UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`PFIZER INC.,
`Petitioner,
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`
`
`
`
`Case IPR2019-00978
`Patent No. 8,603,044 B2
`
`
`
`
`
`PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`Submitted Electronically via the PTAB E2E System
`
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION ......................................................................................... 1
`I.
`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)) ..................................................... 4
`III. CERTIFICATIONS ...................................................................................... 4
`IV.
`IDENTIFICATION OF CHALLENGE; STATEMENT OF PRECISE
`RELIEF REQUESTED ................................................................................. 5
`V. REASONS FOR RELIEF REQUESTED ................................................... 5
`A. Argument Summary .............................................................................. 5
`B.
`ʼ044 Patent ............................................................................................. 6
`1.
`Background ................................................................................. 6
`Brief Overview of Embodiments ............................................................ 9
`Pen-Injector Operation .......................................................................12
`2.
`Prosecution History ...................................................................15
`Level of Ordinary Skill .......................................................................16
`Claim Construction..............................................................................16
`Prior Art ...............................................................................................18
`1. Mǿller ........................................................................................18
`2.
`Steenfeldt-Jensen ......................................................................21
`Ground 1: Obviousness over Steenfeldt-Jensen ..................................23
`
`C.
`D.
`E.
`
`F.
`
`ii
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`Independent Claim ..............................................................................23
`1.
`Element-by-element analysis ....................................................23
`2.
`Reason to modify; reasonable expectation of success ..............41
`Dependent Claims ...............................................................................43
`G. Ground 2: Obviousness over Mǿller and Steenfeldt-Jensen ...............50
`Independent Claim ..............................................................................51
`1.
`Element-by-element analysis ....................................................51
`2.
`Reason to modify; reasonable expectation of success ..............75
`Dependent Claims ...............................................................................78
`VI. CONCLUSION ............................................................................................89
`
`
`
`iii
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`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
`
`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 Charles Clemens 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
`
`1012
`
`Curriculum Vitae of Charles Clemens
`
`1013
`
`1014
`
`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)
`
`iv
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`Exhibit No.
`
`1015
`
`1016
`
`1017
`
`Description
`U.S. Patent Application US 2002/0052578 Al - C.S. Mǿller,
`“Injection Device” (pub’d May 2, 2002)
`
`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)
`
`1018
`
`File History for U.S. Patent 6,582,404
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`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 5,921,966 - 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)
`
`v
`
`

`

`Exhibit No.
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`IPR2019-00978 Patent No. 8,603,044 B2
`
`Description
`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) (ʼ844 Priority Doc.)
`
`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
`
`vi
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`Exhibit No.
`
`Description
`Injection Device, And A Method Of Assembling An Injection
`Device” (pub’d Nov. 8, 2001)
`
`1035
`
`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).
`
`vii
`
`

`

`
`
`I.
`
`INTRODUCTION
`Petitioner (“Pfizer”) petitions for inter partes review of U.S. Patent 8,603,044
`
`(“the ʼ044 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))
`The real parties-in-interest are Pfizer Inc. and Hospira, Inc.
`
`B. Related Matters (37 C.F.R. §42.8(b)(2))
`The Board has instituted review of claims 11, 14, 15, 18, and 19 of the ’044
`
`patent in Mylan Pharmaceuticals Inc. v. Sanofi-Aventis Deutschland GmbH., No.
`
`IPR2018-01676, and Petitioner has moved to join this Petition with that proceeding.
`
`The Board has also instituted review of claims 11, 14, 15, 18, and 19 of the ’044
`
`patent in Mylan Pharmaceuticals Inc. v. Sanofi-Aventis Deutschland GmbH., No.
`
`IPR2018-01675. 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.). The ’044 patent has also been
`
`asserted in Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., No. 1:16-cv-
`
`00812 (D. Del.), Sanofi-Aventis U.S. LLC v. Eli Lily and Co., No. 1:14-cv-00113 (D.
