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
`IPR2018-01676
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`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`Steenfeldt-Jensen4
`
`Steenfeldt-Jensen discloses, “[t]he present invention provides an injection syringe comprises a housing including a
`holder for containing a cartridge of medicine, a piston rod with a non-circular cross-section having an outer thread,
`a piston rod drive, a one way coupling having an annular ring of internal ratchet notches, which annular ring can be
`integral with the housing, and a pawl having at least a pair of resilient arms each having a free end.” Steenfeldt-
`Jensen, at Abstract.
`
`
`
`
`
`
`
`4 All citations to Steenfeldt-Jensen within these invalidity contentions apply equally to the disclosures present in U.S. Patent No.
`6,004,297 to Steenfeldt-Jensen et al., which provides for a substantially similar disclosure.
`
`10
`
`Sanofi Exhibit 2010.002
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`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
`
`Sanofi Exhibit 2010.003
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`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
`
`Sanofi Exhibit 2010.004
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`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 2010.005
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Claims
`
`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;
`
`
`Disclosures anticipating and/or rendering the claims obvious
`Kirchhofer ʼ224 teaches, “The invention relates to a device for administering an injectable product,” and that “[t]he
`injection device comprises a casing with a front casing sleeve 1 and a rear casing sleeve 10 firmly connected to it.”
`Kirchhofer ʼ224, col. 1, ll. 13-14, col. 3, ll. 40-42.
`
`Chanoch
`
`Chanoch fully discloses a main housing extending from a distal end to a proximal end. The “preferred
`embodiment of [the] pen body assembly” in Chanoch includes a “housing 22” with “proximal and distal ends 24
`and 26.” Chanoch, col. 4, ll. 24-26. See also Chanoch at Figure 1 (element 100).
`
`Steenfeldt-Jensen
`
`See Steenfeldt-Jensen, at Figs. 8 and 17 (element 1).
`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
`
`Judson discloses, “[a] dial, generally designated 250, includes a grip portion 252 projecting proximally from
`housing 208, and a reduced diameter cylindrical, tubular body 254 that extends distally of grip portion 252
`and fits within housing hollow 222. Grip portion 252 is externally accessible to be manually rotated by a user for
`dose setting purposes.” Judson, pg. 20, ll. 29-32 (emphasis added).
`
`Judson further discloses, “[d]ial 250 is threadedly engaged with housing 208 via a helical threading 256 on the
`exterior of dial body 254 which engages a corresponding threading 209 on the interior surface of pen housing
`208. The exterior of dial body 254 further includes not shown dosage indicating markings arranged in a helical
`pattern as is conventional.” Judson, pg. 20, l. 32, pg. 21, ll. 1-4 (emphasis added).
`
`
`27
`
`Sanofi Exhibit 2010.006
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`
`Steenfeldt-Jensen
`
`Steenfeldt-Jensen discloses, “a dose setting mechanism comprising a not self locking thread connection along
`which an injection button by rotation of a dose setting element relative to said housing is screwed out from the
`proximal end of the housing to project from this proximal end a distance determined by the angle of said rotation
`and which thread connection by axial returning of the injection button transforms this axial movement to a rotation
`of one of the piston drive elements relative to the other.” Steenfeldt-Jensen, col. 2, ll. 54-62.
`
`Steenfeldt-Jensen further discloses, “[o]n the inner wall of the second division of the housing 1 a helical
`protruding rib 16 is provided defining an inner thread with a high pitch. A dose scale drum 17 is in its outer
`wall provided with a helical groove defining a corresponding external thread mating the inner thread just
`mentioned. The pitch angle of the threads exceeds the angle of friction for the materials forming the parts of the
`thread connection and consequently the thread connection is of the not self locking type which induce a relative
`rotation of the parts of the connection when these part are moved axially relative to each other.” Steenfeldt-Jensen,
`col. 6, ll. 7-17; see also Steenfeldt-Jensen, Figs. 2, 3.
