`
`Mylan Pharmaceuticals Inc. v. Sanofi‐Aventis Deutschland GmbH
`
`IPR2018‐01670 (U.S. 8,679,069)
`IPR2018‐01675 (U.S. 8,603,044)
`IPR2018‐01676 (U.S. 8,603,044)
`IPR2018‐01678 (U.S. 8,992,486)
`IPR2019‐00122 (U.S. 8,992,486)
`IPR2018‐01684 (U.S. 9,604,008)
`
`Oral Hearing
`January 15, 2020
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`1
`
`
`
`069, 044, 486 Patents: Challenged Independent Claims
`
`069 Patent, claim 1
`A housing part for a medication dispensing apparatus, said
`housing part comprising:
`a main housing, said main housing extending from a distal end
`to a proximal end;
`a dose dial sleeve positioned within said housing, said dose
`dial sleeve 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 disposed near a proximal end of said dose dial
`sleeve;
`a piston rod provided within said housing, said piston rod is
`non‐rotatable during a dose setting step relative to said main
`housing;
`a drive sleeve extending along a portion of said piston rod, said
`drive sleeve comprising an internal threading near a distal
`portion of said drive sleeve, said internal threading adapted to
`engage an external thread of said piston rod; and,
`a tubular clutch 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.
`
`044 Patent, claim 11
`A housing part for a medication dispensing apparatus, said
`housing part comprising:
`a main housing, said main housing extending from a distal end
`to a proximal end;
`a dose dial sleeve positioned within said housing, said dose
`dial sleeve 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 disposed near a proximal end of said dose dial
`sleeve;
`a piston rod provided within said housing, said piston rod is
`non‐rotatable during a dose setting step relative to said main
`housing;
`a drive sleeve extending along a portion of said piston rod, said
`drive sleeve comprising an internal threading near a distal
`portion of said drive sleeve, said internal threading adapted to
`engage an external thread of said piston rod; and,
`a tubular clutch 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, and 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.
`
`486 Patent, claim 1
`A housing part for a medication dispensing apparatus, said
`housing part comprising:
`a main housing, said main housing extending from a distal end
`to a proximal end;
`a dose dial sleeve positioned within said housing, said dose
`dial sleeve comprising a helical groove configured to engage a
`threading provided by said main housing;
`
`a dose knob disposed near a proximal end of said dose dial
`sleeve;
`a piston rod provided within said housing, said piston rod is
`non‐rotatable during a dose setting step relative to said main
`housing;
`a driver extending along a portion of said piston rod, said
`driver comprising an internal threading near a distal portion of
`said driver, said internal threading adapted to engage an
`external thread of said piston rod; and,
`a tubular clutch located adjacent a distal end of said dose
`knob, said tubular clutch operatively coupled to said dose
`knob,
`wherein said dose dial sleeve extends circumferentially around
`at least a portion of said tubular clutch.
`
`2
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`008 Patent: Challenged Independent Claim
`
`008 Patent, claim 1
`A drive mechanism for use in a drug delivery device comprising:
`a housing comprising a helical thread;
`a dose dial sleeve having a threaded surface that is engaged with the helical
`thread of the housing,
`an insert provided in the housing, where the insert has a threaded circular
`opening;
`a drive sleeve releasably connected to the dose dial sleeve and having an
`internal helical thread;
`a piston rod 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 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.
