PTO/SB/05 (08-08)
`Approved for use through 09/30/2010. OMB 0651-0032
`U.S. Patent and Trademark Office. U.S. DEPARTMENT OF COMMERCE
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`10-1188-US-CON7
`
`Attorney Docket No.
`
`First Inventor
`
`Title
`
`Robert Frederick Veasey
`
`RELATING TO A PEN-TYPE INJECTOR
`
`UTILITY
`PATENT APPLICATION
`TRANSMITTAL
`
`^
`
`(Only for new nonprovisional applications under 37 CFR 1.53(b))
`
`Express Mail Label No.
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`APPLICATION ELEMENTS
`See MPEP chapter 600 concerning utility patent application contents.
`
`ADDRESS TO:
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria VA 22313-1450
`
`J
`
`1. [V] Fee Transmittal Form (e.g., PTO/SB/17)
`2. EZI Applicant claims small entity status.
`See 37 CFR 1.27.
`3. EZ] Specification
`11
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`b. H Newly executed (original or copy)
`d
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`A copy from a prior application (37 CFR 1.63(d))
`for continuation/divisional with Box 18 completed)
`] DELETION OF INVENTOR(S)
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`name in the prior application, see 37 CFR
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`I—I Copies of citations attached
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`18. If a CONTINUING APPLICATION, check appropriate box, and supply the requisite information below and in the first sentence of the
`specification following the title, or in an Application Data Sheet under 37 CFR 1.76:
`I ^ I Continuation
`I
`I Divisional
`IZZI
`Examiner MENDEZ. MANUEL A
`Prior application information-.
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`15. [^| Certified Copy of Priority Document(s)
`(if foreign priority is claimed)
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`17. Ljd Other: Statement Regarding the Information
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`Disclosure Statement
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`Continuation-in-part (CIP)
`
`of prior application No.:1.4/635,57.3.
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`Art Unit: 3763
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`0
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`The address associated with Customer Number:
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`98548
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`| Correspondence address below
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`19. CORRESPONDENCE ADDRESS
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`Name
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`Address
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`Name
`„ (Print/Type)
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`Zip Code
`Email
`
`/David M. Frischkorn/
`
`David M. Frischkorn
`
`Date
`
`November 19, 2015
`Registration No.
`(Attorney/Agent)
`
`32,833
`
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`If you need assistance in completing the form, call 1-800-PTO-9199 and select option 2.
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1025, p. 1 of 24
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`

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`3.
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`4
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`5.
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`Q
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1025, p. 2 of 24
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`

`

`SPECIFICATION
`
`TITLE
`IMPROVEMENTS IN AND RELATING TO A PEN-TYPE INJECTOR
`
`CROSS REFERENCE TO RELATED APPLICATIONS
`[0001] The present application is a continuation of U.S. Patent Application No. U.S.
`14/635,573, filed March 2, 2015, which is a continuation of U.S. Patent Application No.
`13/919,251, filed June 17, 2013, now U.S. Patent No. 9,011,391, which is a divisional of U.S.
`Patent Application No. 13/040,198, filed March 3, 2011, now U.S. Patent No. 8,512,297, which
`is a continuation of U.S. Patent Application No. 11/483,546, filed July 11, 2006, now U.S. Patent
`No. 7,918,833, which is a continuation of U.S. Patent Application No. 10/790,225, filed March
`2, 2004, which claims priority to GB 0304822.0 filed March 3, 2003, the entire contents of
`which are incorporated herein by reference.
`
`BACKGROUND
`[0002] The present invention relates to pen-type injectors, that is, to injectors of the kind
`that provide for administration by injection of medicinal products from a multidose cartridge. In
`particular, the present invention relates to such injectors where a user may set the dose.
`[0003] Such injectors have application where regular injection by persons without formal
`medical training occurs. This is increasingly common amongst those having diabetes where self-
`treatment enables such persons to conduct effective management of their diabetes.
`[0004] These circumstances set a number of requirements for pen-type injectors of this
`kind.
`The injector must be robust in construction, yet easy to use both in terms of the
`manipulation of the parts and understanding by a user of its operation. In the case of those with
`diabetes, many users will be physically infirm and may also have impaired vision. Where the
`injector is to be disposable rather than reusable, the injector should be cheap to manufacture and
`easy to dispose of (preferably being suitable for recycling).
`
`SUMMARY
`[0005] It is an advantage of the present invention that an improved pen-type injector is
`provided.
`
`1
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1025, p. 3 of 24
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`

