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`PATENT DATE
`Jttl I 4 2001
`
`APPLICATION NO.
`I }- F,F,Ll'rrU
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`CONT/PRIQR:.
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`ISSUING CLASSI FICATION
`cRoss REFERENCE(S)
`'suscllss (oNE SUBcLASS PER BLocK)
`
`INTERNATIONAL CLASSIFICATION
`
`Continued on lssue Slip lnside File Jacket
`
`ISCLAIMER
`
`f] rne term ol this patent
`
`term gf this patent shall
`not extend bevond the expiration date
`or u.s Patent. rrr". Pg,ndlfE
`
`I
`
`4U:3'
`\./i Iti.." c, Doo"rbr
`
`NOTICE OF ALLOWANCE MAILED
`
`L-T-o
`
`Ll The terminal
`of
`this patent have been disclaimed.
`-months
`
`(Primary Examiner)
`
`(Legal Instruments Examine0
`
`ISSUE BATCH NUMBER ...
`
`WARNING:
`The information disclosed herein may be rostricted. Unauthorized disclosure may be prohibited by the United States Code Title 35, Sections 122, 181 and 368.
`Possession outside th€ U.S. Patent & Trademark Office is restricted to authorized employees and contractors only.
`
`Form PTO-436A
`tii6v, 6/99)
`
`Fil-ED wrrH: I orsr (cRD n FrcHE I co-novr
`
`(Aftached in pocket on right inside tlap)
`
`.,,ii
`
`E,W,W FmM &Rf,-t_r
`
`(FACE)
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 1 of 195
`
`

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`PATENT APPL!C-ArI0N i
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`09655922
`
`CONTENTS
`Date Received
`(lncl. C. of M.)
`or
`Date Mailed
`
`Date Recelved
`(lncl. C. of M.)
`or
`Date Mailed
`
`Ti
`
`-J:-
`
`1. Application _
`
`papers.
`
`13.
`
`14.
`
`15.
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`16.
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`17.
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`18.
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`49.
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`5 sl.
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`52.
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`(LEFT OUTSTDE)
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 2 of 195
`
`

`

`PATE}I]' APPLICATION SERIAL NO.
`
`U.S. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
`FEE RECORD SHEET
`
`i:li:i1.jitlrri, 1'':Liiii,;,"i,ifiiti7 14i447 ii!i5I-!3I
`i:!il,'..'ij iii
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`PTO-1556
`(st87)
`
`'U.S. GPO:'! 999459-062/19144
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 3 of 195
`
`

`

`Page 1 of 1
`
`UNrrEp SrATes PATnNT AND ThADeMARx Onnlcn
`
`ffi
`
`UNITED STATES PATENT AND TRADET.4ARK OFFtcE
`WasHrNGrcN, D.C. 20 231
`wwwusDlo,cov
`
`llilil] lil] lillt til|| llll llllll llil lilll llillill lllillilllllllil
`Bib Data Sheet
`
`SERIAL NUMBER
`09/655,922
`
`ATTORNEY
`DOCKET NO,
`6036.200-US
`
`'LICANTS
`Peter Christian Klitgaard, Smorum, DENMARK;
`Steffen Hansen, Hillerod, DENMARK;
`Bo Radmer, Hillerod, DENMARK;
`Claus Schmidt Moller, Fredensborg, DENMARK;
`
`coNTINUING DATA *************************
`THIS APPLN CLAIMS BENEFIT OF 60/155,612 O9/23l1999
`
`- FOREIGN APPLICATIONS ********************
`DENMARK PA 1999 01309 09/16/1999
`
`F REQUIRED, FOREIGN FILING LICENSE
`ANTED ** 10118/2000
`
`USC 119 (a-d) conditions E r". E no [ *",u0",
`
`STATE OR
`COUNTRY
`DENMARK
`
`SHEETS
`DRAWING
`2
`
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`
`f\r
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`se setting limiter
`
`FILING FEE
`RECEIVED
`?20
`
`EES: Authority has been given in Paper
`to charge/credit DEPOSIT ACCOUNT
`for following:
`
`fl t.to Fees ( Fiting )
`E t.t7 Fees ( Processing Ext. of
`
`E t.t8 Fees (lssue )
`
`fi 1e ://C : \APP S\PreExam\correspondence\ I -A.
`
`xml
`
`t2112100
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 4 of 195
`
`