`
`3
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Claimed Invention of Challenged Patents
`
`Main
`Housing
`
`Piston
`Rod
`
`Clicker
`
`Dose Dial
`Sleeve
`
`Clutch
`
`Insert
`
`Drive
`Sleeve
`
`Threaded Engagements
`(Housing & Dose Dial Sleeve)
`(Drive Sleeve & Piston Rod)
`
`‐1676 POR at 6‐12; see also ‐1670 POR at 58‐59; ‐1678 POR at 4‐9
`
`4
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`
`
`Agenda
`
`1. Obviousness Ground: Steenfeldt‐Jensen’s 5th Embodiment
`
`2. Obviousness Ground: Møller + Steenfeldt‐Jensen’s 5th Embodiment
`
`3. Obviousness Ground: Møller + Steenfeldt‐Jensen’s 2nd Embodiment
`
`4. Obviousness Ground: Burroughs
`
`5. Objective Indicia of Nonobviousness
`
`5
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Obviousness: Steenfeldt‐Jensen’s 5th Embodiment
`
`IPR, Ground
`
`Challenged Claims
`
`‐01670, Ground 2
`
`069 Claim 1
`
`‐01676, Ground 1
`
`044 Claims 11, 14, 15, 18, 19
`
`‐01678, Ground 1
`
`486 Claims 1‐6, 12‐18, 20, 23, 26‐30, 32, 33, 36, 38, 40
`
`‐1676 Petition at 3; ‐1670 Petition at 3; ‐1678 Petition at 3
`
`6
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Steenfeldt‐Jensen’s 5th Embodiment
`
`Piston rod (6) with thread and non‐circular cross‐section
`
`Driver tube (85) with non‐circular slot
`
`Member (40) threaded to piston rod
`
`‐01676 Petition at 19‐20; see also ‐1670 Petition at 20‐21; ‐01678 Petition at 17‐19
`
`7
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Missing Limitation from Steenfeldt‐Jensen’s 5th Embodiment
`
`a drive sleeve extending along a portion of said piston rod, said drive sleeve comprising an internal threading near a
`distal portion of said drive sleeve, said internal threading adapted to engage an external thread of said piston rod
`
`Threaded piston rod
`with two flat sides
`
`Non-circular (slotted)
`bore
`
`Threaded bore
`
`Threading of
`end wall 4 of
`member 40
`
`Threading of
`end wall 4 of
`member 40
`
`Ex. 1014 (Steenfeldt‐Jensen), Fig. 17
`
`Ex. 1014 (Steenfeldt‐Jensen), Figs. 15 and 16
`
`‐1676 POR at 18‐19; see also ‐1670 POR at 13‐14; ‐1676 POR at 19‐20
`
`8
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Steenfeldt‐Jensen’s Five Embodiments
`
`1st
`
`2nd
`
`3rd
`
`4th
`
`5th
`
`• Embodiments 1, 3, 4, and
`5 include a driver tube
`
`• None includes a driver
`tube with internal threads
`
`‐1676 POR 14‐15; 1676 PO Sur‐reply at 1; see also ‐1670 POR at 10‐11; ‐1676 PO Sur‐Reply at 7; ‐1678 POR at 15‐16; ‐1678 PO Sur‐Reply at 1
`
`9
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Premise Of Petitioner’s Proposed Modification
`
`‐1676 Petition at 41; see also ‐1670 Petition at 62; ‐1678 Petition at 36‐37
`
`10
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Steenfeldt‐Jensen Does Not Teach Modifying the 5th Embodiment
`
`First Embodiment
`
`Steenfeldt‐Jensen at 7:41‐47
`
`‐1676 POR at 30‐34; see also ‐1670 POR at 28‐32; ‐1676 POR at 31‐34
`
`‐01676 POR at 35; Ex. 2107 at ¶ 44
`
`11
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Steenfeldt‐Jensen’s Nut Element Is Distinct From The Driver Tube
`
`Driver Tube
`
`Nut Element
`
`‐1676 Sur‐Reply at 15; see also ‐1670 Sur‐Reply at 15; ‐1678 Sur‐Reply at 9
`
`12
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`The Passage Cited By Petitioner Is Not Generally Applicable
`
`Slocum Declaration
`
`Ex. 2107 at ¶ 140
`‐1676 POR at 14, 33; see also ‐1670 POR at 10, 31; ‐1678 POR at 15, 33
`
`Ex. 2107 at ¶ 226
`
`13
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Steenfeldt‐Jensen Does Not Teach Modifying the 5th Embodiment
`
`Steenfeldt‐Jensen at 2:40‐53
`
`‐1676 POR at 29; see also ‐1670 POR at 28; ‐1678 POR at 30
`
`14
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Steenfeldt‐Jensen Does Not Teach Modifying the 5th Embodiment
`
`Steefeldt‐Jensen at 3:15‐20
`
`‐1676 POR at 30; see also ‐1670 POR at 28; ‐1678 POR at 31
`
`15
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Steenfeldt‐Jensen Does Not Teach Modifying the 5th Embodiment
`
`Steefeldt‐Jensen at 3:44‐47
`
`‐1676 POR at 30; see also ‐1670 POR at 28; ‐1678 POR at 31
`
`16
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Premise Of Petitioner’s Proposed Modification
`
`‐1676 Petition at 41; see also ‐1670 Petition at 62; ‐1678 Petition at 36‐37
`
`17
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Petitioner’s Modification Fundamentally Alters The Operation
`
`‐1676 POR at 34‐45 (citing Ex. 2107 at ¶ 232‐238); see also ‐1670 POR at 32‐41; ‐1678 POR at 35‐44
`
`18
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Petitioner’s Modification Fundamentally Alters The Operation
`
