EXHIBIT C
`
`DEFENDANTS’ INVALIDITY CONTENTIONS CLAIM CHART FOR U.S. PATENT NO. 8,603,044
`
`The below chart provides examples of prior art that establish that the asserted claims of the ’044 Patent are anticipated and/or
`rendered obvious over the prior art. This case is in the early stages, with most discovery still upcoming, and the close of fact
`discovery is still eight months away. The Court has not construed any claims, and expert reports are not due until sometime after the
`Court’s claim construction order. Further, Plaintiffs have only recently disclosed their validity and infringement contentions, but may
`seek leave to amend their contentions in the future. As a result, Defendant reserves the right to supplement and/or amend these charts
`in response to positions taken by Plaintiffs with additional selections from the cited prior art, as well as with additional prior art
`references. Defendant also incorporates by reference the accompanying Invalidity Contentions with respect to the anticipation and
`obviousness of the other patents in suit, including the prior art descriptions and citations, exemplary prior art combinations, exemplary
`obviousness rationales and motivations to combine, and commentary on potential objective indicia of nonobviousness described
`therein. Additionally, Defendant incorporates by reference the arguments made in the accompanying Invalidity Contentions with
`respect to the invalidity of certain of the following claim limitations under 35 U.S.C. §§ 101, 102, 103, and 112.
`
`Claims
`11. A housing
`part for a
`medication
`dispensing
`apparatus, said
`housing part
`comprising:
`
`
`Disclosures anticipating and/or rendering the claims obvious
`To the extent the preamble of the independent claims are found to be limiting, the following exemplary citations to
`prior art references establish that this claim limitation is taught by the prior art. Additionally, they show that this
`claim limitation would have been obvious in view of the prior art (including the following references alone and in
`combinations) and the knowledge of the person having ordinary skill in the art.
`
`For example:
`
`Judson
`
`Referencing Figures 1 and 2, Judson discloses, “a medication apparatus including a housing.” Judson, pg. 2, ll. 18-
`19.
`
`Judson further discloses that, “[w]ith additional reference to Figs. 3-7, pen proximal portion 24 of injector pen 20
`includes an external, protective housing 60, an axially advanceable drive member 62, a gear set generally
`designated 64, and a plunging member 66.” Judson, pg. 9, ll. 29-31 (emphasis added); see e.g., Fig. 3.
`
`
`
`
`1
`
`Sanofi Exhibit 2010.001
`Mylan v. Sanofi
`IPR2018-01675
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`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`Steenfeldt-Jensen further discloses, “[t]he syringe comprise a tubular housing 1.” Steenfeldt-Jensen, col. 5, l. 38;
`see also Steenfeldt-Jensen, Figs. 16-17.
`
`
`
`Burroughs
`
`Burroughs discloses “[a] multi-use medication dispensing pen made of a plastic material that is recyclable after
`the contents of the medication cartridge have been exhausted. The pen is made of a minimal number of parts, which
`include a housing, a dial mechanism, a generally cylindrical button assembly located within the proximal end of
`the dial mechanism, an internally threaded nut, and an externally threaded leadscrew.” Burroughs, Abstract
`(emphasis added).
`
`Burroughs further discloses, “[r]eferring to FIGS. 1 and 2, there is shown an injection medication device 20 having
`the general appearance of a pen or mechanical pencil. The device comprises a mechanism housing 22 having a first
`part 24 and a second part 26 (FIG. 2).” Burroughs, col. 7, ll. 14-18; see also Fig. 1.
`
`
`
`11
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`Sanofi Exhibit 2010.002
`Mylan v. Sanofi
`IPR2018-01675
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`

`Claims
`
`
`
`Disclosures anticipating and/or rendering the claims obvious
`
`Moller
`
`Moller discloses, “[a]n injection of set doses of medicine from a cartridge.” Moller, at Abstract. Moller further
`discloses, “[i]n the device shown in FIG. 1 an elongated cylindrical housing 1 has a partitioning wall 2 which
`divides the housing in a compartment containing a dose setting mechanism and a compartment 3 designed for the
`accommodation of a not shown ampoule.” Moller, col. 3, ll. 42-46 (emphasis added); see also Moller, Fig. 1.
