teaching of a similar dose-dial sleeve having a 'helical track."' IPR2018-01678
`
`(486-A2) Petition at 65; see also Ex. 1011, ,r,r 352-353. For claim 1 of the 069
`
`Patent and claim 11 of the 044 Patent, which, as noted above, additionally recite
`
`that the helical groove is "provided along an outer surface of said dose dial
`
`sleeve," Petitioner and Mr. Leinsing concede that M0ller's dose-setting drum 17
`
`does not disclose the claimed outer groove. They argue, however, that "a POSA
`
`would have found it obvious to modify the internal threading of [M0ller's] drum
`
`17 as an external threading that engaged the housing for the same rotational
`
`movement relative to the housing as disclosed in Steenfeldt-Jensen." IPR2018-
`
`01670 (069) Petition at 71; see also IPR2018-01676 (044-B) Petition at 57; Ex.
`
`1011, ,r,r 354-361. For the reasons I explain below, in my opinion a POSA would
`
`have not have been motivated to combine M0ller with the groove on Steenfeldt(cid:173)
`
`Jensen's dose scale drum 80 as Petitioner alleges, because M0ller specifically
`
`references and teaches a POSA to avoid Steenfeldt-Jensen's teachings with respect
`
`to the helical groove. In a separate section (addressed further below), I explain that
`
`it is also my opinion that a POSA would not have been motivated to modify
`
`M0ller' s internal threads on dose-setting drum 17 to be external.
`
`a. Moller Teaches Away From a Combination With
`Steenfeldt-J ens en
`
`288.
`
`In my opinion, M0ller teaches a POSA to avoid the teachings of the
`
`outer groove in the dose scale drum 80 as disclosed by Steenfeldt-Jensen. Thus, a
`
`197
`
`Sanofi Exhibit 2107 .204
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`(486-A2) Petition at 65; see also Ex. 1011, ,r,r 352-353. For claim 1 of the 069
`
`Patent and claim 11 of the 044 Patent, which, as noted above, additionally recite
`
`that the helical groove is "provided along an outer surface of said dose dial
`
`sleeve," Petitioner and Mr. Leinsing concede that M0ller's dose-setting drum 17
`
`does not disclose the claimed outer groove. They argue, however, that "a POSA
`
`would have found it obvious to modify the internal threading of [M0ller's] drum
`
`17 as an external threading that engaged the housing for the same rotational
`
`movement relative to the housing as disclosed in Steenfeldt-Jensen." IPR2018-
`
`01670 (069) Petition at 71; see also IPR2018-01676 (044-B) Petition at 57; Ex.
`
`1011, ,r,r 354-361. For the reasons I explain below, in my opinion a POSA would
`
`have not have been motivated to combine M0ller with the groove on Steenfeldt(cid:173)
`
`Jensen's dose scale drum 80 as Petitioner alleges, because M0ller specifically
`
`references and teaches a POSA to avoid Steenfeldt-Jensen's teachings with respect
`
`to the helical groove. In a separate section (addressed further below), I explain that
`
`it is also my opinion that a POSA would not have been motivated to modify
`
`M0ller' s internal threads on dose-setting drum 17 to be external.
`
`a. Moller Teaches Away From a Combination With
`Steenfeldt-J ens en
`
`288.
`
`In my opinion, M0ller teaches a POSA to avoid the teachings of the
`
`outer groove in the dose scale drum 80 as disclosed by Steenfeldt-Jensen. Thus, a
`
`197
`
`Sanofi Exhibit 2107 .204
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`POSA would not have been motivated to combine M0ller with Steenfeldt-Jensen's
`
`teachings.
`
`289. M0ller explains that one of his main objectives of his invention is to
`
`reduce the force required to inject medicament, and M0ller's pen injector designs
`
`are specifically aimed at doing so. See, e.g., Ex. 1015, ,r,r 0004-0005 (explaining
`
`that high injection force "is not quite favorable, as especially [for] users having
`
`reduced finger strength"). One of the ways that M0ller addresses this fundamental
`
`problem is by relying on "gearing" to achieve a mechanical advantage so that
`
`lower force is required by the user to expend medicament. See id. ,r 0006. M0ller
`
`also seeks to reduce the force required for injection by minimizing efficiency
`
`losses that are due to sliding friction between threaded surfaces by using rolling
`
`contact between highly efficient gear teeth. As a specific example of a system that
`
`has undesirable losses due to friction, M0ller cites WO 99/38554 (Ex. 2153),
`
`which includes the same teachings of an externally-grooved dose setting drums as
`
`Steenfeldt-Jensen. I am informed that WO 99/38554 is a foreign related patent
`
`application. Specifically, M0ller states:
`
`A similar gearing is provided in WO 99/38554 [Steenfeldt-Jensen's
`
`foreign related patent application] wherein the thread with the high
`
`pitch is cut in the outer surface of a dose setting drum and is engaged
`
`by a mating thread on the inner side of the cylindrical housing.