`

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`01- 0T-0u
`
`Attorney Docket No.: 6036.200-US
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`FTLTNG UNDER 37 C.F.R. 1.s3(b)
`
`Box Patent Application
`Assistant Commissioner for Patents
`Washington, DC 20231
`
`Express Mail Label No. 8L636737346U5
`Date of Deposit Septenrber 6, 2000
`
`Sir:
`
`This is a request for filing a patent application under 37 C.F.R. 1.53(b) of
`
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`Applicant(s): Klitgaard et al.
`Title: Dose Setting Limiter
`8 pages of specification 2 sheets of Formal Drawings
`3 sheets of Declaration and Power of Attornev
`
`[x] The filing fee is calculated as
`Basic Fee:
`Total Claims: 4 - 20 : 0x 18 :
`Independent Claims: I - 3 : 0 x 78
`Total Fee:
`
`lollows:
`
`$690.00
`
`$o
`
`:$0
`
`$690.00
`
`Priority of Danish application no. PA 1999 01309 filed on September 16, 1999 is
`
`claimed under 35 U.S.C, 119. A certified copy is submitted herewith.
`Priority of U.S. provisional application no. 60/155,612 filed on September 23, 1999
`
`is claimed under 35 U.S.C. 119.
`Address all future communications to Steve T. Zelson, Esq., Novo Nordisk of
`North America, Inc., 405 Lexington Avenue, Suite 6400, New York, NY 10174-6401.
`
`-L
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 5 of 195
`
`

`

`Please charge the required fee, estimated to be $690, to Novo Nordisk of North
`America, Inc., Deposit Account No. 14-1447. A duplicate of this sheet is enclosed.
`
`Date: September 6, 2000
`
`Respectfully submitted,
`
`/')
`,, v
`/,/
`t
`(=' a-."".<- G- \-:\tV4&-
`CarolE. Rozek, Reg. No. 36;993
`Novo Nordisk of North America, Inc.
`405 Lexington Avenue, Suite 6400
`New York, NY 10174-6401
`(212) 867-0123
`
`-2
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 6 of 195
`
`

`

`6036-WO,TNor
`
`DOSE SETTING LIMITER
`
`Cross-Reference to Related Applications
`This application claims priority under35 U.S.C. 1'19 of U.S. provisional application no.
`60/155,612 filed on September 23, 1999 and Danish application no. PA 1999 01309 filed on
`September 16, 1999, the contents of which are fully incorporated herein by reference.
`
`Field of the lnvention
`The present invention relates to injection devices wherein the contents of a cartridge are in-
`jected as a number of individually set doses.
`
`Such devices have a dose setting mechanism by which the doses are set for subsequent
`
`injecting when an injection button is operated. This can be obtained by moving a carrier
`along a piston rod a distance proportional to the wanted dose and subsequently moving the
`carrier back to its original position so that the carrier carries the piston rod with it instead of
`being moved along said piston rod.
`
`Scope of the Related Art
`From EP 327 910 is known a syringe by which a dose is set by screwing a nut member up
`along a threaded piston rod away from a stop in a housing, The set dose is injected by
`pressing the end of the nut member that forms an injection button whereby the nut member
`is moved back to abutment with the stop again. During the latter movement of the nut mem-
`ber the piston rod is carried along by the nut that does not move relative to this piston rod
`during the injection.
`
`When a dose is set it is convenient if a limiting device is provided which makes it impossible
`
`to set a dose that exceeds the amount of medicament which is left in the cartridge. In EP
`327 910 this is obtained by the fact that the thread of the piston rod has such a length that
`the cartridge is just emptied when the nut is screwed to the end of the thread and then
`pressed home to its abutment with the stop. By setting a dose the nut can only be screwed
`to the end of the thread and thereby the size of the last dose is limited to comprise the re-
`
`maining amount in the cartridge.
`
`10
`
`1q
`
`20
`
`z3
`
`30
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 7 of 195
`
`

