Case 1:22-cv-00023-JPB Document 2-18 Filed 03/18/22 Page 1 of 16 PageID #: 436
`
`
`
`
`
`Exhibit R
`
`
`
`
`

`

`USOORE46363E
`
`US RE46,363 E
`(10) Patent Number:
`Apr. 11, 2017
`(45) Date of Reissued Patent:
`
`(52) U.S. Cl.
`CPC ...... A61M 5/14566 (2013.01); A61M 5/3155
`(2013.01); A61M 5/31583 (2013.01);
`(Continued)
`(58) Field of Classification Search
`CPC ............ A61M 5/14566; A61M 5/3155; A61M
`5/31583; A61M 5/20: A61M 5/31535:
`(Continued)
`References Cited
`
`(56)
`
`(19) United States
`(12) Reissued Patent
`Moeller et al.
`
`(54) DIAL-DOWN MECHANISM FOR WIND-UP
`PEN
`
`(71) Applicant: Novo Nordisk A/S, Bagsvaerd (DK)
`
`(72) Inventors: Claus Schmidt Moeller, Fredensborg
`(DK); Christian Peter Enggaard,
`Veby (DK); Bo Radmer, Hilleroed
`(DK); Tom Hede Markussen,
`Bagsvaerd (DK)
`
`(73) Assignee: Novo Nordisk A/S, Bagsvaerd (DK)
`
`(21) Appl. No.: 14/091,774
`
`Nov. 27, 2013
`(22) Filed:
`Related U.S. Patent Documents
`
`U.S. PATENT DOCUMENTS
`
`854,390 A
`2,392,196 A
`
`5/1907 Bridge
`1/1946 Smith
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`AU
`AU
`
`1, 1988
`59.5723
`1, 2004
`2003232576 A1
`(Continued)
`
`OTHER PUBLICATIONS
`
`Annersten, M. et al., Insulin Pens Dribble From the Tip of the
`Needle After Injection, Practical Diabetes Int., vol. 17(4), pp.
`109-111 (2000).
`
`(Continued)
`Primary Examiner — William Doerrler
`(74) Attorney, Agent, or Firm — Wesley Nicolas
`
`ABSTRACT
`(57)
`The present invention relates to a dial-down mechanism for
`an injection device comprising a torsion spring for assisting
`injection of a dose of medicament from the injection device,
`the dial-down mechanism comprising dial-up cam arranged
`to receive and engage with a dial-up key, wherein the dial-up
`cam and the dial-up key are adapted to, upon rotation of a
`dose setting member in a first direction, cooperate to strain
`the torsion spring of the injection device, and a dial-down
`cam arranged to receive and engage with a dial-down key,
`wherein the dial-down cam and the dial-down key are
`(Continued)
`
`7,686,786
`Mar. 30, 2010
`11/665,486
`Oct. 20, 2005
`PCT/EP2005/O11285
`
`Reissue of:
`(64) Patent No.:
`Issued:
`Appl. No.:
`PCT Fed:
`PCT No.:
`S 371 (c)(1),
`Oct. 11, 2007
`(2) Date:
`PCT Pub. No.: WO2006/045526
`PCT Pub. Date: May 4, 2006
`U.S. Applications:
`(62) Division of application No. 13/431,019, filed on Mar.
`27, 2012, which is an application for the reissue of
`Pat. No. 7,686,786.
`(Continued)
`Foreign Application Priority Data
`
`(30)
`
`Oct. 21, 2004 (EP) ..................................... O4O77900
`
`(51) Int. Cl.
`A6M 5/20
`A6M 5/45
`A6M 5/35
`
`
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`Case 1:22-cv-00023-JPB Document 2-18 Filed 03/18/22 Page 2 of 16 PageID #: 437
`
`
`
`Amended
`
`Aleided
`
`

