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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`————————————————
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`MYLAN PHARMACEUTICALS INC.,
`and PFIZER INC.,
`Petitioners,
`v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
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`————————————————
`Case IPR2018-01676
`Patent No. 8,603,044
`————————————————
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`PETITIONERS’ REPLY TO PATENT OWNER RESPONSE
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`Case IPR2018-01676
`Patent No. 8,603,044
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`I.
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`TABLE OF CONTENTS
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`Ground 1: Steenfeldt-Jensen Suggests Modification ........................................... 1
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`A.
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`B.
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`Steenfeldt-Jensen Teaches an Internally-Threaded Driver Tube ............... 2
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`A POSA Would Not Have Viewed Steenfeldt-Jensen’s Suggestion
`as Limited to the First Embodiment ........................................................... 3
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`1.
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`2.
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`Steenfeldt-Jensen Suggests Modification Outside the First
`Embodiment ..................................................................................... 4
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`A POSA Would Have Recognized the Suggestion Applied
`to the Fifth Embodiment .................................................................. 4
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`C.
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`Sanofi’s Arguments that a POSA Would Have Ignored Steenfeldt-
`Jensen’s Suggestion Are Fundamentally Flawed ....................................... 8
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`1.
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`2.
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`3.
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`Sanofi insists that a POSA would have ignored
`Steenfeldt-Jensen’s express instructions .......................................... 9
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`Flawed Premise .............................................................................. 10
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`Flawed Models ............................................................................... 11
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`D.
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`E.
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`Sanofi’s “Additional Problems” Would Arise Only if a POSA
`Were Deliberately Trying to Fail ............................................................. 16
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`Pen Injector Art Shows that POSAs Did Pursue Such Drive
`Mechanisms .............................................................................................. 17
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`II.
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`Ground 2: Møller in view of Steenfeldt-Jensen ................................................. 18
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`A.
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`B.
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`The references teach a drive sleeve .......................................................... 19
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`The references teach an externally-threaded dose-scale drum................. 21
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`1. Møller does not teach away from externally-threaded drive
`sleeves ............................................................................................ 21
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`2.
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`Sanofi’s motivation argument misapprehends Møller and is
`internally inconsistent .................................................................... 24
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`C.
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`D.
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`E.
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`The references teach an externally-threaded dose-dial sleeve
`engaging a main housing’s internal threading ......................................... 25
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`The references teach a clicker with a flexible arm and splines
`(claim 15) ................................................................................................. 26
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`The references teach a main housing with a helical rib seated in the
`dose-dial sleeve’s external groove (claim 19) .......................................... 27
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`III. Conclusion .......................................................................................................... 27
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`I.
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`INTRODUCTION
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`In its response, the patent owner (Sanofi) takes an excessively narrow reading
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`of what the references would mean to a person of ordinary skill in the art (POSA),
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`provides a flawed and biased analysis of the proposed modification using bases
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`deliberately shielded from review, and argues against the combination for reasons that
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`are internally inconsistent and at odds with real-world develops already in the record.
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`Claims 11, 14, 15, 18 and 19 should be held unpatentable for the reasons provided in
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`the petition and further developed below.
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`II. GROUND 1: STEENFELDT-JENSEN SUGGESTS MODIFICATION
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`Sanofi presents three arguments against modifying Steenfeldt-Jensen:
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`(1)
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`Steenfeldt-Jensen’s suggested alternate embodiments “where the piston
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`rod guide is provided in the wall 4 and a nut element is rotated by the driver” do not
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`suggest a threaded driver. POR 21-23.
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`(2) Any suggestion is for the first embodiment only. Id., 24-26.
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`(3) A POSA would not have followed Steenfeldt-Jensen’s suggestion
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`because modification would increase friction losses in the drive mechanism. Id., 26-
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`39.
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` Each argument fails.
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`A.
