`
`'
`
`|
`
`'
`
`4
`
`UNITED STATES PATENT AND TRADEMARKOFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`Vv.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner
`
`
`
`Case No. IPR2018-01670
`Case No. IPR2018-01675
`Case No. IPR2018-01676
`Case No. IPR2018-01678
`Case No. IPR2018-01679
`Case No. IPR2018-01680
`Case No. IPR2018-01682
`Case No. IPR2018-01684
`Case No. IPR2019-00122
`U.S. Patent No. 8,603,044
`US. Patent No. 8,679,069
`USS. Patent No. 8,992,486
`U.S. Patent No. 9,526,844
`U.S. Patent No. 9,604,008
`
`DECLARATION OF ALEXANDER SLOCUM,PH.D. IN SUPPORT OF
`PATENT OWNER RESPONSES
`
`WEILA9708309415\71937.0127
`
`
`
`Sanofi Exhibit 2107.001
`Mylan v. Sanofi
`IPR2018-01680
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01675
`
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`example, a wedge can be driven between two objects to lift one away from the
`
`other or driven into an object, as is the case with an axe anda log,to separate it a-
`molt
`(y
`Most people also knowthat the distance the wedge movesin isJeSs than the
`
`distance it makes the object move up. This is a result of the conservation of
`
`energy:
`
`the product of an applied force with the distance over whichit is applied
`
`(times the efficiency of the system, which is governed byfriction) will equal the
`
`productof the resulting output force over the distance whichit acts. The wedgeis
`
`a simple transmission that makes life easier for people by helping them amplify the
`
`small forces they create with their body in order to do useful work. The sameis
`
`true with screws and nuts, which are essentially rotary wedges.
`
`32. As mentioned above, in a screw-nut system the application of torque
`
`to either a screw or a nut can cause one ofthe two to moveaxially, depending on
`
`which componentis axially fixed and whichis rotationally fixed. The application
`
`of axial force to one of the components, however, may or may not impart rotation
`
`to the other component depending on the circumstances. For example, most
`
`people know that if they were to push down on the nut instead ofrotating it, the nut
`
`will not move. This is because of a small thread angle and high friction.
`
`In this
`
`case, the threads act as self-locking wedges, and, which is the case where if the
`
`wedge angle is small, typically less than 15 degrees, the wedge will not dislodge
`
`itself once the user stops applying force to pushit in to pry apart objects.
`
`Sanofi Exhibit 2107.019
`Mylanv. Sanofi
`IPR2018-01680
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01675
`
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`39. Hence a key fundamental goal for injector pens is to keep the axial
`
`forces passing through rotating elements as closeto the central longitudinal axis of
`
`the pen as possible to minimizefrictional torques and maximizeefficiency.
`
`4,
`
`Screw-Nut Systems in Pen Injector Design
`
`40.
`
`Back to the principle of conservation of energy: The amount of
`
`insulin injected is very small and so the piston that moves in the ampoule must
`
`only move a short distance. See, ¢.g., Ex. 1015, § 0004. However, the needle must
`
`slip easily into the skin and with minimal pain so it needs to be a very small
`
`diameter. See, e.g, Ex. 1015, J 0005. The resistance to fluid flow through the
`Mvels,
`
`needle Is{Proportional to the needle’s internal diameter to the fourth power; hence
`very large forces must be applied to the piston, albeit for a very short distance, to
`
`quickly force out
`
`the medicament.
`
`Because the user can only apply a
`
`comparatively modest force, injector pen designers must create a transmission
`
`inside the pen to amplify the user’s applied force (i.e., a gearing to create a
`
`mechanical advantage), which means the user must apply the force over a greater
`
`distance than the piston movesas it pushesout the fluid from the ampoule.
`
`41.
`
`Dueto the nature of their disease process, diabetics have been found
`
`to have decreased grip and pinch strength, and are also at risk for development of
`
`compression neuropathies that further affect grip strength and hand function (ie.
`
`16
`
`Sanofi Exhibit 2107.023
`Mylan v. Sanofi
`IPR2018-01680
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01675
`
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`
`
`
`
`163
`
`Sanofi Exhibit 2107.170
`Mylan v. Sanofi
`IPR2018-01680
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01675
`
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`124.
`
`In my opinion, a POSA would have understood that the 486 Patent
`
`describes an example of claim 56,
`
`including “an interior of a flange,” in its
`
`depicted embodiment. Specifically, the 486 Patent describes a clutch means 60
`
`xv
`(blue) that includes, at its “second end 64” (or button-end), a “radially inwardly
`ee
`directed flange 62” (yellow). See Ex. 1003, 4:54-55.
`82~
`85
`awa
`
`AS:hieis,
`
`aa
`
`
`Ex. 1003, Fig. 1 (annotated)
`
`With respect to another figure (Figure 8) illustrating the depicted embodiment,
`
`which also shows more detail,® the 486 Patent describes that a series of dog teeth
`
`® We knowthat both figures 5 and 8 are depicting the same embodiment. See, é.g.,
`
`Ex! 1003, 2:58-59 (“FIG. 3 shows a sectional viewof the pen-type injector of FIG.
`
`75
`
`Sanofi Exhibit 2107.082
`Mylan v. Sanofi
`IPR2018-01680
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01675
`
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01675
`
`