`
`34
`
`Sanofi Exhibit 2010.007
`Mylan v. Sanofi
`IPR2018-01676
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`

`

`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 2010.008
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`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.
`
`
`
`Moller further claims, “a dose dial sleeve (17) threadedly engaged with a portion of the device and having a
`scale indicative of dose sizes and wherein the dose dial sleeve is rotatable during a dose setting operation so that it
`can be rotated to a position where a predetermined dose is indicated on the scale.” Moller, col. 7, ll. 21-25
`(emphasis added). See also Moller at Figs. 3, 5.
`
`Giambattista ’095
`
`
`
`39
`
`Sanofi Exhibit 2010.009
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`
`Steenfeldt-Jensen
`
`Steenfeldt-Jensen discloses, “a dose setting mechanism comprising a not self locking thread connection along
`which an injection button by rotation of a dose setting element relative to said housing is screwed out from the
`proximal end of the housing to project from this proximal end a distance determined by the angle of said rotation
`and which thread connection by axial returning of the injection button transforms this axial movement to a rotation
`of one of the piston drive elements relative to the other.” Steenfeldt-Jensen, col. 2, ll. 54-62.
`
`Steenfeldt-Jensen further discloses, “[t]o maintain a clockwise rotation of a dose setting button for increasing the
`set dose the pawl mechanism working between the driver tube and the housing is turned so that it bars clockwise
`rotation and reluctantly allows anticlockwise 10 rotation of the driver tube. Further the thread of the piston rod and
`the thread in the end wall of the housing is so designed that an anticlockwise rotation of the piston will screw the
`piston rod through said end wall and into the cartridge holder compartment. The piston rod has a not round cross-
`
`62
`
`Sanofi Exhibit 2010.010
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`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 2010.011
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`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 2010.012
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`
`See also Moller, Figure 5 (elements 117, 118).
`
`Moller further discloses, “[t]o set a dose the dose setting button 18 is rotated to screw the dose-setting drum 17 up
`along the thread 6. Due to the coupling 21 the cup shaped element will follow the rotation of the dose-setting drum
`17 and will be lifted with this drum up from the end of the housing 1.” Moller, col. 4, ll. 51-55.
`
`Moller further claims, “16. A medication delivery device for expelling settable doses of medication, the device
`comprising: an injection end, a housing, a dose setting drum comprising a scale indicating various dose sizes, and a
`tubular element that is reversibly rotationally coupled to the dose setting drum so that during dose setting the
`tubular element and the drum rotate together but during dose administration the tubular element is rotationally
`decoupled from the drum so that the drum rotates back to a Zero position while the tubular element moves
`longitudinally toward the injection end, the device further comprising a rod that comprises a first
`threaded portion that extends thru a portion of the housing, the rod coupled to the tubular element so that when the
`tubular element moves toward the injection end of the device, the rod also moves toward the injection end but
`wherein the rod travels a different distance than the tubular element, and wherein the tubular element and drum
`move away from the injection end during dose setting and move axially toward the injection end when a force is
`applied to either one or applied to both during dose administration. 17. The device of claim 16, Wherein the
`
`66
`
`Sanofi Exhibit 2010.013
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`distance the rod travels is less than the distance the tubular element travels. 18. The device of claims 16 or 17,
`wherein it further comprises a dose setting limiter that prevents a dose that is
`larger than that remaining in the device from being set and wherein the tubular element is positively precluded from
`rotating during dose administration. 19. The device of claim 18, wherein the drum is threadedly engaged with the
`housing. 20. The device of claim 19, wherein the housing has an internal thread. 21. The device of claim 18,
`wherein the housing has an internal thread and the drum is threadedly engaged with the internal housing thread.”
`Moller, col. 9, ll. 7-42.