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`Steenfeldt-Jensen Teaches an Internally-Threaded Driver Tube
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`Sanofi sows confusion attempting to distinguish between a “nut member” (also
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`referred to as a “nut element”) rotated by the driver tube and the driver tube itself
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`having internal threading. POR, 21; EX2107, ¶215-22. The relevant disclosures in
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`context makes clear that a driver with a nut member is an internally-threaded driver.
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`A POSA would have understood Steenfeldt-Jensen as describing an internally-
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`threaded driver tube when it refers to a driver rotating a nut member. EX1095, ¶¶63-
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`64. Steenfeldt-Jensen describes two ways to configure the driver: a driver can rotate a
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`“piston rod guide” or a “nut member” (also referred to as a “nut element”). Pet., 53-
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`56; EX1014, 3:41-47. These alternative drivers correspond to the well-known
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`screw/nut principles that Dr. Slocum himself described in his background section.
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`EX2107, ¶30 (“Many pen injector designs…operate using screw and nut
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`mechanisms…. [A]xial motion can occur by causing the screw or the nut to rotate
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`while the other is prevented from rotating….”).
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`The depicted embodiments with the driver rotating a piston-rod guide show the
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`guide is not a separate component but simply the driver’s rectangular bore, which
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`prevents relative rotation. EX1095, ¶65; EX1014, 6:35-36 (driver tube 26 is “integral
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`with the piston rod guide”), 11:15-19 (piston rod’s not round cross-section “fits
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`through the driver tube bore which has a corresponding not round cross-section”,
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`transmitting rotation while allowing relative axial movement). Just as no meaningful
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`distinction exists between a driver tube with an integral piston-rod guide and a driver
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`tube with a rectangular bore, no meaningful distinction exists between a driver tube
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`with an integral nut member and a driver tube with a threaded bore. EX1095, ¶65.
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`Indeed, this is exactly how Steenfeldt-Jensen describes a “nut member”.
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`Regarding an embodiment where the driver includes the piston rod guide and the nut
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`member is fixed, Steenfeldt-Jensen states that “end wall 4 with its threaded bore forms
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`a nut member….” EX1014, 7:41-43. A POSA would have understood that a driver
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`tube with a threaded bore similarly operates as a nut member. EX1095, ¶65. Indeed,
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`Sanofi does not offer a single meaningful distinction between an internally-threaded
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`driver tube and a driver tube with an integral nut member for a simple reason: there is
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`none.
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`B. A POSA Would Not Have Viewed Steenfeldt-Jensen’s
`Suggestion as Limited to the First Embodiment
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`Sanofi’s argument that the disclosure at column 7, lines 41-47 applies only to
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`the first embodiment (POR, 24-26) fails for many reasons. As an initial matter,
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`Ground 1 is an obviousness ground, not anticipation. For an obviousness ground, a
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`POSA is capable of applying relevant teachings from one embodiment to those of
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`another embodiment. B.F. Goodrich Co. v. Aircraft Braking Sys., 72 F.3d 1577, 1583
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`(Fed. Cir. 1996) (affirming suggestion to modify found elsewhere in reference).
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`1.
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`Steenfeldt-Jensen Suggests Modification Outside the First
`Embodiment
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`Sanofi attempts to limit the modification to the first embodiment but ignores
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`other instances where the alternative driver mechanisms are discussed. Steenfeldt-
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`Jensen’s alternative driver configuration disclosure at column 7, lines 41-47 is one of
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`many such statements the petition cited. Pet. 53-54 (citing EX1014, 2:40-53, 3:10-20,
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`3:41-47). Indeed, Sanofi commented on these disclosures in the previous section of
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`its response. POR, 22. Sanofi’s focus on column 7 to urge that the modification only
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`applies to the first embodiment ignores the broader context of Steenfeldt-Jensen’s
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`disclosure, which suggests using alternative driver mechanisms generally before
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`turning to specific embodiments. EX1095, ¶66. A POSA is not so myopic. Id. In any
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`case, a POSA is not limited to the specific embodiments and can recognize and apply
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`teachings across embodiments. See KSR Int'l v. Teleflex Inc., 550 U.S. 398, 420 (2007)
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`(explaining a POSA “will be able to fit the teachings of multiple patents together like
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`pieces of a puzzle”).
