Case 1:22-cv-00023-JPB Document 2-13 Filed 03/18/22 Page 1 of 7 PageID #: 351
`
`
`
`
`
`Exhibit M
`
`
`
`
`
`

`

`Case 1:22-cv-00023-JPB Document 2-13 Filed 03/18/22 Page 2 of 7 PageID #: 352
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US010220155B2
`
`(12) United States Patent
`Eiland et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 10,220,155 B2
`Mar. 5, 2019
`
`(54)
`
`(75)
`
`SYRIN)(IK DKYICK WITH A BOSK I.IYHTIN&;
`Ml(CHANISM AND AN ADDITIONAI.
`SAltKTY YIKCIIANISYI
`
`Inventors. Jacob Kiland, %)rum (DK). Christian
`Peter I(nggssrd, I lilierod (i)K): &'lans
`Schmidt Moiler, Ilredensbora (i)K),
`Tom Hede Ylarkussen. Ba svaerd
`(DK)
`
`(73) Assignee Novo NordiskA/S, Baasvaerd (DK)
`
`"
`
`(
`
`) Notice
`
`Subicct to any dlscimmcr, the term of tlus
`patent is extended or adjusted under 35
`U S ('54(b) by 0 days
`
`(21) Appl. No .
`
`11/996,397
`
`(22)
`
`(86)
`
`(87)
`
`(65)
`
`(60)
`
`(30)
`
`PCT Filed:
`
`JuL 17. 2006
`
`P('1 No:
`
`P(:TiKP21)06/007006
`
`ss 371 (c)(1)„
`(2), (4) Date: Mar. 20, 2008
`
`P("I Pub. No WO2007/017t)53
`PCT Pub. Date: Feb. 15, 2007
`
`Prior Publication Data
`US 2008/0234634 Al
`Sep 25. 2008
`
`Related U.S. Application Data
`Provislolml apphcauon No. 60/708,211, Iilcd on Aug.
`15. 2005
`
`Fureign Applicstiun Priurity Data
`
`Jul. 27, 2005
`
`(EP) ...
`
`... 05016286
`
`(51)
`
`Int. CI.
`A 61M 5/315
`A 61M 5/20
`
`(2006 01)
`(2006.01)
`
`(52) U.S. Cl.
`CPC .......... A 61M 5/31583 (2013.01): A 61M 5/20
`(2013.01); A61M 5/31553 (2013.01).
`(Contained)
`lcield of (ilassiiication Search
`('P('.... A61M 5)3155; A61M 5/31528; A61M
`«)31581. A61M 5/31«78, A61M 5)31583,
`(Contained)
`
`(58)
`
`(56)
`
`Rcfcrcnccs &'itcd
`
`U.S. PATENT DOCUMENTS
`4498,904 4
`4 86« «9)t 4
`
`2)1985 Turner ei sl
`9 19fi9 Sama
`(Contained)
`
`FORER)N PATENT DOCUMENTS
`
`DL')h
`
`20209051
`69ti1t)860
`
`4i2003
`I 1 2()03
`(Contained)
`
`O'lT IER Pi.)ill I('A'I IONS
`
`Nos-I issl Dfficc Action issued by thc I/SPID for t. S 4ppl No
`it 9)96,409 dated Dec 31, 2008
`(Contimled)
`
`Primers Elaminer
`Blusma Metha
`.(ssisiani Evami ner
`Larry R Wilson
`igent, or Firm Wesley Nicolas
`(74) Atiorne);
`
`ASSTRACT
`(57)
`A syringe device for ejecting a dose of a medicament, the
`a dose hnutulg ulccbanlsul
`svrulge device conlpllsulg:
`arranged to interact with a dose ciccting mechalusm to
`prevent cjcmtlon of a dose cxcoedulg a sct dose, and a saii:ty
`mechalusm. which ls armugcd such with rcspcct to the duse
`eiectmg mechanism that, if the dose hnlitmg nlechanism
`the safety nlechanism prevents election of a dose
`fags,
`exceedln the set dose.