`

`US RE46,363 E
`Page 2
`
`adapted to, upon rotation of the dose setting member in a
`second direction, cooperate to release the torsion spring of
`the injection device, the second rotation direction being
`opposite to the first rotation direction.
`
`11 Claims, 5 Drawing Sheets
`
`Related U.S. Application Data
`(60) Provisional application No. 60/626,270, filed on Nov.
`9, 2004.
`
`(52) U.S. Cl.
`CPC ........... A61M 5/20 (2013.01); A61M 5/31535
`(2013.01); A61M 5/31553 (2013.01); A61M
`5/31586 (2013.01); A61M 5/31593 (2013.01);
`A61M 2005/202 (2013.01)
`(58) Field of Classification Search
`CPC .......... A61M 5/31586: A61M 5/31593: A61M
`5/31553; A61M 2005/202
`USPC ................ 604/134, 135, 136, 131, 132, 133
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2.956,563 A 10, 1960 Sarnoff
`3,110,310 A 11, 1963 Cislak
`3,115,135 A 12/1963 Sarnoff
`3,144,178 A
`8, 1964 Sarnoff et al.
`3,556,099 A
`1/1971 Knight et al.
`3,729,003 A
`4, 1973 Hurschman
`3,880,162 A
`4, 1975 Simmons
`3,944,843 A
`3, 1976 Vaz Martins
`4,026,288 A
`5, 1977 Costa et al.
`4,231,368 A 11, 1980 Becker
`4,275,727 A
`6, 1981 Keeri-SZanto
`4,277,227 A
`7, 1981 Jenkins
`4,298,000 A 11, 1981 Thill et al.
`4,300,554 A 11/1981 Hessberg et al.
`4,313,439 A
`2f1982 Babb et al.
`4,314,556 A
`2, 1982 Ma
`4,368,731 A
`1/1983 Schramm
`RE31,315 E
`7, 1983 Jenkins et al.
`4,393,723 A
`7, 1983 Brand
`4,430,079 A
`2f1984. Thill et al.
`4,465,478 A
`8, 1984 Sabelman et al.
`4,470,317 A
`9, 1984 Sabloewski et al.
`4493,704 A
`1, 1985 Beard et al.
`4,498,904 A
`2f1985 Turner et al.
`4,515,584 A
`5, 1985 Abe et al.
`4,568,335 A
`2/1986 Updike et al.
`4.584,439 A
`4, 1986 Paddock
`4,585.439 A
`4, 1986 Michel
`4,634,431 A
`1/1987 Whitney et al.
`4,676,122 A
`6, 1987 Szabo et al.
`4,749,109 A
`6, 1988 Kamen
`4,812,724 A
`3/1989 Langer et al.
`4,833,379 A
`5, 1989 Kaibel et al.
`4,838,860 A
`6/1989 Groshong et al.
`4,865,591 A
`9, 1989 Sams
`4,871,351 A 10/1989 Feingold
`4,883,472 A 11, 1989 Michel
`4,893,291 A
`1/1990 Bicket al.
`4,898,578 A
`2/1990 Rubalcaba, Jr.
`4.919,596 A
`4, 1990 Slate et al.
`4,924.737 A
`5, 1990 Gummow
`4,936,833. A
`6, 1990 Sams
`4,950,246 A
`8, 1990 Muller
`4,973,318 A 11/1990 Holm et al.
`4,988,337 A
`1, 1991 to
`
`Case 1:22-cv-00023-JPB Document 2-18 Filed 03/18/22 Page 3 of 16 PageID #: 438
`
`4,994,033
`4,998,922
`5,000,744
`5,002,537
`5,011.479
`5,064,098
`5,078,698
`5,104,380
`5,104,388
`5,112.317
`5,113,869
`5,114,406
`5,122.317
`5,135.485
`5,154,698
`5,163,904
`5,176,646
`5,207,752
`5,221,268
`5,226,342
`5,226,895
`5,226,896
`5,244,461
`5.244.465
`5,246,417
`5,257,987
`5,271,527
`5,279,585
`5,279,586
`5,281,198
`5,284.480
`5,292,976
`5,295,976
`5,304,152
`5,308,340
`5,314,412
`5,318,540
`5,320,609
`5,331,954
`5,368,572
`5,370,629
`5,378,233
`5,383,856
`5,383,865
`5,408,387
`5.440,976
`5,445,606
`5.447,150
`5,478.316
`5,480,387
`5.492.534
`5,496.286
`5,505,697
`5,505,704
`5,514,097
`5,536,249
`5,546,932
`5,549,575
`5,573,729
`5,582,598
`5,584.815
`5,591, 136
`5,593,390
`5,599,314
`5,611,783
`5,611,784
`5,626,566
`5,628.309
`5,637,095
`5,645,052
`5,662,612
`5,674.204
`5,679,111
`5,681,285
`5,685,864
`5,688,251
`5,709.662
`5,716,990
`5,720,733
`
`2, 1991
`3, 1991
`3, 1991
`3, 1991
`4, 1991
`11, 1991
`1, 1992
`4, 1992
`4, 1992
`5, 1992
`5, 1992
`5, 1992
`6, 1992
`8, 1992
`10, 1992
`11, 1992
`1, 1993
`5, 1993
`6, 1993
`7, 1993
`7, 1993
`7, 1993
`9, 1993
`9, 1993
`9, 1993
`11, 1993
`12, 1993
`1, 1994
`1, 1994
`1, 1994
`2, 1994
`3, 1994
`3, 1994
`4, 1994
`5, 1994
`5, 1994
`6, 1994
`6, 1994
`T/1994
`11, 1994
`12, 1994
`1/1995
`1/1995
`1/1995
`4, 1995
`8, 1995
`8, 1995
`9, 1995
`12, 1995
`1, 1996
`2, 1996
`3, 1996
`4, 1996
`4, 1996
`5, 1996
`T/1996
`8, 1996
`8, 1996
`11, 1996
`12, 1996
`12, 1996
`1/1997
`1/1997
`2, 1997
`3, 1997
`3, 1997
`5, 1997
`5, 1997
`6, 1997
`7/1997
`9, 1997
`10, 1997
`10, 1997
`10, 1997
`11, 1997
`11, 1997
`1, 1998
`2, 1998
`2, 1998
`
`Shockey et al.
`Kuracina et al.
`Hoffman et al.
`Hoffman et al.
`Le et al.
`Hutter, III et al.
`Stiehl et al.
`Holman et al.
`Quackenbush
`Michel
`Nappholz et al.
`Gabriel et al.
`Chen et al.
`Cohen et al.
`Compagnucci et al.
`Lampropoulos et al.
`Kuroda
`Sorenson et al.
`Barton et al.
`Panin
`Harris
`Harris
`Derlien
`Michel
`Haak et al.
`Athayde et al.
`Haber et al.
`Balkwill
`Balkwill
`Haber et al.
`Porter et al.
`Dessau et al.
`Harris
`Sams
`Harris
`Rex
`Athayde et al.
`Haber et al.
`Rex et al.
`Shirota
`Michel et al.
`Haber et al.
`Bersin
`Michel
`Murase et al.
`Giuliano et al.
`Haak et al.
`Bacon
`Bitdinger et al.
`Gabriel et al.
`Athayde et al.
`Stiehl et al.
`McKinnon, Jr. et al.
`Pawelka et al.
`Knauer
`Castellano et al.
`Galli
`Giambattista et al.
`Belgardt et al.
`Chanoch
`Pawelka et al.
`Gabriel
`Castellano et al.
`Neill
`Mikkelsen
`Barresi et al.
`Petersen et al.
`Brown
`Nason et al.
`Kersey
`Niehoff
`Chanoch
`Hjertman et al.
`Ford et al.
`Shanley et al.
`Chanoch
`Olive et al.
`Bagshawe et al.
`Brown
`
`