`

`6036-WO,TNor
`
`2
`
`The distance the injection button has to be moved corresponds to the distance the piston in
`the cartridge has to be moved to inject the set dose. Especially by larger cartridges with a
`large cross section diameter this distance can be very short. To obtain a larger movement of
`the injection button a sort of gearing may be used so that the distance the injection button
`has to be moved is proportional with the injected dose but is a number of times the move-
`ment of the piston in the cartridge.
`
`10
`
`1q
`
`EP 608 343 describes an example of such a geared dose setting and injection mechanism.
`In this device the carrier does not cooperate directly with the threaded piston rod but with a
`driver element which can move the piston rod when a set dose is injected. In this device the
`driver element comprises a nut member which is fixed against axial displacement in the in-
`jection device. The thread of the nut member engages an outer thread of the piston rod
`which is secured against rotation in the injection device. By the setting of a dose the carrier
`is rotated away from a stop to which it is returned when the injection button is operated,
`
`During its return the carrier rotates the driver element that moves the piston rod further into
`the cartridge to press the piston of this cartridge so that a set amount of the medicament in
`the cartridge is pressed out through an injection needle at the distal end of the cartridge. As
`the nut member is not moved relative to the piston rod during the setting of a dose, a limiting
`construction as described above cannot be provided limiting the dose so it does not exceed
`
`20
`
`the amount of liquid left in the injection device.
`
`Object and Summary of the lnvention
`
`An object of the invention is to provide a limiting mechanism which prevents setting of a dose
`that exceeds the amount of liquid left in a cartridge of an injection device of the geared type
`
`zc
`
`wherein a dose is set by rotating a dose setting member relative to a driver and away from a
`
`fixed stop in the injection device, and the dose is injected by rotating back the dose setting
`
`member which during this rotation carries the driver element with it to rotate this driver ele-
`ment which moves the piston rod fonrvard.
`
`30
`
`Such a mechanism is according to the invention characterized in that the driver element is
`
`provided with a track having a length which is related to the total amount of medicament in
`
`the cartridge and which track is engaged by a track follower coupled to the dose setting
`
`member to follow rotation of said dose setting member. During the setting of a dose the
`track follower will be advanced in the track of the driver to a position depending on the set
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 8 of 195
`
`

`

`6036-WO,TNor
`
`3
`
`dose as during dose setting the dose setting member and the driver are rotated relative to
`
`each other. As during the injection the driver follows the rotation of the dose setting mernber,
`
`the pin of the dose setting member will keep its position in the track of the driver when the
`set dose is injected. The length of the track is so adapted that the pin reaches the end of the
`
`track and makes an increase of the set dose impossible when a dose is set which corre-
`
`sponds to the amount of liquid remaining in the cartridge,
`
`According to the invention the driver may be disk shaped and have a spiral shaped track
`
`which is engaged by a cam on a member which is flexibly coupled to the dose setting mem-
`
`10
`
`ber so that the pin can be moved radially when it follows the track of the driver.
`
`In another embodiment of the invention the driver may be cylindrical and have a helical track
`
`which is engaged by a cam on the dose setting member which is a cylinder concentric with
`
`the driver.
`
`The track may be provided as a thread in the driver and the track follower may be a nut
`shaped member coupled to the dose setting member and provided with a thread engaging
`the thread of the driver. When a dose is set the dose setting member is screwed with its
`thread along thethread of the driver. The limitation of the setdose is obtained by giving the
`
`zv
`
`threads an appropriate length.
`
`zc
`
`30
`
`Brief Description of the Drawings
`In the following the invention will be explained in further details with references to the draw-
`
`ing, wherein
`
`Figure 1
`
`shows an exploded view of a syringe with a dose limiter according to the
`
`invention;
`
`Figure 2
`
`shows an enlarged view of the dose setting element and the driver element
`
`of the syringe in figure 1; and
`
`Figure 3
`
`shows the dose setting member, the driver, and the track follower of an-
`
`other embodiment of an injection syringe,
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 9 of 195
`
`

