Case 1:22-cv-00023-JPB Document 2-17 Filed 03/18/22 Page 1 of 7 PageID #: 429
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`Exhibit Q
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`( 12 ) United States Patent
`Eiland et al .
`
`( 10 ) Patent No .: US 11,097,063 B2
`( 45 ) Date of Patent :
`* Aug . 24 , 2021
`
`US011097063B2
`
`( 52 ) U.S. CI .
`CPC
`
`( 54 ) SYRINGE DEVICE WITH A DOSE LIMITING
`MECHANISM AND AN ADDITIONAL
`SAFETY MECHANISM
`( 71 ) Applicant : Novo Nordisk A / S , Bagsvaerd ( DK )
`( 72 ) Inventors : Jacob Eiland , Virum ( DK ) ; Christian
`Peter Enggaard , Vejby ( DK ) ; Claus
`Schmidt Moeller , Fredensborg ( DK ) ;
`Tom Hede Markussen , Bagsvaerd
`( DK )
`( 73 ) Assignee : Novo Nordisk A / S , Bagsvaerd ( DK )
`Subject to any disclaimer , the term of this
`( * ) Notice :
`patent is extended or adjusted under 35
`U.S.C. 154 ( b ) by 0 days .
`This patent is subject to a terminal dis
`claimer .
`( 21 ) Appl . No .: 16 / 250,620
`( 22 ) Filed :
`Jan. 17 , 2019
`( 65 )
`Prior Publication Data
`US 2019/0192783 A1
`Jun . 27 , 2019
`
`Related U.S. Application Data
`( 63 ) Continuation of application No. 11 / 996,397 , filed as
`application No. PCT / EP2006 / 007006 on Jul . 17 ,
`2006 , now Pat . No. 10,220,155 .
`( Continued )
`Foreign Application Priority Data
`( 30 )
`Jul . 27 , 2005
`( 51 ) Int . Cl .
`A61M 5/315
`A61M 5/20
`
`( EP )
`
`05016286
`
`( 2006.01 )
`( 2006.01 )
`
`A61M 5/31583 ( 2013.01 ) ; A61M 5/20
`( 2013.01 ) ; A61M 5/31553 ( 2013.01 ) ;
`( Continued )
`( 58 ) Field of Classification Search
`A61M 5/3155 ; A61M 5/31528 ; A61M
`???
`5/31581 ; A61M 5/31578 ; A61M 5/31583 ;
`( Continued )
`References Cited
`U.S. PATENT DOCUMENTS
`2/1985 Turner et al .
`9/1989 Sams
`( Continued )
`FOREIGN PATENT DOCUMENTS
`20209051 U1
`4/2003
`69810860 T2
`11/2003
`( Continued )
`
`4,498,904 A
`4,865,591 A
`
`( 56 )
`
`DE
`DE
`
`OTHER PUBLICATIONS
`Non - Final Office Action issued by the PTO for U.S. Appl . No.
`11 / 996,397 dated Dec. 31 , 2008 .
`( Continued )
`Primary Examiner William R Carpenter
`Assistant Examiner - Larry R. Wilson
`( 74 ) Attorney , Agent , or Firm Wesley Nicolas
`( 57 )
`ABSTRACT
`A syringe device for ejecting a dose of a medicament , the
`syringe device comprising : a dose limiting mechanism
`arranged to interact with a dose ejecting mechanism to
`prevent ejection of a dose exceeding a set dose , and a safety
`mechanism , which is arranged such with respect to the dose
`ejecting mechanism that , if the dose limiting mechanism
`fails , the safety mechanism prevents ejection of a dose
`exceeding the set dose .
`7 Claims , 1 Drawing Sheet
`
`Case 1:22-cv-00023-JPB Document 2-17 Filed 03/18/22 Page 2 of 7 PageID #: 430
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`13
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`14
`18
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`38
`42
`17
`21 .
