US008679069B2
`
`(12) United States Patent
`Veasey et al.
`
`(io) Patent No.:
`(45) Date of Patent:
`
`US 8,679,069 B2
`Mar. 25, 2014
`
`(54) PEN-TYPE INJECTOR
`
`(56)
`
`References Cited
`
`(75)
`
`Inventors: Robert Frederick Veasey, Warwickshire
`(GB); Robert Perkins, Oxfordshire
`(GB); David Aubrey Plumptre,
`Worcestershire (GB)
`
`(73) Assignee: DCA Design International, Ltd.,
`Warwick (GB)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 406 days.
`
`(21) Appl.No.: 12/944,544
`
`(22) Filed:
`
`Nov. 11, 2010
`
`(65)
`
`Prior Publication Data
`US 2012/0089100 Al
`Apr. 12, 2012
`
`Related U.S. Application Data
`(63) Continuation of application No. 11/483,546, filed on
`Jul. 11, 2006, now Pat. No. 7,918,833, and a
`continuation of application No. 10/790,225, filed on
`Mar. 2, 2004, now abandoned.
`
`(30)
`
`Foreign Application Priority Data
`
`Mar. 3, 2003
`
`(GB)
`
`0304822.0
`
`(2006.01)
`
`(51) Int. CI.
`A61M5/00
`(52) U.S. CI.
`USPC
`(58) Field of Classification Search
`USPC
`604/187, 207-211, 218, 221, 224, 232
`See application file for complete search history.
`
`604/209; 604/207
`
`U.S. PATENT DOCUMENTS
`
`5,304,152 A
`5,320,609 A
`5,480,387 A
`5,505,704 A
`5,626,566 A
`5,674,204 A
`5,688,251 A
`
`4/1994 Sams
`6/1994 Haber et al.
`1/1996 Gabriel etal.
`4/1996 Pawelkaetal.
`5/1997 Petersen et al.
`10/1997 Chanoch
`11/1997 Chanoch
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`
`0937471 A2
`8/1999
`0937476
`8/1999
`(Continued)
`OTHER PUBLICATIONS
`
`EP 0937471A2, Walters et al., date of publication: Aug. 25, 1999*
`Primary Examiner — Manuel Mendez
`(74) Attorney, Agent, or Firm — McDonnell Boehnen
`Hulbert & Beighoff LLP
`ABSTRACT
`(57)
`A housing for a dispensing apparatus. The housing compris­
`ing a main housing and a dose dial sleeve. The dose dial sleeve
`comprising a helical groove configured to engage a threading
`provided by the housing. A dose knob is disposed near a
`proximal end of the dose dial sleeve and a piston rod is
`provided within the housing. The piston rod is non-rotatable
`during a dose setting step. A driver comprises an internal
`threading near a distal portion of the driver and is adapted to
`engage an external thread of the piston rod. A tubular clutch is
`located adjacent a distal end of the dose knob and operatively
`coupled to the dose knob. The dose dial sleeve may extend
`circumferentially around at least a portion of the tubular
`clutch.
`
`3 Claims, 7 Drawing Sheets
`
`•78
`
`•80
`•84
`
`86
`
`20-
`
`82-s 85
`75-
`
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`16
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`y
`
`™ ^-12
`
`14-V
`
`Mylan Exhibit - 1001
`Mylan v. Sanofi
`
`

`

`US 8,679,069 B2
`Page 2
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`6,083,197 A
`6,193,698 B1
`6,221,046 B1
`6,248,095 B1
`6,899,698 B2
`7,241,278 B2
`7,918,833 B2 *
`
`7/2000 Umbaugh
`2/2001 Kirchhofer et al.
`4/2001 Burroughs et al.
`6/2001 Giambattista et al.
`5/2005 Sams
`7/2007 Moller
`4/2011 Veaseyetal
`
`2002/0052578 A1
`2004/0059299 A1
`
`5/2002 Moller
`3/2004 Moller
`
`FOREIGN PATENT DOCUMENTS
`
`WO
`WO
`WO
`
`91/14467
`99/38554
`9938554 Al
`
`10/1991
`8/1999
`8/1999
`
`604/209
`
`* cited by examiner
`
`Mylan Exhibit - 1001
`Mylan v. Sanofi
`
`

