Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 1 of 21 PageID #: 408
`
`
`
`
`
`Exhibit P
`
`
`
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 2 of 21 PageID #: 409
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US010376652B2
`
`(12) United States Patent
`Markussen
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 10s376s652 B2
`aAug. 13, 2019
`
`(54) AUTOMATI(: I ~.DICTION DKStl(:k; WITH A
`TOP RKI.KASK MK&:HANISM
`
`(71) Applicant. Novo Nordisk A/S, Bagsvacrd (DK)
`
`(72)
`
`Inventor: Tom Hede Markussen, Bagsvaerd
`(DK)
`
`(73) Assignee Novo ssordisk 4/S, Bagsvaerd (l)K)
`
`"'
`
`(
`
`Notice.
`
`Subtect to any disclaimer, thc term of tlus
`patent is extended or adjusted under 35
`U S C 154(b) by 0 days
`This patent is subject to a temiinal dis-
`CI'littler.
`
`(21) Appl No
`
`15/441,638
`
`(22)
`
`Filed:
`
`Feb. 24, 2017
`
`(65)
`
`Prior Publication Data
`US 2017/0165431 Al
`Jun. 15, 2017
`
`Related U.S. Application Data
`(63) Contuiuatiou of application No. 14/797,350. Iilcd on
`Jul. 13, 2015, now Pat. No. 9,616.180, wluch is a
`(Continued)
`
`(30)
`
`Foreign Application Priority Data
`
`Jan. 21„2005
`
`(DK) ...
`
`... 2005 00113
`
`(51)
`
`Int. Cl.
`AG1M 5/315
`AG1M 5/2/)
`
`(2006.01)
`(2006.01)
`(Colltllluc'il)
`
`(52) U.S. Cl.
`CPC ........ A61M 5/31551 (2013.01). A61 V 5/26
`(2013.01), A6nlf 5/3156 (2013.01),
`(&'ontinued)
`
`(58)
`
`(56)
`
`l)E
`EP
`
`Field of ClassiTication Search
`&'P&'. A61M 5,315 —31596: A61M 5/2033; A61M
`5/326: AG I M 2005/206: A61M 2005/208
`See application tile for complete search history.
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5.104,380 A r
`
`4'1992 Holmes
`
`5,308,340 A
`
`5 1994 Horns
`(Continued)
`
`461M 5t20
`6(/4,'I I 7
`
`I 'OR I il&iN F411:N'I 13(JCI )MEN IS
`
`20317377 IJJ
`4 2(/05
`0293958 Al
`12tl988
`(Continued)
`
`0'l1 IE11 PI.JBI I&'A'I IONS
`
`Danish Ps/eat Appli«a/ion No PA 2004 01576. filed &Jci 14, 2004
`
`Primnrv Eiamtner
`Laura A Bouchelle
`(74) Attorney, Agent, «r J'/rm Wesley Nicolas
`
`(57)
`
`ABSTRACT
`
`invcnuon rclatcs to a bandhcld mechanical
`The prcscnt
`intection device by which set doses of a liquid medicament
`can be injected from a medical reservoir 1'he niedicament is
`expelled tluough an injection needle by release of a power
`reservoir in the device. the power reservoir bein fully or
`partially reieased by actuation of a user operable release
`member beuig postttontx( at or near an upper end of thc
`iuiection device, the upper end being that cnd of thc injec-
`tion device which is opposite the injection needle.
`
`15 Claims, 13 Drawing Sheets
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 3 of 21 PageID #: 410
`
`US 10,376,652 B2
`Page 2
`
`Related U.S..Application Data
`conttnuation of application No. 13/326,738, filed on
`Dec. 15. 2011. now Pat. No. 9.108.002, which is a
`contutuanon ol'ppltcatton No. 11/813,435,
`lilcxl as
`appltcabon No. PCT/DK2006(000032 on Jan. 20,
`2006, now Pat No 8,096,978
`(60) Pmnisional applicatitm No 60/647D20, tiled on Jan.
`26. 2005.
`
`(51)
`
`Int. Cl.
`.46&/6( 5/3/
`&161,11 5/24
`(52) U.S. C I.
