Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 1 of 23 PageID #: 328
`
`
`
`
`
`Exhibit L
`
`
`
`
`
`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 2 of 23 PageID #: 329
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US009861757B2
`
`(12) United States Patent
`Moiler et al.
`
`(10) Patent NO.:
`(4s) Date of Patent:
`
`US 948614757 B2
`Jan. 9, 2018
`
`(54)
`
`INJIo«TION I)EVI(JE WITII AN JSND OF
`DOSE FEEDBACK MECHANISM
`
`(71) Applicant. Novo Nordisk A/S, Bagsvaerd (DK)
`
`(72)
`
`Invmitors: ('lsus Schmidt Muller, Fredeimborg
`(DK), Bo Radmcr. I iilleroed (l)K):
`Lars Ulrik Nielsen, v/irum (DK):
`Christian Peter Enggasrd, Vejby (DK)
`
`(73) Assignee Novo NordiskA/S, Bassvaerd (DK)
`
`"
`
`(
`
`) Notice
`
`Subject to any disclaimer„ the term of tlus
`patent is extended or adjusred under 35
`U S C. IS4(b) by 0 days.
`
`(21) Appl. No.. 15/241,566
`
`(22)
`
`Filed:
`
`Aug. 19, 2016
`
`(65)
`
`Prior Publication Data
`US 2016/0354548 Al
`Dec. 8, 201(i
`
`Related U.S. Application Data
`(63) Contuiuatiou of applicauon No. 11/813,389, Jiied as
`apphcauou No. PCT(EP200G/00048G on Jan 20,
`2006. now Pat. No. 9,457.154.
`(Continued)
`
`(30)
`
`Iroreign Application Priority Data
`
`Jan. 25, 2005
`
`(EP) ...
`
`... 05075187
`
`(51)
`
`Int. Cl.
`AG1M 5/315
`AG1M 5/20
`A 61M 5/24
`(52) U.S. «I.
`CPC .......... A61M 5/3157 (2013.01). A61M 5/20
`(2013.01), A61M 5/24 (2013.01), A6nlf
`S/3155 (2013.01),
`
`(2006.01)
`(2006.01)
`(200G.01)
`
`(58)
`
`(sG)
`
`Field of Clsssiiaicstion Search
`CPC ........ A61M 5/3157: A61M 5/20, A61lvl S 24,
`A61M 5/31SS, A61 M 2205/S81,
`(Colltlllucil)
`
`Refcrcnces Cited
`
`JJ 8 PAI'IIN1 JX)('I JMIJNT)
`
`4,(92,745
`( 114406
`
`6 r9fi6 kcx ct al
`5 1992 Gab«el
`
`(('ontimied)
`
`AG I M 52033
`60441 34
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`EP
`
`ll 1999
`19819409 Al
`594"57 Al
`441994
`(Conrimied)
`I'rimari Irxaniinrr
`limily Schmidt
`.Issistant Exaimner
`Lauren M Peng
`(74) A/i«rney, Agent, «r I'irm Wesley Nicolas
`
`ABSTRACT
`(57)
`An iuirmtron dcvicc with a dose dehv cong mechanism beuig
`adapted to provide a non-visual, e.g. audible and/or tactile,
`feedback si nal when a set dose has been at least substan-
`tially its)ected A lirst and a second parr of the injection
`device are adapted to perfiirm a relative mtational move-
`ment with respect
`to each other. The relative rotational
`movement causes at least uvo parts of the injection device to
`«hilt or cllgagc4 rlllrl rills ributllielit or cllgagcrllcllt ixluscs till:
`nou-visual li:4:dback signal to bc gcneratcd. A very distinct
`and precise feedback is provided as compared to prior art
`axial solutions because the genes(tron of the feedback signal
`is initiated by the relative rotational movement.
`Feedback signal may be generated by a change in a rota-
`tional velocity of at least one part, e
`. by changing the pitch
`of a threaded portion or by engaging a nou-rotating part and
`a rotatrng part, thereby causing thc nou-rotaung part to start
`rotating May alternatively be generated by building up and
`releasing a tension
`1'he mjection device is suitable for injecting insulin
`
`(Continued)
`
`12 Claims, 14 Drawing Sheets
`
`rs
`
`25
`
`24
`
`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 3 of 23 PageID #: 330
`
`US 9,S61,757 B2
`Page 2
`
`Related U.S..Application Data
`(60) Provisional applicutinn No. 60/647,491. file on Jun.
`27. 2005.
`
`(52) U.S. Cl.
`ri6/M 5/3/535 (2013.01):.46/M 5/3/55/
`CPC ....