`19
`46
`42
`28
`24
`
`VIZU
`
`-20
`- 16
`-15
`23
`-12
`
`10
`36
`36
`-26
`30
`48
`34
`50
`31
`32
`44
`
`-22
`
`lahat
`
`orta
`KAZA ??
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`????
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`

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`US 11,097,063 B2
`Page 2
`
`Related U.S. Application Data
`( 60 ) Provisional application No. 60 / 708,211 , filed on Aug.
`15 , 2005 .
`( 52 ) U.S. Ci .
`A61M 5/31541 ( 2013.01 ) ; A61M 5/31558
`???
`( 2013.01 ) ; A61M 5/31561 ( 2013.01 ) ; A61M
`5/31573 ( 2013.01 ) ; A61M 5/31593 ( 2013.01 )
`( 58 ) Field of Classification Search
`A61M 5/31585 ; A61M 5/31586 ; A61M
`CPC
`5/31551 ; A61M 5/3158 ; A61M 5/51535 ;
`A61M 5/31536 ; A61M 5/31538 ; A61M
`2005/3154 ; A61M 5/31541 ; A61M
`5/31543 ; A61M 5/31563 ; A61M 5/31558 ;
`A61M 5/20 ; A61M 5/31533 ; A61M
`5/31545 ; A61M 5/31548 ; A61M 5/31553 ;
`A61M 5/31555 ; A61M 5/31561 ; A61M
`5/31573 ; A61M 5/31593
`See application file for complete search history .
`References Cited
`U.S. PATENT DOCUMENTS
`
`( 56 )
`
`4,883,472 A
`5,104,380 A
`5,626,566 A
`5,921,966 A
`5,938,642 A
`6,221,046 B1
`6,221,053 B1
`6,235,004 B1
`6,248,095 B1
`6,569,123 B2
`6,582,404 B1
`6,585,698 B1
`6,663,602 B2
`6,699,224 B2
`6,899,699 B2
`7,104,972 B2
`7,112,187 B2
`7,169,132 B2
`7,195,616 B2
`7,309,327 B2
`7,500,966 B2
`7,553,299 B2
`7,686,786 B2
`7,811,263 B2
`7,828,779 B2
`8,096,978 B2
`8,357,120 B2 *
`8,444,606 B2
`8,721,601 B2
`8,920,383 B2
`9,775,953 B2
`10,220,155 B2 *
`2002/0120235 A1 *
`
`2002/0165500 A1
`2005/0033224 A1
`
`Case 1:22-cv-00023-JPB Document 2-17 Filed 03/18/22 Page 3 of 7 PageID #: 431
`
`11/1989 Michel
`4/1992 Holman et al .
`5/1997 Petersen et al .
`7/1999 Bendek et al .
`8/1999 Burroughs et al .
`4/2001 Burroughs et al .
`4/2001 Walters et al .
`5/2001 Steenfeldt - Jensen et al .
`6/2001 Giambattista et al .
`5/2003 Alchas et al .
`6/2003 Klitgaard et al .
`7/2003 Packman et al .
`12/2003 Moller
`3/2004 Kirchhofer et al .
`5/2005 Enggaard
`9/2006 Moller et al .
`9/2006 Karlsson
`1/2007 Bendek et al .
`3/2007 Diller et al .
`12/2007 Kirchhofer et al .
`3/2009 Hommann
`6/2009 Veasey et al .
`3/2010 Moller et al .
`10/2010 Burren et al .
`11/2010 Kirchhofer et al .
`1/2012 Markussen
`1/2013 Moller
`
`A61M 5/14566
`604/135
`
`5/2013 Radmer et al .
`5/2014 Burren et al .
`12/2014 Enggaard et al .
`10/2017 Enggaard et al .
`A61M 5/20
`3/2019 Eiland
`8/2002 Enggaard ......... A61M 5/31553
`604/135
`11/2002 Bechtold et al .
`2/2005 Kirchhofer et al .