`

`U.S. Patent
`
`Mar. 25, 2014
`
`Sheet 1 of 7
`
`US 8,679,069 B2
`
`W
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`
`Mylan Exhibit - 1001
`Mylan v. Sanofi
`
`

`

`U.S. Patent
`
`Mar. 25, 2014
`
`Sheet 2 of 7
`
`US 8,679,069 B2
`
`S
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`FIG. 4
`
`Mylan Exhibit - 1001
`Mylan v. Sanofi
`
`

`

`U.S. Patent
`
`Mar. 25, 2014
`
`Sheet 3 of 7
`
`US 8,679,069 B2
`
`M §
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`n
`4"XN
`a
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`
`Mylan Exhibit - 1001
`Mylan v. Sanofi
`
`

`

`U.S. Patent
`
`Mar. 25, 2014
`
`Sheet 4 of 7
`
`US 8,679,069 B2
`
`54
`
`7
`52
`
`66
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`
`FIG 8
`
`• JUP
`
`I I
`
`Mylan Exhibit - 1001
`Mylan v. Sanofi
`
`

`

`U.S. Patent
`
`Mar. 25, 2014
`
`Sheet 5 of 7
`
`US 8,679,069 B2
`
`42
`
`54
`
`A(82)
`
`0(40).
`36
`
`F(50) 20
`
`E(60)
`C(70)
`D(30)
`
`B(76)
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`
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`
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`FIG. 9
`
`F(50)
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`A(82)
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`FIG. 10
`74
`
`40
`
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`
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`E(60) C(70) D(30)
`
`A(82)
`
`FIG. 11
`
`Mylan Exhibit - 1001
`Mylan v. Sanofi
`
`

`

`U.S. Patent
`
`Mar. 25, 2014
`
`Sheet 6 of 7
`
`US 8,679,069 B2
`
`74
`
`70
`I
`
`106
`
`108
`
`104
`
`FIG. 12
`
`106
`1
`
`FIG. 13
`
`108
`
`•/////////////////.
`
`'TT
`
`70
`
`V//////////////////////7/
`
`f C
`112 110
`
`FIG. 14
`
`Mylan Exhibit - 1001
`Mylan v. Sanofi
`
`

`

`U.S. Patent
`
`Mar. 25, 2014
`
`Sheet 7 of 7
`
`US 8,679,069 B2
`
`42
`
`\gg v///////////T^ \
`
`44
`
`y//////////77777Z
`
`g
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`100
`FIG. 15
`
`46
`
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`'///////////////A 7
`46
`
`FIG. 16
`
`Mylan Exhibit - 1001
`Mylan v. Sanofi
`
`

