throbber

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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. IPR2018-01675
`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 (37 C.F.R. §42.104(a)) .................................................. 3
`
`IV.
`
`V.
`
`IDENTIFICATION OF CHALLENGE AND STATEMENT OF
`THE PRECISE RELIEF REQUESTED ...................................................... 3
`
`STATEMENT OF REASONS FOR THE RELIEF REQUESTED ........... 3
`A.
`Summary of the Argument .................................................................. 3
`B.
`’044 Patent ............................................................................................ 4
`1.
`Background ................................................................................ 4
`Brief Overview of the Disclosed Embodiments ..................................... 8
`Operation of the Pen Injector ............................................................... 11
`2.
`Prosecution History .................................................................. 13
`Level of Ordinary Skill in the Art ..................................................... 14
`C.
`Claim Construction ............................................................................ 15
`D.
`The Prior Art ...................................................................................... 17
`E.
`F. Ground 1: Claims 11, 14, 18, and 19 Were Obvious
`over Burroughs .................................................................................. 19
`1.
`Element-by-element analysis.................................................. 20
`2.
`Reason to modify and reasonable expectation of
`success ...................................................................................... 40
`
`VI. CONCLUSION ............................................................................................ 48
`
`
`-i-
`
`

`

`
`
`
`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)
`
`-ii-
`
`

`

`
`
`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.)
`
`
`
`-iii-
`
`

`

`
`
`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).
`
`
`
`-iv-
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`

`

`
`
`
`I.
`
`INTRODUCTION
`Petitioner (“Mylan”) petitions for inter partes review (“IPR”) of U.S. Patent
`
`8,603,044 to Veasey et al., entitled “Pen-Type Injector” (“the ’044 patent,” EX1002).
`
`35 U.S.C. 311.
`
`This Petition shows a reasonable likelihood that prior art renders claims 11, 14,
`
`15, 18, and 19 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))
`The ’044 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 and Biocon
`
`entities 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.
`
`-1-
`
`

`

`
`
`Mylan has filed IPR2018-01676 also challenging claims 11, 14, 15, 18 and 19
`
`of the ’044 patent. Mylan has filed IPR2018-01670, IPR2018-01677, IPR2018-01678,
`
`IPR2018-01679, 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 at the
`
`contact information above. Mylan consents to electronic mail service at
`
`
`
`-2-
`
`

`

`
`
`34943.682.palib1@matters.wsgr.com and the email addresses above. A power of
`
`attorney accompanies this petition.
`
`III. CERTIFICATIONS (37 C.F.R. §42.104(a))
`Mylan certifies that the ’044 patent is available for IPR and Mylan is not barred
`
`or estopped from requesting IPR on the identified ground.
`
`IV.
`
`IDENTIFICATION OF CHALLENGE AND STATEMENT OF THE
`PRECISE RELIEF REQUESTED
`Mylan requests IPR and cancellation of ’044 patent claims 11, 14, 15, 18, and
`
`19 under pre-AIA 35 U.S.C. 103, as Mylan’s detailed statement of the reasons for the
`
`relief requested sets forth, supported with exhibits, including the Declaration of Karl
`
`Leinsing (EX1011).
`
`Claims 11, 14, 15, 18, and 19 of the ’044 patent were obvious over U.S. Patent
`
`6,221,046 (EX1013, “Burroughs”) (Ground 1).
`
`V. STATEMENT OF REASONS FOR THE RELIEF REQUESTED
`Summary of the Argument
`A.
`The challenged claims relate to a drive mechanism for dispensing medicine,
`
`such as insulin and insulin analogs, from a pen-type injector. EX1002, Title, 1:20-29.
`
`At its core, the challenged independent claim broadly recites a six-component
`
`structure forming this mechanism. Those six components include structural elements
`
`that are themselves claimed broadly. As shown below, however, each of the six
`
`components claimed was known and commonly used together in the prior art.
`
`
`
`-3-
`
`

