Trials@uspto. gov
`571-272-7822
`
`Paper No. 28
`Entered: April 2, 2019
`
`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 IPR2018-01675
`
`Patent 8,603,044 B2
`
`Before HYUN J. JUNG, BART A. GERSTENBLITH, and
`JAMES J. MAYBERRY, Administrative Patent Judges.
`
`GERSTENBLITH, Administrative Patent Judge.
`
`DECISION
`
`Institution of Inter Partes Review
`
`35 US. C. § 314
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`

`

`IPR2018-01675
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`Patent 8,603,044 B2
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`I.
`
`INTRODUCTION
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`A.
`
`Background
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`Mylan Pharmaceuticals Inc. (“Petitioner”) filed a Petition (Paper 2,
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`“Pet.”) requesting institution of an inter partes review of claims 11, 14, 15,
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`18, and 19 of US. Patent No. 8,603,044 B2 (Ex. 1002, “the ’044 patent”).
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`Sanofi-Aventis Deutschland GmbH (“Patent Owner”) filed a Preliminary
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`Response (Paper 12). With prior authorization, Petitioner filed a Reply to
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`Patent Owner’s Preliminary Response (Paper 16; “PR Reply”) limited to
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`addressing whether we should exercise our discretion under 35 U.S.C.
`
`§ 314(a) to deny the Petition, and Patent Owner filed 'a Sur-Reply in
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`response (Paper 19, “PR Sur-Reply”). Also with prior authorization,
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`Petitioner filed a Motion to Correct the Petition (Paper 15) and Patent Owner
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`filed an Opposition to the Motion (Paper 18). We granted Petitioner’s
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`Motion to Correct (Paper 21), resulting in a citation change on page 25 of
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`the Petition, which is shown in Exhibit 1037.1 We also granted Patent
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`Owner’s request to file an Amended Preliminary Response, which Patent
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`Owner filed as Paper 23 (“Prelim Resp”), to respond to the corrected
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`citation in the Petition. Paper 21, 4. Pursuant to 35 U.S.C. § 314, an inter
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`partes review may not be instituted “unless .
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`.
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`. there is a reasonable-
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`' Because it was a very minor change, we did not require Petitioner to file a
`“corrected petition”; rather, we agreed that we would treat the originally
`filed Petition as though the correction had been made. See Ex. 1039, 14:17—
`16:4. The citation on page 25 to Exhibit 1002 was thus changed from “cf.
`EX1002, 3:42—44” to “cf. EX1002, 3:62—64.” Ex. 1037.
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`

`

`IPR2018-01675
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`Patent 8,603,044 B2
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`likelihood that the petitioner would prevail with respect to at least 1 of the
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`claims challenged in the petition.”
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`Upon consideration of the present record and for the reasons
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`explained below, we determine that Petitioner has shown a reasonable
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`likelihood that it would prevail with respect to at least one of the challenged
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`claims. Accordingly, we institute an inter partes review of claims 11, 14,
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`15, 18, and 19 on all grounds raised in the Petition.
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`.3.
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`Related Proceedings
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`The parties indicate that the ’044 patent has been asserted in Sanofi-
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`Averttis US. LLC v. Mylan GmbH, No. 2:17-cv-09105 (D.N.J.); Sanof-
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`Aventis US. LLC v. Merck Sharp & Dohme Corp, No. 1:16-cv-00812
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`(D. Del.); and Sanofi—Aventis US. LLC v. Eli Lilly and Co., No. 1:14-cv-
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`00113 (D. Del.). Paper 10, 2; Paper 11, 2—3.
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`'
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`The parties state that the ’044 patent also is challenged in Case
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`IPR2018-01676. Paper 10, 2; Paper 11, 3. The parties also state that patents
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`related to the ’044 patent are challenged in Cases IPR2018—01670, IPR2018-
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`01677, IPR2018-01678, IPR2018-01679, IPR2018-01680, IPR2018-01682,
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`IPR2018-01684, IPR2018-01696, and IPR2019-00122. Paper 10, 2—3;
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`Paper 11, 2—3.
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`C.
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`Real Parties in Interest
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`Petitioner identifies Mylan Pharmaceuticals Inc., Mylan Inc., Mylan
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`GmbH, Biocon Research Ltd., Biocon Ltd., and Becton, Dickinson and
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`Company as real parties in interest. Paper 10, 2. Patent Owner identifies
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`Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis US. LLC, and Sanofi
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`Winthrop Industrie as real parties in interest. Paper 11, 2.
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`

