"#ÿ$%ÿ&& ÿ'()%*ÿ
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`;<=ÿ$%ÿG!H(!(ÿIJ H *ÿ
`+9,ÿ./01ÿ20-8ÿ3.41/ÿ5 6/ÿ7829://////////////////////////////////////////////////////////////////////////////////////////////////-ÿ
`;J)#K?"LÿM )Hÿ$%ÿNO;ÿN )%*ÿ
`+C,ÿ./01ÿ209Bÿ3.41/ÿ5 6/ÿ782+://////////////////////////////////////////////////////////////////////////////////////////////////Cÿ
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`7870ÿ@Aÿ08B+7B0ÿ3.41/ÿ5 6/ÿUV6/ÿ7B*ÿ7870:ÿ////////////////////////////////////////////////////////////////7*ÿ0*ÿB*ÿ,ÿ
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`9,8ÿ./01ÿ208Bÿ3.41/ÿ5 6/ÿ782B:////////////////////////////////////////////////////////////////////////////////////////////////28ÿ
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`,2Bÿ./01ÿ27BBÿ3.41/ÿ5 6/ÿ788+://////////////////////////////////////////////////////////////////////////////////////////////////-ÿ
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`7-,ÿ./ÿ`EVV/ÿ01ÿB,Bÿ3a/ÿa4b/ÿ7829:ÿ///////////////////////////////////////////////////////////////////////////////////////////+ÿ
`I ?J "ÿ< " )HÿP?(>ÿ=?Tÿ$%ÿ; ""ÿSJ ?)*ÿ
`+02ÿ./01ÿ20,8ÿ3.41/ÿ5 6/ÿ782-://////////////////////////////////////////////////////////////////////////////////////////////7*ÿ0ÿ
` J ?cÿ'()%ÿ$%ÿ;?!?>ÿ'( "T ( *ÿ
`,97ÿd/`/ÿ+C+ÿ3782B:ÿ///////////////////////////////////////////////////////////////////////////////////////////////////////////////////7ÿ
` ÿ
`ÿÿ
`
`GE Lighting v. AgiLight,
`750 F.3d 1304 (Fed. Cir, 2014)... ccccccssesccseeseceeeseceaeeeeseeceeeaecaeeeeceaeeeceaeeeeeaeeaeeeecaeeeeseaseeeeaeeaees 10
`
`Cases
`
`Aylus Networks v. Apple Inc.,
`856 F.3d 1353 (Fed. Cir. 2017).....ccceccccccceeesceseceeeeeeeceaeceeeeaeeenceseeaecaeeaaeeaeeeeeeeeeaeeeaeeaeeeaeeeeeeeees 8
`
`BASFv. Ingevity,
`2023 WL 4115908 (Fed. Cir. June 22, 2023) oo. ceccsccscssseseeseceeeeceeeeecsaeeeeeaecaeeaeceeeeseaeeeeeaeeneeaes 8
`
`BASF y. Johnson Matthey,
`875 F.3d 1360 (Fed. Cir, 2017).....ccccccccccseeseceseceeeeeseceaecaeeeacesaceseeeaesaeeaaeeaeeeeeeeeeaeeeaeeaeeeeeeeeeeeeees 6
`
`Blackbird Tech v. ELB Elecs.,
`895 F.3d 1374 (Fed. Cir. 2018)......ccccccccsceceeeseceseeeseceaecaeeeaeeaeeseeeaeceaeeaaeeaeeeeeeseeeaeseaeeaeeaeeeeeeeeees9
`
`Canopy Growth v. GWPharma,
`2023 WL 3048243 (Fed. Cir. Apr. 24, 2023) .......ccccsccsscsscesessecseecseeseeseeeseesseeseesseesseeaes2, 3,4,5
`
`Dow Chem. v. Nova Chem.,
`803 F.3d 620 (Fed. Cir, 2015)... ecccccccccscesceceeeeeeeeeceeceaeceaeeaeeeaceaeeseeeaaeeaeeeeeeeeeaeseaeeaeeaeeeeeeeeees7
`
`Halliburton v. M-I LLC,
`514 F.3d 1244 (Fed. Cir, 2008).......ccccccccsccsccseseceaeeeeeeeceeeecaeeecaeeeceaeeaeeaeeaeeaecaeeeseeeeeseaeeeeeaeenees 6
`
`Intel v. Qualcomm,
`21 F.4th 801 (Fed. Cir, 2021) ...ceccccccccscescssecseeeecseeeeceesecsaeeeceaecaeeaecaeesecaaeeeceaeeaeceeeeseaeeeeeaeeneeaes2
`
`Interval Licensing v. AOL,
`766 F.3d 1364 (Fed. Cir. 2014)... ccccccsssccssesecseeeeceaeceesaeceeesecaeesecaeseeceaeeaecaeeaeeaecaeeeeseaeeeceaeenseaes7
`
`Littelfuse v. Mersen USA,
`29 F.4th 1376 (Fed. Cir, 2022) oo... cccccccscesccsseseceeeeeceaeceesaecaeesecaeeeeceaeeecsaeeeeeaecaeeaeceeeeeeaseneeaeeas 3,4
`
`In re Mobile Telecomms.,
`265 F. Supp. 3d 454 (D. Del. 2017)... ccccccsscsccsseseceaeeeesaeceeeaecaeeseceeeeceaeeaeeaeeaeeaecaeeeeseaeeeeeaeeneeaes 8
`
`Multilayer Stretch Cling Film v. Berry Plastics,
`831 F.3d 1350 (Fed. Cir, 2016).......ccccccccceseecsseceeeeeceeeseceeeeeceeeeeceaeeaeeaeeaeeaecaeeeeseaeeeseaeeneeaeenees2,3
`
`Nautilus, Inc. v. Biosig Instruments,