`

`
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`Similarly, each of the structural elements for the components was known and
`
`commonly used in the prior art. Where there are differences between what the prior
`
`art disclosed and what is claimed, the differences are merely “[t]he combination of
`
`familiar elements according to known methods.” KSR Int’l Co. v. Teleflex Inc., 550
`
`U.S. 398, 416 (2007). The claimed invention combined familiar elements in a
`
`predictable way. Claims 11, 14, 15, 18, and 19 are therefore unpatentable over the
`
`prior art.
`
`B.
`
`’044 Patent1
`Background
`1.
`The ’044 patent relates to a pen-type injector for self-administration of
`
`medicine, such as insulin and insulin analogs. EX1002, Title, 1:20-29. According to
`
`the ’044 patent, such injectors are appropriate for patients who do not have formal
`
`medical training, including diabetes patients. Id., 1:25-29. The ’044 patent states that
`
`such injectors must be easy to use, because patients using the device may have
`
`impaired vision or other physical infirmities. Id., 1:23-31.
`
`The ’044 patent specifically describes and claims a housing part containing a
`
`drive mechanism for dispensing medicine from an injector. The ’044 patent issued
`
`1 For uniformity, when discussing both the ’044 patent and the prior art,
`
`description of the positioning and movement of components will be relative to the
`
`“button-end” of the device and the “needle-end” of the device.
`
`
`
`-4-
`
`

`

`
`
`with 20 claims, of which this petition challenges only claims 11, 14, 15, 18, and 19.
`
`Claim 11 is an independent claim from which claims 14, 15, 18, and 19 ultimately
`
`depend. 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
`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
`
`
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`-5-
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`

`

`
`
`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, therefore, recites six components that form the claimed
`
`device:
`
`(1) a “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) a “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;
`
`(3) a “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) a “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) a “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) a “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.
`
`FIGS. 1 (left) and 2 (right) of the ’044 patent are reproduced below, with color-
`
`coding added to highlight the above components. EX1011, ¶38.
`
`
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`-6-
`
`

`

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`
`
`
`
`
`Each of the claimed components, along with other aspects of the disclosed
`
`injector, is described below, followed by a description of the injector’s operation.
`
`
`
`-7-
`
`

`

`
`
`Brief Overview of the Disclosed Embodiments
`The ’044 patent describes an injector having a housing formed from two parts:
`
`(1) a first cartridge-retaining part 2, which contains a cartridge 8 from which medicine
`
`is dispensed, and (2) a second main-housing part 4 (gray). EX1002, 3:27-38, FIG. 1.
`
`The second main-housing part 4 houses the mechanism that serves to drive a piston 10
`
`contained within the cartridge 8 to dispense medicine. Id., FIG. 1.
`
`In an exemplary embodiment, at a needle-end2 of the housing part 4, an insert
`
`16 is provided. Id., 3:49-50; FIG. 1. The insert 16 is fixedly connected to the
`
`housing, both rotationally and axially, and includes a threaded circular opening 18,
`
`through which the needle-end of a piston rod 20 (yellow) extends. Id., 3:49-59;
`
`FIG. 1. The piston rod 20 includes a first thread 19 that engages with the insert’s
`
`threaded opening 18. Id., 3:56-59; FIG. 1. The piston rod 20 also includes a pressure
`
`foot 22 at this end, which abuts a piston 10 of the cartridge 8. Id., 3:59-61; FIG. 1.
`
`
`2 The specification refers to the needle-end of the device as its “first end,” and the
`
`button-end as its “second end.” E.g., id., 3:8-14. Claim 11 refers to the needle-end
`
`of the device as its “distal end,” and the button-end as its “proximal end.” Id.,
`
`claim 11.
`
`
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`-8-
`
`

`

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`
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`
`
`
`Partial view of FIG. 1 showing injector in a cartridge-full position, prior to dose
`setting (id., 2:53-55), highlighting components (EX1011, ¶39)
`
`Partial view of FIG. 2 showing injector in a maximum dose-dialed position
`(EX1002, 2:56-57), annotated to highlight components (EX1011, ¶39)
`
`
`
`
`
`The piston rod 20 also includes a second thread 24 that extends from its button-
`
`end. EX1002, 3:61-62; FIGS. 1-2. A drive sleeve 30 (red) extends about the piston
`
`rod 20. Id., 4:4; FIG. 1. The drive sleeve 30 includes a helical groove 38 extending
`
`
`
`-9-
`
`