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`IPR2018-01675
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`Patent 8,603,044 B2
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`D.
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`The Asserted Ground 0f Unpatentability
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`Petitioner asserts claims 11, 14, 15, 18, and 19 of the ’044 patent are
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`unpatentable under 35 U.S.C. § 103(a) as obvious over Burroughs et al.2
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`(Ex. 1013, “Burroughs”). Petitioner supports its challenge with a declaration
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`by Karl R. Leinsing, dated September 8, 2018 (Ex. 1011, “the Leinsing
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`Declaration”).
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`E.
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`The ’044 Patent
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`The ’044 patent “relates to pen-type injectors .
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`.
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`.
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`. where a user may
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`set the dose.” Ex, 1002, 1:20—24. Figures 1 and 2 of the ’044 patent are
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`reproduced below.
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`
`
`W..._[,7...-IJII_:'3:!“UM!r,"t..,‘n—nu—nmu—Imn—nzwal‘
`
`
` EL!
`
`FIG. 1
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`FIG. 2
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`Figure 1 “shows a sectional View of a pen—type injector .
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`.
`
`. in a first,
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`cartridge full, position,” and Figure 2 “shows a sectional View of the pen-
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`2 US 6,221,046 B1, iss. Apr. 24, 2001.
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`

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`IPR2018-01675
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`Patent 8,603,044 B2
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`type injector of FIG. 1 in a second, maximum first dose dialed, position.”
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`Id. at 2:53—57. The pen-type injector includes first cartridge retaining part 2
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`and second main housing part 4.3 Id. at 3:27—28. Insert 16 is at a first end
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`of housing part 4 and is fixed rotationally and axially to main housing 4. Id.
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`at 3:49—51. Insert 16 includes threaded circular opening 18, through which
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`piston rod 20 extends. Id. at 3:51—53, 3:57—59. Piston rod 20 includes first
`thread 19 that engages threaded circular opening 18. Id. at 3:56.-
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`Piston rod 20 also includes pressure foot 22 that abuts piston 10 of
`cartridge 8. Id. at 3:36—37, 3:59—60. Drive sleeve 30 extends about piston
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`rod 20, and second thread 24 of piston rod 20 engages internal helical
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`groove 38 of drive sleeve 30. Id. at 3:61—62, 4:4, 4:13—14.
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`Clutch or clutch means 60 is disposed about drive sleeve 30 adjacent
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`its second end. Id. at 4:33—35, 4:49—50. Clutch 60 is keyed to drive
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`sleeve 30 by splines to prevent relative rotation between clutch 60 and drive
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`sleeve 30. Id. at 4:60—62. Clutch 60 also has teeth 66 that engage dose-dial
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`sleeve 70. Id. at 4:50—52.
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`Dose dial sleeve 70 is outside of clutch 60 but within main housing 4.
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`Id. at 53—5. Dose dial sleeve 70 has helical groove 74 on its outer' surface,
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`and helical rib 46 of housing 4 is seated in helical groove 70. Id. at 5:5—6,
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`5:9—1 1. Dose dial grip 76 is disposed about and secured to the second end
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`of dose dial sleeve 70. Id. at 5:24—25, 5:27—28.
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`A user rotates dose dial grip 76 to set a dose and cause dose-dial
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`sleeve 70, clutch 60, and drive sleeve 30 to rotate together out of main
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`3 The ’044 patent refers to “second main housing part 4” and “main
`housing 4” interchangeably. Compare Ex. 1002, 3:28 (“second main
`housing part 4”) with id. at 3:30 (“main housing 4”).
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`

`

`IPR2018-01675
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`Patent 8,603,044 B2
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`housing 4. Id. at 5:50—53, 5:61-65, Fig. 9. The dose can be reduced by
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`turning dose dial grip 76 in the opposite direction. Id. at 6: 19—20, Fig. 10.
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`The user then presses button 82, which causes clutch 60 to disengage from
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`dose dial sleeve 70 so that clutch 60 moves axially and dose dial sleeve 70
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`rotates back into main housing 4. Id. at 6:28—35, 6:38—40, Fig. 11. Drive
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`sleeve 30 also moves axially and causes piston rod 20 to rotate through
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`threaded opening 18 to dispense medicine from cartridge 8. Id. at 6:45—47.
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`F.
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`Illustrative Claim
`
`Claim 11, the sole independent claim challenged in this proceeding, is
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`representative of the claimed subject matter and reproduced below:
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`A housing part for a medication dispensing apparatus, said
`1 1.
`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,
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`wherein
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`said
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`dose
`
`dial
`
`sleeve
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`extends
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`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
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`