`(2013.01): SGlM 5/3l56/ (2013.01); rl6/M
`5/3/585 (2013.01), SG/M 2205/58/ (2013.01),
`SG&/M 2205/582 (2013 01)
`(58) Field of Classiftcatiun Search
`CPC ...... A61M 2205/582: A61M 5/31535, A61M
`5/31551; A61M 5/31585
`See application file for complete search history
`
`(56)
`
`References Cited
`U S. PA'11(N'I'O('UMI(N'I'S
`
`«.391,1«7 A *
`
`2 199« Hmris
`
`«.501,670 A *
`
`3 1996 Sat
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`5 582,«98 A *
`
`12 1996 ('hsnoch
`
`461M «:31«l I
`604 208
`461M «:31«ll
`604 110
`A61VI« 315«l
`222 3Q9
`
`5W)57,889
`6,004,297 A
`6.221,046 Dl
`6 248 0«)Q P I
`6.277,098 Dl
`fu454. 43 Bl
`G.6G3,602 B2
`6,699),224 B2
`6,796,970 BI
`7.241,278 D2
`8202,2«fi B2
`8.206,161 D2
`8,2f)7.899 82
`K333,739 B2
`2004 021019)9 Al
`
`9 199')
`12 1999
`42001
`6 2001
`8s2001
`92002
`132003
`3 2004
`9 2004
`7)2007
`6)2012
`6s2012
`') 2012
`132012
`10 2004
`
`Poulscn ct al
`Steenfeldt-Jensen et al
`Burroughs e( al
`Jensen et al
`Klstmose el al
`«Vcbc&
`hlolier
`Knchhofc& ct al
`Klnmose et al
`Moiler
`hi oiler
`Moiler
`Vloilcr
`hi oiler
`Anc&bu&y ct al
`
`FOREIGN PATENT DOCUMENTS
`
`681i«71 Al
`I'(P
`2002-503116 A
`JP
`2002-«13647 A
`.IP
`22122«4
`Rl.
`1521i330
`SU
`98«7688
`WO
`99s5680«AI
`WO
`2004007002 Ai
`WO
`" cited by examiner
`
`12,'199 5
`I, 2002
`« 2002
`9s2003
`12,'198')
`12 1998
`iis1999
`Is2004
`
`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 4 of 23 PageID #: 331
`
`U.S. Patent
`
`Jan. 9,2018
`
`Sheet 1 of 14
`
`US 9,861,757 B2
`
`FIG. 1
`
`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 5 of 23 PageID #: 332
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`U.S. Patent
`
`Jan. 9,2018
`
`Sheet 2 of 14
`
`US 9,861,757 B2
`
`FIG. 2
`
`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 6 of 23 PageID #: 333
`
`U.S. Patent
`
`Jan. 9,2018
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`Sheet 3 of 14
`
`US 9,861,757 B2
`
`FIG. 3
`
`FIG. 5
`
`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 7 of 23 PageID #: 334
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`U.S. Patent
`
`Jan. 9,2018
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`Sheet 4 of 14
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`US 9,861,757 B2
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`FIG. 4
`
`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 8 of 23 PageID #: 335
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`U.S. Patent
`
`Jan. 9,2018
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`Sheet 5 of 14
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`US 9,861,757 B2
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`15
`
`FIG. 6
`
`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 9 of 23 PageID #: 336
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`U.S. Patent
`
`Jan. 9,2018
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`Sheet 6 of 14
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`US 9,861,757 B2
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`10
`
`FIG. 7
`
`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 10 of 23 PageID #: 337
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`U.S. Patent
`
`Jan. 9,2018
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`Sheet 7 of 14
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`US 9,861,757 B2
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`10
`
`FIG. 8
`
`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 11 of 23 PageID #: 338
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`U.S. Patent
`
`Jan. 9 2018
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`Sheet 8 of 14
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`US 9,861,757 B2
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`10
`
`25
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`24
`
`FIG. 9
`
`

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`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 12 of 23 PageID #: 339
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`U.S. Patentent
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`Jan. 9, 2018
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`Sheet 9 of 14
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`US 9,861,757 B2
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`FIG. 10
`
`

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`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 13 of 23 PageID #: 340
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`U.S. Patent
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`Jan. 9,2018
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`Sheet 10 of 14
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`US 9,861,757 B2
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`14
`
`FIG. 11
`
`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 14 of 23 PageID #: 341
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`U.S. Patent
`
`Jan. 9,2018
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`Sheet 11 of 14
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`US 9,861,757 B2
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`27
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`14
`
`FIG. 12
`
`

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`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 15 of 23 PageID #: 342
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`U.S. Patent
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`Jan. 9,2018
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`Sheet 12 of 14
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`US 9,861,757 B2
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`18
`
`FIG. 13
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`

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`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 16 of 23 PageID #: 343
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`U.S. Patent
`
`Jan. 9,2018
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`Sheet 13 of 14
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`US 9,861,757 B2
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`18
`
`FIG. 14
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`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 17 of 23 PageID #: 344
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`U.S. Patent
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`Jan. 9,2018
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`Sheet 14 of 14
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`US 9,861,757 B2
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`18
`
`FIG. 15
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`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 18 of 23 PageID #: 345
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`US 9,861,757 B2
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`1
`INJECTION DEVICE WITH AN END OF
`DOSE FEEDBACK MECHANISM
`
`('RO)S-Rlilil]REN( E I'0 R]!],Aj ill)
`APPLICATIONS
`
`llus applicduon is a continuation of application Scr. No.
