(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`8 November 2001 (08.11.2001)
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`(43) International Publication Date
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`(10) International Publication Number
`WO 01/83008 A1
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`(51) International Patent Classification7:
`
`A61M 5/31
`
`(21) International Application Number:
`
`PCT/DK01/00281
`
`DE, DK, DM, DZ, EE, ES, FI, GB, GD, GE, GH, GM, HR,
`HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR,
`
`LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ,
`NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM,
`
`(22) International Filing Date:
`
`27 April 2001 (27.04.2001)
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`TR: TT: TZ: UA: UG, UZ: VN, YU: ZA: ZW
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`(25) Filing Language:
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`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`PA 2000 00739
`
`4 May 2000 (04.05.2000)
`
`DK
`
`(71) Applicant: NOVO NORDISK A/S [DK/DK]; Novo Allé,
`DK—2880 Bagsveerd (DK).
`
`(72) Inventors: HANSEN, Steffen; Gl. Frederiksborgvej 64A,
`DK—3400 Hillerod (DK). MILLER, Thomas, Dedenroth;
`Teglstrupvej 15, Emdrup, DK—2100 Copenhagen 0 (DK).
`
`(84) Designated States (regional): ARIPO patent (GH, GM,
`KE, LS, MW, MZ, SD, SL, SZ, TZ, UG, ZW), Eurasian
`
`132E611t (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM): European
`patent (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE,
`
`IT, LU, MC, NL, PT, SE, TR), OAPI patent (BF, BJ, CF,
`CG: CL CM: GA: GN: GW: ML: MR: NE: SN: TD: TG)«
`
`Published:
`7 with international search report
`7 before the expiration of the time limit for amending the
`
`claims and to be republished in the event 0f reeeipt 0f
`amendments
`
`(81) Designated States (national): AE, AG, AL, AM, AT, AU,
`AZ, BA, BB, BG, BR, BY, BZ, CA, CH, CN, CR, CU, CZ,
`
`For two-letter codes and other abbreviations, refer to the ”Guid-
`ance Notes on Codes andAbbreviations ” appearing at the begin-
`ning ofeach regular issue ofthe PCT Gazette.
`
`(54) Title: AN INJECTION DEVICE, A PREASSEMBLED DOSE SETTING AND INJECTION MECHANISM FOR AN IN—
`JECTION DEVICE, AND A METHOD OF ASSEMBLING AN INJECTION DEVICE
`
` /
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`1 0
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`/’/
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`01/83008A1
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`(57) Abstract: An injection device made up from a housing, a dose setting and injection mechanism, a dose setting member and an
`injection button is described. The dose setting and injection mechanism is made as a preassembled unit insertable into the housing.
`Both the dose setting member and the injection button is thereafter connected to the preassembled dose setting and injection mecha—
`O nism inside the boundaries of the housing, while being accessible for a user from outside the housing. The same preassembled dose
`setting and injection mechanism can fit into a large variety of different houses making production of different variants of an injection
`device somewhat easier.
`
`Mylan Exhibit - 1034
`
`Mylan v. Sanofl
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`

`

`WO 01/83008
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`PCT/DK01/00281
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`An injection device, a preassembled dose setting and injection mechanism for an in-
`
`jection device, and a method of assembling an injection device.
`
`1
`
`The Technical Field of the Invention:
`
`The invention relates to injection devices of the kind comprising a housing accommodating
`
`an cartridge, a dose setting and injection mechanism, a dose-setting member coupled to the
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`dose setting and injection mechanism, and an injection button coupled to the dose setting
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`and injection mechanism and by which a piston rod drive can be activated for advancing the
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`piston rod forward to press out a set dose through a conduit connected to the cartridge.
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`The invention furthermore relates to a preassembled dose setting and injection mechanism
`
`for an injection device.
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`Finally the invention relates to a method of assembling an injection device.
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`Description of the Related Art:
`
`A prior art injection device of this kind is shown in WO 98/56436, which injection device is
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`also shown in figure 1 of this application. This device consists of three basic parts; a dose
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`setting and injection mechanism, a dose-setting member and an injection button. The dose
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`setting and injection mechanism contains a piston rod 1 and a piston rod drive comprising
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`gear wheels 2 and 3, a coupling ring 4, and a driver 5. The coupling ring 4 and the driver 5
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`are connected through a unidirectional coupling. The dose-setting element 6 has a carrier 7
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`and a finger grip 8. The injection button 9 works a not shown gearvvheel placed at the hub of
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`the coupling ring 4.
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`In injection devices of this type the dose setting and injection mechanism is made as an inte-
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`grated part of the housing. The outer shape of the housing has to facilitate the appearance of
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`the close setting and injection mechanism, and the housing is moulded with a number of pro-
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`trusions supporting the various elements of the dose setting and injection mechanism.
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`Mylan Exhibit - 1034
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`Mylan V. Sanofi
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`Mylan Exhibit - 1034
`Mylan v. Sanofi
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`

