Mylan Pharmaceuticals Inc.
`and Pfizer, Inc.,*
`Petitioners
`v.
`Sanofi-Aventis Deutschland GmbH
`Patent Owner
`U.S. Patent No. 8,679,069
`U.S. Patent No. 8,603,044
`U.S. Patent No. 8,603,044
`U.S. Patent No. 8,992,486
`U.S. Patent No. 9,604,008
`U.S. Patent No. 8,992,486
`
`IPR2018-01670
`IPR2018-01675
`IPR2018-01676
`IPR2018-01678
`IPR2018-01684
`IPR2019-00122
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`January 15, 2020
`*Pfizer is not a party to the -1670 proceeding.
`
`1
`
`
`and Pfizer, Inc.,*
`Petitioners
`v.
`Sanofi-Aventis Deutschland GmbH
`Patent Owner
`U.S. Patent No. 8,679,069
`U.S. Patent No. 8,603,044
`U.S. Patent No. 8,603,044
`U.S. Patent No. 8,992,486
`U.S. Patent No. 9,604,008
`U.S. Patent No. 8,992,486
`
`IPR2018-01670
`IPR2018-01675
`IPR2018-01676
`IPR2018-01678
`IPR2018-01684
`IPR2019-00122
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`January 15, 2020
`*Pfizer is not a party to the -1670 proceeding.
`
`1
`
`
`
`Overview of IPR Grounds
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`Unless otherwise noted, papers refer to IPR2018-01670.
`
`2
`
`
`
`IPRs -1670, -1675, -1676, -1678, -0122:
`Burroughs, Møller, and Steenfeldt-Jensen
`
`Ground
`
`Claims
`
`1
`
`2
`
`3
`
`1
`
`1
`
`1
`
`The ’069 Patent (-1670)
`Basis
`
`Obvious over Burroughs (EX1013)
`
`Obvious over Steenfeldt-Jensen (EX1014)
`Obvious over Møller (EX1015) and Steenfeldt-
`Jensen
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`3
`
`
`
`IPRs -1670, -1675, -1676, -1678, -0122:
`Burroughs, Møller, and Steenfeldt-Jensen
`
`Ground
`
`1
`
`Claims
`11, 14-15,
`18-19
`
`The ’044 Patent (-1675)
`Basis
`
`Obvious over Burroughs
`
`Ground
`
`1
`
`2
`
`Claims
`11, 14-15,
`18-19
`11, 14-15,
`18-19
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`The ’044 Patent (-1676)
`Basis
`
`Obvious over Steenfeldt-Jensen
`
`Obvious over Møller and Steenfeldt-Jensen
`
`4
`
`
`
`IPRs -1670, -1675, -1676, -1678, -0122:
`Burroughs, Møller, and Steenfeldt-Jensen
`
`The ’486 Patent (-0122)
`
`Ground
`
`1
`
`Claims
`1-6, 12-18, 20, 23, 26-30,
`32-33, 36, 38-40
`
`Basis
`
`Obvious over Burroughs
`
`The ’486 Patent (-1678)
`
`Ground
`
`1
`
`2
`
`Claims
`1-6, 12-18, 20, 23, 26-30,
`32-33, 36, 38-40
`1-6, 12-18, 20, 23, 26-30,
`32-33, 36, 38-40
`
`Basis
`
`Obvious over Steenfeldt-Jensen
`
`Obvious over Møller and
`Steenfeldt-Jensen
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`5
`
`
`
`IPR -1684: Møller and Steenfeldt-Jensen
`
`Ground
`
`1
`
`Claims
`1, 3, 7, 8,
`11, 17
`
`The ’008 Patent (-1684)
`Basis
`
`Obvious over Møller and Steenfeldt-Jensen
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`6
`
`
`
`IPRs -1670, -1675, -1676, -1678, -0122:
`Independent Claims Substantially Similar
`
`(3)
`(4)
`
`(5)
`
`“A housing part for a medication dispensing apparatus…comprising:”
`“a main housing [4, gray] … extending from a distal end to a proximal end;”
`(1)
`“a dose dial sleeve [70, green] positioned within said housing…comprising a helical
`(2)
`groove configured to engage a threading provided by said main housing, said helical
`groove provided along an outer surface of said dose dial sleeve1;”
`“a dose dial grip2 [76, purple] disposed near a proximal end of said dose dial sleeve;”
`“a piston rod [20, yellow] provided within said housing, said piston rod is non-
`rotatable during a dose setting step relative to said main housing;”
`“a drive sleeve3 [30, red] extending along a portion of said piston rod…comprising an
`internal threading near a distal portion…adapted to engage an external thread of said
`piston rod;”
`“a tubular clutch [60, blue] located adjacent a distal end of said dose dial grip, said
`tubular clutch operatively coupled to said dose dial grip,”
`“wherein said dose dial sleeve extends circumferentially around at least a portion of said
`tubular clutch”
`“wherein said helical groove of the dose dial sleeve has a first lead and said internal
`threading of said drive sleeve has a second lead, and wherein said first lead and said
`second lead are different4”
`
`(6)
`
`Source: Pet., 5-7 (citing EX1011, ¶38).