`5, 2007 (Notice of Allowance
`filed .]ul
`1],IN]3.3N9,
`received). which is a 35 U.S.C ss371 national stage appli-
`cation of International Patent Application PCT/EP2006/
`filed jan 20,
`000486 (published as WO 2006/079481].
`2006, which clmmcd puouty ol'uropean Patent Applica-
`uon 05075187.4, li]cx] Jmi 25, 2005: tlus application fuuhcr
`clduns priority under 35 U.S.(k sr i]9 of U.S. Provisiorml
`Application 60/647,491, filed .Ian 27. 2005: the contents of
`which are incorporated herein by reference
`
`FIELD OF THE INVENTION
`
`1'he present invention relates to an apparatus for dehver-
`ing liquid drugs to a manunal. preferably o lnuuan being,
`prefemsbly in a subcutaneous manner. More particularly. the
`present invention relates to an injection device which is
`capable of proioding a uon-visual I'icdbdck signal to a user
`indicating that a sct dose has bimn in]ected by Ihc uijection
`device
`
`IO
`
`BACKGROUND OF THE INVENTION
`
`In the present disclosure reference is mainly made to the io
`treatment of diabetes by injection of insulin. I lov ever, tlus
`is merely an exeniplary use of the present invention 1'lnis,
`the present invention may be used for injection of ony other
`suitable kind of drug. e g. growth hormone.
`Injection devices. e g. In Ihe form of uijcction pens, are ls
`mamly made lbr users who have Io ui]ecl
`Ihcmsclvcs
`frequently, c.g people havuig insulin-dependent ihabctcs or
`needing treatment by gnlw:th hormones A number of
`requirements are set to such injection devices I he setting of
`a dose must be easy and unambiguous and it nmsr be easy so
`to read the set dose Furthermore, it nnist be possible, v.ith
`miiumum of trouble, Io cancel or clmngc a wrongly sct
`duse. Fuially. when the dose is in]ected Ihc dose salting
`mecharusm must return to zero. This is very important suicc
`the set dose is actually irtjected,
`it ensures that
`thereby
`allowing the user to keep track of which dose is injected
`Many injection devices work with a threaded piston rod
`which cooperates v ith a nut, the mit and the pisron being
`capable Ol'rotaung rclativcly to each other. Thc dose settuig
`may be Obtauled by dialling thc nut away from a stop 10
`winch It is rctumcd duuug uijccuon by prcssuig thc piston
`rod forward. either nianually or by means of a mechanically
`biased mechanism, such as a spring. until the nut nieniber
`abuts the stop. In other injection devices one of rhe elements,
`the nut or the piston rod, is I ept inrotatable ivhile the orher Ss
`onc is allowlx] to rotate a sct an lc depcnduig on the sct
`duse, whereby tlm piston rod is dial]cd a distance in a
`forward direction tluough thc nut member.
`In such prior art injection devices a dose is normally set
`a dose setting member, and the set dose is io
`by dial]in
`injected by pushing an injection button. In elongored pen
`shaped injection devices the dose setting member and the
`in]imuon button normally form a suigle mmnber. When the
`in] imuon button is pushes] the sct dose is expelled. How cvcr,
`thc amount of drug expelhxl is only equal to Ihc set duse if ss
`the injection button has been pushed as far as possible. the
`dose setting, member thereby having been brought back to
`
`0
`
`zero. In order Io cnsurc Ihdi the correct dose has actually
`bimu rnjcctixk the user there]bra has to visually uispect Ihe
`position of the dose setting member duung the htjection.
`This is disadvantageous because the injection in some cases
`will take place in a part of the body where visual inspection
`duung the injection is very difficult or even inipossible
`Furthcmiorc, ln case thc user Is visually impmrcd lt may be
`lbr the user to visually inspect
`thc dose seuuig
`difiicult
`member during or after the injection„regardless of where on
`the body the injection is performed. Since it is not uncom-
`mon for people having diabetes ro be visually impaired. this
`is an important aspect.