`
`
`
`
`
`
`
`12
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`Sanofi Exhibit 2010.003
`Mylan v. Sanofi
`IPR2018-01675
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`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`Sams ‘591 discloses, “[w]here such a housing is used, the needle end of the cartridge can project through a terminal
`aperture in the housing or that end of the housing can be closed and can carry a needle or other outlet integrally
`therewith which projects axially inwardly into the housing to penetrate the membrane at the end of the cartridge.”
`Sams ‘591, col. 4, ll. 36-41.
`
`Burroughs
`
`Burroughs discloses, “[t]he present invention, in one form thereof, provides a medication injection pen having a
`distal end and a proximal end. The pen comprises a housing, a cartridge, a drive stem, a rotatable nut, and a dial
`mechanism.” Burroughs, col. 4, ll. 43-46 (emphasis added).
`
`Burroughs further discloses, “[r]eferring to FIGS. 1 and 2, there is shown an injection medication device 20 having
`the general appearance of a pen or mechanical pencil. The device comprises a mechanism housing 22 having a
`first part 24 and a second part 26 (FIG. 2).” Burroughs, col. 7, ll. 14-18 (emphasis added). See also Burroughs, Fig.
`1 (element 22).
`
`Moller
`
`Moller discloses, “[a]n injection of set doses of medicine from a cartridge.” Moller, at Abstract. Moller further
`discloses, “[i]n the device shown in FIG. 1 an elongated cylindrical housing 1 has a partitioning wall 2 which
`divides the housing in a compartment containing a dose setting mechanism and a compartment 3 designed for the
`accommodation of a not shown ampoule.” Moller, col. 3, ll. 42-46 (emphasis added); see also Moller, Fig. 1
`(showing housing 1 extending from a distal end to a proximal end).
`
`Moller further discloses, “a dose setting drum which can be screwed outward in the housing along a thread with a
`second pitch to lift an injection button with it up the proximal end of the housing.” Moller, col. 2, ll. 57-60. See
`also Moller, Figs. 1 (element 1) and 5 (element 101).
`
`Giambattista ’095
`
`Giambattista ’095 discloses a medication delivery pen 10 including, “a body 5 having a distal end 51 and a
`
`21
`
`Sanofi Exhibit 2010.004
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`
`
`
`See also Steenfeldt-Jensen, at cols. 8:4-9 (elements 16 and 17), 11:15-17 (“helical track” groove provided along an
`outer surface of and element 16).
`
`Burroughs
`
`Burroughs discloses, “[r]eferring to FIG. 2, the other major components of medication device 20 include button 32,
`dial mechanism 34, nut 36, and a drive stem in the form of leadscrew 38.” Burroughs, col. 7, ll. 31-33 (emphasis
`added).
`
`Burroughs further discloses, “[i]n order to set a dose for injection, it is first necessary to manually Zero dial
`mechanism 34 from the initial radial position of the dial resulting from the previous injection. In the initial radial
`position of dial mechanism 34 with respect to housing part 26, finger 170 of housing part 26 is located in
`
`
`
`35
`
`Sanofi Exhibit 2010.005
`Mylan v. Sanofi
`IPR2018-01675
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`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`groove 148 of dial mechanism 34. Groove 148 can be rotated by rotating dial mechanism 34 with respect to the
`housing.” Burroughs, col. 9, ll. 47-54 (emphasis added); see also Burroughs, Fig. 2, 6.
`
`
`36
`
`
`
`Sanofi Exhibit 2010.006
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`Burroughs further discloses, “[p]roximal portion 78 of dial mechanism 34 further includes a first U-shaped groove
`100 (FIG. 6) and a second U-shaped groove 101 (FIG. 8) Which form flexible legs 102, 104. Referring to FIG. 9,
`each leg 102, 104, respectively includes an inwardly extending finger 106, 108, and an outwardly extending
`thread 110, 112.” Burroughs, col. 8, ll. 24-29 (emphasis added).