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`2.
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`A POSA Would Have Recognized the Suggestion Applied to
`the Fifth Embodiment
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`A POSA would have understood the suggestion at column 7, lines 41-47 was
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`relevant to the fifth embodiment as well. EX1095, ¶¶67-69. First, as noted above,
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`Steenfeldt-Jensen discussed the same drive-mechanism alternatives in the general
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`description before reaching the first embodiment. EX1014, 2:40-53, 3:10-20, 3:41-47.
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`These sections explain Steenfeldt-Jensen’s invention generally, not a specific
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`description limited to one embodiment. EX1095, ¶66 (citing EX1014, 2:36-3:47). A
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`POSA would have read column 7, lines 41-47 in context and understood the described
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`alternative as an example of Steenfeldt-Jensen’s broader discussion of drive
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`mechanisms that can use rotating piston rod guides or rotating nut members. EX1095,
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`¶66.
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`In context, not repeating this general suggestion again the fifth embodiment did
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`not indicate Steenfeldt-Jensen had abandoned its previous suggestion. Steenfeldt-
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`Jensen frequently avoids redundant disclosures, relying on POSAs to recognize earlier
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`discussions apply to analogous aspects of later embodiments. EX1095, ¶67.
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`The relevant aspects of the drive mechanisms in the first and fifth embodiments
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`are analogous. Both have a scale drum that rotates up and out during dose setting and
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`rotates down and in during injection to rotate the driver tube. EX1095, ¶68 (citing
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`EX1014, 7:3-8, 7:17-21, 11:52-55, 12:4-10, FIGS. 3, 17). Both have driver tubes with
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`rectangular bores (i.e. piston rod guides) that rotate the piston rod.1 EX1095, ¶68
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`1 While the fifth embodiment does not expressly label a piston-rod guide, there is
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`no dispute that driver tube 85 has a rectangular bore that applies torque to and rotates
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`the piston rod while allowing the piston rod to move axially relative to the driver tube.
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`That is precisely what a “piston rod guide” is. EX1095, ¶68; EX1014, 2:48-49
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`(citing EX1014, 5:55-61, 6:35-37, 7:21-35, 7:41-43, 11:15-21, 12:10-13, FIGS. 2-3,
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`16-17). Both have threaded piston rods that rotate through the threaded bore of wall 4
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`during injection.2 In other words, while certain surrounding components may be
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`different, the driver tube (with a rectangular bore) and the nut member (i.e., a wall
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`with a threaded bore that does not rotate during injection) have analogous structures
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`and functions for driving the piston rod. EX1095, ¶68.
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`Given the analogous drive mechanisms, a POSA would have recognized that
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`Steenfeldt-Jensen’s suggested alternative configuration in the first embodiment also
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`applies to the fifth embodiment. EX1095, ¶69. That is, a POSA would have
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`recognized that the modifications to the driver tube (26 or 85) and wall 4 would have
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`(describing piston rod guide), 6:35-36 (driver tube 26 “integral” with piston rod guide
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`14), FIG. 2 (identifying piston rod guide 14 as portion of driver tube 26 with
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`rectangular bore abutting flat surfaces of piston rod).
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`2 While the first and fifth embodiments have different dose-setting processes (i.e.
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`the rotating ampoule holder vs. rotating the dose knob), wall 4 operates in the same
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`manner during injection (i.e. remaining fixed relative to the housing while the piston
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`rod rides down through the threaded bore). EX1095, ¶68 (citing EX1014, 5:55-61,
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`7:30-40).