`It is thcrcfilrc dcsirablc to provide a fi:edback signal to thc
`user indicating that thc set dose has bccn uijectixk Ihe
`feedback si nal being of a kind which mal es it unnecessary
`for the user to visually inspect whether or not the set dose is
`iniected.
`Some prior art injection devices have a mechanism which
`iufilrms Ihc user that a duse is being uijcctcd by produculg
`an midiblc 'clrck'or eaCh dose urut bcuig injectixk How-
`ever, since these clicks appear durin the entire injection
`they do not provide a feedback si~al indicating that the set
`dose has been injected, and the pmblem indicated above is
`therefore not soiled by these injection devices. Prior art
`injection devrccs of Ibis type arc, c.g., dcscubixl ln U.S. Pat.
`No. 4.592.745, EP 0 6SS 571 and US 2004/0210199.
`In WO 98/57688 an injection device is disclo~ed wlfich
`above mentioned pmblem. Thus. WO
`addresses
`the
`98/576NN discloses an injection device having a dose setting
`device A dose is set by dialling a dose setting member Apart
`frolll SC]lulg II doSC I]IC ihdlllllg IICtlorl Caiiscs dll ill]CCI1011
`button to bc moves] from a position w herc it abuts a hmisuig
`of the htjection device to a position where it protrudes from
`the housing. The set dose is subsequently dehvered by
`pushin the injection button back into abutntent with the
`housmg.
`In onc embodiment d luck Is acus atcd when the in]ection
`button reaches Ihc housing, and Ihc acuvatiou ol Ihe lock
`produces an audible click indicating that the Injection button
`is in abutment with the housing and thereby that the set dose
`has been delivered IJuirin the injection, includmg the final
`part v hen the lock is activated. the htjection button is Ilulved
`luicarly. Thc linear distance trdvellixl by thc uijection button
`durmg thc last fcw doses is relatively short. It may thcrcforc
`be dificult to determine accumstely from the audible click
`produced by the lock whether or not and v hen the set dose
`has been delivered
`EP 0 594 357 discloses another htjection device which
`addrcsscs thc above mon]Ionia] problmn. Thus, EP 0 594 357
`ihscloscs rill ul]ccuoll ih:lice havlrlg a Iop ace]lou wuh
`resilient legs depending perpendicularly from the top sec-
`tion. The outer surface of the resilient legs has a ridge which
`rests on a ledge inside of the dose knob. 'I'he dose knob may
`have an elongated section which tits into a cylindrical sleeve
`such I]mt when Ihe dose knob ls pushes] into Ihe sleeve, at Ihe
`mid of uijcction, thc Iop portion ol'hc slecvc touches mid of
`the le of the resilient legs displacing the ndge from the
`ledge and causin a snapping noise As it is the case with the
`in]ection device described in W0 98/5768N, the dose knob
`is moved linearlv during injection. also during the final part
`of the Injection when the resilient legs are displaced from the
`ridge cmising Ihc srmpping noise. Thcrcforc thc shorlcom-
`iugs dcscribcd above arc also apphcable here.
`
`SIJMMARY OF THE INVENTION
`
`It is, thus, an ob] rut ol Ihe present invention Io provide an
`iujcctron device being capable of precisely and ui a nim-
`visual manner indicating to a user when a set dose has been
`iniected.
`
`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 19 of 23 PageID #: 346
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`US 9,861,757 B2
`
`I i 1
`
`Io
`
`i( is a further object of thc prescn& ulven&&on Io provide an
`injection device being capable of non-visually indicating to
`a user when a sct dose has been int ected, thc indication being
`delivered to the user m a very distinct manner.
`i( &s an even further obycct of Ihe prcscnl invention Io
`pmvide a dose dehvering nlechanism (i&r an injection
`the dose delivering mechanism being capable of
`device.
`precisely and in a non-visual manner indicating to a user
`&vien a set dose has been injected.
`According to Ihc presm&1 ulvcn&&on Ihc above and other
`objects are fulfilled by prov&ding an injection device com-
`p&&sulg.
`a housing.
`a dose scuing mcmbcr bculg operable (o sct a dcs&rcd dose
`&o be mjected,
`a piston rod being adapted to cooperate with a piston so
`as to cause a set dose to be injected from an ampoule,
`and
`II ilt&st: dcllvcrulg ulcchdnlsnl bculg a&tap&&xi Io opc&'Bu: thc&O
`piston rod in such a way that a set dose is injected. the
`dose dcl&venng mcchan&sm further bemg adapted to
`pmvide a non-v&sual feedback signal to a user only at
`the end of injection of a set dose. wherein first and
`second parts of the injection device are adapted to
`perfilrm a relet&ve rotational movement &virh respect to
`each other during iniect&on of a dose, and wherein said
`rcldiivc rotut&onal movcmcnl causes al lcasl two parts
`ol Ihc inject&on dev&cc Io abut or cn agc. said abu&mml&
`or en agement causing the non-visual feedback signal
`&o be generated.