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`WO 01/83008
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`Description of the Invention:
`
`If for some reason an injection device with a different outer design is needed, it is necessary
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`to reconstruct the entire dose setting and injection mechanism in order to fit it into the new
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`redesigned housing. This takes a substantial amount of time, both to the reconstruction of
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`the entire device, but also to get the proper approvals from the authorities. Therefore many
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`manufactures of injection devices are very reluctance to market new injection devices, de—
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`signed in accordance with the trends in the world of fashion.
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`1O
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`Although a new type of injection devices are approved by the authorities prior to the market-
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`ing, there always persists a small risk of malfunction due to an erroneous construction of the
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`dose setting and injection mechanism. Another safety disadvantage is that the function of the
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`dose setting and injection mechanism cannot be tested once the injection device is assem-
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`bled, while it is impossible to move the piston rod backwards once the injection device is as-
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`15
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`sembled.
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`It is an object of the present invention to provide an injection device where the outer design
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`of the housing can be altered without having to change the dose setting and injection
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`mechanism. Further, it is an object to provide an injection device, which can be new in de-
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`sign but having a save and well-proven dose setting and injection mechanism, thereby mini-
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`mizing the risk of malfunction. Finally it is an object of the present invention to provide an in-
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`jection device where the function of the dose setting and injection device can be properly
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`tested before the injection device is completely assembled.
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`This is obtained by an injection device having a housing accommodating an cartridge con-
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`taining medicine sufficient for a number of dosed injections, which doses are injected by ad-
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`vancing a piston forward inside said cartridge, comprising:
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`A dose setting and injection mechanism comprising a piston rod abutting said piston and a
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`piston rod drive for driving said piston rod,
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`A dose-setting member coupled to said dose setting and injection mechanism for setting up a
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`dose, and
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`Mylan Exhibit - 1034
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`

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`WO 01/83008
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`PCT/DK01/00281
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`3
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`An injection button coupled to said dose setting and injection mechanism and by which said
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`piston rod drive can be activated for advancing said piston rod and said piston fonivard to
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`press out a set dose through a conduit connected to said cartridge,
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`Which injection device according to the invention is characterized in that
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`1O
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`15
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`said dose setting mechanism is a preassembled unit insertable into said housing to form a
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`complete assembly, and that said dose-setting member and said injection button, both being
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`accessible for the user from outside said housing, is connected to said preassembled dose
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`setting and injection mechanism inside the boundaries of said housing.
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`By making the dose setting and injection mechanism as a preassembled unit, this unit is in—
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`dependent of the housing, and if a new injection device with a new outer design is called for,
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`it is fairly simple to redesign the housing and then insert the standardized dose setting and
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`injection mechanism. From a manufacturing point of view production of a large variety of in-
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`jection devices each carrying a different design is made very simple by using a preassem-
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`bled dose setting and injection mechanism. But from a safety point of view it is certainly a
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`great safety issue to be able to manufacture injection devices with a new outer design, but
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`still containing the well proven standardized dose and injection mechanism of an earlier de- .
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`20
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`vice.
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`It is also a particular advantage that the preassembled dose setting and injection mechanism
`
`permits a testing of the function of the mechanism before the complete assembly is done.
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`When, as disclosed in claim 2, the dose-setting member is provided with a number of carri-
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`ers, which carriers is received in depressions in said preassembled dose setting and injection
`
`mechanism, it is in a very handy way ensured that the dose-setting member interfaces the
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`preassembled dose setting and injection mechanism. The carriers could be provided with
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`click-pawls, which would lock the dose-setting member to the preassembled dose setting and
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`injection device in a inseparable way.
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`When, as disclosed in claim 3, the injection button is provided with a toothed rack, which
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`toothed rack is received in a slot in said preassembled dose setting and injection mecha-
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`nism, it is ensured that the longitudinal movement of the injection button is transferred to a
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`rotational movement of the coupling ring. The injection button could be provided with a pro—
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`30
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`35
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`Mylan Exhibit - 1034
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`Mylan V. Sanofi
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`Mylan Exhibit - 1034
`Mylan v. Sanofi
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`WO 01/83008
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`trusion, which fits into a longitudinal track in the housing, thereby locking the injection button
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`to the housing.
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`4
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`It is also an object of the present invention to provide a preassembled close setting and injec-
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`tion mechanism, which can be fitted into a large variety of different housings.
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`This is obtained by a preassembled dose setting and injection mechanism for an injection
`
`device according to the invention, which preassembled dose setting and injection mechanism
`
`is characterized in that said preassembled dose setting and injection mechanism comprises:
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`a coupling ring driven by said injection button,
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`a driver driving the piston rod through a suitable gearing, and
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`a unidirectional coupling connecting the coupling ring and the driver in a unidirectional man—
`ner.
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`By making the dose setting and injection mechanism as a single preassembled unit it will be
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`possible to recycle the injection device. The recycled device can be disassembled, and the
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`preassembled dose setting and injection mechanism can be reused after the piston rod has
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`been moved backward to its original position. The other parts of the injection device can off
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`cause be recycled in the same manor. The various parts can either be recycled by using the
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`same part again as described, or more likely, the various parts can be sorted into the differ-
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`ent types of plastic and then granulated for recycling.
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`Finally it is an object of the invention to provide a method of assembling an injection device in
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`a way, which is both easy and inexpensive.
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`This is obtained by a method of assembling an injection device according to the invention,
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`which method is characterized in comprising the steps of:
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`a) Preassembling the close setting and injection mechanism to provide a preassembled unit,
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`b) Placing the preassembled unit in the housing and connecting said preassembled unit to
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`35
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`said housing,
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`Mylan Exhibit — 1034
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`