`

`US RE46,363 E
`Page 3
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3, 1998 Chanoch et al.
`5,725,508 A
`3, 1998 Castellano et al.
`5.728.074 A
`3, 1998 Nilsson et al.
`5,728,559 A
`4, 1998 Renirie et al.
`5,741,211 A
`4, 1998 Sams
`5,743,889. A
`5, 1998 Manicom
`5.755,692 A
`7, 1998 Muhlbauer
`5,782,633. A
`9, 1998 Hodosh et al.
`5,807,334 A
`9, 1998 Antanavich et al.
`5,814,022 A
`5,820,602 A 10, 1998 Kovelman et al.
`5,823,998 A 10/1998 Yamagata
`5,827,232 A 10/1998 Chanoch et al.
`5,830, 194 A 11/1998 Anwar et al.
`5,843,036 A 12/1998 Olive et al.
`5,879,360 A
`3, 1999 Crankshaw
`5,879,630 A
`3, 1999 Lescouzeres et al.
`5,882,718 A
`3, 1999 Pommer et al.
`5,898.028 A
`4/1999 Jensen et al.
`592566 A
`7, 1999 Bendek et al.
`5,928,201 A
`7, 1999 Poulsen et al.
`5,933,671 A
`8/1999 Stephany et al.
`5,938,642 A
`8/1999 Burroughs et al.
`5,947,934 A
`9, 1999 Hansen et al.
`5,951,530 A
`9/1999 Steengaard et al.
`5,954,689 A
`9, 1999 Poulsen
`5,954,700 A
`9, 1999 Kovelman
`5,957,889 A
`9, 1999 Poulsen et al.
`5,961,496 A 10/1999 Nielsen et al.
`5,971,963 A 10, 1999 Choi
`5.980,491 A 11/1999 Hansen
`5.984,900 A 11/1999 Mikkelsen
`5,989,221 A 1 1/1999 Hjertman
`5,998,989 A 12/1999 Lohberg
`6,003,736 A 12/1999 Ljunggren
`6,004,297 A 12/1999 Steenfeldt-Jensen et al.
`6,010,485 A
`1/2000 Buch-Rasmussen et al.
`6,019,745 A
`2/2000 Gray
`6,033,376 A
`3/2000 Rockley
`6,033,377 A
`3/2000 Rasmussen et al.
`6,036,675 A
`3, 2000 Thorne et al.
`6.048.336 A
`4/2000 Gabriel
`607437. A
`6, 2000 Hansen
`6,083.197 A
`7/2000 Umbaugh
`6,086,567 A
`7/2000 Kirchhofer et al.
`6,096,010 A
`8, 2000 Walters et al.
`6.110,148 A
`8, 2000 Brown et al.
`6,110,149 A
`8/2000 Klitgaard et al.
`6.129,080 A 10, 2000 Pitcher et al.
`6,14636. A
`1/2000 DiBiasiet al.
`6.159,161 A 12/2000 Hodosh
`6.161364 A 12/2000 Kolberg
`6,193,698 B1
`2/2001 Kirchhofer et al.
`6,221,046 B1
`4/2001 Burroughs et al.
`6,221,053 B1
`4/2001 Walters et al.
`6,231,540 B1
`5/2001 Smedegaard
`6,235,004 B1
`5/2001 Steenfeldt-Jensen et al.
`6.245,046 B1
`6, 2001 Sibbitt
`6,248,090 B1
`6/2001 Jensen et al.
`6,248,095 B1
`6/2001 Giambattista et al.
`6,258,062 B1
`7/2001 Thielen et al.
`6,268,722 B1
`7/2001 Kogure et al.
`6.269,340 B1
`7/2001 Ford et al.
`637097 B1
`8, 2001 Mikkelsen et al.
`6,277,098 B1
`8/2001 Klitmose et al.
`6,281.225 B1
`8, 2001 Hearst et al.
`6,283,941 B1
`9, 2001 Schoenfeld et al.
`6,287,283 B1
`9/2001 Ljunggreen et al.
`6,302,869 B1 10/2001 Klitgaard
`6,312.413 B1
`1 1/2001 Jensen et al.
`6,340,357 B1
`1/2002 Poulsen et al.
`6,364,860 B1
`4/2002 Steck et al.
`6,379,339 B1
`4/2002 Klitgaard et al.
`6,383,167 B2
`5, 2002 Kirchhofer et al.
`6,391,005 B1
`5, 2002 Lum et al.
`6,419,661 B1
`7/2002 Kuhr et al.
`
`Case 1:22-cv-00023-JPB Document 2-18 Filed 03/18/22 Page 4 of 16 PageID #: 439
`
`2/2003 Munk et al.
`6,514,230 B1