`'Ihe injection dev&ce of the present
`invention is very
`suitable for use by persons which have to frequently inject
`themselves, e.g persons having insulin-dependenr diabetes
`or nctxiing trcatmm&t by growth hormones. The dcs&rcd dose li
`beulg sc& by means of the dose sc&tm mcmbcr is, tluis, a
`dose of a spccilic drug wluch &hc person ul qucsnon needs
`to inject at that specific point in time 'I'he desired dose may
`be a fixed dose which the person needs to inject each time
`an injection is performed. or it may bee varying amount. e g. do
`varying according to the time of day and!or one or more
`parmnctcrs wluch may be measured or chosen pnor to
`scu&ng the dose /c g. blood glucose /BG) level, contents of
`d u&CBI, t:IC.).
`'Ihe piston rod is preferably adapted to push a piston into
`an mnpoule. thereby causing the set dose to be injected Tlus
`may be obtained in van ous ways and is well known and well
`described in the art.
`Tile close delivcnng mcchan&sm is adapted to provide a
`thc cnd of
`non-tisual feedback s&goal
`to a user only at
`intiwuon of a sct dose. Thus. &he Ihcdbdck signal may be
`enemted ivhen the set dose has been injected, e g. exactly
`when or imnlediately after the last unit has been injected.
`Alternatively, the feedback Big&Bi may be generated before
`the complete dose has been delivered. e.g. when a few units ss
`it:Blah& 10 bc hltcctixl, Ihc Icnuunulg &nuts bculg ulfccu:il
`w lulc thc fi:cdback s&gual &s scnscd by the user. Thus. when
`Ihe user pcrce&vcs thc fi:cdb&wk s&gnal Ihc scl dose will l&avc
`been delivered, and the user will therefore not be able to tell
`the difference between a feedback signal being generated to
`after the dose has been completely it)ected and a feedback
`signal being enemted immediately before the dose has been
`con&pit:Iciy'llcctcxl. hl Inly'vcu& Ihc user cau n:gB&d Ihc
`perccpl&on ol Ihc fi cdback s&goal as dn uldrca non Ihal Ihc sc&
`dose luis been dcl&vcrcd, and thc user may Ihcrcforc rcac& Si
`correspondingly, e g by removing a pressure applied nlanu-
`ally to an injection button.
`
`o
`
`Since thc non-visual fccdback signal &s provided only at
`the end of injection of a set dose the user w&ll know distinctly
`that when the feedback signal &s received the set dose has
`been fully injected This is an advantage con&pared to prior
`art Injection devices where a click for each injected dose unit
`is produced. in tlfis case the user ivould have to count the
`number of cl&cks produced and compare th&s to the number
`of sct dose un&ts in order to &cll exactly when thc set dose has
`been h&lly injected
`A first part and a second parr of the injection device are
`adapted to perform a relative rotational movement
`tvith
`respect to each other during injection of a dose This may,
`., be the housing and the piston rod. or it may be a
`e
`scparatc mcmbcr and mly other part ol'hc &ntccnon device.
`c g. Ihc housulg and/or ihe piston rod, thc sole purpose of thc
`separate member bein &o aenerate the non-visual feedback
`signal Three or more parts of the i&jjection device &nay
`perfornl mutual rotational n&ovements duri&lg nljection of a
`dose.
`Furthermore. the relative rotational movement may be
`pcrfi&nned all tluough the uficct&on ol'
`dose or &I may be
`pcrfi&nned dunng only par& of Ihc u&jcction. Thus,
`Ihc
`relative rotational movement may be started or stopped at
`the end of injection of a se& dose as defined above, in which
`case this starting or stopping nlay advantageously cause the
`non-visual feedback si nal to be generated
`The relative rotational movenlent causes at least two parts
`of thc uljcction dcv&ce to abut or engage, and tins abu&mcnt
`or cngagcmcnt causes the non-1 isual li:cdback s&goal to bc
`generated. One or both of the parts &vhich abut or engage
`may be the first and/or second parts, i e. the parts performing,
`the relative rotational movemen& Alternatively. one or both
`of the parts v:hich abut or engage may be other parts of the
`inlect&on device. This will be described in further details
`bclolv
`Duc Io lhc fac( Ihat thc rcla&&vc rota&&onal movmucn&
`init&a&ca thc gcncra&ion ol'hc non-v&suul fi:cdback signal &I
`is ensured that the movement generating the non-visual
`feedback signai is much longer &han a corresponding move-
`ment in an injection device &vhere the feedback signal is
`generated by a linear movement of one or more parts.