`
`Burroughs further discloses, “[r]eferring to FIGS. 3 and 5, housing parts 24 and 26 form a proximal groove 154
`having a tapered surface 156. Housing parts 24 and 26 further form a helical spiral groove 158 and a
`circumferential surface 160. Circumferential surface 160 includes opening 162 and keyed opening 163 to allow
`threads 110 and 112 respectively to enter helical groove 158 during the commencement of the dosing process.
`Housing parts 24 and 26 further include a circular centering ring 164 which circumscribes splines 150 to maintain
`proper alignment of dial 34. Housing part 26 includes grooves formed therein to define a flexible leg 168 having an
`inwardly extending finger 170 at the end thereof (FIG. 5). Finger 170 includes tapered surfaces 172, proximal end
`174, and a distal end 176.” Burroughs, col. 8, l. 62 – col. 9, l. 8 (emphasis added); see also Burroughs, Figs. 5, 6, 8.
`
`
`37
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`Sanofi Exhibit 2010.007
`Mylan v. Sanofi
`IPR2018-01675
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`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`
`
`
`
`
`
`
`38
`
`Sanofi Exhibit 2010.008
`Mylan v. Sanofi
`IPR2018-01675
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`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`section and fits through the driver tube bore which has a corresponding not round cross-section. This way rotation
`is transmitted whereas the piston rod is allowed to move longitudinally through the driver tube. A scale drum 80 is
`in its outer wall provided with a helical track which is engaged by a helical rib 16 along the inner wall of the
`housing 1.” Steenfeldt-Jensen, col. 11, ll. 6-22 (emphasis added).
`
`Steenfeldt-Jensen further discloses, “[a]t its proximal end the scale drum 80 has a diameter exceeding the inner
`diameter of the housing to form a dose setting button 81 which on its cylindrical outer wall is knurled to
`ensure a good finger grip.” Steenfeldt-Jensen, col. 11, ll. 22-25 (emphasis added); see also Steenfeldt-Jensen,
`Figs. 16, 17.
`
`
`See also Steenfeldt-Jensen, Fig. 8 (elements 17, 23).
`
`Burroughs
`
`Burroughs discloses, “[i]n order to set a dose for injection, it is first necessary to manually Zero dial mechanism
`34 from the initial radial position of the dial resulting from the previous injection. In the initial radial position of
`dial mechanism 34 with respect to housing part 26, finger 170 of housing part 26 is located in groove 148 of dial
`
`
`
`63
`
`Sanofi Exhibit 2010.009
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`mechanism 34. Groove 148 can be rotated by rotating dial mechanism 34 with respect to the housing.”
`Burroughs, col. 9, ll. 47-54 (emphasis added).
`
`Burroughs further discloses, “[d]ial mechanism 34 comprises proximal portion 78, intermediate portion 80, and
`distal portion 82. Proximal portion 78 comprises enlarged diameter portion 84, tapered portion 86, and ring 90
`extending about the circumference of proximal portion 78. Ring 90 also includes an enlarged “Zero-dose”
`protrusion 88 as best shown in FIG. 7.” Burroughs, col. 8, ll. 2-8; see also Burroughs, Figs. 6-9. Comparing figure
`6 to figure 1 shows that enlarged diameter portion 84 of proximal portion 78 is the dose knob of dial mechanism
`34. Compare Burroughs, Figs. 1, 6.
`
`
`
`
`
`
`64
`
`Sanofi Exhibit 2010.010
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`
`
`Moller
`
`Moller discloses, “[a] tubular dose setting drum 17 fitting into the housing 2 is at an end provided with an
`internal thread mating and engaging the outer thread 6 of the tubular element 5 and has at its other end a
`part with enlarged diameter forming a dose setting button 18. Due to the engagement with the thread 6 the dose
`setting drum 17 may be screwed in and out of the housing to show a number on a not shown helical scale on its
`outer surface in a not shown window in the housing 1.” Moller, col. 4, ll. 11-18 (emphasis added); see also Moller,
`Fig. 1 (showing dose setting button 18 at proximal end of the dose setting drum 17).
