PROLLENIUM US INC.
`V. ALLERGAN INDUSTRIE, SAS
`
`PATENT OWNER’S DEMONSTRATIVES
`
`IPR2019-01505
`IPR2019-01506
`IPR2019-01508
`IPR2019-01509
`IPR2019-01617
`IPR2019-01632
`IPR2020-00084
`
`Demonstrative Exhibit –
`NOT EVIDENCE
`
`1
`
`
`V. ALLERGAN INDUSTRIE, SAS
`
`PATENT OWNER’S DEMONSTRATIVES
`
`IPR2019-01505
`IPR2019-01506
`IPR2019-01508
`IPR2019-01509
`IPR2019-01617
`IPR2019-01632
`IPR2020-00084
`
`Demonstrative Exhibit –
`NOT EVIDENCE
`
`1
`
`
`
`TABLE OF CONTENTS
`
`General Issues Affecting All Arguments
`
`Group A: Lebreton + Sadozai (& CTA Summary in -01632 IPR)
`
`Group B: Kinney + Zhao + Narins
`
`Group C: Reinmuller + Lebreton
`
`Group D: -00084 IPR Grounds
`
`Allergan’s Motion to Exclude
`
`**Unless otherwise noted, citations herein are to the papers and exhibits of
`record in the -01617 IPR**
`
`2
`
`
`
`BACKGROUND AND STATE OF THE ART
`
`BACKGROUND AND STATE OF THE ART
`
`3
`
`
`
`ALLERGAN’S INVENTIONS
`
`Source: Ex. 1001 at 2:23-30, 2:39-52; POR at 15-16.
`
`4
`
`
`
`REPRESENTATIVE CLAIMS OF THE CHALLENGED PATENTS
`
`’676 Patent, claim 1
`
`Source: POR at 15-16; Ex. 1001.
`
`’676 Patent, claims 12, 22-23, 26, 29
`
`5
`
`
`
`’475 Patent
`-01505 IPR
`
`18* (filler heat
`sterilized); 31*
`(heat-sterilized,
`stable dermal
`filler); 34* (stable
`after heat
`sterilization at 120
`°C and 130 °C)
`
`Lidocaine
`Freely
`Released/
`Unbound
`
`Heat-Sterilized
`Filler
`
`Maintain
`Various Filler
`Properties
`During Storage
`Over Time.
`
`’795 Patent
`-01506 and -01632 IPRs
`1* (freely released in vivo); 22*
`(unbound lidocaine HCl); 37
`(freely released in vivo); 38
`(substantially unbound); 39
`(substantially unbound)
`
`28 (stable to autoclaving)
`
`29* (stable at least 3 mos.); 30
`(stable at least 6 mos.); 31 (stable
`at least 9 mos.); 32 (lido. conc.
`constant at least 3 mos.); 33 (HA
`conc. constant at least 3 mos.); 34
`(EF constant at least 3 mos.); 35
`(homogenous & transparent at
`least 3 mos.); 36 (no increase in
`2,6-dimethyl-aniline at least 3
`mos.); 41 (EF constant at least 6
`mos.)
`
`’013 Patent
`-01508 IPR
`
`’322 Patent
`-01509 IPR
`
`’676 Patent
`-01617 IPR
`1* (freely released in vivo)
`
`’519 Patent
`-00084 IPR
`2 (freely
`released in
`vivo); 4 (freely
`released in
`vivo); 8 (freely
`released in vivo)
`
`1* (heat
`sterile); 4*
`(heat sterilize
`120 °C-130 °C
`for 1 min. to
`15 mins.)
`
`4* (stable at
`25 deg. C for
`at least 6
`mos. after
`heat
`sterilization)
`
`1* (sterile)
`
`1* (sterile); 12 (sterilized by
`autoclave); 22 (sterilized by heat
`sterilization 120 °C and 130 °C)
`
`13 (Extrusion force (“EF”) constant
`3 mos.); 14 (EF constant 6 mos.);
`15 (EF constant 9 mos.); 16
`(Viscosity (“V”) constant 3 mos.)
`17 (V constant 6 mos.); 18 (V
`constant 9 mos.); 19 (lido. not
`degrade 3 mos.); 20 (lido. not
`degrade 6 mos.); 21 (lido. not
`degrade 9 mos.); 23-31 (same
`limitations as claims 13-21, but
`post-sterilization)
`
`5* (1st comp. as
`stable for 3 mos.
`as 2nd comp.
`w/o lido.); 6 (1st
`comp. as stable
`for 6 mos.); 7
`(1st comp. as
`stable for 9
`mos.)
`
`Source: -1505, Ex. 1001; -1506/-1632, Ex. 1001; -1508, Ex. 1001; -1509, Ex. 1001;
`-1617, Ex. 1001; -0084, Ex. 1001. * = Independent Claims.
`
`6
`
`
`
`SCIENTIFIC BACKGROUND
`
`PERSON OF ORDINARY SKILL IN THE ART AND
`SCIENTIFIC BACKGROUND
`
`PERSON OF ORDINARY SKILL IN THE ART AND
`
`7
`
`
`
`PERSON OF ORDINARY SKILL IN THE ART
`
`Petitioner’s definition
`
`Patent Owner’s definition
`
`Source: Pet. at 18; POR at 17.
`
`8
`
`
`
`PETITIONER'S EXPERTS
`
`Dr. DeVore
`
`• Misrepresented his Degrees
`
`• Commercial Executive
`
`• Agrees HA chemistry matters but does
`not know the chemistry
`
`Dr. Prestwich
`
`• Ph.D., Organic Chemistry
`
`• Previously submitted declarations
`in Galderma and Teoxane IPRs
`
`• Not aware of grounds
`
`• Only testimony supporting Petitions
`
`• Deleted unhelpful testimony
`
`Source: POR at 26-31; Surreply at 5-8, 14, 16, 27; Ex. 1002; Ex. 1003; Ex. 1105, Ex. 1106;
`Ex. 2200, 429:18-432:13.