`
`2005/0033244 A1 *
`
`2005/0261634 A1
`2006/0270985 A1
`2008/0208142 A1
`2008/0221530 A1
`2015/0080812 A1
`
`2/2005 Veasey
`11/2005 Karlsson
`11/2006 Hommann et al .
`8/2008 Moller
`9/2008 Glejbol et al .
`3/2015 Enggaard et al .
`
`A61M 5/31535
`604/211
`
`FOREIGN PATENT DOCUMENTS
`2/2004
`10229122 A1
`6/2005
`10351596 A1
`2/1999
`897728
`2/1999
`897729 A2
`8/1999
`0937471
`8/1999
`937476 A2
`5016291.6
`7/2005
`1909870 A1
`4/2008
`2002-503116 A
`1/2002
`2005-508205 A
`3/2005
`2091087 C1
`9/1997
`9/2003
`2212254 C2
`12/1989
`1528330 A3
`5/1987
`8702895 A1
`1996/027400 A1
`9/1996
`2006/114395 Al
`8/1999
`9938554
`8/1999
`01/19434 A1
`3/2001
`12/2001
`0195959 Al
`02/053214
`7/2002
`2002/092153 A2
`11/2002
`2/2003
`03/011374 A1
`2004/007003 A1
`1/2004
`4/2004
`2004/028598 Al
`2004/030730 A2
`4/2004
`9/2004
`04/078240 A2
`3/2005
`2005018721
`5/2006
`2006045526 A1
`6/2006
`06/058883
`7/2006
`2006076921
`06/089768 A1
`8/2006
`11/2006
`06/125328 A1
`06/125329 A1
`11/2006
`
`DE
`DE
`EP
`EP
`EP
`EP
`EP
`EP
`JP
`JP
`RU
`RU
`SU
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`OTHER PUBLICATIONS
`Non - Final Office Action issued by the PTO for U.S. Appl . No.
`11 / 996,397 dated Aug. 25 , 2009 .
`Final Rejection in U.S. Appl . No. 11 / 996,397 , filed January 1 , 2008
`by Eiland et al . dated Apr. 20 , 2010 .
`Statement by Dr. Nils Basso printed May 8 , 2010 .
`Description of the Mechanical Components of the OPTICLIK Pen
`printed May 8 , 2010 .
`Ypsomed Ag Press Release Jan. 16 , 2005 ( German and English
`versions )
`Anlage E23 Eidesstattliche Versichemng Herr Peter Ryser .
`Anlage E24 Eidesstattliche Versicherung Herr Nicolas Binggeli .
`Anlage E25 Eidesstattliche Versichemng Frau Daniela Moser .
`Offenkundige Vorbenutzung Durch Die Injektionsvorrichtung “ Flexpen "
`E20a - c .
`Anlage E26 ( Fig . 10 ) .
`Notice of Opposition in EP1909870 dated Dec. 12 , 2011 .
`* cited by examiner
`
`

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`U.S. Patent
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`2
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`Aug. 24 , 2021
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`US 11,097,063 B2
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`Case 1:22-cv-00023-JPB Document 2-17 Filed 03/18/22 Page 4 of 7 PageID #: 432
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`US 11,097,063 B2
`
`1
`SYRINGE DEVICE WITH A DOSE LIMITING
`MECHANISM AND AN ADDITIONAL
`SAFETY MECHANISM
`
`2
`In one embodiment the dose limiting mechanism and the
`safety mechanism are two independent mechanisms work
`ing independently from each other .
`In one embodiment the two mechanisms are adapted to
`5 simultaneously prevent ejection of a dose exceeding the set
`CROSS - REFERENCE TO RELATED
`APPLICATIONS
`dose . In another embodiment the safety mechanism is only
`activated if the dose limiting mechanism fails to prevent
`This application is a Continuation of U.S. application Ser .