`
`8 (:laims, I Drasving Sheet
`
`

`

`Case 1:22-cv-00023-JPB Document 2-13 Filed 03/18/22 Page 3 of 7 PageID #: 353
`
`US 10,220,1ii B2
`Page 2
`
`/5&2)
`
`/58)
`
`IJ.S. CL
`('PC
`
`MG/M 5/3/54/ (2013 01): 86/iH 5/3/558
`/2013.01): 86/M 5/3/56/ (2013 01): .4&&JM
`5/3/573 /2013 01): d6/M 5/3/593 (2013 01)
`Field of Classiiicatinn 'Search
`&'P('.... A61M 5/31585: A61M 5&31586; A61M
`5/31551: A61 M 5/3158: A61M 5/51535,
`AGI M 5/31536: A61M 5/31538; A61M
`2005/3154: A61M 5/31541; A61M
`5/31543, A61M 5/31563; A61M 5/31558,
`A611(i 5/20: A61M 5/31533, A61M
`5/31545; Af&IM 5/31548: Atil M 5!31553,
`Af&IM 5/31555: AfilM 5/31561; A61M
`5/31573; )Mi I M 5/31593
`USPC ............. 604/181, 187, 207 211. 218 231
`See application file for complete search history.
`
`/5&& )
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`4.8tC,4i2
`i. (04,3 80
`5.921,966
`5.93S,fi42
`6.221,046
`6.22 (,0 53
`6.23 (,004
`6.248,095
`6 569 (s)
`6.(82,404
`6.585,fi9(i
`6.663,602
`6.699,224
`6. 899,699
`7.104,9i2
`7.169,132
`7.19(,616
`7.309,327
`7. 500,966
`7. 5 i 3,299)
`7.686,786
`i,g 11,263
`7. 828,779
`S.096,9i8
`8,357,120
`
`11&1989
`4 1992
`7&1999
`S&19')9)
`2001
`4 200(
`5 2001
`6"2001
`5 2003
`6"200
`7&2003
`
`A
`A
`A
`A *
`BI "'
`B(
`Bl
`BI
`B2*
`BI
`B2 "'2 2003
`B( *
`i 2004
`i 2005
`9"2006
`I 2007
`3 "2007
`(2&2007
`3 2009
`6 2009
`3 2010
`10"2010
`11 2010
`I "&012
`1&2013
`
`B2
`B2
`B2
`B2
`B2 s
`82
`B2
`B2
`B2
`B2
`B2
`B2
`82 *
`
`Michel
`Ho(man et al
`Bendek ei ai
`Bunoughs ct al
`Buiroughs et al
`(Valtc&s et al
`Steenteldt-Jensen
`Guunbai(isis et al
`Alchas ct al
`Klitgaard et aL
`Packman et al
`Moiler
`Kuchhofm et al
`Enggaaid
`Vloiler et al
`Bendek et al.
`D&lier ei ai
`K&rchhofm et al
`Honunmn
`Vessey et al
`Moiler et al
`Buiren et al
`K.uchhofer et al
`Markussen
`MoHc&
`
`Rarbncr ct al
`Buiren et al
`I'Inggaard et d
`Enggaaid et al
`L'nggaard
`
`8,444,fi06 82
`i&2013
`i 2014
`87&1601 B2
`8920,383 B2
`12 2014
`9.775,9(3 B2
`10 2017
`2002&0120235 Al '"2002
`2002&016(500 Al
`Zoos 003 &244 A 1 *
`
`11 "2002 Bechioid ei al
`2 200( Vessey
`
`Zoos BZfi 1634 A 1 *
`2006(0270985 Al
`2008&0208142 Al
`200S 0221530 Al
`2015'0080812 Al
`
`I ( 200(
`I L&2006
`8"2008
`9 2008
`3 "Zol i
`
`Km lsson
`Hommann et aJ.