`
`9
`
`
`
`PATENT OWNER’S EXPERT
`
`Dr. Berkland
`
`• Ph.D., Chemical and Biomolecular Engineering
`
`• Solon E. Summerfield Distinguished Professor
`in the Department of Pharmaceutical
`Chemistry at the University of Kansas
`
`• Years of experience chemically modifying HA
`
`• Authored ~25 papers on HA-based materials
`
`• Explains complexity of designing HA fillers
`
`• Supports testimony with contemporaneous art
`
`Source: Ex. 2014; Ex. 2013 at ¶¶ 3-14; POR at 3.
`
`10
`
`
`
`DR. BERKLAND: HYDROPHILIC NATURE OF HA PROVIDES
`FILLER VOLUME AND LIFT
`
`11
`Source: Ex. 1045 at 41; POR at 41; see also Ex. 2015 at 10; Ex. 2071 at 3336; Ex. 2013, ¶ 36, 42.
`
`
`
`DR. BERKLAND: HA MUST BE MODIFIED TO INCREASE
`PRODUCT LONGEVITY
`
`(1)
`
`Source: Ex. 2013 at ¶ 52; Ex. 1045 at 37; Ex. 2049 at 65; POR at 4; see also
`Ex. 2015 at 12.
`
`12
`
`
`
`DR. BERKLAND: FILLERS MUST BE INJECTABLE, REMAIN IN
`PLACE AND MAINTAIN KEY PERFORMANCE PROPERTIES
`
`(2)
`
`(3)
`
`(4)
`
`Source: Ex. 2013 at ¶¶ 53-55; Ex. 1011 at 370; Ex. 1045 at
`40; POR at 5.
`
`13
`
`
`
`DR. BERKLAND: MANY COMPLEX FACTORS IMPACT DERMAL
`FILLERS
`
`HA Molecular Weight
`
`pH
`
`Type of
`Crosslinker
`
`Density and
`Degree of
`Crosslinking
`
`Particle Size
`Shape &
`Distribution
`
`HA Concentration
`
`Degree of Swelling
`
`Additives
`
`Sterility
`
`Post-Crosslinking
`Steps
`
`Ionic Strength
`
`HA Solubility
`
`Crosslinking
`Conditions
`
`Heating
`
`Source: POR at 4-15; Ex. 2013 at ¶ 62.
`
`Monophasic or
`Biphasic Gel
`
`14
`
`
`
`THE ART RECOGNIZED THE COMPLEXITY OF DERMAL FILLER
`COMPOSITIONS AND THEIR DIVERSITY
`
`Source: Ex. 1045 at 35-36, 41; POR at 4-15; see also, e.g., Ex. 2015 at 7-10, 14, 55-63,
`68-69, 79-95; Ex. 2013 at ¶ 62.
`
`15
`
`
`
`DR. BERKLAND: THE TYPE OF CROSSLINKER IMPACTS REACTION
`CONDITIONS AND DRAMATICALLY AFFECT GEL CHARACTERISTICS
`
`Dr. Berkland’s declaration:
`
`Source: Ex. 2013 at ¶ 71; Ex. 2028 at 783; POR at 7-10.
`
`16
`
`
`
`DIFFERENT GELS ARISE FROM DIFFERENT PROCESSES
`
`Source: Ex. 1015 at S128; Ex. 2061 at 977-78; POR at 10-11; Ex. 2013, ¶¶ 88-89, 113-114.
`
`17
`
`
`
`DR. BERKLAND: PROCESSING CONDITIONS CAUSE IRREVERSIBLE
`CHANGES IN GEL STRUCTURE THAT IMPACT GEL SWELLING
`
`Dr. Berkland’s declaration:
`
`Source: Ex. 2013 at ¶ 73; Ex. 2062 at 125; Ex. 2072 at 296; POR at 12.
`
`18
`
`
`
`DR. BERKLAND: NON-COVALENT INTERACTIONS PLAY
`IMPORTANT ROLES IN THE PROPERTIES OF HA COMPOSITIONS
`
`Source: Ex. 2013 at ¶ 79; POR at 40; Surreply at 14.
`
`19
`
`
`
`DR. DEVORE: DESIGNING DERMAL FILLERS IS “FORMIDABLE”
`
`Source: Ex. 2128 at 6:30-36; Ex. 2100 at 200:8-203:21; POR at 5.
`
`20
`
`
`
`DR. DEVORE: MAKING DERMAL FILLERS IS UNPREDICTABLE
`
`Source: Ex. 2100 at 103:20-104:4; 158:16-24; 367:18-21; POR at 27, 47.
`
`21
`
`
`
`DR. PRESTWICH: CREATING STABLE HA HYDROGELS IS
`CHALLENGING
`
`Source: Surreply at 19; Ex. 2200 at 461:22-463:6.
`
`22
`
`
`
`DR. BERKLAND: POST-CROSSLINKING STEPS FURTHER
`AFFECT GEL PROPERTIES
`
`Source: Ex. 2013 at ¶ 88; POR at 11-12.
`
`23
`
`
`
`DR. BERKLAND: HEAT STERILIZATION DRAMATICALLY
`IMPACTS GEL PROPERTIES
`
`Source: Ex. 2013 at ¶ 94; POR at 12-13.
`
`24
`
`
`
`PRIOR ART: HEAT STERILIZATION DRAMATICALLY IMPACTS GEL
`PROPERTIES
`
`Source: Ex. 1048, 3:52-62; Ex. 2015 at 41; POR at 12-13.
`
`25
`
`
`
`CUI: HEAT STERILIZATION DRAMATICALLY IMPACTS BDDE-
`CROSSLINKED HA GELS
`
`Source: Ex. 1025 at 1506, 1510; Ex. 2013, ¶¶ 192-194; POR at 13, 32.
`
`26
`
`
`
`DR. BERKLAND: CHANGES IN pH CAN DESTABILIZE HA
`POLYMERS
`
`Dr. Berkland’s declaration:
`
`Source: Ex. 2038 at 270; Ex. 1056 at 543; Ex. 2013 at ¶¶ 99, 105-11; POR at
`13-15; Surreply at 13.
`
`27
`
`
`
`DR. BERKLAND: THE COMBINATION OF LIDOCAINE AND HEAT
`CREATES ADDITIONAL COMPLEXITY AND INSTABILITY
`
`Source: Ex. 2013 at ¶¶ 178-79; POR at 13-15.