`

`
`
`along its internal surface that engages with the 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. The clutch
`
`60 is “generally cylindrical” and located adjacent the button-end of the drive sleeve
`
`30. 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. At its button-end, the clutch 60 includes a plurality of dog teeth 65. Id.,
`
`4:58-60; FIGS. 1-2, 8. The teeth 65 are configured to releasably engage with the
`
`button-end of dose-dial sleeve 70.3 Id., 2:17-19, 6:27-30; FIG. 1.
`
`Dose-dial sleeve 70 is “provided outside of” the clutch 60 and “radially inward
`
`of” the housing 4. Id., 5:3-5; FIG. 1. “A helical groove 74 is provided about an outer
`
`surface of the dose dial sleeve 70.” Id., 5:5-6; FIGS. 1-2, 12. “The main housing 4 is
`
`further provided with a helical rib 46, adapted to be seated in the helical groove 74” to
`
`allow for relative rotation. Id., 5:9-11; FIGS. 15-16. “A dose dial grip 76 [purple] is
`
`
`3 The specification does not specifically explain or show how the teeth 65 engage
`
`with the dose dial sleeve 70. As Mr. Leinsing explains, the teeth 65 engage with
`
`“an inwardly directed flange in the form of [a] number of radially extending
`
`members 75” provided at the dose dial sleeve 70’s button-end. EX1011, ¶196
`
`(citing EX1002, 5:22-24).
`
`
`
`-10-
`
`

`

`
`
`disposed about an outer surface of the [button-end] of the dose dial sleeve 70.” Id.,
`
`5:24-25; FIGS. 1-2. “The dose dial grip 76 is secured to the dose dial sleeve 70 to
`
`prevent relative movement therebetween.” Id., 5:27-29.
`
`Operation of the Pen Injector
`Dose setting: To set a dose, the user rotates dose dial grip 76 in one direction.
`
`Id., 5:50-51; FIG. 9 (reproduced and color-coded below). At this stage, the teeth 65 of
`
`the clutch 60 are engaged to dose-dial sleeve 70. Id., 2:17-19; 5:50-53. Such
`
`engagement causes the dose-dial sleeve 70, the clutch 60, and the drive sleeve 30 to
`
`rotate together out of the housing. Id., 5:50-53; FIG. 9. The drive sleeve 30 rotates up
`
`the piston rod 20, toward its button-end, due to its engagement with the piston rod
`
`20’s second thread 24. Id., 5:61-65. The piston rod 20 is prevented from rotating due
`
`to its opposing, threaded engagement with the insert 16. Id., 4:1-2, 6:1-3.
`
`
`
`
`
`FIG. 9: Dialing up (id., 3:3-4), highlighting components (EX1011, ¶78)
`
`
`
`-11-
`
`
`
`

`

`
`
`
`
`The user also may dial down a dose, if needed. Id., 6:16-19; FIG. 10
`
`(reproduced and color-coded below). To dial down, the user rotates the dose-dial grip
`
`76 in the opposite direction. Id., 6:19; FIG. 10. “This causes the system to act in
`
`reverse,” where the dose-dial sleeve 70, the clutch 60, and the drive sleeve 30 rotate
`
`together back into the housing. Id., 6:19-20; FIG. 10. As such, the drive sleeve 30
`
`rotates down the piston rod 20, toward its needle-end, without corresponding rotation
`
`of the piston rod 20. Id., 6:1-3, 6:16-20; FIG. 10.
`
`
`
`FIG. 10: Dialing down (id., 3:5-6), highlighting components (EX1011, ¶83)
`
`
`Injection: Once the dose is set, the user presses a button 82, applying a force
`
`toward the device’s needle-end. Id., 6:27-28; FIG. 11 (reproduced and color-coded
`
`below). This displaces the clutch 60 axially such that the teeth 65 disengage from
`
`the dose-dial sleeve 70. Id., 6:28-30. Dose-dial sleeve 70 rotates back into the
`
`
`
`-12-
`
`

