UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PFIZER INC.,
`Petitioner,
`v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`Case IPR2019-00977
`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
`
`

`

`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 (37 C.F.R. §42.104(a)) ................................................... 5
`IV.
`IDENTIFICATION OF CHALLENGE AND STATEMENT OF THE
`PRECISE RELIEF REQUESTED .................................................................. 5
`STATEMENT OF REASONS FOR THE RELIEF REQUESTED ............... 5
`A.
`Summary of the Argument .................................................................... 5
`B.
`’044 Patent ............................................................................................. 6
`1.
`Background ................................................................................. 6
`Brief Overview of the Disclosed Embodiments ...................................10
`Operation of the Pen Injector ..............................................................13
`2.
`Prosecution History ...................................................................15
`Level of Ordinary Skill in the Art .......................................................16
`Claim Construction..............................................................................16
`The Prior Art .......................................................................................19
`Ground 1: Claims 11, 14, 15, 18, and 19 Were Obvious over
`Burroughs ............................................................................................21
`1.
`Element-by-element analysis ....................................................22
`2.
`Reason to modify and reasonable expectation of success ........42
`Dependent Claims ...............................................................................44
`VI. CONCLUSION ..............................................................................................49
`
`
`
`V.
`
`C.
`D.
`E.
`F.
`
`IPR2019-00977 Patent No. 8,603,044 B2
`
`TABLE OF CONTENTS
`
`
`
`-i-
`
`

`

`IPR2019-00977 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
`
`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 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
`
`Curriculum Vitae of Charles Clemens
`
`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 2002/0052578 Al - C.S. Moller,
`“Injection Device” (pub’d May 2, 2002)
`
`-ii-
`
`

`

`Exhibit No.
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`IPR2019-00977 Patent No. 8,603,044 B2
`
`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 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)
`
`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
`
`IPR2019-00977 Patent No. 8,603,044 B2
`
`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-
`
`

`

`I.
`
`INTRODUCTION
`Petitioner (“Pfizer”) 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))
`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.
`
`IPR2018-01675, 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.
`
`IPR2018-01676. 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.
`
`

`

`IPR2019-00977 Patent No. 8,603,044 B2
`
`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.
`
`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 IPR2019-00978 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.
`
`
`1 Pfizer has also filed motions for joinder with these IPRs to join Mylan’s instituted
`
`IPRs. Specifically, Pfizer has filed motions to join IPR2019-00978 with IPR2018-
`
`01676, 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 IPR 2018-01680, and
`
`IPR2019-01023 with IPR2018-01682.
`
`-2-
`
`

`

`10/790,225, now abandoned, and claims priority to GB Patent Application No.
`
`IPR2019-00977 Patent No. 8,603,044 B2
`
`0304822.
`
`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; 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,
`
`-3-
`
`

`

`IPR2019-00977 Patent No. 8,603,044 B2
`
`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. 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
`
`-4-
`
`

`

`IPR2019-00977 Patent No. 8,603,044 B2
`
`III. CERTIFICATIONS (37 C.F.R. §42.104(A))
`Pfizer certifies that the ’044 patent is available for IPR and Pfizer is not barred
`
`or estopped from requesting IPR on the identified ground.
`
`IV.
`
`IDENTIFICATION OF CHALLENGE AND STATEMENT OF THE
`PRECISE RELIEF REQUESTED
`Pfizer requests IPR and cancellation of ’044 patent claims 11, 14, 15, 18, and
`
`19 under pre-AIA 35 U.S.C. 103, as Pfizer’s detailed statement of the reasons for
`
`the relief requested sets forth, supported with exhibits, including the Declaration of
`
`Charles Clemens (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.
`
`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
`
`-5-
`
`

`

`IPR2019-00977 Patent No. 8,603,044 B2
`
`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 Patent2
`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
`
`with 20 claims, of which this petition challenges only claims 11, 14, 15, 18, and 19.
`
`
`2 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.
`
`-6-
`
`

`

`IPR2019-00977 Patent No. 8,603,044 B2
`
`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
`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.
`
`-7-
`
`

`

`IPR2019-00977 Patent No. 8,603,044 B2
`
`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.
`
`
`
`
`
`-8-
`
`

`

`IPR2019-00977 Patent No. 8,603,044 B2
`
`
`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.
`
`-9-
`
`