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`1Not required in claim 1 of ’486 patent.
`2Recited as “dose knob” in claim 1 of ’486 patent.
`3Recited as “driver” in claim 1 of ’486 patent.
`4Only required in claim 11 of ’044 patent.
`
`7
`
`
`
`IPR -1684: Independent Claim 1
`
`(3)
`
`“A drive mechanism for use in a drug delivery device comprising:”
`“a housing [4, gray] comprising a helical thread;”
`(1)
`“a dose dial sleeve [70, green] having a threaded surface that is
`(2)
`engaged with the helical thread of the housing,”
`“an insert [16, purple] provided in the housing, where the insert has a
`threaded circular opening;”
`“a drive sleeve [30, red] releasably connected to the dose dial sleeve
`and having an internal helical thread;”
`“a piston rod [20, yellow] having a first thread and a second thread,
`wherein the first thread is engaged with the threaded circular opening
`of the insert and the second thread is engaged with the internal
`helical thread of the drive sleeve; and”
`“a clutch [60, blue] located between the dose dial sleeve and the
`drive sleeve, wherein the clutch is located (i) radially outward of the
`drive sleeve and (ii) radially inward of the dose dial sleeve.”
`
`(4)
`
`(5)
`
`(6)
`
`Source: EX1011, ¶¶40-41; -1684 Pet., 6-8.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`8
`
`
`
`Sanofi’s Response to Each Ground
`Repeats the Same Errors
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`9
`
`
`
`Sanofi’s Repeated Errors
`
`Flawed premise: myopic focus on injection force
`• Claims not limited to insulin pens
`• Claims do not require low injection force
`•
`Injection force just one of many design factors
`• Cost and reliability are key
`
`Flawed analysis of modifications
`• Outsourced bases for testimony to named inventor
`• Flawed inputs
`•
`Ignored routine skill
`
`Source: Pet. Reply, 3-4, 13-18; EX1048, ¶¶28-32; EX1095, ¶¶72-75; Pet. Resp. to Obs., 1.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`10
`
`
`
`Claims Are Obvious Over Burroughs
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`11
`
`
`
`IPRs -1670, -1675, -0122:
`Burroughs Renders the Claims Obvious
`
`(3)
`
`Burroughs describes an injector pen having:
`“a main housing [housing 22, gray]…extending from a distal end to a proximal end;”
`(1)
`“a dose dial sleeve [dial mechanism 34, green] positioned within said
`(2)
`housing…comprising a helical [rib] configured to engage a threading provided by said
`main housing, said helical [rib] provided along an outer surface of said dose dial
`sleeve;”
`“a dose dial grip [or dose knob] [proximal portion 78, purple] disposed near a
`proximal end of said dose dial sleeve;”
`“a piston rod [leadscrew 38, yellow] provided within said housing, said piston rod is
`non-rotatable during a dose setting step relative to said main housing;”
`“a drive sleeve [or driver] [nut 36, red] extending along a portion of said piston
`rod…comprising an internal threading near a distal portion…adapted to engage an
`external thread of said piston rod;”
`“a tubular clutch [button 32, blue] located adjacent a distal end of said dose dial grip,
`said tubular clutch operatively coupled to said dose dial grip,”
`“wherein said dose dial sleeve extends circumferentially around at least a portion of said
`tubular clutch”
`
`(4)
`
`(5)
`
`(6)
`
`Source: Pet., 18-20 (citing EX1011, ¶¶125-28), 25-40.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`12
`
`
`
`Rib-to-Groove Connection:
`A Predictable Variation
`
`Source: EX1011, ¶165; EX1013, 10:34-38, 12:30-39; EX2103; Pet., 29-30, 40-42 (citing EX1011, ¶¶161-71).
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`13
`
`
`
`Rib-to-Groove Connection:
`A Predictable Variation
`
`Source: EX1011, ¶¶169-70; Pet., 29-30, 40-42 (citing EX1011, ¶¶161-71).
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`14
`
`
`
`Burroughs Modification: Sanofi’s Strawman
`
`Rationale not merely “that a POSA could have
`performed the proposed modification….” as alleged.
`
`“If a person of ordinary skill can implement a
`predictable variation, §103 likely bars its patentability.”
`KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
`
`Rib-to-groove and groove-to-rib engagements were
`known, interchangeable implementations.
`•
`Sanofi does not dispute the modification’s workability or that
`grooved dial sleeves were commonplace.