`
`Del.), Sanofi-Aventis U.S. LLC v. Eli Lily and Co., No. 1:14-cv-00884 (D. Del.), and
`
`Sanofi-Aventis U.S. LLC, et al. v. Mylan GmbH, et al., No. 1:17-cv-00181 (N.D.W.
`
`Va.). See EX1029 (Markman opinion in Merck); EX1030 (Markman opinion in Eli
`
`Lilly). The real parties-in-interest listed above are not parties to these litigations.
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`Mylan has filed IPR2018-01670, IPR2018-01677, IPR2018-01678, IPR2018-
`
`01679, IPR2018-01680, IPR2018-01682, IPR2018-01684, IPR2018-01696, and
`
`IPR2019-00122 against related patents. Pfizer has also filed IPR2019-00977 against
`
`the ’044 patent and has filed IPR2019-00979, IPR2019-00980, IPR2019-00981,
`
`IPR2019-00982, IPR2019-00987, IPR2019-01022, and IPR2019-01023 against the
`
`same related patents challenged by Mylan.1
`
`The ’044 Patent issued from U.S. Application No. 13/909,649, which is a
`
`continuation of U.S. Patent Application No. 12/944,544, now U.S. Patent No.
`
`8,679,069, which is a continuation of U.S. Patent Application No. 11/483,546, now
`
`U.S. Patent No. 7,918,833, which is a continuation of U.S. Patent Application No.
`
`10/790,225, now abandoned, and claims priority to GB Patent Application No.
`
`0304822.
`
`
`1 Pfizer has also filed motions for joinder with these IPRs to join Mylan’s instituted
`
`IPRs. Specifically, Pfizer has filed motions to join IPR2019-00977 with IPR2018-
`
`01675, IPR2019-00979 with IPR2018-01670, IPR2019-00980 with IPR2018-
`
`01678, IPR2019-00981 with IPR2018-01679, IPR2019-0982 with IPR2019-00122,
`
`IPR2019-00987 with IPR2018-01684, IPR2019-01022 with IPR2018-01680, and
`
`IPR2019-01023 with IPR2018-01682.
`
`2
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`No U.S. patents or U.S. patent applications claim priority to the ’044 patent.
`
`The following additional U.S. patents and U.S. patent applications claim priority to
`
`one or more of the same application(s) to which the ’044 patent claims priority: U.S.
`
`Patent Application No. 10/790,866; U.S. Patent Application No. 15/681,604; U.S.
`
`Patent Application No. 15/787,737; U.S. Patent Application No. 12/320,189, now
`
`U.S. Pat. No. 7,850,662; U.S. Patent Application No. 11/520,598, now U.S. Pat. No.
`
`7,935,088; U.S. Patent Application No. 13/040,198, now U.S. Pat. No. 8,512,297;
`
`U.S. Patent Application No. 13/075,212, now U.S. Pat. No. 8,556,864; U.S. Patent
`
`Application No. 13/909,681, now U.S. Pat. No. 8,992,486; U.S. Patent Application
`
`No. 13/919,251, now U.S. Pat. No. 9,011,391; U.S. Patent Application No.
`
`12/941,702, now U.S. Pat. No. 9,028,454; U.S. Patent Application No. 12/357,899,
`
`now U.S. Pat. No. 9,205,197; U.S. Patent Application No. 14/635,573, now U.S. Pat.
`
`No. 9,233,211; U.S. Patent Application No. 14/946,203, now U.S. Pat. No.
`
`9,408,979; U.S. Patent Application No. 15/156,616, now U.S. Pat. No. 9,526,844;
`
`U.S. Patent Application No. 14/319,379, now U.S. Pat. No. 9,533,105; and U.S.
`
`Patent Application No. 14/319,384, now U.S. Pat. No. 9,561,331; U.S. Patent
`
`Application No. 14/319,388, now U.S. Pat. No. 9,604,008; U.S. Patent Application
`
`No. 14/319,394, now U.S. Pat. No. 9,604,009; U.S. Patent Application No.