`('P('
`
`(2006 01)
`(2006.01)
`
`&161M 5/31525 (2013 01); H6111 5/5152/I
`(2013 01): rtdl.tf 5/31555 (2013.01); &I6/M
`5/31585 (2013.01); .46/M 5/24 (2013.01),
`&I6/M 5/31583 (2013.01)'I &161M .5/31.593
`(2013.01), &I6/M 20(/5/2(/2 (2013.01); &I6/M
`2005/31 '6 (2013.01)
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5.383,865
`5.496,293
`5.658,259
`5.66&,oil
`5,728,074
`5 8&06&02
`6.221,046
`6.277,101
`6.164,860
`6.387,078
`6.620, 1." 7
`
`A
`A
`A
`A
`A
`A
`B 1
`BI
`D I
`Bl
`B2
`
`L&1995
`3&1996
`8 1997
`9&1997
`3&19&JS
`10&1998
`4 2001
`8 2001
`4"2002
`5 2002
`9 "&003
`
`Mtchel
`Huggenberger
`Pemson et al
`Wynck
`('esto(lane ct al
`Ko&elman et al
`Bu&roughs ct al
`Kuchhofe& et al
`Steck et al
`Gtfiespte, HI
`Kuchhofe& et al
`
`6,663,602 B2
`6,673,049 B2
`6.699,224 02
`6,743,203 Bl
`6.899,699 02
`7,241.278 B2
`7.445,613 B2
`7,500,966 B2
`7,740,618 B2
`8,357,120 B2
`8.684,969 02
`9.616,180 02 s
`2002&0095120 Al
`2004 0019326 41
`
`12 2003
`I 2004
`3(2004
`6 2004
`5&2005
`7 2007
`11(2008
`3 200'1
`6 2010
`I 2013
`4'2014
`4'2017
`7&2002
`1 2004
`
`X(oiler
`Honunann et al
`Ku ch ho fe& et el
`P&ckhm 6
`Fnggmud
`Mlollcr
`Honunann
`Hommann
`h(arkussen
`h(oiler et al
`Moiler et al
`Markussen
`Larsen et al
`(hlbcn ct al
`
`FOREIGN PATENT DOCUMENTS
`
`461M 5&20
`
`EP
`EP
`EP
`EP
`I'(P
`EP
`JP
`JP
`RU
`Rl.
`Sl I
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`0293958 B
`338806
`Oic4996 A I
`0554996 B
`0516473 41
`1003581
`2071i58
`2002-502296 A
`209108i
`22122&4
`1528330 A"
`sti 011725 41
`94(13343 Al
`99&38(54
`0141838 Al
`0195959 Al
`02&os3214
`&OO&&O97»l
`1294418
`2006039930 Al
`2006&045528 A I
`
`12& 1988
`10& 1989
`8 1'193
`8'1993
`2,&1996
`8 1999
`3&1990
`1&2002
`9& 1997
`91 2003
`12&1989
`I l,&1988
`6 1994
`8&1999
`6&2001
`12&2001
`7 2002
`H&2003
`9&2005
`4 &OOD&
`& 2006
`
`c&ted by cxamincr
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 4 of 21 PageID #: 411
`
`U.S. Patent
`
`Aug. 13,2019
`
`Sheet 1 of 13
`
`US 10,376,652 B2
`
`FIG. 'I
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 5 of 21 PageID #: 412
`
`U.S. Patent
`
`Aug. 13,2019
`
`Sheet 2 of 13
`
`US 10,376,652 B2
`
`FIG. 2
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 6 of 21 PageID #: 413
`
`U.S. Patent
`
`Aug. 13,2019
`
`Sheet 3 of 13
`
`US 10,376,652 B2
`
`13
`
`10
`
`14
`6
`
`12
`
`FIG. 3
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 7 of 21 PageID #: 414
`
`U.S. Patent
`
`Aug. 13,2019
`
`Sheet 4 of 13
`
`US 10,376,652 B2
`
`FIG. 4
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 8 of 21 PageID #: 415
`
`U.S. Patent
`
`Aug. 13,2019
`
`Sheet 5 of 13
`
`US 10,376,652 B2
`
`FIG. 5
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 9 of 21 PageID #: 416
`
`U.S. Patent
`
`Aug. 13,2019
`
`Sheet 6 of 13
`
`US 10,376,652 B2
`
`20
`
`22
`21
`
`19
`
`FIG. 6
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 10 of 21 PageID #: 417
`
`U.S. Patent
`
`Aug. 13,2019
`
`Sheet 7 of 13
`
`US 10,376,652 B2
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`20
`
`25
`
`21
`
`FIG. 7
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 11 of 21 PageID #: 418
`
`U.S. Patent
`
`Aug. 13,2019
`
`Sheet 8 of 13
`
`US 10,376,652 B2
`
`20
`
`21
`
`FIG. 8
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 12 of 21 PageID #: 419
`
`U.S. Patent
`
`Aug. 13,2019
`
`Sheet 9 of 13
`
`US 10,376,652 B2
`
`31
`
`FIG. 9
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 13 of 21 PageID #: 420
`
`U.S. Patent
`
`Aug. 13,2019
`
`Sheet 10 of 13
`
`US 10,376,652 B2
`
`40
`
`38
`
`FIG. 10
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 14 of 21 PageID #: 421
`
`U.S. Patent
`
`Aug. 13,2019
`
`Sheet 11 of 13
`
`US 10,376,652 B2
`
`40
`
`FIG. 11
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 15 of 21 PageID #: 422
`
`U.S. Patent
`
`Aug. 13,2019
`
`Sheet 12 of 13
`
`US 10,376,652 B2
`
`40
`
`FIG. 12
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 16 of 21 PageID #: 423
`
`U.S. Patent
`
`Aug. 13,2019
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`Sheet 13 of 13
`
`US 10,376,652 B2
`
`FIG. 13
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 17 of 21 PageID #: 424
`
`US 10,376
`
`,652 B2
`
`1
`AUTOMATIC INJECTION DEVICE WITH A
`TOP RELEASE MECHANISM
`
`CROSS-REFERENCE TO RELATED
`APPI.I('A1'IONS
`
`This application &s a continuation of IJ.S. patent applica-
`tion Ser. No 14/797,350, filed Jul. 13, 2015 (Issue Fee Paid),
`&vhich is a continuation of U S, patent application Ser No.