`

`[0006] According to a first aspect of the present invention, a pen-type injector comprises
`a housing;
`a piston rod adapted to operate through housing;
`a dose dial sleeve located between the housing and the piston rod, the dose dial sleeve
`having a helical thread of first lead;
`a drive sleeve located between the dose dial sleeve and the piston rod, the drive sleeve
`having a helical groove of second lead;
`characterized in that the first lead of the helical thread and the second lead of the helical
`groove are the same.
`[0007] Preferably, the piston rod has a first threaded portion at a first end and a second
`threaded portion at a second end;
`an insert or radially inwardly extending flange is located in the housing and through
`which the first threaded portion of the piston rod may rotate;
`the dose dial sleeve being rotatable with respect to the housing and the insert;
`the drive sleeve being releasably connected to the dose dial sleeve and connected to the
`piston rod for rotation with respect thereto along the second threaded portion of the piston rod;
`a button is located on the dose dial sleeve and rotatable with respect to the does dial
`sleeve; and
`clutch means are provided which upon depression of the button permit rotation between
`the dose dial sleeve and the drive sleeve.
`[0008] Preferably, the injector further comprises a nut which is rotatable with respect to
`the drive sleeve and axially displaceable but not rotatable with respect to the housing.
`[0009] More preferably, the drive sleeve is provided at a first end with first and second
`flanges with an intermediate thread between the first and second flanges, the nut being disposed
`between the first and second flanges and keyed to the housing by spline means. Additionally, a
`first radial stop may be provided on a second face of the nut and a second radial stop may be
`provided on a first face of the second flange.
`[0010] Preferably, the first thread of the piston rod is oppositely disposed to the second
`thread of the piston rod.
`[0011] Preferably, a second end of the clutch is provided with a plurality of dog teeth
`adapted to engage with a second end of the dose dial sleeve.
`
`2
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1025, p. 4 of 24
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`

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`[0012] Preferably, the pen-type injector further includes clicker means disposed between
`the clutch means and spline means provided on the housing.
`[0013] More preferably, the clicker means comprises a sleeve provided at a first end with
`a helically extending arm, a free end of the arm having a toothed member, and at a second end
`with a plurality of circumferentially directed saw teeth adapted to engage a corresponding
`plurality of circumferentially saw teeth provided on the clutch means.
`[0014] Alternatively, the clicker means comprises a sleeve provided at a first end with at
`least one helically extending arm and at least one spring member, a free end of the arm having a
`toothed member, and at a second end with a plurality of circumferentially directed saw teeth
`adapted to engage a corresponding plurality of circumferentially directed saw teeth provided on
`the clutch means.
`[0015] Preferably, the main housing is provided with a plurality of maximum dose stops
`adapted to be abutted by a radial stop provided on the dose dial sleeve. More preferably, at least
`one of the maximum dose stops comprises a radial stop located between a helical rib and spline
`means provided at a second end of the housing. Alternatively, at least one of the maximum dose
`stops comprises a part of a raised window portion provided at a second end of the housing.
`[0016] Preferably, the dose dial sleeve is provided with a plurality of radially extending
`members adapted to abut a corresponding plurality of radial stops provided at a second end of the
`housing.
`
`BRIEF DESCRIPTION OF THE FIGURES
`[0017] The invention will now be described with reference to the accompanying
`drawings in which:
`[0018] Figure 1 shows a sectional view of a pen-type injector in accordance with the
`present invention in a first, cartridge full, position;
`[0019] Figure 2 shows a sectional view of the pen-type injector of Figure 1 in a second,
`maximum first dose dialed, position;
`[0020] Figure 3 shows a sectional view of the pen-type injector of Figure 1 in a third,
`first maximum first dose dispensed, position;
`[0021] Figure 4 shows a sectional view of the pen-type injector of Figure 1 in a fourth,
`final dose dialed, position;
`
`3
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1025, p. 5 of 24
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`[0022] Figure 5 shows a sectional view of the pen-type injector of Figure 1 in a fifth,
`final dose dispensed, position;
`[0023] Figure 6 shows a cut-away view of a first detail of the pen-type injector of Figure
`
`i;
`
`[0024] Figure 7 shows a partially cut-away view of a second detail of the pen-type
`injector of Figure 1;
`[0025] Figure 8 shows a partially cut-away view of a third detail of the pen-type injector
`of Figure 1;
`[0026] Figure 9 shows the relative movement of parts of the pen-type injector shown in
`Figure 1 during dialing up of a dose;
`[0027] Figure 10 shows the relative movement of parts of the pen-type injector shown in
`Figure 1 during dialing down of a dose;
`[0028] Figure 11 shows the relative movement of parts of the pen-type injector shown in
`Figure 1 during dispensing of a dose;
`[0029] Figure 12 shows a partially cut-away view of the pen-type injector of Figure 1 in
`the second, maximum first dose dialed, position;
`[0030] Figure 13 shows a partially cut-away view of the pen-type injector of Figure 1 in
`the fourth, final dose dialed, position;
`[0031] Figure 14 shows a partially cut-away view of the pen-type injector of Figure 1 in
`one of the first, third or fifth positions;
`[0032] Figure 15 shows a cut-away view of a first part of a main housing of the pen-type
`injector of Figure 1; and
`[0033] Figure 16 shows a cut-away view of a second part of the main housing of the pen-
`type injector of Figure 1.
`
`DETAILED DESCRIPTION
`[0034] Referring first to Figures 1 to 5, there may be seen a pen-type injector in
`accordance with the present invention in a number of positions.
`[0035] The pen-type injector comprises a housing having a first cartridge retaining part 2,
`and second main housing part 4. A first end of the cartridge retaining means 2 and a second end
`of the main housing 4 are secured together by retaining features 6.
`In the illustrated
`
`4
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1025, p. 6 of 24
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`