`
`Source: Pet., 40-42; EX1011, ¶¶166-71; POR, 18-19; Pet. Reply, 3-4; EX1095, ¶43.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`15
`
`
`
`Burroughs Modification: Sanofi’s Strawman
`
`Faced with predictable variation involving known threading solution:
`•
`Literal translation of Mr. Leinsing’s general representation of modification
`•
`Ignores routine skill
`
`Mr. Leinsing:
`
`Source: POR, 19-22; EX2107, ¶¶170-93; Pet. Reply, 3-4; EX1095, ¶¶40-43.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`16
`
`
`
`Burroughs Modification: Sanofi’s Strawman
`
`Faced with predictable variation involving known threading solution:
`•
`Literal translation of Mr. Leinsing’s general representation of modification
`•
`Ignores routine skill
`
`Source: POR, 19-22; EX2107, ¶¶174-93, App’x D; Pet. Reply, 3-4; EX1095, ¶¶40-43.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`17
`
`
`
`Burroughs Modification: Sanofi’s Strawman
`
`Faced with predictable variation involving known threading solution:
`•
`Literal translation of Mr. Leinsing’s general representation of modification
`•
`Ignores routine skill
`
`Mr. Leinsing:
`
`Source: POR, 19-22; EX2107, ¶¶174-93, App’x D; Pet. Reply, 3-4; EX1095, ¶¶40-43.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`18
`
`
`
`Burroughs Modification: Sanofi’s Strawman
`
`Even if Sanofi’s figures were correct, they do not
`undercut the modification.
`
`• Alleged 10% increase in width advantageous for some patients
`
`Dr. Biggs:
`
`• Alleged 15% increase in injection force:
`•
`Speculative
`• No allegation that even speculative increase is problematic
`
`Source: POR, 19-22; Pet. Reply, 3-4; EX1048, ¶50; EX2107, ¶192; EX1095, ¶41.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`19
`
`
`
`No Dispute Burroughs Meets “Clutch” Limitation Under
`Sanofi’s Proposed District-Court Construction
`
`These IPRs apply broadest reasonable interpretation.
`
`Construction proposed by Sanofi in district court:
`•
`“[Tubular] structure that couples and decouples a moveable
`component from another component.”
`
`Sanofi cannot dispute reasonableness of its own
`construction
`•
`Same construction adopted by District Court of Delaware in
`previous case (Sanofi v. Eli Lilly)
`
`Waiver: no dispute that Burroughs satisfies this construction.
`
`Source: Pet., 16-17; POR, 6-8, 23-25; Pet. Reply, 1-2, 5-6; EX1019, 21-23; EX1030, 12; EX1095,
`¶¶35-36, 45-47.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`20
`
`
`
`’044 Patent, Claim 11 (-1675):
`Burroughs’ Pen Has First and Second leads
`
`“wherein said helical groove of the dose dial sleeve has a first lead and said internal threading of said drive sleeve has a
`second lead, and wherein said first lead and said second lead are different”
`
`Dial mechanism 34 (“dose dial sleeve”) has a
`“first lead”:
`
`Nut 36 (“drive sleeve”) has a “second lead”:
`
`Source: EX1013, 10:34-42, FIGS. 7, 11; -1675 Pet. at 36-40 (citing EX1011, ¶¶189-99).
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`21
`
`
`
`’044 Patent, Claim 11 (-1675):
`Lead Difference Known
`
`“wherein said helical groove of the dose dial sleeve has a first lead and said internal threading of said drive sleeve has a
`second lead, and wherein said first lead and said second lead are different”
`
`Different leads = different rates of travel:
`
`Source: EX1015, ¶¶5-6; EX1002, 5:61-65; -1675 Pet., 36-40 (citing EX1011, ¶¶189-99).
