Attorney Docket No.: 5472.003-US
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`FILING UNDER 37 C.F.R. §1.53(c)
`
`Assistant Commissioner for Patents
`Washington, DC 20231
`
`Express Mail Label No. EL021373705US
`Date of Deposit February 5, 1998
`
`Sir:
`
`This is a request for filing a provisional application under 37 C.F.R §1.53(c),
`
`of the inventors:
`
`Steenfeldt-Jensen, S0ren, a citizen of Denmark, residing at Holmevrenget 2B,
`
`DK-3100 Hombrek; and
`
`Hansen, Steffen, a citizen of Denmark, residing at GI. Frederiksborgvej 64A,
`
`DK-3400 Hillernd, Denmark for application entitled An Injection Syringe.
`The provisional application contains:
`
`15 pages of specification
`i sheets of drawings
`Address all future communications to Steve T. Zelson, Esq., Novo Nordisk of
`
`North America, Inc., 405 Lexington Avenue, Suite 6400, New York, NY 10174-6401.
`
`Please charge the required fee, estimated to be $150, to Novo Nordisk of North
`
`America, Inc., Deposit Account No. 14-1447. A duplicate of this sheet is enclosed.
`
`Date: February 5, 1998
`
`Respectfully submitted,
`
`ris, Reg. No. 33,728
`Novo Nordisk of North America, Inc.
`405 Lexington Avenue, Suite 6400
`New York, NY 10174-6401
`(212) 867-0123
`
`Sanofi Exhibit 2127.001
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`An injection syringe
`
`1
`
`The invention relates to injection syringes of the kind apportioning set doses of a medicine
`
`from a cartridge containing an amount of medicine sufficient for the preparation of a number
`
`5
`
`of therapeutic doses.
`
`Such syringes are mainly made for users who have to inject themselves frequently, e.g.
`
`diabetics. A number of demands are set to such syringes. The setting of a dose must be
`
`easy an unambiguous and it must be easy to read the set dose. It must be possible with a
`1 o minimum of trouble to cancel or change a wrongly set dose and when the dose is injected
`the dose setting must return to zero . When a disposable syringe is in question, i.e. a syringe
`
`which is disposed of when the cartridge is empty, the syringe must further be cheap and
`
`made of materials suited for recycling or burning without producing noxious gases. For these
`
`purposes the number of parts from which the syringe is constructed and the number of dif-
`
`15
`
`ferent kinds of materials used in the syringe should be kept at a minimum.
`
`Most dose setting devices work with a threaded piston rod co-operating with a nut where the
`
`nut and the piston rod may be rotated relative to each other. The dose setting may be ob(cid:173)
`
`tained by screwing the nut away from a stop to which it is returned during the injection by
`
`20
`
`pressing the piston rod until the nut member abuts the stop. By other dose setting devices
`
`one of the elements, the nut or the piston rod, is kept inrotatable and the other is allowed to
`
`rotate a set angle depending on the set dose, whereby the piston rod is screwed a distance
`
`through the nut.
`
`25
`
`In most syringes for apportioning set doses it is preferred that the piston rod is backing up
`
`the piston upon which it works during the injection. To obtain this precaution is taken to pre(cid:173)
`
`vent the piston rod from moving in a proximal direction.
`
`The syringe according to EP 327 910 is of the type wherein a nut is screwed away from a
`
`30
`
`stop. During the setting of the dose the screwing may be performed in both direction so that
`
`a too large set dose may be lowered just by rotating the nut in an opposite direction. Means
`
`are provided preventing that negative doses are set. The mutual rotation of the piston rod
`
`and the nut is obtained by rotating a cap relative to the pen housing and a set dose may be
`
`54 72. 000-DK, EiT/PGy
`
`Sanofi Exhibit 2127.002
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`2
`
`read on a scale and a pointer provided at adjacent edges of the housing and the cap, these
`
`edges being so shaped that the cap can only be mounted firmly on the housing when the
`
`pointer points zero on the scale. It may be seen as a weak point that doses larger than the
`
`one obtained by rotating the parts 360° must be calculated by adding the number pointed at
`
`5
`
`on the scale and a number printed on the side of a tubular extension of the nut which is
`
`moved out from the proximal end of the housing proportionally with the dose set and which
`
`tubular extension is closed at its proximal end to form an injection button.