`

`embodiment, the cartridge retaining means 2 is secured within the second end of the main
`housing 4.
`[0036] A cartridge 8 from which a number of doses of medicinal product may be
`dispensed is provided in the cartridge retaining part 2. A piston 10 is retained in a first end of the
`cartridge 8.
`[0037] A removable cap 12 is releasably retained over a second end of the cartridge
`retaining part 2. In use the removable cap 12 can be replaced by a user with a suitable needle
`unit (not shown). A replaceable cap 14 is used to cover the cartridge retaining part 2 extending
`from the main housing 4. Preferably, the outer dimensions of the replaceable cap 14 are similar
`or identical to the outer dimensions of the main housing 4 to provide the impression of a unitary
`whole when the replaceable cap 14 is in position covering the cartridge retaining part 2.
`[0038] In the illustrated embodiment, an insert 16 is provided at a first end of the main
`housing 4. The insert 16 is secured against rotational or longitudinal motion. The insert 16 is
`provided with a threaded circular opening 18 extending therethrough. Alternatively, the insert
`may be formed integrally with the main housing 4 the form of a radially inwardly directed flange
`having an internal thread.
`[0039] A first thread 19 extends from a first end of a piston rod 20. The piston rod 20 is
`of generally circular section. The first end of the piston rod 20 extends through the threaded
`opening 18 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 second end of the cartridge piston 10. A second thread
`24 extends from a second end of the piston rod 20. In the illustrated embodiment the second
`thread 24 comprises a series of part threads rather than a complete thread. The illustrated
`embodiment is easier to manufacture and helps reduce the overall force required for a user to
`cause medicinal product to be dispensed.
`[0040] The first thread 19 and the second thread 24 are oppositely disposed. The second
`end of the piston rod 20 is provided with a receiving recess 26.
`[0041] A drive sleeve 30 extends about the piston rod 20. The drive sleeve 30 is
`generally cylindrical. The drive sleeve 30 is provided at a first end with a first radially extending
`flange 32. A second radially extending flange 34 is provided spaced a distance along the drive
`sleeve 30 from the first flange 32. An intermediate thread 36 is provided on an outer part of the
`drive sleeve 30 extending between the first flange 32 and the second flange 34. A helical groove
`
`5
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1025, p. 7 of 24
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`