`
`However, by this kind of gearing relative large surfaces are sliding
`
`198
`
`Sanofi Exhibit 2107 .205
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`over each other so that most of the transformed force is lost due to
`
`friction between the sliding surfaces. Therefore a traditional gearing
`
`using mutual engaging gear wheels and racks is preferred.
`Ex. 1015, ,r 0008 (emphasis added). M0ller then goes on to say that "[i]t is an
`
`objection of [M0ller's] invention to provide an injection device, which combines
`
`the advantages of the devices according to the prior art without adopting their
`
`disadvantages" (Ex. 1015, ,r 0011), which a POSA would understand to include
`
`specific Steenfeldt-Jensen's threaded dose setting drum that was expressly noted as
`
`being disadvantageous three paragraphs before.
`
`290. A POSA would have understood that M0ller teaches away from
`
`applying Steenfeldt-Jensen's "thread with the high pitch [that] is cut in the outer
`
`surface of a dose setting drum" because when it is used for gearing then "relative
`
`large surfaces are sliding over each other so that most of the transformed force is
`
`lost due to friction between the sliding surfaces." Id. ( emphasis added). In my
`
`opinion a POSA would not have had a reason to look to Steenfeldt-Jensen's
`
`threaded dose setting drum given M0ller's statement to specifically avoid it.
`
`291. Further, I note that although the last sentence of the paragraph 0008 in
`
`M0ller states that a "gearing using mutual engaging gear wheels and racks is
`
`preferred," M0ller does not advise using Steenfeldt-Jensen's externally-grooved
`
`dose scale drum. Instead, the two pen injector embodiments that M0ller designed
`
`specifically lack the externally-grooved dose scale drum described by Steenfeldt-
`
`199
`
`Sanofi Exhibit 2107 .206
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`Jensen. A POSA would have understood from these disclosures that Steenfeldt(cid:173)
`
`Jensen's externally-grooved dose scale drum should be avoided when applying
`
`M0ller's teachings.
`
`292. Therefore, m my opm10n, M0ller teaches a POSA to avoid the
`
`teachings of the outer groove in the dose scale drum 80 taught by Steenfeldt-Jensen
`
`and so a POSA would not have been motivated to combine M0ller with Steenfeldt-
`
`Jensen's teachings.
`
`b.
`
`A POSA Would Not Have Been Motivated to Make
`the Relied-Upon Combination Due to a Purported
`Benefit Alleged by Petitioner
`
`293. Even though M0ller teaches a POSA to avoid Steenfeldt-Jensen's
`
`externally-groove dose setting drum, for the IPR2018-01670 (069) and IPR2018-
`
`01678 (486-A2) IPRs, Petitioner and Mr. Leinsing allege that there is an advantage
`
`to placing an external high-pitch thread taught by Steenfeldt-Jensen on M0ller's
`
`dose-setting drum 17. Specifically, Petitioner alleges that "[b ]ecause Steenfeldt(cid:173)
`
`Jensen's threaded engagement is configured to reduce the friction between the
`
`sliding surfaces of the drum and housing, a POSA would have understood that this
`
`configuration would reduce the force needed to rotate the drum back into the
`
`housing during injection."
`
`IPR2018-01676 (044-B) Petition at 78; see also
`
`IPR2018-01670 (069) Petition at 86-87; Ex. 1011, if 360.
`
`200
`
`Sanofi Exhibit 2107 .207
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`294.