`
`In EP 450 905 the above drawback is overcome by writing the numbers along a helical line
`
`1 o
`
`on a tubular extension of the nut so that these number may successively be seen in a win(cid:173)
`
`dow in a housing element enclosing said tubular extension. Hereby the size of the dose is
`
`indicated unambiguously but the user have to remember to set the dose setting device on
`
`zero before the next setting of a dose is performed. If this is forgotten a wrong dose may be
`
`set and the number may not be seen clearly in the window.
`
`15
`
`In EP 608 343 is described a pen having a dose setting mechanism wherein the dose is set
`
`by rotating a button relative to a housing to set a dose. By the rotation the button is screwed
`
`up from the end of the housing in a thread having a pitch so large that the thread connection
`
`is not self blocking, i. e. when the button is presses back to the end of the housing it will ro-
`
`20
`
`tate back in the thread. The button is through a ratchet coupled to a driver, the ratchet form(cid:173)
`
`ing a unidirectional coupling which during the rotation of the button in one direction to set a
`
`dose rides or clicks over the teeth of the ratchet. The cylindrical side of the button carries
`
`numbers which shows the size of the set dose in a window when the button is screwed out(cid:173)
`
`ward. When the button is screwed back the unidirectional coupling will transmit the rotation
`
`25
`
`to the driver which has a nut co-operating with a threaded piston rod which is made inro(cid:173)
`
`tatable in a housing. This thread connection has a pitch which makes the nut self locking on
`
`the piston rod. A set dose may be cancelled by drawing the engaging parts of the ratchet out
`
`of engagement against the force of a spring so that the rotation of the button is not trans(cid:173)
`
`mitted to the driver and then press the button back to the housing . This pen fulfils all the
`
`30
`
`objects mentioned only the dose cancelling procedure is a little troublesome as the dose set
`
`button cannot as it will come most naturally just be screwed back if a too large dose is set.
`
`Concomitantly forcing the coupling parts apart against the force of the spring and pressing or
`
`5472.000-DK,EiT/PGy
`
`Sanofi Exhibit 2127.003
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`3
`
`screwing the button back may be a little difficult and the demand for a spring necessitates
`
`use of metal parts in the syringe.
`
`It is an object of the invention to provide a syringe which has the mentioned advantageous
`
`5
`
`features without having the drawbacks known from existing syringes.
`
`This is obtained by an injection syringes for apportioning set doses of a medicine from a
`
`cartridge containing an amount of medicine sufficient for the preparation of a number of
`
`therapeutic doses, comprising
`
`10
`
`a housing
`
`a piston rod having a not circular cross-section and an outer thread
`
`15
`
`a piston rod drive comprising two elements
`
`a)
`
`a piston rod guide in relation to which the piston rod is axially displaceable but not
`
`rotatable, and
`
`20
`
`a nut member which is rotatable but not axially displaceable in the housing and
`
`b)
`which has an inner thread mating the thread of the piston rod to form a self locking thread
`
`connection,
`
`a dose setting mechanism comprising a not self locking thread connection along which an
`
`25
`
`injection button by rotation of a dose setting element relative to said housing is screwed out
`
`from the proximal end of the housing to project from this proximal end a distance deter(cid:173)
`
`mined by the angle of said rotation and which thread connection by axial returning of the in(cid:173)
`
`jection button transforms this axial movement to a rotation of one of the piston drive ele(cid:173)
`
`ments relative to the other,
`
`30
`
`which syringe according to the invention ischaracterised in that
`
`5472.000-DK,EiT/PGy
`
`Sanofi Exhibit 2127.004
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`4
`
`a unidirectional coupling is provided between the nut member and the piston rod guide al(cid:173)
`
`lowing rotation of these parts relative to each other in one direction but not in the opposite
`
`direction, the allowed rotation being one by which the piston rod is transported in a distal di(cid:173)
`
`rection in the syringe, the coupling being so designed that a set initial reluctance has to be
`
`5
`
`overcome before the rotation takes place.
`
`During the setting of a dose a torque is exerted on the unidirectional coupling in the direction
`
`in which this coupling allows rotation after a set initial reluctance has been overcome. As this
`
`torque is a weak one resulting when the male and the female part of a not self locking thread
`
`connection is rotated relative to each other the initial reluctance can be made large enough
`
`10
`
`to allow this rotation without causing any relative rotation of the parts in the coupling.