`Thcrcby thc gcncm ted s&gnal will bc much more priwisc and
`d&s&&nct, and a I'ar more accurate fcixlbuck s&gnal has thcrcby
`biwn prov&dcd. Tins &s very advantd eous bccdusc it makes
`it nn&ch easier for the person to ascertain that the expected
`and des&red dose has actually been injected
`The non-visual feedback signal may compose an audible
`and/or a tactile signal. in this case the person using the
`intccnon device w&11 bc able Io hear and/or fi:cl &hat Ihc sc&
`dose has bccn uljecttxb Altcma&ivcly or add&1&onally, Ihc
`non-v&sual Ihcdback s&gnal nu&y compwse any other suitable
`kind of signal v,hich can be perceived by other senses than
`sight. Furthermore, the non-visual feedback signal may be
`followed by a visual signal. e.g. a scale drum showing a
`'zero'. a lamp or a diode &vhich is tumed on or ofl'or starts
`enerat&on ol'hc non-
`fiaslung sinn&l&aneously w&th &lu:
`v&sual fiicdback signal. Thereby thc user may, u& ad&it&on to
`thc non-v&sual fhcdback s&goal. usc this v&sual
`liwdback
`signal to further ensure thar &he set dose has actuallv been
`in)ected.
`in one embodiment of the present Invention the abutment
`or engagement is caused by a change in a rotational velocity
`of a& less& onc par& of thc duse dclivenng mccha&usm. Tlus
`may. C.g., bc accomplished by allowing a scpara&c member
`to alar& rota hug a& Ihecnd of in(ccnon ol a sc& dose, typically
`in such a way that this member rotates during injection of the
`last few units of the se& dose 'I he mtation of this separate
`
`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 20 of 23 PageID #: 347
`
`US 9,861,757 B2
`
`housing dunng uilccnon of a dose and thc first dose part
`comprising means for engaging the second dose part at the
`end of injection of a set dose, thereby causing the second
`dose part to mtate along with the first dose part, in which
`case the non-visual feedback Bi~Bi
`Is generated by the
`resultin rotational nu&vement of the second dose part.
`In llus cmboduncnl lhc rota iional movcmcnl of thc almond
`dose part uicrcascs from zero to a non-zero value al thc end
`of injection of the set dose. 1'he second dose part may be
`pmvided ivith teeth, protmsions. flexible arnis or similar
`means being adapted to be moved against another part of the
`device during rotation of the second dose part,
`thereby
`a soiuid which at
`least partly constitutes the
`producin
`non-vlsuill IccdbBck slglrJI.
`Thc second dose part mdy be positioned between thc first
`dose part and the housing ln case the second dose part is
`pmvided with teeth, protmsions. tlexible anna or the like as
`these niay advantageously be moved
`described above,
`a ainst a part of the lu&using when the second dose part is
`mtated along v, ith the first dose part.
`thc non-visual
`fcnlback signal nmy be
`Altcmativcly,
`gcncratcd as a result of an abulmcnl bclw ccn two parts of lhc
`dose delivering mechanism performing a relative mtational
`I'he feedback sianal may. e g. be obtained by
`nx&vement
`releasing a tension which has previously been Introduced in
`a part of the injection device. the release of the tension being
`caused by the abutment between the tv o parts.
`Thc lcnscd part may compnsc a spruig means, such as a
`separate spring mcmbcr or ai least ouc resihcnt ponion of al
`least one of the first and second parts performing the relative
`rotational movenient. In case the spnng means is in the form
`of at least one resilient ponion of the part(s) the non-visual
`feedback sigrml may be generated in the followmg ntaluter.
`First the resilient portion(s) is/are bent into a tensed position.
`At a later lime tlus ternion Is rclcascd, c.g by roniling lhc
`rcmhnil portion(s) away Ibom a part wluch holds thc rcsil-
`icnl pornon(s) In lhc tensn! position. Thereby Ihc resilient
`portimi(s) will restore its,'their relaxed position(s), and this
`nx&vement will generate a clickiim sound, i e. a non-visual
`feedback signai. The resilient portion(s) may be in the form
`of spring ann(s). in ivhich case a sound may be generated
`duc lo moving air caused by sudden rclcasc of thc tcnsod
`spnng ann(s). Allcrndtivcly, abutmnit bctwcen a movuig
`part iind II rclcasc nlcchdnlsni nuly'cli Bsc Ihc tension of Ihc
`I'csllmflt polsion(s)
`'I'he tension may be introduced during dose setting, e g by
`a sprin meniber or movin a resilient portion
`tightenui
`into a tensed position as described above. This may be
`Obtauicd by letting thc dose seuing nuxhanism bc conncctcxf
`in such a way that a spnng Is
`to a spring mcmbcr. c.g.
