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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`————————————————
`Case No. IPR2018-01676
`Patent No. 8,603,044
`————————————————
`
`PETITION FOR INTER PARTES REVIEW
`
`

`

`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`INTRODUCTION .......................................................................................... 1
`
`II. MANDATORY NOTICES ............................................................................ 1
`A. Real Parties-In-Interest (37 C.F.R. §42.8(b)(1)) ............................... 1
`B.
`Related Matters (37 C.F.R. §42.8(b)(2)) .............................................. 1
`C.
`Identification of Counsel (37 C.F.R. §42.8(b)(3)) and
`Service Information (37 C.F.R. §42.8(b)(4)) ....................................... 2
`
`III. CERTIFICATIONS ....................................................................................... 3
`
`IV.
`
`V.
`
`IDENTIFICATION OF CHALLENGE; STATEMENT OF
`PRECISE RELIEF REQUESTED ................................................................ 3
`
`REASONS FOR RELIEF REQUESTED ..................................................... 3
`A.
`Argument Summary ............................................................................ 3
`B.
`’044 Patent ............................................................................................ 4
`1.
`Background ................................................................................ 4
`Brief Overview of Embodiments ............................................................ 7
`Pen-Injector Operation ......................................................................... 10
`2.
`Prosecution History .................................................................. 13
`Level of Ordinary Skill ....................................................................... 14
`Claim Construction ............................................................................ 14
`Prior Art ............................................................................................. 16
`1. Møller ....................................................................................... 16
`2.
`Steenfeldt-Jensen ..................................................................... 19
`F. Ground 1: Steenfeldt-Jensen ............................................................ 21
`1.
`Element-by-element analysis.................................................. 21
`2.
`Reason to modify; reasonable expectation of success .......... 40
`G. Ground 2: Møller and Steenfeldt-Jensen ....................................... 49
`
`C.
`D.
`E.
`
`-i-
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`

`

`
`TABLE OF CONTENTS
`(Continued)
`
`Page
`
`
`
`1.
`2.
`
`Element-by-element analysis.................................................. 50
`Reason to modify; reasonable expectation of success .......... 76
`
`VI. CONCLUSION ............................................................................................ 90
`
`
`
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`-ii-
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`

`

`
`
`
`LIST OF EXHIBITS
`
`Exhibit No.
`1001
`
`Description
`U.S. Patent 8,679,069, Pen-Type Injector (issued Mar. 25, 2014)
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`U.S. Patent 8,603,044, Pen-Type Injector (issued Dec. 10, 2013)
`U.S. Patent 8,992,486, Pen-Type Injector (issued Mar. 31, 2015)
`
`U.S. Patent 9,526,844, Pen-Type Injector (issued Dec. 27, 2016)
`
`U.S. Patent 9,604,008, Drive Mechanisms Suitable for Use in Drug
`Delivery Devices (issued Mar. 28, 2017)
`File History for U.S. Patent 8,679,069
`
`File History for U.S. Patent 8,603,044
`
`File History for U.S. Patent 8,992,486
`
`File History for U.S. Patent 9,526,844
`
`File History for U.S. Patent. 9,604,008
`
`Expert Declaration of Karl Leinsing MSME, PE in Support of
`Petition for Inter Partes Review of U.S. Patent Nos. 8,679,069;
`8,603,044; 8,992,486; 9,526,844 and 9,604,008
`Curriculum Vitae of Karl Leinsing MSME, PE
`
`U.S. Patent 6,221,046 - A. Burroughs et al., “Recyclable Medication
`Dispensing Device” (issued Apr. 24, 2001)
`U.S. Patent 6,235,004 – S. Steenfeldt-Jensen & S. Hansen, “Injection
`Syringe” (issued May 22, 2001)
`
`U.S. Patent Application US 2002/0053578 A1 – C.S. Møller, “Injection
`Device” (pub’d May 2, 2002)
`
`-iii-
`
`