`
`When the injection button is pressed the movement of this button is transformed into a rota(cid:173)
`
`tion of the piston rod (or the nut member) relative to the nut member (or the piston rod).
`
`When the button is pressed hard enough the initial reluctans is overcome so that the two
`
`15
`
`elements, the piston rod and the nut member, are rotated relative to each other.
`
`According to the invention a click coupling providing an moderate resistance against rotation
`
`is established between the housing and the element rotated relative to the housing to set a
`
`dose. Hereby it is ensured that the position corresponding to a set dose is maintained and is
`
`20
`
`not inadvertently altered. The clicks may be taken as an audible signal indicating the size of
`
`the set dose.
`
`The unidirectional coupling may be a coupling comprising a pawl sliding over a pawl wheel
`
`with teeth having a steep front edge and a ramp shaped trailing edge, and the initial reluc-
`
`25
`
`tance may be obtained by the fact that the trailing edges of the pawl wheel teeth has a de(cid:173)
`
`pression engaged by a mating protrusion on the pawl.
`
`A dose scale drum which has in its surface a helical track engaged by a helical rib on the
`
`inner side of the housing to form a not self locking thread connection between the housing
`
`30
`
`and the drum may be coupled to the injection button to be moved axially with this button.
`
`This way the dose scale drum will be rotated relative to the housing when it is axially dis(cid:173)
`
`placed with the injection button in said housing.
`
`5472.000-DK,EiT/PGy
`
`Sanofi Exhibit 2127.005
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`5
`
`The thread connection by which the injection button is screwed out from the housing by set(cid:173)
`
`ting a dose may be the thread connection between the dose scale drum and the housing. In
`
`this case the dose scale drum must be coupled to a driver rotating the piston rod (or the nut
`
`member) relative to the nut member (or the piston rod) when the injection button is pressed.
`
`5
`
`A dose is set by rotating an element relative to the housing, and this element may be an
`
`element carrying the nut member and the unidirectional coupling so that the rotation is
`
`transmitted through said unidirectional coupling to the dose setting drum. The rotation
`
`transmitted is in the direction in which the coupling can run free when an initial reluctance is
`
`1 o
`
`overcome. However, the force needed to screw the dose scale drum up along its thread is
`
`not large enough to overcome said reluctance and consequently the rotation is transmitted
`
`through the coupling.
`
`In one embodiment of the syringe according to the invention the element rotated relative to
`
`15
`
`the housing may be a part carrying the nut member and the unidirectional coupling through
`which the rotation is transmitted to the dose setting drum.
`
`In another embodiment of the syringe according to the invention the element rotated relative
`
`to the housing may be the injection button and the not self locking thread connection which
`
`20
`
`determines the lifting of the injection button may be an inner thread in a bore in the injection
`
`butt on engaging an outer thread on an enlargement of the piston rod. When the injection
`
`button is screwed up along the piston rod to project from the housing a torque is exerted on
`
`the piston rod trying to rotate this piston rod in a direction which will move it in a distal direc(cid:173)
`
`tion in the syringe. Such a rotation is just the rotation which is allowed by the uniderectional
`
`25
`
`coupling which blocks rotation in the opposite direction. Due to the initial reluctance against
`
`rotation of the coupling parts relative to each other the piston rod will not be rotated when the
`
`injection button is screwed up along it in a proximal direction in the syringe. If the injection
`
`button is screwed in the opposite direction the unidirectional coupling will definitively block a
`
`relative rotation of the piston rod and the nut member in the direction which would draw the
`
`30
`
`piston rod in a proximal direction.
`
`In the last mentioned embodiment of the injection syringe the dose scale drum may be
`
`mounted rotateable but not axially displaceable on the injection button. When the dose scale
`
`54 72.000-DK,EiT/PGy
`
`Sanofi Exhibit 2127.006
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`6
`
`drum is moved with the injection button in the axial direction of the syringe the drum will be
`
`rotated due to the not self locking thread connection between said drum and the housing so
`
`that a number on the drum corresponding to the set dose is visible in a window provided in
`
`the wall of the housing. In this embodiment the pitch of the dose drum thread need not be
`
`5
`
`identical with the pitch of the thread along which the injection button is screwed to set a
`
`dose, only both thread connections must have a pitch large enough to make the thread con(cid:173)
`
`nection the not self locking type, i.e. of the type by which an axial movement can be trans(cid:173)
`
`formed into a rotation.