`
`Chanoch
`
`Chanoch discloses a dose dial grip (the gnarled exterior surface of the proximal end 60 of the dose knob 58)
`disposed near the proximal end of the dose dial sleeve. Chanoch, col. 5, ll. 8-11; see also Fig. 2, Fig. 3 (elements,
`400, 401).
`
`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, “FIG. 8 is a perspective view of dose set knob 7 having a distal end 71 and a
`proximal end 72, with a textured section 76 near proximal end 72 to aide the user in turning dose set knob 7 to
`set a desired dose when using medication delivery pen 10.” Giambattista ’095, col. 4, ll. 22-26; see also
`Giambattista ’095, Fig. 8.
`
`67
`
`Sanofi Exhibit 2010.014
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`Furthermore, Horstman discloses, “[s]ince hand wheel 51 is limited to rotation in only the advancing direction,
`product elevator 48 is only allowed to translate in one direction. Thus, dispensing device 10 is unidirectional in
`nature.” Horstman, col. 6, ll. 42-45.
`
`Sams ‘591
`
`Sams ‘591 discloses, “[t]he device comprise an elongated generally cylindrical housing 1 having an axial socket at
`one end into which a generally cylindrical cartridge 2 can be screw or push fitted.” Sams ‘591, col. 10, ll. 39-42.
`
`Sams ‘591 further discloses, “[a] piston 4 journalled within the cartridge 2 is incrementally moved by a plunger 5
`extending substantially co-axially rearwardly into the housing 1 of the device. The plunger 5 is separate from the
`piston and forms part of the device of the invention.” Sams ‘591, col. 10, ll. 45-49; see also Sams ‘591, Fig. 2.
`
`Steenfeldt-Jensen
`
`Steenfeldt-Jensen discloses, “[m]ost dose setting devices work with a threaded piston rod co-operating with a nut
`where the nut and the piston rod may be rotated relative to each other.” Steenfeldt-Jensen, col. 1, ll. 30-32.
`
`Additionally, Steenfeldt-Jensen discloses, “[t]he dose setting may be obtained by screwing the nut away from a
`stop to which it is returned during the injection by pressing the piston rod until the nut member abuts the stop.”
`Steenfeldt-Jensen, col. 1, ll. 30-32 (emphasis added).
`
`Steenfeldt-Jensen further discloses, “[b]y other dose setting devices one of the elements, the nut or the piston
`rod, is kept inrotatable and the other is allowed to rotate a set angle depending on the set dose , whereby the
`piston rod is screwed a distance through the nut.” Steenfeldt-Jensen, col. 1, ll. 35-39 (emphasis added).
`
`Moreover, Steenfeldt-Jensen discloses, “[w]hen the button is screwed back the unidirectional coupling will
`transmit the rotation to the driver which has a nut co-operating with a threaded piston rod which is made
`inrotatable in a housing.” Steenfeldt-Jensen, col. 2, ll. 19-22 (emphasis added).
`
`Steenfeldt-Jensen further discloses, “[t]his thread connection has a pitch which makes the nut self locking on the
`
`80
`
`Sanofi Exhibit 2010.015
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`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
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`Sanofi Exhibit 2010.016
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`
`
`Additionally, Sams ‘591 discloses, “[s]leeve 30 carries an external screw thread 31 which engages a similar
`thread 32 carried internally by section 7 of the body of the device .” Sams ‘591, col. 12, ll. 66-68 (emphasis
`added).
`
`Sams ‘591 further discloses, “[s]leeve 30 is rotated and thus caused to move axially by means of collar 10 driving
`the sleeve through a spined drive 33 shown in FIGS. 2 and 3.” Sams ‘591, col. 12, l. 68, col. 13, ll. 1-3.
`
`Moreover, Sams ‘591 discloses, “[r]e -engagement of jaws 23 and 24 with the plunger, breaks the latch 27/28
`and allows the push sleeve 25 and the jaws 23 and 24 to move independently of the screw sleeve 30 and the jaw
`drive sleeve 26.” Sams ‘591, col. 13, ll. 9-12 (emphasis added).