`

`6036-WO,TNor
`
`4
`
`Detailed Description of the lnvention
`The syringe in Figure 1 comprises a housing 1 accommodating a cartridge 2from which the
`content can be pressed out by a piston rod 3 which is by injection via gear wheels 4 and 5
`advanced a distance corresponding to a dose set by dose setting. A dose setting member 6
`is provided with a toothed wheel 7 surrounding a central bore through which a pinion B on a
`driver 9 projects as it is shown in Figure 2. The dose setting element 6 is operated through
`an operation element 10 which has a fingergrip 11, a carrier 12 which engages the dose
`setting member 6, and a arrow 13 pointing on a scale 14 provided on a lid 15 which forms a
`part of the housing 1. Figure 1 further shows a cap25 which can be put on to protect a not
`shown needle which may be mounted on the syringe, and an injection button 16 which is
`
`sliding mounted in the housing 1 and which has a recess 17 which is on one of its side sur-
`faces provided with a cogging 18,
`
`10
`
`In the assembled syringe the toothed wheel 7 on the dose setting member 6 engages the
`
`15
`
`cogging 18 of the button element 16 whereas the pinion 8 on the driver 9 engages the part
`
`with the large diameter of the gear wheel 5 the part of which with the small diameter en-
`gages the other gear wheel 4 which further engages a cogging 19 on the piston rod 3.
`
`The driver member 9 is provided with pawl 26 which with not shown teeth in the housing
`
`20
`
`forms an unidirectional coupling allowing the driver 9 to rotate only in the direction by which
`the piston rod 3 is advanced into the cartridge 2. A ratchet is provided by saw tooth shaped
`protrusions on the dose setting element 6 engaging a saw tooth cogging2T at the perimeter
`
`of the driver 9, this ratchet being so oriented that only rotation of the dose setting member 6
`
`in the direction in which the driver 9 can move is transmitted from the dose setting member 6
`to the driver 9. By rotation of the dose setting member 6 in the opposite direction the teeth
`of the ratchet parts will ride over each other.
`
`30
`
`To set a dose the finger grip 11 of the operation element 10 is gripped and the element 10 is
`rotated clockwise until the arrow points at the wanted dose on the scale '14. As mentioned
`this rotation will make the ratchet parts of the dose setting element and the driver ride over
`each other. lf the dose setting member 6 is rotated in the clockwise direction to reduce the
`set dose, the ratchet will cause transmission of the rotation from the dose setting member 6
`
`to the driver 9, but the when a torque in this direction is transmitted from the operating ele-
`
`ment through the carrier 12to the dose setting member 6, this dose setting member is de-
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 10 of 195
`
`

`

`6036-WO,TNor
`
`c
`
`formed so that the protrusion on the dose setting member 6 is drawn out of its engagement
`with the toothing 27 of the driver 9 and an anticlockwise rotation of the dose setting member
`6 is allowed without the rotation being transmitted to the driver 9.
`
`Due to the engagement between the toothed wheel 7 on the dose setting member 6 and the
`cogging 18 of the injection button 16 this button will be lifted from the end of the housing '1
`when a dose is set and will be lowered when a dose is reduced.
`
`10
`
`When the injection button 16 is pressed to inject a set dose the engagement between the
`toothed wheel 7 on the dose setting member 6 and the cogging 18 of the injection button '16
`will cause the dose setting member 6 to rotate in an anticlockwise direction. As the torque is
`
`not transmitted to the dose setting member 6 by the operating element 10, the ratchet cou-
`pling between the dose setting member 6 and the driver g will be active and the driver 9 will
`be rotated with the dose setting member 6 in the anticlockwise direction and will drive the
`piston rod 3 into the cartridge.
`
`20
`
`25
`
`2n
`
`As it is seen in Figure 2 the disk shaped driver t has in its side facing the dose setting mem-
`ber 6 a spiral shaped track 20 which is engaged by a cam 21 provided at the end of an arm
`22 which is by a flexible beam 23 fastened to the dose setting member 6 so that the arm 22
`can swing to let the cam 21 move in the radial direction of the driver 9. When the dose set-
`ting member 6 during the setting of a dose is rotated relative to the driver 9 the cam is
`
`moved along the track 20 whereas the cam during the injection due to the concomitant rota-
`
`tion of the dose setting member 6 and the driver 9 remains in its position in the track 20 ob-
`tained during the dose setting. This way the position of the cam in the track reflects the total
`amount of medicine administered. When the cam 21 abuts the end wall24 of the track 20
`the set dose cannot be increased and by adapting the length of the track to the total amount
`
`of medicine in the cartridge it is ensured that a dose larger than the amount of medicine re-
`maining in the cartridge cannot be set.
`
`Figure 3 shows a dose setting member 30 surrounding a driver 31 of another embodiment
`of a dose setting limiter. The dose setting member 30 is cylindrical and is on its outer wall
`provided with a helical track 29 which is designed to co-operate with a helical inner ridge in a
`
`not shown housing so that the dose setting member 30 is screwed outward in said housing
`
`when rotated to set a dose and inward in said housing when rotated to reduce a too large set
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 11 of 195
`
`