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`been the same and had the same impact. Id. Accordingly, a POSA would have seen
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`no reason to limit Steenfeldt-Jensen’s express teachings to the first embodiment. Id.
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`Sanofi’s point that Steenfeldt-Jensen’s second embodiment cannot use this
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`modification is irrelevant: that drive mechanism is not analogous to the first and fifth
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`embodiments’ drive mechanism. In the latter embodiments, pressing the button back-
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`drives the scale drum, transmitting rotation to the driver tube, which rotates the piston
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`rod via the piston-rod guide on the driver tube. EX1095, ¶70 (citing EX1014, 7:3-6,
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`7:17-21, 11:52-55, 12:4-10). The second embodiment, however, does not have a
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`driver tube, so Sanofi’s comparison is irrelevant. EX1014, 7:51-54 (“Different from
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`the embodiment in FIG. 1-5 is the fact that…the driver tube 26 is omitted.”), FIGS. 6-
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`10. In the second embodiment, the button’s axial movement during injection directly
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`back-drives the piston rod via its second thread on enlargement 37. EX1095, ¶70
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`(citing EX1014, 7:55-67, 8:25-33, FIGS. 6-10). In other words, while the first and
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`fifth embodiments’ drive mechanisms have equivalent structure and operation for
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`injection, the second embodiment’s drive mechanism operates fundamentally
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`differently.
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`Dr. Slocum himself acknowledged these differences between the second-
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`embodiment drive mechanism and the first- and fifth-embodiment drive mechanisms.
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`Dr. Slocum agreed that the driver tubes in the first and fifth embodiments have “the
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`same engagement method” with the piston rod and apply torque in the same way.
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`EX1054, 306:23-307:19; see also id., 342:3-343:18 (agreeing that transmission of
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`force in first/fifth embodiments was “the same fundamental type of thing” and that
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`“driver tube 85…essentially is the same as 26”). He also agreed that the drive
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`mechanisms’ “force chain” was similar. Id., 307:20-308:9. He also agreed the second
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`embodiment’s drive mechanism did not share these similarities with the first and fifth
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`embodiments’ drive mechanisms. Id., 344:7-346:25. For example, he explained:
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`Well, embodiment 1, what you’re doing is you’re back driving a
`thread to rotate drive tube 26, which then rotates the piston [rod]. What
`embodiment 2 is doing is they are directly back driving the piston rod by
`the threaded connection between the button and that end 37 on the rods.
`So that’s why they’ve eliminated the driver tube 26.
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`Id., 346:18-25.
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`POSAs understand context. Given the admitted similarities between the first- and
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`fifth-embodiment drive mechanisms, a POSA would have recognized that the first-
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`embodiment configuration was applicable to the fifth embodiment despite the second
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`embodiment having its own, different drive mechanism. EX1095, ¶70.
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`C.
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`Sanofi’s Arguments that a POSA Would Have Ignored
`Steenfeldt-Jensen’s Suggestion Are Fundamentally Flawed
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`After failing to limit Steenfeldt-Jensen’s suggestion to the first embodiment,
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`Sanofi introduces an “analytical model” and a “physical model” (or “collar friction
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`model”) to argue that a POSA would have ignored Steenfeldt-Jensen’s suggestion
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`altogether. POR, 26-39. This argument has three critical flaws. First, Sanofi’s
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`position implies that a POSA would have disregarded Steenfeldt-Jensen’s express
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`instructions. Second, both models are premised on the incorrect assumption that
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`POSAs would have limited themselves to designing insulin injector pens. Third, both
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`models suffer from bias and numerous design flaws.
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`1.