`
`
`65
`
`Sanofi Exhibit 2010.011
`Mylan v. Sanofi
`IPR2018-01675
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`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`piston rod.” Steenfeldt-Jensen, col. 2, ll. 23-24.
`
`See also Steenfeldt-Jensen, Figures 8, 17 (element 6); cols. 7:65 to 8:9, 11:47-65.
`
`Burroughs
`
`Burroughs discloses, “[r]eferring to FIG. 2, the other major components of medication device 20 include button 32,
`dial mechanism 34, nut 36, and a drive stem in the form of leadscrew 38.” Burroughs, col. 7, ll. 31-33 (emphasis
`added). See also Burroughs, Fig. 1 (element 38); col. 10: 15-52.
`
`Burroughs further discloses, “[t]he housing further includes radially inwardly extending tangs at the distal end of
`the housing which engage ratchet teeth in the leadscrew to prevent the leadscrew from backing up in the proximal
`direction. These tangs are in constant engagement with the leadscrew, thereby preventing the leadscrew from
`rotating upon rotation of the nut.” Burroughs, col. 3, ll. 47-52 (emphasis added).
`
`Burroughs further discloses, “[t]he dial mechanism is rotatably engaged with the nut when in the dose-setting
`position whereby rotation of the dial mechanism relative to the housing causes the nut to rotate relative to the drive
`stem to thereby set a dose.” Burroughs, col. 4, ll. 56-59.
`
`Moller
`
`Moller further discloses, “[a] piston rod 4 has a not round cross section by which it fits through a central opening
`in the wall 2 so that the piston rod 4 can be displaced longitudinally through the central opening in the wall 2 but
`not rotated relative to this wall.” Moller, col. 3, ll. 46-50 (emphasis added). See also Moller, Figs. 1 (element 4)
`and 5 (element 104); col. 4:51 to 5:34.
`
`Giambattista ’095
`
`Giambattista ’095 discloses, “[m]edication delivery pen 10 includes a dose set knob 7, a driver 8, a lead screw 9, a
`lead screw spinner 3, a retract nut 4, a reset ring 6, and a thumb button 71.” Giambattista ’095, col. 3, ll. 21-23
`(emphasis added).
`
`
`81
`
`Sanofi Exhibit 2010.012
`Mylan v. Sanofi
`IPR2018-01675
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`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`14 will not immediately be rotatable.” Steenfeldt-Jensen, col. 8, ll. 1-8; see also Steenfeldt-Jensen, Fig. 2.
`
`
`
`
`Steenfeldt-Jensen further discloses, “said piston rod drive including a first part rotatably mounted within said
`housing and mating with the not circular cross-section of said piston rod, and a second part integral with said
`housing and having an internal thread mating the thread of said piston rod to form a self-locking thread
`connection.” Steenfeldt-Jensen, col. 12, ll. 26-32 (emphasis added).
`
` See also Steenfeldt-Jensen, col. 7:57-62, Figs. 7 and 16.
`
`Burroughs
`
`Burroughs discloses, “[r]eferring to FIG. 2, the other major components of medication device 20 include button 32,
`dial mechanism 34, nut 36, and a drive stem in the form of leadscrew 38.” Burroughs, col. 7, ll. 31-33 (emphasis
`added).
`
`Burroughs further discloses, “[a]s best shown in FIGS. 1 and 2, medical delivery device 20 further includes nut 36
`and leadscrew 38. Nut 36 is generally cylindrical in shape and includes a pair of axially extending grooves 186
`(FIG. 10 and FIG. 11) to form resilient proximal legs 188. Each leg 188 includes a proximal raised portion 190 and
`two small axially extending splines 192. The distal end of nut 36 comprises a flange 194 having, in the exemplary
`embodiment, three teeth 196 thereon. Flange 194 also includes a raised surfaces 199 which contacts bulkhead
`ledges 178 and 180 to indicate to the user that the end of an injection has been reached. The interior surface of the
`
`96
`
`Sanofi Exhibit 2010.013
`Mylan v. Sanofi
`IPR2018-01675
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`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`distal end of nut 36 includes a helical thread 198. Thread 198 extends 350° about the inner surface of nut
`36.” Burroughs, col. 9, ll. 11-25 (emphasis added).