`

`1
`PEN-TYPE INJECTOR
`
`US 8,679,069 B2
`
`5
`
`45
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`2
`provided on a second face of the nut and a second radial stop
`may be provided on a first face of the second flange.
`Preferably, the first thread of the piston rod is oppositely
`disposed to the second thread of the piston rod.
`Preferably, a second end of the clutch is provided with a
`plurality of dog teeth adapted to engage with a second end of
`The present application is a continuation application of
`U.S. patent application Ser. No. 11/483,546, filed Jul. 11,
`the dose dial sleeve.
`Preferably, the pen-type injector further includes clicker
`2006, currently pending, which is a continuation application
`means disposed between the clutch means and spline means
`of U.S. patent application Ser. No. 10/790,225, filed Mar. 2,
`2004, abandoned, and claims priority to GB Patent Applica- 10 provided on the housing.
`tionNo. 0304822.0, filed Mar. 3, 2003, the entire contents of
`More preferably, the clicker means comprises a sleeve
`provided at a first end with a helically extending arm, a free
`each of which are incorporated herein by reference.
`The present invention relates to pen-type injectors, that is
`end of the arm having a toothed member, and at a second end
`to injectors of the kind that provide for administration by
`with a plurality of circumferentially directed saw teeth
`injection of medicinal products from a multidose cartridge. In 15 adapted to engage a corresponding plurality of circumferen-
`particular, the present invention relates to such injectors
`tially saw teeth provided on the clutch means.
`where a user may set the dose.
`Alternatively, the clicker means comprises a sleeve pro­
`Such injectors have application where regular injection by
`vided at a first end with at least one helically extending arm
`persons without formal medical training occurs. This is
`and at least one spring member, a free end of the arm having
`increasingly common amongst those having diabetes where 20 a toothed member, and at a second end with a plurality of
`circumferentially directed saw teeth adapted to engage a cor­
`self-treatment enables such persons to conduct effective man­
`agement of their diabetes.
`responding plurality of circumferentially directed saw teeth
`These circumstances set a number of requirements for
`provided on the clutch means.
`Preferably, the main housing is provided with a plurality of
`pen-type injectors of this kind. The injector must be robust in
`construction, yet easy to use both in terms of the manipulation 25 maximum dose stops adapted to be abutted by a radial stop
`provided on the dose dial sleeve. More preferably, at least one
`of the parts and understanding by a user of its operation. In the
`case of those with diabetes, many users will be physically
`of the maximum dose stops comprises a radial stop located
`infirm and may also have impaired vision. Where the injector
`between a helical rib and spline means provided at a second
`end of the housing. Alternatively, at least one of the maximum
`is to be disposable rather than reusable, the injector should be
`cheap to manufacture and easy to dispose of (preferably being 30 dose stops comprises a part of a raised window portion pro­
`suitable for recycling).
`vided at second end of the housing.
`Preferably, the dose dial sleeve is provided with a plurality
`It is an advantage of the present invention that an improved
`of radially extending members adapted to abut a correspond­
`pen-type injector is provided.
`ing plurality of radial stops provided at a second end of the
`According to a first aspect of the present invention, a pen-
`35 housing.
`type injector comprises a housing;
`a piston rod adapted to operate through the housing;
`The invention will now be described with reference to the
`a dose dial sleeve located between the housing and the piston
`accompanying drawings, in which:—
`rod, the dose dial sleeve having a helical thread of first lead;
`FIG. 1 shows a sectional view of a pen-type injector in
`a drive sleeve located between the dose dial sleeve and the
`accordance with the present invention in a first, cartridge full
`piston rod, the drive sleeve having a helical groove of second 40 position;
`lead;
`FIG. 2 shows a sectional view of the pen-type injector of
`FIG. 1 in a second, maximum first dose dialed, position;
`characterised in that the first lead of the helical thread and the
`second lead of the helical groove are the same.
`FIG. 3 shows a sectional view of the pen-type injector of
`FIG. 1 in a third, first maximum first dose dispensed, position;
`Preferably, the piston rod has a first threaded portion at a
`FIG. 4 shows a sectional view of the pen-type injector of
`first end and a second threaded portion at a second end;
`FIG. 1 in a fourth, final dose dialed, position;
`an insert or radially inwardly extending flange is located in
`FIG. 5 shows a sectional view of the pen-type injector of
`the housing and through which the first threaded portion of
`FIG. 1 in a fifth, final dose dispensed, position;
`the piston rod may rotate;
`FIG. 6 shows a cut-away view of a first detail of the pen-
`the dose dial sleeve being rotatable with respect to the hous­
`50 type injector of FIG. 1;
`ing and the insert;
`FIG. 7 shows a partially cut-away view of a second detail of
`the drive sleeve being releasably connected to the dose dial
`the pen-type injector of FIG. 1;
`sleeve and connected to the piston rod for rotation with
`FIG. 8 shows a partially cut-away view of a third detail of
`respect thereto along the second threaded portion of the pis­
`the pen-type injector of FIG. 1;
`ton rod;
`a button is located on the dose dial sleeve and rotatable with 55
`FIG. 9 shows the relative movement of parts of the pen-
`type injector shown in FIG. 1 during dialing up of a dose;
`respect to the dose dial sleeve; and
`FIG. 10 shows the relative movement of parts of the pen-
`clutch means are provided which upon depression of the
`type injector shown in FIG. 1 during dialing down of a dose;
`button permit rotation between the dose dial sleeve and the
`drive sleeve.
`FIG. 11 shows the relative movement of parts of the pen-
`Preferably, the injector further comprises a nut which is 60 type injector shown in FIG. 1 during dispensing of a dose;
`rotatable with respect to the drive sleeve and axially displace-
`FIG. 12 shows a partially cut-away view of the pen-type
`injector of FIG. 1 in the second, maximum first dose dialed,
`able but not rotatable with respect to the housing.
`position;
`More preferably, the drive sleeve is provided at a first end
`FIG. 13 shows a partially cut-away view of the pen-type
`with first and second flanges with an intermediate thread
`between the first and second flanges, the nut being disposed 65 injector of FIG. 1 in the fourth, final dose dialed, position;
`between the first and second flanges and keyed to the housing
`FIG. 14 shows a partially cut-away view of the pen-type
`by spline means. Additionally, a first radial stop may be
`injector of FIG. 1 in one of the first, third or fifth positions;
`
`Mylan Exhibit - 1001
`Mylan v. Sanofi
`
`