`13/326.738. Iilcd Dcc. 15, 2011 (U.S. Pat. No. 9,108,002) ui
`wluch &s a connnuauon of U S. paten dpplmat&on Ser No.
`11,&8]3.435 filed .]un 2, 2008 (U 8 Pat No 8.0')6,978)
`which is a 35 ].I ) ('S 371 national stage application of
`Intenlational Patent Application PCT,'DK2006/000032
`(published as WO 2006/076921). filed Jan. 20. 2006, wluch Is
`claimed pnonty of Darush Patent Application PA 2005
`00113. Iihxi Jau. 21, 2005: this apphcat&on I'urthcr clainw
`&S 119 of U.S. Prov&a&onal Apph-
`poor&ty under 3S U.S.C.
`cation 60&647.320, filed .]an. 26, 2005.
`1'he present invent&on relates to an automatic and hand-
`held mechanical injection device where an injection of a set
`dose of nledicament
`is initiated by actuatillg a release
`member being armnged at or near the top of the injection
`dcvicc.
`
`10
`
`BACK(]ROUND OF THE INVENTION
`
`Automatic iu]ccuou devices i&ave prev&ously bema d&s-
`closcd in &hc putent literature. Aulomauc ul]ect&on dcv&ces
`contain some sort of power reservoir where electrical or &0
`mechanical energy can be accumulated 1'he accumulated
`energy is easily released by actuating a release mechanisnl
`whereby the accumulated energy assists the user in h&)ecting
`a set dose of med&cine and/or assisting needle insertion.
`For example, EP 0 S]6 473 Al d&scloscs an injection ls
`device haling a ncedlc wluch, when the device is opera&Oak
`is first et&used 10 p&OJ Oct. then hquul Is fire&xi Out tlu ough i],
`and finally the needle is automatically retracted 1 he needle
`extends for&vardly fronl a capsule that can slide longitudi-
`nally within a barrel-like body, a relatively weak spring 40
`normally maintainin the capsule and needle retracted. A
`nlorc pov:elfld spung acts oppositely'n a plungcl which,
`when rclcasn!. shoots thc capsule forward by acling on thc
`1&qu&d &herc&n, and then I'orccs the hquid out lluough thc
`the end of the fo&ward stmke the
`pmjecting needle At
`plunger and capsule are decoupled and the weak spring
`retunls the exhausted capsule and its needle to the retracted
`position. The spring acting on the plunger can be released by
`a re]case button pos&t&oned on thc outer surlace of the
`hl]ccuon iles&cc.
`In WO 01/41838 d&suloses a handheld uljection device by
`which set doses of el&qu&d medicament can be injected front
`a medical reservoir. such as cylinder a&npoule. by release of
`a power reservo&r in the device. The power reservoir can
`either be an electric battery by which a motor can be 11
`nlerg&zed &o press out a set dose of med&cule, or a slrauled
`spr&ng main&au&cd u»ts ~traulcd pos&1&on by a delen! which
`spllng when rclcdscd iuul press 001 a scl dose of &unhculc.
`(Vien the power reservo&r &s released. the liquid medicine
`will be pressed out from the cylinder ampoule through an ic
`injection needle mounted on the cylinder ampoule or on the
`injection device carrying the cylinder ampoule. The power
`reservo&r &s rcleascd fully or partially by aclivalulg a release
`buiton, such as an clectuc switch. located on lhc lx&using of
`thc Injection dcv&cc and ul thc distal ilail of die length of the ss
`injection device By making at least a part of the distal third
`ofthe injection device of an er onomic shaped cross section,
`
`0
`
`thc tlscr cdn gup thc n&Jccl&on dcv&cc as a pencil ls gllppix!