`572 U.S. 898 (2014) ce ceccccccecceseceeeceeeeeeeeeeseeeaeesaecsaeeaeeaeeseeeaessaecaaeeaeeeaeeeeeaeseaeseaeeaeeeeeeeeeeeeeeaeeaaes2
`
`ii
`
`
`
`Case 1:20-cv-01730-RGA-JLH Document 143 Filed 07/12/23 Page 4 of 17 PageID #: 11543
`Case 1:20-cv-01730-RGA-JLH Document 143 Filed 07/12/23 Page 4 of 17 PagelD #: 11543
`
`Nevro v. Boston Sci.,
`955 F.3d 35 (Fed. Cir. 2020).......ccccccsccssecsesseceeeseceeeeeceaeenecaeeeceeeeceaeeeeeaecaeeeecaeeeeeeaeeeeeaeenees 5, 6, 7
`
`Sysmex Corp. v. Beckman Coulter, Inc.,
`2022 WL 1237787 (D. Del. Apr. 27, 2022) ....c..cccesceccesesseeseeeeceeeeeceeeeeceaeeeesaeeaeeaecaeeeeseateeeeaneneeaes 1
`
`Truinject v. Galderma,
`2020 WL 3287047 (D. Del. June 18, 2020)... cccccccscssecseeeeceeeeceeeeeceaeeeecaeeaeeaecaeeeeseaeeeeeateneeaes 5
`
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`that meet the claim limitation and examplesthat do not,” or any other guidance sufficient to permit
`
`a skilled artisan to discern the claims’ bounds. Halliburton v. M-I LLC, 514 F.3d 1244, 1255—56
`
`(Fed. Cir. 2008). As a result, each of these termsis indefinite.
`
`In reaching the opposite conclusion, the R&R appears to credit Dr. Van Ness’s testimony
`
`that “a POSITA reading the specifications and claims would have understood how to determine
`
`whetheran agent is a membranestabilizer or a cell lysis inhibitor.” R&R at 9.4 But as Defendants’
`
`brief explained, Dr. Van Ness could not substantiate that conclusion. See Joint Br. at 52-57. When
`
`asked to define “cell lysis inhibitor,” for example, Dr. Van Nesstestified that it would have “a
`
`demonstrated impact on the inhibition of lysis .
`
`.
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`. at least a demonstratable amountoflysis
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`inhibition.” Ex. D26, 113:10—-114:5. But when pressed as to what amountofinhibition is required,
`
`Dr. Van Ness concededthat “J don’t think there’s a single answerto that.” Id. Given that Dr.
`
`Van Ness was unable to explain his own subjective dividing line between an agent that qualifies
`
`as a “cell lysis inhibitor” and one that does not, his conclusory testimony that a skilled artisan
`
`would somehow knowit when they see it cannot be credited.
`
`The R&Ralso cites BASF v. Johnson Matthey, 875 F.3d 1360, 1367 (Fed. Cir. 2017) for
`
`the proposition that “breadth is not indefiniteness” and Nevro for the proposition that a potential
`
`infringer need not “be able to determine ex ante if a particular act infringes the claims.” R&R at
`
`9. But Defendants have never argued that breadth alone renders the claims indefinite,” and the
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`4 The R&R’s reliance on Dr. Van Nesshere conflicts with its rejection of Dr. Van Ness’s opinion
`that “cell lysis inhibitor’ is a class of compounds with the “common mechanistic capabilit[y]” of
`preserving “the structural integrity of cells.” Ex. P44 { 16; see also Joint Br. at 35—36. The R&R
`rejects Dr. Van Ness’s opinion, holding that “the specification does notlimit the cell lysis inhibitor
`to those agents that work by a particular mechanism.” R&Rat 8.
`> As Defendants have explained, BASF is distinguishable because: (1) its disputed terms had
`known meaningin theart, (2) the specification there disclosed specific chemical reactions defining
`the claimed functions, and (3) the experts in BASF agreed objective tests for assessing the claimed
`functions were known. Joint Br. at 21, 56 n.53. The R&R did not address these differences.