`

`6036-WO,TNor
`
`o
`
`dose. During the dose setting rotation the dose setting member 30 is rotated freely relative
`
`to the driver 31 which it surrounds. Between the dose setting member 30 and the driver 31 a
`
`nut member 32 is coupled which can when it is rotated relative to the driver 31 be screwed
`up along this driver which is at its outer surface provided with a helical track 33. At its outer
`wall the nut member 32 is in the axial direction provided with a recess 34 which is engaged
`
`by a ridge 35 in the axial direction on the inner side of the dose setting element 30.
`
`During the setting of a dose the nut member 32 is due to the engagement between the ridge
`
`35 ancj the recess 34 rotated with the dose setting member 30 relative to the driver 31 so
`that the position of the nut member 32 on this driver is dependent on the dose set. When
`the dose is injected by pressing a not shown injection button which is placed in an end part
`
`36 of the dose setting member 30 this button presses a flange 37 at an end of the driver 31
`
`into engagement with coupling teeth 38 at the bottom of the end part 36 of the dose setting
`member 30. On its lower not visible side the flange 37 is provided with coupling teeth corre-
`sponding to the coupling teeth 38 of the dose setting member 30 and when the dose setting
`member 30 is due to the engagement between the track 29 in the dose setting member 30
`
`and the ridge in the housing forced to rotate relative to the housing when it is pressed into
`the housing the rotation will be transmitted to the driver 31 which due to the engaging cou-
`
`pling teeth is forced to rotated with the dose setting member and during this rotation the nut
`member 32 will maintain its position on the driver 31. This way the position of the nut mem-
`ber 32 on the driver 31 will always indicate the total sum of set and injected doses. When
`the length of the helical track 33 in the driver 31 is adapted to the amount of medicine in a
`
`cartridge the nut member 32 will reach the end of the track 33 and stop for setting a dose
`
`larger than the amount remaining in the cartridge.
`
`10
`
`tc
`
`20
`
`25
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 12 of 195
`
`

`

`6036-WO,TNor
`
`What is claimed is:
`
`1. A limiting mechanism which prevents setting of a dose that exceeds the amount of liquid
`leftrln a cartridge of an injection device wherein a dose is set by rotating a dose setting
`memDie{ relative to a driver and away from a fixed stop in the injection device, and the dose
`is injecte$Qy rotating back the dose setting member which during this rotation carries the
`driver with itlqrotate this driver which moves the piston rod fonruard, wherein the driver is
`10 provided with a\tqack having a length which is related to the total amount of medicament in
`the cartridge and r,i[ich track is engaged by a track follower coupled to the dose setting
`member to follow rotation of this dose setting member.
`
`2. Thelimiting mechanismrOt-clSiml;:n(erein the driver is disk shaped and has a spiral
`
`that
`
`3. The limiting mechanism of claim
`which is engaged by a c.am cou
`
`the driver is cylindrical and has a helical track
`tne'bob
`
`member which is a cylinder concen-
`
`to
`
`)n
`
`tric with the driver,
`
`'t..,,
`4. The limiting mechanism of claim 3, wherein the trab{is provided as a thread in the driver
`and that the track follower is a nut shaped member couRh{to the dose setting member and
`provided with a thread engaging the thread of the driver, t\
`
`25
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 13 of 195
`
`

`

`6036-WO,TNor
`
`10
`
`15
`
`20
`
`Abstract of the Disclosure
`
`A limiting mechanism which prevents the setting of a dose, which exceeds the amount of
`liquid left in a cartridge of an injection device, is disclosed. The injection device is the type
`where a dose is set by rotating a dose setting member relative to a driver and away from a
`fixed stop in the injection device. The dose setting member interfaces the driver such that
`the dose setting member can be rotated in one direction without rotating the driver. The
`dose is injected by rotating back the dose setting member which during the backward rota-
`tion carries the driver with it. Rotating the driver causes the piston rod to move forward in-
`side the cartridge and expel some of the liquid contained in the cadridge. The driver is pro-
`vided with a track having a length which is related to the total amount of liquid in the car-
`tridge and which track is engaged by a track follower coupled to the dose setting member to
`follow rotation of this dose setting member. Each time a dose is set and injected, the track
`follower moves further into the track. When the track follower reaches the end of the track
`the dose setting member can not be rolated further, and a dose larger than the remaining
`
`liquid in the carlridge cannot be set.
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 14 of 195
`
`