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`WO 01/83008
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`PCT/DK01/00281
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`0) Connecting the dose—setting member to said preassembled unit inside the boundaries of
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`said housing, and
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`d) Connecting the injection button to said preassembled unit inside the boundaries of said
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`housing.
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`This method makes production somewhat easier since one production line constantly can
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`produce and assembly the standardized dose setting and injection mechanism, while other
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`production lines again can manufacture housings of various designs. The preassembled
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`close setting and injection mechanism can then be placed inside the various houses.
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`Brief Description of the Drawings:
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`The invention will be explained more fully below in connection with a preferred embodiment
`
`and with reference to the drawings in which:
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`10
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`15
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`Figure 1
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`Shows an exploded view of the prior art injection device.
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`Figure 2
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`Shows an exploded top view of the injection device according to
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`the invention.
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`Figure 3
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`Shows an exploded bottom view of the injection device according
`to the invention.
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`Figure 4
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`Shows an exploded view of the preassembled dose setting and
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`injection mechanism.
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`Figure 5
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`Shows a schematically bottom view of the preassembled dose set-
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`ting and injection mechanism.
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`Figure 6
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`Shows a schematically top view of the preassembled dose setting
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`and injection mechanism.
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`Mylan Exhibit - 1034
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`

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`WO 01/83008
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`PCT/DK01/00281
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`The figures are schematic and simplified for clarity, and they just show details, which are es-
`
`sential to the understanding of the invention, while other details are left out. Throughout, the
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`same reference numerals are used for identical or corresponding parts.
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`Detailed Description of Embodiments:
`
`Figure 1 shows an injection device according to the preamble of claim 1. This injection de—
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`vice contains three basic parts; a dose setting and injection mechanism being fully built into
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`the housing 10, a dose-setting member 6 and an injection button 9. The dose setting and in-
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`jection mechanism contains a piston rod 1 and a piston rod drive comprising gear wheels 2
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`and 3, a coupling ring 4, and a driver 5. The dose-setting member 6 for setting up a dose is
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`integral with the carrier 7 and the finger grip 8. The injection button 9 works a not shown
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`geanNheel placed at the hub of the coupling ring 4. When setting up a dose by rotating the
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`dose-setting member 6, the coupling ring 4 is rotated due to the carrier 7 placed on the dose—
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`setting member 6. This rotation will lift the injection button 9 away from the device. Pressing
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`back the injection button 9 will cause the coupling ring 4 to rotate, since this ring through a
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`unidirectional coupling is connected to the driver 5, this driver 5 will also rotate. A not shown
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`gear wheel placed on the hub of the driver 5 engages the first gear wheel 3 which again en-
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`gages the second gear wheel 2 and advances the piston rod 1. A more detailed description
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`of this prior art injection device is given in WO 98/56436.
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`An injection device according to the invention is shown in figure 2. This device is made from
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`a housing 10 containing a cartridge 13 containing medicine sufficient for a number of dosed
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`injections. inserted into the housing 10 is a preassembled dose setting and injection mecha-