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`22
`
`
`
`’044 Patent, Claim 11 (-1675):
`Lead Difference Known
`
`“wherein said helical groove of the dose dial sleeve has a first lead and said internal threading of said drive sleeve has a
`second lead, and wherein said first lead and said second lead are different”
`
`Institution Decision:
`
`Sanofi asked Mr. Leinsing no questions on this testimony during trial
`
`Source: -1675 Institution Decision, 24-26.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`23
`
`
`
`Claims Are Obvious Over Steenfeldt-Jensen
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`24
`
`
`
`IPRs -1670, -1676, -1678: Steenfeldt-Jensen
`Rendered the Claims Obvious
`
`(2)
`
`Steenfeldt-Jensen describes an injector pen having:
`“a main housing [tubular housing 1, gray]…extending from a distal end to a proximal
`(1)
`end;”
`“a dose dial sleeve [scale drum 80, green] positioned within said housing…comprising
`a helical groove configured to engage a threading provided by said main housing, said
`helical groove provided along an outer surface of said dose dial sleeve;”
`“a dose dial grip [or dose knob] [dose setting button 81, purple] disposed near a
`proximal end of said dose dial sleeve;”
`“a piston rod [piston rod 6, yellow] provided within said housing, said piston rod is
`non-rotatable during a dose setting step relative to said main housing;”
`“a drive sleeve [or driver] [driver tube 85, red] extending along a portion of said
`piston rod…comprising [a noncircular bore]…adapted to engage…said piston rod;”
`“a tubular clutch [bushing 82, blue] located adjacent a distal end of said dose dial grip,
`said tubular clutch operatively coupled to said dose dial grip,”
`“wherein said dose dial sleeve extends circumferentially around at least a portion of said
`tubular clutch”
`“wherein said helical groove of the dose dial sleeve has a first lead and said internal threading
`of said drive sleeve has a second lead, and wherein said first lead and said second lead are
`different”
`
`(3)
`
`(4)
`
`(5)
`
`(6)
`
`Source: Pet., 20-22 (citing EX1011, ¶¶130-33), 42-59.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`25
`
`
`
`Steenfeldt-Jensen’s Piston Rod Drive
`
`Source: EX1014, 46-53; Pet., 60-62.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`26
`
`
`
`The Piston Rod Drive of Steenfeldt-Jensen’s
`Fifth Embodiment
`
`Source: EX1014, FIGS. 16-17; Pet., 21.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`27
`
`
`
`Steenfeldt-Jensen Repeatedly Suggests an
`Internally Threaded Driver Tube
`
`Source: EX1014, 3:15-20, 3:44-47; Pet., 60-62.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`28
`
`
`
`Steenfeldt-Jensen Repeatedly Suggests an
`Internally Threaded Driver Tube
`
`Source: EX1014, 7:44-47; Pet., 60-62.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`29
`
`
`
`Steenfeldt-Jensen: Sanofi’s Flawed Rebuttal
`
`No dispute that independent claims are obvious
`over Steenfeldt-Jensen as modified
`
`Sanofi’s attempts to escape Steenfeldt-Jensen’s
`repeated suggestions do not withstand scrutiny:
`1) Meaningless distinction between “rotating nut” and
`“threaded driver tube”
`2) Strained attempt to limit suggestion to first
`embodiment
`3) Flawed “friction” analysis
`4) Speculative concerns about pawl mechanism
`
`Source: POR, 27-43; Pet. Reply, 8-19.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`30
`
`
`
`Steenfeldt-Jensen Expressly Suggests
`Threaded Driver Tube
`1) No difference between “rotating nut” and “threaded driver tube”
`
`Rotating nut is a threaded driver
`
`Sur-reply argues Steenfeldt-Jensen suggests rotating nut
`that is separate from driver
`•
`Sanofi points to wall 4, but Steenfeldt-Jensen expressly states that
`wall 4 is piston rod guide as modified (i.e. no longer threaded)
`• No plausible meaning other than threaded driver
`
`Source: Pet. Reply, 8-9; EX1095, ¶¶63-65; EX1014, 2:46-52, 7:41-47; PO Sur-reply, 14-17.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`31
`
`
`
`Steenfeldt-Jensen Repeatedly Suggests
`Threaded Driver Tube
`2) Threaded-driver teachings not limited to first embodiment
`
`Numerous teachings of threaded driver tube throughout reference
`• Only one provided during discussion of first embodiment
`•
`Even that passage still relevant to fifth embodiment
`
`Dr. Slocum admitted that
`first and fifth embodiments
`have “very similar”
`structures and force chains
`for dose-dispensing.
`
`Source: Pet., 60-62; Pet. Reply, 9-13; EX1054, 306:23-307:19; EX1095, ¶¶66-70; Pet. Obs., 2; EX1115,
`531:12-22.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`32
`
`
`
`POSA Would Not Ignore Steenfeldt-Jensen’s
`Express, Repeated Teachings
`3) Sanofi’s friction models are flawed
`Skewed results: not showing net change in friction
`
`Dr. Slocum admitted model does not account for corresponding
`reductions in friction
`•
`Unmodified: piston rod rotates = friction at pressure foot (bearing full injection force)
`• Modified: no piston-rod rotation = total elimination of friction at pressure foot
`
`Source: Pet. Reply, 16; EX1095, ¶75; EX1014, FIG. 16; Pet. Obs., 4; EX1115, 561:19-563:6.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`33
`
`
`
`POSA Would Not Ignore Steenfeldt-Jensen’s
`Express, Repeated Teachings
`3) Sanofi’s friction models are flawed
`Not net change: ignores total elimination of friction at pressure foot
`
`Source: Pet. Reply, 16; EX1095, ¶75; EX1014, FIG. 16; Pet. Obs., 4; EX1115, 561:19-563:6.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`34
`
`
`
`POSA Would Not Ignore Steenfeldt-Jensen’s
`Express, Repeated Teachings
`3) Sanofi’s friction models are flawed
`Biased inputs further skew results.
`• Named inventor (Mr. Veasey) controlled vast majority of inputs.