`Moiler
`Gle)bol et al
`L'nggaard ei al
`
`et al
`
`&&04 208
`604 153
`
`&&04& 192
`
`&&04 207
`604 211
`
`604"224
`
`46(M i&14566
`604(1 5
`
`A61M 5&20
`604 135
`
`461M i 24
`604(211
`&&04& 197
`
`I 'OIL l &I(iN PA I I:N'I D(X'I IMI IN IS
`
`DE
`DE
`DL'P
`
`EP
`I'IP
`EP
`EP
`EP
`JP
`.(P
`RI.
`R(:
`Sl I
`9/0
`WO
`WO
`WO
`WO
`WO
`WO
`9/0
`WO
`WO
`WO
`WO
`WO
`WO
`9/0
`WO
`WO
`WO
`WO
`WO
`
`69810860
`102 &9122
`10351(96
`0 ti')772 8
`897i29
`09)3747(
`937476
`ioi6291 6
`1909870
`2002-503116
`2005-508)oi
`209108i
`2212254
`1528330
`V'0 87&02895
`1996 027400
`2006 & 114 19 s
`9938554
`VVO OL'19434
`01959s9
`0 r&053214
`2002&0')2 Is)
`03 (0 I I 374
`W&0 2004&007003
`2004&028598
`2004&030i30
`04 07(i240
`2005018721
`2006045526
`06 058883
`2006076921
`06&0897G8
`06&125328
`06 125329
`
`T2
`A I
`Al
`
`A2
`
`A I
`A
`A
`Cl
`(.'2
`A3
`
`A I
`Al
`
`4(
`
`A2
`A I
`
`Al
`A2
`AZ
`
`A(
`
`/U
`Al
`4(
`
`11&2003
`2&2004
`6&2005
`2 I')99
`2&1999
`fi,i(999
`8 1999
`7 2005
`4&2008
`1,200 I
`3 2005
`9&1997
`9,&2003
`12 1989
`s (')87
`9&199G
`8&1999
`8 1999
`3&2001
`(2,&2001
`7 2002
`(I 2002
`2&2003
`1& 2004
`4 2004
`4&2004
`9,&2004
`3 2005
`s 2006
`6&200G
`&2006
`8 sOO&i
`11&2006
`l(,&2006
`
`OTHER PUBLICATIONS
`
`Non-Final Ollice Act&on issued by (he I ISPTO for I. S Appl No
`(( 9)96,409 dated Aug Zi, Z009
`S(a(emeni by Di N&ls Basso punted May 8. 2010
`Descopt&on of the Meehan&cal ('omponen(s of ihe OPTICLIK Pen
`pnntcd May 8, 20 (0
`Anlage L'23 brdcsstattbchc Vers&chcmng Hcn Pctcr Ryser
`Anlage E24 Etdesstattliche Veis&cherung Herr N&colas B&nggeii.
`Anlage E25 Etdesstattliche Veisichemn Fiau Dan&ela Moser
`
`OffenkundigeVoihenu(run * Diuch D&ein)ekuonsion&chiung"I'lexpen*'20a-r:
`
`Anlage L26 (I.tg 10)
`Notice ot'Opposrtion in EP(909870 dated Dcc (2, 2011
`Enghsh Abstract of DE202009051 Publ&shed Api 24. 2003
`Ypsomed AG Press Release Jan 16, 2005 (German and En lish
`seis&onsl
`Descopt&on of the Meehan&cal Components ol'he Op(&cl&k Pen
`Statement by Dr Xiii Basso
`(iooglc 1&anslatron of Affidm it by Dr Nils Basso
`F&nal Reiect&on m I: S Appl No 11&996,409. filed Jan 22. 200tl by
`Iinggamd ct al, dated Ap& 20. 2010
`"'ited by examiner
`
`

`

`Case 1:22-cv-00023-JPB Document 2-13 Filed 03/18/22 Page 4 of 7 PageID #: 354
`
`U.S. Patent
`
`Mar. i, 2019
`
`US 10,220,155 B2
`
`

`

`Case 1:22-cv-00023-JPB Document 2-13 Filed 03/18/22 Page 5 of 7 PageID #: 355
`
`US 10,220
`
`,155 B2
`
`1
`SYRINGE DEVICE WITH A DOSE LIMITING
`MECHANISM AND AN ADDITIONAL
`SAFETY MECHANISM
`
`CROSS-REFERENCE TO RELATED
`Appl.l('ATIONS
`
`'Iliis apphcation is a 35 U S (. ss 37] national stage
`application of
`Patent Application PCT/
`International
`EP2006/007006 (published as WO 2007/017053). tiled Jul.