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`nism 14, which inside the boundaries of the housing 10 is connected to the injection button
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`11 and to the dose—setting member 12.
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`As shown in figure 3 the dose~setting member 12 has on its backside a carrier 15, which is
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`connected to the preassembled dose setting and injection mechanism 14 as will be de-
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`scribed later. Although only one carrier 15 is shown there could off cause be more than one
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`carrier 15 if so wanted. The injection button 11 is connected to the preassembled dose set-
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`ting and injection mechanism 14 through a toothed rack 16. The injection button 11 is pref-
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`erably provided with a protrusion 17, which protrusion 17 is guided in a not shown track in
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`the housing 10, which track has a not shown stop-pawl, which prevents the injection button
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`Mylan Exhibit - 1034
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`Mylan V. Sanofi
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`Mylan Exhibit - 1034
`Mylan v. Sanofi
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`

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`WO 01/83008
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`PCT/DK01/00281
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`7
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`11 from being disconnected from the housing 10. When manufacturing the housing, this
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`could be done by moulding the housing in two parts, which two parts then could be glued to—
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`gether, or otherwise connected.
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`Referring now to figure 4 to 6, the preassembled dose setting and injection mechanism 14 is
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`made up from a rod guiding part 20 in which a flexible piston rod 21 is guided. The rod guid-
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`ing part 20 has a slot 31 and an inwardly pointing protrusion 39. The flexible rod 21 is being
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`driven by a first gear wheel 22, which again is being driven by the hub-wheel 25 of the sec—
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`ond gear wheel 23. The second gear wheel 23 is made up from an outer gear wheel 24,
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`which is integral with a hub-wheel 25. The outer geanNheel 24 is driven by the hub-wheel 26
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`on the driver 27. This driver 27 also has an outer gear wheel 28, which is located inside the
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`coupling ring 29 and in unidirectional contact with the coupling ring 29. The coupling ring 29
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`is provided with a hub-wheel 30, which hub-wheel 30 is driven by the toothed rack 16, guided
`in a slot 31, of the injection button 11 when the injection device is being operated.
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`‘
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`The entering part of the slot 31 formed in the rod guiding part 20 need not be formed as an
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`open track-like slot 31 as shown in figure 6, but can easily be made as a slot 31 solely ac-
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`cessible from the periphery of the rod guiding part 20 i.e. similar to the exit part of the slot 31
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`shown in figure 5.
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`The hub-wheel 30 of the coupling ring 29 is connected to the coupling ring 29 through a rigid
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`part 37 and a flexible part 38. The coupling ring 29 has on its inside a number of barbs 40,
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`which barbs 40 interconnects with the barbs 41 of the outer gear—wheel 28 of the driver 27.
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`The barbs 41 at the outer gear wheel 28 of the driver 27 are by a protrusion 39 located on
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`the rod guiding part 20 prevented from rotation in one direction. The direction in which the
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`driver can move freely is the direction by which the piston rod 21 is moved forward in the car-
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`tridge 13.
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`An arm 32 is at the centre 34 connected to the centre of the rod guiding part 20. On the other
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`end, the arm 32 is equipped with a cam 35 interacting with a notch 42 provided at the rim of
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`the coupling ring 29, thereby locking the arm 32 to the coupling ring 29. The arm 32 also has
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`a depression 33 into which to the carrier 15 on the backside of the dose-setting member 12
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`is fitted. A second arm 36 is situated parallel to the first arm 32 and is connected thereto
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`through a flexible beam. The second arm 36 has on its backside a not shown cam, situated
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`Mylan Exhibit - 1034
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`Mylan V. Sanofi
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`Mylan Exhibit - 1034
`Mylan v. Sanofi
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`