`
`28
`
`
`
`DR. PRESTWICH: LIDOCAINE “MAY RESULT IN MORE HA
`DEGRADATION DURING AUTOCLAVING”
`Dr. Prestwich’s declaration contradicts his testimony on cross-examination:
`Dr. Prestwich’s declaration:
`Dr. Prestwich’s deposition on adding lidocaine:
`
`Source: Ex. 1105 at ¶ 172; Ex. 2200 at 191:7-16, 193:20-194:3; Surreply at 13-14.
`
`29
`
`
`
`DR. DEVORE: HEAT AND ACIDITY (FROM LIDOCAINE) DEGRADE
`HA
`
`Source: POR at 13-15, 31-33; Ex. 2100, 73:16-18; 76:10-17, 361:6-15.
`
`30
`
`
`
`DR. BERKLAND: LIDOCAINE HAS BEEN SHOWN TO INTERACT
`WITH HA, RESULTING IN A “STRONG DELAY EFFECT”
`
`Source: Ex. 2013, ¶ 87; Ex. 2046, ¶¶ 40, 42; POR at 50.
`
`31
`
`
`
`DR. BERKLAND: BUFFER IS NOT “SUFFICIENT TO PREVENT
`SIGNIFICANT VISCOSITY LOSS” AND INTRODUCES MORE COMPLEXITY
`
`Source: Ex. 2013 at ¶ 190; POR at 34.
`
`32
`
`
`
`pH ADJUSTMENT IS NOT SUFFICIENT TO PREVENT SIGNIFICANT
`VISCOSITY LOSS
`
`Source: Ex. 1001, Figs. 1 and 2; Ex. 2013 at ¶185; POR at 34.
`
`33
`
`Berkland Declaration, Table 1
`
`
`
`CONTEMPORANEOUS REFERENCES APPRECIATED THE
`INCLUSION OF LIDOCAINE AFFECTS GEL PROPERTIES
`
`Source: Ex. 2067, 2:30-53, 3:28-32; POR at 33.
`
`34
`
`
`
`THE ART STILL APPRECIATES THE INCLUSION OF LIDOCAINE
`AFFECTS GEL PROPERTIES
`
`Source: Ex. 2060 at Abstract; POR at 14.
`
`35
`
`
`
`THE BOARD SHOULD NOT RELY ON DR. DEVORE AS IT
`
`DID IN THE INSTITUTION DECISION
`
`THE BOARD SHOULD NOT RELY ON DR. DEVORE AS IT
`DID IN THE INSTITUTION DECISION
`
`36
`36
`
`
`
`DR. DEVORE ADMITTED HE IMPROPERLY USED HINDSIGHT
`
`Source: Ex. 2100 at 371:24-372:5; POR at 28-29.
`
`37
`
`
`
`DR. DEVORE AGREES THAT KNOWLEDGE OF CHEMICAL
`STRUCTURES AND HOW THEY INTERACT IS IMPORTANT . . .
`
`HA - Ex. 2158
`
`Lidocaine - Ex. 2165
`
`pBCDI - Ex. 2156
`
`DEO - Ex. 2152
`
`Source: Ex. 1002 at ¶ 189; Ex. 2100 at 357:20-358:1; Ex. 2152; Ex.
`2153; Ex. 2156, Ex. 2158, Ex. 2165; POR at 29-30.
`
`BDDE - Ex. 2153
`
`38
`
`
`
`BUT DR. DEVORE COULD NOT IDENTIFY THE RELEVANT
`STRUCTURES
`
`Source: POR at 29-30.
`
`39
`
`
`
`AND DR. DEVORE COULD NOT EXPLAIN THE CORE LIDOCAINE
`CHEMISTRY AT ISSUE IN THIS CASE
`
`HA - Ex. 2158
`
`Lidocaine - Ex. 2165
`
`pBCDI - Ex. 2156
`
`DEO - Ex. 2152
`
`BDDE - Ex. 2153
`Source: Ex. 2100 at 359:6-13; Ex. 2013 at ¶ 68 n.8; POR at 29-30; Ex. 2152;
`Ex. 2153; Ex. 2156; Ex. 2158; Ex. 2165.
`
`40
`
`
`
`DR. DEVORE REPEATEDLY MISREPRESENTED HIMSELF AS
`HAVING DEGREES IN “BIOCHEMISTRY”
`
`PTAB
`
`ITC
`
`D. Ct.
`
`Source: Ex. 1003 at 3; Ex. 2100 at 48:14-17, 50:9-21; 312:2-4, Ex. 2129; Ex. 2140;
`POR at 30-31.
`
`41
`
`
`
`MISREPRESENTATION OF CREDENTIALS VIOLATES THE DUTY
`OF CANDOR
`
`Source: POR at 31; Blackberry Corp. v. Zipit Wireless, Inc., IPR2014–01506, Paper 50 at
`10 (PTAB Mar. 29, 2016).
`
`42
`
`
`
`DR. PRESTWICH’S LATE DECLARATION IS
`PREJUDICIAL AND HE IS UNRELIABLE
`
`43
`
`
`
`DR. PRESTWICH DID NOT KNOW THE IPR GROUNDS
`
`Source: Ex. 2200, 429:10-432:13; Surreply at 6-7.
`
`44
`
`
`
`LARGE PORTIONS OF DR. PRESTWICH’S DECLARATION HAVE
`ALREADY BEEN CONSIDERED AND REJECTED
`
`Source: Ex. 2200 at 171:16-24; 477:4-12; Surreply at 7-8.
`
`45
`
`
`
`DR. PRESTWICH SELECTIVELY SUBMITTED EVIDENCE AND
`EXCLUDED RELEVANT PREVIOUS TESTIMONY
`
`Source: Compare Ex. 2200G at ¶83 with Ex. 1105 at ¶176; Surreply at 14.
`
`46
`
`
`
`PETITIONER’S FOUR-CROSSLINKER UNIVERSE IS
`FICTION
`
`47
`
`
`
`PETITIONER’S FOUR-CROSSLINKER-UNIVERSE IS FICTION
`
`Source: Pet. at 12.
`
`48
`
`
`
`PETITIONER’S FOUR-CROSSLINKER-UNIVERSE IS FICTION
`
`Source: POR at 41-42.
`
`49
`
`
`
`EX. 1059, REINMULLER, DOES NOT DISCLOSE A DVS-
`CROSSLINKED DERMAL FILLER
`
`Source: POR at 41-42; Ex. 1059.