`ejection of a dose exceeding the set dose . In one embodi
`No. 11 / 996,397 , filed Mar. 20 , 2008 , which is a 35 U.S.C. S
`ment the two mechanisms are arranged such that even if the
`371 national stage application of International Patent Appli 10 dose limiting mechanism fails , the safety mechanism is
`cation PCT / EP2006 / 007006 ( published as WO 2007 /
`activated instantaneously such that the ejected dose does not
`017053 ) , filed Jul . 17 , 2006 , which claimed priority of
`exceed the set dose . In another embodiment the ejected dose
`European Patent Application 05016286.6 , filed Jul . 27 ,
`is insignificantly larger than the set dose , if the dose limiting
`2005 ; this application further claims priority under 35
`mechanism fails and the safety mechanism is activated . By
`U.S.C. $ 119 of U.S. Provisional Application 60 / 708,211 ,
`filed Aug. 15 , 2005. The contents of all above - named 15 insignificantly larger is meant that the change in dose is too
`small to have serious or fatal consequences .
`applications are incorporated herein by reference .
`The housing may define a passage for the piston rod , the
`passage may have a threaded inner surface for engagement
`FIELD OF THE INVENTION
`with a threaded outer surface of the piston rod , the piston rod
`The present invention relates to a syringe device com- 20 may be arranged with respect to the housing such that
`rotation of the piston rod relative to the housing causes the
`prising a mechanism for preventing ejection of a dose
`piston rod to be displaced translationally relative to the
`exceeding a set dose . In particular the present invention
`housing .
`relates to a syringe device comprising two independent
`In one embodiment at least one of the dose limiting
`mechanisms for preventing ejection of a dose exceeding a
`25 mechanism and the safety mechanism is adapted to limit
`set dose .
`relative rotational movement between the piston rod and the
`housing , to a rotation corresponding to ejection of the set
`BACKGROUND OF THE INVENTION
`dose . This may be the case , when the piston rod comprises
`When drugs are to be injected into the human body , it may
`a threaded outer surface adapted to engage a threaded inner
`have serious or even lethal consequences if the injected dose 30 surface of the housing . Accordingly , rotational locking of the
`exceeds the set dose . Accordingly , it is important that the
`piston rod ( relative to the housing ) results in a translational
`syringe devices comprises means for limiting ejection to the
`locking of the piston rod relative to the housing .
`The dose limiting mechanism may comprise at least one
`set dose .
`It is an object of the present invention to provide a syringe
`first stopping surface adapted to engage at least one corre
`device comprising means for prevention ejection of a dose 35 sponding second stopping surface of the housing . Further
`exceeding the set dose . Furthermore , as such means may
`more , rotation of the dose setting member during dose
`fail , it is an object of the present invention to provide a
`setting may cause the first stopping surface to move away
`syringe device comprising a safety mechanism adapted to
`from the second stopping surface and rotation during dose
`prevent ejection of a dose exceeding the set dose if the
`ejection may cause the first and the second surface ( s ) to
`40 move towards each other . Furthermore , ejection of a dose
`means for preventing fails .
`may be prevented when the first stopping surface abut the
`second stopping surface . The dose setting member may
`SUMMARY OF THE INVENTION
`comprise the at least one first stopping surface . Alterna
`tively , or as a supplement , the dose setting member may be
`The present invention relates to a syringe device for
`ejecting a dose of a medicament , the syringe device com- 45 coupled to a cylinder comprising a first stopping surface , and
`prising :
`said cylinder may be adapted to indicate the set dose . The
`first and second stopping surfaces may be substantially plane
`a housing ,
`a dose ejecting mechanism comprising :
`surfaces which may extend in a direction parallel with the
`a dose setting member being rotatable in relation to the
`axial direction of the syringe device . Alternatively , the
`housing so as to set a dose to be ejected ,
`50 stopping surfaces may extend in a plane transverse to the
`a piston rod arranged with respect to the housing such
`axial direction , such as a plane orthogonal to the axial
`that translational movement of the piston rod in a
`direction .