`
`1 o
`
`In an appropriate embodiment of the syringe according to the invention the dose scale drum
`
`is mounted rotatable but not axially displaceable on the injection button.
`
`During the injection the injection button must be kept inrotatable but axially displaceable
`
`relative to the housing in the angular position to which the injection button is rotated during
`
`15
`
`the setting of a dose. This may be obtained by letting the click coupling between the housing
`
`and the injection button comprise protrusions on one part engaging axial grooves in the
`
`other. When the injection button is pressed home into the housing the internal thread in the
`
`bore of this button will act on the engaging outer thread on the enlargement at the end of the
`
`piston rod and convert the axial movement of the injection button to a rotational movement of
`
`20
`
`the piston rod in a direction by which the piston rod is screwed through the nut member in a
`
`distal direction in the syringe. The piston rod guide which is connected to one part of the uni(cid:173)
`
`directional coupling is allowed to rotate when the initial reluctance against rotation in the di(cid:173)
`
`rection else allowed by the coupling is overcome. Also a rotational movement of the dose
`
`scale drum is induced by the axial movement of the injection button so that the scale is re-
`
`25
`
`turned to its zero position when the button is pressed home. When rotation of the dose
`
`scale drum and the piston rod is induced by the axial movement of the injection button this
`
`button is reacted upon by a torque which must be taken up by the click connection between
`
`the injection button and the housing which connection must consequently be strong enough
`
`to absorb this force without rotating.
`
`30
`
`In the following the invention is described in further details with references to the drawing,
`
`wherein
`
`5472.000-DK,EiT/PGy
`
`Sanofi Exhibit 2127.007
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`7
`
`Figure 1
`
`shows a front view of an embodiment of an injection syringe according to
`
`the invention,
`
`Figure 2
`
`shows a sectional view along the line 11-11 in figure 1,
`
`5
`
`Figure 3
`
`shows in a reduced scale an exploded view of the syringe in figure 1,
`
`Figure 4
`
`shows a sectional view along the line IV-IV in figure 1,
`
`10
`
`Figure 5
`
`shows a sectional view along the line V-V in figure 1,
`
`Figure 6
`
`shows a front view of another embodiment of an syringe according to the
`
`invention,
`
`15
`
`Figure 7
`
`shows a sectional view along the line VII-VII in figure 6,
`
`Figure 8
`
`shows i a reduced scale an exploded view of the syringe in figure 6,
`
`Figure 9
`
`shows a sectional view along the line IX-IX in figure 6, and
`
`20
`
`Figure 10
`
`shows a sectional view along the line X-X in figure 6.
`
`Initially it may be convenient to define that in this application directions of rotation are always
`
`seen from the proximal end of the pen and designed as clockwise or anticlockwise seen in
`
`25
`
`this direction.
`
`Figure 1 shows an injection syringe of the kind by which a liquid from an ampoule can be
`
`apportioned in a number of individually set does. Figure 3 shows an exploded view of this
`syringe and the figures 2, 4 and 5 sectional views taken along different lines in figure 1.
`
`30
`
`The syringe comprise a tubular housing 1 which is by a partition 15 divided into a first and a
`
`second division into the first one of which an ampoule holder 2 is snapped by a snap lock
`
`comprising a ring shaped bead 3 on the ampoule holder 2 which bead is snapped into a cor-
`
`5472.000-DK,EiT/PGy
`
`Sanofi Exhibit 2127.008
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`8
`
`responding circumferantial grove in the inner wall of the housing 1 near an open end thereof.
`
`By this snap connection the ampoule holder 2 is secured in the housing 1 so that it can be
`
`rotated but not axially displaced relative to this housing.
`
`5
`
`In the syringe ready for use an ampoule is mounted in the ampoule holder which is then at
`
`its distal end closed by an end wall provided with a needle hub receiving part onto which a
`
`needle hub can be mounted having a needle with one end communicating with the content of
`
`the ampoule and the other end free to be inserted into a patient. In the shown syringe, how(cid:173)
`
`ever, neither ampoule, end wall nor needle hub are shown.
