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`
`Customer Number 22,852
`Attorney Docket No. 02481.1839
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of: Robert Frederick VEASEY et al.
`
`Application No.: 10/790,225
`
`Filed: March 2, 2004
`
`For:
`
`IMPROVEMENTS IN AND RELATING TO A PEN-
`TYPE INJECTOR
`
`)
`)
`) Group Art Unit: 3763
`)
`) Examiner: Not yet available
`)
`)
`)
`
`MAIL STOP MISSING PART
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`CLAIM FOR PRIORITY
`
`Under the provisions of Section 119 of 35 U.S.C., applicants hereby claim the
`
`benefit of the filing date of Great Britain Application No. 03 04822.0, filed March 3, 2003,
`
`for the above identified United States Patent Application.
`
`In support of applicants' claim for priority, filed herewith is one certified copy of
`
`the above.
`
`Respectfully submitted,
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`
`Dated: August 20, 2004
`Enclosure
`EFC/FPD/blc
`
`By:
`
`Ernest F. Chapn
`Reg. No. 23^961
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 1 of 34
`
`

`

`#-9
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 2 of 34
`
`

`

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`INVESTOR IN PEOPLE
`The Patent Office
`Concept House
`Cardiff Road
`Newport
`South Wales
`NP10 8QQ
`
`L the undersigned, being an officer duly authorised in accordance with Section 74(1) and (4)
`If the Deregulation & Contracting Out Act 1994, to sign and issue certificates on behalf of the
`lomptroller-General, hereby certify that annexed hereto is a true copy of the documents as
`figinally filed in connection with the patent application identified therein.
`
`Iso certify that the attached copy of the request for grant of a Patent (Form 1/77) bears an
`lendment, effected by this office, following a request by the applicant and agreed to by the
`imptroller-General.
`
`iccordance with the Patents (Companies Re-registration) Rules 1982, if a company named
`[lis certificate and any accompanying documents has re-registered under the Companies Act
`b with the same name as that with which it was registered immediately before re-
`ktration save for the substitution as, or inclusion as, the last part of the name of the words
`klic limited company" or their equivalents in Welsh, references to the name of the company
`Is certificate and any accompanying documents shall be treated as references to the name
`Iwhich it is so re-registered.
`
`ordance with the rules, the words "public limited company" may be replaced by p.l.c.,
`L.C. or PLC.
`
`istration under the Companies Act does not constitute a new legal entity but merely
`s the company to certain additional company law rules.
`
`Signed
`
`Dated
`
`18 May 2004
`
`3
`
`CERTIFIED COPY OF
`PRIORITY DOCUMENT
`
`An Executive Agency of the Department of Trade and Industry
`
`•*".r •
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 3 of 34
`
`

`

`&
`
`0
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 4 of 34
`
`

`

`Paten
`orm H I !
`Patents^^P 1977
`(Rule 16)
`
`Request for grant of a patent
`(See the notes on the back of this form. You can also get
`an explanatory leaflet from the Patent Office to help you fill in
`this form)
`
`The
`^apffFArENT OFFICE
`g
`(pffice
`- SMM2)0$
`NEWPORT
`
`Rule 4(1)
`
`1/77
`
`The Patent Office
`
`Cardiff Road
`Newport
`Gwent NP9 1RH
`
`Your reference
`
`Patent application number
`(The Patent Office will fill in this part)
`
`JAM/P96042UK
`MAR 2003
`
`(mm £789261-1 DOGtti
`P01/7700 0,00-0304822.0
`
`3.
`
`Full name, address and postcode of the or of each
`applicant (underline all surnames)
`
`DCA International Limited
`19 Church Street
`Warwick CV34 4AB
`
`0304822.0
`
`i.
`
`Patents ADP number (if you know it)
`
`If the applicant is a corporate body, give the
`country/state of its incorporation
`
`Title of the invention
`
`Improvements in and relating to a pen-type injector
`
`Marks & Clerk
`Name of your agent (if you have one)
`49 Stoney Street
`* ^
`"Address for service" in the United Kingdo^jiftoVj NOTTINGHAM
`which all correspondence should be senk-S _
`NG1 1LX
`-
`(including the postcode)
`ADP No. 00000018015
`
`_
`
`^
`
`6.
`
`8.
`
`Patents ADP number (if you know it)
`
`If you are declaring priority from one or more
`earlier patent applications, give the country and
`the date of filing of the or each of these earlier
`applications and (if you know it) the or each
`application number
`
`Country
`
`Priority application number
`(if you know it)
`
`•7*
`
`Date of filing
`(day/month /
`year)
`
`If this application is divided or otherwise derived
`from an earlier UK application, give the number
`and filing date of the earlier application
`
`Number of earlier application
`
`Date of filing
`(day / month /year)
`
`Is a statement of inventorship and of right to
`grant of a patent required in support of this
`request? (Answer 'yes' if:
`a) any applicant named in part 3 is not an inventor, or
`b) there is an inventor who is not named as an
`applicant, or
`c) any named applicant is a corporate body.
`
`S:\Public\DATAWOPlJPROC\3>ATEHTS\rK:A\DCA PS>6042UK Alpha Mechanism Concept 12\P96042UK 20030303 Form 1 77.-wpd
`
`Patents Form 1/77
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 5 of 34
`
`