`3/2003 Klitmose
`6,537,251 B2
`4/2003 Lippe et al.
`6,547,755 B1
`4/2003 Steenfeldt-Jensen et al.
`6,547,763 B2
`4/2003 Larsen et al.
`6,547,764 B2
`5/2003 Buch-Rasmussen et al.
`6,562,011 B1
`5/2003 Poulsen et al.
`6,569,126 B1
`6/2003 Klitgaard et al.
`6,582.404 B1
`7/2003 Packman et al.
`6,585,698 B1
`7/2003 Hjertman et al.
`6,599.272 B1
`8/2003 Larsen
`6,605,067 B1
`9, 2003 Munk
`6,613,019 B2
`6,663,602 B2 12/2003 Moller
`6,666,849 B1
`12/2003 Marshall et al.
`6,673,033 B1
`1/2004 Sciulli et al.
`6,692.472 B2
`2/2004 Hansen et al.
`6,699,224 B2
`3/2004 Kirchhofer et al.
`6,716, 198 B2
`4/2004 Larsen
`6,726,661 B2
`4/2004 Munk et al.
`6,752,798 B2
`6/2004 McWethy et al.
`6770.288 B2
`8/2004 Duirs
`6,796,970 B1
`9, 2004 Klitmose et al.
`6,852.404 B2
`2/2005 Kuwajima et al.
`6,887,238 B2
`5/2005 Jahns et al.
`6,893,415 B2
`5/2005 Madsen et al.
`6,899,698 B2
`5/2005 Sams
`6,899,699 B2
`5 2005 Enggaard
`6,945,961 B2
`9, 2005 Miller et al.
`7,008,399 B2
`3/2006 Larsen et al.
`7,080,936 B 72006 Simpson
`7,090,662 B2
`8/2006 Wimpenny et al.
`7,094.221 B2
`8/2006 Veasey et al.
`7,104,972 B2
`9, 2006 Moller et al.
`7,133,329 B2 11/2006 Skyggebjerg et al.
`7, 175,055 B2
`2/2007 Hansen et al.
`7, 195,609 B2
`3/2007 Huegli
`7, 195,616 B2
`3/2007 Diller et al.
`7,241,278 B2
`7, 2007 Moller
`7,500,966 B2
`3/2009 Hommann
`7,678,084 B2
`3/2010 Judson et al.
`7,686,786 B2
`3/2010 Moller et al.
`7,704.238 B2
`4/2010 Diller et al.
`7,771,399 B2
`8, 2010 Burren et al.
`8,048,037 B2 1 1/2011 Kohlbrenner et al.
`8,202,256 B2
`6, 2012 Moller
`8,206.361 B2
`6/2012 Moller
`8,267,899 B2
`9/2012 Moller
`8,870,831 B2 10/2014 Holmqvist et al.
`9,132,239 B2
`9/2015 Moller et al.
`2001 OO16571 A1
`8, 2001 Ohikubo et al.
`2001/003450.6 A1 10, 2001 Hirschman et al.
`2001.0053893 A1 12/2001 Larsen
`2002/0002326 A1
`1/2002 Causey et al.
`2002fOOO2354 A1
`1/2002 Vetter et al.
`2002fOOOT154 A1
`1/2002 Hansen et al.
`2002.0020654 A1
`2/2002 Eilersen
`2002.00494.15 A1
`4/2002 Fukuda
`2002fOO52578 A1
`5, 2002 Moller
`2002fOO77852 A1
`6/2002 Ford et al.
`2002/0107486 A1
`8, 2002 Munk
`2002/O120235 A1
`8/2002 Enggaard
`2002fO165500 A1
`11/2002 Bechtold et al.
`2002/0173752 A1* 11, 2002 Polzin ........................... 604,233
`2002/0188250 A1 12/2002 Landau et al.
`2003/0009133 A1
`1/2003 Ramey
`2003/OO39679 A1
`2/2003 DuirS
`2003/004O715 A1
`2/2003 D'Antonio et al.
`2003/0050609 A1
`3, 2003 Sams
`2003/OO73954 A1
`4/2003 Moberg et al.
`2003.0114800 A1
`6/2003 Veasey et al.
`2003/0172924 A1
`9, 2003 Staniforth et al.
`2003/0176871 A1
`9, 2003 Pavlov et al.
`2003/0216663 Al 11/2003 Jersey-Willuhn et al.
`2003/0233075 A1 12/2003 Huegli
`2004/0010204 A1
`1/2004 Weber et al.
`2004.0024361 A1
`2/2004 Fago et al.
`2004/005.1368 A1
`3/2004 Caputo et al.
`2004.0054326 A1
`3/2004 Hommann et al.
`2004/0059299 A1
`3/2004 Moller
`
`