`17. 2006, which claimed priority of European Patent Appli-
`cauon 05016236.6,
`llus application
`liled Jul 27, 2005,
`further claims priority under 35 U.S.('j 119 of U.S.
`Provisional Application 60/703.211, tiled Aug. 15, 2005.
`
`FIELD OF THE INVENTION
`
`The present invention relates to a syringe device com-
`prising a mechanism for preventing ejection of a dose
`exceeding a set dose. In particular the present invention
`relaies lo a syuugc dcvicc comprising lwo independent
`mechanisms for preventing ejection of a dose exceeding a
`scl ilosl:.
`
`BACKGROUND OF THE INVENTION
`
`When drugs arc to be uiiccted uilo lhe lnunan body, i! may
`have serious or even lethal consequences if the injected dose
`exceeds the set dose. Accordingly. it is important that the io
`syrin e devices coniprises means for limiting ejection to the
`set dose.
`Il is mh object ol'he prcscnt invcnuon to provide a syruige
`device compnsin means for prevention ejection of a dose
`cxcecduig the sct dose. Furthermore, Bs suCh means may
`is an object of the present invention to pmvide a
`fail.
`it
`syrmgc devwe compnsing a safi:ty mcchimism adaptu! Io
`prevent ejection of a dose exceeding the set dose if the
`means for preventing fails.
`
`hs
`
`so
`
`SUMlVLhhRY OF THE INVENTION
`
`o
`
`invention relates to a syringe device for
`The present
`qtccsuhg a dose of a medicament, thc synnge device cum-
`PISSllig:
`tl lhollSllhg.
`a dose ejecting niechanism comprising
`B dose seuing mcmbcr bmng roiatable in relation to the
`housing so as to set a dose to be ejected,
`B pislolh rod tlirtlligcd willi lcspccl lii tlic liousllig siicli
`that translational niovement of the piston rod ui a
`distal direction causes the dose to be ejected,
`means for transfomilng translational movement of the
`dose setting member into translational movement of ss
`thc piston rod,
`a dose limiliug mechanism arranged lo uhleracl with thc
`dose ejecting mechanism lo prevenl cjeclion of a dose
`exceeding the set dose, and
`a safety niechanisni, which is arranged such v ith respect
`to the dose ejectin mechanism that. if the dose limiting
`mechanism fails, the safety mechanism prevents ejec-
`uon of a dose cxcceding lhe sel dose.
`An advantage of the present invenuon is that if a dose
`limiung mechtuusm fails to limit
`lhe ejected dose.
`the ss
`security mechanism is activated, and. thus, pmvides an extra
`safely for the patient
`
`io
`
`In one mnbodiment thc dose limiting mechanism and thc
`safety niechanism are tivo independent mechanisms work-
`ing independently from each other.
`In one embodiment the tv o niechanisnis are adapted to
`simultaneousiy prevent ejection of a dose exceedin the set
`dose. In another embodiment the safety mechanism is only
`activated if lhc dose luniling mcchunism lails lo prevent
`election of a dose cxcecduhg Ihc scl dose. In one embodi-
`ment the Iwo nhechanishus are arran ed such that even if the
`the safety mechanism is
`dose limiting niechanism fails.