`

`
`
`housing 4 via its threaded connection with the housing. Id., 6:32-34; FIG. 11.
`
`Now disengaged from the dose-dial sleeve 70, clutch 60 does not follow this
`
`rotation but instead moves axially toward the device’s needle-end. Id., 6:30-32,
`
`6:37-39. The drive sleeve 30 also moves axially toward the needle-end, driving the
`
`piston rod 20 to rotate through the threaded opening 18, causing medicine to be
`
`dispensed from the cartridge 8. Id., 6:44-46, FIG. 11.
`
`
`
`FIG. 11: Injecting dose (id., 3:7-8), highlighting components (EX1011, ¶86)
`
`
`
`Prosecution History
`2.
`The ’044 patent issued from U.S. Application 13/909,649 (the “’649
`
`application”), which claims priority to GB Application No. 0304822.0, filed March 3,
`
`2003. This is the ’044 patent’s earliest possible priority date.
`
`During prosecution, the examiner rejected the ’649 application’s claims for
`
`
`
`-13-
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`

`

`
`
`lack of written description and double-patenting. Additionally, claims 1-20 were
`
`rejected under §103(a) as obvious over European Patent EP 0937471 A2 (“Walters”).
`
`EX1007, 138.
`
`In response, applicants amended the claims to address rejections under §112
`
`and to overcome the §103 rejection by requiring that the “helical groove” of the dose-
`
`dial sleeve be “provided along an outer surface of [the] dose dial sleeve.” EX1007,
`
`211. Applicants argued that Walters did not disclose (1) a helical groove provided
`
`along an outer surface of a dose-dial sleeve, (2) a helical groove to engage a threading
`
`provided by a main housing, (3) a clutch as described in the ’649 application, or (4) a
`
`dose-dial sleeve that extends circumferentially around at least a portion of a tubular
`
`clutch. Id., 211-12.
`
`Level of Ordinary Skill in the Art
`C.
`For the purposes of this petition, the relevant timeframe is prior to March 3,
`
`2003, the earliest priority date the ’044 patent claims. As Mr. Leinsing explains, a
`
`POSA at the relevant time would have had at least a bachelor’s degree in mechanical
`
`engineering, or an equivalent degree, and approximately three years of experience in
`
`medical-device design. EX1011, ¶104. The POSA also would have understood the
`
`basics of medical-device design and manufacturing, and the basic mechanical
`
`elements (e.g., gears, pistons) involved in drug-delivery devices. Id.
`
`
`
`-14-
`
`

`

`
`
`D. Claim Construction
`For this petition, claim terms may be given their ordinary and accustomed
`
`meaning, consistent with the specification and how a POSA would have understood
`
`them. 37 CFR §42.100(b); Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir.
`
`2005) (en banc).
`
`The Patent Owner has taken positions regarding the meaning of certain claim
`
`terms in related litigations, and cannot now argue these positions are unreasonable.
`
`Ex parte Schulhauser, Appeal No. 2013-007847, slip op. 9 (PTAB Apr. 28, 2016)
`
`(precedential) (“A proper interpretation of claim language, under the broadest
`
`reasonable interpretation of a claim during prosecution, must construe the claim
`
`language in a way that at least encompasses the broadest interpretation of the claim
`
`language for purposes of infringement.”). The relevant terms are listed below, along
`
`with Sanofi’s proffered construction for those terms.
`
`drive sleeve: “An essentially tubular component of essentially circular cross-
`
`section releasably connected to the dose-dial sleeve that drives the piston during dose
`
`dispensing.” EX1019, 19.
`
`main housing: “An exterior unitary or multipart component configured to
`
`house, fix, protect, guide, and/or engage with one or more inner components.”
`
`EX1019, 21.
`
`piston rod: “A rod that engages with the drive sleeve ... to advance the piston
`
`
`
`-15-
`
`