`
`I disagree that this alleged benefit would have motivated a POSA to
`
`make Petitioner's proposed combination. M0ller itself already has a solution to
`
`this purported "problem." In M0ller, the thread friction arising from the internal
`
`threads 6 of its dose-setting drum 17 is counteracted by a "helical reset spring 36,"
`
`which is a torsional spring meant to bias the dose-setting drum 17 back into the
`
`housing 1 after it has been dialed out. M0ller states that this spring "exerts a
`
`torque approximately corresponding to the torque necessary to overcome the
`
`friction in the movement of the dose setting drum along the thread 6 so that the
`
`force which the user have [sic] to exert on the injection button is only the force
`
`necessary to drive the piston rod into the ampoule to inject the set dose." Ex. 1015,
`
`,r 0033 ( emphasis added). Neither Petitioner nor Mr. Leinsing has identified any
`
`reason why a POSA would abandoned the solution proposed by M0ller' s for a
`
`solution outside M0ller. In sum, Mr. Leinsing creates a problem already addressed
`
`by M0ller. 12
`
`12 Indeed, as I explain in the next section, moving the threads from the interior of
`
`the dose-setting drum 17 to the exterior is not a good idea, because the losses due
`
`to friction are multiplied by the increase in distance the threads are moved from the
`
`pen injector's central axis. Thus, not only is there not a reason to use Steenfeldt-
`
`201
`
`Sanofi Exhibit 2107 .208
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`295. Accordingly, it is my opinion that a POSA would not have been
`
`motivated to combine M0ller with Steenfeldt-Jensen as Petitioner alleges for the
`
`challenged claims of the 069, 044, and 486 Patents.
`
`3.
`
`The Combination of Moller and Steenfeldt-Jensen Does Not
`Teach or Render Obvious "said dose dial sleeve comprising
`a helical groove configured to engage a threading provided
`by said main housing" [069 Patent Claim 1; 044 Patent
`Claim 11; 486 Patent Claim l] and "said helical groove
`provided along an outer surface of said dose dial sleeve"
`[069 Patent Claim 1; 044 Patent Claim 11]
`
`296. Claim 1 of the 069 Patent, claim 11 of the 044 Patent, and claim 1 of
`
`the 486 Patent each require 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." Claim 1 of the 069 Patent and Claim 11 of the
`
`044 Patent additionally require "said helical groove provided along an outer
`
`surface of said dose dial sleeve."
`
`297. For the 069 Patent, 044 Patent, and 486 Patent, Petitioner identifies
`
`the combination of M0ller's housing 1 (grey, below), wall 2, and tubular element 5
`
`Jensen's exterior threads, a POSA would not have wanted to when the threads
`
`could be formed on the interior.
`
`202
`
`Sanofi Exhibit 2107 .209
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`(orange, below) as the claimed "main housing." 13 See IPR2018-01670 (069)
`
`Petition at 66-68; IPR2018-01676 (044-B) Petition at 52-54; IPR2018-01678 (486-
`
`A2) Petition at 60-61. For the 486 Patent, Petitioner argues that M0ller's dose(cid:173)
`
`setting drum 17 is the claimed "dose dial sleeve" that "engage[ s] a threading
`
`provided by said main housing." See IPR2018-01678 (486-A2) Petition at 62-66.
`
`For the 069 Patent and 044 Patent, which additionally require that the helical
`
`groove of the dose dial sleeve is on its exterior surface, Petitioner argues that a
`
`POSA would have been motivated to modify M0ller's internally-threaded dose(cid:173)
`
`setting drum 17 to be externally-threaded as taught by Steenfeldt-Jensen's dose
`
`scale drum 80. See IPR2018-01670 (069) Petition at 68-71, 85-88; IPR2018-
`
`01676 (044-B) Petition at 54-57, 76-79.
`
`13 I note that in certain places in its petitions, Petitioner annotates Figure 1 of
`
`M0ller so that all three components-housing 1, wall 2, and tubular element 5-
`
`are grey, but in certain other places it annotates wall 2, which sits between housing
`
`1 and tubular element 5, in purple. See, e.g., IPR2018-01678 (486-A2) Petition at
`
`97; see also IPR2018-01684 (008) Petition at 13-14 (shading M0ller's housing 1
`
`and tubular element 5 as the 008 Patent's claimed "housing" and shading wall 2 as
`
`the 008 Patent's claimed "piston rod holder").
`
`203
`
`Sanofi Exhibit 2107.210
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`
`
`298. For the reasons specified below, I disagree with Petitioner's
`
`arguments and it is my opinion that M0ller in combination with Steenfeldet-Jensen
`
`does not teach or render obvious these claim limitations.