`
`10
`
`The end of the ampoule holder 2 inserted in the housing 1 is closed by a wall 4 having a
`
`central bore with an internal thread 5. A piston rod 6 having an external thread 7 mating the
`
`thread 5 of said bore extends through said bore. The threads are so designed that a clock(cid:173)
`
`wise rotation of the piston rod will drive this rod into an ampoule accommodating compart-
`
`15 ment 8 in the first division of the housing 1. At its end projecting into the compartment 8 the
`
`piston rod 6 is provided with a pressure foot 9 designed to abut a piston closing the rear end
`
`of an ampoule accommodated in the ampoule holder 2.
`
`In the proximal side of the end wall 4 the bore is enlarged and the internal side of the en-
`
`20
`
`largement is provided with pawl wheel teeth 10 having a steep front edge 11 facing the
`clockwise direction and a ramp shaped rear edge 12 facing the anticlockwise direction. At
`
`least one pawl 13 mounted on a piston rod guide 14 co-operates with the pawl teeth 10 so
`that said piston rod guide can only be rotated clockwise in the ampoule holder 2.
`
`25 On the inner wall of the second division of the housing 1 a helical protruding rib 16 is pro(cid:173)
`
`vided defining an inner thread with a high pitch. A dose scale drum 17 is in its outer wall pro(cid:173)
`
`vided with a helical grove defining a corresponding external thread mating the inner thread
`
`just mentioned. The pitch angle of the threads exceeds the angle of friction for the materials
`
`forming the parts of the thread connection and consequently the thread connection is of the
`
`30
`
`not self locking type which induce a relative rotation of the parts of the connection when
`
`these part are moved axially relative to each other.
`
`54 72. 000-DK, EiT/PGy
`
`Sanofi Exhibit 2127.009
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`9
`
`Numbers indicating set doses are printed on the outer wall of the dose drum 17 and the
`
`number corresponding to a set dose is shown in a window 18 provided in the side wall of the
`
`housing 1.
`
`5
`
`The dose scale drum 17 is provide with a tubular extension 21 having an end near the
`
`proximal end of the syringe. Said end of the extension is closed by an end wall 19 having a
`
`central outer protrusion 20. In a part of the wall adjacent to the end wall 19 the extension 21
`
`is provided with slots 22. The said end of the extension is covered by a cup shaped cap 23
`
`forming an injection button. Internal hooks 24 at the open end of this cap snaps over an ex-
`
`10
`
`ternal circumferential bead 25 on the extension 21 and the protrusion 20 on the end wall 19
`
`abuts the inner side of the bottom of the cap 23 to form a journal about which the injection
`
`button can rotate relative to the extension 21 whereas it cannot be axially displaced relative
`
`to this extension.
`
`15
`
`A driver tube 26 integral with the piston rod guide 14 extends from this piston rod guide to
`
`the end wall 19 of the dose scale drum extension 21 and is at its proximal end divided into
`
`tongues 27 terminated by external hooks 28 engaging the slots 22 in the extension 21. This
`
`way the dose scale drum 17 is bound to rotate with the driver tube 26 but is axially displace(cid:173)
`able relative to this tube.
`
`20
`
`To set a dose the ampoule holder 2 is rotated anticlockwise in the first division of the hous(cid:173)
`
`ing 1. This rotation is performed against a resistance presented due to the fact that a protru(cid:173)
`
`sion 30 on the outer wall of the ampoule holder rests in one of a number of depressions 31
`
`circumferentially provided in the inner wall of said first division of the housing as shown in the
`
`25
`
`cross-sectional view in figure 3. The angular spacing of the depressions are appropriately
`
`made so that a dose of one unit is set when the protrusion
`
`is moved from one depression to
`
`the neighbouring depression so that the number of clicks heard and felt during the dose set(cid:173)
`
`ting rotation corresponds to the size of the set dose.