`by a thumb. an index finger and a long finger.
`In both EP 0 516 473 Al and WO 01/41838 thc release
`buttons arc posiuoncd on ml outcr surlacc of the in]cct&on
`devices. In EP 0 516 473 Al the release button is position on
`the outer side of the cylindrical body, &vhereas in WO
`01/41838 the release button is positioned close to the
`iniect&on needle of the injection device. However, it may be
`advantageous to position the release button or mechanism so
`that thc uljcction device cml be acuvated by proviihng a
`force to thc upper region of thc Inject&on dcv&cc
`pre]'erably
`to a release button or mechanism armnged ax&ally with the
`in]ection device.
`is an object of the present
`invention to provide an
`It
`automatic and handheld mechanical injection device bavin
`a combined release member and dose settin member
`It &s a further object of &hc present Invent&ou to prov&dc an
`automatic and Ilandhcld mecllanicdl u&jcction device where
`an uljection of a set dose can be initiated using the thumb or
`the index finger of the hmld hand]in the injection device by
`provid&n an axial force to an upper region of the injection
`device
`fi&rther object of the present
`invention to
`is a still
`It
`provide an automauc and hdndhcld mimhanical
`in]ect&on
`dcv&ce llav&ng an cxtcrior design very s&m&lar to conven-
`tional manual injection devices.
`
`SUMMS&RY OF THE INVENTION
`
`'I'he above-mentioned objects are complied with by pro-
`viding, in a first aspect, a handheld injection device by which
`set doses of a liquid medicament can be injected from a
`medical reservoir tlmlugh an injection needle by release of
`a power reservoir in the device„ the power reservoir bein
`adapted to be fully or parlially released by actuauon ol'a user
`Opcrablc rclcasc member pos&&ion&xi at or near an upper end
`Of Ihe inicct&on dcv&ce, thc upper end be&ng that end ol the
`in]ect&on device which is oppos&te the injection needle. the
`power reservoir heing adapted to be po&vered by rotation of
`a rotatably mounted dose setting member.
`The amount of power provided to the power reservoir
`may depend on Ihe angle of rotat&on ol'hc dose seuulg
`member. Thus, a rddler lun&ted rotat&ou of thc dose seuulg
`member provides a rcldtivcly small amount energy 10 thc
`power reservoir, &vhereas a large mtation of the dose setting,
`men&her provides a relatively large anlount of energy to the
`power reservoir.
`The release member may be positioned less than one fifih
`Or onc sixth Of thc length of &hc in]imt&on device from the
`upper cnd. Altcrnaui ely. the release member may bc axmlly
`dlrtulgcd &clat&vc 10 &hc nl]ection device so thB& lhc Iclcdsc
`men&her forms a push button like release member on the top
`of the injection device.
`The release member may be operatively connected to a
`dose settin member of the injection device In that the
`release mcmbcr may cngagc the dose sett&ng mcmbcr via a
`kcy/kcysvay corulcc &ion when the dose sett&ng member &s in
`a dose setting pos&&ion. Thc re]case member may bc re]cased
`from the key/key&vay connection with the dose setting,
`men&her when the dose setting member is in a dose injecting,
`the handheld injection
`position. With tins arrangement.
`device has no rotating exterior parts or elements.
`Thc power rcservo&r may bc a rcs&1&n&t mnnber, such as
`a lorsion spring or a linear spring,
`thc rcs&bent member
`being, when released, adapted to press out a set dose of
`medicine from the nledical reservoir through the injection
`needle 11le release menlber may be operatively connected
`
`

`

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`US 10,376,652 B2
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`iii
`
`io
`
`11
`
`to a rclcasc mechanism adapted to release the rcsilimlt
`member when said release member is actuated. The release
`mcmbcr may have a shape wluch is ergonomw. shaped to be
`activated by a tlnunb or an index finger of the user
`lhc medical reservoir may be a cylinducal mnpoulc
`comprisin a first and a second end of which the tirst end is
`closed by a pierceable membrane which may be pierced by
`a first end of the infection needle ivhen thi ~ needle is
`mounted on the device. The other end ofthe injection needle
`may bc sharp so as to be able to pierce thc skul at
`the
`position lvhere Bn infection is to be made. The second end of
`the;mlpoule may bc closcxf by a piston which may be lbrccd
`into the ampoule so as to expel Inedicainent through the
`needle.