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`8
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`near the centre 34. This cam is movable locked in the spiral shaped track of the driver 27. In
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`this way the number of rotations the driver 27 can perform relatively to the second arm 32
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`and the rod guiding part 20 is limited, and the total length of the track is adapted to the total
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`amount of medicine in the cartridge 13 thereby ensuring that a dose larger than the amount
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`of medicine remaining in the cartridge 13 cannot be set.
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`When operating the injection device the dose is set by turning the dose-setting member 12,
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`which is connected to the arm 32. Due to the connection between the cam 35 on the arm 32
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`and the notch 42 on the coupling ring 29, the coupling ring 29 is rotated to. Since the hub 30
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`of the coupling ring 29 is connected to the toothed rack 16 of the injection button 11, this but-
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`ton 11 is lifted away from the injection device. Due to the protrusion 39 interfering with the
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`barbs 41, the driver 27 is prevented from rotating, while the barbs 40 rides over the barbs 41
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`on the driver 27. This at the same times makes an audible sound.
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`If a set dose is regretted the dose-setting member 12 is rotated in the opposite direction. Due
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`to the flexible part 38 of the coupling ring 29, the coupling ring 29 expands outward, allowing
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`the barbs 40 to slide over the barbs 41 of the driver 27. Hence the driver 27 is not affected by
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`this backward rotation of coupling ring 29.
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`The bulging ends 43, 44 provided at the coupling ring 29 rides over the barbs 45 situated on
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`the inside of the rod guiding part 20 and keeps the coupling ring 39 stretched at all times
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`such that the bulging ends 40 interconnects with the barbs 41 of the driver 27
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`When delivering the set dose, the injection button 11 is pressed home. The toothed rack 16
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`of the injection button 11 works the hub-wheel 30 of the coupling ring 29. This rotates the
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`coupling ring 29, where the barbs 40 force the outer gear wheel 28 of the driver 27 and the
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`hub-wheel 26 to rotate. The hub-wheel 26 rotates the outer gear wheel 24 of the second gear
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`wheel 23 being integral with the hub-wheel 25, which rotates the first gear wheel 22. Rotation
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`of the first gear-wheel 22 causes the piston rod 21 to advance inside the cartridge 13,
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`thereby expelling the set close of medicine though the not shown needle connected to the
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`distal end of the cartridge 13.
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`When manufacturing an injection device according to the invention, the dose setting and in-
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`jection mechanism 14 is first assembled into a preassembled unit 14. Then the preassem—
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`bled unit 14 is placed in the housing 10 and connected to the housing through suitable
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`Mylan Exhibit - 1034
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`Mylan V. Sanofi
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`Mylan Exhibit - 1034
`Mylan v. Sanofi
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`

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`9
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`means. Pressing the carrier 15 into the depression 33 on the arm 32 of the preassembled
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`unit 14 connects the dose-setting member 12 to the preassembled unit 14. Finally the injec—
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`tion button 11 is connected to the preassembled unit 14 by placing the toothed rack 16 of the
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`injection button 11 into the slot 31 of the preassembled unit 14.
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`Assembling the preassembled unit 14 can be done in one production line, while other pro—
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`duction lines can do the final assembling of the various injection devices using the same pre-
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`assembled unit 14.
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`Some preferred embodiments have been shown in the foregoing, but it should be stressed
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`that the invention is not limited to these, but may be embodied in other ways within the sub-
`ject matter defined in the following claims. The principles described could e.g. easily be
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`adapted to a pencil shaped injection device without derogating from the scope of the claims.
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`10
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`Mylan Exhibit - 1034
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`

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`WO 01/83008
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`Claims:
`
`10
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`1. An injection device having a housing accommodating an cartridge containing medicine
`
`sufficient for a number of closed injections, which doses are injected by advancing a piston
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`fonrvard inside said cartridge, comprising:
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`A dose setting and injection mechanism comprising a piston rod abutting said piston and a
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`piston rod drive for driving said piston rod forward,
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`A dose—setting member coupled to said dose setting and injection mechanism for setting up a
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`dose to be injected, and
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`An injection button coupled to said dose setting and injection mechanism and by which said
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`piston rod drive can be activated for advancing said piston rod and said piston forward to
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`press out the set close through a conduit connected to said cartridge,
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`characterized in that
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`Said dose setting and injection mechanism is a preassembled unit insertable into said hous-
`
`ing to form a complete assembly, and that said dose—setting member and said injection but-
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`ton, both being accessible for the user from outside said housing is connected to said preas-
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`sembled dose setting and injection mechanism inside the boundaries of said housing.
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`2. An injection device according to claim 1, characterized in that said dose-setting member is
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`provided with a number of carriers, which carriers are received in depressions in said preas—
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`sembled dose setting and injection mechanism.
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`3. An injection device according to claim 1 or 2, characterized in that said injection button is
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`provided with a toothed rack, which toothed rack is received in a slot in said preassembled
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`dose setting and injection mechanism.
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`4. A preassembled dose setting and injection mechanism for an injection device according to
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`anyone of the claims 1 - 3, having a housing accommodating an cartridge containing medi-
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`cine sufficient for a number of dosed injections, which doses are injected by advancing a pis-
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`ton forward inside said cartridge, a dose setting and injection mechanism comprising a piston
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`10
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`15
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`20
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`25
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`30
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`35
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`Mylan Exhibit - 1034
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`Mylan V. Sanofi
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`