`activated instantaneously such that the ejected dose does not
`exceed the set dose. In another embodunent the ejected dose
`is inslenificantly lar er than the set dose„ if the dose limiting
`mccharusm lhils mid lhc safely mechanism is activated. By
`insignificantly larger is meant llial the change uh dose is loo
`small to have serious or fatal consequences
`'I'he housing may detine a passage for the piston rod, the
`passage may have a threaded inner surface for engagement
`v ith a threaded outer surface of the piston rod. the piston rod
`may be arranged with respect
`to the housing such that
`rolalion ol Ihc piston rod rclalii c lo thc housing causes Ihe
`piston rod lo be displacid Iranslutionally rclativc Io Ihe
`housmg.
`least one of the dose limiting
`In one einbodinient at
`mechanism and the safety mechanism is adapted to limit
`relative rotational movenhent betii een the piston rod and the
`housuig. to a rotation corresponding to ejection of the set
`dose. Tlus may be Ihc case. when the pwlon rod comprises
`a tlueadcd outcr surface adapted to cngugc a tlucadcd inner
`surface of the housing Accordingly, rotational locking of the
`piston rod (relative to the Ihousingj results in a translational
`locking of the piston rod relative to the housing
`The dose limiting mechanism may compose at least one
`first stopping surface adaspted to engage at least one corre-
`sponding second slopping surface of the housing. Further-
`more, rotation of lhe dose scning mcmbcr dunng duse
`scullhg iiia3'aiisc llic llist sliippllhg siiilacc lo iiiovc tiwav
`from the second stopping surface and mtation during dose
`election may cause the first and the second surface(sj to
`move towards each other. Furthermore„ejection of a dose
`may be prevented when the first stopping surface abut the
`second stoppuhg surface. Thc dose sctung mcmbcr may
`compose Ihc at least onc lirsl sloppuig surlacc. Altcma-
`tively. or as a supplement. Ihc dose setting mcmbcr may bc
`coupled to a cylinder comprising a first stopping surface, and
`said cylinder may be adapted lo indicate the set dose. 'the
`first and second stopping surfaces may be substantially plane
`surfaces which may extend in a direction pamllel with the
`axial diriction ol'he synnge device. Altcruativcly.
`Ihe
`stoppuhg surlbccs may extend in a plane transvcrsc lo Ihe
`to thc axial
`axial direction, such as a plane orthogonal
`direction.
`In one embodiment the safety mechanisni coniprises a
`limiter defining a passage for the piston md. the passage of
`the hmiter defining a tlu ceded inner surface for engagement
`wilh llm llui Bdcd outcr surface of Ihc piston rod, and a dover
`dclining a passage I'or thc linuter, lhc dnvcr being rolation-
`ally rctauicd in relation to the limiter,
`thc driver bcuhg
`coupled to the dose setting member such that mtation of the
`dose setting member during dose setting causes the driver to
`mtate. wherein relative rotation between the dnve and the
`piston rod durin dose setting causes the hmiter to move
`away from a slopping posiuon w hcrcin thc limiter prevenls
`qicclloii oi B dose.
`In onc cmboduuent
`thc synngc device is adapted lo
`prevent setting of a dose which exceeds the amount of a
`medicament in a reservoir of lhe synnge device In such
`
`

`

`Case 1:22-cv-00023-JPB Document 2-13 Filed 03/18/22 Page 6 of 7 PageID #: 356
`
`US 10,220,155 B2
`
`mubodimcnts, thc piston rod nuiy comprise an end-of-dose
`stopping surface adapted engage a corresponding surface of
`Ihc llllilu:n whcll thc sct dose corresponds Io Ihc illlloillil of
`thc medicament in the rcscrvoir of thc device. Accordingly,
`in such enibodinients the limiter serves Iwo functions, a hrst
`function being prevention of setting of a dose exceeding the
`aniount of the medicament left in the reservoir and a second
`function bemg a secunty function adapted to prevent ejec-
`tion of a dose exceeding the set dose.