`

`38 extends along the internal surface of the drive sleeve 30. The second thread 24 of the piston
`rod 20 is adapted to work within the helical groove 38.
`[0042] A first end of the first flange 32 is adapted to conform to a second side of the
`insert 16.
`[0043] A nut 40 is located between the drive sleeve 30 and the main housing 2, disposed
`between the first flange 32 and the second flange 34. In the illustrated embodiment the nut 40 is
`a half-nut. This assists in the assembly of the injector. The nut 40 has an internal thread
`matching the intermediate thread 36. The outer surface of the nut 40 and an internal surface of
`the main housing 4 are keyed together by splines 42 (see Figures 10, 11, 15 and 16) to prevent
`relative rotation between the nut 40 and the main housing 4, while allowing relative longitudinal
`movement therebetween.
`[0044] A shoulder 37 is formed between a second end of the drive sleeve 30 and an
`extension 38 provided at the second end of the drive sleeve 30. The extension 38 has reduced
`inner and outer diameters in comparison to the remainder of the drive sleeve 30. A second end
`of the extension 38 is provided with a radially outwardly directed flange 39.
`[0045] A clicker 50 and a clutch 60 are disposed about the drive sleeve 30, between the
`drive sleeve 30 and a dose dial sleeve 70 (to be described below).
`[0046] The clicker 50 is located adjacent the second flange 34 of the drive sleeve 30.
`The clicker 50 is generally cylindrical and is provided at a first end with a flexible helically
`extending arm 52 (shown most clearly in Figure 6). A free end of the arm 52 is provided with a
`radially directed toothed member 54. A second end of the clicker 50 is provided with a series of
`circumferentially directed saw teeth 56 (of Figure 7). Each saw tooth comprises a longitudinally
`directed surface and an inclined surface.
`[0047] In an alternative embodiment (not shown) the clicker means further includes at
`least one spring member. The at least one spring member assists in the resetting of the clutch
`means 60 following dispense.
`[0048] The clutch means 60 is located adjacent the second end of the drive sleeve 30.
`The clutch means 60 is generally cylindrical and is provided at a first end with a series of
`circumferentially directed saw teeth 66 (see Figure 7).
`Each saw tooth comprises a
`longitudinally directed surface and an inclined surface. Towards the second end 64 of the clutch
`means 60 there is located a radially inwardly directed flange 62. The flange 62 of the clutch
`
`6
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1025, p. 8 of 24
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`

`

`means 60 is disposed between the shoulder 37 of the drive sleeve 30 and the radially outwardly
`directed flange 39 of the extension 38. The second end of the clutch means 60 is provided with a
`plurality of dog teeth 65 (Figure 8). The clutch 60 is keyed to the drive sleeve 30 by way of
`splines (not shown) to prevent relative rotation between the clutch 60 and the drive sleeve 30.
`[0049] In the illustrated embodiment, the clicker 50 and the clutch 60 each extend
`approximately half the length of the drive sleeve 30. However, it will be understood that other
`arrangements regarding the relative lengths of these parts are possible.
`[0050] The clicker 50 and the clutch means 60 are normally engaged, that is as shown in
`Figure 7.
`[0051] A dose dial sleeve 70 is provided outside of the clicker 50 and clutch means 60
`and radially inward of the main housing 4. A helical groove 74 is provided about an outer
`surface of the dose dial sleeve 70.
`[0052] The main housing 4 is provided with a window 44 through which a part of the
`outer surface of the dose dial sleeve may be seen. The main housing 4 is further provided with a
`helical rib 46, adapted to be seated in the helical groove 74 on the outer surface of the dose dial
`sleeve 70. The helical rib 46 extends for a single sweep of the inner surface of the main housing
`4. A first stop 100 is provided between the splines 42 and the helical rib 46 (Figure 15). A
`second stop 102, disposed at an angle of 180° to the first stop 100 is formed by a frame
`surrounding the window 44 in the main housing 4 (Figure 16).
`[0053] Conveniently, a visual indication of the dose that may be dialed, for example
`reference numerals (not shown), is provided on the outer surface of the dose dial sleeve 70. The
`Window 44 conveniently only allows to be viewed a visual indication of the dose currently
`dialed.
`
`[0054] A second end of the dose dial sleeve 70 is provided with an inwardly directed
`flange in the form of number of radially extending members 75. A dose dial grip 76 is disposed
`about an outer surface of the second end of the dose dial sleeve 70. An outer diameter of the
`dose dial grip 76 preferably corresponds to the outer diameter of the main housing 4. The dose
`dial grip 76 is secured to the dose dial sleeve 70 to prevent relative movement therebetween.
`The dose dial grip 76 is provided with a central opening 78. An annular recess 80 located in the
`second end of the dose dial grip 76 extends around the opening 78.
`
`7
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1025, p. 9 of 24
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`[0055] A button 82 of generally T section is provided at a second end of the pen-type
`injector. A stem 84 of the button 82 may extend through the opening 78 in the dose dial grip 76,
`through the inner diameter of the extension 38 of the drive sleeve 30 and into the receiving
`recess 26 of the piston rod 20. The stem 84 is retained for limited axial movement in the drive
`sleeve 30 and against rotation with respect thereto. A head 85 of the button 82 is generally
`circular. A skirt 86 depends from a periphery of the head 85. The skirt 86 is adapted to be
`seated in the annular recess 80 of the dose dial grip 76.
`[0056] Operation of the pen-type injector in accordance with the present invention will
`now be described. In Figures 9, 10 and 11 arrows A, B. C, D, E, F and G represent the respective
`movements of the button 82, the dose dial grip 76, the dose dial sleeve 70, the drive sleeve 30,
`the clutch means 60, the clicker 50 and the nut 40.
`[0057] To dial a dose (Figure 9) a user rotates the dose dial grip 76 (arrow A). With the
`clicker 50 and clutch means 60 engaged, the drive sleeve 30, the clicker 50, the clutch means 60
`and the dose dial sleeve 70 rotate with the dose dial grip 76.
`[0058] Audible and tactile feedback of the dose being dialed is provided by the clicker 50
`and the clutch means 60. Torque is transmitted through the saw teeth 56, 66 between the clicker
`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 dispose such that each click
`corresponds to a unit dose.
`[0059] The helical groove 74 on the dose dial sleeve 70 and the 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 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.
`[0060] The nut 40, keyed to the main housing 4, is advanced along the intermediate
`thread 36 by the rotation of the drive sleeve 30 (arrow D). When the final dose dispensed
`position (Figures 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 the nut 40 and the drive sleeve 30 from rotating further.
`
`8
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1025, p. 10 of 24
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`