`
`Burroughs further discloses, “[r]otation of dial mechanism 34 causes rotation of nut 36 so that internal helical
`raised groove 198 of nut 36 rotates along external threads 208 of leadscrew 38 to cause nut 36 to axially retract
`a corresponding axial distance.” Burroughs, col. 10, ll. 38-42 (emphasis added). See also Burroughs, Figures 1 and
`11.
`
`Moller
`
`Moller claims, “a drive sleeve (20) for driving the piston rod.” Moller, col. 7, ll. 26. Moller further claims, “[t]he
`device of claim 1, wherein the drive sleeve is coupled to a gear box that is in turn coupled to the threaded
`piston rod so that a portion of the longitudinal force exerted by the user that is transmitted to the piston rod is
`transmitted thru both the drive sleeve and the gear box and wherein the gear box multiples the force.” Moller, col.
`7, ll. 40-46.
`
`Moller further claims, “[t]he apparatus of claim 9, wherein the threaded portion is integral with the housing and
`wherein the drive further comprises a piston rod having at least a threaded section and wherein the piston rod reacts
`to a force on the drive sleeve and moves axially to expel drug from the device.” Moller, col. 8, ll. 28-32.
`
`Moller further claims, “23. The device of claim 22, wherein the drive sleeve is operably coupled to the piston rod
`and transmits a force to the piston rod. 24. The device of claim 23, wherein the piston rod comprises a threaded
`portion.” Moller, col. 10, ll. 14-19.
`
`See also Moller, cols. 3:63-66; 6:5-8, figures 1 and 5.
`
`Giambattista ’095
`
`Giambattista ’095 discloses, “[m]edication delivery pen 10 includes a dose set knob 7, a driver 8, a lead screw 9, a
`lead screw spinner 3, a retract nut 4, a reset ring 6, and a thumb button 71.” Giambattista ’095, col. 3, ll. 21-23
`(emphasis added).
`
`
`97
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`Sanofi Exhibit 2010.014
`Mylan v. Sanofi
`IPR2018-01675
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`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`
`Figure 5
`
`See also Moller at cols. 4:51 to 5:3, 5:12-19, 5:35-64, 6:5-8, 7:11-14, 7:34-40.
`
`Burroughs
`
`Burroughs discloses a tubular clutch comprised of clutch teeth 144 engaging clutch teeth 192 of the drive sleeve,
`referred to as “nut 36.” Burroughs, col. 12, ll. 17-18. Burroughs further discloses that the tubular clutch comprises
`a plurality of splines extending circumferentially about the interior surface of a dial member, dial mechanism 34.
`Id., col. 8, ll. 42-50. See also id., Figures 9 and 10 (showing tubular shape of clutch and clutch is positioned within
`an open end of the dial member and located adjacent a distal end of said dose knob and operatively coupled to said
`dose knob, and wherein said dial member extends circumferentially around at least a portion of said clutch):
`
`
`
`
`116
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`Sanofi Exhibit 2010.015
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`
`
`
`See also Burroughs at col. 9:32-34, 11 :13-34.
`
`Giambattista ’095
`
`Giambattista discloses a cartridge retaining part (vial retainer 2) operatively coupled to the main housing and
`comprising a fluid container. Giambattista ’095, col. 3, ll. 15-20 (“Vial retainer receives a vial (not shown) that
`commonly used in such medication delivery pens to provide medication and/or insulin for an injection. Medication
`delivery pen 10 includes a body 5 having a distal end 51 and a proximal end 52, with vial retainer 2 being attached
`to distal end 51 of body 5.”), Fig. 1. Giambattista ’095 also discloses, “[m]edication delivery pen 10 includes a
`dose set knob 7, a driver 8, a lead screw 9, a lead screw spinner 3, a retract nut 4, a reset ring 6, and a thumb
`button 71.” Giambattista ’095, col. 3, ll. 21-23 (emphasis added).