`

`U2
`
`959240,4
`
`15
`
`13
`
`11
`
`9 6
`
`Fig. 1
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 15 of 195
`
`

`

`7 F
`
`ig.2
`
`2t2
`
`26
`
`20
`
`aA
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 16 of 195
`
`

`

`PR.L\T OF DRAWU\Gs
`As__o_BlqwL$L!"r
`
`U2
`
`t5
`13
`
`11
`
`Fig. 1
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 17 of 195
`
`

`

`PRL\T OF DII.T\IL\GS
`.ds_-oSlqwl_ru.!r
`
`2t2
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 18 of 195
`
`

`

`COMBINED DECLARATION T
`)ATENT APPLICATION AND POWER OF ORNEY
`(lncludes Ret'erence to PCT Interna. ^al Applications)
`
`Attorney's Docket Nurnber:
`6036.200-US
`
`As a below named inventor, I hereby declare that:
`
`My residence, post office address and citizenship are as stated below next to my name.
`
`I believe I am the original, first and sole inventor (if only one name is listed below) or an original, tlrst and
`joint inventor (if plural names are listed below) of the subject matter which is claimed and for which a
`patent is sought on the invention entitled:
`
`Dose Settine Limiter
`
`lhe specification of which (check only one item below):
`t I
`is attached hereto
`i X I was filed as United States application
`
`Application No. To Be Assigned
`
`on
`Septernber 6, 2000
`and rvas amended
`on
`
`[ | rvas tlled as PC]-l- international application
`N um ber
`on
`and was amended under PC-f Article l9
`on
`
`I hereby state that I have reviewed and understand the contents of the above-identified specification,
`including the claims, as amended by an amendment referred to above.
`
`I acknowledge the duty to disclose information which is material to patentability of this application in
`accordance with Title 37, Code of Federal Regulations, ti 1.56.
`
`I hereby claim priority beneflts under Title 35, United States Code, $119 of any provisional or fbreign
`application(s) fbr patent or inventor's certificate or ofany PCT international applications(s) for patenr or
`inventor's certiflcate or ofany PCT international applications(s) designating at least one country other than
`the United States of America listed below and have also identified below any foreign application(s) tbr
`patent or inventor's certificate or any PCT international application(s) designating at least one counrry
`other than the United States of America filed by me on the same subject matter having a filing date belbre
`that of the application(s) of which priority is claimed:
`
`APPLICATION NUMBER
`PA 1999 01309
`
`PRIOR U.S. PROVISIONAL/FOREIGN/PCT APPLICATION(S) AND ANY PRIORITY CLAIMS UNDER 35 U.S.C. I I9:
`COUNTRY
`DATE OF FILINC
`PRIORITY CLAIMED
`UNDER 35 USC II9
`(if PCT, indicated "PCT")
`(day, month, year)
`[x] YES
`t lNo
`Denmark
`16 September 1999
`[x]YES [ ]No
`[ ]YES
`t lNo
`t IYES
`t lNo
`[ ]YES
`t lNo
`
`United States
`
`60t155,612
`
`23 Septembet 1999
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 19 of 195
`
`