`

`
`
`during dose dispensing.” EX1019, 27.
`
`threading: “A rib or groove on a first structure that engages a corresponding
`
`groove or rib on a second structure.” EX1019, 30.
`
`tubular clutch: “A tubular structure that couples and decouples a moveable
`
`component from another component.” EX1019, 23.
`
`In related litigation with Sanofi, Mylan proffered preliminary means-plus-
`
`function constructions for “tubular clutch” and “clicker.” EX1028, 54-59, 65-68. The
`
`district court in that litigation has not yet issued a claim construction. To the extent
`
`that the Board concludes that the broadest reasonable interpretation of those terms is a
`
`means-plus-function construction, Mylan identifies the following corresponding
`
`structure. For the “tubular clutch” or “clutch,” the function is that, during dose setting,
`
`it “clutch[es], i.e., coupling and decoupling a movable component from another
`
`component,” or it “operates to reversibly lock two components in rotation.” Id., 56.
`
`FIGS. 1, 5-11, component 60 provide the corresponding structure for the clutch. Id.,
`
`54, 57; also EX1002, 2:16-18, 4:49-62, 4:63-65, 6:33-43.
`
`
`
`For a clicker,4 the function is “providing at least an audible feedback to a user
`
`
`4 Even if the claim scope is indefinite, the Board still can determine whether
`
`embodiments plainly within the claim scope would have been obvious. Ex parte
`
`
`
`
`
`-16-
`
`

`

`
`
`when said dose dial grip is rotated.” EX1028, 67-68. FIGS. 6-8 provide the structure
`
`of the clicker, component 50. Id., 62-63; EX1002, 2:20-22, 2:23-28, 2:29-35, 4:33-
`
`35, 4:36-48, 4:63-67.
`
`The ground presented below relies on the ordinary and customary meaning of
`
`the claim terms as a POSA would have understood them. The ground also addresses
`
`the “tubular clutch” and “clicker” limitations to the extent that those terms may be
`
`construed as means-plus-function limitations.
`
`The Prior Art
`E.
`As Mr. Leinsing explains, and as addressed in further detail below (§V.F),
`
`claims 11, 14, 15, 18, and 19 would have been obvious to a POSA at the relevant
`
`time. Numerous pen-type injectors were known before March 3, 2003, including
`
`many that used the same six-component structure broadly claimed in the ’044 patent.
`
`Burroughs is prior art to the ’044 patent under pre-AIA §102(b). Burroughs
`
`discloses a medication-dispensing pen for dispensing selectively measured dosages of
`
`medicine. EX1013, 1:13-16. In particular, as shown in FIGS. 1 and 2 (color-coded
`
`below), Burroughs describes a pen that comprises six components (EX1011, ¶126):
`
`(1) a “housing 22,” having a “first part 24” and a “second part 26” (gray),
`
`
`McAward, App. No. 2015-006416 at 22 n.5 (PTAB 2017) (precedential); Ex parte
`
`Tanksley, 26 USPQ2d 1384, 1387 (BPAI 1991) (same).
`
`
`
`-17-
`
`

`

`
`
`which houses the drive mechanism for dispensing medicine from a cartridge,
`
`EX1013, 7:15-20; EX1011, ¶157;
`
`(2) a “dial mechanism 34” (green), which the user manipulates to set a specific
`
`dose for injection, EX1013, 10:38-42;
`
`(3) a “proximal portion 78” (purple), which serves as a grip for the user to
`
`manipulate the dial mechanism, EX1013, 8:2-8;
`
`(4) a “leadscrew 38” (yellow), which is driven to move a piston provided
`
`within the cartridge to dispense medicine, EX1013, 9:26-34;
`
`(5) a “nut 36” (red), which drives the leadscrew, EX1013, 9:12-25, 11:31-34;
`
`and
`
`(6) a “button 32” (blue), which rotationally decouples the dial mechanism from
`
`the housing and the nut during injection, EX1013, 11:13-34.
`
`
`
`
`
`-18-
`
`

`

`
`
`
`
`EX1013, FIGS. 1 (top above) and 2 (bottom above); EX1011, ¶126.
`
`
`
`Burroughs discloses each of the six components in independent claim 11,
`
`except Burroughs’ “dose dial sleeve” (dial mechanism 34) includes a helical rib,
`
`rather than a helical groove. §V.F.1 (below). But a POSA at the relevant time would
`
`have considered modifying Burroughs’ dial mechanism 34 to include a helical groove
`
`instead to be an obvious alternative. §V.F.2.
`
`F. Ground 1: Claims 11, 14, 18, and 19 Were Obvious over
`Burroughs
`Burroughs disclosed a medication dispensing pen that includes the same six
`
`components broadly claimed by the ’044 patent. Five of those components include
`
`the same structural elements recited in independent claim 11. Regarding the sixth,
`
`
`
`-19-
`
`