`
`14/319,381, now U.S. Pat. No. 9,610,409; U.S. Patent Application No. 14/319,371,
`
`now U.S. Pat. No. 9,623,189; U.S. Patent Application No. 15/180,148, now U.S. Pat.
`
`3
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`No. 9,623,190; U.S. Patent Application No. 15/180,141, now U.S. Pat. No.
`
`9,775,954; U.S. Patent Application No. 14/319,377, now U.S. Pat. No. 9,827,379.
`
`C.
`
`Identification of Counsel (37 C.F.R. §42.8(b)(3)) and Service
`Information (37 C.F.R. §42.8(b)(4))
`
`Jovial Wong (Reg. No. 60,115)
` Lead counsel:
`
` Back-up counsel:
`
`Charles B. Klein*
`
` Back-up counsel:
`
`Dan H. Hoang*
`
`* Back-up counsel to seek pro hac vice admission.
`
`Please address all correspondence to lead counsel at the address shown below.
`
`Petitioner consents to electronic service at the below listed email address. A power
`
`of attorney accompanies this petition. 37 C.F.R. §42.10(b).
`
` Email address:
`
`PfizerIPRs@winston.com
`
` Mailing address: WINSTON & STRAWN LLP
`
`1700 K Street, NW
`
`Washington, DC 20006
`
` Telephone number:
`
`(202) 282-5000
`
` Fax number:
`
`
`
`(202) 282-5100
`
`III. CERTIFICATIONS
`Pfizer certifies the ʼ044 patent is available for IPR and that Pfizer is not barred
`
`or estopped from requesting IPR on these grounds.
`
`4
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`IV.
`
`IDENTIFICATION OF CHALLENGE; STATEMENT OF PRECISE
`RELIEF REQUESTED
`Pfizer 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 Charles Clemens (EX1011), on the following grounds:
`
`Ground Claims
`1
`11, 14,
`15, 18, 19
`
`Basis
`Obviousness over U.S. Patent 6,235,004 (EX1014, “Steenfeldt-
`Jensen”)
`
`2
`
`11, 14,
`15, 18, 19
`
`Obviousness over U.S. Patent Published Application
`2002/0052578 (EX1015, “Mǿller”) 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 components
`
`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 according to known methods.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
`
`5
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`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.
`
`ʼ044 Patent2
`Background
`1.
`The ʼ044 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
`provided by said main housing, said helical groove provided along an
`outer surface of said dose dial sleeve;
`
`
`2 For uniformity, component positioning and movement will be described relative
`
`to the device’s “button-end” and the “needle-end”.
`
`6
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`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;
`
`(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;
`
`7
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`(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.
`
`8
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`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. Second main-housing part 4 houses the mechanism that drives piston 10
`
`contained within the cartridge 8 to dispense medicine. Id., FIG. 1.
`
`9
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`In an exemplary embodiment, insert 16 is at the needle-end3 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),
`annotated (EX1011, ¶39)
`
`
`
`
`3 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.
`
`10
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
`
`
`
`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-
`
`11
`
`

`

`IPR2019-00978 Patent No. 8,603,044 B2
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`2, 8. Teeth 65 releasably engage dose-dial sleeve 70’s button-end.4 Id., 2:17-19,
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`6:27-30; FIG. 1.
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`Dose-dial sleeve 70 is “provided outside of’ clutch 60, “radially inward of’
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`housing 4. Id., 5:3-5; FIG. 1. Helical groove 74 is provided about an outer surface
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`of dose-dial sleeve 70. Id., 5:5-6; FIGS. 1-2,12. Main housing 4 has helical rib 46,
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`adapted to seat in helical groove 74 for relative rotation. Id., 5:9-11; FIGS. 15-16.
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`Dose-dial grip 76 (purple) is disposed about an outer surface at the button-end of
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`dose-dial sleeve 70. Id., 5:24-25; FIGS. 1-2. Dose-dial grip 76 is secured to dose-
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`dial sleeve 70 to prevent relative movement. Id., 5:27-29.