`'lhe handheld mjection device may further comprise a
`rotatably arranged dove member being adapted to at least
`least part of a drive track of an
`partly engage with at
`associated piston rod. the drive member beiilg adapted to be
`postttonlxf ul a lirst axial posluon when thc dose salting IO
`member is in a dose setting position. the drive member
`further being adapted to bc positioned in a second axial
`position lvhen the dose setting member is in a dose injection
`position, the drive member bemg adapted to release energy
`accumulated in the power reservoir when the drive nienlber
`is in its second axial position.
`The drive member may be adapted to rotate the associated
`piston rod upon relcasulg the Bccumulalcd energy in thc
`power resorb oir. However, in its lirst axial posil ion. Ihe drive
`member is prevented fmm rotating because the drive mens-
`ber engages at least part of a housing of the injection device.
`'I'he injection device niay further comprise a resilient men&-
`her. such as a linear sprin, for biasing the drive member in
`a direction towards the dose setting member. The linear
`sprmg opcratn cly connects the drive mcmbcr and the hous-
`ulg.
`lhc dose scttulg member may bc adapted to be moved a
`distance along an axial direction of the injection device so as
`to move the drive member between the first and second axial
`positions. The drive member may be adapted to be moved do
`from the first to the second axial position by Bpplyiilg B force
`to thc dose seuing member, the I'orcc bculg applied alon thc
`dxml dirixuon of thc ultcction device.
`lhc injection device may, as already menlioncd. further
`comprise a push button axially arranged with the dose
`settin member. the push button beino adapted to engage
`with the dose setting member when the dose setting member
`is in its dose setting position, and disco. age fhom the dose
`acting member when thc dose seuing member is in its dose
`intiouon position. By discngagc is mcmlt
`that Ihe push
`button Bnd thc dose setting member Brc mutually rotatable
`when this disengaged state is reached I'he injection device
`nlay further comprise a resilient member. Such as a linear
`spring. for axially biasing the push button in a direction
`away from the drive member.
`lllc hdnilhcld llljccdton device Iuay'ilrlhcl colnpllsc
`rotdtably mountcxf display mcmbcr adapted to display thc
`duse to be ctcctcd I'rom thc uljcction device in accordance
`with a setting of the dose setting member,
`the rotatably
`mounted display nlember being rotatable over an angle io
`least one revolution of the dispLay
`corresponding to at
`member. The display member may comprise a dose indicator
`barrel havulg numerals arranged along a substantially helical
`path on an outer surface thereof. Altcmatively or ul addition,
`thc display member may compnse a countulg device having si
`two or more display wheels having numerals arranaed on an
`outer surface thereof
`
`o
`
`SS
`
`Thc handheld ugecuon device may I'urthcr compnse thc
`associated the piston rod, the piston rod having a threaded
`outcr surface with fhe dove track arranged in a longluidinal
`direction of the outer surlhcc of the piston rod. The dove
`menlber may be opemtively connected to the dose setting
`menlber via a ratchet
`The power reservoir nlay be arranged between the hous-
`ing and the dose settin member in such a v ay that when the
`dose setting member is rotated, ener~ is accumulated in the
`powcl rcscrvolr. 111c pow'cr Icscrvoll'lay'onlprlsc B tol-
`ston spllllg follnixl ils d helical spllng cxtclldulg coBxlallv
`v ith the associated piston rod.
`is to be noted that the interaction between the drive
`It
`member. the piston rod Bnd the housing may be implemented
`in various ways. Above, the piston rod has a threaded outer
`surface and a drive track arranged in the longitudinal direc-
`tion of thc rod. A key arranged on thc dove mmnbcr cngd cs
`the drive track ol'hc rod and thc forward movemcnt of the
`rod reLItive to the housing is caused by the threaded outer
`portimi of the md which meshes lvith a corresponding
`threaded portion of the housin . Alternatively. the threaded
`outer surface of the rod nlay mesh v ith a corresponding
`threaded portion of the drive member whereas the drive
`track arranged in thc longitudinal diriouou of thc rod
`mlgagcs with a kcy Iixcdly arranged rclatlvc lo thc housulg.
