`9197/20”
`
`of“
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC,
`Petitioner,
`
`V.
`
`SANOFl-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner
`
`
`
`Case No.
`
`1P'R2018-01670
`
`Case No.
`Case No.
`
`Case No‘
`
`Case No.
`Case No.
`
`Case No.
`
`IPR2018-01675
`
`IPR2018-01676
`IPR2018-01678
`
`IPR2018-01679
`
`IPR2018-01680
`IPR2018-01682
`
`Case No.
`
`IPR2018- 01684
`
`Case No.
`
`IPR2019- 00122
`
`U. S Patent No. 8 603 ,044
`U. S Patent No. 8,679,069
`US. Patent No. 8,992,486
`
`US. Patent No. 9,526,844
`
`US. Patent No. 9,604,008
`
`DECLARATION OF ALEXANDER SLOCUM, 'PH.D. IN SUPPORT OF
`PATENT OWNER RESPONSES
`
`WEIL:\97083094\5\71937.012 7
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`
`
`Sanofi Exhibit 2107.001
`
`Mylan v. Sanofi
`lPR2018-01680
`
`Mylan Ex. 1050
`
`Mylan V. Sanofi - IPR2018-01676
`
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01676
`
`
`
`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 and a log, to separate itD/s/
`mof'C
`Most people also know that the distance the wedge moves in is/Less than the
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`distance it makes the object move up. This is a result of the conservation of
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`energy:
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`the product of an applied force with the distance over which it is applied
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`(times the efficiency of the system, which is governed by friction) will equal the
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`product of the resulting output force over the distance which it acts. The wedge is
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`a simple transmission that makes life easier for people by helping them amplify the
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`small forces they create with their body in order to do useful work. The same is
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`true with screws and nuts, which are essentially rotary wedges.
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`32. As mentioned above, in a screw-nut system the application of torque
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`to either a screw or a nut can cause one of the two to move axially, depending on
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`which component is axially fixed and which is rotationally fixed. The application
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`of axial force to one of the components, however, may or may not impart rotation
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`to the other component depending on the circumstances. For example, most
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`people know that if they were to push down on the nut instead of rotating it, the nut
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`will not move. This is because of a small thread angle and high friction.
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`In this
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`case, the threads act as self-locking wedges, and, which is the case where if the
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`wedge angle is small, typically less than 15 degrees, the wedge will not dislodge
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`itself once the user stops applying force to push it in to pry apart objects.
`
`Sanofi Exhibit 2107.019
`
`Mylan v. Sanofi
`|PR2018-01680
`
`Mylan Ex. 1050
`
`Mylan v. Sanofi - IPRZOl 8—01676
`
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01676
`
`
`
`39. Hence a key fundamental goal for injector pens is to keep the axial
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`forces passing through rotating elements as close to the central longitudinal axis of
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`the pen‘as possible to minimize frictional torques and maximize efficiency.
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`4.
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`Screw-Nut Systems in Pen Injector Design
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`40.
`
`Back to the principle of conservation of energy: The amount of
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`insulin injected is very small and so the piston that moves in the ampoule must
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`only move a short distance. See, cg, Ex. 1015, ‘H 0004. However, the needle must
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`slip easily into the skin and with minimal pain so it needs to be a very small
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`96/
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`diameter. See, e.g., Ex. 1015, 11 0005. The resistance to fluid flow through the
`
`‘
`_
`,
`)
`Avast»,
`needle lfiproportional to the needle s Internal diameter to the fourth power, hence
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`very large forces must be applied to the piston, albeit for a very short distance, to
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`quickly force out
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`the medicament.
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`Because the user can only apply a
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`comparatively modest force, injector pen designers must create a transmission
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`inside the pen to amplify the user’s applied force (i.e., a gearing to create a
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`mechanical advantage), which means the user must apply the force over a greater
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`distance than the piston moves as it pushes out the fluid from the ampoule.
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`41. Due to the nature of their disease process, diabetics have been found
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`to have decreased grip and pinch strength, and are also at risk for development of
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`compression neuropathies that further affect grip strength and hand function (i.e.
`
`.
`
`i
`‘
`
`I
`
`16
`
`Sanofi Exhibit 2107.023
`Mylan v. Sanofi
`lPR2018-O1680
`Mylan Ex. 1050
`Mylan v. Sanofi - IPR201 8—01676
`
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01676
`
`
`
`
`
` 163
`
`Sanofi Exhibit 2107.170
`
`Mylan v. Sanofi
`IPR2018-01680
`
`Mylan EX.1050
`
`Mylan V. Sanofi - IPR2018-01676
`
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01676
`
`
`
`82
`
`85 /oi§fwbg 1‘.“3
`
`124.
`
`In my opinion, a POSA would have understood that the 486 Patent
`
`describes an example of claim 56,
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`including “an interior of a. flange,” in its
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`depicted embodiment. Specifically, the 486 Patent describes a clutch means 60
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`0\
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`(blue) that includes, at its “second end 64” (or button-end), a “radially inwardly <6
`r9
`directed flange 62” (yellow). See Ex. 1003, 4:54-55.
`Q3 \3‘
`I
`my? in
`
` ‘11-'33:
`
`Ex. 1003, Fig. 1 (annotated)
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`With respect to another figure (Figure 8) illustrating the depicted embodiment,
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`which also shows more detail,8 the 486 Patent describes that a series of dog teeth
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`8 We know that both figures 5 and 8 are depicting the same embodiment. See, eig,
`
`Ex: 1003, 2:5 8-59 (“FIG 3 shows a sectional View of the pen-type injector of FIG.
`
`75
`
`Sanofi Exhibit 2107.082
`
`Mylan v. Sanofi
`IPR2018-01680
`
`Mylan Ex. 1050
`
`Mylan V. Sanofi - IPR2018-01676
`
`Mylan Ex.1050
`Mylan v. Sanofi - IPR2018-01676
`
`