`

`US 8,679,069 B2
`
`4
`3
`The outer surface of the nut 40 and an internal surface of the
`FIG. 15 shows a cut-away view of a first part of a main
`main housing 4 are keyed together by splines 42 (see FIGS.
`housing of the pen-type injector of FIG. 1; and
`10,11,15 and 16) to prevent relative rotation between the nut
`FIG. 16 shows a cut-away view of a second part of the main
`40 and the main housing 4, while allowing relative longitu-
`housing of the pen-type injector of FIG. 1.
`Referring first to FIGS. 1 to 5, there may be seen a pen-type 5 dinal movement therebetween,
`injector in accordance with the present invention in a number
`A shoulder 37 is formed between a second end of the drive
`of positions.
`sleeve 30 and an extension 38 provided at the second end of
`the drive sleeve 30. The extension 38 has reduced inner and
`The pen-type injector comprises a housing having a first
`outer diameters in comparison to the remainder of the drive
`cartridge retaining part 2, and second main housing part 4. A
`first end of the cartridge retaining means 2 and a second end 10 sleeve 30. A second end of the extension 38 is provided with
`a radially outwardly directed flange 39.
`of the main housing 4 are secured together by retaining fea­
`A clicker 50 and a clutch 60 are disposed about the drive
`tures 6. In the illustrated embodiment, the cartridge retaining
`means 2 is secured within the second end of the main housing
`sleeve 30, between the drive sleeve 30 and a dose dial sleeve
`70 (to be described below).
`A cartridge 8 from which a number of doses of medicinal 15
`The clicker 50 is located adjacent the second flange 34 of
`product may be dispensed is provided in the cartridge retain­
`the drive sleeve 30. The clicker 50 is generally cylindrical and
`ing part 2. A piston 10 is retained in a first end of the cartridge
`is provided at a first end with a flexible helically extending
`arm 52 (shown most clearly in FIG. 6). A free end of the arm
`8.
`A removable cap 12 is releasably retained over a second
`52 is provided with a radially directed toothed member 54. A
`end of the cartridge retaining part 2. In use the removable cap 20 second end of the clicker 50 is provided with a series of
`circumferentially directed saw teeth 56 (cf FIG. 7). Each saw
`12 can be replaced by a user with a suitable needle unit (not
`shown). A replaceable cap 14 is used to cover the cartridge
`tooth comprises a longitudinally directed surface and an
`retaining part 2 extending from the main housing 4. Prefer­
`inclined surface.
`ably, the outer dimensions of the replaceable cap 14 are simi­
`In an alternative embodiment (not shown) the clicker
`lar or identical to the outer dimensions of the main housing 4 25 means further includes at least one spring member. The at
`least one spring member assists in the resetting of the clutch
`to provide the impression of a unitary whole when the
`replaceable cap 14 is in position covering the cartridge retain­
`means 60 following dispense.
`The clutch means 60 is located adjacent the second end of
`ing part 2.
`In the illustrated embodiment, an insert 16 is provided at a
`the drive sleeve 30. The clutch means 60 is generally cylin-
`first end of the main housing 4. The insert 16 is secured 30 drical and is provided at a first end with a series of circum-
`ferentially directed saw teeth 66 (see FIG. 7). Each saw tooth
`against rotational or longitudinal motion. The insert 16 is
`provided with a threaded circular opening 18 extending there­
`comprises a longitudinally directed surface and an inclined
`through. Alternatively, the insert may be formed integrally
`surface. Towards the second end 64 of the clutch means 60
`with the main housing 4 the form of a radially inwardly
`there is located a radially inwardly directed flange 62. The
`directed flange having an internal thread.
`35 flange 62 of the clutch means 60 is disposed between the
`A first thread 19 extends from a first end of a piston rod 20.
`shoulder 37 of the drive sleeve 30 and the radially outwardly
`The piston rod 20 is of generally circular section. The first end
`directed flange 39 of the extension 38. The second end of the
`of the piston rod 20 extends through the threaded opening 18
`clutch means 60 is provided with a plurality of dog teeth 65
`(FIG. 8). The clutch 60 is keyed to the drive sleeve 30 by way
`in the insert 16. A pressure foot 22 is located at the first end of
`the piston rod 20. The pressure foot 22 is disposed to abut a 40 of splines (not shown) to prevent relative rotation between the
`second end of the cartridge piston 10. A second thread 24
`clutch 60 and the drive sleeve 30.
`extends from a second end of the piston rod 20. In the illus­
`In the illustrated embodiment, the clicker 50 and the clutch
`trated embodiment the second thread 24 comprises a series of
`60 each extend approximately half the length of the drive
`part threads rather than a complete thread. The illustrated
`sleeve 30. However, it will be understood that other arrange-
`embodiment is easier to manufacture and helps reduce the 45 ments regarding the relative lengths of these parts are pos-
`overall force required for a user to cause medicinal product to
`sible.
`be dispensed.
`The clicker 50 and the clutch means 60 are normally
`The first thread 19 and the second thread 24 are oppositely
`engaged, that is as shown in FIG. 7.
`disposed. The second end of the piston rod 20 is provided with
`A dose dial sleeve 70 is provided outside of the clicker 50
`a receiving recess 26.
`50 and clutch means 60 and radially inward of the main housing
`A drive sleeve 30 extends about the piston rod 20. The drive
`4. A helical groove 74 is provided about an outer surface of the
`sleeve 30 is generally cylindrical. The drive sleeve 30 is
`dose dial sleeve 70.
`provided at a first end with a first radially extending flange 32.
`The main housing 4 is provided with a window 44 through
`A second radially extending flange 34 is provided spaced a
`which a part of the outer surface of the dose dial sleeve may be
`distance along the drive sleeve 30 from the first flange 32. An 55 seen. The main housing 4 is further provided with a helical rib
`intermediate thread 3 6 i s provided on an outer part of the drive
`46, adapted to be seated in the helical groove 74 on the outer
`sleeve 30 extending between the first flange 32 and the second
`surface of the dose dial sleeve 70. The helical rib 46 extends
`flange 34. A helical groove 38 extends along the internal
`for a single sweep of the inner surface of the main housing 4.
`surface of the drive sleeve 30. The second thread 24 of the
`A first stop 100 is provided between the splines 42 and the
`piston rod 20 is adapted to work within the helical groove 38 . 60 helical rib 46 (FIG. 15). A second stop 102, disposed at an
`A first end of the first flange 32 is adapted to conform to a
`angle of 180° to the first stop 100 is formed by a frame
`second side of the insert 16.
`surrounding the window 44 in the main housing 4 (FIG. 16).
`A nut 40 is located between the drive sleeve 30 and the
`Conveniently, a visual indication of the dose that may be
`dialed, for example reference numerals (not shown); is pro-
`main housing 2, disposed between the first flange 32 and the
`second flange 34. In the illustrated embodiment the nut 40 is 65 vided on the outer surface of the dose dial sleeve 70. The
`a half-nut. This assists in the assembly of the injector. The nut
`window 44 conveniently only allows to be viewed a visual
`40 has an internal thread matching the intermediate thread 36.
`indication of the dose currently dialed.
`
`Mylan Exhibit - 1001
`Mylan v. Sanofi
`
`