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`Sanofi insists that a POSA would have ignored
`Steenfeldt-Jensen’s express instructions
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`First, Sanofi presents this argument as an attack on the modification’s
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`desirability in the fifth embodiment, but Dr. Slocum admitted that he was arguing
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`against modifying either the first or fifth embodiment. After he acknowledged
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`similarities between the first and fifth embodiments’ drive mechanisms (EX1054,
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`306:23-308:9), Dr. Slocum was asked to explain why a POSA would view Steenfeldt-
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`Jensen’s teaching—which he admitted applied to the first embodiment—as not
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`applying to the fifth embodiment. Id., 308:10-14. He clarified that he was not
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`suggesting modifying only the first embodiment and not the fifth; rather that a POSA
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`would not have modify either embodiment. Id., 308:15-313:6. He explained he
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`thought it was “a really stupid idea for the first one” and “a lawyer add-on” that a
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`POSA would have ignored. Id. 308:15-310:6. While Dr. Slocum is incorrect that a
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`POSA would have ignored Steenfeldt-Jensen’s explicit suggestion to use the
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`alternative driver tube—see the next two sections—at a minimum, his admission
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`undercuts Sanofi’s previous attempt to distinguish the first and fifth embodiments.
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`2.
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`Flawed Premise
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`Sanofi’s and Dr. Slocum’s argument that a POSA would reject a modification
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`causing any increase in friction stems from Sanofi’s flawed assumption that a POSA
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`would have been singularly focused on designing an insulin pen injector. POR 27-28.
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`The claims are not limited to insulin pens. The applied references are not
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`limited to insulin pens. Nevertheless, Dr. Slocum focused a POSA designing an
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`insulin pen for the specific needs of a diabetic patient. EX2107, ¶¶44-61 (detailing
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`diabetic comorbidities and corresponding design considerations); EX1053, 62:13-71:2
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`(discussing POSA). For example, during cross-examination he explained “a POSA
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`would read [these]…injector pen claims in the context of understanding that this is
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`going to be used by a diabetic person for injecting insulin.” Id., 63:20-24. He further
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`explained that “in general all diabetics have, with time, decreasing manual capabilities”
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`and that “a POSA would understand what the context of that claim is about. This is a
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`diabetic patient -- this is an insulin pen injector and that person will have
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`comorbidities….” Id., 69:1-71:2; see also id., 72:3-11 (“[T]he POSA understands
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`these claims are all in [the] context of an injector pen for insulin.”), 75:22-76:3
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`(admitting lack of knowledge that injector pens were used for medications other than
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`insulin). He thus mistakenly limited the POSA to designing a pen for diabetic patients,
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`leading him to limit the POSA’s design objectives to reducing injection force at all
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`costs to accommodate the particular needs of diabetic patients.
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`Even if a POSA were appropriately limited to concerns about diabetic patients,
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`a singular focus on injection force is misplaced. Injection force is a factor when
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`designing pen injectors, but not the only factor. EX1095, ¶72. Dr. Biggs explains
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`cost and reliability are key. EX1048, ¶¶28, 32. From the patient’s and the engineer’s
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`perspective, injection force is only thing (lesser) consideration, even for insulin pens.
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`Id., ¶¶29-30.
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`Even with this flawed premise, Sanofi never alleges that the petition’s
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`modification is unworkable or that a POSA would not have reasonably expected
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`success. This is not surprising, since the modification is so straightforward that its
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`workability was never in serious question. EX1095, ¶72.
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`3.
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`Flawed Models
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`Even if Sanofi were correct that a POSA would have avoided any change that
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`would increase friction, and therefore injection force, the analytical and physical
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`models have numerous problems.
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` Bias
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`First, the models are unreliable because they were primarily designed not by Dr.
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`Slocum, but by an inventor of the challenged patent. Dr. Slocum acknowledged at the
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`outset of his cross-examination that he “had not done…any design work
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`or…investigative studies of [injector pens]” (EX1053, 12:22-13:5) and “didn’t have
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`personal knowledge of the industry at the time of the invention” (id., 28:18-29:2).