`‐1676 POR at 34‐45 (citing Ex. 2107 at ¶ 232‐238); see also ‐1670 POR at 32‐41; ‐1678 POR at 35‐44
`
`19
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Dr. Slocum’s Analytical Model
`
`‐1676 POR at 36‐37 (citing Ex. 2107 at Appx. A); see also ‐1670 POR at 34‐35; ‐1678 POR at 36‐37
`
`20
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Injection Force Is An Important Design Consideration
`
`Slocum Declaration
`
`‐1676 POR at 35; see also ‐1670 POR at 33; ‐1678 POR at 35
`
`21
`
`Ex. 2107 at ¶ 44
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Injection Force Is An Important Design Consideration
`
`Leinsing Apr. 3 2019 Deposition
`
`Slocum Declaration
`
`Ex. 2107 at ¶ 56
`
`Ex. 2163 at 80:17‐81:5
`
`‐1676 POR at 35; see also ‐1670 POR at 33; ‐1678 POR at 35
`
`22
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Injection Force Is An Important Design Consideration
`
`044 Patent at 1:25‐35
`
`‐1676 POR at 6; see also ‐1670 POR at 3; ‐1678 POR at 3
`
`23
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Injection Force Is Highly Relevant to Steenfeldt‐Jensen
`
`Steenfeldt‐Jensen at 1:12‐17
`
`‐1676 PO Sur‐reply at 4; see also ‐1670 PO Sur‐Reply at 10; ‐1678 PO Sur‐Reply at 4
`
`24
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Injection Force Is Highly Relevant to Steenfeldt‐Jensen
`
`Leinsing D.N.J. Cross‐Examination
`
`Leinsing D.N.J. Cross‐Examination
`
`Ex. 2227 at 338:6‐11
`
`‐1670, ‐1676, ‐1678 Paper No. 68 at 2
`
`Ex. 2227 at 338:23‐339:10
`
`25
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Injection Force Is Highly Relevant to Steenfeldt‐Jensen
`
`Plutzner, Prefilled Insulin Device with Reduced Injection Force…
`
`‐1676 POR at 5; ‐1670 POR at 4; ‐1678 POR at 3; see also Ex. 2107 at ¶ 56
`
`26
`
`Ex. 2175 at .005
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Injection Force Is An Important Design Consideration
`
`van der Burg, Injection Force of SoloStar Compared….
`
`Møller
`
`Ex. 2100 at .002
`[‐01676 POR at 35 (citing Ex. 2107 at ¶ 56‐57)]
`
`See also ‐1670 POR at 33; ‐1678 POR at 35, 57
`
`Ex. 1015 at [0005]‐[0006]
`[‐01676 POR at 25, 58 (citing Ex. 2107 at ¶ 289)]
`
`27
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Agenda
`
`1. Obviousness Ground: Steenfeldt‐Jensen’s 5th Embodiment
`
`2. Obviousness Ground: Møller + Steenfeldt‐Jensen’s 5th Embodiment
`
`3. Obviousness Ground: Møller + Steenfeldt‐Jensen’s 2nd Embodiment
`
`4. Obviousness Ground: Burroughs
`
`5. Objective Indicia of Nonobviousness
`
`28
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Obviousness: Møller + Steenfeldt‐Jensen’s 5th Embodiment
`
`IPR, Ground
`
`Challenged Claims
`
`‐01670, Ground 3
`
`069 Claim 1
`
`‐01676, Ground 2
`
`044 Claims 11, 14, 15, 18, 19
`
`‐01678, Ground 2
`
`486 Claims 1‐6, 12‐18, 20, 23, 26‐30, 32, 33, 36, 38, 40
`
`29
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`069, 044, 486 Patents: Challenged Independent Claims
`
`069 Patent, claim 1
`A housing part for a medication dispensing apparatus, said
`housing part comprising:
`a main housing, said main housing extending from a distal end
`to a proximal end;
`a dose dial sleeve positioned within said housing, said dose
`dial sleeve 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 disposed near a proximal end of said dose dial
`sleeve;
`a piston rod provided within said housing, said piston rod is
`non‐rotatable during a dose setting step relative to said main
`housing;
`a drive sleeve extending along a portion of said piston rod, said
`drive sleeve comprising an internal threading near a distal
`portion of said drive sleeve, said internal threading adapted to
`engage an external thread of said piston rod; and,
`a tubular clutch 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.
`
`044 Patent, claim 11
`A housing part for a medication dispensing apparatus, said
`housing part comprising:
`a main housing, said main housing extending from a distal end
`to a proximal end;
`a dose dial sleeve positioned within said housing, said dose
`dial sleeve 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 disposed near a proximal end of said dose dial
`sleeve;
`a piston rod provided within said housing, said piston rod is
`non‐rotatable during a dose setting step relative to said main
`housing;
`a drive sleeve extending along a portion of said piston rod, said
`drive sleeve comprising an internal threading near a distal
`portion of said drive sleeve, said internal threading adapted to
`engage an external thread of said piston rod; and,
`a tubular clutch 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, and 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.