`

`US 8,679,069 B2
`
`6
`5
`A second end of the dose dial sleeve 70 is provided with an
`mitted through the clutch means 60 causes the saw teeth 56,66
`inwardly directed flange in the form of number of radially
`to ride over one another to create the clicks corresponding to
`extending members 75. A dose dial grip 76 is disposed about
`dialed dose reduction. Preferably the saw teeth 56,66 are so
`an outer surface of the second end of the dose dial sleeve 70.
`disposed that the circumferential extent of each saw tooth
`An outer diameter of the dose dial grip 76 preferably corre- 5 corresponds to a unit dose,
`sponds to the outer diameter of the main housing 4. The dose
`When the desired dose has been dialed, the user may then
`dial grip 76 is secured to the dose dial sleeve 70 to prevent
`dispense this dose by depressing the button 82 (FIG. 11). This
`displaces the clutch means 60 axially with respect to the dose
`relative movement therebetween. The dose dial grip 76 is
`dial sleeve 70 causing the dog teeth 65 to disengage. However
`provided with a central opening 78. An annular recess 80
`located in the second end of the dose dial grip 76 extends 10 the clutch means 60 remains keyed in rotation to the drive
`sleeve 30. The dose dial sleeve 70 and associated dose dial
`around the opening 78.
`grip 76 are now free to rotate (guided by helical rib 46 located
`A button 82 of generally'T' section is provided at a second
`in helical groove 74).
`end of the pen-type injector. A stem 84 of the button 82 may
`The axial movement deforms the flexible arm 52 of the
`extend through the opening 78 in the dose dial grip 76,
`through the inner diameter of the extension 38 of the drive 15 clicker 50 to ensure the saw teeth 56,66 cannot be overhauled
`sleeve 30 and into the receiving recess 26 of the piston rod 20.
`during dispense. This prevents the drive sleeve 30 from rotat­
`The stem 84 is retained for limited axial movement in the
`ing with respect to the main housing 4 though it is still free to
`drive sleeve 30 and against rotation with respect thereto. A
`move axially with respect thereto. This deformation is sub­
`sequently used to urge the clicker 50, and the clutch 60, back
`head 85 of the button 82 is generally circular: A skirt 86
`depends from a periphery of the head 85. The skirt 86 is 20 along the drive sleeve 30 to restore the connection between
`adapted to be seated in the annular recess 80 of the dose dial
`the clutch 60 and the dose dial sleeve 70 when pressure is
`removed from the button 82.
`grip 76.
`The longitudinal axial movement of the drive sleeve 30
`Operation of the pen-type injector in accordance with the
`present invention will now be described. In FIGS. 9,10 and 11
`causes the piston rod 20 to rotate though the opening 18 in the
`arrows A, B, C, D, E, F and G represent the respective move- 25 insert 16, thereby to advance the piston 10 in the cartridge 8.
`Once the dialed dose has been dispensed, the dose dial sleeve
`ments of the button 82, the dose dial grip 76, the dose dial
`sleeve 70, the drive sleeve 30, the clutchmeans 60, the clicker
`70 is prevented from further rotation by contact of a plurality
`50 and the nut 40.
`of members 110 (FIG. 14) extending from the dose dial grip
`76 with a corresponding plurality of stops 112 formed in the
`To dial a dose (FIG. 9) a user rotates the dose dial grip 76
`(arrow A). With the clicker 50 and clutch means 60 engaged, 30 main housing 4 (FIGS. 15 and 16). In the illustrated embodi-
`the drive sleeve 30, the clickerSO, the clutchmeans 60 and the
`ment, the members 110 extend axially from the dose dial grip
`dose dial sleeve 70 rotate with the dose dial grip 76.
`76 and have an inclined end surface. The zero dose position is