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`Given his admitted lack of expertise with injector pens, he “wanted to talk to someone
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`who was clearly in the thick of it at the time.” Id. He turned to Robert Veasey, a
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`named inventor and therefore not a disinterested party. Id.; In re Newman, 782 F.2d
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`971, 974 (Fed. Cir. 1986) (ex parte tests entitled to little weight); cf. Apator Miitors
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`APS v. Kamstrup A/S, 887 F.3d 1293, 1295 (Fed. Cir. 2018) (noting risk of inventor
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`testimony being self-serving).
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`Incredibly, Dr. Slocum did not simply obtain background information from
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`Mr. Veasey, but actually allowed him to control many aspects of the analytical model.
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`See EX1054, 313:10-325:12. Repeatedly under questioning, Dr. Slocum revealed that
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`Mr. Veasey, not Dr. Slocum, made crucial decisions that skewed the tests’ outcomes.
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`For the analytical model, Dr. Slocum relied on Mr. Veasey to provide many
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`inputs for his spreadsheets that yielded the supposed 51% increase in friction. POR,
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`28-29; EX2107, ¶¶242-43. For example, Dr. Slocum admitted that he allowed Mr.
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`Veasey to set the friction coefficient to 0.1 despite admitting that lubricious plastics
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`can have a coefficient of 0.08 or lower. EX1054, 316:10-318:5 (“He said .1. That’s
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`why I used .1.”). Of fifteen unique variables in Dr. Slocum’s spreadsheet, Dr. Slocum
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`only set two himself. Id., 319:7-325:12. Dr. Slocum and Mr. Veasey jointly
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`determined two more, while Mr. Veasey alone set 11 of 15 variables. Id. Mr.
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`Leinsing explains that the choices made for these variables (e.g. the coefficient of
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`friction and the inner and outer diameters of the “collar”) have a significant impact on
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`the calculation, and the choices that were made in Mr. Veasey and Dr. Slocum
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`differed significantly from the approach of a POSA concerned about friction. EX1095,
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`¶73.
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`The physical model was similarly designed by Mr. Veasey (or others at
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`Mr. Veasey’s company, DCA Design International Ltd. (“DCA”)). Dr. Slocum
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`admitted that Mr. Veasey or DCA designed the rig that was used in the “collar friction”
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`tests. EX1053, 30:5-32:7. He also admitted that Mr. Veasey or DCA chose the
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`dimensions of the components tested on the rig. Id., 32:8-33:4. In accepting this
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`setup, Dr. Slocum relied on Mr. Veasey’s decision to use the FlexPen as a stand-in for
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`Steenfeldt-Jensen’s fifth embodiment. Id., 30:5-16 (“[Veasey] told me [that]
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`[Steenfeldt-Jensen’s] fifth embodiment closely corresponds to the disposable FlexPen.
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`I didn’t know that, but he knew that.”). Moreover, Dr. Slocum accepted Mr. Veasey’s
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`or DCA’s choice to use components (i.e. the collared sleeves) that were “much bigger,
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`obviously than an actual injector pen” because he thought the proportions were fair.
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`Id., 33:5-13. Mr. Leinsing explains, however, that actual collar size, not just its
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`proportions, significantly impacts the resulting friction. EX1095, ¶74.
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`Despite Mr. Veasey’s significant control over these models, Sanofi did not
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`present Mr. Veasey as a witness in this case, avoiding review for pivotal aspects of the
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`experiments. Additionally, Dr. Slocum could not answer deposition questions about
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`numerous aspects of the models he did not design, meaning he could not disclose key
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`facts or data underlying his opinions during cross-examination. 37 CFR §42.65(b).
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`Accordingly, both models are unreliable due to the bias—and absence—of their
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`ultimate designer. Because Sanofi did not offer Mr. Veasey as a witness, the results
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`reported based on the models are entitled to no weight.