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`Pen-Injector Operation
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`Dose setting: To set a dose, the user rotates dose dial grip 76 in one direction.
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`Id., 5:50-51; FIG. 9 (annotated below). Teeth 65 of clutch 60 engage dose-dial sleeve
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`70 (id., 2:17-19; 5:50-53), causing dose-dial sleeve 70, clutch 60, and drive sleeve
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`30 to rotate out together. Id., 5:50-53; FIG. 9. Drive sleeve 30 rotates up piston rod
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`20, toward the button-end, due to its engagement with piston rod 20’s second thread
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`4 Teeth 65 engage “an inwardly directed flange in the form of [a] number of radially
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`extending members 75” at dose dial sleeve 70’s button-end. EX1011, ¶196 (citing
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`EX1001, 5:22-24).
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`IPR2019-00978 Patent No. 8,603,044 B2
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`24. Id., 5:61-65. Piston rod 20 cannot rotate due to its opposing, threaded
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`engagement with insert 16. Id., 4:1-2, 6: 1-3.
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`
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`FIG. 9: Dialing up (id., 3:3-4), annotated (EX1011, ¶78)
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`The user may dial down a dose. Id., 6:16-19; FIG. 10 (annotated below). To
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`dial down, the user rotates dose-dial grip 76 in the opposite direction, causing the
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`system to act in reverse, whereby dose-dial sleeve 70, clutch 60, and drive sleeve 30
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`rotate back together. Id., 6:19-20; FIG. 10. Drive sleeve 30 rotates down piston rod
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`20, toward the needle-end, without rotating piston rod 20. Id., 6:1-3, 6:16-20; FIG.
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`10.
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`IPR2019-00978 Patent No. 8,603,044 B2
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`
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`FIG. 10: Dialing down (id., 3:5-6), annotated (EX1011, ¶83)
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`Injection: Once the dose is set, the user presses button 82, applying force
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`toward the device’s needle-end (id., 6:27-28; FIG. 11 (annotated below)), displacing
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`clutch 60 axially so teeth 65 disengage from dose-dial sleeve 70. Id., 6:28-30. Dose-
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`dial sleeve 70 rotates back into housing 4 via its threaded connection with the
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`housing. Id., 6:32-34; FIG. 11. Now disengaged from dose-dial sleeve 70, clutch 60
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`does not rotate but moves axially toward the needle-end. Id., 6:30-32, 6:37-39. Drive
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`sleeve 30 also moves axially toward the needle-end, driving piston rod 20 to rotate
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`through threaded opening 18, causing medicine to dispense from cartridge 8. Id.,
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`6:44-46, FIG. 11.
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`IPR2019-00978 Patent No. 8,603,044 B2
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`
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`FIG. 11: Injecting dose (id., 3:7-8), annotated (EX1011, ¶86)
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`Prosecution History
`2.
`The ʼ044 patent issued from U.S. Application 13/909,649, which claims
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`priority to March 3, 2003, the patent’s earliest possible priority date.
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`The examiner rejected the application claims for lack of written description
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`and double-patenting. Additionally, claims 1-20 were rejected under §103 as
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`obvious over European Patent EP 0937471 A2 (“Walters”). EX1007, 138.
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`Applicants amended claims to address the § 112 rejection and overcame the
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`§103 rejection by requiring the “helical groove” of the dose-dial sleeve be “provided
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`along an outer surface of [the] dose dial sleeve.” EX1007, 211. Applicants argued
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`Walters did not disclose (1) a helical groove along an outer surface of a dose-dial
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`sleeve, (2) a helical groove to engage threading provided by a main housing, (3) a
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`IPR2019-00978 Patent No. 8,603,044 B2
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`clutch as described in the application, or (4) a dose-dial sleeve extending
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`circumferentially around at least a portion of a tubular clutch. Id., 211-12.
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`Applicants disclosed a Steenfeldt-Jensen PCT publication (W099/38554) and
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`the Mǿller reference. Id., 38. The examiner did not apply these references to the
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`challenged claims.