`
`4. Moller Does Not Disclose a Dose Dial Sleeve That
`Engages a Threading of a "Main Housing"
`
`299. As I explained above in the section on claim construction, it is my
`
`opinion that the broadest reasonable interpretation of a "main housing" that is
`
`consistent with the specifications of the challenged patents is a type of exterior
`
`housing that does not encompass separate or integrally-formed interior housings,
`
`which is consistent with both Sanofi' s construction and the ordinary meaning in
`
`the context of the challenged patents. Because the threads on M0ller's dose-setting
`
`drum 17 are engaged with M0ller's tubular element 5, which is not the required
`
`"main housing" as I explain below, it is my opinion that M0ller fails to disclose
`
`"said dose dial sleeve comprising a helical groove configured to engage a
`
`threading provided by said main housing" as recited by claim 1 of the 069 Patent,
`
`claim 11 of the 044 Patent, and claim 1 of the 486 Patent.
`
`300.
`
`In my opinion, a POSA would not have understood that M0ller's
`
`tubular element 5 ( orange, below) is a "main housing" within the meaning of the
`
`challenged patents. At best, it is an interior, not an exterior, housing. No part of
`
`tubular element 5 is on the exterior of the pen. Moreover, M0ller treats tubular
`
`205
`
`Sanofi Exhibit 2107.212
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`element 5 as a component distinct from the housing 1 (grey, below), which unlike
`
`tubular element 5 is on the exterior of the pen and is therefore an exterior housing:
`
`Concentrically with the housing 1 the wall 2 carries on its side
`
`turning away from the compartment 3 a tubular element 5 which is at
`
`a part of it adjacent to the wall 2 provided with an outer thread 6 and
`
`which has at its free end a circumferential recess 7.
`
`Ex. 1015, ,r 0023 (emphasis added).
`
`206
`
`Sanofi Exhibit 2107.213
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`
`
`301. Notably, M0ller's housing 1 (grey) and tubular element 5 (orange)
`
`correspond to main housing 4 (grey) and insert 16 (orange) that is depicted and
`
`described in all of the challenged patents, as shown above. Even though the
`
`tubular element 5 in M0ller is depicted as being formed integrally with housing 1
`
`(through wall 2), this is like the insert 16 and main housing 4 in the challenged
`
`patents. Specifically, the challenged patents state:
`
`In the illustrated embodiment, an insert 16 is provided at a first end of
`
`the main housing 4. The insert 16 is secured against rotational or
`
`longitudinal motion. The insert 16 is provided with a threaded circular
`
`opening 18 extending therethrough. Alternatively, the insert may be
`
`formed integrally with the main housing 4 the form of a radially
`
`inwardly directed flange having an internal thread.
`
`Ex. 1002, 3:49-55 (emphasis added). Thus, like M0ller's tubular element 5 being
`
`formed integrally with the housing 1, which M0ller identifies as distinct
`
`components, the insert 16 of the challenged patents can be formed integrally with
`
`the main housing 4, which the challenged patents identify as distinct components.
`
`Notably, the excerpted language above says that the "insert may be formed
`
`integrally with the main housing 4 [in] the form of a radially inwardly directed
`
`flange," and it does not say that the insert may be replaced by an inwardly directed
`
`flange of the main housing 4. In other words, the challenged patents treat a "main
`
`208
`
`Sanofi Exhibit 2107.215
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`housing" ( an exterior housing) separate from an "insert" (interior housing), even if
`
`integrally formed.
`
`302. Accordingly, it is my opinion that a POSA would have understood
`
`that because M0ller' s dose-setting drum 1 7 engages a threading on tubular element
`
`5, which is an interior housing, and because there is no threading on M0ller' s
`
`housing 1, which is a main housing, M0ller fails to teach a "dose dial sleeve
`
`comprising a helical groove configured to engage a threading provided by said
`
`main housing" a recited by claim 1 of the 069 Patent, claim 11 of the 044 Patent,
`
`and claim 1 of the 486 Patent.
`
`5.