`

`
`
`the claimed “dose dial sleeve,” Burroughs’ dial mechanism has threads on its outer
`
`surface that form a helical rib, which engages with the main housing’s helical
`
`groove, rather than an outer-surface helical groove engaging with main-housing
`
`threading as recited in independent claim 11. As discussed in §V.F.2 below,
`
`however, a POSA would have considered swapping these features to provide a dial
`
`mechanism with a helical groove on its outer surface that on its outer surface that
`
`engages with a thread on the main housing an obvious alternative.
`
`Independent Claim
`
`1. Element-by-element analysis
`To the extent the preamble of claim 11 is limiting, Burroughs discloses it:
`
`’044 Patent
`
`Burroughs
`
`[11.Preamble] A
`housing part for a
`medication
`dispensing
`apparatus, said
`housing part
`comprising:
`
`Burroughs discloses a multi-use medication dispensing pen:
`
`“A multi-use medication dispensing pen made of a plastic
`material that is recyclable after the contents of the medication
`cartridge have been exhausted. The pen is made of a minimal
`number of parts, which include a housing ....” EX1013,
`Abstract.
`
`
`
`-20-
`
`

`

`
`
`
`
`Id., FIG. 1 (annotated above); EX1011, ¶157.
`
`“Referring to FIGS. 1 and 2, there is shown an injection
`medication device 20 having the general appearance of a pen
`or mechanical pencil. The device comprises a mechanism
`housing 22 having a first part 24 and a second part 26 (FIG.
`2).” EX1013, 7:15-19, FIGS. 1-2.
`
`
`
`Burroughs discloses an injection medication device 20 for dispensing
`
`medicine. E.g., EX1013, Abstract, 7:15-17, FIG. 1; EX1011, ¶156. The device 20
`
`includes a mechanism housing 22 containing the device’s drive mechanism.
`
`EX1013, 7:17-19, FIG. 1; EX1011, ¶156. Accordingly, Burroughs taught the
`
`preamble of claim 11.
`
`Burroughs taught “a main housing” as recited in element [11.1]:
`
`’044 Patent
`
`Burroughs
`
`
`
`-21-
`
`

`

`
`
`[11.1] a main
`housing, said
`main housing
`extending from a
`distal end to a
`proximal end;
`
`Burroughs discloses a mechanism housing 22:
`
`“The device comprises a mechanism housing 22 having a first
`part 24 and a second part 26 (FIG. 2). Housing parts 24 and 26
`are secured together by ultrasonic welding ....” EX1013, 7:17-
`20, FIGS. 1-3, 5.
`
`Id., FIGS. 3 (above-left), 5 (above-right); EX1011, ¶158.
`
`
`
`
`
`Id., FIG. 1 (partial, above; annotating housing gray); EX1011,
`¶159.
`
`
`
`
`
`-22-
`
`

`

`
`
`The mechanism housing 22 includes a first part 24 and a second part 26 that
`
`are secured together to house the drive mechanism. EX1013, 7:18-20, FIGS. 1, 2,
`
`3, 5; EX1011, ¶158. As shown in FIG. 1, the mechanism housing 22 extends from
`
`a button-end (referred to as the proximal end) to a needle-end (referred to as the
`
`distal end). EX1013, 7:9-13; EX1011, ¶160. Burroughs thus taught the claimed
`
`“main housing.”
`
`Burroughs taught “a dose dial sleeve” as recited in element [11.2], but
`
`teaches a “helical rib” instead of “a helical groove”:
`
`’044 Patent
`
`Burroughs
`
`[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;
`
`Burroughs discloses a dial mechanism 34:
`
`“Referring to FIGS. 6-9, dial mechanism 34 is shown in
`detail. Dial mechanism 34 is generally cylindrical in
`shape and is hollow throughout its axial length.”
`EX1013, 7:65-67, FIGS. 1-2, 6

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