`Audible and tactile feedback of the dose being dialed is
`determined by the abutment of one of the axially extending
`provided by the clicker 50 and the clutch means 60. Torque is
`edges of the members 110 with a corresponding stop 112.
`transmitted through the saw teeth 56,66 between the clicker 35
`50 and the clutch means 60. The flexible arm 52 deforms and
`drags the toothed member 54 over the splines 42 to produce a
`click. Preferably, the splines 42 are disposed such that each
`click corresponds to a unit dose.
`The helical groove 74 on the dose dial sleeve 70 and the 40
`helical groove 38 in the drive sleeve 30 have the same lead.
`This allows the dose dial sleeve 70 (arrow C) to extend from
`the main housing 4 and the drive sleeve 30 (arrow D) to climb
`the piston rod 20 at the same rate. At the limit of travel, a radial
`stop 104 on the dose dial sleeve 70 engages either the first stop 45
`100 or the second stop 102 provided on the main housing 4 to
`prevent further movement. Rotation of the piston rod 20 is
`prevented due to the opposing directions of the overhauled
`and driven threads on the piston rod 20.
`The nut 40, keyed to the main housing 4, is advanced along 50
`the intermediate thread 36 by the rotation of the drive sleeve
`30 (arrow D). When the final dose dispensed position (FIGS.
`4, 5 and 13) is reached, a radial stop 106 formed on a second
`surface of the nut 40 abuts a radial stop 108 on a first surface
`of the second flange 34 of the drive sleeve 30, preventing both 55
`the nut 40 and the drive sleeve 30 from rotating further.
`In an alternative embodiment (not shown) a first surface of
`the nut 40 is provided with a radial stop for abutment with a
`radial stop provided on a second surface of the first flange 32.
`This aids location of the nut 40 at the cartridge full position 60
`during assembly of the pen-type injector.
`Should a user inadvertently dial beyond the desired dosage,
`the pen-type injector allows the dosage to be dialed down
`without dispense of medicinal product from the cartridge
`(FIG. 10). The dose dial grip 76 is counter rotated. This causes 65
`the system to act in reverse. The flexible arm 52 now acts as a
`ratchet preventing the clicker from rotating. The torque trans-
`
`The invention claimed is:
`1. A housing part for a medication dispensing apparatus,
`said housing part comprising:
`a main housing, said main housing extending from a distal
`end to a proximal end;
`a dose dial sleeve positioned within said housing, said dose
`dial sleeve comprising a helical groove configured to
`engage a threading provided by said main housing, said
`helical groove provided along an outer surface of said
`dose dial sleeve;
`a dose dial grip disposed near a proximal end of said dose
`dial sleeve;
`a piston rod provided within said housing, said piston rod is
`non-rotatable during a dose setting step relative to said
`main housing;
`a drive sleeve extending along a portion of said piston rod,
`said drive sleeve comprising an internal threading near a
`distal portion of said drive sleeve, said internal threading
`adapted to engage an external thread of said piston rod;
`and,
`a tubular clutch located adjacent a distal end of said dose
`dial grip, said tubular clutch operatively coupled to said
`dose dial grip,
`wherein said dose dial sleeve extends circumferentially
`around at least a portion of said tubular clutch.
`2. The housing part of claim 1, further comprising
`a cartridge retaining part operatively coupled to said main
`housing, said cartridge retaining part comprising a fluid
`container,
`wherein said fluid container defines a medicament filled
`reservoir with a movable plunger at a proximal end and
`an outlet at a distal end,
`
`Mylan Exhibit - 1001
`Mylan v. Sanofi
`
`