`In one embodiment the safety mechanism comprises : a
`distal direction causes the dose to be ejected ,
`means for transforming translational movement of the
`limiter defining a passage for the piston rod , the passage of
`dose setting member into translational movement of 55 the limiter defining a threaded inner surface for engagement
`with the threaded outer surface of the piston rod , and a driver
`the piston rod ,
`a dose limiting mechanism arranged to interact with the
`defining a passage for the limiter , the driver being rotation
`dose ejecting mechanism to prevent ejection of a dose
`ally retained in relation to the limiter , the driver being
`coupled to the dose setting member such that rotation of the
`exceeding the set dose , and
`a safety mechanism , which is arranged such with respect 60 dose setting member during dose setting causes the driver to
`to the dose ejecting mechanism that , if the dose limiting
`rotate , wherein relative rotation between the drive and the
`mechanism fails , the safety mechanism prevents ejec-
`piston rod during dose setting causes the limiter to move
`away from a stopping position wherein the limiter prevents
`tion of a dose exceeding the set dose .
`An advantage of the present invention is that if a dose
`ejection of a dose .
`limiting mechanism fails to limit the ejected dose , the 65
`In one embodiment the syringe device is adapted to
`security mechanism is activated , and , thus , provides an extra
`prevent setting of a dose which exceeds the amount of a
`safety for the patient .
`medicament in a reservoir of the syringe device . In such
`
`Case 1:22-cv-00023-JPB Document 2-17 Filed 03/18/22 Page 5 of 7 PageID #: 433
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`

`

`US 11,097,063 B2
`
`4
`3
`the safety mechanism 31. An air gap may be provided
`embodiments , the piston rod may comprise an end - of - dose
`between the bottom surface 30 and the upper surface 32
`stopping surface adapted engage a corresponding surface of
`which allows the limiter and the piston rod to rotate an angel
`the limiter , when the set dose corresponds to the amount of
`corresponding an insignificant increase in the injected dose
`the medicament in the reservoir of the device . Accordingly ,
`in such embodiments the limiter serves two functions , a first 5 e.g. 3 IU of insulin , if the dose limiting mechanism 21 fails
`function being prevention of setting of a dose exceeding the
`during dose injection .
`amount of the medicament left in the reservoir and a second
`Moreover , an upper end - of - content surface 36 of the
`function being a security function adapted to prevent ejec-
`limiter 28 is adapted to engage a lower end - of - content
`surface 38 of a T - shaped end part 40 of the piston rod . The
`tion of a dose exceeding the set dose .
`Moreover , the syringe device may comprise an ejection 10 end - of - content surfaces are adapted to engage , when the set
`assisting system for providing an ejection force for assisting
`dose corresponds to the amount of a medicament remaining
`an operator of the device in forcing the piston in said distal
`in a reservoir ( not shown ) of the device . Accordingly , the
`direction so as to eject the set dose . The ejection assisting
`engagement of the end - of - content surfaces prevents setting
`system may be adapted to force the piston in the distal
`of a dose exceeding the amount of a medicament remaining
`direction so as to eject the dose , without the aid of the user , 15 in the reservoir . It will be appreciated that the distance
`between the end - of - content surfaces thus corresponds to the
`when the user has initiated the ejection .
`The ejection assisting system may comprise a spring , such
`amount of the medicament remaining in the reservoir .
`as a torsional spring which is arranged to rotate the driver
`Moreover , an upper surface 11 of the drum 12 may be
`relative to the housing . The spring may be pre - strained when
`adapted to engage a lower surface 13 of the housing , when
`limiter is in the stopping position . Especially when the 20 the maximum dose is set . The maximum dose is the largest
`spring is pre - strained , the redundant security system of the
`dose which may be set for each ejection ( provided that the
`present invention is advantageous , as accidental un - straining
`syringe device comprises the required amount of medica
`ment ) . The maximum dose does not correspond to the
`of the pre - strained spring , may cause the piston rod
`( and thus move translationally ) corresponding to a lethal
`end - of - content dose which relates the remaining amount of
`25 a medicament in the device . Accordingly , as long as the
`dose , such as 100 IU of insulin .