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` Not testing total change in friction
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`The bias noted above may explain why the Veasey-Slocum models fail to
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`consider aspects of the modification that would reduce friction. Despite Dr. Slocum’s
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`acknowledgement that “a careful accounting of all the forces and motions of elements
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`in the structural loop” must be assessed (EX2107, ¶58), both models narrowly focus
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`on friction at one point in the system without accounting for other changes. EX1095,
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`¶75. For example, in the unmodified embodiment, the piston rod rotates during
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`injection, meaning pressure foot 9, which abuts the piston at the cartridge’s top end,
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`rotates against the piston rod’s bottom end while bearing the full injection force. Id.
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`This drag disappears in the modified embodiment, however, since the piston rod does
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`not rotate during injection. Id. The models thus only look at the aspect that adds
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`friction while ignoring other aspects that reduce friction.
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`Even within this misleading framing, the Veasey-Slocum models are skewed in
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`multiple respects to exaggerate frictional losses. First, the models fail to consider that
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`a POSA is “a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421.
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`Far from applying ordinary creativity, the Veasey-Slocum models avoided even the
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`most common-sense approaches to mitigating friction. EX1095, ¶¶73, 75. Mr.
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`Leinsing explains that Dr. Slocum failed to consider numerous friction-mitigation
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`strategies that would have occurred immediately to a POSA. EX1095, ¶75. For
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`example, both models assumed no lubrication despite Dr. Slocum’s admitted
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`recognition that this assumption increased the “percent increase in friction” result.
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`EX1054, 325:22-327:6 (admitting POSAs understood that lubricant would reduce
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`total increase in friction).
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`The pen characteristics used in the models are also suspect. As explained above,
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`a named inventor, Mr. Veasey, mostly selected those characteristics, not Dr. Slocum.
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`Supra, section II.C.3.a. Mr. Veasey purportedly supplied FlexPen parameters, which
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`Dr. Slocum simply assumed accurately represented Steenfeldt-Jensen’s fifth
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`embodiment. EX1053, 41:3-42:13. Again, even if it were somehow appropriate to
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`use FlexPen dimensions as a stand-in, Dr. Slocum still failed to consider net friction
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`for the full device and deliberately refrained from applying a POSA’s ordinary
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`creativity. The “collar friction” model also used components (i.e. the collared sleeve)
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`that were admittedly “much bigger, obviously, than an actual pen injector”, despite the
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`fact that this “obvious” discrepancy would increase the amount of friction in the
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`modified embodiment. Id., 33:5-13; EX1095, ¶74.
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`On closer inspection, the models designed primarily by Mr. Veasey apparently
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`were deliberately designed to exaggerate the collar friction’s impact in Steenfeldt-
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`Jensen’s alternate embodiment. A POSA applies ordinary creativity to achieve
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`success, not deliberate failure, so these experiments are entitled to no weight.
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`D.
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`Sanofi’s “Additional Problems” Would Arise Only if a POSA
`Were Deliberately Trying to Fail
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`Sanofi’s purported “additional problems” provide yet another example that
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`Sanofi is not applying the POSA’s perspective. Sanofi argues that if the drive-tube
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`flange, which includes a pawl mechanism, were subjected to additional force in the
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`modified embodiment, it could break in several ways. POR 38-39. In particular, the
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`pawl mechanism’s “flexible arms” allegedly might break, get stuck, or push through
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`an opening in the wall above. Id.; EX2107, ¶¶239-41. Again, Sanofi approaches the
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`modification as if straightforward tasks would stump a POSA. Even if the pawl
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`mechanism’s operation would be affected at all—and Sanofi offers no evidence that it
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`would be—Mr. Leinsing explains that this would be the type of routine task that a
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`POSA would have no difficultly addressing. EX1095, ¶76 (explaining, for example,
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`use of a collar as the bearing surface).
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`E.
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`Pen Injector Art Shows that POSAs Did Pursue Such Drive
`Mechanisms
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`The choices actual pen-injector designers made is the final blow for Sanofi’s
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`argument that a POSA would not have considered following Steenfeldt-Jensen’s
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`suggestion to implement the driver tube as a rotating nut member relative to a non-
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`rotating piston rod guide. A reference used in a related IPR shows that POSAs did
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`design pens with the type of drive mechanism suggested by Steenfeldt-Jensen.