`

`
`
`Exhibit No.
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`Description
`U.S. Patent 6,932,794 B2 – L. Giambattista & A. Bendek,
`“Medication Delivery Pen” (issued Aug. 23, 2005)
`U.S. Patent 6,582,404 B1 – P.C. Klitgaard et al., “Dose Setting
`Limiter” (issued June 24, 2003)
`File History for U.S. Patent 6,582,404
`
`Plaintiffs’ Preliminary Claim Constructions and Preliminary
`Identification of Supporting Intrinsic and Extrinsic Evidence,
`Sanofi-Aventis U.S. LLC v. Mylan GmbH, No. 2:17-cv-09105
`(D.N.J.)
`U.S. Patent 4,865,591 – B. Sams, “Measured Dose Dispensing
`Device” (issued Sep. 12, 1989)
`U.S. Patent 6,248,095 B1 – L. Giambattista et al., “Low-cost
`Medication Delivery Pen” (issued June 19, 2001)
`U.S. Patent 6,921,995 B1 – A.A. Bendek et al., “Medication
`Delivery Pen Having An Improved Clutch Assembly” (issued
`July 13, 1999)
`U.S. Patent 5,226,895 – D.C. Harris, “Multiple Dose Injection Pen”
`(issued July 13, 1993)
`U.S. Patent 5,851,079 – R.L. Horstman et al., “Simplified
`Unidirectional Twist-Up Dispensing Device With Incremental
`Dosing” (issued Dec. 22, 1998)
`Application as filed: U.S. Patent App. 14/946,203 – R.F. Veasey,
`“Relating to a Pen-Type Injector” (filed Nov. 19, 2015)
`GB 0304822.0 – “Improvements in and relating to a pen-type
`injector” (filed Mar. 3, 2003) (‘844 Priority Doc.)
`
`
`
`-iv-
`
`

`

`
`
`Exhibit No.
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`Description
`WO 99/38554 – S.Steenfeldt-Jensen & S.Hansen, “An Injection
`Syringe” (pub’d Aug. 5, 1999) (Steenfeldt-Jensen PCT)
`Mylan GmbH and Biocon’s Preliminary Claim Constructions and
`Supporting Evidence Pursuant to L. Pat. R. 4.2, Sanofi-Aventis
`U.S., LLC v. Mylan N.V., C.A. No. 17-cv-09105
`Memorandum Opinion, Sanofi-Aventis U.S. LLC v. Merck Sharp &
`Dohme Corp., No. 16-cv-812 (filed Jan. 12, 2018)
`Memorandum Opinion, Sanofi -Aventis U.S. LLC v. Eli Lilly and
`Co., No. 14-cv-113 (filed Jan. 20, 2015)
`N. Sclater & N.P. Chironis, Mechanisms & Mechanical Devices
`Sourcebook 191-95, “Twenty Screw Devices” (3d ed., July 2,
`2001)
`EP 0 608 343 B1 – L. Petersen & N.-A. Hansen, “Large Dose Pen”
`(pub’d Oct. 18, 1991)
`A.G. Erdman & G.N. Sandor, “Mechanical Advantage”, §3.7 in
`1 Mechanism Design: Analysis and Synthesis (1984)
`WO 01/83008 – S. Hansen & T.D. Miller., “An Injection Device, A
`Preassembled Dose Setting And Injection Mechanism For An
`Injection Device, And A Method Of Assembling An Injection
`Device” (pub’d Nov. 8, 2001)
`K.J. Lipska et al., Association of Initiation of Basal Insulin Analogs
`vs Neutral Protamine Hagedorn Insulin With Hypoglycemia-
`Related Emergency Department Visits or Hospital Admissions
`and With Glycemic Control in Patients With Type 2 Diabetes,
`320 J. Am. Med. Ass’n 53-62 (2018).
`
`
`
`-v-
`
`

`

`
`
`
`I.
`
`INTRODUCTION
`Petitioner (“Mylan”) petitions for inter partes review of U.S. Patent 8,603,044
`
`(“the ’044 patent,” EX1002). 35 U.S.C. 311. This petition shows a reasonable
`
`likelihood that claims 11, 14, 15, 18, and 19 are unpatentable.
`
`II. MANDATORY NOTICES
`A. Real Parties-In-Interest (37 C.F.R. §42.8(b)(1))
`Mylan’s real parties-in-interest are Mylan Pharmaceuticals Inc., Mylan Inc.,
`
`and Mylan GmbH (Mylan N.V. subsidiaries), and Biocon Research Ltd. and Biocon
`
`Ltd.
`
`B. Related Matters (37 C.F.R. §42.8(b)(2))
`This patent has been asserted in Sanofi-Aventis U.S. LLC, et al. v. Mylan
`
`GmbH, et al., No. 2:17-cv-09105 (D.N.J.), filed October 24, 2017. Mylan, Biocon,
`
`and their real parties-in-interest listed above are parties to this litigation. Becton
`
`Dickinson and Company supplies pens to Mylan, but has not been named as a party.
`
`The ’044 patent also has been asserted in Sanofi-Aventis U.S. LLC v. Merck
`
`Sharp & Dohme Corp., No. 1:16-cv-00812 (D. Del.) and in Sanofi -Aventis U.S. LLC
`
`v. Eli Lily and Co., No. 14-cv-113 (D. Del.) (consent judgment). See EX1029
`
`(Markman opinion in Merck); EX1030 (Markman opinion in Eli Lilly ). The real
`
`parties-in-interest are not parties to these litigations.
`
`Mylan also challenges claims 11, 14, 15, 18, and 19 in IPR2018-01675. Mylan
`
`has filed IPR2018-01670, IPR2018-01677, IPR2018-01678, IPR2018-01679,
`
`-1-
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`