`
`Source: EX1054, 319:17-320:9, 322:7-20; Pet. Reply at 14-16; Pet. Obs., 2-3; EX1115, 546:18-552:23.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`35
`
`
`
`POSA Would Not Ignore Steenfeldt-Jensen’s
`Express, Repeated Teachings
`3) Sanofi’s friction models are flawed
`Biased inputs further skew results.
`• Dr. Slocum acquiesced to Mr. Veasey even when key input (coefficient
`of friction) contradicted Dr. Slocum’s previously published views.
`Initially denied 0.05 was reasonable but relented when confronted
`with his own book (showing 0.05-0.1 was reasonable).
`• Admitted he would have used 0.05 if Mr. Veasey had requested it.
`During direct testimony:
`Confronted with own book during cross:
`
`•
`
`Source: Pet. Reply, 14-17; Pet. Obs., 3-4; EX1114, 463:13-16; EX1115, 555:5-12, 557:22-559:23.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`36
`
`
`
`POSA Would Not Ignore Steenfeldt-Jensen’s
`Express, Repeated Teachings
`3) Sanofi’s friction models are flawed
`Biased inputs further skew results.
`• Dr. Slocum acquiesced to Mr. Veasey even when key input (coefficient
`of friction) contradicted Dr. Slocum’s previously published views.
`Initially denied 0.05 was reasonable but relented when confronted
`with his own book (showing 0.05-0.1 was reasonable).
`• Admitted he would have used 0.05 if Mr. Veasey had requested it.
`Admitting deference to Mr. Veasey:
`
`•
`
`Source: Pet. Reply, 14-17; Pet. Obs., 3-4; EX1114, 463:13-16; EX1115, 555:5-12, 557:22-559:23.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`37
`
`
`
`POSA Would Not Ignore Steenfeldt-Jensen’s
`Express, Repeated Teachings
`3) Sanofi’s friction models are flawed
`
`Physical model (“rig”)
`also designed by Mr.
`Veasey (or by employees
`at his company, “DCA”)
`
`Source: Pet. Reply, 14-17; EX1053, 30:5-33:4.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`38
`
`
`
`POSA Would Not Ignore Steenfeldt-Jensen’s
`Express, Repeated Teachings
`3) Sanofi’s friction models are flawed
`Rig bias: Dr. Slocum again deferred to Mr. Veasey
`• Mr. Veasey chose components tested on rig
`• Mr. Veasey chose to use FlexPen as stand-in for Steenfeldt-Jensen
`• Mr. Veasey chose to use components that Dr. Slocum noted were
`“much bigger, obviously than an actual injector pen”
`
`Mr. Leinsing:
`
`Source: Pet. Reply, 14-17; EX1053, 30:5-33:13; EX2107, ¶¶245-54; EX1095, ¶74.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`39
`
`
`
`POSA Would Not Ignore Steenfeldt-Jensen’s
`Express, Repeated Teachings
`4) Speculative pawl issues
`
`No evidence whatsoever that pawl would fail
`
`Sanofi yet again ignores routine skill
`• Mr. Leinsing: configuring robust pawl mechanism was
`“routine task” for POSA
`
`Source: Pet. Reply, 17-18; EX1095, ¶76.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`40
`
`
`
`POSA Would Not Ignore Steenfeldt-Jensen’s
`Express, Repeated Teachings
`
`Actual pen designers used threaded drivers with rotating collars
`
`Source: Pet. Reply, 18-19; EX1016, 3:1-26, FIGS. 2-7; EX1095, ¶77.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`41
`
`
`
`’486 Claims 30 and 32 (-1678, Grounds 1-2): Steenfeldt-Jensen
`Teaches a “Radial Stop”
`
`Steenfeldt-Jensen demonstrates the known and predictable use of “stops” to limit the length of travel of a rotating
`component:
`
`During dose-setting, tooth on dose scale drum (green)
`abuts corresponding tooth on bushing (gray) to stop
`scale drum’s rotation when maximum axial length of
`travel is reached
`
`Source: EX1014, 9:57-62, FIG. 12; -1678 Pet., 51-53 (citing EX1011, ¶¶327-32); -1678 Pet. at 94-95 (citing
`EX1011, ¶¶431-37).