`
`BRIEF DESCRIPTION OF THE INVENTION
`
`Thc prcscnt 1m canon will ixiw be cxplaulcd in further
`details with reference to the accompanying figures wherein
`lilt i
`I shows an injection device according to the present
`invention where the release button arnsnged at the top of the
`device is activated by the thumb of the user,
`FICi. Z shows an injection device according to the present
`invention whcrc Ihc relcasc buuon arranged at thc top of the
`dcvicc is activated by thc index linger of the user,
`FICi 3 shows an intiouon dcvicc according to thc plcsclll
`invention ivhere the release button is arranged on the top
`surface of the dose settin member, and where the drive
`member is in its locked position (dial position of dose setting
`member),
`FICi 4 shows an inlcctlon dcvicc according to the prcscnt
`iuvmltion where the release button is arranged on the iop
`surface of the dose seuing member, and whcrc the dove
`meniber is in its released position (dosing position of dose
`setting member),
`FICi. 5 shows an expanded vielv of the drive member in
`its released position,
`FICi 6 shows im cxlvdndcxf 1 icw ol'hc relcasc mcmbcr in
`its locked position with the dose setting member,
`FICi 7 shows im cxlvdndcxf 1 icw ol'hc relcasc mcmbcr in
`its released position with the dose setting nlember,
`lilt i
`ff shov, s an expanded vielv of the release member in
`a huther released position where the dose setting member is
`allowed to rotate,
`9 shows onc way of implemcnuug thc relcasc
`FICi
`mccharusm fbr rcleasulg the mlergized power reservoir,
`IO shows another way ol'unplemmltlng thc relcasc
`FICi
`mechanism for releasin the energized power reservoir,
`lilt i
`11 shows a third lvay of implenienting the release
`mechanism for releasing the energized power reservoir.
`FICi. 12 shows a fourth way of implementing the release
`tucchanlsln for lclwlsnlg thc cnclglzlxl povvcl rcsclvou; dnd
`FICi 13 shows B lil'th way of implcmcnting thc release
`tucchanlsln lol rclcasulg Ihc cllcrglzcd povvcl reservoir.
`While the invention is susceptible to various modifica-
`tions and alternative forms. specific embodiments have been
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 19 of 21 PageID #: 426
`
`US 10,376,652 B2
`
`i
`shown by way of example ui thc drawuigs and will bc
`described in detail herein. It should be understood. hocvever,
`llltclldix! «i bc llllilu:il Io Illc
`lllc ilivclltioli
`Is lint
`tlitll
`particular forms disclosed Rather, the invention i ~ to cover
`dll modifications, ctlutvalcnts. and altcmativcs falluig w i!lan
`the spirit and scope of the imention as detined by the
`appended clauns.
`
`DETAILED DESC:RIPTION OF THE
`IN%I IN I'ION
`
`I it
`
`migagc via a kcy connccuon dic dove mcmbcr 8 is allowed
`to move axially relative to the piston rod 9
`'I'he drive member 8 has been released fmm its engage-
`ment with the housing 6 in I'lti 4 In order to achieve this
`releasing a force. indicated by arrow 15. hos been provided
`to the release member 13 whereby the release member 13,
`the dose member 7 mid thc drive mcmbcr 8 have all hemi
`moved a distaimc towards the mcdicinc ampoule 12. The
`force indicated by armw 15 ivould normally be pmvided by
`the thunib or the index finaer of the user
`As seen in lil(i 4 the engaging region 16 of the housing
`is nov separated from the en aging region 17 of the drive
`the ctrained
`member 8. Tius disen cgement al)oct s
`that
`torsion spnng 10 can relcdsc its micrgy to thc dose seuuig
`member 7. Thc dose sc«ing member 7 and thc drive member
`8 are fixedlv related via the interniediate ratchet (not shown)
`'I'hus, when a disengc enient between engaging regions 16
`and 17 has been established. the dose setting member 7 and
`the drive member 9 will rotate until the torsion cpring 10
`reaches an unstrained state. Since the dnve member 8 and
`the piston rod 9 is conncctcd Yui a kcy connection Ihe
`rotation of thc dose sc«ing mmnber 7 and thc dnve member
`8 v ill cause the piston rod 9 to rotate as well 1 he piston rod
`9 has an outer threaded surface which engages with a
`corresponding threaded portion 18 of the housing whereby
`the piston rod 9. upon rotation thereof. will perform a
`translational movement along the axial direction of the
`in)ection device in thc dirixuon of thc tunpoulc 12.
`Thus, the fiirce provulcd to the rclcasc member 13 will
`release accunndated energy in the torsion spring 'I'his
`energy is converted to a translational movement of the piston
`rod towards the ampoule ivhereby a set dose of medicine can
`be in)ected from the injection device.