`

`
`
`IPR2018-01680, IPR2018-01682, IPR2018-01684 and IPR2018-01696 against
`
`related patents.
`
`C.
`
`Identification of Counsel (37 C.F.R. §42.8(b)(3)) and Service
`Information (37 C.F.R. §42.8(b)(4))
`Lead Counsel
`Richard Torczon, Reg. No. 34,448
`WILSON SONSINI GOODRICH &
`ROSATI
`1700 K Street N.W., 5th Floor,
`Washington, DC 20006-3817
`Tel.: 202-973-8811 Fax: 202-973-8899
`Email: rtorczon@wsgr.com
`
`Back-Up Counsel
`Douglas Carsten, Reg. No. 43,534
`WILSON SONSINI GOODRICH &
`ROSATI
`12235 El Camino Real,
`San Diego CA 92130
`Tel.: 858-350-2300 Fax: 858-350-2399
`Email: dcarsten@wsgr.com
`
`Wesley Derryberry, Reg. No. 71,594
`WILSON SONSINI GOODRICH &
`ROSATI
`1700 K Street N.W., 5th Floor,
`Washington, DC 20006-3817
`Tel.: 202-973-8842 Fax: 202-973-8899
`Email: wderryberry@wsgr.com
`
`Tasha Thomas, Reg. No. 73,207
`WILSON SONSINI GOODRICH &
`ROSATI
`1700 K Street N.W., 5th Floor,
`Washington, DC 20006-3817
`Tel.: 202-973-8883 Fax: 202-973-8899
`Email: tthomas@wsgr.com
`
`Please direct all correspondence to lead counsel and back-up counsel.
`
`Mylan consents to electronic mail service at 34943.682.palib1@matters.wsgr.com
`
`and the email addresses above. A power of attorney accompanies this petition.
`
`
`
`-2-
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`

`

`
`
`III. CERTIFICATIONS
`Mylan certifies the ’044 patent is available for IPR and that Mylan is not barred
`
`or estopped from requesting IPR on these grounds.
`
`IV.
`
`IDENTIFICATION OF CHALLENGE; STATEMENT OF PRECISE
`RELIEF REQUESTED
`Mylan requests IPR and cancellation claims 11, 14, 15, 18, and 19 under pre-
`
`AIA 35 U.S.C. 103, as explained below with exhibits, including an expert declaration
`
`from Karl Leinsing (EX1011), on the following grounds:
`
`Ground Claims
`1
`11, 14,
`15, 18, 19
`
`2
`
`11, 14,
`15, 18, 19
`
`Basis
`U.S. Patent 6,235,004 (EX1014, “Steenfeldt-Jensen”)
`
`U.S. Patent 6,663,602 (EX1015, “Møller”) and Steenfeldt-Jensen
`
`V. REASONS FOR RELIEF REQUESTED
`A. Argument Summary
`The challenged claims relate to a drive mechanism for dispensing medicine
`
`from a pen-type injector. EX1002, Title, 1:20-29. Independent claim 11 broadly
`
`recites a six-component structure forming this mechanism. These components
`
`include structural elements that are also claimed broadly. Yet, these component were
`
`known and commonly used together in the prior art. Similarly, the structural elements
`
`were known and commonly used together in the prior art. What differences exist
`
`between the prior art and claims are merely “[t]he combination of familiar elements
`
`
`
`-3-
`
`

`

`
`
`according to known methods.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416
`
`(2007). The claims combined familiar elements in a predictable way. Claims 11, 14,
`
`15, 18, and 19 are unpatentable over the prior art.
`
`B.
`
`’044 Patent1
`Background
`1.
`The ’044 patent relates to a pen-type injector for self-administrating medicine.
`
`EX1002, Title, 1:20-29. Such injectors are appropriate for patients who do not have
`
`formal medical training. Id., 1:25-29. Thus, such injectors must be easy to use. Id.,
`
`1:23-31. The patent describes and claims a housing part containing a drive mechanism
`
`for dispensing medicine from an injector. The patent issued with twenty claims, but
`
`this petition challenges only claims 11, 14, 15, 18, and 19. Claim 11 is independent;
`
`claims 14, 15, 18, and 19 depend from it. Claim 11 recites:
`
`11. A housing part for a medication dispensing apparatus, said
`housing part comprising:
`
`a main housing, said main housing extending from a distal end
`
`to a proximal end;
`
`a dose dial sleeve positioned within said housing, said dose dial
`
`sleeve comprising a helical groove configured to engage a threading
`
`
`1 For uniformity, component positioning and movement will be described relative
`
`to the device’s “button-end” and the “needle-end”.
`
`
`
`-4-
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`