`Morcovcr, thc synugc dcvicc may compnse an ejection iii
`assisiing system lor providuig mi ejection fiircc lor assisting
`an openstor of the device in forcing the piston in said distal
`direction so as to elect the set dose 'I'he ejection assisting
`system niay be adapted to force the piston in the distal
`direction so as to eject the dose, without the Bid of the user,
`when the user has initiated the ejection.
`Tile 9\ col i Bit Bsslstlllg svstclll BIBy colllpl1sc a sprlllg. silcll
`as a iorsional spnug which is arrangod to rolatc Ihc dnvcr
`relative to the housing 'I he spring inay be pre-strained v hen
`limiter is in the stoppulg position. Especially ivhen the 2O
`spring is pre-strained. the redundant security system of the
`present invention is advantageous. as accidental un-straining
`of the pre-strained spnng. may cmtse the piston rod to rotate
`Rmd thus move Iranslationally) corrcsponduig Io a lethal
`duse, such as 100 IU of insului.
`
`DESCRIPTION OF THE DRAWINGS
`
`io
`
`lhc invention will uow bc dcscnbcd ui further detail with
`reference to I'l(i. I, which discloses a syringe device accord-
`111g Io Ihc prcscllt lilvcutloll
`l1(i 1 shows a syringe device 2 comprising, a housing 4
`and B piston rod 6. The syringe device 2 also comprises a
`dose setting member 8 and a driver 10, which in the
`FIGURE are combined into onc single unit. Tlic syruige ii
`device Ibrther compnses a scale drum 12 for indicating a set
`dose Iluuugh a wuidow 14. Thc scale drum 12 has a threaded
`outer surface 15 adapted to engage a corresponding threaded
`'Ihe scale dnun 12 is
`inner surface 16 of the housing.
`rotationally retained relative to the driver 10 tiuougt a so
`grove-tongue en agement 18. The dntm scale 12 comprises
`lira( stopping surface 17 adapted to cngagc a scmond
`stopping surlbcc 19 ol'hc housuig. The lirst stopping
`surlhcc 17 and thc second stopping surface 19 constitutes thc
`dose limitin mechanism 21. 'I'he first stopping surface is
`moved mvay front the second stopping surface 19 during
`dose settin and towards each other during dose ejectin .
`the device is
`When the two surfaces abut each other,
`pret clltcil frolll cjcinillg Illc uicdicBuicilu
`FIG. I further show s an example ol a dose act tuig member
`8 rotatablc and longituduially lixed in relation to thc housing
`4 so as to set a dose to be injected
`1he syringe device coniprises an ejection assisting systeni
`in the fomi of a pre-strained torsional sprin 23 extending
`between the driver 10 and a proximal part 20 of the housing. Ss
`Accorduigly. when the dose scuing member 8 is rotated to
`sct a dose. the spring is strmncd cvcn further.
`lhc piston rod 6 comprises B tlucadcd outer surface 22
`adapted to engage a corresponding threaded inner surface of
`the housing, 24 and accordingly rotation of the piston rod io
`relative to the housing causes the piston rod to move
`translationally in reLation to the housing. The threaded outer
`surface 22 ol'hc pm(on rod also engages a Ihrmidcd inner
`surface 26 of a limiter 28, wluch ui FIG. 1 is positioned in
`a stoppuig position wlmreui B bottom surf'acc 30 of the si
`limiter en ages an upper surface 32 of a pistim rod guide 34.
`'I'he bottom surface 30 and the upper surface 32 constitute
`
`o
`
`thc safety mccharusm 31. An mr gap may be providod
`between the bottom surface 30 and the upper surface 32
`v hich allows the limiter and the piston rod to mtate an angel
`corresponding an insignificant mcrease in the injected dose
`e g. 3 IU of insulin. if the dose limitin mechanism 21 fails
`dunng dose injection.
`Moreover, an upper cnd-oitcontmit surface 36 of Ihe
`limiter 28 is attaptcd to migagc a lower end-of-content
`surface 38 of a lishaped end part 40 of the piston rod The
`end-of-content surfaces are adapted to engage. when the set
`dose corresponds to the amount of a medicament remaining
`in a reservoir (not shown) of the device. Accordingly, the
`engagement of the end-of-content surfaces prevents setting
`of B dose excccding Ihc mnount ol' mcdicammit remaiiung
`iu thc rcscrvoir.