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`IPR2018-01675
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`Patent 8,603,044 B2
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`drive sleeve has a second lead, and wherein said first lead
`and said second lead are different.
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`Id. at 827—36.
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`11.
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`35 U.S.C. § 314(a)
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`Patent Owner contends we should exercise our discretion under
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`35 U.S.C. §§ 314(a) and 324(a)4 to deny the Petition, as instituting trial
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`“would waste the Board’s finite resources and is fundamentally unfair and
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`inefficient to require Patent Owner to expend resources on an IPR trial
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`where the final written decision will issue only after the conclusion and
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`resolution of the identical validity challenge in the related District Court
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`case.” Prelim. Resp. 4. Patent Owner provides a procedural history leading
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`to the related district court litigation and filing of the Petition in this
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`proceeding. Id. at 6—8. Patent Owner indicates it initiated district court
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`litigation as part of the Hatch-Waxman Act process, which was triggered by
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`Petitioner’s submission of an application to the Food and Drug
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`Administration (“FDA”) to market a follow-on insulin glargine product. Id.
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`at 6. Petitioner notified Patent Owner of the application and included a
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`“Paragraph IV” certification alleging that the claims of the ’044 patent were
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`not valid, unenforceable, and/or not infringed. Id. at 6—7.
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`Patent Owner indicates it filed a patent infringement case against
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`Petitioner on October 24, 2017, Petitioner served its invalidity contentions
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`on January 25, 2018 (which Petitioner amended on April 25, 2018), and
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`Patent Owner responded with its validity contentions on August 12, 2018.
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`Id. at 7. The Petition in this proceeding was filed on September 10, 2018.
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`4 35 U.S.C. § 324 applies to post-grant reviews, which this is not. Therefore,
`our focus is on § 314.
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`

`

`IPR2018-01675
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`Patent 8,603,044 B2
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`Paper 8, 1. Patent Owner alleges the Petition “assert[s] substantially the
`same invalidity grounds” alleged in the district court case. Prelim. Resp. 7—
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`8.
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`Patent-Owner additionally indicates the parties in the district court
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`case jointly requested trial for October 2019, to reach resolution before the
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`end of the FDA’s 30-month stay. Id. at 8 (citing Ex. 2006 11 8); see also PR
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`Sur-Reply 1 (arguing Petitioner sought trial in advance of March 2020).
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`Patent Owner asserts, “even if the trial date shifts to later in 2019, there is
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`simply no basis to suggest that the District Court will not resolve all of the
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`issues in this case, including validity, before the March 2020 transition date
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`and expiration of the stay.” PR Sur-Reply 3.5 Thus, according to Patent
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`Owner, the related district court litigation will be concluded before a final
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`written decision is issued in this proceeding. Prelim. Resp. 8.
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`Patent Owner argues that the Board has discretion to deny under
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`35 U.S.C. § 314(a), pointing to statements in the August 2018 Trial Practice
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`Guide Update regarding a purpose of the inter partes review system to
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`establish a more efficient patent system and limit unnecessary litigation
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`costs. Prelim. Resp. 9 (citing Office Patent Trial Practice Guide, August
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`2018 Update, 83 Fed. Reg. 39,989 (Aug. 13, 2018); HR. Rep. 112-98, pt. 1,
`
`at 48 (2011)). Patent Owner also notes that the Board has exercised its
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`discretion to deny institution in circumstances similar to those presented
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`5 Patent Owner states that “[a] Markman hearing is likely to occur in early
`February 2019.” Prelim. Resp. 8. We note that the hearing is now
`scheduled for April 12, 2019. See Ex. 3001. Also, an amended scheduling
`order in the case indicates that Patent Owner proposed, and the court
`accepted, a trial date in January 2020, subject to the court’s availability. See
`id.
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`