`
`A POSA Would Not Have Been Motivated to Modify
`M0ller's Internally-Threaded Dose Dial Sleeve to Be
`Externally-Threaded
`
`303. As noted above, claim 1 of the 069 Patent and claim 11 of the 044
`
`Patent additionally require that the claimed dose dial sleeve has a "helical groove
`
`provided along [its] outer surface." Because M0ller's dose-setting drum 17 has at
`
`a thread provided along its inner surface, Petitioner and Mr. Leinsing argue that it
`
`would have been obvious to modify the dose-setting drum 17 such that its threads
`
`were external. See IPR2018-01670 (069) Petition at 68-71, 85-88; IPR2018-01676
`
`(044-B) Petition at 54-57, 76-79; Ex. 1011, ,r,r 347-361. I disagree as explained
`
`below.
`
`209
`
`Sanofi Exhibit 2107.216
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`304. As I already explained above, a POSA would not have been motivated
`
`to combine M0ller with Steenfeldt-Jensen because M0ller teaches a POSA to avoid
`
`the externally-grooved helical thread on Steenfeldt-Jensen's dose setting drum.
`
`Further, as I also explained above, the benefit of making this combination alleged
`
`by Petitioner and Mr. Leinsing fails, because M0ller already proposes a solution to
`
`counteract the negative effects of thread friction at thread 6 of its dose-setting drum
`
`17 (i.e., the helical reset spring 36). See Ex. 1015, ,r 0033.
`
`305. Moreover, a POSA would not have wanted to make the proposed
`
`modification because it would have resulted in an inferior pen injector. First,
`
`placing the internal threads 6 of the dose-setting drum 1 7 on the outer surface,
`
`which would also mean putting interior threads on the inner surface of the M0ller's
`
`housing 1, would lead to mechanical interference with M0ller's helical reset
`
`spring. See Ex. 1015, Fig. 1 (element 36). This interference could cause the pen
`
`injector to malfunction. For example, the spring could get caught between the
`
`crest and root of the mating screw threads to jam and prevent rotation of the dose(cid:173)
`
`setting drum 1 7, or the interaction between the screw threads and the spring could
`
`damage or break the spring, preventing it from working properly. Neither
`
`Petitioner or Mr. Leinsing have considered or explained how to avoid these
`
`problems.
`
`210
`
`Sanofi Exhibit 2107.217
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`306. Second, moving threads (and their inherent friction) from near the
`
`center of the pen injector to farther from the center of the pen injector, as Petitioner
`
`and Mr. Leinsing propose, would increase the parasitic torque ( efficiency losses)
`
`due to friction during dose injection. As I have explained in the background of the
`
`technology section of this declaration, part of the force that the user puts into a pen
`
`injector goes into overcoming the frictional forces in the device. These frictional
`
`forces arise from thread surfaces that rub against each other during dose injection.
`
`If one were to move these thread interfaces farther away from the axis of rotation,
`
`however, the drag (parasitic) torque caused by this friction is multiplied by the
`
`distance of the threaded interface from the axis of rotation ( 1 = r x F) to create a
`
`larger parasitic drag that would likely frustrate a user. As I also explained in the
`
`background of the technology section of this declaration, reducing injection force
`
`was an important design objective and a POSA would have known to reduce the
`
`efficiency losses due to friction in furtherance of this objective. A POSA therefore
`
`would not have understood that moving the internal threads of M0ller' s dose(cid:173)
`
`setting drum 17 to its exterior would be beneficial, and a POSA would not have
`
`been motivated to make this change.
`
`307. Notably, Steenfeldt-Jensen discloses an externally-threaded dose scale
`
`drum 80, but as shown below Steenfeldt-Jensen does not disclose an interior
`
`housing on which threads may be formed. M0ller does disclose an interior
`
`211
`
`Sanofi Exhibit 2107.218
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`housing, and in fact requires the interior housing to support the gearbox 9 in its
`
`first embodiment. A POSA would have understood that when presented with an
`
`option to thread a dose dial sleeve with the interior of an exterior housing ( as
`
`Petitioner proposes) or an exterior of an interior housing ( as M0ller does), it is
`
`better to do the latter to reduce losses due to thread friction.
`
`308. Thus, even though M0ller sets out to reduce injection force and
`
`mm1m1ze losses from friction, Petitioner and Mr. Leinsing argue that a POSA
`
`would have ignored these teachings ( and the motivating design principles in pen
`
`injector design generally) and made a pen injector that is inferior. In my opinion,
`
`this is incorrect. A POSA would not have been motivated to modify M0ller as
`
`Petitioner proposes, and thus it is my opinion that M0ller and Steenfeldt-Jensen
`
`does not teach or render obvious a "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" as recited by
`
`claim 1 of the 069 Patent and claim 11 of the 044 Patent.