`FICi. 5 shows a cut half illustration of the housing 6 of the
`in)ection device. As seen. thc drive mmnbcr 8 composes an
`cngagcmcnt region/part 17 liinncd as gear wlmcl. Similarly,
`the housing 6 composes a corresponding cngagcment
`region/part 16 adapted to receive and engage with the teeth
`of the gear v,heel 17
`FICi 6 shocvs another embodunent of the present inven-
`tion. In contrast to the embodituent shown in FICIS. 3-5 the
`mubodunent shown in FIG. 6 contaim no rotating exterior
`parts oi clciiiciins All lotattllg paim or clclllclils drc piisi-
`tioncd uisidc thc housmg 19. FIG. 6 shows a rclcasc member
`2U (formed as a push button) which is niechanically biased
`towards the end of the injection device by spring element 22
`The release member 20 and dose settin member 21 are
`forced into engagement as long as the dose setting member
`21 is in its dose sclung position. The dose scning mcmbcr 21
`is mechanically biased towards the same end of Ihc in)ection
`dcvicc as Ihc release mmnber 20 duc to a spnng elmuent
`(shown as spring element ll in lil(i 3) acting on the drive
`meniber (shocvn as drive member 8 in I'Iti 3) which again
`acts on dose settin member 21. As seen in FICi. 6 the dose
`setting member 21 is biased against a mechanical stop 24
`where a shoulder fomicd in the dose setung mcmbcr 21
`abuts a part ol'hc housing 19.
`In FIG. 7 an uitcnnmlmtc stage is illustrated. Herc thc
`release member 2U has been pushed an axial distance
`suflicient to release the release member 20 front the dose
`setting member 21. Note that the engagement region 25 and
`26 are disengaged, but since the shoulder of the dose settin
`member still abuts thc housing part no axial movement of
`the dose soning mcmbcr 21 has been achtcvoxt at tlus stage.
`Thus, thc dose seuing mcmbcr 21 is prevented from mtatuig
`since the drive meniber (not shown) is still engcging the
`housmg.
`
`I
`
`FIGS. 1 and 2 show thc present uivention m «s most
`In FICi. I a handheld injection device I Is
`genemsl aspect
`shown. The in)ection device has an injection ncuIIC 2
`fastened to one of its ends, whereas a release button 3 is
`anuugcd at the opposite mid of thc in)ection device. When
`the release button 3 is actuated by provided a tiirce to it
`along the axial direction of the device energy is released
`fmm an internal power reservoir whereby a set dose of io
`medicine is injected from the injection device. In Flo 1 I the
`IClcdSC blltloll
`is SCtndtixl bY 111C dlulllb 4 Of lllC ilSCr,
`whereas in FICi. 2 the release button is actuated by the index
`lillgci 5 of fllo User.
`1'he medicine to be injected is contained in a medical
`reservoir typically formed as a cylindrical ampoule.
`The ener y released when the release button 3 is mechani-
`cal cncrgy. Thc power reservoir can bc a rcsiiicnt member,
`such as a torsion spnng, thc rcsihent member being. when
`released, adapted to press out a set dose of medicine fnim the so
`medical reservoir through the injection needle. 1'he release
`button is operatively connected to soine sort of release
`mechanism adapted to release the resilient member when the
`release button is actuated.
`FIG. 3 shows a cross-sccuonal view of onc cmboduucut
`ol'Ihc present invenuou Thc uifocuon device shown m FIG.
`3 comprises a housing 6. a dose scum member 7. a dove
`niember 8, a piston rod 9. a torsion spring 10, a biasiag
`sprina I l. a cylindrical ampoule 12 and a release nieniber
`13. Fit). 3 shows the injection device in a state where the do
`dose setting member 7 is in its doce setting position.
`A duse is sct by rotaung thc dose scuuig member 7 a
`cernim angle or a certaui number of Iunw. By rotatuig thc
`duse scuing member 7 the torsion spruig 10 is strauied
`becmise the two ends of the torsion spring 10 are tixed to the
`housing 6 and to the dose setting meinber 7, respectively.
`The dose setting member 7 is opemstively connected to the
`drive member 8 via a ratchet (not shown). This ratchet
`pres cnN that thc dose acting mcmbcr 7 returns Io its initial
`posiiion upon strau»ng Ihc torsion spung 10. Suicc Ihc dove
`mcmbcr 8 migagcs thc housuig 6 via a key/keyway connec-
`tion or a gear wheel. the dove member 8 is not allowed to
`rotate relative to the housing 6 as long as the dose settiag
`member 7 is in its dose settin pocition ac illustrated in FICI.
`3. In order to keep the dose setting member 7 ond the drive s.
`member 8 in thc dose seuing position, the dove member 8
`dnd Ihc dose scuing mcmbcr 7 is biased in a direction
`towards the top mid ol'hc uilimtion dcvicc. Tins biasing is
`pmvided by a spnng elenient, such as a linear spring ll,
`arranged between the drive member 8 and part of the io
`housing 6. Thus„ in order to release the drive member 8 from
`its engagement with the housing 6, a force needs to be
`provided in order move thc dose seuing member 7 mid the
`duce member 8 towards thc meihcinc mnpoulc 12. A miner
`cm ity 14 ensures that this fomard movemcnt ol'hc dose sc
`set tine member 7 and the drive member 8 can be performed.