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`EX1095, ¶77.
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`Giambattista (applied in IPR2018-01680) has an internally-threaded driver tube
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`that is, in relevant part, analogous to Steenfeldt-Jensen’s modified driver tube.
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`EX1095, ¶77. As in Steenfeldt-Jensen, the driver rotates during injection and has a
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`flange (snap ring 64) at its distal end that is secured against the housing:
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`EX1016, FIG. 5; see also id., 3:16-26 (snap ring 64 fixes driver axially relative to
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`housing); FIGS. 2-3, 6-7. As in the modified Steenfeldt-Jensen, Giambattista’s driver
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`24 has an internal thread that engages the piston rod, and the piston rod is prevented
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`from rotating by its engagement with rectangular aperture 26 in bulkhead 44 (i.e. what
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`Steenfeldt-Jensen would call a piston rod guide). Id., 3:1-26. Mr. Leinsing explains
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`that Giambattista would experience “collar friction” in a manner analogous to
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`Steenfeldt-Jensen as modified. EX1095, ¶77.
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`Sanofi’s argument betrays Dr. Slocum’s lack of qualifications. He asserts that
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`Steenfeldt-Jensen’s suggestion of a “rotating nut” driver tube and a non-rotating
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`piston rod guide were “stupid”, a type of “glib sentence[] added that makes no sense”
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`and that a POSA “would never actually do” (EX1054, 308:10-310:22), actual pen
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`designers, yet a reference on which he opines in another IPR actually did pursue this
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`approach. The record shows that, unlike the approach evident in Sanofi’s models,
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`those of ordinary skill in the art apply routine creativity with success.
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`III. GROUND 2: MØLLER IN VIEW OF STEENFELDT-JENSEN
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`Sanofi defends the independent claims with two main arguments:
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`(1) Møller does not teach a drive “sleeve” because the driver’s top portion in
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`the first embodiment includes “bars” that are not tubular, and the driver of the second
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`embodiment—which Sanofi does not dispute is a sleeve—is structurally and
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`functionally different from the first driver. POR, 47-56.
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`(2) A POSA would not have modified Møller to have an externally-threaded
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`dose-dial sleeve. Id., 56-63.
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`Sanofi also argues that a POSA would not have reason to provide a clicker with
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`a flexible arm and a spline as dependent claim 15 recites. Id., 64-65.
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`Each of these arguments lacks merit.
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`A. The references teach a drive sleeve
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`Sanofi does not dispute that Møller’s second embodiment discloses a drive
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`sleeve, arguing only that the first embodiment’s bar/nut implementation is not a sleeve
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`and that the second embodiment’s sleeve would interfere with the device’s operation.
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`POR 47-56. This argument ignores the first driver’s actual structure and exaggerates
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`the differences between the embodiments.
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`Møller’s first and second embodiments include analogous drive mechanisms,
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`with “corresponding … elements … given the same reference … with a prefixed ‘1’.”
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`EX1015, ¶35; EX1095, ¶94. In both embodiments, the driver (connection bars 12 and
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`nut 13, tubular connection element 112 and nut 113) is connected to a gear-wheel
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`assembly (gear wheels 14/16, 114) engaging two racks: the first rack (rack 15, 115)
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`indirectly attached to the button, the second (rack 10, 110) attached to the gearbox
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`(gearbox 9, 109). EX1015, ¶¶24, 39-40; EX1095, ¶95. In both embodiments, the
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`driver rotates and rides up the piston rod during dose-setting and pushes straight down
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`during injection (carrying the piston rod with it). EX1015, ¶¶24, 30-32, 40; EX1095,
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`¶95. In both embodiments, axial movement of the button, and therefore the first rack,
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`Case IPR2018-0167
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