`
`486 Patent, claim 1
`A housing part for a medication dispensing apparatus, said
`housing part comprising:
`a main housing, said main housing extending from a distal end
`to a proximal end;
`a dose dial sleeve positioned within said housing, said dose
`dial sleeve comprising a helical groove configured to engage a
`threading provided by said main housing;
`
`a dose knob disposed near a proximal end of said dose dial
`sleeve;
`a piston rod provided within said housing, said piston rod is
`non‐rotatable during a dose setting step relative to said main
`housing;
`a driver extending along a portion of said piston rod, said
`driver comprising an internal threading near a distal portion of
`said driver, said internal threading adapted to engage an
`external thread of said piston rod; and,
`a tubular clutch located adjacent a distal end of said dose
`knob, said tubular clutch operatively coupled to said dose
`knob,
`wherein said dose dial sleeve extends circumferentially around
`at least a portion of said tubular clutch.
`
`30
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Obviousness Ground: Møller + Steenfeldt‐Jensen’s 5th Embodiment
`
`1. Overview
`2. Dose Dial Sleeve With an Outer Groove (069 Patent, 044 Patent, and
`486 Claim 4)
`3. Dose Dial Sleeve with a Threaded Engagement to a “Main Housing”
`(486 Patent)
`4. Drive Sleeve (069 Patent, 044 Patent), or a Driver Comprising a
`Cylindrical Shape (486 Claim 5)
`5. Clicker Comprising at Least One Flexible Arm and at Least One Spline
`(044 Claim 15, 486 Claims 18 & 20)
`
`31
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Møller’s Primary Objective Is to Reduce Injection Force
`
`Møller
`
`Møller
`
`Ex. 1015 at ¶ 0005
`
`‐01670 POR at 15, 33, 51‐53; ‐01676 POR at 25, 57‐58 (citing Ex. 2107 at ¶ 289); ‐01678 POR at 57‐59 (citing Ex. 2107 at ¶ 289)
`
`Ex. 1015 at ¶ 0006
`
`32
`
`Ex. 1015 (Møller)
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Møller’s Primary Objective Is to Reduce Injection Force
`
`Møller
`
`Møller
`
`Ex. 1015 at ¶ 0008
`
`Ex. 1015 (Møller)
`
`‐01670 POR at 51‐53; ‐01676 at 57‐59, ‐01678 at 57‐59
`
`Ex. 1015 at ¶ 0011
`
`33
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Obviousness Ground: Møller + Steenfeldt‐Jensen’s 5th Embodiment
`
`1. Overview
`2. Dose Dial Sleeve With an Outer Groove (069 Patent, 044 Patent,
`and 486 Claim 4)
`3. Dose Dial Sleeve with a Threaded Engagement to a “Main Housing”
`(486 Patent)
`4. Drive Sleeve (069 Patent, 044 Patent), or a Driver Comprising a
`Cylindrical Shape (486 Claim 5)
`5. Clicker Comprising at Least One Flexible Arm and at Least One Spline
`(044 Claim 15, 486 Claims 18 & 20)
`
`34
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Petitioner’s Proposed Modification to Møller
`
`• Petitioner proposes
`exchanging Moller’s internal
`threads for Steenfeldt‐
`Jensen’s external grooves
`• Petitioner argues that
`Steenfeldt‐Jensen’s high‐
`pitched threads will have
`less friction
`
`Ex. 1015 (Møller), Fig. 1
`‐01670 Petition at 68‐71, 85‐87; ‐01676 Petition at 54‐57, 76‐79; ‐01678 Petition at 77‐81
`
`35
`
`Ex. 1014 (Steenfeldt‐Jensen), Fig. 17
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Møller Teaches Away From Steenfeldt‐Jensen’s Dose Scale Drum
`
`Møller
`
`Ex. 1015 (Møller)
`
`‐01670 POR at 51‐54; ‐01676 POR at 57‐58; ‐01678 POR at 56‐59, 61
`
`Ex. 1015 at ¶ 0008
`
`36
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`No Reason to Look Beyond Møller’s Teachings
`
`Møller teaches a “helical reset spring 36” to overcome any
`problematic friction with dose dial sleeve threads
`
`Møller
`
`Reset spring 36
`
`‐01670 POR at 54‐55; ‐01676 POR at 60‐61; ‐01678 POR at 61‐62
`
`37
`
`Ex. 1015 (Møller), Fig. 1
`
`Ex. 1015 at ¶ 0033
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`No Reason to Multiply Effects of Friction by Moving Threads Outward
`
`Moving the threads from Møller’s dose‐setting drum to the exterior