`

`IPR2019-00977 Patent No. 8,603,044 B2
`
`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-end3 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.
`
`
`
`
`3 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.
`
`-10-
`
`

`

`IPR2019-00977 Patent No. 8,603,044 B2
`
`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 along its internal surface that engages with the second thread 24. Id., 4:11-
`
`14; FIG. 1.
`
`-11-
`
`

`

`IPR2019-00977 Patent No. 8,603,044 B2
`
`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
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`splines ... to prevent relative rotation between the clutch 60 and the drive sleeve 30.”
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`Id., 4:60-62. At its button-end, the clutch 60 includes a plurality of dog teeth 65. Id.,
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`4:58-60; FIGS. 1-2, 8. The teeth 65 are configured to releasably engage with the
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`button-end of dose-dial sleeve 70.4 Id., 2:17-19, 6:27-30; FIG. 1.
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`Dose-dial sleeve 70 is “provided outside of’ the clutch 60 and “radially inward
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`of’ the housing 4. Id., 5:3-5; FIG. 1. “A helical groove 74 is provided about an outer
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`surface of the dose dial sleeve 70.” Id., 5:5-6; FIGS. 1-2,12. “The main housing 4 is
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`further provided with a helical rib 46, adapted to be seated in the helical groove 74”
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`to allow for relative rotation. Id., 5:9-11; FIGS. 15-16. “A dose dial grip 76 [purple]
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`is disposed about an outer surface of the [button-end] of the dose dial sleeve 70.”
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`4 The specification does not specifically explain or show how the teeth 65 engage
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`with the dose dial sleeve 70. As Mr. Clemens explains, the teeth 65 engage with “an
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`inwardly directed flange in the form of [a] number of radially extending members
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`75” provided at the dose dial sleeve 70’s button-end. EX1011, ¶196 (citing EX1002,
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`5:22-24).
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`IPR2019-00977 Patent No. 8,603,044 B2
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`Id., 5:24-25; FIGS. 1-2. “The dose dial grip 76 is secured to the dose dial sleeve 70
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`to prevent relative movement therebetween.” Id., 5:27-29.
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`Operation of the Pen Injector
`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 (reproduced and color-coded below). At this stage, the teeth 65
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`of the clutch 60 are engaged to dose-dial sleeve 70. Id., 2:17-19; 5:50-53. Such
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`engagement causes the dose-dial sleeve 70, the clutch 60, and the drive sleeve 30 to
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`rotate together out of the housing. Id., 5:50-53; FIG. 9. The drive sleeve 30 rotates
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`up the piston rod 20, toward its button-end, due to its engagement with the piston
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`rod 20’s second thread 24. Id., 5:61-65. The piston rod 20 is prevented from rotating
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`due to its opposing, threaded engagement with the insert 16. Id., 4:1-2, 6:1-3.
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`FIG. 9: Dialing up (id., 3:3-4), highlighting components (EX1011, ¶78)
`The user also may dial down a dose, if needed. Id., 6:16-19; FIG. 10
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`(reproduced and color-coded below). To dial down, the user rotates the dose-dial
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`
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`IPR2019-00977 Patent No. 8,603,044 B2
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`grip 76 in the opposite direction. Id., 6:19; FIG. 10. “This causes the system to act
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`in reverse,” where the dose-dial sleeve 70, the clutch 60, and the drive sleeve 30
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`rotate together back into the housing. Id., 6:19-20; FIG. 10. As such, the drive sleeve
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`30 rotates down the piston rod 20, toward its needle-end, without corresponding
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`rotation of the piston rod 20. Id., 6:1-3, 6:16-20; FIG. 10.
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`
`
`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
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`toward the device’s needle-end. Id., 6:27-28; FIG. 11 (reproduced and color-coded
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`below). This displaces the clutch 60 axially such that the teeth 65 disengage from
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`the dose-dial sleeve 70. Id., 6:28-30. Dose-dial sleeve 70 rotates back into the
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`housing 4 via its threaded connection with the housing. Id., 6:32-34; FIG. 11. Now
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`disengaged from the dose-dial sleeve 70, clutch 60 does not follow this rotation but
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`instead moves axially toward the device’s needle-end. Id., 6:30-32, 6:37-39. The
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`IPR2019-00977 Patent No. 8,603,044 B2
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`drive sleeve 30 also moves axially toward the needle-end, driving the piston rod 20
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`to rotate through the threaded opening 18, causing medicine to be dispensed from
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`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
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`3, 2003. This is the ’044 patent’s earliest possible priority date.
`
`During prosecution, the examiner rejected the ’649 application’s claims for
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`lack of written description and double-patenting. Additionally, claims 1-20 were
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`rejected under § 103(a) as obvious over European Patent EP 0937471 A2
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`(“Walters”). EX1007, 138.
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`IPR2019-00977 Patent No. 8,603,044 B2
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`In response, applicants amended the claims to address rejections under §112