`[0061] 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 during assembly of the pen-type
`injector.
`[0062] 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
`(Figure 10). The dose dial grip 76 is counter rotated. This causes the system to act in reverse.
`The flexible arm 52 now acts as a ratchet preventing the clicker from rotating. The torque
`transmitted through the clutch means 60 causes the saw teeth 56,66 to ride over one another to
`create the clicks corresponding to dialed dose reduction. Preferably the saw teeth 56,66 are so
`disposed that the circumferential extent of each saw tooth corresponds to a unit dose.
`[0063] When the desired dose has been dialed, the user may then dispense this dose by
`depressing the button 82 (Figure 11). This displaces the clutch means 60 axially with respect to
`the dose dial sleeve 70 causing the dog teeth 65 to disengage. However the clutch means 60
`remains keyed in rotation to the drive sleeve 30. The dose dial sleeve 70 and associated dose
`dial grip 76 are now free to rotate (guided by the helical rib 46 located in helical groove 74).
`[0064] The axial movement deforms the flexible arm 52 of the clicker 50 to ensure the
`saw teeth 56,66 cannot be overhauled during dispense. This prevents the drive sleeve 30 from
`rotating with respect to the main housing 4 though it is still free to move axially with respect
`thereto. This deformation is subsequently used to urge the clicker 50, and the clutch 60, back
`along the drive sleeve 30 to restore the connection between the clutch 60 and the dose dial sleeve
`70 when pressure is removed from the button 82.
`[0065] The longitudinal axial movement of the drive sleeve 30 causes the piston rod 20
`to rotate though the opening 18 in the insert 16, thereby to advance the piston 10 in the cartridge
`8. Once the dialed dose has been dispensed, the dose dial sleeve 70 is prevented from further
`rotation by contact of a plurality of members 110 (Figure 14) extending from the dose dial grip
`76 with a corresponding plurality of stops 112 formed in the main housing 4 (Figures 15 and 16).
`In the illustrated embodiment, the members 110 extend axially from the dose dial grip 76 and
`have an inclined end surface. The zero dose position is determined by the abutment of one of the
`axially extending edges of the members 110 with a corresponding stop 112.
`
`9
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1025, p. 11 of 24
`
`

`

`CLAIMS
`A method of determining a final dose of a medicament contained in a cartridge in
`a pen-type injector comprising,
`providing a housing containing a drive sleeve having a nut threadedly engaged to an outer
`surface of the drive sleeve between a first and second flange;
`configuring the nut and thread to be indicative of dispensed doses; and
`configuring the second flange to engage the nut when a final dose of medicament is
`dispensed from a cartridge attached to the pen-type injector.
`
`10
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1025, p. 12 of 24
`
`

`

`ABSTRACT
`The present invention relates to injectors, such as pen-type injectors, that provide for
`administration of medicinal products from a multidose-cartridge and permit a user to set the
`delivery dose. The injector may include a housing, a piston rod adapted to operate through the
`housing, a dose dial sleeve located between the housing and the piston rod, and a drive sleeve
`located between the dose dial sleeve and the piston rod. The dose dial sleeve may have a helical
`thread of first lead and the drive sleeve may have a helical groove of second lead. The first lead
`of the helical thread and the second lead of the helical groove may be the same.
`
`11
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1025, p. 13 of 24
`
`

`

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`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1025, p. 14 of 24
`
`

`

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