`increases the radius at which friction exists, thus multiplying drag
`
`Slocum Declaration
`
`r
`
`r
`
`Ex. 1015 (Møller), Fig. 1
`‐01670 POR at 56‐57; ‐01676 POR at 62‐63
`
`Ex. 2107 at ¶ 306
`
`38
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Obviousness Ground: Møller + Steenfeldt‐Jensen’s 5th Embodiment
`
`1. Overview
`2. Dose Dial Sleeve With an Outer Groove (069 Patent, 044 Patent, and
`486 Claim 4)
`3. Dose Dial Sleeve with a Threaded Engagement to a “Main
`Housing” (486 Patent)
`4. Drive Sleeve (069 Patent, 044 Patent), or a Driver Comprising a
`Cylindrical Shape (486 Claim 5)
`5. Clicker Comprising at Least One Flexible Arm and at Least One Spline
`(044 Claim 15, 486 Claims 18 & 20)
`
`39
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Petitioner’s Argument
`
`Tubular element 5
`
`Housing 1
`
`Wall 2
`
`‐01684 Petition at 14
`
`Ex. 1015 (Møller), Fig. 1
`
`40
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Challenged Patents Treat a “Main Housing” as Exterior
`
`The “main housing” does not include an integrally formed
`inner housing, which is separately called the insert
`
`486 Patent at 3:49‐55
`
`‐01678 POR at 11‐13
`
`Ex. 1003 (486 Patent), Fig. 1 41
`
`Ex. 1003 at 3:49‐55
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`008 Patent Confirms Difference Between “Main Housing” and Inner Housing
`
`008 Patent at 2:66‐3:2
`
`Ex. 1005 at 2:66‐3:2
`
`‐01678 POR at 9‐11
`
`42
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`The “Main Housing” Corresponds to Møller’s “Housing 1”
`
`Housing 1
`(exterior housing)
`
`Wall 2
`(integral interior
`housing)
`
`Main housing 4
`(exterior housing)
`
`Insert 16
`(integral interior
`housing)
`
`‐01684 Petition at 14; ‐01678 POR at 12
`
`Ex. 1015 (Møller), Fig. 1
`
`Ex. 1003 (486 Patent), Fig. 3
`
`43
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Obviousness Ground: Møller + Steenfeldt‐Jensen’s 5th Embodiment
`
`1. Overview
`2. Dose Dial Sleeve With an Outer Groove (069 Patent, 044 Patent, and
`486 Claim 4)
`3. Dose Dial Sleeve with a Threaded Engagement to a “Main Housing”
`(486 Patent)
`4. Drive Sleeve (069 Patent, 044 Patent), or a Driver Comprising a
`Cylindrical Shape (486 Claim 5)
`5. Clicker Comprising at Least One Flexible Arm and at Least One Spline
`(044 Claim 15, 486 Claims 18 & 20)
`
`44
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Petitioner Proposes Modifying Møller to Have a Drive Sleeve
`
`Møller’s 1st Embodiment
`
`Møller’s 2nd Embodiment
`
`Connection Bars 12
`(not a drive sleeve)
`
`Ex. 1015 (Møller), Fig. 2
`
`Connection Element 112
`(a drive sleeve)
`
`‐01670 Petition at 74‐77; ‐01676 Petition at 60‐63; ‐01678 Petition at 81‐82
`
`Ex. 1015 (Møller), Fig. 1
`
`Ex. 1015 (Møller), Fig. 5
`
`45
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`No Reason to Modify Møller’s 1st Embodiment
`
`Slocum Declaration
`
`Slocum Declaration
`
`Ex. 2107 at ¶ 281
`
`‐01670 POR at 48, 50; ‐01676 POR at 53, 55; see also ‐1678 POR at 62‐63 (citing Ex. 2107 at ¶¶ 319‐323)
`
`Ex. 2107 at ¶ 283
`
`46
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Petitioner’s Expert Is Wrong
`
`Engagement between gear wheels 16 (blue) and rack 10 (yellow)
`would be blocked if the connection bars (red) are formed as a sleeve
`
`Leinsing Reply Declaration
`
`‐01670 POR at 48, 50; ‐01676 POR at 53, 55; see also ‐1678 POR at 62‐63 (citing Ex. 2107 at ¶¶ 319‐323)
`
`47
`
`Ex. 1015 (Møller), Fig. 2
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Obviousness Ground: Møller + Steenfeldt‐Jensen’s 5th Embodiment
`
`1. Overview
`2. Dose Dial Sleeve With an Outer Groove (069 Patent, 044 Patent, and
`486 Claim 4)
`3. Dose Dial Sleeve with a Threaded Engagement to a “Main Housing”
`(486 Patent)
`4. Drive Sleeve (069 Patent, 044 Patent), or a Driver Comprising a
`Cylindrical Shape (486 Claim 5)
`5. Clicker Comprising at Least One Flexible Arm and at Least One
`Spline (044 Claim 15, 486 Claims 18 & 20)
`
`48