`II will bc apprcciatcd that Ihe distance
`between the end-of-content surfaces tints corresponds to the
`,'1111011111 of Ilm iueibCaiueltt I'Cui'lilllflg ul tilC
`I'CSCIVOII'oreover, an upper surface ll of the dnun 12 may be
`adapted to engage a lovver surface 13 of the housing, when
`the maxinuun dose is set. The maxinuuu dose is the largest
`dose which may bc sct for each etixuou (provided that Ihe
`syruigc device compnscs Ihc required amount ol'edica-
`'I'he inaximum dose does not correspond to the
`ment).
`end-of-content dose which relates the remaining amount of
`a medicament in the device. Accordingly, as long as the
`remainin amount of medicament in the device is larger than
`the maxinuun dose, the end-of-content surfaces v ill not abut
`each other during dose acting. whereas when thc remaiiung
`Illall
`Bllloullt Of IBCdlCIIIIICIII
`Illc dCVICC IS low ci
`ill
`IIIC
`maxinnim dose. the maxiniuni dose surfaces will not abut
`each other during dose settina. as the end-of-cimtent sur-
`faces prevents further rotation
`The limiter 28 and the driver 10 are locked for relative
`mtation by means of grove-tongue enga ement 42. Thus,
`when the piston rod is lockcxl for rotauon rclativc to Ihe
`housuig, a rclativc rotauon bctwcen thc dover 8 and Ihe
`piston rod 6 causes Ihc limiter to move awav from Ihe
`stopping position and toivards the t-shaped end part 41) (i.e
`I'he piston rod is locked for
`upwards in the lil(iURii).
`rotation relative to the housing Ivhen the piston rod guide 34
`is locked for rotation relative to the housin foot shown). as
`thc piston rod guide 34 Bnd Ihc piston rod arc locked for
`rclativc rotation due Io Ihc grove-tongue engagcmcnt 44.
`Thc dnvcr 12 aiul thc piston rod guide 34 arc uitcrcon-
`nected by a nvo-way ratchet mechanisni 46 comprising at
`least one first retaining member 48 defined by the driver 12
`and at least one second retainin member 50 defined by the
`piston rod guide 34. The two-way ratchet mechanism is
`adapted to Bllou rclntivc rotational movemmit bctwccn Ihe
`dnver 12 Bnd the piston rod guide 34 dunug dose scuing and
`to mwurc that rotauona1 movemcnt of the driver during duse
`election is transferred to the piston rod guide 34
`I'he use of the device is as follows Initially the piston rod
`guide is locked for rotation relative to the housing. Then the
`dose setting member is rotated„wluch causes the driver and
`thc drum scale Io rotate mid the prc-strmncd spnng Io bc
`StraulCd CVCB Ilu(IICI. At IIIC %1111C tltllC flic llllll(CI uuivCS
`towards Ihe T-shaped cnd part. If the user Ines Io set a dose
`exceedmg the amount of medicament
`in the device. the
`linuter shuts the lishaped end part whereby an even larger
`dose cannot be set. The dose is elected by removing the
`lock betvveen the piston rod guide 34 and the
`mtational
`housuig whereby the strmnixt spring lbrccs thc driver Io
`rotate. Thc rotatui driver forces thc piston rod guide Io
`rotalc vvluch again lorccs Ihc piston rod to rotate. Duc to Ihe
`gmve-tongue engsgenient 44 and the threaded mterconnec-
`tion between the piston rod and the housing. the mtating
`
`

`

`Case 1:22-cv-00023-JPB Document 2-13 Filed 03/18/22 Page 7 of 7 PageID #: 357
`
`US 10,220,155 B2
`
`piston rod is lorccd Io move forward mid Ihus Ihe medica-
`ment is expelled from the device.