`
`
`provided by said main housing, said helical groove provided along an
`outer surface of said dose dial sleeve;
`
`a dose dial grip disposed near a proximal end of said dose dial
`
`sleeve;
`
`a piston rod provided within said housing, said piston rod is
`
`non-rotatable during a dose setting step relative to said main housing;
`
`a drive sleeve extending along a portion of said piston rod, said
`
`drive sleeve comprising an internal threading near a distal portion of
`said drive sleeve, said internal threading adapted to engage an external
`thread of said piston rod; and
`
`a tubular clutch located adjacent a distal end of said dose dial
`
`grip, said tubular clutch operatively coupled to said dose dial grip,
`
`wherein said dose dial sleeve extends circumferentially around
`
`at least a portion of said tubular clutch, and
`
`wherein said helical groove of the dose dial sleeve has a first
`lead and said internal threading of said drive sleeve has a second lead,
`and wherein said first lead and said second lead are different.
`
`Id., 8:7-36.
`
`Independent claim 11 recites six components forming the claimed device:
`
`(1) “main housing” (4, gray), which houses the drive mechanism for dispensing
`
`medicine from a cartridge, e.g., id., 3:27-33, FIGS. 1-5;
`
`(2) “dose dial sleeve” (70, green), which the user manipulates to set a specific
`
`dose for injection, e.g., id., 5:3-6, FIGS. 1-5, 9-11;
`
`
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`-5-
`
`

`

`
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`(3) “dose dial grip” (76, purple), which is a grip for the user to manipulate the
`
`dose dial sleeve, e.g., id., 5:24-32, 50-53, FIGS. 1-5, 9-11;
`
`(4) “piston rod” (20, yellow), which is driven to move a piston provided within
`
`the cartridge to dispense medicine, e.g., id., 3:56-67, 6:44-46, FIGS. 1-5;
`
`(5) “drive sleeve” (30, red), which drives the piston rod in order to move the
`
`piston, e.g., id., 4:4-13, 6:44-46, FIGS. 1-15, 9-11; and
`
`(6) “tubular clutch” (60, blue), which releasably connects components within
`
`the drive mechanism for common movement during use, e.g., id., 2:1-3, 2:16-18,
`
`5:50-53, 6:27-34, FIGS. 1-5, 9-11.
`
`Below, annotated FIGS. 1 (left) and 2 (right) color-code these components.
`
`EX1011, ¶38.
`
`
`
`-6-
`
`

`

`
`
`Brief Overview of Embodiments
`An injector housing has two parts: (1) first cartridge-retaining part 2, containing
`
`cartridge 8, and (2) second main-housing part 4 (gray). EX1002, 3:27-38, FIG. 1.
`
`
`
`
`
`-7-
`
`

`

`
`
`Second main-housing part 4 houses the mechanism that drives piston 10 contained
`
`within the cartridge 8 to dispense medicine. Id., FIG. 1.
`
`In an exemplary embodiment, insert 16 is at the needle-end2 of housing part 4.
`
`Id., 3:49-50; FIG. 1. Insert 16, fixed to the housing rotationally and axially, includes
`
`threaded circular opening 18, through which the needle-end of piston rod 20 (yellow)
`
`extends. Id., 3:49-59; FIG. 1. Piston rod 20 includes first thread 19 that engages the
`
`insert’s threaded opening 18. Id., 3:56-59; FIG. 1. Piston rod 20 also includes
`
`pressure foot 22, which abuts piston 10 of cartridge 8. Id., 3:59-61; FIG. 1.
`
`FIG. 1 (partial) cartridge-full position, before dose setting (id., 2:53-55),
`
`
`
`
`2 In the specification, the needle-end is the device’s “first end,” the button-end is its
`
`“second end.” E.g., EX1002, 3:8-14. In claim 11, the needle-end is the device’s
`
`“distal end,” the button-end is its “proximal end.” Id., claim 11.
`
`
`
`-8-
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`