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`rod abutting said piston and a piston rod drive for driving said piston rod forward, a dose-
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`setting member coupled to said dose setting and injection mechanism for setting up a dose
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`to be injected, and an injection button coupled to said dose setting and injection mechanism
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`and by which said piston rod drive can be activated for advancing said piston rod and said
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`piston forward to press out said set dose through a conduit connected to said cartridge,
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`characterized in that said preassembled dose setting and injection mechanism comprises;
`
`a coupling ring driven by said injection button,
`
`a driver driving said piston rod through a suitable gearing, and
`
`a unidirectional coupling connecting said coupling ring and said driver in a unidirectional
`manner.
`
`5. A preassembled dose setting and injection mechanism for an injection device according to
`
`claim 4, characterized in that said preassembled dose setting and injection mechanism is
`
`provided with depressions into which depressions a number of carriers on said dose-setting
`member is received.
`
`6. A preassembled dose setting and injection mechanism for an injection device according to
`
`claim 4 or 5, characterized in that said preassembled dose and injection mechanism is pro-
`
`vided with a slot in which slot a toothed rack of said injection button is received.
`
`7. A method of assembling an injection device according to anyone of the claims 1 — 3, hav—
`
`ing a housing accommodating an cartridge containing medicine sufficient for a number of
`
`dosed injections, which doses are injected by advancing a piston fonNard inside said car—
`
`tridge, a dose setting and injection mechanism comprising a piston rod abutting said piston
`
`and a piston rod drive for driving said piston rod forward, a dose-setting member coupled to
`
`said dose setting and injection mechanism for setting up a close to be injected, and an injec-
`
`tion button coupled to said dose setting and injection mechanism and by which said piston
`
`rod drive can be activated for advancing said piston rod and said piston fonNard to press out
`
`said set dose through a conduit connected to said cartridge, which method is characterized
`
`in comprising the steps of:
`
`a) Preassembling the dose setting and injection mechanism to provide a preassembled unit,
`
`1O
`
`15
`
`20
`
`25
`
`3O
`
`35
`
`Mylan Exhibit - 1034
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`

`

`WO 01/83008
`
`PCT/DK01/00281
`
`12
`
`b) Placing the preassembled unit in the housing and connecting said preassembled unit to
`
`said housing,
`
`c) Connecting the dose-setting member to said preassembled unit inside the boundaries of
`
`said housing, and
`
`d) Connecting the injection button to said preassembled unit inside the boundaries of said
`
`housing.
`
`8. A method of assembling an injection device according to claim 7, characterized in that a
`
`number of carriers situated on said dose-setting member is placed into depressions in said
`
`preassembled dose setting and injection mechanism.
`
`9. A method of assembling an injection device according to claim 7 or 8, characterized in that
`
`a toothed rack situated on said injection button is placed into a slot in said preassembled
`
`dose setting and injection mechanism.
`
`10
`
`15
`
`20
`
`25
`
`3O
`
`35
`
`Mylan Exhibit - 1034
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`

`

`WO 01/83008
`
`PCT/DK01/00281
`
`1/5
`
`
`
`Fig. 1
`
`Mylan Exhibit - 1034
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`

`

`WO 01/83008
`
`PCT/DK01/00281
`
`2/5
`
`
`
`Mylan Exhibit - 1034
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`

`

`WO 01/83008
`
`PCT/DK01/00281
`
`3/5
`
`
`
`Mylan Exhibit - 1034
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`

`

`WO 01/83008
`
`PCT/DK01/00281
`
`4/5
`
`
`
`Fig. 5
`
`Mylan Exhibit - 1034
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`