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`42
`
`
`
`Claims Are Obvious Over
`Møller and Steenfeldt-Jensen
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`43
`
`
`
`IPRs -1670, -1676, -1678: Møller and Steenfeldt-
`Jensen Rendered the Claims Obvious
`
`(3)
`
`Møller describes an injector pen having:
`“a main housing [housing 1, gray]…extending from a distal end to a proximal end;”
`(1)
`“a dose dial sleeve [dose setting drum 17, green] positioned within said
`(2)
`housing…comprising a helical groove configured to engage a threading provided by
`said main housing, said helical groove provided along an [inner] surface of said dose
`dial sleeve;”
`“a dose dial grip [or dose knob] [dose setting button 18, purple] disposed near a
`proximal end of said dose dial sleeve;”
`“a piston rod [piston rod 4, yellow] provided within said housing, said piston rod is
`non-rotatable during a dose setting step relative to said main housing;”
`“a drive sleeve [or driver] [connection bars 12/nut 13, red] extending along a portion
`of said piston rod…comprising an internal threading near a distal portion…adapted to
`engage an external thread of said piston rod;”
`“a tubular clutch [bottom 19/cup shaped element 20, blue] located adjacent a distal
`end of said dose dial grip, said tubular clutch operatively coupled to said dose dial
`grip,”
`“wherein said dose dial sleeve extends circumferentially around at least a portion of said
`tubular clutch”
`“wherein said helical groove of the dose dial sleeve has a first lead and said internal threading
`of said drive sleeve has a second lead, and wherein said first lead and said second lead are
`different”
`
`(4)
`
`(5)
`
`(6)
`
`Source: Pet., 22-24 (citing EX1011, ¶¶138-39, 141-42), 62-85.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`44
`
`
`
`IPRs -1670, -1676, -1678: Møller and Steenfeldt-
`Jensen Teach a Helical Groove
`
`Source: EX1015, ¶25; EX1011, ¶350; -1678 Pet., 65.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`45
`
`
`
`IPRs -1670, -1676, -1678: Møller and Steenfeldt-
`Jensen Teach a Helical Groove
`
`Source: EX1011, ¶¶352-53; EX1014, FIG. 17; -1678 Pet., 65-66.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`46
`
`
`
`’069 & ’044 Patents (-1670, -1676): Møller and
`Steenfeldt-Jensen Teach an Externally Grooved Drum
`
`Source: EX1015, ¶¶6, 8; Pet., 70-71, 85-87.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`47
`
`
`
`’069 & ’044 Patents (-1670, -1676): Møller and
`Steenfeldt-Jensen Teach an Externally Grooved Drum
`
`Source: EX1015, ¶¶11-12, 14, 33; Pet., 85-87.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`48
`
`
`
`’069 & ’044 Patents (-1670, -1676): Møller and
`Steenfeldt-Jensen Teach a Helical Groove on the Outer
`Surface
`
`Source: EX1014, 6:7-17; Pet., 85-87.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`49
`
`
`
`’069 & ’044 Patents (-1670, -1676): Møller and
`Steenfeldt-Jensen Teach a Drive “Sleeve”
`
`Source: EX1015, ¶¶35, 40, FIG. 5; Pet., 74-77 (citing EX1011, ¶¶370-71).
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`50
`
`
`
`Møller: Sanofi’s Failed Rebuttal
`
`1) References teach driver tube
`
`2) References teach externally threaded dial
`sleeve
`
`3) References teach main housing (-1678)
`
`Source: POR, 43-57; Pet. Reply, 19-24; EX1095, ¶¶94-97, 101-06.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`51
`
`
`
`Sanofi’s Failed Møller Rebuttal
`1) References teach driver tube
`No dispute that tubular connection element 112 and nut 113
`are a “sleeve”
`No meaningful difference between first and second
`embodiments (gears outside vs. inside)
`•
`Similar rack engagement, movement
`•
`Second embodiment simply uses one gear size instead of two
`
`•
`
`•
`
`No “significant redesign”
`as Sanofi alleges:
`
`Source: Pet. Reply, 19-21; EX1015, ¶¶12-13, 24, 30-32, 34-35, 39-40, FIGS. 1, 3-5; EX1095, ¶¶94-97.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`52
`
`
`
`Sanofi’s Failed Møller Rebuttal
`
`2) References teach externally threaded dial sleeve
`No dispute that Steenfeldt-Jensen teaches this
`
`Møller does not teach away:
`• Addresses external threading on drum that is part of
`gearing (i.e. drum transforms force to piston rod)
`
`Source: Pet. Reply, 21-24; EX1014, FIGS. 15-17; EX1015, ¶¶8, 11; EX1095, ¶¶101-06.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`53
`
`
`
`Sanofi’s Failed Møller Rebuttal
`
`2) References teach externally threaded dial sleeve
`But Møller’s drum not part
`of gearing
`• Admitted by Dr. Slocum
`
`Externally threaded drum would
`not increase injection force.