`
`Giambattista ’095 further discloses, “FIG. 5 is a perspective view of reset ring 6 having a plurality of keys 63
`therein that travel within a respective set of keyways 86 on driver 8, shown in FIG. 1 . Reset ring 6 also
`includes a distal end 61 and a proximal end 62, proximal end 62 having a flange 65 and a plurality of ratchets 64
`extending from flange 65 to distal end 61. Ratchets 64 engage with a plurality of ratchet fingers 73 on a distal end
`71 of dose set knob 7, shown in FIG. 8.” Giambattista ’095, col. 4, ll. 1-9 (emphasis added).
`
`Giambattista ’095 further discloses, “[w]hen medication delivery pen 10 is in the reset condition, reset ring 6 has
`disengaged from dose set knob 7 as clearly seen in FIG. 10. Alternatively, as shown in FIG. 9 during a dose setting
`condition, reset ring 6 is within dose set knob 7 such that ratchet 64 are engaged with ratchet fingers 73. When a
`user is turning dose set knob 7 and thereby turning reset ring 6because of the engagement of ratchet 64 and ratchet
`
`117
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`Sanofi Exhibit 2010.016
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`
`Figure 5
`
`Furthermore, Møller discloses a dose dial sleeve threadedly engaged to the housing, whereas the drive sleeve is
`operably engaged to the piston rod by a threading. The dose dial sleeve threading and the drive sleeve threading are
`different. See also Moller at cols. 4:51 to 5: 19, 6:5 to 7:16.
`
`Burroughs
`
`Burroughs discloses a tubular clutch comprised of clutch teeth 144 engaging clutch teeth 192 of the drive sleeve,
`referred to as “nut 36.” Burroughs, col. 12, ll. 17-18. Burroughs further discloses that the tubular clutch comprises
`a plurality of splines extending circumferentially about the interior surface of a dial member, dial mechanism 34.
`Id., col. 8, ll. 42-50. See also id., Figures 9 and 10 (showing tubular shape of clutch and clutch is positioned within
`an open end of the dial member and located adjacent a distal end of said dose knob and operatively coupled to said
`dose knob, and wherein said dial member extends circumferentially around at least a portion of said clutch):
`
`
`
`
`136
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`Sanofi Exhibit 2010.017
`Mylan v. Sanofi
`IPR2018-01675
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`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`
`
`Furthermore, Burroughs discloses that the dial mechanism groove 158 designed to mate with threadings 110 and
`112 and the internal helical raised groove 198 of nut 36 designed to mate with the threading of the lead screw are
`different. Thus, Burroughs discloses a dose dial sleeve and drive sleeve with different leads. See also Burroughs,
`cols. 9:12 to 10:52.
`
`Giambattista ’095
`
`Giambattista discloses a cartridge retaining part (vial retainer 2) operatively coupled to the main housing and
`comprising a fluid container. Giambattista ’095, col. 3, ll. 15-20 (“Vial retainer receives a vial (not shown) that
`commonly used in such medication delivery pens to provide medication and/or insulin for an injection. Medication
`delivery pen 10 includes a body 5 having a distal end 51 and a proximal end 52, with vial retainer 2 being attached
`to distal end 51 of body 5.”), Fig. 1. Giambattista ’095 discloses, “[m]edication delivery pen 10 includes a dose set
`knob 7, a driver 8, a lead screw 9, a lead screw spinner 3, a retract nut 4, a reset ring 6, and a thumb button 71.”
`Giambattista ’095, col. 3, ll. 21-23 (emphasis added).
`
`Giambattista ’095 further discloses, “FIG. 5 is a perspective view of reset ring 6 having a plurality of keys 63
`therein that travel within a respective set of keyways 86 on driver 8, shown in FIG. 1. Reset ring 6 also includes
`a distal end 61 and a proximal end 62, proximal end 62 having a flange 65 and a plurality of ratchets 64 extending
`from flange 65 to distal end 61. Ratchets 64 engage with a plurality of ratchet fingers 73 on a distal end 71 of dose
`set knob 7, shown in FIG. 8.” Giambattista ’095, col. 4, ll. 1-9 (emphasis added).