`6
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`4 The R&R’s reliance on Dr. Van Nesshere conflicts with its rejection of Dr. Van Ness’s opinion
`that “cell lysis inhibitor’ is a class of compounds with the “common mechanistic capabilit[y]” of
`preserving “the structural integrity of cells.” Ex. P44 { 16; see also Joint Br. at 35—36. The R&R
`rejects Dr. Van Ness’s opinion, holding that “the specification does notlimit the cell lysis inhibitor
`to those agents that work by a particular mechanism.” R&Rat 8.
`> As Defendants have explained, BASF is distinguishable because: (1) its disputed terms had
`known meaningin theart, (2) the specification there disclosed specific chemical reactions defining
`the claimed functions, and (3) the experts in BASF agreed objective tests for assessing the claimed
`functions were known. Joint Br. at 21, 56 n.53. The R&R did not address these differences.
`6
`
`
`
`Case 1:20-cv-01730-RGA-JLH Document 143 Filed 07/12/23 Page 11 of 17 PageID #: 11550
`Case 1:20-cv-01730-RGA-JLH Document 143 Filed 07/12/23 Page 11 of 17 PagelD #: 11550
`
`issue is not solely a skilled artisan’s inability to determine infringement ex ante. The issue is that
`
`a skilled artisan could never make this determination. Nevro, 955 F.3d at 40 (noting claims are
`
`indefinite where “infringement could not be determined at any time”). This is because the patents
`
`provide no guidance on whatconstitutes “lysis inhibition”or “membranestabilization,” how much
`
`inhibition or stabilization is needed, relative to what baseline of lysis or stability, or under what
`
`conditions. Without such guidance, the Agent Limitation is indefinite. Jd. at 39—40.
`
`Ravgen’s statements to this Court and to the PTAB confirm the absence of the necessary
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`“terms of degree.” R&R at 9. But no matter what label is applied to these terms, the patents fail
`to provide the “objective boundaries” neededto clarify the scope of the Agent Limitation. Dow
`Chem. v. Nova Chem., 803 F.3d 620, 630 (Fed. Cir. 2015); Joint Br. at 22-24, 57-60.
`7
`
`guidance. For example, Ravgen and Dr. Van Nesscontendthat the claimed “lysis inhibition” or
`
`“membranestabilization” must exceed some minimum threshold. Ex. D26, 112:16—114:5 (Dr.
`
`Van Ness: “If you have onecell out ofmillions, you’ve never demonstrated[lysis inhibition].”);
`
`Ex. D28, 49:5—11 (arguing that a “membranestabilizer” may “stabiliz/e] the membrane to some
`
`degree” without “actually [] imped[ing] cell lysis”). But Dr. Van Ness admits that the patents do
`
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`
`amount would be....”).© Instead, he says, any “demonstratable amount” will suffice. But that
`
`subjective standard—not mentioned in the patents—only confirms that the Agent Limitation
`
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`
`andis thus indefinite. Interval Licensing v. AOL, 766 F.3d 1364, 1370-74 (Fed. Cir. 2014).
`
`Ravgenhasnot attempted to identify the necessary guidancein the record. Instead, Ravgen
`
`argues that “cell lysis inhibitor” and “membranestabilizer” are definite because they “present a
`
`‘binary inquiry,’ i.e., either a chemical is in the category,or it is not.” Joint Br. at 43; see alsoid.
`
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`“terms of degree.” R&R at 9. But no matter what label is applied to these terms, the patents fail
`to provide the “objective boundaries” neededto clarify the scope of the Agent Limitation. Dow
`Chem. v. Nova Chem., 803 F.3d 620, 630 (Fed. Cir. 2015); Joint Br. at 22-24, 57-60.
`7
`
`guidance. For example, Ravgen and Dr. Van Nesscontendthat the claimed “lysis inhibition” or
`
`“membranestabilization” must exceed some minimum threshold. Ex. D26, 112:16—114:5 (Dr.
`
`Van Ness: “If you have onecell out ofmillions, you’ve never demonstrated[lysis inhibition].”);
`
`Ex. D28, 49:5—11 (arguing that a “membranestabilizer” may “stabiliz/e] the membrane to some
`
`degree” without “actually [] imped[ing] cell lysis”). But Dr. Van Ness admits that the patents do
`
`not explain whatthis threshold is. Ex. D26, 117:23—120:23 (“I don’t know what the minimum
`
`amount would be....”).© Instead, he says, any “demonstratable amount” will suffice. But that
`
`subjective standard—not mentioned in the patents—only confirms that the Agent Limitation
`
`“leav[es] the skilled artisan to consult the ‘unpredictable vagaries of any one person’s opinion’”
`
`andis thus indefinite. Interval Licensing v. AOL, 766 F.3d 1364, 1370-74 (Fed. Cir. 2014).
`
`Ravgenhasnot attempted to identify the necessary guidancein the record. Instead, Ravgen
`
`argues that “cell lysis inhibitor” and “membranestabilizer” are definite because they “present a
`
`‘binary inquiry,’ i.e., either a chemical is in the category,or it is not.” Joint Br. at 43; see alsoid.
`
`
`
`Case 1:20-cv-01730-RGA-JLH Document 143 Filed 07/12/23 Page 12 of 17 PageID #: 11551
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