`remaining amount of medicament in the device is larger than
`the maximum dose , the end - of - content surfaces will not abut
`DESCRIPTION OF THE DRAWINGS
`each other during dose setting , whereas when the remaining
`The invention will now be described in further detail with
`amount of medicament in the device is lower than the
`reference to FIG . 1 , which discloses a syringe device accord- 30 maximum dose , the maximum dose surfaces will not abut
`ing to the present invention .
`each other during dose setting , as the end - of - content sur
`FIG . 1 shows a syringe device 2 comprising a housing 4
`faces prevents further rotation .
`and a piston rod 6. The syringe device 2 also comprises a
`The limiter 28 and the driver 10 are locked for relative
`dose setting member 8 and a driver 10 , which in the
`rotation by means of grove - tongue engagement 42. Thus ,
`FIGURE are combined into one single unit . The syringe 35 when the piston rod is locked for rotation relative to the
`device further comprises a scale drum 12 for indicating a set
`housing , a relative rotation between the driver 8 and the
`dose through a window 14. The scale drum 12 has a threaded
`piston rod 6 causes the limiter to move away from the
`outer surface 15 adapted to engage a corresponding threaded
`stopping position and towards the t - shaped end part 40 ( i.e.
`inner surface 16 of the housing . The scale drum 12 is
`upwards in the FIGURE ) . The piston rod is locked for
`rotationally retained relative to the driver 10 through a 40 rotation relative to the housing when the piston rod guide 34
`grove - tongue engagement 18. The drum scale 12 comprises
`is locked for rotation relative to the housing ( not shown ) , as
`a first stopping surface 17 adapted to engage a second
`the piston rod guide 34 and the piston rod are locked for
`stopping surface 19 of the housing . The first stopping
`relative rotation due to the grove - tongue engagement 44 .
`surface 17 and the second stopping surface 19 constitutes the
`The driver 12 and the piston rod guide 34 are intercon
`dose limiting mechanism 21. The first stopping surface is 45 nected by a two - way ratchet mechanism 46 comprising at
`moved away from the second stopping surface 19 during
`least one first retaining member 48 defined by the driver 12
`dose setting and towards each other during dose ejecting .
`and at least one second retaining member 50 defined by the
`When the two surfaces abut each other , the device is
`piston rod guide 34. The two - way ratchet mechanism is
`prevented from ejecting the medicament .
`adapted to allow relative rotational movement between the
`FIG . 1 further shows an example of a dose setting member 50 driver 12 and the piston rod guide 34 during dose setting and
`8 rotatable and longitudinally fixed in relation to the housing
`to ensure that rotational movement of the driver during dose
`ejection is transferred to the piston rod guide 34 .
`4 so as to set a dose to be injected .
`The syringe device comprises an ejection assisting system
`The use of the device is as follows . Initially the piston rod
`in the form of a pre - strained torsional spring 23 extending
`guide is locked for rotation relative to the housing . Then the
`between the driver 10 and a proximal part 20 of the housing . 55 dose setting member is rotated , which causes the driver and
`Accordingly , when the dose setting member 8 is rotated to
`the drum scale to rotate and the pre - strained spring to be
`set a dose , the spring is strained even further .
`strained even further . At the same time the limiter moves
`The piston rod 6 comprises a threaded outer surface 22
`towards the T - shaped end part . If the user tries to set a dose
`adapted to engage a corresponding threaded inner surface of
`exceeding the amount of medicament in the device , the
`the housing 24 and accordingly rotation of the piston rod 60 limiter abuts the T - shaped end part whereby an even larger
`relative to the housing causes the piston rod to move
`dose cannot be set . The dose is ejected by removing the
`translationally in relation to the housing . The threaded outer
`rotational lock between the piston rod guide 34 and the
`surface 22 of the piston rod also engages a threaded inner
`housing whereby the strained spring forces the driver to
`surface 26 of a limiter 28 , which in FIG . 1 is positioned in
`rotate . The rotating driver forces the piston rod guide to
`a stopping position wherein a bottom surface 30 of the 65 rotate which again forces the piston rod to rotate . Due to the
`limiter engages an upper surface 32 of a piston rod guide 34 .