`
`50
`
`
`
`REINMULLER DOES NOT DISCLOSE A CROSSLINKED DERMAL
`FILLER WITH LIDOCAINE
`
`Dr. DeVore’s testimony:
`
`Source: Ex. 1059 at 7:1-29; Ex. 2100 at 438:20-25; POR at 41; -1508 POR at 27-28.
`
`51
`
`
`
`REINMULLER EXCLUDES CROSS-LINKED HA FROM COSMETIC
`APPLICATIONS
`
`Source: Ex. 1059 at 6:46-52; -1508 POR at 27.
`
`52
`
`
`
`EX. 1050, THE CTA SUMMARY, DOES NOT DISCLOSE A “BDCI”
`(pBCDI)-CROSSLINKED DERMAL FILLER
`
`Source: POR at 41-42; Ex. 1050.
`
`53
`
`
`
`THE PETITION RELIES SOLELY ON DR. DEVORE’S PERSONAL
`KNOWLEDGE TO SHOW THAT ELEVESS WAS pBCDI-CROSSLINKED
`
`-1617 Petition:
`
`Dr. DeVore’s declaration (¶ 115):
`
`Dr. DeVore’s deposition:
`
`Source: Pet. at 11, 28; POR at 41-42; Ex. 1002 at ¶¶ 115-16; Ex. 2100 at 111:21-24.
`
`54
`
`
`
`DUE TO STABILITY PROBLEMS, ELEVESS WAS NOT ON THE
`MARKET AS OF 2008 PRIORITY DATE
`
`Source: POR at 42; Ex. 2100 at 236:19-237:3; Ex. 2105 at 5.
`
`55
`
`
`
`EX. 1012, KINNEY, DOES NOT DISCLOSE THE DETAILS OF A
`DEO-CROSSLINKED DERMAL FILLER
`
`Source: POR at 41-42; Ex. 1012.
`
`56
`
`
`
`THE POSA WOULD HAVE BEEN AWARE OF UNRESOLVED
`“DIFFICULTIES” WITH PURAGEN PLUS
`
`Source: Ex. 2100 at 230:5-231:2; Ex. 2137 at 4; POR at 42.
`
`57
`
`
`
`PETITIONER’S FOUR-CROSSLINKER-UNIVERSE IS FICTION
`
`Source: POR at 41-42.
`
`58
`
`
`
`CLAIM CONSTRUCTION
`
`CLAIM CONSTRUCTION
`
`59
`59
`
`
`
`UNDISPUTED CLAIM CONSTRUCTIONS
`
`Relevant IPR Agreed Construction
`All except
`substantially free of detectable, viable microorganisms
`-1508
`
`a composition that 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
`water soluble HA (i.e., uncrosslinked HA and/or lightly
`crosslinked HA)
`
`could be formed by a variety of methods—including sieving
`or mechanical homogenization—and can have a range of
`sizes
`
`Term
`sterile
`
`stable
`
`All except
`-1617
`
`uncrosslinked
`HA / free HA /
`soluble form HA
`particles
`
`-1505, -1508,
`-1509, -1617
`
`-1505, -1508
`
`Source: Pet. at 19, 21; -1505 Pet. at 15-17; POR at 19; -1505 POR at 19-20.
`
`60
`
`
`
`THE SPECIFICATION DESCRIBES “FREELY RELEASED IN VIVO”
`
`Source: Ex. 1001 at 17:4-45; POR at 19.
`
`61
`
`
`
`THE PROSECUTION HISTORY CONSISTENTLY EXPLAINS
`“FREELY RELEASED IN VIVO”
`
`Source: Ex. 1023 at 68; POR at 19.
`
`62
`
`
`
`DR. BERKLAND APPLIES THE PLAIN AND ORDINARY MEANING
`CONSISTENT WITH THE PATENT
`
`Source: Ex. 2013 at ¶ 208; Surreply at 22.
`
`63
`
`
`
`WHILE DR. PRESTWICH INTRODUCED AN ENTIRELY NEW
`CONSTRUCTION
`
`Petition:
`
`Dr. Prestwich’s Reply Declaration:
`
`Source: Petition at 31-32, 43-44; Ex. 1105 at ¶ 82; POR at 19; Surreply at 21-23.
`
`64
`
`
`
`DR. PRESTWICH’S TESTIMONY UNDERMINED BY SCIENTIFIC
`LITERATURE: “CONTROLLED RELEASE” IS NOT “FREELY
`RELEASED IN VIVO”
`
`Source: Ex. 2200 at 385:8-24; Surreply at 22-23.
`
`65
`
`
`
`DR. PRESTWICH’S PUBLICATIONS CONTRADICT HIS
`DECLARATION
`
`Source: U.S. Patent No. 5,502,081 at 4:7-15, 20:56-67; Surreply at 22-23.
`
`66
`
`
`
`DISPUTED TERMS: “UNBOUND,” “UNBOUND TO HA” (-1506,
`-1632)
`
`Source: -1506 Ex. 1002 at ¶¶ 138-139; -1632 POR at 21.
`
`67
`
`
`
`DISPUTED TERMS: “UNBOUND,” “UNBOUND TO HA” (-1506,
`-1632)
`
`Source: Ex. 2013 at ¶ 215; -1632 POR at 21.
`
`68
`
`
`
`DISPUTED TERM: “COHESIVE” (-1506)
`
`Source: -1506 Ex. 1001 at 5:62-67; -1506 POR at 20.
`
`69
`
`
`
`DISPUTED TERM: “HEAT STERILE” (-1508)
`
`Source: - 1508 Ex. 1001 at 8:56-61; -1508 POR at 20-21.
`
`70
`
`
`
`DISPUTED TERM: “HEAT STERILE” (-1508)
`
`Source: Ex. 2013 at ¶ 201; -1508 POR at 20-21.
`
`71
`
`
`
`DISPUTED TERM: “STABLE TO AUTOCLAVING” (-1632)
`
`Source: -1632 Ex. 1001 at 5:13-20; -1632 POR at 20-21.