`

`WO 01/83008
`
`PCT/DK01/00281
`
`5/5
`
`
`
`Fig. 6
`
`Mylan Exhibit - 1034
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`[me
`
`.al Application No
`
`PCT/DK 01/00281
`
`t? CLASSIFICATION OF SUBJECT MATI'ER
`PC 7
`A61M5 31
`
`According to International Patent Classification (IPC) or to both national classification and [PC
`B. FIELDS SEARCHED
`
`Minimum documentation searched (classification system followed by classification symbols)
`IPC 7
`A61M
`
`Documentation searched otherthan minimum documentation to the extent that such documents are included in the fields searched
`
`Electronic data base consulted during the international search (name of data base and, where practical, search terms used)
`
`EPO-Internai
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category °
`
`Citation of document, with indication, where appropriate, of the relevant passages
`
`Relevant to claim No.
`
`NO 98 10812 A (NOVONORDISK AS)
`19 March 1998 (1998-03-19)
`abstract; figures
`
`US 6 074 372 A (HANSEN STEFFEN)
`13 June 2000 (2000-06-13)
`abstract; figures
`
`
`
`
`
`
`
`El Further documents are listed in the continuation of box C.
`° S ecial cate ories of cited documents :
`p
`g
`"A" document defining the general state of the art which is not
`considered to be of particular relevance
`"E" earlier document butpublished on or afterthe international
`filing date
`"L" document which may throw doubts on priority claim(s) or
`which is cited to establish the publication date of another
`citation or other special reason (as specified)
`"0" document referring to an oral disclosure, use, exhibition or
`other means
`
`"P" document published priorto the international filing date but
`later than the priority date claimed
`
`Patent family members are listed in annex.
`
`"T" later document published afterthe international filing date
`or priority date and not in conflict with the application but
`cited to understand the principle or theory underlying the
`invention
`
`"X" document of particular relevance;the claimed invention
`cannot be conSIdered novel or cannot be conSIdered to
`involve an inventive step when the document is taken alone
`"Y" document of particular relevance; the claimed invention
`cannot be considered to involve an inventive step when the
`document is combined with one or more other such docu-
`ments, such combination being obvious to a person skilled
`in the art.
`"&" document member of the same patent family
`
`Date of the actual completion of the international search
`
`Date of mailing of the international search report
`
`27 August 2001
`Name and mailing address of the lSA
`European Patent Office, PB. 5818 Patentlaan 2
`NL - 2280 HV Rijswijk
`Tel. (+31-70) 340-2040, Tx. 31 651 epo nl,
`Fax: (+31-70) 340—301 6
`
`Form PCT/lSA/Zio (second sheet) (July 1992)
`
`20. 09. 200‘!
`
`Authorized officer
`
`Helene Erikson
`
`DAykulEXhflflt-1034
`
`h4yku1V.Sanofi
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`

`

` A
`
`INTERNATIONAL SEARCH REPORT
`
`
`Intel
`
`
`
`al Application No
`
`
`
`
`
`PCT/DK 01/00281
`
`
`
`Patent document
`Publication
`Patent family
`
`cited in search report
`date
`member(s)
`
`
`NO 9810812
`19-03-1998
`A
`726245 B
`AU
`4199797 A
`AU
`9711786 A
`BR
`1230126 A
`CN
`9900835 A
`CZ
`0927056 A
`EP
`0000089 A
`HU
`JP 2001501501 T
`NO
`991166 A
`PL
`332043 A
`
`US 6074372
`
`A
`
`13-06-2000
`
`AU
`BR
`CN
`NO
`EP
`NO
`PL
`HU
`
`7757398 A
`9809988 A
`1259056 T
`9856436 A
`0988073 A
`996024 A
`337218 A
`0002856 A
`
`date
`
`02-11-2000
`02-04-1998
`24-08—1999
`29-09-1999
`16-06—1999
`07-07-1999
`28-05-2000
`. 06-02—2001
`10—03-1999
`16-08-1999
`
`30-12-1998
`01-08-2000
`05-07-2000
`17-12-1998
`29-03-2000
`08-02-2000
`14-08-2000
`28-12-2000
`
`
`
`Form PCT/lSA/210 (patent family annex) (July 1992)
`
`
`
`DAykulEXhflflt-1034
`
`h4yku1V.Sanofi
`
`Mylan Exhibit - 1034
`Mylan v. Sanofi
`
`