`tighlnicd when a dose setluig mcmbcr Is tunicd. or ui such
`a way that a part heing pmvided with a resilient portion is
`rotated along with a dose settin member, thereby causing
`the resilient part to be nioved into a tensed position.
`Altemativeiy. the ternion may be introduced durin injec-
`tion of a dose. Tlus may bc obtained in a maiuicr very similar
`to wlml is dcscnbcd above. However, In this case the tcnsod
`part shoukl bc opcraui sly conncctcd to the dose dehvcnng
`irlcch'Inisnl
`'I'he dose delivering mechanism may be adapted to be
`manually operated, e., by means of an Injection button
`v hich the user must press manually durin the injection.
`thc dose dclneriug mechiuusm may be
`Altcmativcly,
`adapted to bc operated by means of a nuxhanically biascxf
`nlcchanisnl. c.g. conipllsulg ilt
`lcdsl onc sprulg. Thc
`mechanically biased mechanism may. in this case, be biased
`dunng setting of a dose i/hen the injection is subsequently
`
`Io
`
`i
`member will In turn generate a non-visual fi:nlback signal to
`the user 'thus.
`in this case the rotational velocity of tlus
`member relatively to, e g, the housing„chanaes from zero to
`a certain velocity, and this change causes the non-visual
`feedback signal to be enerated, e.g, in the foun of a clicking
`sound generated by protruding parts present on the separate
`BICnibci niovhlg Bganist Bn nulCI pall Ol lhC honSuig 01 Bn
`ouicr part Ol'hc piston rod.
`Alternatively or additionally,
`the clmnge in rotational
`velocity may cause a tactile feedback signal to be generated.
`lt may, e.g. be possible to feel the rotational movement
`itself, and thereby It may be possible for the user ro detect
`a substantial change (decrease or increase) in the romtional
`1 clocitv&
`lhc nljcclion dcvicc nlay'urther I
`In onc cnlboduncnt
`comprise a ratchet open&ting the piston md and having a
`threaded portion heing adapted to engage with a part of the
`dose delivering mechanisni, in which case the change in a
`enerated by a change in the pitch of
`rotational velocity is
`the tlueaded portion of the mstchet. said change in the pitch 30
`in rctuni causing a change in a translauonal velocity ol'aid
`part of thc dose dchvenng mechanism, smd change In
`two parts of the
`least
`translational velocity causing at
`thereby causing the non-visual
`injection device to abut,
`feedback signal to be generated.
`In tlfis embodiment the non-visual feedback signai pref-
`erably comprises a tactile feedback signal. Thus. the part of
`the dose dchvcruig mcclrdnism which is adapted to nigagc
`with lhc tlueadcd portion ol'hc cmchet Is preferably In
`directly or Indirectly contact with the user during, injection so
`of a dose Tints,
`form part of or be
`the part may be.
`operatively connected to an mjection button ivhich the user
`presses during injection Thereby the user will be able to feel
`the change in tmnshstional velocity.
`Thc pitch may be chmigcd I'rom a ccrlmn value used &s
`duruig lhc main part of Ihc Inlccnon lo zero, I C. Ihc threaded
`portion sunply slops Bl a posinon corrcsponduig 10 Ihe cnd
`of injection of a set dose. In this case the user v ill feel a kind
`of 'axial resistance'uring the injection until the ratchet/
`dose delivery part reaches the position where the tlueaded do
`portion stops. Then the part will stop rotating Bnd instead
`ulcrcdsc thc velocity of a II'iinskiniulal (axial) nlovcnn:nl
`which Is dlsii pcrfornlcd while lhc I'iilchcl/dose dclivciy pdit
`Iravels thc tlucadcd pornon, duc to lhc pilch 01 lhe fiucaded
`'I'he user will be able to feel
`portion.
`this increase in
`translational velocity. I'unhermore, the tmnslational niove-
`ment is preferably eventually stopped, e.g. due to part of the
`dose delivery mechanism abutting a stop member. Tlus stop
`will also bc Very dmuuctly li:lt by thc user, thereby produc-
`ing d nonvisual fixdback signal, and it may furtherproduce
`Ii:n!back sigiml
`a sound, ui which case thc non-visual
`comprises a tactile as well as an audible signal
`In tlus
`embodiment the two parts of the injection device which are
`caused to abut may advanta eously be a scale drum and a
`part of the housing, the scale drum peril&nuing, a rorational &s
`dnd axial movcmcnl defined by thc llucadcd porlion.