`
`The invention cLaimed is:
`1. A syringe device for ejectin a dose of a medicmnent,
`thc svungc iles ice comprlmllg.
`d hoIISlng,
`a dose settin nlember rotatable and kmuitudinally fixed
`in relation to the housmg so as to set a dose to be
`ejected,
`a dose ejecting mechanism comprising:
`a piston rod arranged v ith respect to the housillg such
`tlmt trmlslational movement of Ihe piston rod in a
`distal dirccuon causes Ihc sct dose to bc ctecrcxl,
`stnicture for transforming rotational movement of the
`dose setting member into translational movenleilt of
`the piston md duung ejection of the set dose in the
`form of an ejection assisting system comprising a
`pre-strained torsional spring arran ed to rotate a
`the prc-strmncd tor-
`dover relutivc Io thc hmisulg,
`sional sprulg providulg an vlcc(ion lhrcc forcul
`the
`piston rod in the distal direction so as to eject the set
`dose lvithout the aid of a user, when the user has
`initiated the ejection of the set dose:
`a dose limiting mechanism operably connecred wirh the,,
`dose ejecting mechanism to prevent ejecrion of a dose
`cxcoedulg the sct dose, and
`SafCI('BCChalusnl SllilCtillc OpCIIIblv CO1111CCILd Iii thC
`dose ejecting mechanism such that if the dose limiting
`nlechanism fails, the safety meclmnism structure pre-
`vents ejection of a dose exceeding the set dose.
`2. A syringe device accordin to claim 1, wherein the
`housing defines a passage for the piston rod. the passage
`having a Ilueadcd inner surlacc fur cngagemmll wilh a
`tlucadlxt outcr surlbcc ol'he piston rod. Ihc piston rod being 3(
`arranged lvith respect to the housing such that rotation of the
`piston rod relative to the housing causes the piston rod to be
`displaced translationally relative to the housing
`
`lo
`
`3 A syringe dc(ice accordulg to claim 1, whcrcul at least
`ouc of Ihc ihisc linuting mcclmnism and thc safhty mecha-
`nism structure is adapted to linlit relative rotational move-
`ment between the piston rod and the housing. to a rotation
`corresponding to ejection of the set dose.
`4 A syringe delice accordin to claim 1. wherein the dose
`llnlltlllg IIICChilllislu Colupllscs d
`fil'Su Stopping SillfBCC
`aiLipted to cngagc a corrcspondulg second stoppulg surface
`of the housing. and wherein rotation of the dose settin
`member during dose setting causes the first stopping surface
`to nlove away fronl the second stopping surface and wherein
`election of a dose is prevented when the first stopping
`surface abum Ihc second slopping surl'acc
`5 dr syringe dcvicc according Io claim 4. whcrcul Ihc duse
`setting member comprises the first stopping surface.
`6 dr syrulgc device according to elena 4, whereul the dose
`sclting mcmbcr is coupled Io a cylinder comprisulg Ihc lirsl
`stopping surface. said cylinder beiim adapted to indicate the
`set dose
`7 .d( syringe device according to clainl
`safety mechanism structure comprises:
`B linuter defining a passage for the piston rod, the passage
`of thc linutcr dclilung a Qucadcd inner surface lor
`mlgagcment with a Ilucdded outcr surface ol'he piston
`lod, Bnd
`the driver defining, a passe e for the linliter. the driver
`being rotationally retained in relation to the limiter. the
`driver bein coupled to the dose setting member such
`that rotation of the dose setting member during dose
`ac(ling causes Ihc dll(icr to liiuuc:
`wherein rclativc rotation between thc dover and thc pision
`rod dunng dose sctung causes the limiter to move away 1'rom
`a stopping position wherein the limiter prevents ejection of
`a dose exceeding the set dose
`8 A syrin e device according to claim 1. v herein the
`torsional spring is prestrained when the dose limitin
`IBCChalllSlu IS Ill B Skipping poSllloll.
`
`l. wherein the
`
`