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Møller’s Clicker Does Not Have Flexible Arms and Splines
`
`Møller already has a clicker: “V‐shaped teeth” that ride over each
`other when rotating
`
`Møller
`
`Clicking
`V‐Shaped
`Teeth
`
`v
`
`v
`
`Ex. 1015 (Møller), Fig. 1
`‐01676 POR at 64 (citing Ex. 2107 at ¶ 310); ‐01678 POR at 63‐64 (citing Ex. 2107 at ¶¶324‐326)
`
`Ex. 1015 at ¶ 0027
`
`49
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`
`
`Møller’s Clicker Is Not Interchangeable with Steenfeldt‐Jensen’s
`
`Ex. 2107 at ¶ 369; ‐01676 Petition at 43‐45; see also ‐01676 Sur‐reply at 18‐19; ‐01678 Sur‐reply at 18‐19
`
`50
`
`Ex. 1015 (Møller), Fig. 1
`
`Ex. 1014 (Steenfeldt‐Jensen), Fig. 17
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Agenda
`
`1. Obviousness Ground: Steenfeldt‐Jensen’s 5th Embodiment
`
`2. Obviousness Ground: Møller + Steenfeldt‐Jensen’s 5th Embodiment
`
`3. Obviousness Ground: Møller + Steenfeldt‐Jensen’s 2nd Embodiment
`
`4. Obviousness Ground: Burroughs
`
`5. Objective Indicia of Nonobviousness
`
`51
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`
`
`Obviousness: Møller + Steenfeldt‐Jensen’s 2nd Embodiment
`
`IPR, Ground
`
`Challenged Claims
`
`‐01684, Ground 1
`
`008 Claims 1, 3, 7‐8, 11, 17
`
`52
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`
`
`008 Patent, Challenged Claims
`
`Ex. 1005, claims 1, 3, 7, 8, 11, 17
`
`53
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Obviousness Ground: Møller + Steenfeldt‐Jensen’s 2nd Embodiment
`
`1. No motivation to combine Møller with Steenfeldt‐Jensen’s 2nd
`embodiment
`2. Does not render obvious both a housing comprising a helical thread
`and an insert provided in the housing
`3. Does not render obvious an insert secured in the housing (008
`Patent Claim 3)
`4. Does not render obvious a housing having an internal helical thread
`(008 Patent Claim 11)
`
`54
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Petitioners’ Proposed Combination
`
`Møller’s 1st Embodiment
`
`Steenfeldt‐Jensen’s
`2nd Embodiment
`
`‐01684 Petition at 14, 17
`
`Ex. 1015 (Møller), Fig. 1
`
`Ex. 1014 (Steenfeldt‐Jensen), Figs. 7, 8
`
`55
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Møller Sets Out to Reduce Injection Force
`
`Møller
`
`Møller
`
`Ex. 1015 at ¶ 0005
`
`Ex. 1015 (Møller)
`
`‐01684 POR at 36 (citing Ex. 2107 at ¶ 381)
`
`Ex. 1015 at ¶ 0006
`
`56
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`
`
`Petitioners Ignore Møller’s Express Teaching Away from Threaded Gearing
`
`Møller
`
`Møller
`
`Ex. 1015 at ¶ 0008
`
`Ex. 1015 at ¶ 0011
`
`‐01684 POR at 25‐28
`
`57
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Møller Teaches Using a Gearing with Rolling Contact, Not Sliding Contact
`
`Ex. 2107 ¶ 287
`
`Ex. 1015 (Møller), Fig. 1
`
`Ex. 1015 (Møller), Fig. 5
`
`58
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Petitioners Concede that Møller Criticizes Steenfeldt‐Jensen’s Teachings
`
`Petitioners’ Reply
`
`‐01684 Reply at 1‐2
`
`59
`
`‐01684 Reply at 1‐2
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Møller Teaches Away from Threaded Gearing, Whether on a Drum or Spindle
`
`Møller
`
`Møller
`
`Ex. 1015 at ¶ 0007
`
`Ex. 1015 (Møller)
`
`‐01684 Sur‐reply at 3‐4
`
`Ex. 1015 at ¶ 0008
`
`60
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`The Combination Increases Rotational‐to‐Linear Transformations
`
`Møller
`
`‐01684 POR at 27‐28, ‐01684 Sur‐reply at 4
`
`61
`
`Ex. 1015 at ¶ 0011
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`No Evidence to Show that Møller Had Durability Problems
`
`Leinsing June 3, 2019 Deposition
`
`Slocum Declaration
`
`Ex. 2163 at ¶ 140:8‐16
`
`‐01684 POR at 34 (citing Ex. 2107 at ¶ 377)
`
`Ex. 2107 at ¶ 378
`
`62
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`
`
`Modified Pen Injector Would be Harder to Use
`
`Slocum Declaration
`
`Sur‐reply
`
`Ex. 2107 at ¶ 379
`
`‐01684 POR at 34; ‐01684 Sur‐reply at 7
`
`‐01684 Sur‐reply at 7
`
`63