`

`COMBINED DECLARATION I
`.)ATENT APPLICATION AND POWER OF ORNEY
`(tncludes Rel'erence to PCT International Applications)
`
`Attoftey's Dockel Nuilrb€r
`
`6036.200-US
`
`pLovided by the first paLagraplr of Tide 35, United States Code, I 12, I acknowledge the duty to disclose material information as defned in Title 37, Code of Federal
`l{cgulations,'I56(a)whichoccun.edbetrveenthelillgdate
`
`PRIOR U.S. APPLICATIONS OR PCT INTERNATIONAL APPLICATIONS DESIGNATINC THE U,S, FOR BENEFIT
`UNDER 35 U,S,C, I20:
`
`U S APPLICAI'IONS
`
`STATUS (Check one)
`
`U.S. APPLICATION NUMBER
`
`U,S. FILING DATE
`
`Patented
`
`Pending
`
`A ba n doned
`
`PCT APPLICATIONS DESIGNATING THE U.S,
`
`APPLICATION NO
`
`FILINC DATE
`
`US SERIAL NUMBERS
`ASSIGNED (ifanv)
`
`'frademark Office connected therewith. Steve T. Zelson Elias J. Larnbitis Valeta A. Gregg Carol E. Rozek Roberl L. Starles Reza Green, Reg. No. i0,335 Reg No
`33,728 Reg. No.35,127 Reg. No.36,993 Reg. No.41,324 Reg. No.38,475
`Send Correspondence to: Steve l-. Zelson, Esq.
`Novo Nordisk ofNorth Anrcrica, lnc
`405 Lexington Avenuc, Suite 6400
`New York. New York 10174-6400
`
`Direct l elephone Crlls 'l'oi
`Steve'f. Zelson
`(2 t2) 861 -0 t23
`
`I
`
`Full N am€
`of lnveItor
`
`Klitgaard
`
`KeSroence &
`Citizenslrip
`
`Post Oflice
`Addrcss
`
`Full Narne of
`lnventol
`
`Residence &
`C itizenship
`
`Post Office
`Addrcss
`
`Full Narne of
`lnventor
`
`Residence &
`Citizenship
`
`Post Oflice
`Address
`
`4
`
`Full Narne of
`lnventor
`
`Kesloence &
`Citizenship
`
`tsost uIIrc(
`Address
`
`DK-2765 Smsrum
`rosr vrllfc Aourcss
`
`Astershaven 49
`ratrlly rfnul
`
`Hansen
`L rt]
`DK-3400 Hillersd
`
`Gl. Frederiksborgvej 644
`rrnilry r\ame
`
`Radmer
`Lly
`3400 Hillerod
`
`Avang 40
`rrnrily l\4fl
`Msller
`
`DK-3480 Fredensborg
`
`Peter
`Slate or lorcigtr Coutrtry
`
`Denmark
`Lrry
`
`DK-2765 Smorum
`ftrsl utv€n Ntm€
`
`Steffen
`Itlte or lorcrgn Loililtry
`
`Denmark
`
`DK-3400 Hillerod
`
`Bo
`Sttte 0r l0rergn country
`
`Denmark
`Lrry
`
`3400 Hillersd
`ltr3l utveD Name
`
`Claus
`Stnte or Ioreign Country
`
`Denmark
`Lrry
`
`)econu utvcil Nrnte
`
`Christian
`L0utrtry ol Lrlrzcnshrp
`
`Denmarlr
`strte & ZrD Lodr/Lountrt
`
`Denmark
`Second Giveil Nrnre
`
`Uourtrv ol Cilizeilship
`
`Denmark
`tlfl(e q zrp (_oo
`
`Denmark
`Secoild Given Nrnle
`
`LOUnrry or Lrllzen
`
`Denmark
`stnte & zrp Lode/Louiltfy
`
`Denmark
`
`Schmidt
`Luunrr J ur LrrzEnrrrp
`Denmark
`srrre d zrp Loo
`
`Denmark
`
`Paludan Miillers Vej 7
`
`DK-3480 Fredensborg
`
`IOIJ
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 20 of 195
`
`

`

`COMBINED DECLARATION FOR PATBNT APPLICATION AND POWER OF ATTORNEY
`(Includes Refbrence to PCT International Applications)
`
`Attorney's Dock€t N[ilrbcr:
`
`6036.200-US
`
`of Inventor
`
`theteon.
`
`3 of 3
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 21 of 195
`
`