`

`US 8,679,069 B2
`
`7
`said cartridge piston movable by said piston rod to be
`advanced toward an outlet of said fluid container when
`said piston rod is moved distally, wherein during a dose
`setting step, said dose dial grip, is rotated and moves
`away from said proximal end of said main housing so 5
`that a dose of a medicament contained within said medi­
`cament filled reservoir can be selected.
`3. The housing part of claim 2, wherein said dose dial grip
`is operatively configured to said tubular clutch so that, during
`said dose setting step, said tubular clutch, said dose dial 10
`sleeve, and said dose dial grip rotate and move in a proximal
`direction in relation to said main housing.
`
`8
`
`Mylan Exhibit - 1001
`Mylan v. Sanofi
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO.
`APPLICATION NO.
`DATED
`INVENTOR(S)
`
`8,679,069 B2
`12/944544
`March 25, 2014
`Robert Frederick Veasey et al.
`
`Page 1 of 1
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is hereby corrected as shown below:
`
`Title page, item 73, Assignee:
`
`delete "DCA DESIGN INTERNATIONAL LTD."
`
`replace with - SANOFI-AVENTIS DEUTSCHLAND GMBH -
`
`Signed and Sealed this
`Twenty-second Day of July, 2014
`
`Michelle K. Lee
`Deputy Director of the United States Patent and Trademark Office
`
`SL
`
`Mylan Exhibit - 1001
`Mylan v. Sanofi
`
`