`

`
`
`annotated (EX1011, ¶39)
`
`
`
`FIG. 2 (partial) maximum dose-dialed position (EX1002, 2:56-57),
`
`annotated (EX1011, ¶39)
`
`Piston rod 20 also includes second thread 24 extending from its button-end.
`
`EX1002, 3:61-62; FIGS. 1-2. Drive sleeve 30 (red) extends about piston rod 20. Id.,
`
`4:4; FIG. 1. Drive sleeve 30 includes helical groove 38 extending along its internal
`
`surface, engaging second thread 24. Id., 4:11-14; FIG. 1.
`
`Clutch 60 (blue) is “disposed about the drive sleeve 30, between the drive
`
`sleeve 30 and a dose dial sleeve 70 [green].” Id., 4:33-35; FIGS. 1, 6-7. Clutch 60 is
`
`“generally cylindrical” and located adjacent drive sleeve 30’s button-end. Id., 4:49-
`
`51; FIG. 1. “The clutch 60 is keyed to the drive sleeve 30 by way of splines ... to
`
`prevent relative rotation between the clutch 60 and the drive sleeve 30.” Id., 4:60-62.
`
`Clutch 60 includes a plurality of button-end dog teeth 65. Id., 4:58-60; FIGS. 1-2, 8.
`
`
`
`-9-
`
`

`

`
`
`Teeth 65 releasably engage dose-dial sleeve 70’s button-end.3 Id., 2:17-19, 6:27-30;
`
`FIG. 1.
`
`Dose-dial sleeve 70 is “provided outside of” clutch 60, “radially inward of”
`
`housing 4. Id., 5:3-5; FIG. 1. Helical groove 74 is provided about an outer surface of
`
`dose-dial sleeve 70. Id., 5:5-6; FIGS. 1-2, 12. Main housing 4 has helical rib 46,
`
`adapted to seat in helical groove 74 for relative rotation. Id., 5:9-11; FIGS. 15-16.
`
`Dose-dial grip 76 (purple) is disposed about an outer surface at the button-end of
`
`dose-dial sleeve 70. Id., 5:24-25; FIGS. 1-2. Dose-dial grip 76 is secured to dose-dial
`
`sleeve 70 to prevent relative movement. Id., 5:27-29.
`
`Pen-Injector Operation
`Dose setting: To set a dose, the user rotates dose dial grip 76 in one direction.
`
`Id., 5:50-51; FIG. 9 (annotated below). Teeth 65 of clutch 60 engage dose-dial sleeve
`
`70 (id., 2:17-19; 5:50-53), causing dose-dial sleeve 70, clutch 60, and drive sleeve 30
`
`to rotate out together. Id., 5:50-53; FIG. 9. Drive sleeve 30 rotates up piston rod 20,
`
`toward the button-end, due to its engagement with piston rod 20’s second thread 24.
`
`Id., 5:61-65. Piston rod 20 cannot rotate due to its opposing, threaded engagement
`
`
`3 Teeth 65 engage “an inwardly directed flange in the form of [a] number of
`
`radially extending members 75” at dose dial sleeve 70’s button-end. EX1011,
`
`¶196 (citing EX1001, 5:22-24).
`
`
`
`-10-
`
`

`

`
`
`with insert 16. Id., 4:1-2, 6:1-3.
`
`
`
`
`
`FIG. 9: Dialing up (id., 3:3-4), annotated (EX1011, ¶78)
`
`
`
`
`
`The user may dial down a dose. Id., 6:16-19; FIG. 10 (annotated below). To
`
`dial down, the user rotates dose-dial grip 76 in the opposite direction, causing the
`
`system to act in reverse, whereby dose-dial sleeve 70, clutch 60, and drive sleeve 30
`
`rotate back together. Id., 6:19-20; FIG. 10. Drive sleeve 30 rotates down piston
`
`rod 20, toward the needle-end, without rotating piston rod 20. Id., 6:1-3, 6:16-20;
`
`FIG. 10.
`
`
`
`-11-
`
`

`

`
`
`
`
`FIG. 10: Dialing down (id., 3:5-6), annotated (EX1011, ¶83)
`
`
`
`Injection: Once the dose is set, the user presses button 82, applying force
`
`toward the device’s needle-end (id., 6:27-28; FIG. 11 (annotated below)),
`
`displacing clutch 60 axially so teeth 65 disengage from dose-dial sleeve 70. Id.,
`
`6:28-30. Dose-dial sleeve 70 rotates back into housing 4 via its threaded
`
`connection with the housing. Id., 6:32-34; FIG. 11. Now disengaged from dose-
`
`dial sleeve 70, clutch 60 does not rotate but moves axially toward the needle-end.
`
`Id., 6:30-32, 6:37-39. Drive sleeve 30 also moves axially toward the needle-end,
`
`driving piston rod 20 to rotate through threaded opening 18, causing medicine to
`
`dispense from cartridge 8. Id., 6:44-46, FIG. 11.
`
`
`
`-12-
`
`