`
`6.
`
`The Combination of Moller and Steenfeldt-Jensen Does Not
`Teach or Render Obvious "at least one flexible arm ... and
`at least one spline ... to provide said audible feedback" [044
`Patent Claim 15]
`
`309. Claim 15 of the 044 Patent requires "wherein said clicker comprises:
`
`at least one flexible arm, said flexible arm comprising at least one tooth member,
`
`and at least one spline, wherein when said dose dial grip is rotated, said at least one
`
`212
`
`Sanofi Exhibit 2107.219
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`flexible arm deforms and drags said tooth member over said at least one spline so
`
`as to provide said audible feedback."
`
`310. M0ller does not disclose a clicker compnsmg a flexible arm and
`
`spline to provide audible feedback, and neither Petitioner nor Mr. Leinsing identify
`
`one. Instead, Petitioner and Mr. Leinsing identify protrusion 87 on the flange 83 of
`
`the bushing 82 in Steenfeldt-Jensen's fifth embodiment. IPR2018-01676 (044-B)
`
`Petition at 82-84; Ex. 1011, ,r,r 310-312. Neither Petitioner nor Mr. Leinsing offer
`
`any explanation about how M0ller would be modified to incorporate protrusion 87
`
`from Steenfeldt-Jensen to form a clicker (e.g., there is no description of where to
`
`place the protrusion 87 and any corresponding splines). Further, neither Petitioner
`
`nor Mr. Leinsing explain why a POSA would have been motivated to make any
`
`such modification. M0ller already provides clicking during dose dialing via the
`
`interaction of teeth between cup-shaped element 19 and ring 25, and it does so
`
`without flexible arms and splines. See Ex. 1015, ,r,r 0026-0027.
`
`311. Accordingly, it is my opinion that Petitioner has failed to demonstrate
`
`that M0ller combined with Steenfeldt-Jensen teach or render obvious claim 15 of
`
`the 044 Patent.
`
`213
`
`Sanofi Exhibit 2107 .220
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`7.
`
`The Combination of Moller and Steenfeldt-Jensen Does Not
`Teach or Render Obvious "wherein said main housing
`further comprises a helical rib ... adapted to be seated in
`said helical groove provided along said outer surface of said
`dose dial sleeve" [044 Patent Claim 19]
`
`312. Claim 19 of the 044 Patent requires "wherein said main housing
`
`further comprises a helical rib, said helical rib adapted to be seated in said helical
`
`groove provided along said outer surface of said dose dial sleeve."
`
`313. For this claim, Petitioner simply refers to the same arguments it made
`
`for claim 11 of the 044 Patent to argue that it would have been obvious to modify
`
`M0ller' s dose-setting drum 17 to have an external helical thread as taught by
`
`Steenfeldt-Jensen's externally-threaded dose scale drum 80. As I explained above
`
`in Sections XI.C.4, however, M0ller does not disclose a dose dial sleeve with
`
`threads that engage a "main housing" (they engage tubular element 5, which is an
`
`interior, housing), a POSA would not have been motivated to combine M0ller and
`
`Steenfeldt-Jensen because the former teaches away from the latter's externally(cid:173)
`
`threaded dose dial sleeve, and a POSA would not have been motivated to move the
`
`threads on the interior of M0ller's dose dial sleeve to the exterior (and thus farther
`
`away from the axis of rotation) due to increases in frictional torque and because of
`
`mechanical interference with helical reset spring 36.
`
`314. Thus, it is my opinion that M0ller in combination with Steenfeldt(cid:173)
`
`Jensen does not teach or render obvious claim 19 of the 044 Patent.
`
`214
`
`Sanofi Exhibit 2107.221
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`8. Moller Does Not Teach or Render Obvious "a helical rib
`provided on an inner surface of said outer housing" [486
`Patent Claim 4]
`
`315. Claim 4 of the 486 Patent requires "wherein said window is located
`
`near a proximal end of said main housing and near a helical rib provided on an
`
`inner surface of said outer housing."