`
`72
`
`
`
`PETITIONER MISAPPLIES THE LAW OF OBVIOUSNESS
`
`PETITIONER MISAPPLIES THE LAW OF OBVIOUSNESS
`
`73
`73
`
`
`
`PETITIONER BEARS THE BURDEN OF SHOWING BOTH
`MOTIVATION AND A REASONABLE EXPECTATION OF SUCCESS
`
`In any inter partes review, “the petitioner shall have the burden of proving a
`proposition of unpatentability by a preponderance of the evidence.”
`
`35 U.S.C. § 316(e).
`
`At every stage of the proceeding, the petitioner’s burden “never shifts to the
`patentee.”
`
`In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1378-79 (Fed. Cir. 2016).
`
`It remains Petitioner’s burden to demonstrate motivation to make the
`claimed composition in the first place, and a reasonable expectation of
`success of achieving it.
`
`Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1089 (Fed. Cir. 2008).
`
`Source: Surreply at 4,15, 20.
`
`74
`
`
`
`RELIANCE ON THE PATENT TO PIECE TOGETHER CLAIM
`ELEMENTS IS IMPROPER HINDSIGHT
`
`In any inter partes review, “the petitioner shall have the burden of proving a
`proposition of unpatentability by a preponderance of the evidence.”
`…
`“[I]t is improper to combine references ‘like separate pieces of a simple
`jigsaw puzzle’ without ‘explaining what reason or motivation one of ordinary
`skill in the art at the time of the invention would have had to place these
`pieces together.”
`
`…
`Where “the only way to arrive at the [claimed invention] is by using [the
`challenged patent] as a roadmap to piece together various elements of [the
`prior art],” “[t]hat represents an improper reliance on hindsight.”
`
`Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC, 711 Fed. Appx. 633, 636-37 (Fed. Cir. 2017).
`
`Source: POR at 29.
`
`75
`
`
`
`KNOWLEDGE OF EACH INDIVIDUAL PROCESSING STEP DOES
`NOT SHOW REASONABLE EXPECTATION OF SUCCESS
`
`The Federal Circuit rejected an obviousness argument where, despite the
`“many scientific publications cited by both Dow and the PTO, none suggests
`that any process could be used successfully in this three-component
`system, to produce this product having the desired properties.”
`…
`“There must be a reason or suggestion in the art for selecting the procedure
`used, other than the knowledge learned from the applicant’s disclosure.”
`In re Dow Chem. Co., 837 F.2d 469, 473 (Fed. Cir. 1988).
`
`Source: Surreply at 28.
`
`76
`
`
`
`PETITIONER’S OBVIOUSNESS ARGUMENTS FOCUS ON WHAT A
`POSA COULD DO NOT WHAT THEY WOULD DO
`
`Source: Pet. at 29, 30.
`
`77
`
`
`
`THERE IS A DIFFERENCE BETWEEN ABILITY AND MOTIVATION
`
`Petitioner’s Reply:
`
`Dr. Berkland’s testimony:
`
`Source: Reply at 26-27; Ex. 1200 at 358:21-359:7; Surreply at 4.
`
`78
`
`
`
`THE QUESTION, AGAIN, IS WHAT THE POSA WOULD BE
`MOTIVATED TO DO
`
`Dr. Prestwich agrees that, even when individual steps are within
`the level of skill of a POSA, the POSA still requires motivation:
`
`Source: Ex. 2200 at 306:19-23; Surreply at 12.
`
`79
`
`
`
`THE OBVIOUSNESS INQUIRY REQUIRES ACTUAL MOTIVATION
`PROVIDED BY THE PRIOR ART, NOT CONCLUSORY EXPERT TESTIMONY
`
`“Conclusory expert testimony does not qualify as substantial evidence.”
`TQ Delta, LLC v. Cisco Sys., 942 F.3d 1352, 1358 (Fed. Cir. 2019).
`
`“The obviousness inquiry does not merely ask whether a skilled artisan could
`combine the references, but instead asks whether ‘they would have been
`motivated to do so.’”
`
`Adidas AG v. Nike, Inc., 963 F.3d 1355, 1359 (Fed. Cir. 2020).
`
`Source: Surreply at 4, 13.
`
`80
`
`
`
`(& CTA SUMMARY IN -01632 IPR)
`
`GROUP A: LEBRETON + SADOZAI
`(& CTA SUMMARY IN -01632 IPR)
`
`GROUP A: LEBRETON + SADOZAI
`
`81
`81
`
`
`
`LEBRETON + SADOZAI COMBINATIONS
`01505
`01506
`01508
`01509
`01617
`Lebreton +
`Lebreton +
`Sadozai
`Sadozai
`+ CTA
`Summary
`Lebreton +
`Sadozai
`+ CTA
`Summary
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Clark
`Lebreton +
`Sadozai
`+ Smith
`
`Lebreton +
`Sadozai
`+ Clark
`
`01632
`Lebreton +
`Sadozai
`
`00084
`Lebreton +
`Sadozai
`
`CTA
`Summary
`
`82
`
`
`
`LEBRETON + SADOZAI COMBINATIONS
`01505
`01506
`01508
`01509
`01617
`Lebreton +
`Lebreton +
`Sadozai
`Sadozai
`+ CTA
`Summary
`Lebreton +
`Sadozai
`+ CTA
`Summary
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Clark
`Lebreton +
`Sadozai
`+ Smith
`
`Lebreton +
`Sadozai
`+ Clark
`
`01632
`Lebreton +
`Sadozai
`
`00084
`Lebreton +
`Sadozai
`
`CTA
`Summary
`
`83
`
`
`
`LEBRETON—EXHIBIT 1029
`
`• Patent publication describing crosslinking with a mixture of high and
`low molecular weight HA for dermal filler application
`• Lebreton describes “monophasic” gels with a “soft and free-flowing
`appearance”
`• Lebreton’s BDDE-tailored processes use aqueous (not organic)
`solvents
`• No discussion or suggestion of lidocaine
`
`Source: POR at 19-20; Ex. 1029 at Abstract, ¶¶ 64-65, 74-76, 81, 85-91.
`
`84
`
`
`
`SADOZAI—EXHIBIT 1030
`
`• Patent publication describes superiority of BCDI crosslinking of HA with lidocaine
`
`• Describes “controlled or sustained release” of lidocaine from BCDI-crosslinked
`HA
`
`• Describes BCDI-crosslinking processes resulting in “water-insoluble, hydrated HA
`gel particles”
`
`• BCDI-crosslinked particles are isolated by precipitation with organic solvent prior
`to rehydration to prepare a dermal
`
`Source: POR at 20-22; Ex. 1030 at Abstract, ¶¶ 8, 45-46, 54, 59, 105, 107.