`

`Page I of I
`
`UMrep SrerEs PerEur aNo TirnpnMARK Onnrce
`
`APPLICA llON NLMBER I
`0et655.922
`
`FILINC{{ECEIPT DATE
`09rc6i2000
`
`I
`
`Steve T Zelson Esq
`Novo Nordisk of Norlh America lnc
`405 Lexington Avenue Suite 6400
`New York, NY 10'174-6401
`
`CoMMISSIoNER FoR PATENTS
`UN TED STATES PATENT AND TnroaurRr< Orrrce
`WASH NcrcN. D a. ?O231
`wwwuspro,9ov
`FIRST NAMED APPLICANT I ATTORNEY Dr)CKLl NUNIBIR
`Peter Christian Kliteaard
`603(r.200-US
`
`FORMALITIES LETTER
`il111||11 111ililfiil|ililililililil tilil ililililil iltil ilil ilili1Ii ii|iiii 11|ii1
`
`'oc000000005484923',
`
`Date Mailed : 101 18l2A0A
`
`NOTICE TO FILE MISSING PARTS OF NONPROVISIONAL APPLICATION
`
`FrLED UNDER 37 CFR 1.53(b)
`
`Filing Date Granted
`
`An application number and filing date have been accorded to this application. The item(s) indicated below.
`however, are missing. Applicant is given TWO MONTHS from the date of this Notice within which to file all
`required items and pay any fees required belowto avoid abandonment. Extensions of time may be obtained
`by filing a petition accompanied by the extension fee under the provisions of 37 CFR 1.136(a).
`r The oath or declaration is unsigned.
`o To avoid abandonment, a late filing fee oroath ordeclaration surcharge as set forth in 37 CFR 1.16(e)
`of $130 for a non-small entity, must be submitted with the missing items identified in this letter.
`
`o The balance due by applicant is $ 130.
`
`A copy of'this notice MUST be returnerl with the reply.
`
`Center
`Custorner Se
`InitialPatent Exarnination Division (703) 308-1202
`PART3.OFFICECOPY
`
`fi le : //C : \APP S\preexam\correspondence\2_C. xml
`
`r 0/r 8/00
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 22 of 195
`
`

`

`..fl :i
`-4" --"
`
`i/r,)
`\ud/\
`
`i
`
`,*.+-
`
`PATENT
`
`."- lljp
`
`,t
`
`Attorney Docket No.: 6036.200-US
`
`b r FF
`
`i:,.
`.,!,, :
`
`$r
`
`IN THE I.INITED STATES
`
`PA
`
`AND TRADEMARK OFFICE
`
`In re Application of: Klitgaard et al.
`
`SerialNo.: 091655,922
`
`Group ArlUnit: 3762
`
`Filed: September 6, 2000
`
`Examiner: To be assigned
`
`For: Dose Setting Limiter
`
`CERTIFICATE OF MAILING UNDER 37 CFR 1.8(a)
`
`Comm issioner for Patents
`Washington,DC 20231
`
`Sir:
`
`I hereby certifl, that the attached cogespondence comprising:
`
`Response to Notice to File Missing Parts (in duplicate)
`Copy of Notice to File Missing Parts
`Executed Combined Declaration and Power of Attorney
`
`L 2
`
`.
`J.
`
`is being deposited with the United States Postal Service as first class mail in an envelope
`addressed to:
`
`Commissioner for Patents
`Washington,DC 20231
`
`on November 27,2000.
`
`Svlvia Gonzalez
`(name of person mailing paper)
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 23 of 195
`
`

`

`Attorney Docket No.: 6036.200-U
`
`0r
`
`lt0y 3
`
`-+{ .)
`jt)
`
`PATENT
`
`IN THE T]NITED STATES
`
`ND TRADEMARK OFFICE
`
`In re Application of: Klitgaard et al.
`
`SerialNo.: 091655,922
`
`Group Artunit: 3762
`
`Filed: September 6, 2000
`
`Examiner: To be assigned
`
`For: Dose Setting Limiter
`
`RESPONSE TO NOTICE TO FILE MISSING PARTS
`
`Comm issioner for Patents
`Washington, DC 20231
`
`Sir:
`
`In response to the Notice to File Missing Parts dated October 18, 2000 (a copi,
`thereof is attached hereto), Applicants submit the Combined Declaration and Power o1'
`Attorney signed and dated by Applicants for the above-captioned application,
`
`Please charge the required fee, estimated to be $130.00, to Novo Nordisk of
`North America, Inc., Deposit Account No. l4-1447. Please credit any overpayment to
`
`Deposit Account No. l4-1447. A duplicate of this sheet is enclosed.
`
`Date: November27.2000
`
`Respectfu I ly submitted.
`
`Carol E. Rozek, Reg. N<i. 36,993
`Novo Nordisk of North America, Inc.
`405 Lexington Avenue, Suite 6400
`New York, NY 10174-6401
`(2r2) 867-0123
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1018, p. 24 of 195
`
`

`

`COMBINED DECLARATION r.-r{i PATENT APPLICATION AND POWER Ot .ITORNEY
`(lncludes Reference to PCT International Applications)
`
`Attorney's Docket Number:
`608f.-2,00,.us
`
`-,ntF;l"
`
`" "4::-
`
`4
`
`As a below named inventor. I herebv declare that:
`
`My residence, post office address and citizenship are as stated below ne