`

`US RE46,363 E
`Page 4
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5, 2004 WoO1ston
`2004/0097.879 A1
`6/2004 Hansen et al.
`2004/0108339 A1
`8/2004 Cory et al.
`2004/0158304 A1
`9/2004 Sparks et al.
`2004/0171983 A1
`9, 2004 Graf et al.
`2004/0186431 A1
`10, 2004 Giambattista et al.
`2004/O 1991 17 A1
`2004/0207385 A1 10, 2004 Gafner et al.
`2004/0210199 A1 10/2004 Atterbury et al.
`2004/0230157 A1 1 1/2004 Perry et al.
`2004/0236282 A1
`11/2004 Braithwaite
`2004/0249348 Al 12/2004 Wimpenny et al.
`2004/0260247 A1 12/2004 Veasey et al.
`2004/0267207 Al 12/2004 Veasey et al.
`2004/0267208 Al 12/2004 Veasey et al.
`2005/0004529 A1
`1/2005 Veasey et al.
`2005/00 19400 A1
`1/2005 Deveney et al.
`2005/0033244 A1
`2/2005 Veasey et al.
`2005/0055011 A1
`3/2005 Enggaard
`2005/0090782 A1* 4, 2005 Marshall et al. ............. 604/211
`2005. O1976.25 A1
`9, 2005 Haueter et al.
`2005/0205083 A1
`9, 2005 Stanforth et al.
`2005/0209570 A1
`9, 2005 Moller
`2005/02689 15 A1 12/2005 Wassenaar et al.
`2006/01186 12 A1
`6, 2006 Christoffersen et al.
`2006/0258988 A1
`11/2006 Keitel et al.
`2006/0264838 A1
`11/2006 Volckmann et al.
`2007/0093761 A1
`4/2007 Veasey et al.
`2007/016791.6 A1
`7, 2007 Lee et al.
`2007/0244445 A1 10, 2007 Moller
`2007,0265568 A1 11, 2007 Tsals et al.
`2008, OO65026 A1
`3, 2008 Moller
`2008. O147005 A1
`6, 2008 Moller et al.
`2008/0221530 A1
`9/2008 Glebol et al.
`2008/0281275 A1 11, 2008 Moller
`2008/0306445 A1 12/2008 Burren et al.
`2008/0312592 A1 12/2008 Barrow-Williams et al.
`2009/0043264 A1
`2/2009 Glebol et al.
`2009 OO62748 A1
`3, 2009 Moller et al.
`2009/0209920 A1
`8, 2009 Moller et al.
`2011 0046565 A1
`2/2011 Radmer et al.
`2011 0125100 A1
`5, 2011 Schwirtz et al.
`2012/0095410 A1
`4/2012 Moller et al.
`2012/0209208 A1
`8, 2012 Stefanski
`2013/0204197 A1
`8, 2013 Bicknell et al.
`2013/0274676 A1 10, 2013 Ekman et al.
`2013/0310739 A1
`11/2013 Galbraith et al.
`2014/0350478 A1
`11/2014 Hansen et al.
`2015,0148750 A1
`5, 2015 Pedersen et al.
`
`FOREIGN PATENT DOCUMENTS
`
`Case 1:22-cv-00023-JPB Document 2-18 Filed 03/18/22 Page 5 of 16 PageID #: 440
`
`BR
`CA
`CN
`RE
`DE
`DE
`DE
`DE
`DE
`DE
`DE
`DE
`DE
`DE
`DE
`DE
`DE
`DE
`DE
`DE
`DE
`DK
`DK
`
`PIO613926 A2
`2/2011
`235.9375 A1
`T 2000
`1214292 A
`4f1999
`39.3 A. 28
`3609555 A1
`9, 1987
`3638984 A1
`5, 1988
`3923079 A1
`1/1991
`4223958 A1
`1/1993
`4419235 A1 12, 1995
`19503230 A1
`8/1996
`29513214 U1
`1/1997
`19723647 C1 12/1998
`19838760 A1
`4, 2000
`29907880 U1
`9, 2000
`10 103287 A1
`8/2001
`20209051 U1
`4, 2003
`102O1875 C1
`5/2003
`10229122 A1
`2/2004
`10237258 A1
`3f2004
`20317377 U1
`4, 2005
`102004O46003 A1
`3f2006
`20010O240
`11 2001
`2005.00116 U1
`6, 2005
`
`EA
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`FR
`FR
`FR
`FR
`FR
`FR
`GB
`SE
`SE
`GB
`GB
`IN
`JP
`JP
`JP
`JP
`JP
`
`4/2007
`O08160
`9, 1980
`15617
`10, 1980
`O17318 A1
`11F1982
`OO64858 A1
`12, 1988
`295O75
`8, 1989
`327810 A2
`8, 1989
`327910
`10, 1989
`338806
`4, 1990
`O362484 A2
`9, 1990
`387854
`4f1991
`422482
`10, 1991
`454331
`8, 1992
`498.737
`8, 1992
`87961O
`4f1993
`608343
`8/1993
`554995 A1
`8, 1993
`554996
`4f1994
`59.4349
`9, 1994
`615762
`9, 1994
`O615762 A1
`7, 1995
`513,128
`9, 1995
`O673482
`679440 A1 11, 1995
`7O297O
`3, 1996
`O704225 A2
`4f1996
`O708179 A2
`4f1996
`897728
`2, 1999
`897729 A2
`2/1999
`908273
`4f1999
`O9374.71
`8, 1999
`O937472
`8, 1999
`93,7476
`8, 1999
`O937476 A2
`8, 1999
`10O3581
`8, 1999
`956873 A2 11/1999
`1351732
`1, 2001
`1074273
`2, 2001
`1095668 A1
`5, 2001
`1216717 A1
`6, 2002
`1216719 A1
`6, 2002
`1000631
`T 2002
`O747391
`3, 2004
`1462134 A1
`9, 2004
`1541.185
`6, 2005
`155.7163
`7/2005
`1557.189 A1
`T 2005
`1568389
`8, 2005
`1304129
`11/2005
`1610848 A1
`1/2006
`1645301
`4/2006
`1723977
`11 2006
`1728,529
`12/2006
`1768725 A1
`4, 2007
`1782853
`5/2007
`1819.382
`8, 2007
`1909871 A1
`4, 2008
`1926514 A1
`6, 2008
`2OOO161
`12/2008
`2O19701 A1
`2/2009
`2373361 A1
`10, 2011
`2583.291
`12, 1986
`26224.57
`5, 1989
`2697434 A1
`5.1994
`2740345
`4f1997
`2767479
`2, 1999
`2857654
`1, 2005
`574705
`1, 1946
`s: ! E:
`5.
`2309644
`OOOTO714
`16.5367
`56-1634.86
`57-OOOO33
`O1-035671 A
`O1-100495
`02071758 A
`
`8, 1997
`3, 2000
`3, 1986
`12/1981
`1, 1982
`2, 1989
`4f1989
`3, 1990
`
`