`
`85
`
`
`
`THERE IS NO MOTIVATION TO COMBINE
`LEBRETON + SADOZAI
`
` BDDE-
`crosslinked
`dermal fillers
` Monophasic
` No lidocaine
` No organic
`solvents
`(aqueous)
`
` “Superior”
`BCDI-
`crosslinked
`dermal fillers
` Synergy with
`lidocaine
` Dense particles
` Organic
`solvents
`
`Source: POR at 19-22, 38-46.
`
`86
`
`
`
`SADOZAI MOTIVATED A POSA TO USE pBCDI CROSSLINKER
`WITH LIDOCAINE OVER OTHER KNOWN CROSSLINKERS
`
`Source: Ex. 1030 at Fig. 5, ¶ 105; POR at 20-21, 40.
`
`87
`
`
`
`SADOZAI MOTIVATED A POSA TO USE pBCDI CROSSLINKER
`WHEN INCORPORATING LIDOCAINE
`
`Source: Ex. 1030 at ¶¶ 90, 107, Fig. 7; POR at 21.
`
`88
`
`
`
`SADOZAI DESCRIBES SUSTAINED RELEASE
`
`Source: Ex. 1030 at ¶ 59; POR at 48-49.
`
`89
`
`
`
`DR. DEVORE: NO MOTIVATION TO MODIFY EXISTING DERMAL
`FILLERS TO INCLUDE LIDOCAINE
`
`Source: Ex. 2100 at 426:17- 427:2; -1508 POR at 63.
`
`90
`
`
`
`DR. BERKLAND: SIGNIFICANT DIFFERENCES IN CHEMISTRY
`BETWEEN pBCDI AND BDDE
`
`Source: Ex. 2013 at ¶ 221; POR at 39.
`
`91
`
`
`
`PETITIONER AND DR. DEVORE IGNORE THE DIFFERENCES BETWEEN
`pBCDI’S AND BDDE’S INTERACTIONS WITH LIDOCAINE
`
`The distributed pi orbitals found in
`aromatic ring structures like in
`pBCDI and lidocaine can interact:
`
`Petitioner failed to account for these interactions:
`
`As did Petitioner’s expert, Dr. DeVore:
`
`Source: Pet. at 33; POR at 40; Ex. 2100 at 364:24-365:2; Ex. 2013 at ¶ 125.
`
`92
`
`
`
`A POSA WOULD RECOGNIZE THAT THE PROCESSES OF
`LEBRETON AND SADOZAI WERE INCOMPATIBLE
`
`Source: POR at 44; Ex. 2013 at ¶¶ 220, 223, 231.
`
`93
`
`
`
`DR. BERKLAND EXPLAINED THE INCOMPATIBILITY THAT
`EXISTS BETWEEN LEBRETON AND SADOZAI
`
`• Sadozai uses organic solvents, dehydration, and washing with solvents:
`• This would dehydrate HA, increasing H+ bonding and ionic interactions,
`cause chain entanglement and irreversible changes to the gel (reduced
`swelling capacity).
`• Results in densely packed particles suspended in a physiological buffer
`solution—i.e., a biphasic composition.
`• Lebreton does not teach organic solvents, dehydration, or solvent washing:
`• Aqueous NaOH solutions which avoid irreversible changes—only possible
`because BDDE is a water-soluble crosslinker.
`• Results in soft, free-flowing, monophasic composition—not biphasic with
`dense particles like in Sadozai
`
`Source: Ex. 2013 at ¶¶ 223, 225, 231; POR at 44-45.
`
`94
`
`
`
`DR. BERKLAND: PROCESS STEPS AND THEIR ORDER AFFECT
`THE FINAL PROPERTIES
`
`Source: POR at 45; Compare Pet. at 30 with Ex. 1002 at ¶ 140; see Ex. 2013 at ¶¶ 232-35.
`
`95
`
`
`
`DR. BERKLAND: THE POSA WOULD NOT ADD LIDOCAINE
`DURING NEUTRALIZATION STEP OR DIALYSIS STEP
`
`• Problems with adding lidocaine
`during a neutralization step :
`• Solution pH is ~13.5—high
`enough to precipitate lidocaine
`• Lidocaine will affect buffer pH,
`osmolarity, and ionic strength
`• Composition is not yet purified—
`unreacted chemicals can have
`detrimental interactions with
`lidocaine
`
`• Problems with adding lidocaine
`during a dialysis step:
`• Would require numerous lidocaine
`dialysate solutions—tremendous
`waste of lidocaine
`• Must continuously monitor to
`quantify equilibrated lidocaine
`• Would not use a process intended
`to remove impurities to add a
`highly pure active ingredient
`
`Source: Ex. 2013 at ¶¶ 234, 235; POR at 45-46.
`
`96
`
`
`
`EVEN IF COMBINED, LEBRETON + SADOZAI DOES NOT
`DISCLOSE FREELY RELEASED OR UNBOUND LIDOCAINE
`
`“Freely released in vivo”/
`“unbound”
`Petitioner relies on Sadozai’s
`disclosures to supply this limitation
`
`Dr. DeVore’s declaration:
`
`Source: -1506 Pet. at 28-29; -1506 Ex. 1002 at ¶ 152; POR at 48-49;
`-1506 POR at 45-47; -1632 POR at 63-66.
`
`97
`
`
`
`LEBRETON + SADOZAI IS SILENT REGARDING SPECIFIC EXTRUSION
`FORCE AND VISCOSITY LIMITATIONS
`
`Dr. DeVore’s testimony:
`
`Extrusion force and viscosity
`limitations
`Petitioner relies solely on the alleged
`properties of certain products and
`unsubstantiated expert testimony, but
`does not point to any evidence
`establishing the claimed properties in
`the asserted references
`
`Source: -1506 Pet. at 32-37; -1506 POR at 52-57; Ex. 2100 at 396:11-397:19.