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`and to overcome the §103 rejection by requiring that the “helical groove” of the
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`dose- dial sleeve be “provided along an outer surface of [the] dose dial sleeve.”
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`EX1007, 211. Applicants argued that Walters did not disclose (1) a helical groove
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`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
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`application, or (4) a dose-dial sleeve that extends circumferentially around at least a
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`portion of a tubular clutch. Id., 211-12.
`
`C. Level of Ordinary Skill in the Art
`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. Clemens explains, a
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`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
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`the basics of medical-device design and manufacturing, and the basic mechanical
`
`elements (e.g., gears, pistons) involved in drug-delivery devices. Id.
`
`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
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`them. 37 CFR §42.100(b); Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed.
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`IPR2019-00977 Patent No. 8,603,044 B2
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`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.
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`drive sleeve: “An essentially tubular component of essentially circular cross-
`
`section releasably connected to the dose-dial sleeve that drives the piston during dose
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`dispensing.” EX1019, 19.
`
`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.”
`
`EX1019, 21.
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`piston rod: “A rod that engages with the drive sleeve ... to advance the piston
`
`during dose dispensing.” EX1019, 27.
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`threading: “A rib or groove on a first structure that engages a corresponding
`
`groove or rib on a second structure.” EX1019, 30.
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`IPR2019-00977 Patent No. 8,603,044 B2
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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 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 district court in that litigation has not yet issued a claim construction. To the
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`extent that the Board concludes that the proper interpretation of those terms is a
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`means-plus-function construction, Pfizer identifies the following corresponding
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`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
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`another component,” or it “operates to reversibly lock two components in rotation.”
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`Id., 56. FIGS. 1, 5-11, component 60 provide the 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 the structure
`
`
`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 n.5 (PTAB 2017) (precedential); Ex parte
`
`Tanksley, 26 USPQ2d 1384, 1387 (BPAI 1991) (same).
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`of the clicker, component 50. Id., 62-63; EX1002, 2:20-22, 2:23-28, 2:29-35, 4:33-
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`IPR2019-00977 Patent No. 8,603,044 B2
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`35, 4:36-48, 4:63-67.
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`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
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`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. Clemens explains, and as addressed in further detail below (§V.F),
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`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
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`many that used the same six-component structure broadly claimed in the ’044 patent.
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`Burroughs is prior art to the ’044 patent under pre-AIA § 102(b). Burroughs
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`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)
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`a “housing 22,” having a “first part 24” and a “second part 26” (gray),
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`which houses the drive mechanism for dispensing medicine from a cartridge,
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`EX1013, 7:15-20; EX1011, ¶157;
`
`(2)
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`a “dial mechanism 34” (green), which the user manipulates to set a
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`specific dose for injection, EX1013,10:38-42;
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`-19-
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`IPR2019-00977 Patent No. 8,603,044 B2
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`(3)
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`a “proximal portion 78” (purple), which serves as a grip for the user to
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`manipulate the dial mechanism, EX1013, 8:2-8;
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`(4)
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`a “leadscrew 38” (yellow), which is driven to move a piston provided
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`within the cartridge to dispense medicine, EX1013, 9:26-34;
`
`(5)
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`a “nut 36” (red), which drives the leadscrew, EX1013, 9:12-25, 11:31-
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`34; and
`
`(6)
`
`a “button 32” (blue), which rotationally decouples the dial mechanism
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`from the housing and the nut during injection, EX1013, 11:13-34.
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`
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`IPR2019-00977 Patent No. 8,603,044 B2
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`
`
`EX1013, FIGS. 1 (top above) and 2 (bottom above); EX1011, ¶126.
`Burroughs discloses each of the six components in independent claim 11,
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`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, 15, 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
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`the same structural elements recited in independent claim 11. Regarding the sixth,
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`IPR2019-00977 Patent No. 8,603,044 B2
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`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 heli