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Obviousness Ground: Møller + Steenfeldt‐Jensen’s 2nd Embodiment
`
`1. No motivation to combine Møller with Steenfeldt‐Jensen’s 2nd
`embodiment
`2. Does not render obvious both a housing comprising a helical
`thread and an insert provided in the housing
`3. Does not render obvious an insert secured in the housing (008
`Patent Claim 3)
`4. Does not render obvious a housing having an internal helical thread
`(008 Patent Claim 11)
`
`64
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`008 Patent, Claim 1 Requires a Separate Housing and Insert
`
`The plain language treats the insert as distinct from the threaded
`housing
`
`008 Patent, Claim 1
`
`Ex. 1005 at claim 1
`
`Ex. 1005 at claim 1
`
`65
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`There Is No Threaded Housing and an Insert Provided in the Housing
`
`The Petition identifies Møller’s wall 2 as the “insert”
`
`008 Patent, Claim 1
`
`Ex. 1005 at claim 1
`
`‐01684 POR at 37‐41, ‐01684 Petition at 14
`
`Ex. 1015 (Møller), Fig. 1
`
`66
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`The 008 Patent Specification Does Not Support Petitioners’ Position
`
`008 Patent at 7:33‐39
`
`Ex. 1005 at 7:33‐39
`
`‐01684 Sur‐reply at 12‐13; ‐01684 Petition at 14
`
`Ex. 1015 (Møller), Fig. 1
`
`67
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Obviousness Ground: Møller + Steenfeldt‐Jensen’s 2nd Embodiment
`
`1. No motivation to combine Møller with Steenfeldt‐Jensen’s 2nd
`embodiment
`2. Does not render obvious both a housing comprising a helical thread
`and an insert provided in the housing
`3. Does not render obvious an insert secured in the housing (008
`Patent Claim 3)
`4. Does not render obvious a housing having an internal helical thread
`(008 Patent Claim 11)
`
`68
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Petitioners’ Proposed Combination
`
`The Petition relies on wall 4 of Steenfeldt‐Jensen for the proposed
`combination and argues that it “is secured in the housing against
`rotational and longitudinal motion” as required by claim 3
`‐01684 Petition
`
`‐01684 Petition at 45
`
`‐01684 Petition at 45
`
`69
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`The Combination Does Not Teach an Insert That Is Secured Against Rotation
`
`Steenfeldt‐Jensen
`
`Ex. 1014 (Steenfeldt‐Jensen), Figs. 2, 7
`
`‐01684 POR at 43‐45
`
`Ex. 1014 at 5:38‐46
`
`70
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Obviousness Ground: Møller + Steenfeldt‐Jensen’s 2nd Embodiment
`
`1. No motivation to combine Møller with Steenfeldt‐Jensen’s 2nd
`embodiment
`2. Does not render obvious both a housing comprising a helical thread
`and an insert provided in the housing
`3. Does not render obvious an insert secured in the housing (008
`Patent Claim 3)
`4. Does not render obvious a housing having an internal helical
`thread (008 Patent Claim 11)
`
`71
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Agenda
`
`1. Obviousness Ground: Steenfeldt‐Jensen’s 5th Embodiment
`
`2. Obviousness Ground: Møller + Steenfeldt‐Jensen’s 5th Embodiment
`
`3. Obviousness Ground: Møller + Steenfeldt‐Jensen’s 2nd Embodiment
`
`4. Obviousness Ground: Burroughs
`
`5. Objective Indicia of Nonobviousness
`
`72
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Obviousness: Burroughs
`
`IPR, Ground
`
`Challenged Claims
`
`‐01670, Ground 1
`
`069 Claim 1
`
`‐01675, Ground 1
`
`044 Claims 11, 14, 15, 18, 19
`
`‐00122, Ground 1
`
`486 Claims 1‐6, 12‐18, 20, 23, 26‐30, 32, 33, 36, 38, 40
`
`73
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Obviousness Ground: Burroughs
`
`1. Does not teach or render obvious a dose dial sleeve comprising a
`helical groove (069 Patent, 044 Patent, 486 Patent)
`2. Does not teach or render obvious a tubular clutch (069 Patent, 044
`Patent, 486 Patent)
`
`74
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Petitioner’s Modification: Adding Threads to Form a Groove