`
`98
`
`
`
`LEBRETON + SADOZAI DOES NOT DISCLOSE OR SUGGEST
`MANY OF THE CLAIMED LIMITATIONS
`• Petitioner has failed to establish the following limitations in the asserted
`references:
`• Amount of free HA
`• Degree of crosslinking
`• Viscosity and extrusion force requirements
`• Lidocaine concentration, HA concentration, extrusion force, and
`appearance remain “substantially constant” during storage under ambient
`conditions for at least 3 months
`• pH
`• HA concentration
`• Cohesive composition
`• Dialysis equilibrium
`Source: Pet. at 35-40; POR at 53-58; -1506 Pet. at 32-37; -1632 Pet. at 43; -1505 POR at 50-
`51, 53-56; -1506 POR at 47-48; -1632 POR at 48-49, 66.
`
`99
`
`
`
`LEBRETON + SADOZAI COMBINATIONS
`01505
`01506
`01508
`01509
`01617
`Lebreton +
`Lebreton +
`Sadozai
`Sadozai
`+ CTA
`Summary
`Lebreton +
`Sadozai
`+ CTA
`Summary
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Clark
`Lebreton +
`Sadozai
`+ Smith
`
`Lebreton +
`Sadozai
`+ Clark
`
`01632
`Lebreton +
`Sadozai
`
`00084
`Lebreton +
`Sadozai
`
`CTA
`Summary
`
`100
`
`
`
`THERE IS NO MOTIVATION TO COMBINE
`LEBRETON + SADOZAI + CTA SUMMARY
`
` “Superior”
`BCDI-
`crosslinked
`dermal fillers
` Synergy with
`lidocaine
` Dense particles
` Organic
`solvents
`
`Source: POR at 19-22, 25, 38-46.
`
` BDDE-
`crosslinked
`dermal fillers
` Monophasic
` No lidocaine
` No organic
`solvents
`(aqueous)
`
` Crosslinked
`(unspecified)
`dermal filler
` 0.3% lidocaine
` No comp’n
`processing
` Elution test
` Proposed 15
`mo. expiration
`
`101
`
`
`
`CTA SUMMARY—EXHIBIT 1050
`
`• Petitioner fails to demonstrate CTA Summary was publicly available as
`of August 2008
`• Document provides only a partial description of CTA and its properties
`• Does not identify the crosslinking agent, amount of crosslinking, or any
`details regarding processing, manufacturing, sterilization or stability
`
`Source: Ex. 1050 at 6; POR at 25, 35-37.
`
`102
`
`
`
`DRAFT CTA LABEL—EXHIBIT 1031
`
`• No evidence that Ex. 1030 is prior art or available to the POSA
`• Ex. 1031 has no relevant date, is marked “CONFIDENTIAL,” and has
`markings of being a draft document
`• Not in the grounds
`• Document provides only a partial description of CTA
`• Does not identify crosslinker, details regarding processing or
`manufacturing
`
`Source: POR at 25; Ex. 1031 at 1.
`
`103
`
`
`
`CTA SUMMARY LIKEWISE DOES NOT SUPPLY THE “FREELY
`RELEASED” LIMITATION
`
`“Freely released in vivo”
`
`Dr. DeVore’s testimony:
`
`Source: Ex. 2100 at 237:20-22, 238:20-24, 239:13-21; POR at 50-51.
`
`104
`
`
`
`LEBRETON + SADOZAI + CTA DOES NOT SUGGEST THE
`CLAIMED DEGREE OF CROSSLINKING
`
`Degree of crosslinking
`
`• Petitioner fails to show how
`Lebreton’s crosslinking ranges
`would inform the degree of
`crosslinking necessary for a BDDE-
`crosslinked dermal filler with
`lidocaine
`• Petitioner cannot rely on a product,
`Restylane, to fill gaps in the prior art
`
`Source: Ex. 2100 at 113:18-114:2; Pet. at 35; POR at 53-54.
`
`105
`
`
`
`LEBRETON + SADOZAI + CTA DOES NOT SUGGEST EXTRUSION
`FORCE, VISCOSITY, AND DEGRADATION LIMITATIONS
`
`Extrusion force, viscosity, and
`degradation limits
`• Petitioner inappropriately relies on
`products like CTA, Puragen Plus,
`and Prevelle Silk to establish
`properties not in prior art
`• Petitioner misapprehends that
`stability is not required for FDA
`approval—approval says nothing of
`extrusion force or viscosity
`
`Source: Ex. 2100 at 107:23-108:3; Pet. at 37-40; POR at 55-58.
`
`106
`
`
`
`PETITIONER’S RELIANCE ON CTA IS MISPLACED—CTA
`CONTINUED TO HAVE STABILITY PROBLEMS
`
`Source: Ex. 2100 at 236:19-237:3; Ex. 2122 at 1; POR at 55-56; see also Ex. 2105 at 5.
`
`107
`
`
`
`LEBRETON + SADOZAI + CTA DOES NOT DISCLOSE OR
`SUGGEST MANY OF THE CLAIMED LIMITATIONS
`
`• Petitioner has failed to establish the following limitations in the asserted
`references:
`• Average particle size
`• Degree of crosslinking
`• pH
`• Extrusion force and viscosity remain “substantially constant” and “lidocaine
`does not substantially degrade the HA” during storage under ambient
`conditions for at least 3, 6, or 9 months
`
`Source: Pet. at 34-40; POR at 52-58; -1506 POR at 54-57.
`
`108
`
`
`
`LEBRETON + SADOZAI COMBINATIONS
`01505
`01506
`01508
`01509
`01617
`Lebreton +
`Lebreton +
`Sadozai
`Sadozai
`+ CTA
`Summary
`Lebreton +
`Sadozai
`+ CTA
`Summary
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Clark
`Lebreton +
`Sadozai
`+ Smith
`
`Lebreton +
`Sadozai
`+ Clark
`
`01632
`Lebreton +
`Sadozai
`
`00084
`Lebreton +
`Sadozai
`
`CTA
`Summary
`
`109
`
`
`
`MONHEIT DOES NOT DISCUSS ADDING FREE HA TO
`MONOPHASIC COMPOSITIONS
`
`Source: Ex. 2100 at 453:23-454:2; 454:3-13; POR at 58-59.