`Altcnuitmcly. the two parts may be a dose knob and a
`proximal part ol'hc housing. thc dose knob perfomun an
`axial movement which follows the axial part of the niove-
`ment of the scale drum as described above
`Alteniatively. the pitch may either increase or decrease
`front one non-zero value to another. This has the advantage
`that lhc nigaguig part Is readily movnl back uilo engagc-
`mcnt w ilh the flu cdded portion when a new dose Is lo be scl.
`In another embodimnit thc dose dchvcring mcchiuusm ss
`niay compose a first dose part and a second dose part. the
`first dose part bemg adapted to rotate relatively to the
`
`0
`
`So
`
`

`

`Case 1:22-cv-00023-JPB Document 2-12 Filed 03/18/22 Page 21 of 23 PageID #: 348
`
`US 9,861,757 B2
`
`pcrformixl Ilus m done by releasing thc ternion previously
`built up in the mechanically biased mechanism, and the
`stored nlcrgy will then cause thc set dose to be in)ected. Tlus
`kind of injection device does not require a force applied by
`the user in order to ulject a sct dose.
`
`BRIEF DESCRIPTION OF THE DR%(VINES
`
`Ill
`
`The invention v ill now be further described with refer-
`nlce to the accompanying drawulgs ul wluch:
`FIG. I shows a cross section through an mjcction device
`accordin to a first embodiment of the invention and being
`in a position where a dose has hens set.
`FIG. 2 shows a cross section throu h the injection device
`of FIG. 1 in B position where a dose has been injected,
`FIG. 3 shoes a clicl
`item adapted to be positioned in the
`intivuon dcvicc ol'IGS. 1 Bnd 2.
`FIG. 4 shows a threaded ulncr pan beulg adaptn! to be
`positioned in an injection device according to a second
`embodiment of the invention.
`FIG, 5 shows a top view of an outer part beillg adopted to
`engage with the inner part of FICI. 4,
`FIG, 6 is a cmss section along line A-A in FICi. 5.
`FIGS. 7-10 show pnrts ol'lnlimuon devices accordin to
`0 third. Iburth, fifih and ~ixth embodiment ol'he invention,
`respectively, all having a spring arm and a wedge structure,
`l1Ci H shows part of an injection device according to a
`seventh embodunent of the invention havillg 0 spring aml
`and B release mechanism,
`FIG. 12 shows an outer part of the injection device of FICi.
`11 from 0 difii:rnlt angle, and
`FIGS. 13-15 shots part olhm lnlimuon device accordulg to
`an ei hth embodiment of the imention having a spring arnl,
`Bt various polllts lfl tine
`1'he I'i urea are schenlatic and siinplified for clarity. and ls
`they only show details which are essential to the understand-
`ing of the invention wlfile other details are left out. Tluough-
`Ihc description of the drawings thc name rcfernlcc
`oul
`numerals will be used for identical or corrcspondulg pans.
`
`20
`
`Io
`
`DETAILED DESCRIPTION OF THE DRAWINGS
`
`So
`
`When in the folloss ulg terms as 'upper'id 'lower','lcfi'nd*right'.
`
`'clockwise'nd
`'horreoutnl'nd 'vcriical*,
`'counter clockwise'r similar relative expressions are used,
`these only refer to the acconlpanying drawings and not tn the
`actual situation of use The shown Figures are schematic
`representations for winch reason the configuration of the
`dlfiblcut slructui'cs as well ris Ihcu lclauvc dllucllsloils Brc
`ultcndixl to serve illustrative purposes only. In that context
`it may bc convenient to dcline thai Ihe term *distal cnd'n
`the acconlpanying drawings ls meant to refer to the end of
`the injection device carrying an injection needle. whereas
`the term 'proximal end's meant to refer to the opposite end
`pointing away from the in)ection needle.
`FIG. I shows a cross section through an mjcction device
`1 according to a lira( nnbodimcnt of Ihe ulvention. At ils
`distal cnd the in)ection dcvlcc 1 ls provided wilh a portion
`2 bein arkspted to carry an inlection needle (not shown). At
`its proxinml end the injection device I comprises a cnnl-
`bined dose setting Bnd in)ection button 3. Durillg dose
`setting the dose settin and Injection button 3 is rotated. Tlus
`cmises ihe dose acting and lnlimtion button 3 Io be moved
`away Ibom a housing 4 to the posiuon shown m FIG. 1.
`Dunng ullcction thc user presses thc dose scttulg and ss
`injection button 3, thereby movino it back into the housing
`4
`
`0
`
`ss
`
`io
`
`This movement causes thc set dose to be in)ected from thc
`inside the dose setting and injection
`in)ection device 1
`button 3 there is positioned