`
`316. As with other claim limitations that I have analyzed above, Petitioner
`
`and Mr. Leinsing note that M0ller does not disclose that its dose-setting drum 17
`
`have external threads that engage with inner threads of the housing 1 ("a helical rib
`
`provided on an inner surface of said outer housing"), but that it would have been
`
`obvious to modify M0ller's dose-setting drum 17 to have an external helical thread
`
`as taught by Steenfeldt-Jensen's externally-threaded dose scale drum 80. See
`
`IPR2018-01678 (486-A2) Petition at 77-81 (citing Mr. Leinsing's arguments for
`
`claim 1 of the 069 Patent and claim 11 of the 044 Patent); Ex. 1011, ,r 391
`
`(referring to his arguments for claim 1 of the 069 Patent and claim 11 of the 044
`
`Patent at ,r,r 355-361).
`
`317. As I explained above in Section X.C.4., however, M0ller does not
`
`disclose a dose dial sleeve with threads that engage a "main housing" (they engage
`
`tubular element 5, which is an interior housing), a POSA would not have been
`
`motivated to combine M0ller and Steenfeldt-Jensen because the former teaches
`
`away from the latter's externally-threaded dose dial sleeve, and a POSA would not
`
`215
`
`Sanofi Exhibit 2107 .222
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`have been motivated to move the threads on the interior of M0ller' s dose dial
`
`sleeve to the exterior (and thus farther away from the axis of rotation) due to
`
`increases in frictional torque and because of mechanical interference with helical
`
`reset spring 36.
`
`318. Thus, it is my opinion that M0ller in combination with Steenfeldt(cid:173)
`
`Jensen does not teach or render obvious claim 19 of the 044 Patent.
`
`9. Moller Does Not Teach or Render Obvious a Driver
`Comprising "a cylindrical shape" [486 Patent Claim 5]
`
`319. Claim 5 of the 486 Patent requires "wherein said driver comprises a
`
`cylindrical shape."
`
`320.
`
`[reserved]
`
`321. Petitioner additionally, but
`
`incorrectly, argues
`
`that M0ller's
`
`connection bars 12 and nut 13 are structurally and functionally equivalent to
`
`connection element 112 with nut 113. IPR2018-01678 (486-A2) Petition at 82; see
`
`also Ex. 1011, ,r 395. As I explained above in Section XI.C.l. for this exact same
`
`argument, a POSA would not have understood that connection bars 12 and nut 13
`
`are structurally and functionally equivalent to tubular connection element 112 and
`
`nut 113.
`
`322. Petitioner also argues
`
`that "a POSA would have recognized
`
`connection bars 12 with nuts 13 could be formed as a tubular structure." IPR2018-
`
`216
`
`Sanofi Exhibit 2107 .223
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`01678 (486-A2) Petition at 82; see also Ex. 1011, ,r 395. I have also addressed this
`
`argument above. See Section X.C.l.
`
`323. In my view, neither Petitioner nor Mr. Leinsing has provided a reason
`
`to modify M0ller's first embodiment to form parallel connection bars 12 as "a
`
`tubular structure" as they allege, let alone as the connection element 112 of
`
`M0ller' s second embodiment.
`
`10. Moller Does Not Teach or Render Obvious a Clicker
`Comprising "at least one flexible [extending] arm" [486
`Patent Claims 18 and 20]
`
`324. Both claims 18 and 20 of the 486 Patent require at least one flexible
`
`arm. Specifically, claim 18 of the 486 Patent requires "wherein said clicker
`
`comprises, at least one flexible arm, said flexible arm comprising at least one tooth
`
`member, and at least one spline, wherein when said dose knob is rotated, said at
`
`least one flexible arm deforms and drags said tooth member over said at least one
`
`spline so as to provide said audible feedback." Claim 20 of the 486 Patent requires
`
`"wherein said clicker generally comprises a cylindrical shape having a first and a
`
`second end, and said cylindrical shape is provided at said first end with at least one
`
`flexible extending arm."
`
`325. As I explained for claim 15 of the 044 Patent in Section XI.C.6.,
`
`above, M0ller does not disclose a clicker comprising a flexible arm to provide
`
`audible feedback, and neither Petitioner nor Mr. Leinsing identifies one. Instead,
`
`217
`
`Sanofi Exhibit 2107 .224
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`Petitioner and Mr. Leinsing identify protrusion 87 on the flange 83 of the bushing
`
`82 in Steenfeldt-Jensen's fifth embodiment. IPR2018-01678 (486-A2) Petition at
`
`88; Ex. 1011, ,r,r 413-15. However, neither Petitioner nor Mr. Leinsing offers any
`
`explanation about how M0ller would be modified to incorporate protrusion 87
`
`from Steenfeldt-Jensen to form a clicker (e.g., there is no description of where to
`
`place the protrusion 87 and any corresponding splines). Further, neither Petitioner
`
`nor Mr. Leinsing explains why a POSA would have been motivated to make any
`
`such modification. M0ller already provides clicking during dose dialing via the
`
`interaction of teeth between cup-shaped element 19 and ring 25, and it does so
`
`without flexible arms and splines. See Ex. 1015, ,r,r 0026-0027.