`
`30
`
`The rotation of the ampoule holder is due to the friction in the engaging threads 5 and 7
`
`transmitted to the piston rod 6 and further through the unidirectional coupling to the piston
`
`rod guide 14 although the torque is transmitted in a such a direction that the pawl will intend
`
`to click over the pawl wheel teeth 10. However, before this click function is performed a re-
`
`54 72. 000-DK, EiT/PGy
`
`Sanofi Exhibit 2127.01 0
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`10
`
`luctance have to be overcome. This reluctance is obtained by providing the pawl 13 with a
`
`protrusion 29 at its end engaging the pawl wheel teeth 10 and by providing depressions 32 in
`
`the ramp shaped edges 12 of the pawl wheel teeth into which depressions the protrusion
`
`29 on the pawl 13 will rest. Before the clicking release of the coupling is obtained a torque
`
`5
`
`sufficient to lift up the protrusion 29 of the pawl 13 from the depression 32 in the ramp
`
`shaped edge 12 must be provided. Altogether a moderate torque can be transmitted from
`
`the rotated ampoule holder 2 to the driver tube 26. As the hooks 28 at the proximal end of
`
`the driver tube 26 engage the slots 22 in the dose scale drum extension 21 the dose scale
`
`drum will be rotated and be screwed upwards in the second division of the housing 1 and the
`
`1 o
`
`injection button 23 will be lifted to protrude from the proximal end of the housing 1. As only a
`
`small torque is needed to screw up the dose scale drum this is obtained without releasing
`
`the unidirectional coupling to its clicking release function mode. The size of the set dose can
`
`currently be seen on the part of the dose scale drum which is presented in the window 18. If
`
`a too large dose has been set the ampoule holder can be rotated in a clockwise direction
`
`15
`
`until the number corresponding to the size of the wanted doe is presented in the window 18.
`
`To inject the set dose the injection button 23 is pressed home into the housing 1. Thereby
`
`the dose scale drum 17 is pressed in the distal direction and due to the thread connection
`
`between said drum and the housing 1 a torque is exerted on the drum rotating this drum in a
`
`20
`
`clockwise direction. Said torque is via the slots 22 in the drum extension 21 and the hooks
`
`28 at the end of the driver tube 26 and this tube itself transmitted to the piston rod guide 14.
`
`The pawls 13 on the piston rod guide are allowed to rotate in the clockwise direction when
`
`the torque is strong enough to overcome the reluctance provided by the protrusions 29 on
`
`the pawls engaging the depressions 32 in the ramp shaped edges of the pawl wheel teeth.
`
`25
`
`Such a strong torque is provided if only the inject button 23 is pressed hard enough. The
`
`piston rod guide 14 will now rotate clockwise with the unidirectional coupling working in its
`
`clicking released mode and the piston rod will be rotated clockwise too and will thereby be
`
`screwed through the wall 4 further into the ampoule accommodating compartment 8. The
`
`unidirectional coupling will never allow an anticlockwise rotation of the piston rod guide and
`
`30
`
`the piston and this way it is ensured that the pressure foot 9 will never be drawn out of
`
`abutment with the piston in a not shown ampoule in the compartment 8.
`
`5472.000-DK,EiT/PGy
`
`Sanofi Exhibit 2127.011
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`11
`
`In the shown embodiment the end wall 4 with its threaded bore forms a nut member relative
`
`to which the piston rod is rotated by the piston rod guide 14 and the driver tube 26. Embodi(cid:173)
`
`ments may be imagined wherein the piston rod guide is provided in the wall 4 and a nut ele(cid:173)
`
`ment is rotated by the driver tube and such embodiment will not be beyond the scope of the
`
`5
`
`invention.
`
`Another embodiment is described with reference to the figures 6-10. Elements correspond(cid:173)
`ing to elements in the embodiment described with references to the figures 1-5 are is pro(cid:173)
`vided with the same reference numbers. Different from the embodiment in figure 1-5 is the
`fact that the injection button 23 and not the dose scale drum 17 is provided with an extension
`
`1 o
`
`33, and that the driver tube 26 is omitted. Further the injection button 23 is provided with a
`
`flange 32 which abuts the end of the housing when the injection button is pressed home. The
`
`extension 33 serves as a journal for the dose scale drum 17 which is free to rotate on this
`
`journal but bound to follow axial movements of the injection button 23 due to hooks 34 at the
`
`15
`
`end of the extension 33. A longitudinal bore 35 in the injection button and its extension 33 is
`
`provided with an internal helical rib 36 engaging a corresponding helical groove in an en(cid:173)
`
`largement 37 at the proximal end of the piston rod to form a thread connection between said
`
`button 23 and said piston rod 6. The pitch of this thread connection is so that a not self lock(cid:173)
`
`ing thread connection is formed.