`
`Steenfeldt-Jensen
`
`Steenfeldt-Jensen discloses, “[t]he end of the ampoule holder 2 inserted in the housing 1 is closed by a wall 4
`having a central bore with an internal thread 5. A piston rod 6 having an external thread 7 mating the thread 5
`of said bore extends through said bore . The threads are so designed that a clockwise rotation of the
`piston rod will drive this rod into an ampoule accommodating compartment 8 in the first division of the housing 1.
`At its end projecting into the compartment 8 the piston rod 6 is provided with a pressure foot 9 designed to abut a
`piston closing the rear end of an ampoule accommodated in the ampoule holder 2.” Steenfeldt-Jensen, col. 5, ll. 55-
`65.
`
`Steenfeldt-Jensen further discloses, “[i]n the proximal side of the end wall 4 the bore is enlarged and the internal
`side of the enlargement is provided with pawl teeth 10 having a steep front edge 11 facing the clockwise direction
`and a ramp shaped rear edge 12 facing the anticlockwise direction. At least one pawl 13 mounted on a piston rode
`guide 14 co-operates with the pawl teeth 10 so that said piston rod guide can only be rotated clockwise in the
`ampoule holder 2.” Steenfeldt-Jensen, col. 5, l. 67 – col. 6, l. 6 (emphasis added).
`
`Steenfeldt-Jensen further discloses, “[t]o set a dose the injection button 23 is manually rotated in a clockwise
`direction Thereby this button is screwed outwards from the housing 1 as the piston rod 6 will through the piston rod
`guide 14 and the unidirectional coupling be kept inrotatable although said unidirectional coupling in
`influenced by a torque in its release direction, however, due to the provided initial reluctance the piston rod guide
`
`95
`
`Sanofi Exhibit 2010.017
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Claims
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`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.
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`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.
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`Burroughs
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`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
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`96
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`Sanofi Exhibit 2010.018
`Mylan v. Sanofi
`IPR2018-01676
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`

`

`Claims
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`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.
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`Moller
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`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.
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`Giambattista ’095
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`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).
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`97
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`Sanofi Exhibit 2010.019
`Mylan v. Sanofi
`IPR2018-01676
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`

`

`Claims
`
`Disclosures anticipating and/or rendering the claims obvious
`provides consistent rotational movement between dial 680 and barrel 700 while permitting dial 680 to move
`axially relative to barrel 700.” Atterbury, pg. 45, ll. 10-13 (emphasis added); See also Atterbury Fig. 27.
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`Bendek
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`Bendek discloses, “means in said dose setting means for controlling torque applied by said rotatable dose setting
`knob to said dosing ring during rotation of said dosing knob, wherein said means for controlling the torque
`applied by said rotatable dose setting knob to said dosing ring during rotation of said dosing knob includes a
`clutch; characterised in that said clutch includes a clutch detent spring attached to said dosing ring and
`rotatably mounted to said dose setting knob to rotate within said dose setting knob when a predetermined
`torque is applied to said dose setting knob, said clutch detent spring including a plurality of outer legs and a
`plurality of internal tabs, wherein said internal tabs attach to said dosing ring and said outer legs are in sliding
`contact with said dose setting knob.” Bendek, col. 3, ¶ 9, ll. 33-49 (emphasis added); see also Bendek ’966;
`Bendek ’896.
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`Steenfeldt-Jensen
`
`Steenfeldt-Jensen discloses, “a dose setting mechanism comprising a not self locking thread connection along
`which an injection button by rotation of a dose setting element relative to said housing is screwed out from the
`proximal end of the housing to project from this proximal end a distance determined by the angle of said rotation
`
`111
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`Sanofi Exhibit 2010.020
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Claims
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`Disclosures anticipating and/or rendering the claims obvious
`and which thread connection by axial returning of the injection button transforms this axial movement to a rotation
`of one of the