`

`(56)
`
`References Cited
`
`FOREIGN PATENT DOCUMENTS
`
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`PL
`PL
`PL
`RU
`RU
`RU
`RU
`SU
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`Case 1:22-cv-00023-JPB Document 2-18 Filed 03/18/22 Page 6 of 16 PageID #: 441
`
`5, 1990
`O2-126184
`7, 1990
`O2-182267
`8, 1992
`4-224764
`9, 1992
`O4256757 A
`12/1992
`4-507059
`12/1993
`O5-337179
`1, 1994
`06-055644
`10, 1994
`06-034825
`10, 1994
`06-296.691
`1, 1995
`HOT-500039
`3, 1995
`7-5O2678
`6, 1997
`O9166474
`10, 1999
`11511364
`11, 1999
`3017167
`9, 2000
`200O2373O8
`1, 2002
`20025.03122
`10, 2003
`2003284777
`2, 2004
`2004503303 A
`6, 2004
`2004-516895
`2004.533285 A 11 2004
`2005536300 A 12/2005
`2006250582
`9, 2006
`2007-5O9662
`4/2007
`2008-528071 A
`T 2008
`2008-196696 A
`8, 2008
`2010.523183 A
`T 2010
`2011:524212 A
`9, 2011
`EP 1804865
`10/2005
`2O8660 B1
`5, 2011
`EP 2373.361
`9, 2012
`2111019
`5, 1997
`2091087
`9, 1997
`2212254
`9, 2003
`2254878 C2
`6, 2005
`1528330 A3 12/1989
`85O2256
`5, 1985
`8702895 A1
`5, 1987
`89.07463
`8, 1989
`90,092O2
`8, 1990
`91 10460 A1
`7, 1991
`9110677
`7, 1991
`91/14467 A1 10, 1991
`93O1573
`1, 1993
`93O378O
`3, 1993
`93O7922
`4f1993
`9412228
`6, 1994
`95/21645 A1
`8/1995
`9524233
`9, 1995
`96O7443
`3, 1996
`9626754
`9, 1996
`96.32973
`10, 1996
`96381.90
`12/1996
`97.07841
`3, 1997
`97.10865 A1
`3, 1997
`973O742
`8, 1997
`9733638
`9, 1997
`9734919
`9, 1997
`97.36626
`10, 1997
`9810813
`3, 1998
`9856436
`12/1998
`9856439
`12/1998
`98.57688
`12/1998
`99.07425
`2, 1999
`99.15214
`4f1999
`99.16487
`4f1999
`992.1598
`5, 1999
`9938554
`8, 1999
`99.48546
`9, 1999
`9965548 A1 12/1999
`OO15224 A1
`3, 2000
`OO37098 A1
`6.2
`OO37129
`3.
`OOf 51668
`9, 2000
`01.10484
`2, 2001
`01, 19434 A1
`3, 2001
`
`US RE46,363 E
`Page 5
`
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`4/2001
`O 126710
`5, 2001
`O1/30425
`10, 2001
`O172361
`O195959 A1 12/2001
`O2O5876
`1, 2002
`O224257
`3, 2002
`02/050214 A2
`6, 2002
`O2/O53214
`T 2002
`WO O2/O53214 A1
`T 2002
`O2O641.96
`8, 2002
`O2/O76535
`10, 2002
`O2/O76537
`10, 2002
`O2O76.536
`10, 2002
`O2/O92153 A2 11/2002
`O3,057285 A2
`T 2003
`O3,057286 A1
`T 2003
`O3057283
`T 2003
`O3063680
`8, 2003
`O3O8O160
`10, 2003
`O309.9357
`12/2003
`2004/OO2556 A1
`1, 2004
`2004.004.825
`1, 2004
`2004007002 A1
`1, 2004
`2004/024.218
`3, 2004
`2004/028598 A1
`4/2004
`2006/04.5529
`4/2004
`2004.035113 A2
`4/2004
`2004.054644 A1
`T 2004
`2004/078240
`9, 2004
`2004/078242 A2
`9, 2004
`2004.078239 A1
`9, 2004
`2004.078241
`9, 2004
`2004080306
`9, 2004
`2004084.795
`10, 2004
`2004/093940 A2 11/2004
`2004O953.79
`11 2004
`2005O18721
`3/2005
`2005037352
`4/2005
`2005/046770
`5, 2005
`2005089835
`9, 2005
`2005097233
`10/2005
`2005097240
`10/2005
`2005,102421 A1 11/2005
`2006/003130 A1
`1, 2006
`2006/026754 A2
`3, 2006
`2006/037434 A1
`4/2006
`2006O39930 A1
`4/2006
`2006040296 A2
`4/2006
`2006/045528
`5, 2006
`2006045425
`5, 2006
`2006O455.25
`5, 2006
`2006O45526 A1
`5, 2006
`2006/0694.54
`T 2006
`2006O76921
`T 2006
`2006116997
`11 2006
`2006/128794
`12/2006
`2007021195 A1
`2, 2007
`2007/030957
`3, 2007
`2007041843
`4/2007
`2007063342 A1
`6, 2007
`2007104636 A1
`9, 2007
`2007107558 A2
`9, 2007
`2007107561
`9, 2007
`2007 134954
`11/2007
`2008/OO3130 A1
`1, 2008
`2008/031239 A1
`3, 2008
`2008/0378O1
`4/2008
`2008057223
`5, 2008
`2010046394 A1
`4/2010
`2010O89418 A2
`8, 2010
`2011025448 A1
`3, 2011
`2011 136718 A1
`11, 2011
`2013, 178372 A1 12/2013
`
`OTHER PUBLICATIONS
`
`Answer in Novo Nordisk A/S v. Sanofi-Aventis U.S. LLC and
`Sanofi-Aventis downloaded from Pacer on Feb. 29, 2008.
`
`