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`C. Level of Ordinary Skill
`For this petition, the relevant time is before March 3, 2003. A POSA at that
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`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
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`CFR §42.100(b); Phillips v. AWH Corp., 415 F.3d 1303,1312-13 (Fed. Cir. 2005)
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`(en 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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`IPR2019-00978 Patent No. 8,603,044 B2
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`(precedential) (“A proper interpretation of claim language ... at least encompasses
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`the 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.
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`The court has not yet issued a claim construction. If a means-plus-function
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`construction applies, corresponding structure is identified for the “tubular clutch” or
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`“clutch”. Its function, during dose setting, is “coupling and decoupling a movable
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`IPR2019-00978 Patent No. 8,603,044 B2
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`component from another component,” or “to reversibly lock two components in
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`rotation.” Id., 56. Component 60 in FIGS. 1, 5-11 is corresponding structure for the
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`clutch. Id., 54, 57; also EX1002, 2:16-18, 4:49-62, 4:63-65, 6:33-43.
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`For a clicker,5 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
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`as 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. Mǿller
`Mǿller is pre-AIA § 102(a) and (e) prior art. EX1015, cover; EX1011, ¶138.
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`Mǿller describes a device for injecting set doses, including a similar six-component
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`5 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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`IPR2019-00978 Patent No. 8,603,044 B2
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`structure. EX1015, ¶22; EX1011, ¶139. As FIG. 1 (annotated below) shows, Mǿller
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`discloses an injection device comprising:
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`(1)
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`“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)
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`“dose setting drum 17” (green), which the user manipulates to set a
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`specific injection dose, EX1015, ¶25;
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`(3)
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`“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)
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`“piston rod 4” (yellow), which is driven to dispense medicine from the
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`cartridge, EX1015, ¶22;
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`(5)
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`“connection bars 12” having “nut 13” (red), which drives the piston
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`rod, EX1015, ¶¶22, 32; and
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`(6)
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`“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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`IPR2019-00978 Patent No. 8,603,044 B2
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`EX1015, FIG. 1, EX1011, ¶139.
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`
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`Mǿller also discloses a second embodiment with largely equivalent
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`components and operation. EX1015, ¶¶35-40, FIGS. 3-5; see also EX1011, ¶80-81
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`n.16.
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`Mǿller discloses each structural element, except Mǿller’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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`IPR2019-00978 Patent No. 8,603,044 B2
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`Steenfeldt-Jensen
`2.
`Steenfeldt-Jensen is pre-AIA § 102(b) prior art. EX1014, cover; EX1011,
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`¶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)
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`“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)
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`“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)
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`“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)
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`“piston rod 6” (yellow), which is driven to move a piston provided
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`within the ampoule to dispense medicine, EX1014, 5:57-65;
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`(5)
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`“piston rod drive,” having “driver tube 85” (red) and “member 40”,
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`which drives the piston rod, EX1014, 2:47-53, 11:6-19, 11:52-12:13; and
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`(6)
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`“bushing 82” (blue), which releasably connects the scale drum and
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`driver tube for rotational movement during injection, EX1014, 12:4-12.
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`IPR2019-00978 Patent No. 8,603,044 B2
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`EX1014, FIGS. 16 (left above), 17 (right above); EX1011, ¶139.
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`IPR2019-00978 Patent No. 8,603,044 B2
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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: Obviousness over 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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`Element-by-element analysis
`1.
`If the preamble is limiting, Steenfeldt-Jensen taught it:
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`ʼ044 Patent
`[11. Preamble] A
`housing part for a
`medication
`dispensing
`apparatus, said
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`Steenfeldt-Jensen
`Steenfeldt-Jensen discloses a medicine-dispensing syringe:
`“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. 15-17;
`also Abstract; 5:38-44, FIGS. 15-17.6:
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`6 Steenfeldt-Jensen assigns corresponding elements in the embodiments the same
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`refer