`

`
`
`
`
`FIG. 11: Injecting dose (id., 3:7-8), annotated (EX1011, ¶86)
`
`
`
`Prosecution History
`2.
`The ’044 patent issued from U.S. Application 13/909,649, which claims
`
`priority to March 3, 2003, the patent’s earliest possible priority date.
`
`The examiner rejected the application claims for lack of written description and
`
`double-patenting. Additionally, claims 1-20 were rejected under §103 as obvious
`
`over European Patent EP 0937471 A2 (“Walters”). EX1007, 138.
`
`Applicants amended claims to address the §112 rejection and overcame the
`
`§103 rejection by requiring the “helical groove” of the dose-dial sleeve be “provided
`
`along an outer surface of [the] dose dial sleeve.” EX1007, 211. Applicants argued
`
`Walters did not disclose (1) a helical groove along an outer surface of a dose-dial
`
`sleeve, (2) a helical groove to engage threading provided by a main housing, (3) a
`
`
`
`-13-
`
`

`

`
`
`clutch as described in the application, or (4) a dose-dial sleeve extending
`
`circumferentially around at least a portion of a tubular clutch. Id., 211-12.
`
`Applicants disclosed a Steenfeldt-Jensen PCT publication (WO99/38554) and a
`
`published application (US 2002/0052578 A1) that issued as the Møller reference. Id.,
`
`38. The examiner did not apply these references to the challenged claims.
`
`Level of Ordinary Skill
`C.
`For this petition, the relevant time is before March 3, 2003. A POSA at that
`
`time had at least a bachelor’s degree in mechanical engineering, or an equivalent
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`degree, and three-year’s experience. EX1011, ¶¶104-06. The POSA understood the
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`basics of medical-device design and manufacturing, and the basic mechanical
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`elements (e.g., gears, pistons) in drug-delivery devices. Id.
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`D. Claim Construction
`For this petition, claim terms may be given their ordinary and accustomed
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`meaning, consistent with the specification and how a POSA understood them. 37 CFR
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`§42.100(b); Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en
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`banc).
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`The Patent Owner (Sanofi) has defined certain claim terms in related
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`litigations, and cannot now argue its definitions are unreasonable. Ex parte
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`Schulhauser, Appeal No. 2013-007847, slip op. 9 (PTAB Apr. 28, 2016)
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`(precedential) (“A proper interpretation of claim language … at least encompasses the
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`-14-
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`broadest interpretation of the claim language for purposes of infringement.”).
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`Sanofi’s proffered constructions are:
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`drive sleeve: “An essentially tubular component of essentially circular cross-
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`section releasably connected to the dose-dial sleeve that drives the piston during dose
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`dispensing.” EX1019, 19.
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`main housing: “An exterior unitary or multipart component configured to
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`house, fix, protect, guide, and/or engage with one or more inner components.”
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`EX1019, 21.
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`piston rod: “A rod that engages with the drive sleeve ... to advance the piston
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`during dose dispensing.” EX1019, 27.
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`threading: “A rib or groove on a first structure that engages a corresponding
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`groove or rib on a second structure.” EX1019, 30.
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`tubular clutch: “A tubular structure that couples and decouples a moveable
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`component from another component.” EX1019, 23.
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`In the related litigation with Sanofi, Mylan proffered preliminary means-plus-
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`function constructions for “tubular clutch” and “clicker.” EX1028, 54-59, 65-68. The
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`court has not yet issued a claim construction. If a means-plus-function construction
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`applies, corresponding structure is identified for the “tubular clutch” or “clutch”. Its
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`function, during dose setting, is “coupling and decoupling a movable component from
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`another component,” or “to reversibly lock two components in rotation.” Id., 56.
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`-15-
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`Component 60 in FIGS. 1, 5-11 is corresponding structure for the clutch. Id., 54, 57;
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`also EX1002, 2:16-18, 4:49-62, 4:63-65, 6:33-43.
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`
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`For a clicker,4 the function is “providing at least an audible feedback to a user
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`when said dose dial grip is rotated.” EX1028, 67-68. FIGS. 6-8 provide structure of
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`the clicker, component 50. Id., 62-63; EX1002, 2:20-22, 2:23-28, 2:29-35, 4:33-35,
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`4:36-48, 4:63-67.
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`The grounds rely on the ordinary and customary meaning of the claim terms as
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`a POSA would have understood them, but also address the “tubular clutch” and