`
`326. Accordingly, it is my opinion that Petitioner has failed to demonstrate
`
`that M0ller combined with Steenfeldt-Jensen teaches or renders obvious claims 18
`
`and 20 of the 486 Patent.
`
`11. Moller Does Not Teach or Render Obvious a Dose Dial
`Sleeve That Is "radially inward of said main housing" [486
`Patent Claim 26]
`
`327. Claim 26 of the 486 Patent requires "wherein said dose dial sleeve is
`
`provided outside said tubular clutch and radially inward of said main housing."
`
`328. Petitioner and Mr. Leinsing identify M0ller's housing 1, wall 2, and
`
`tubular element 5 as the claimed "main housing." See IPR2018-01678 (486-A2)
`
`Petition at 60-61, 90-91; Ex. 1011, ,r,r 345-346. As I explained above in Section
`
`218
`
`Sanofi Exhibit 2107 .225
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`XI.C.4. for claim 1 of the 486 Patent, a "main housing" in the context of the 486
`
`Patent does not encompass interior housing, even if integrally formed with the
`
`main housing, and thus M0ller's wall 2 and tubular element 5 would not have been
`
`understood by a POSA to be the claimed "main housing."
`
`329. Under Petitioner's incorrect view, however, M0ller's dose-setting
`
`drum 17 (green) is not "radially inward" of the alleged main housing (grey),
`
`because it is not radially inward of the tubular element 5 as illustrated below. In
`
`fact, it is radially outside of tubular element 5 as illustrated below. Although the
`
`dose-setting drum 17 may be radially inward of M0ller's housing 1, the claim
`
`limitation does not recite that the dose dial sleeve is radially inward of at least part
`
`of the main housing and a POSA would not have understood that the claim should
`
`be understood this way.
`
`219
`
`Sanofi Exhibit 2107 .226
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`
`
`330. The piston rod 4 (yellow) is an example of a component that would be
`
`radially inward of the main housing under Petitioner's incorrect view of "main
`
`housing."
`
`331. Accordingly, it is my opinion that Petitioner has failed to demonstrate
`
`that M0ller combined with Steenfeldt-Jensen teaches or renders obvious claim 26
`
`of the 486 Patent.
`
`12. Moller Combined With Steenfeldt-Jensen Does Not Teach
`or Render Obvious a "radial stop positioned near an end of
`[a] helical groove" or "near a distal end of said helical
`groove" [ 486 Patent Claims 30 and 32]
`
`332. Claim 30 of the 486 Patent requires "wherein said dose dial sleeve
`
`comprises at least one radial stop, said radial stop positioned near an end of said
`
`helical groove." Claim 32 of the 486 Patent depends on claim 30 and further
`
`requires "wherein said radial stop is positioned near a distal end of said helical
`
`groove."
`
`333. Petitioner and Mr. Leinsing argue that it would have been "apparent"
`
`to modify M0ller to include a radial stop on M0ller' s dose-setting drum 17 near the
`
`end of its helical groove. IPR2018-01678 (486-A2) Petition at 94-95; Ex. 1011, ,r,r
`
`431-439. To make this argument, both Petitioner and Mr. Leinsing refer to
`
`Steenfeldt-Jensen's third embodiment-not the fifth embodiment that Petitioner
`
`relies on to argue that the 486 Patent claims are obvious-and its teaching of a
`
`"saw tooth 91" on the button-end of a dose scale drum 18. In my opinion, neither
`
`221
`
`Sanofi Exhibit 2107 .228
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`Petitioner not Mr. Leinsing has explained how a POSA would have implemented a
`
`tooth like Steenfeldt-Jensen's saw tooth 91 at an end a groove on M0ller's dose(cid:173)
`
`setting drum 1 7.
`
`D.
`
`Neither Moller nor Steenfeldt-Jensen Teaches or Renders
`O
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