`

`Patents Form 1/77
`
`9
`
`fr
`
`r the number of sheets for any of the
`owing items you are filing with this form.
`imlo
`Do not count copies of the same document
`
`Continuation sheets of this form
`Description
`
`Claim(iJ
`
`Abstract
`
`10.
`
`Drawing^
`If you are also filing any of the following, state
`how many against each item.
`
`1 1
`
`3
`
`-n
`7 A
`
`Priority documents
`Translation of priority documents
`Statement of inventorship and right to
`grant of a patent (Patents Form 7/77)
`Request for preliminary examination and
`search (Patents Form 9/77)
`Request for substantive examination
`(Patents Form 10/77)
`
`Any other documents
`(please specify)
`
`1 1 .
`
`I/We request the grant of a patent on the basis of this application.
`Date
`Signature
`3 March 2003
`ItuC
`PA Moffat
`(024) 7622 2756/7145
`
`Ur
`
`1 2 .
`
`Name and daytime telephone number of person to
`contact in the United Kingdom
`Warning
`After an application for a patent has been filed, the Comptroller of the Patent Office will consider whether publication or
`communication of the invention should be prohibited or restricted under Section 22 of the Patents Act 1977. You will be informed if it is
`necessary to prohibit or restrict your invention in this way. Furthermore, if you live in the United Kingdom, Section 23 of the Patents
`Act 1977 stops you from applying for a patent abroad without first getting written permission from the Patent Office unless an
`application has been filed at least 6 weeks beforehand in the United Kingdom for a patent for the same invention and either no
`direction prohibiting publication or communication has been given, or any such direction has been revoked.
`
`S :\PubUc\f ATAWOPX-PP.OCVPATEMT E\r>CA\DCA PS«P42UK Alphi Meckankm Concept 12\P96042UK 20030303 Fotm 1 77.wpd
`
`Patents Form 1/77
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 6 of 34
`
`

`

`DUPUCATE
`
`P96042UK 20030303 SpecforFiling.doc
`
`Improvements in and relating to a pen-type injector
`
`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.
`
`5
`
`Such injectors have application where regular injection by persons without formal
`medical training occurs. This is increasingly common amongst those having
`10 diabetes where self-treatment enables such persons to conduct effective
`management of their diabetes.
`
`15
`
`20
`
`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).
`
`It is an advantage of the present invention that an improved pen-type injector is
`provided.
`
`25 According to a first aspect of the present invention, a pen-type injector comprises
`a housing;
`a piston rod adapted to operate through the 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;
`characterised in that the first lead of the helical thread and the second lead of the
`helical groove are the same.
`
`30
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 7 of 34
`
`

`

`P96042UK 20030303 SpecforFiling.doc
`
`#
`
`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 dose
`dial sleeve; and
`clutch means are provided which upon depression of the button permit rotation
`between the dose dial sleeve and the drive sleeve.
`
`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.
`
`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.
`
`Preferably, the first thread of the piston rod is oppositely disposed to the second
`thread of the piston rod.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`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.
`
`30
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 8 of 34
`
`

`

`P96042UK 20030303 SpecforFiling.doc
`
`Preferably, the pen-type injector further includes clicker means disposed between
`the dutch means and spline means provided on the housing.
`
`More preferably, the clicker means comprises a sleeve provided at a first end
`5 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.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`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.
`
`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.
`
`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.
`
`The invention will now be described with reference to the accompanying
`drawings, in which:-
`Figure 1 shows a sectional view of a pen-type injector in accordance with the
`present invention in a first, cartridge full, position;
`Figure 2 shows a sectional view of the pen-type injector of Figure 1 in a second,
`maximum first dose dialed, position;
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 9 of 34
`
`

`

`P96042UK 20030303 SpecforFiling.doc
`
`™ 4 —
`
`Figure 3 shows a sectional view of the pen-type injector of Figure 1 in a third, first
`maximum first dose dispensed, position;
`Figure 4 shows a sectional view of the pen-type injector of Figure 1 in a fourth,
`final dose dialed, position;
`Figure 5 shows a sectional view of the pen-type injector of Figure 1 in a fifth, final
`dose dispensed, position;
`Figure 6 shows a cut-away view of a first detail of the pen-type injector of
`Figure 1;
`Figure 7 shows a partially cut-away view of a second detail of the pen-type
`injector of Figure 1;
`Figure 8 shows a partially cut-away view of a third detail of the pen-type injector
`of Figure 1;
`Figure 9 shows the relative movement of parts of the pen-type injector shown in
`Figure 1 during dialing up of a dose;
`Figure 10 shows the relative movement of parts of the pen-type injector shown in
`Figure 1 during dialing down of a dose;
`Figure 11 shows the relative movement of parts of the pen-type injector shown in
`Figure 1 during dispensing of a dose;
`Figure 12 shows a partially cut-away view of the pen-type injector of Figure 1 in
`the second, maximum first dose dialed, position;
`Figure 13 shows a partially cut-away view of the pen-type injector of Figure 1 in
`the fourth, final dose dialed, position;
`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;
`Figure 15 shows a cut-away view of a first part of a main housing of the pen-type
`injector of Figure 1; and
`Figure 16 shows a cut-away view of a second part of the main housing of the
`pen-type injector of Figure 1.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30 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.
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 10 of 34
`
`