`• Not part of gearing force chain =
`not transforming injection force
`• Optional reset spring can
`counteract even minimal reset force
`
`Source: Pet. Reply, 21-24; EX1015, ¶33; EX1054, 354:19-355:24; EX1095, ¶¶101-06.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`54
`
`
`
`Sanofi’s Failed Møller Rebuttal
`
`2) References teach externally threaded dial sleeve
`
`Allegation of interference with reset spring yet another example of
`Sanofi ignoring routine skill of POSA
`• Petition never suggested placing threads “precisely” on spring
`•
`Sanofi presumes POSA incapable of simply moving spring
`•
`Sanofi also ignores that reset spring is optional
`
`Source: POR, 55-57; Pet. Reply, 24; EX1015, ¶33; EX1095, ¶¶105-06.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`55
`
`
`
`Sanofi’s Failed Møller Rebuttal
`
`3) References teach main housing (-1678)
`
`Sanofi imports limitations from different patent with
`different, later-filed disclosure
`
`Source: -1678 POR, 54-55; -1678 Reply, 1-3, 20-21.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`56
`
`
`
`’486 Claim 5 (-1678, Ground 2): Møller and Steenfeldt-Jensen
`Teach a “Driver” that “Comprises a Cylindrical Shape”
`
`Connection bars 12 includes nut 13
`• No dispute that nut 13 has “a cylindrical shape”:
`
`No dispute that analogous driver
`(tubular connection element 112
`and nut 113) has “cylindrical shape”:
`
`Source: -1678 Pet., 81-82 (citing EX1011, ¶¶394-95); -1678 Reply, 21-23.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`57
`
`
`
`’044 Claim 15 (-1676, Ground 2) and ’486 Claims 18 and 20
`(-1678, Ground 2): Møller and Steenfeldt-Jensen Teach a
`“Clicker” with a Flexible Arm
`
`Møller and Steenfeldt-Jensen disclose predictable variations of “clickers”:
`
`Source: EX1015, ¶29; EX1014, 11:62-67, FIG. 17; -1678 Pet., 84-88 (citing EX1011, ¶¶413-15).
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`58
`
`
`
`The ’008 Claims Are Obvious Over
`Møller and Steenfeldt-Jensen
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`59
`
`
`
`IPR -1684: Møller and Steenfeldt-Jensen
`Rendered the ’008 Claims Obvious
`
`(3)
`(4)
`
`(5)
`
`Møller describes an injector pen having:
`“a housing [housing 1, gray] comprising a helical thread;”
`(1)
`“a dose dial sleeve [dose setting drum 17, green] having a threaded
`(2)
`surface that is engaged with the helical thread of the housing,”
`“an insert [wall 2, purple] provided in the housing . . .;”
`“a drive sleeve [connection bars 12/nut 13, red] releasably connected
`to the dose dial sleeve and having an internal helical thread;”
`“a piston rod [piston rod 4, yellow] having . . . a second thread,
`wherein . . . the second thread is engaged with the internal helical
`thread of the drive sleeve; and”
`“a clutch [bottom 19/cup shaped element 20, blue] located between
`the dose dial sleeve and the drive sleeve, wherein the clutch is
`located (i) radially outward of the drive sleeve and (ii) radially inward
`of the dose dial sleeve.”
`
`(6)
`
`Source: -1684 Pet., 13-15, 18-41.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`60
`
`
`
`IPR -1684: Møller and Steenfeldt-Jensen
`Rendered the ’008 Claims Obvious
`
`(3)
`
`Steenfeldt-Jensen describes an injector pen having:
`“a housing [housing 1, gray] comprising a helical thread;”
`(1)
`“an insert [wall 4, purple] provided in the housing, where the insert
`(2)
`has a threaded circular opening;”
`“a drive sleeve [injection button 23, red] releasably connected to the
`dose dial sleeve and having an internal helical thread;”
`“a piston rod [piston rod 6, yellow] having a first thread and a second
`thread, wherein the first thread is engaged with the threaded circular
`opening of the insert and the second thread is engaged with the
`internal helical thread of the drive sleeve”
`
`(4)
`
`Source: -1684 Pet., 15-41.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`61
`
`
`
`IPR -1684: Møller and Steenfeldt-Jensen Teach
`Analogous Drive Mechanisms
`
`Dose-setting (green arrows): Driver
`moves up and rotates
`
`Dose-dispensing (blue arrow): Driver
`(red) moves down, but does not rotate
`
`Source: EX1014, 7:48-8:33; EX1015, ¶¶30-31; -1684 Pet., 41-42 (citing EX1011, ¶¶832-37).
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`62
`
`
`
`IPR -1684: Møller Teaches the Use of Direct Gearing
`
`Source: EX1015, ¶¶6, 11; -1684 Pet., 41-44 (citing EX1011, ¶¶832-37).