`
`Giambattista ’095 further discloses, “[w]hen medication delivery pen 10 is in the reset condition, reset ring 6 has
`disengaged from dose set knob 7 as clearly seen in FIG. 10. Alternatively, as shown in FIG. 9 during a dose setting
`
`137
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`Sanofi Exhibit 2010.018
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`See also Steenfeldt-Jensen, col. 8:16-20, 11 :57-62.
`
`Burroughs
`
`See Burroughs, cols. 9:4-8, 10:42-47.
`
`Moller
`
`See Moller, col. 5:1-14.
`
`Bush
`
`See Bush, col. 5:1-14.
`
`Giambattista ’794
`
`Giambattista ’794 discloses a medication delivery pen 10 including, “a cap 12, a cartridge holder 14, a spinner 16, a
`body 18, a dose knob 20, a dosing ring 22, a driver 24, a leadscrew 26, a dosing ring adaptor 28, and a thumb
`button 30.” Giambattista ’794, col. 2, ll. 36-40 (emphasis added).
`
`Giambattista ’794 further discloses, “[t]he dose knob 20 preferably includes one or more ratchet arms 96 formed
`to be biased inwardly. With reference to FIG. 8, with the dose knob 20 being coaxially disposed about the dosing
`ring 22, the ratchet arms 96 are aligned with the longitudinal ribs 80 so that rotation of the dose knob 20
`relative to the dosing ring 22 results in the ratchet arms 96 acting against the ribs 80 in a ratcheting manner
`giving a user an audible signal of such rotation.” Giambattista ’794, col. 4, ll. 1-12 (emphasis added).
`
`Bendek ’132
`
`Bendek ’132 discloses, “[t]he dose knob 22 preferably includes one or more ratchet arms 104 formed to be biased
`inwardly. With reference to FIG. 11, in a fully-assembled state of the pen 10, the dose knob 22 is coaxially
`disposed about the reset ring 20 with the ratchet arms 104 being aligned with the grooves 90 of the reset ring 20 so
`that rotation of the dose knob 22 relative to the reset ring 20 results in the ratchet arms 104 acting against the reset
`
`156
`
`Sanofi Exhibit 2010.019
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`Burroughs
`
`See Burroughs, cols. 9:4-8, 10:42-47.
`
`Moller
`
`See Moller, col. 5:1-14.
`
`Bush
`
`See Bush, col. 5:1-14.
`
`Giambattista ’794
`
`Giambattista ’794 discloses a medication delivery pen 10 including, “a cap 12, a cartridge holder 14, a spinner 16, a
`body 18, a dose knob 20, a dosing ring 22, a driver 24, a leadscrew 26, a dosing ring adaptor 28, and a thumb
`button 30.” Giambattista ’794, col. 2, ll. 36-40 (emphasis added).
`
`Giambattista ’794 further discloses, “[t]he dose knob 20 preferably includes one or more ratchet arms 96 formed
`to be biased inwardly. With reference to FIG. 8, with the dose knob 20 being coaxially disposed about the dosing
`ring 22, the ratchet arms 96 are aligned with the longitudinal ribs 80 so that rotation of the dose knob 20
`relative to the dosing ring 22 results in the ratchet arms 96 acting against the ribs 80 in a ratcheting manner
`giving a user an audible signal of such rotation.” Giambattista ’794, col. 4, ll. 1-12 (emphasis added); see also
`Giambattista ’794, Fig. 8 (showing ratchet arm 96 having what could be interpreted as a tooth member).
`
`
`
`166
`
`Sanofi Exhibit 2010.020
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`
`
`Steenfeldt-Jensen
`
`Steenfeldt-Jensen discloses, “[t]he proximal end surface of the guide member 56 has one or more axially directed
`protrusions 63 which can co-operate with radial recesses 64 in the bottom of the button 23, but mainly a
`biasing keeps these recesses and protrusions out of engagement.” Steenfeldt-Jensen, col. 9, ll. 26-30 (emphasis
`added).