`
`Leinsing June 3, 2019 Deposition
`
`Ex. 2163 at 186:11‐5, 195:14‐21
`
`‐01670 POR at 21, 16‐17; ‐01675 POR at 37, 25‐26; ‐00122 POR at 37, 24‐26,
`
`75
`
`Ex. 2103
`[Ex. 2107 ¶ 171]
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Dr. Slocum’s Testimony
`
`Slocum Declaration
`
`Slocum Declaration
`
`Ex. 2107 at ¶ 181
`
`Ex. 2107 at ¶ 186
`
`‐01670 POR at 19‐20, 20‐21; ‐01675 POR at 35, 36; ‐00122 POR at 35, 36
`
`76
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Response to Petitioner’s Reply
`
`Petitioner Reply
`
`Slocum August 28, 2019 Deposition
`
`‐01670 Reply at 4
`
`Ex. 1054 at 281:9‐18
`‐01679 Reply at 4 (see also ‐01670 Reply at 9; ‐00122 Reply at 9); ‐01670 Sur‐reply at 6; ‐01675 Sur‐reply at 10; ‐00122 Sur‐reply at 10
`
`77
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`‐01675 and ‐00122 IPRs: Petitioner’s Original Argument
`
`Petition argument: Protruding grooves
`
`‐01675 Petition
`
`‐00122 Petition
`
`Institution Decision
`
`‐01675 Petition at 41
`
`‐00122 Petition at 39
`
`‐01675, ID at 23‐24; ‐00122, ID at 23
`
`‐01675 Petition at 41; ‐00122 Petition at 39; ‐01675 ID at 23‐24; ‐00122 ID at 23
`
`78
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`
`
`‐01675 and ‐00122 IPRs: Petitioners’ New Reply Argument
`
`Reply argument: Duplication of threads
`
`‐01675 Reply
`
`‐01675 Reply at 5, ‐00122 Reply at 5
`
`‐01675 Reply at 5; ‐00122 Reply at 5
`
`79
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Obviousness Ground: Burroughs
`
`1. Does not teach or render obvious a dose dial sleeve comprising a
`helical groove (069 Patent, 044 Patent, 486 Patent)
`2. Does not teach or render obvious a tubular clutch (069 Patent, 044
`Patent, 486 Patent)
`
`80
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Claim Construction – “Tubular Clutch”
`
`Patent Owner’s Construction
`District Court of N.J. Construction
`“a tubular component that can
`operate to reversibly lock two
`components in rotation”
`
`‐01670 POR at 7‐8, ‐01675 POR at 11‐13, ‐00122 POR at 11‐13
`
`Petitioner’s Construction
`“a tubular structure that
`couples and decouples a
`moveable component from
`another component”
`‐01670 Reply at 1, ‐01675 Reply at 3, ‐00122 Reply at 3
`
`‐01670 POR at 7‐8; ‐01675 POR at 11‐13; ‐00122 POR at 11‐13; ‐01670 Reply at 1; ‐01675 Reply at 3; ‐00122 Reply at 3
`
`81
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`
`
`Patent Owner’s Construction Reflects Ordinary Meaning of “Clutch”
`
`District Court of New Jersey Claim Construction Order
`
`Ex. 2165 at 13.
`
`‐01670 POR at 7; ‐01675 POR at 11‐12; ‐00122 POR at 11‐12
`
`82
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Petitioner’s Theory: Button 32
`
`‐01670 Petition
`
`Ex. 1013, Figs. 1, 14
`
`‐01670 Petition at 39
`
`‐01670 Petition at 37, 39
`
`83
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Button 32 Does Not Lock The Dial And Housing In Rotation
`
`Slocum Declaration
`
`Burroughs
`
`Ex. 2107 at ¶ 207
`
`Ex. 1013 at 10:34‐37
`
`‐01670 POR at 24‐25; ‐01675 POR at 46; ‐00122 POR at 41
`
`84
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`Button 32 Does Not “Reversibly Lock” The Dial And Nut
`
`Slocum Declaration
`
`Burroughs
`
`Ex. 2107 at ¶ 208
`
`Ex. 1013 at 10:15‐26
`
`‐01670 POR at 25 (both cites); ‐01675 POR at 46‐47; ‐00122 POR at 42
`
`85
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`
`
`Agenda
`
`• Overview
`• Background and State of the Art
`• Obviousness Ground: Steenfeldt‐Jensen’s 5th Embodiment
`• Obviousness Ground: Møller + Steenfeldt‐Jensen’s 5th Embodiment
`• Obviousness Ground: Møller + Steenfeldt‐Jensen’s 2nd Embodiment
`• Obviousness Ground: Burroughs
`• Objective Indicia of Nonobviousness
`
`86
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`
`
`Lantus® SoloSTAR® Practices the Challenged Claims
`
`• The Lantus® SoloSTAR® practices:
`• 069 Patent claim 1
`• 486 Patent claim 1
`• 008 Patent claim 1
`• Petitioners have not prov