`grove - tongue engagement 44 and the threaded interconnec
`The bottom surface 30 and the upper surface 32 constitute
`tion between the piston rod and the housing , the rotating
`
`Case 1:22-cv-00023-JPB Document 2-17 Filed 03/18/22 Page 6 of 7 PageID #: 434
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`

`

`US 11,097,063 B2
`
`5
`6
`2. A syringe device according to claim 1 , wherein the
`piston rod is forced to move forward and thus the medica-
`housing defines a passage for the piston rod , the passage
`ment is expelled from the device .
`having a threaded inner surface for engagement with a
`The invention claimed is :
`threaded outer surface of the piston rod , the piston rod being
`1. A syringe device for ejecting a dose of a medicament ,
`5 arranged with respect to the housing such that rotation of the
`the syringe device comprising :
`piston rod relative to the housing causes the piston rod to be
`a housing ;
`displaced axially relative to the housing .
`a dose ejecting mechanism comprising :
`3. A syringe device according to claim 1 , wherein at least
`a dose setting member rotatable in relation to the
`one of the dose limiting mechanism and the safety mecha
`housing so as to set a dose to be ejected ,
`a piston rod arranged with respect to the housing such 10 nism structure is adapted to limit relative rotational move
`ment between the piston rod and the housing , to a rotation
`that axial movement of the piston rod in a distal
`corresponding to ejection of the set dose .
`direction causes the set dose to be ejected ,
`4. A syringe device according to claim 1 , wherein the dose
`structure for transforming rotational movement of the
`setting member comprises the first stopping surface .
`dose setting member into axial movement of the
`5. A syringe device according to claim 1 , wherein the dose
`piston rod during ejection of the set dose in the form 15
`setting member is coupled to a cylinder comprising the first
`of an ejection assisting system comprising a pre
`stopping surface , said cylinder being adapted to indicate the
`strained torsional spring arranged to rotate a driver
`set dose .
`relative to the housing , the pre - strained torsional
`6. A syringe device according to claim 1 , wherein the
`spring providing an ejection force forcing the piston
`rod in the distal direction so as to eject the set dose 20 safety mechanism structure comprises :
`a limiter defining a passage for the piston rod , the passage
`without the aid of a user , when the user has initiated
`of the limiter defining a threaded inner surface for
`the injection of the set dose ;
`engagement with a threaded outer surface of the piston
`a dose limiting mechanism operably connected with the
`rod ; and
`dose ejecting mechanism to prevent ejection of a dose
`the driver defining a passage for the limiter , the driver
`exceeding the set dose , wherein the dose limiting 25
`being rotationally retained in relation to the limiter , the
`mechanism comprises a first stopping surface adapted
`driver being coupled to the dose setting member such
`to engage a corresponding second stopping surface of
`that rotation of the dose setting member during dose
`the housing , and wherein rotation of the dose setting
`setting causes the driver to rotate ;
`member during dose setting causes the first stopping
`wherein relative rotation between the driver and the piston
`surface to move away from the second stopping surface 30
`rod during dose setting causes the limiter to move away
`and wherein ejection of a dose is prevented when the
`from a stopping position wherein the limiter prevents
`first stopping surface abuts the second stopping surface ;
`ejection of a dose exceeding the set dose .
`and
`7. A syringe device acco ccording to claim 1 , wherein the
`a safety mechanism structure operably connected to the
`torsional spring is prestrained when the dose limiting
`dose ejecting mechanism such that if the dose limiting
`35
`mechanism is in a stopping position .
`mechanism fails , the safety mechanism structure pre
`vents ejection of a dose exceeding the set dose .
`
`*
`
`Case 1:22-cv-00023-JPB Document 2-17 Filed 03/18/22 Page 7 of 7 PageID #: 435
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