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`63
`
`
`
`IPR -1684: Steenfeldt-Jensen Teaches Achieving Direct
`Gearing with Fewer Parts
`
`Dual-threaded piston rod
`
`Rack-and-pinion system
`
`Source: -1684 Pet., 13-18, 25-35, 41-44 (citing EX1011, ¶¶135-44, 804-23, 832-37); -1684 Pet. Reply, 1-5, 8-9.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`64
`
`
`
`Møller and Steenfeldt-Jensen:
`Sanofi’s Failed Rebuttal
`
`Sanofi’s responses fail:
`1) Møller does not teach away
`2) Ample motivation, expectation of success
`•
`Clear advantages
`•
`Compatible operation
`3) Clear teaching of threaded housing/insert
`
`Source: -1684 Reply, 1-12; EX1095, ¶¶138-48.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`65
`
`
`
`Møller and Steenfeldt-Jensen:
`Sanofi’s Failed Rebuttal
`1) No teach away: Sanofi again misapprehends Møller
`Møller addresses external threading on drum with large
`surface area, not threaded gearing generally
`
`Dual-threaded piston rod has small surface area
`compared to drum (i.e. much less friction)
`
`Source: -1684 Reply, 1-5; EX1095, ¶¶138-41.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`66
`
`
`
`Møller and Steenfeldt-Jensen:
`Sanofi’s Failed Rebuttal
`2) Ample motivation: clear advantages
`
`Reference expressly states advantage of fewer components
`
`Sanofi’s POR disputes goal of minimizing parts at p. 34
`despite admitting teaching of this goal at p. 32.
`
`Steenfeldt-Jensen:
`
`Source: -1684 Pet., 43; -1684 Reply, 7-9; EX1011, ¶¶835-54; EX1095,¶¶145-46; -1684 POR, 32 (citing EX1014,
`1:27-30).
`67
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`
`
`Møller and Steenfeldt-Jensen:
`Sanofi’s Failed Rebuttal
`2) Ample motivation: clear advantages
`
`POSA can balance injection-force and part-minimization
`goals
`• Dr. Slocum admits “[t]here will of course be tradeoffs
`between cost and injection force….”
`
`Sanofi argues Steenfeldt-Jensen’s threaded gearing “does
`not, and cannot,” provide reduced injection force
`• Yet Sanofi touts SoloSTAR (with analogous gearing) as
`providing “greatly reduced injection force”
`
`Source: -1684 Pet., 42-44; -1684 Reply, 7-9; EX1011, ¶¶835-37; EX1095,¶¶145-46; -1684 POR, 32 (citing
`EX1014, 1:27-30); EX2107, ¶36.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`68
`
`
`
`Møller and Steenfeldt-Jensen:
`Sanofi’s Failed Rebuttal
`2) Ample motivation/expectation of success: compatible operation
`
`Drive sleeves rotate and ride up to set dose, push
`straight down to inject
`• Møller’s pen operates same in combination as before
`• Threaded gearing (with dual-threaded piston rod)
`operates same in combination as in Steenfeldt-Jensen
`
`Sanofi only points to extraneous differences without
`even alleging they matter
`• All relevant aspects of mechanisms same
`
`Source: -1684 Pet., 41-44; -1684 Reply, 5-6; EX1011, ¶¶832-37; EX1095, ¶¶143-44; -1684 POR, 29-30
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`69
`
`
`
`Møller and Steenfeldt-Jensen:
`Sanofi’s Failed Rebuttal
`3) Recited housing and insert can be internal, integral
`Sanofi contradicts specification, arguing wall 4 not “housing”, and
`wall 2 not “insert”, because they are internal and integrally formed
`
`’008 patent:
`
`Source: -1684 Reply, 10-12; EX1095, ¶¶147-48; EX1005, 2:66-3:10, 7:33-39.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`70
`
`
`
`Møller and Steenfeldt-Jensen:
`Sanofi’s Failed Rebuttal
`
`Claim 3 (insert “secured in the housing against rotational and
`longitudinal motion”):
`•
`Sanofi attacks references individually
`• Petition described application of Steenfeldt-Jensen’s direct-
`gearing mechanics, not bodily incorporation of rotating
`ampoule holder
`In combination, threaded flange fixed relative to housing
`
`•
`
`Source: -1684 Pet., 41; -1684 Reply, 12-14; EX1015, ¶36, FIGS. 1, 3-5; EX1011, ¶¶832-34; EX1095, ¶149.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`71
`
`
`
`Experts: A Study in Contrasts
`
`Source: EX1011, ¶¶1-8; EX1012; Mot. Excl., 5-7.
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`72
`
`
`
`Blocking patent
`Only Mr. Leinsing Has the Proper Expertise
`
`“qualified as an expert by knowledge, skill, experience, training, or education” but also
`“based on sufficient facts or data” and “the product of reliable principles and methods”
`FRE 702.
`
`Karl Leinsing:
`• MS Mechanical Engineering
`• Registered Professional Engineer
`• Decades of experience with medical
`devices
`• Decade of directly relevant experience
`right before claimed priority date
`Inventor on injector device patents
`Testimony based on relevant
`experience
`
`•
`•
`
`Alexander Slocum:
`•
`PhD Mechanical Engineering
`• General focus and experience
`• No relevant industry experience
`•
`Testified that he “didn't have
`personal knowledge of the industry
`at the time of the invention, so I
`wanted to talk to [inventor Rob
`Veasey] who was clearly in the thick
`of it at the ti
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