`
`110
`
`
`
`MONHEIT RECOGNIZES DISADVANTAGES TO FREE HA
`
`Source: Ex. 1022 at 78; POR at 58-59.
`
`111
`
`
`
`DR. DEVORE: MONHEIT PROVIDES NO SPECIFIC DETAILS ON
`HOW A POSA WOULD INCORPORATE FREE HA
`
`Source: Ex. 2100 at 454:21-455:6; POR at 58-59.
`
`112
`
`
`
`LEBRETON + SADOZAI + MONHEIT DOES NOT DISCLOSE OR
`SUGGEST MANY OF THE CLAIMED LIMITATIONS
`
`• Petitioner has failed to establish the following limitations in the asserted
`references:
`• pH
`• Extrusion force
`• Viscosity
`• Degree of crosslinking
`
`Source: -1508 Pet. at 28-33; -1509 Pet. at 34; -1508 POR at 51-54; -1509 POR at
`52-54.
`
`113
`
`
`
`LEBRETON + SADOZAI COMBINATIONS
`01505
`01506
`01508
`01509
`01617
`Lebreton +
`Lebreton +
`Sadozai
`Sadozai
`+ CTA
`Summary
`Lebreton +
`Sadozai
`+ CTA
`Summary
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Clark
`Lebreton +
`Sadozai
`+ Smith
`
`Lebreton +
`Sadozai
`+ Clark
`
`01632
`Lebreton +
`Sadozai
`
`00084
`Lebreton +
`Sadozai
`
`CTA
`Summary
`
`114
`
`
`
`DR. DEVORE: NEITHER SMITH NOR CLARK DISCUSS FREE HA IN
`MONOPHASIC HA GELS OR HA GELS WITH LIDOCAINE
`
`Smith
`
`Clark
`
`Source: Ex. 2100 at 446:18-23, 447:9-12, 449:7-10, 452:2-5; -1505 POR at 48-49.
`
`115
`
`
`
`LEBRETON + SADOZAI COMBINATIONS
`01505
`01506
`01508
`01509
`01617
`Lebreton +
`Lebreton +
`Sadozai
`Sadozai
`+ CTA
`Summary
`Lebreton +
`Sadozai
`+ CTA
`Summary
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Monheit
`
`Lebreton +
`Sadozai
`+ Clark
`Lebreton +
`Sadozai
`+ Smith
`
`Lebreton +
`Sadozai
`+ Clark
`
`01632
`Lebreton +
`Sadozai
`
`00084
`Lebreton +
`Sadozai
`
`CTA
`Summary
`
`116
`
`
`
`THE CTA SUMMARY DOES NOT ENABLE THE CLAIMED
`INVENTIONS
`• Dr. DeVore admits that CTA Summary does not describe what crosslinker
`was used, what crosslinking reaction conditions were followed, what, if any,
`post-crosslinking steps were performed, or how the product was sterilized.
`
`In order to render a claimed apparatus or method obvious, the prior art must
`enable one skilled in the art to make and use the apparatus or method.
`Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989) (emphasis added).
`
`Source: Ex. 2100 at 237:20-22, 238:8-19; -1632 POR at 37-39.
`
`117
`
`
`
`CTA SUMMARY DOES NOT DISCLOSE OR SUGGEST THE
`CLAIMED pH RANGES
`
`pH range
`
`• CTA Summary pH range is 6.2 to
`7.6—does not suggest a pH above
`7.5.
`See Atofina v. Great Lakes Chem.
`Corp., 441 F.3d 991, 1000 (Fed. Cir.
`2006) (holding that “slightly
`overlapping range”—150 to 350 in
`reference as compared to 330 to
`450 in patent—was insufficient to
`establish that limitation).
`
`-1632 Ex. 1001 (’795 patent)
`
`Ex. 1050 at 6
`
`118
`Source: -1632 Ex. 1001 at claims 26-28; Ex. 1050 at 6; -1632 Pet. at 23-24; -1632 POR at 39-40.
`
`
`
`CTA SUMMARY DOES NOT DISCLOSE OR SUGGEST
`AUTOCLAVE STERILIZATION
`
`-1632 Pet. at 25
`
`Ex. 2100 at 82:15-21
`
`Autoclave sterilization
`• Petitioner admits that CTA
`Summary does not disclose that it is
`autoclaved
`• Cites to only the Lebreton patent for
`its claim that autoclaving was
`predominant method in 2008, but
`Dr. DeVore admitted other methods
`were used
`• Petitioner cannot rely on Sadozai to
`gap-fill—POSA would recognize no
`connection between the two
`
`Source: -1632 Pet. at 25; -1632 POR at 41-43; Ex. 2100 at 82:15-21.
`
`119
`
`
`
`CTA SUMMARY DOES NOT DISCLOSE OR SUGGEST MANY OF
`THE CLAIMED LIMITATIONS
`
`• Petitioner has failed to establish the following limitations in the asserted
`references:
`• HA concentration about 22 mg/mL
`• Stability, concentration, appearance, and extrusion force maintained from 3
`to 9 months
`• “Freely released” or “substantially unbound” lidocaine
`• Dialysis to lidocaine equilibrium within 1 hour
`
`Source: -1632 Pet. at 24-30; -1632 POR at 43-49.
`
`120
`
`
`
`GROUP B: KINNEY + ZHAO + NARINS
`
`GROUP B: KINNEY + ZHAO + NARINS
`
`121
`121
`
`
`
`KINNEY + ZHAO + NARINS COMBINATIONS
`
`01505
`
`Kinney +
`Zhao + Narins
`+ Monheit
`Kinney +
`Zhao + Narins
`+ Clark
`Kinney +
`Zhao + Narins
`+ Smith
`
`01506
`Kinney +
`Zhao + Narins
`
`01508
`Kinney +
`Zhao + Narins
`
`01509
`
`01617
`Kinney +
`Zhao + Narins
`
`Kinney +
`Zhao + Narins
`+ Monheit
`
`Kinney +
`Zhao + Narins
`+ Smith
`
`122
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`KINNEY—EXHIBIT 1012
`
`• Author’s preliminary observations of “Puragen Plus” clinical trial performance at 1
`trial site
`• Describes Puragen as an HA-based dermal filler that is “double-crosslinked” with
`DEO and contains 0.3% lidocaine
`• Kinney provides no discussion of:
`o
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