`Similarly. since the drive member 7 and the piston rod 9
`
`ic
`
`o
`
`

`

`Case 1:22-cv-00023-JPB Document 2-16 Filed 03/18/22 Page 20 of 21 PageID #: 427
`
`US 10,376,652 B2
`
`11)
`
`In FIG. 8 lhc dose scuing member 21 has been mo& cd an
`axial distance towards the ampoule (not shown) whereby the
`dose setting mentber is allowed to mtate freely causing the
`piston md 27 push a set dose of medicine out ofthe ampoule
`(not shown). Note that the release member 20 and the dose
`setting member 21 are disengaged in FIG. 8. This means tlmt
`thc relcasc mmnbcr 20 is uot rolatuig relalive lo lhc housuig
`duruig inleclion ol'
`scl dose. Then ihc sct dose has been
`injected the user removes his thumb or index finger front the
`release mentber whereby the release inember and the dose lo
`settina member return to their respective positions as illus-
`trated in FICi. 6. but now with the spring element 23 being
`in a relaxed state.
`In case the user wants to sct a ncw dose. Ihc user rolales
`the rclense member which cngagcs Ihe dose setting mmnber
`whereby the new dose can be set. Injecting the set dose is
`achieved by following the steps illustrated in l&3(ig 7 and 8.
`l)Cig 9-13 show various embodiinents of release ntecha-
`nisnts for releasin the ener ized power reservoir.
`In FIG. 9 a torsion spnng (not shown) is energized by zo
`rotating a ratchet 28 wluch is operatively connected to the
`housing 30 of thc in)ection dcvicc when the dose to be
`injected is being set
`In the dose setting position the ratchet
`28 is operatively connected with housing part 31 via ratchet
`arm 32 I incr y accumulated in the torsion spring i ~ released
`by dispLacing the ratchet 28 axially ivhereby it is released
`from its connection v ith housing part 31 in that the mtcbet
`ami 32 is moved into housing pan 33 whereby lhc piston rod
`34 is allowed to rotate thcrcby cxpclluig a scl dose of
`medicmnent.
`In the embodiment depicted in I&i(i. 9 a dose indicator
`barrel (not shown) moves in the direction mvay from the
`push-button (not shown) during setting of a dose. Obviously,
`the dose inchcator barrel may be adapted to move in the
`opposite direction duung selling of a dose, i.c. Inwards the &i
`push-buuon
`In the embodiment dcpictcd in FIG. 10 the ratchet 35 is
`only in indirect operation with the housing 39 'I'he drive
`ntember of the embodiment depicted in I'lfi 10 is consti-
`nlted by three part
`one part 36 being adapted to corpomte so
`ivith the lu&using 39„another part 38 being adapted to dove
`the piston rod 40 and a ihcxiblc member 37 ronnccnng pans
`36 mid 38. Thc flexiblc mcmbcr 37 is flcxiblc in lhc axial
`dirccuon but cstubhshcs a substantially sufl'oiuiection
`bet&veen parts 36 and 38 when these parts are rotated relative
`to each other 'thus. the flexible member 37 ensures that
`parts 36 and 38 are not rotatably armnged relative to each
`other. Thus, &&hen the mtchet 35 is moved towards the needle
`cnd ol'hc in) ixuon device thc pan 36 is discoiuiccled from
`thc housuig 39 whcrcby parts 36. 37 anti 38 are allowed to
`rotate thcrcby rotatuig thc piston rod 40. The rotaung piston
`rod 40 causes a set dose of niedicament to be expelled front
`the injection device
`The embodiment depicted in FICi. 11 is similar to the
`entbodiment in FICi 9 except that the piston rod is moved»
`forward by having guiding tmcks arranged m the housing
`(mslcad ol in Ihc dove member) and a llueadcrl cngagmnmil
`bclwcmi piston rod and lhc drive member (uwtead of a
`threaded en agement between piston rod and housing).
`l)Cig 12 and 13 show other release mechanisms between ro
`ratchet, drive member and housing.
`The invention cLaimed is:
`1. A handlu:ld uijcction device, composing:
`a rotatable dose setting mcmbcr.
`a power reservoir comprising a torsion spnng lbr storuig si
`energy to expel a dose of medication fmm the injection
`device.
`
`o
`
`a relcasc mcmbcr axially arranged relative to thc in)ection
`device. v:herein the release member forms a push
`button like relcasc mmnber,
`the injection device hirther contprising a multi-compo-
`nent dover (36, 3'7, 38) havuig at
`least a part (38)
`adapted to drive a piston n&d. and a further part (36)
`bein axial movable into a position disconnected from
`the housing releasina the energy accuniulated in the
`power reservoir,
`the further part (36) bemg axially
`movable by thc user applyuig a fi&rcc ont