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`“clicker” limitations as means-plus-function limitations.
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`Prior Art
`E.
`Pen-type injectors were known before March 3, 2003, including many using
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`the same six-component structure broadly claimed here. EX1011, ¶114.
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`1. Møller
`Møller is pre-AIA §102(a) and (e) prior art. ; EX1015, cover; EX1011, ¶138.
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`Møller describes a device for injecting set doses, including a similar six-component
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`structure. EX1015, ¶22; EX1011, ¶139. As FIG. 1 (annotated below) shows, Møller
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`4 Even if the claim scope is indefinite, the Board still can determine whether
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`embodiments plainly within the claim scope would have been obvious. Ex parte
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`McAward, App. No. 2015-006416 at 22 n.5 (PTAB 2017).
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`-16-
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`discloses an injection device comprising:
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`(1) “housing 1” (gray), which houses the drive mechanism for dispensing
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`medicine from a cartridge, EX1015, Abstract, ¶22;
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`(2) “dose setting drum 17” (green), which the user manipulates to set a specific
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`injection dose, EX1015, ¶25;
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`(3) “dose setting button 18” (purple), which serves as a grip for the user to
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`manipulate the dose-setting drum, EX1015, ¶29;
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`(4) “piston rod 4” (yellow), which is driven to dispense medicine from the
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`cartridge, EX1015, ¶22;
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`(5) “connection bars 12” having “nut 13” (red), which drives the piston rod,
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`EX1015, ¶¶22, 32; and
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`(6) “bottom 19” (blue), which rotationally decouples the dose-setting drum
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`from the connection bars and nut during injection, EX1015, ¶¶26, 29, 33.
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`-17-
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`EX1015, FIG. 1; EX1011, ¶139.
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`
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`Moller also discloses a second embodiment with largely equivalent
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`components and operation. EX1015, ¶¶35-40, FIGS. 3-5; see also EX1011, ¶80-
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`81 n.16.
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`Møller discloses each structural element, except Møller’s dose-dial sleeve
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`includes an inner helical thread to engage the housing, rather than an outer helical
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`groove. A POSA would have considered an outer helical groove to engage a housing
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`to be an obvious modification. §V.F.2.
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`2. Steenfeldt-Jensen
`Steenfeldt-Jensen is pre-AIA §102(b) prior art. EX1014, cover; EX1011,
`
`¶130. Steenfeldt-Jensen discloses medicine-dispensing syringes. EX1014, Abstract;
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`EX1011, ¶131. As FIGS. 16 and 17 (annotated below) show, Steenfeldt-Jensen
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`disclosed one embodiment comprising a six-component structure:
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`(1) “tubular housing 1” (gray), which houses the drive mechanism for
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`dispensing medicine from an ampoule, EX1014, 5:38-54;
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`(2) “scale drum 80” (green), which the user manipulates to set a specific
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`injection dose, EX1014, 11:51-55;
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`(3) “dose setting button 81” (purple), which serves as a grip for the user to
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`manipulate the scale drum, EX1014, 11:51-55;
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`(4) “piston rod 6” (yellow), which is driven to move a piston provided within
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`the ampoule to dispense medicine, EX1014, 5:57-65;
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`(5) “piston rod drive,” having “driver tube 85” (red) and “member 40”, which
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`drives the piston rod, EX1014, 2:47-53, 11:6-19, 11:52-12:13; and
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`(6) “bushing 82” (blue), which releasably connects the scale drum and driver
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`tube for rotational movement during injection, EX1014, 12:4-12.
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`-19-
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`EX1014, FIGS. 16 (left above), 17 (right above); EX1011, ¶139.
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`-20-
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`Steenfeldt-Jensen describes a piston-rod drive formed from two parts: driver
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`tube 85 and member 40. Steenfeldt-Jensen rendered claim 1’s “drive sleeve”
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`obvious. §V.G.2.
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`F. Ground 1: Steenfeldt-Jensen
`Steenfeldt-Jensen disclosed a single device comprising all claim 11
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`components, including the same structural limitations. If Steenfeldt-Jensen does not