`

`US RE46,363 E
`Page 6
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`Beckmann, Sensors, Memory, Circuits, Polyapply Newsletter, vol.
`1(3), (2006).
`Chia Kai Su et al. Process Biochemistry, 2006, vol. 41, Part 2, pp.
`257-263.
`Common Insulin Injection Challenges: http://www.bd.com/us/dia
`betes/page.aspx?cat=7001&id=7265.
`Complaint in Novo Nordisk A/S v. Sanofi-Aventis U.S. LLC and
`Sanofi-Aventis downloaded from Pacer on Feb. 29, 2008.
`Declaration of Benard Sams in Novo Nordisk A/S v. Sanofi-Aventis
`U.S. LLC and Sanofi-Aventis downloaded from Pacer on Feb. 29.
`2008.
`Dennison, Clive et al. Protein Expression and Purification, 1997.
`vol. 11, Part 2, pp. 149-161.
`Fransson et al. Pharmaceutical Research, 1997, vol. 14, Part 5, pp.
`606-612.
`Gnanalingham, M.G. et al., Accuracy and Reproducibility of Low
`Dose Insulin Administration Using Pen-Injectors and Syringes,
`Downloaded From adc. bm.com on Jan. 9, 2008.
`International Search Report and Written Opinion issued in connec
`tion with counterpart PCT Application No. PCT/EP2006/061747,
`mailed Sep. 29, 2006.
`Leonil et al. Enzyme and Microbiol Technology, 1994, vol. 16, Part
`7, pp. 591-595.
`Owen Mumford Product Range.
`File history of U.S. Appl. No. 10/610,926 which is owned by the
`same assignee as U.S. Appl. No. 11/122,289 and U.S. Appl. No.
`11/765,789.
`Paule, B.J. A. et al. Protein Expression and Purification, 2004, vol.
`34, Part 2, pp. 311-316.
`Search Report issued in connection with counterpart Danish Appli
`cation No. PA 2005 00588, mailed Feb. 13, 2006.
`Search Report issued in connection with counterpart Danish Appli
`cation No. PA 2005 00589, mailed Feb. 16, 2006.
`Search Report Issued in Connection With PCT Applin. No. PCT/
`EP2007/052630, Mailed Nov. 12, 2007.
`Search Report issued in connection with European Application No.
`06005599.3, mailed Oct. 4, 2006.
`
`Search Report issued in connection with PCT Application No.
`PCT/EP2007/052633, mailed Feb. 20, 2008.
`Search Report Issued in Connection With European Applin No.
`06005602.5, Mailed Oct. 16, 2006.
`Trankler, Hans-Rolf, R. Oldenbourg, Verlag, Munchen, Wien,
`Taschenbuch Der Messtechnik, 1996.
`Reissue U.S. Appl. No. 10/442,855 File History.
`Reissue U.S. Appl. No. 10/960,900 File History.
`Reissue U.S. Appl. No. 11/121.331 File History.
`Reissue U.S. Appl. No. 1 1/640,610 File History.
`May 17, 2002 Office Action in U.S. Appl. No. 09/768,760 and
`accompanying 892 and 1149 forms.
`File history of U.S. Appl. No. 10/610,926, which is owned by the
`same assignee as U.S. Appl. No. 1 1/765,789.
`Advisory Action mailed on Mar. 23, 2010 in U.S. Appl. No.
`11/122.289 filed on May 4, 2005 by Moller et al.
`Notice of Opposition by Owen Mumford (UK).
`Notice of Opposition by Genentech (USA).
`Notice of Opposition by Techpharma (CH) Including English Trans
`lation.
`Opposition in Related European Patent Application EP 0271 1784.5
`of Sep. 19, 2008.
`Validity Opinion by the UK PTO.
`Opinion of US District Court for the District of NJ in Novo Nordisk
`A/S v. Sanofi-Aventis U.S. LLC and Sanofi-Aventis Denying motion
`of a preliminary injunction entered Feb. 20, 2008.
`Written Opinion issued in connection with counterpart PCT Appli
`cation No. PCT/EP2006/061747, mailed Nov. 8, 2006.
`Written Opinion issued in connection with counterpart PCT Appli
`cation No. PCT/EP2006/061748, mailed Nov. 8, 2006.
`Rose, Keith et al., Bioconjugate Chemistry, “Natural Peptides as
`Building Blocks for the Synthesis of Large Protein-Like Molecules
`With Hydrazone and Oxime Linkages', 1996, vol. 7, 2, pp. 552-556.
`Yurkovetskiy, A. et al., Biomacromolecules. "Fully Degradable
`Hydrophilic Polyals for Protein Modification', 2005, vol. 6, 5, pp.
`2648-2658.
`International Search Report and Written Opinion issued in connec
`tion with counterpart PCT Application No. PCT/EP2006/061748
`mailed Aug. 10, 2006.
`* cited by examiner
`
`Case 1:22-cv-00023-JPB Document 2-18 Filed 03/18/22 Page 7 of 16 PageID #: 442
`
`

`

`U.S. Patent
`
`Apr. 11, 2017
`
`Sheet 1 of 5
`
`US RE46,363 E
`
`
`
`Case 1:22-cv-00023-JPB Document 2-18 Filed 03/18/22 Page 8 of 16 PageID #: 443
`
`Fig. B Amended
`
`

`

`U.S. Patent
`
`Apr. 11, 2017
`
`Sheet 2 of 5
`
`US RE46,363 E
`
`
`
`Case 1:22-cv-00023-JPB Document 2-18 Filed 03/18/22 Page 9 of 16 PageID #: 444
`
`Fig. 28 Amended
`
`

`

`U.S. Patent
`
`Apr. 11, 2017
`
`Sheet 3 of 5
`
`US RE46,363 E
`
`
`
`Case 1:22-cv-00023-JPB Document 2-18 Filed 03/18/22 Page 10 of 16 PageID #: 445
`
`Fig. 3 Amended
`
`

`

`U.S. Patent
`
`Apr. 11, 2017
`
`Sheet 4 of 5
`
`US RE46,363 E
`
`3O
`
`\ \
`
`·
`
`
`
`36
`
`Case 1:22-cv-00023-JPB Document 2-18 Filed 03/18/22 Page 11 of 16 PageID #: 446
`
`Fig. 4 Amended
`
`

`

`U.S. Patent
`
`Apr. 11, 2017
`
`Sheet S of 5
`
`US RE46,363 E
`
`FIG. 5B Amended
`
`
`
`Case 1:22-cv-00023-JPB Document 2-18 Filed 03/18/22 Page 12 of 16 PageID #: 447
`
`FG, SA
`
`Amended
`
`