`

`P96042UK 20030303 SpecforFiling.doc
`
`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 embodiment, the cartridge retaining
`5 means 2 is secured within the second end of the main housing 4.
`
`10
`
`IS
`
`20
`
`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.
`
`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 replacable 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.
`
`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.
`
`25 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
`
`30
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 11 of 34
`
`

`

`P96042UK 20030303 SpecforFiling.doc
`
`- 6 -
`
`is easier to manufacture and helps reduce the overall force required for a user to
`cause medicinal product to be dispensed.
`
`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.
`
`5
`
`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 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.
`
`A first end of the first flange 32 is adapted to conform to a second side of the
`insert 16.
`
`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.
`
`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.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 12 of 34
`
`

`

`P96042UK 20030303 SpecforFiling.doc
`
`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).
`
`5 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 dicker 50 is provided with a series of circumferentially directed saw teeth 56
`(cf Figure 7). Each saw tooth comprises a longitudinally directed surface and an
`inclined surface.
`
`10
`
`15
`
`20
`
`25
`
`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.
`
`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 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.
`
`30
`
`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.
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 13 of 34
`
`

`

`P96042UK 20030303 SpecforFiling.doc
`
`The clicker 50 and the clutch means 60 are normally engaged, that is as shown
`in Figure 7.
`
`5 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.
`
`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).
`
`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.
`
`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.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 14 of 34
`
`

`

`P96042UK 20030303 SpecforFiling.doc
`
`• 9 -
`
`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.
`
`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.
`
`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.
`
`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 dicker 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 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
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 15 of 34
`
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`P96042UK 20030303 SpecforFiling.doc
`
`- 1 0 -
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`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 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.
`
`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.
`
`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.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`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.
`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).
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 16 of 34
`
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`P96042UK 20030303 SpecforFiling-doc
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`- 1 1 -
`
`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 dicker 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.
`
`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.
`
`5
`
`10
`
`15
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 17 of 34
`
`

`

`P96042UK 20030303 SpecforFiling.doc
`
`- 1 2 -
`
`CLAIMS
`
`5
`
`10
`
`15
`
`20
`
`25
`
`A pen-type injector comprising a housing;
`1
`a piston rod adapted to operate through the 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;
`characterised in that the first lead of the helical thread and the second lead of the
`helical groove are the same.
`
`A pen-type injector according to claim 1, characterised in that the piston
`2
`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 dose
`dial sleeve; and
`clutch means are provided which upon depression of the button permit rotation
`between the dose dial sleeve and the drive sleeve.
`
`A pen-type injector according to claim 1 or claim 2, in which the injector
`3
`further comprises a nut which is rotatable with respect to the drive sleeve and
`axially displaceable but not rotatable with respect to the housing.
`
`30
`
`A pen-type injector according to claim 3, in which the drive sleeve is
`4
`provided at a first end with first and second flanges with an intermediate thread
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 18 of 34
`
`

`

`P96042UK 20030303 SpecforFiling-doc
`
`- 13 -
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`between the first and second flanges, the nut being disposed between the first
`and second flanges and keyed to the housing by spline means.
`
`5
`
`A pen-type injector according to claim 4, in which a first radial stop is
`5
`provided on a second face of the nut and a second radial stop is provided on a
`first face of the second flange.
`
`A pen-type injector according to any of claims 2 to 5, in which the first
`6
`thread of the piston rod is oppositely disposed to the second thread of the piston
`rod.
`
`10
`
`A pen-type injector according to any of claims 2 to 6, in which a second
`7
`end of the clutch is provided with a plurality of dog teeth adapted to engage with
`a second end of the dose dial sleeve.
`
`A pen-type injector according to any of claims 2 to 7, in which the pen-type
`8
`injector further includes clicker means disposed between the clutch means and
`spline means provided on the housing.
`
`A pen-type injector according to claim 8, in which the clicker means
`9
`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.
`
`A pen-type injector according to claim 8, in which the clicker means
`10
`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.
`
`15
`
`20
`
`25
`
`30
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1026, p. 19 of 34
`
`

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`P96042UK 20030303 SpecforFiling.doc
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`- 14-
`
`A pen-type inj