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`disclose a “drive sleeve”, it would have been routine to modify the Steenfeldt-Jensen
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`device to include one. A detailed discussion of reasons to modify Steenfeldt-Jensen
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`follows the discussion of the individual claim elements. §V.G.2.
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`Independent Claim
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`1. Element-by-element analysis
`If the preamble is limiting, Steenfeldt-Jensen taught it:
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`’044 Patent
`
`Steenfeldt-Jensen
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`[11.Preamble] A
`housing part for a
`medication
`dispensing
`apparatus, said
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`Steenfeldt-Jensen discloses a medicine-dispensing syringe:
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`“The invention relates to injection syringes of the kind
`apportioning set doses of a medicine from a cartridge
`containing an amount of medicine sufficient for the preparation
`of a number of therapeutic doses.” EX1014, 1:12-15, FIGS.
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`-21-
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`housing part
`comprising:
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`15-17; also Abstract; 5:38-44, FIGS. 15-17.5:
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`Id., FIG. 17 (annotated above); EX1011, ¶262.
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`
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`Steenfeldt-Jensen describes a medicine-dispensing syringe. EX1014, 1:12-
`
`15, FIGS. 15-17; EX1011, ¶261. The syringe includes tubular housing 1.
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`EX1014, 5:38-44, FIGS. 15-17; EX1011, ¶263. As FIGS. 15-16 show, tubular
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`housing 1 holds the drive mechanism for dispensing medicine from the syringe.
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`EX1011, ¶261. Accordingly, Steenfeldt-Jensen taught claim 11’s preamble.
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`Steenfeldt-Jensen taught “a main housing”:
`
`’044 Patent
`
`Steenfeldt-Jensen
`
`Steenfeldt-Jensen discloses a main housing having
`proximal and distal ends:
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`[11.1] a main housing,
`said main housing
`extending from a distal
`end to a proximal end;
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`5 Steenfeldt-Jensen assigns corresponding elements in the embodiments the same
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`“The syringe comprise[s] a tubular housing 1[.]”
`EX1014, 5:38-44, FIGS. 15-17.
`
`reference number. EX1014, 7:49-51. Thus, a POSA would have understood those
`
`embodiments informed the structure of the Figures 15-17 embodiment, at least for
`
`elements having identical reference numbers. EX1011, ¶131 n.13.
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`“A medication delivery pen comprising ... a housing
`having proximal and distal ends[.]” Id., claim 11.
`
`Id., FIG. 17 (left, partial; housing); FIG. 16 (right,
`partial; annotating housing (gray)); EX1011, ¶263.
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`
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`As FIGS. 15-17 show, housing 1 extends from button-end (proximal end) to
`
`needle-end (distal end) of the syringe. EX1011, ¶263. Steenfeldt-Jensen thus
`
`taught the elements of the claimed “main housing.”
`
`Steenfeldt-Jensen taught “a dose dial sleeve”:
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`’044 Patent
`
`Steenfeldt-Jensen
`
`[11.2] a dose dial sleeve
`positioned within said
`housing, said dose dial
`sleeve comprising a
`helical groove
`configured to engage a
`threading provided by
`said main housing, said
`helical groove provided
`along an outer surface
`of said dose dial sleeve;
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`Steenfeldt-Jensen discloses scale drum 80:
`
`“A scale drum 80 is in its outer wall provided with a
`helical track which is engaged by a helical rib 16 along
`the inner wall of the housing 1.” EX1014, 11:20-22,
`FIGS. 15-17.
`
`“When a dose is set by rotating the dose setting button
`81 in a clockwise direction, the scale drum is screwed
`out of the housing[.]” Id., 11:52-54.
`
`“When the injection button 88 is pressed to inject the set
`dose ... the anticlockwise rotation of the dose setting
`button 81 ... is induced by the thread engagement
`between the helical track of the scale drum 80 and the
`rib 16 in the housing when the scale drum 80 is pressed
`back into said housing.” Id., 12:4-9.
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`Id., FIG. 17 (left, partial; showing drum); FIG. 16 (right,
`partial; annotating drum (green)); EX1011, ¶264.
`
`Steenfeldt-Jensen discloses that the syringe includes a dose-dial sleeve: scale
`
`drum 80. Id., 11:20-22. FIGS. 15-16 show drum 80 within housing 1. EX1014,
`
`FIGS. 15-16; EX1011, ¶¶264-65. The drum includes a “helical groove provided
`
`along an outer surface” as a helical track, extending along the drum’s outer wall.
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`EX1014, 11:20-22, FIGS. 16-17; EX1011, ¶265. The helical track is “configured
`
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`-25-
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`to engage a threading provided by” housing 1 via helical rib 16, which extends
`
`along housing 1’s inner wall. EX1014, 11:20-22, FIGS. 16-17; EX1011, ¶264.
`
`Steenfeldt-Jensen thus taught the claimed dose-dial sleeve.
`
`Steenfeldt-Jensen taught “a dose dial grip”:
`
`’044 Patent
`
`Steenfeldt-Jensen
`
`[11.3] a dose dial grip
`disposed near a
`proximal end of said
`dose dial sleeve;
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`Steenfeldt-Jensen discloses dose-setting button 81:
`
`“At its proximal end the scale drum 80 has a diameter
`exceeding the inner diameter of the housing to form a
`dose setting button 81, which on its cylindrical outer
`wall is knurled to ensure a good finger grip.” EX1014,
`11:22-25; FIGS. 15-17.
`
`
`Id., FIG. 16 (above, partial; showing dose-setting button
`(purple)); EX1011, ¶267; also EX1014, 11:52-62.
`
`
`
`Steenfeldt-Jensen discloses a “dose dial grip”, dose-setting button 81, which
`
`the user rotates to se