`

`1.
`DAL-DOWN MECHANISM FOR WIND-UP
`PEN
`
`US RE46,363 E
`
`appears in the
`Matter enclosed in heavy brackets
`original patent but forms no part of this reissue specifica
`tion; matter printed in italics indicates the additions
`made by reissue; a claim printed with strikethrough
`indicates that the claim was canceled, disclaimed, or held
`invalid by a prior post-patent action or proceeding.
`
`10
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`15
`
`This application is a 35 U.S.C. S. 371 national stage
`application of International Patent Application PCT/
`EP2005/011285 (published as WO 2006/045526), filed Oct.
`20, 2005, which claimed priority of European Patent Appli
`cation 04077900.1, filed Oct. 21, 2004; this application
`further claims priority under 35 U.S.C. S 119 of U.S.
`Provisional Application 60/626,270, filed Nov. 9, 2004.
`This application is a Divisional Reissue of U.S. application
`Ser: No. 13/431,019, filed Mar: 27, 2012, which is an
`Application for Reissue of U.S. Pat. No. 7,686,786, issued
`Mar: 30, 2010 (U.S. application Ser: No. 1 1/665,486, filed
`Oct. 11, 2007), which is a 35 U.S.C. S371 national stage
`application of International Patent Application PCTV
`EP2005/01 1285 (published as WO2006/045526), filed Oct.
`20, 2005, which claimed priority of European Patent Appli
`cation 04077900. 1, filed Oct. 21, 2004; this application
`further claims priority under 35 U.S.C. S I 19 of U.S. Provi
`Sional Application 60/626,270, filed Nov. 9, 2004, incorpo
`rated herein by reference.
`
`25
`
`30
`
`35
`
`FIELD OF THE INVENTION
`
`The present invention relates to a dial-down mechanism
`for automatic wind-up pens. In particular, the present inven
`tion relates to integrated axial and radial dial-down mecha
`nisms for wind-up pens.
`
`40
`
`BACKGROUND OF THE INVENTION
`
`Case 1:22-cv-00023-JPB Document 2-18 Filed 03/18/22 Page 13 of 16 PageID #: 448
`
`In known injection devices, such as wind-up pens, based
`on torsion springs, the use of dial-down mechanisms rely on
`that the user of the injection device applies a force to a
`rotatable dose setting member of the injection device. The
`force must be applied in order to axially withdraw the dose
`setting member a certain distance to release the dose setting
`member from a toothing mechanism or ratchet positioned
`within the body of the injection device. By releasing the
`dose setting member from this toothing mechanism the dose
`setting member can be reversed by rotation and set at a new
`and lower dose.
`An example of a known wind-up pen applying a torsion
`spring may for example be found in U.S. Pat. No. 5,104,380.
`However, the pen suggested in U.S. Pat. No. 5,104,380 does
`not offer a dial-down mechanism. A dial-down mechanism
`is provided in WO 02/053214. However, the proposed
`solution in WO 02/053214 involves a linear spring.
`It is a disadvantage of known torsion spring-based dial
`down systems that the user must apply a force to withdraw
`the dose setting member a certain axial distance and, at the
`same time, adjust the angular position of the dose setting
`member. Especially for persons having reduced motoric
`
`45
`
`50
`
`55
`
`60
`
`65
`
`2
`skills or reduced finger strength, Such as children, elderly
`people or disabled people this is a rather complicated
`procedure.
`US 2004/1991 17 discloses a medication delivery pen
`including an arrangement where incorrect dosage settings
`may be corrected by a user via a dial-back feature that
`enables the user to reset the dose amount without expelling
`medication and without having to dial a dose knob to an
`extended, reset position. The medication delivery pen of US
`2004/1991 17 is a so-called manual pen where the injection
`of a medicament from the pen is driven by a force purely
`provided by the user of the pen. Thus, the injection of a
`medicament is not assisted by any resilient member, Such as
`a spring, and the dial-down arrangement disclosed in US
`2004/1991 17 is not arranged to maintain a resilient member
`in a given strained position.
`It is an object of the present invention to provide a
`dial-down mechanism for automatic wind-up pens. Auto
`matic wind-up pens are here to be understood as pens having
`a resilient member, Such as a spring, to assist injecting a
`medicament from an injection device.
`
`SUMMARY OF THE INVENTION
`
`The above-mentioned object is complied with by provid
`ing, in a first aspect, a dial-down mechanism for an injection
`device comprising a torsion spring for assisting injection of
`a dose of medicament from the injection device, the dial
`down mechanism comprising
`dial-up cam arranged to receive and engage with a dial-up
`key, wherein the dial-up cam and the dial-up key are
`adapted to, upon rotation of a dose setting member in
`a first direction, cooperate to strain the torsion spring of
`the injection device, and
`a dial-down cam arranged to receive and engage with a
`dial-down key, wherein the dial-down cam and the
`dial-down key are adapted to, upon rotation of the dose
`setting member in a second direction, cooperate to
`release the torsion spring of the injection device, the
`second rotation direction being opposite to the first
`rotation direction.
`Generally speaking the dial-down mechanism may be
`implemented as a radial dial-down mechanism or as an axial
`dial-down mechanism. In the radial dial-down mechanism
`the dial-down key or keys are arranged to move in the radial
`direction of the mechanism. This may also be the radial
`direction of the injection device. In the axial dial-down
`mechanism, the dial-down key or keys are arranged to move
`in the axial direction of the injection device.
`Also it should be noted that the dial-up key or keys, and
`the dial-down key or keys may be different keys—i.e.
`physically separated keys. However, it may also be that the
`dial-up and dial-down key is constituted by the same key.
`Thus, it may be that the mechanism according to the present
`invention comprises only a single key which is used for both
`dial-up and dial down.
`The dial-up