`
`Steenfeldt-Jensen further discloses, “the guide member has at its proximal end at least one radial protrusion 65
`which is biased to engage axial recesses 66 in an inner wall of the button to produce a click sound each time
`the button is rotated relative to the bushing so that the protrusion jump from one recess to the neighbor recess.”
`Steenfeldt-Jensen, col. 9, ll. 30-35 (emphasis added).
`
`See also Steenfeldt-Jensen, col. 8:16-20, 11 :57-62.
`
`Burroughs
`
`See Burroughs, cols. 9:4-8, 10:42-47.
`
`176
`
`Sanofi Exhibit 2010.021
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`See also Steenfeldt-Jensen, col. 8:16-20, 11 :57-62.
`
`Burroughs
`
`See Burroughs, cols. 9:4-8, 10:42-47.
`
`Moller
`
`See Moller, col. 5:1-14.
`
`Bush
`
`See Bush, col. 5:1-14.
`
`Giambattista ’794
`
`Giambattista ’794 discloses a medication delivery pen 10 including, “a cap 12, a cartridge holder 14, a spinner 16, a
`body 18, a dose knob 20, a dosing ring 22, a driver 24, a leadscrew 26, a dosing ring adaptor 28, and a thumb
`button 30.” Giambattista ’794, col. 2, ll. 36-40 (emphasis added).
`
`Giambattista ’794 further discloses, “[t]he dose knob 20 preferably includes one or more ratchet arms 96 formed
`to be biased inwardly. With reference to FIG. 8, with the dose knob 20 being coaxially disposed about the dosing
`ring 22, the ratchet arms 96 are aligned with the longitudinal ribs 80 so that rotation of the dose knob 20
`relative to the dosing ring 22 results in the ratchet arms 96 acting against the ribs 80 in a ratcheting manner
`giving a user an audible signal of such rotation.” Giambattista ’794, col. 4, ll. 1-12 (emphasis added); see also
`Giambattista ’794, Fig. 8.
`
`Bendek ’132
`
`Bendek ’132 discloses, “[t]he dose knob 22 preferably includes one or more ratchet arms 104 formed to be
`biased inwardly. With reference to FIG. 11, in a fully-assembled state of the pen 10, the dose knob 22 is coaxially
`
`190
`
`Sanofi Exhibit 2010.022
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`the interior of the same and surrounds the other portion of the clutch 32 or 132. Id., col. 4, l. 51 – col. 5, l. 3.
`
`See also id., Figure 1 and Figure 5 (showing tubular clutch is within the dose setting drum, which acts as the dose
`dial sleeve in Møller. Thus, the dose dial sleeve is outside of the tubular clutch and radially inward of the main
`housing.):
`
`
`
`
`
`Figure 5
`
`Burroughs
`
`
`199
`
`Sanofi Exhibit 2010.023
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`Burroughs discloses a tubular clutch comprised of clutch teeth 144 engaging clutch teeth 192 of the drive sleeve,
`referred to as “nut 36.” Burroughs, col. 12, ll. 17-18. Burroughs further discloses that the tubular clutch comprises
`a plurality of splines extending circumferentially about the interior surface of a dial member, dial mechanism 34.
`Id., col. 8, ll. 42-50. See also id., Figures 9 and 10 (showing the tubular clutch is positioned inside of an open end
`of the dose dial sleeve and the dose dial sleeve is radially inward of the main housing):
`
`
`
`
`
`
`
`Giambattista ’095
`
`Giambattista ’095 discloses, “[m]edication delivery pen 10 includes a dose set knob 7, a driver 8, a lead screw 9, a
`lead screw spinner 3, a retract nut 4, a reset ring 6, and a thumb button 71.” Giambattista ’095, col. 3, ll. 21-23
`(emphasis added).
`
`Giambattista ’095 further discloses, “a dose control mechanism for setting a desired dos e to be delivered and
`initiating a reset condition…wherein said dose control mechanism includes a dose set knob rotatably mounted
`
`200
`
`Sanofi Exhibit 2010.024
`Mylan v. Sanofi
`IPR2018-01675
`
`