`
`20
`
`To set a dose the injection button 23 is manually rotated in a clockwise direction Thereby
`
`this button is screwed outwards from the housing 1 as the piston rod 6 will through the piston
`
`rod guide 14 and the unidrectional coupling be kept inrotatable although said unidirectional
`
`coupling in influenced by a torque in its release direction, however, due to the provided initial
`
`25
`
`reluctance the piston rod guide 14 will not immediately be rotatable. In its movement out(cid:173)
`
`wards the injection button 23 will draw the dose scale drum 17 with it. When this drum is
`
`moved axially in the housing it will be rotated due to the not self locking thread connection
`
`between said drum 17 and the housing 1.
`
`30
`
`By this construction the thread along which the injection button is screwed outwards and the
`
`tread along which the dose scale drum is rotated in the housing may be different.
`
`A click connection corresponding to the one established between the cartridge holder 2 and
`
`the housing 1 in the embodiment according to figure 1 is in the embodiment according to fig-
`
`5472.000-DK,EiT/PGy
`
`Sanofi Exhibit 2127.012
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`12
`
`ure 6 appropriately provided between the injection button 23 and the housing 1 where one or
`
`more protrusions 38 provided on the inner wall of the housing engages grooves 39in a cylin(cid:173)
`
`drical outer wall of thebutton 23. Thereby axial movement of the injection button is allowed
`
`in all its possible angular positions.
`
`5
`
`When the injection button is pressed to inject a set dose said button will be maintained inro(cid:173)
`
`tatable during its axial movement as the locking between the above mentioned protrusions
`
`on the inner wall of the housing and grooves on the outer wall of the button is strong enough
`
`to absorb the torque exerted on the injection button when it drives the piston rod to rotation
`
`1 o
`
`in a clockwise direction after having overcome the reluctance against rotation in the release
`
`direction of the unidirectional coupling.
`
`5472.000-DK,EiT/PGy
`
`Sanofi Exhibit 2127.013
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`CLAIMS
`
`13
`
`1. An injection syringes for apportioning set doses of a medicine from a cartridge containing
`
`an amount of medicine sufficient for the preparation of a number of therapeutic doses, com-
`
`5
`
`prising
`
`a housing
`
`10
`
`15
`
`a piston rod having a not circular cross-section and an outer thread
`
`a piston rod drive comprising two elements
`
`a)
`
`a piston rod guide in relation to which the piston rod is axially displaceable but not
`
`rotatable, and
`
`b)
`
`a nut member which is rotatable but not axially displaceable in the housing and
`
`which has an inner thread mating the thread of the piston rod to form a self locking thread
`connection,
`
`20
`
`a dose setting mechanism comprising a not self locking thread connection along which an
`
`injection button by rotation of a dose setting element relative to said housing is screwed out
`
`from the proximal end of the housing to project from this proximal end a distance deter(cid:173)
`
`mined by the angle of said rotation and which thread connection by axial returning of the in(cid:173)
`
`jection button transforms this axial movement to a rotation of one of the piston drive ele-
`
`25 ments relative to the other,
`
`characterised in that
`
`a unidirectional coupling is provided between the nut member and the piston rod guide al-
`
`30
`
`lowing rotation of these parts relative to each other in one direction but not in the opposite
`
`direction, the allowed rotation being one by which the piston rod is transported in a distal di(cid:173)
`
`rection in the syringe, the coupling being so designed that a set initial reluctance has to be
`
`overcome before the rotation takes place.
`
`5472.000-DK,EiT/PGy
`
`Sanofi Exhibit 2127.014
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`14
`
`2. An injection syringe according to claim 1, characterised in that a click coupling providing
`
`an moderate resistance against rotation in either directions is established between the
`
`housing and the element rotated relative to this housing to set a dose.
`
`5
`
`3. An injection syringe according to claim 1 or 2, characterised in that the unidirectional cou(cid:173)
`
`pling comprises a pawl sliding over a pawl wheel with teeth having a steep front edge and a
`
`ramp shaped trailing edge.
`
`10
`
`4. An injection syringe according to claim 3, characterised in that the trailing edges of the
`
`pawl wheel teeth has a depression engaged by a mating protrusion on the pawl.
`
`5. An injection syringe according to anyone of the preceding claims, characterised in that a
`
`dose scale drum has in its surface a helical track engaged by a helical rib on the inner side
`
`15
`
`of the housing to form a not self locking thread connection between the housing and the
`
`drum and is coupled to the injection button to be moved axially with this button.
`
`6. An injection syringe according to claim 5, characterised in that the thread connection by
`
`which the injection button is lifted by setting a dose is the thread connection between the
`
`20
`
`dose