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`IPR2018-01675
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`Patent 8,603,044 B2
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`here. Id. (citing NHK Spring Co. v. Intri-Plex Techs., Inc., Case IPR2018-
`
`00752 (PTAB Sept. 12, 2018) (Paper 8) (“NHK Spring”)).
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`Patent Owner contends the facts here are similar to the facts of NHK
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`Spring because the parties are at an advanced stage in district court
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`litigation, Petitioner relies on prior art in this proceeding that is at issue in
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`the litigation, and the district court trial will conclude before a final written
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`decision is issued. Id at 9—12. Patent Owner also argues instituting trial in
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`this proceeding gives Petitioner a tactical advantage because Petitioner was
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`able to review Patent Owner’s response to Petitioner’s invalidity contentions
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`in the related litigation, which amounts to “two bites at the apple.” Id. at 13.
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`Patent Owner asserts Petitioner was aware of the timing of the district court
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`case and engaged in gamesmanship that is highly prejudicial to Patent
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`Owner. Id.; see also PR Sur-Reply 5 n.1 (contending Petitioner “can still
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`tailor its District Court invalidity grounds to address weaknesses identified
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`in the Patent Owner’s Preliminary Response or the institution decision”).
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`Patent Owner also applies the factors discussed in General Plastic
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`Industrial Co. v. Canon Kabuslziki Kaisha, Case IPR2016-01357 (PTAB
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`Sept. 6, 2017) (Paper 19) (“General Plastic”) to the facts of this case and
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`contends that each factor favors denying the Petition. Prelim. Resp. 14—18.
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`Patent Owner argues, although those factors were articulated in the context
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`of denying follow-on petitions, the underlying logic applies to the present
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`proceeding. Id. at 15. In its analysis of the factors, Patent Owner points to
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`Petitioner’s duplication of invalidity arguments in the related district court
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`case and the present proceeding, the filing of the Petition after receipt of
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`Patent Owner’s response to the invalidity contentions, and the likelihood that
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`

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`IPR2018-01675
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`Patent 8,603,044 B2
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`the district court case will be decided no later than March 18, 2020. See id.
`at 15—18.
`’
`
`In its Reply to the Preliminary Response, Petitioner argues its
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`contentions in district court listed exemplary combinations, including
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`Burroughs in combination with thirty-three additional references. PR
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`Reply 1—2. Petitioner contends Patent Owner provides no evidence of its
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`“detailed validity positions,” other than an email that demonstrates service of
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`the contentions. Id. at 2.
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`Petitioner also contends that the number of patents asserted by Patent
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`Owner in the district court litigation and the word count limits in our rules
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`necessitated Petitioner’s filing of ten petitions. Id. at 2—3. Petitioner argues
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`that our discretionary denial of the timely filed petitions would penalize
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`Petitioner merely because Patent Owner asserted multiple patents in
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`litigation. Id. at 3.
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`Petitioner also argues Patent Owner speculates that a final written
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`decision in this case will issue after the related litigation has been resolved.
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`Id. at 3-4. Petitioner asserts, contrary to Patent Owner’s contentions, it did
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`not stagger the filing of the petitions nor did it file the petitions on the eve of
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`the one-year time limit. Id. at 4—5. Instead, the petitions (with one
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`exception) were filed on the same day almost two months before the
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`deadline. Id. Petitioner also contends Patent Owner’s arguments run afoul
`
`of statute, case law, and the Administrative Procedure Act. Id. at 5—12.
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`Patent Owner responds, contending the district court litigation will
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`conclude by March 2020 and asserting the District of New Jersey and Judge
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`Chesler are known to resolve Hatch-Waxman litigation “expeditiously and
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`in advance of stay expiration.” PR Sur-Reply 2 (referring to statements
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`10
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`

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`IPR2018-01675
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`Patent 8,603,044 B2
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`made in a related action in the Northern District of West Virginia). Patent
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`Owner also asserts an exercise of discretion under § 314(a) in this case will
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`not apply necessarily to all broadly Hatch-Waxman litigants. Id. at 3—4.
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`Rather, Patent Owner points to the alleged duplicate grounds in the district
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`court and this proceeding and timing issues that Patent Owner contends are
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`“unique issues” to the facts presented here. Id.
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`In view of the arguments presented, we are not persuaded to exercise
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`our discretion under 35 U.S.C. § 314(a) to deny the Petition. We understand
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`that the facts in NHK Spring and the circumstances of this case may seem
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`similar. The record, however, does not indicate that trial in the related
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`district court case will occur in October 2019 or even in January 2020, in
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`light of the latest schedule.6 See Ex. 3001. Although the record indicates
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`that the district court and the parties are working together toward resolving
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`the litigation before the end of the FDA’s 30-month stay, there are no
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`assurances that the related litigation will in fact be resolved before then.
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`Indeed, as indicated in the latest scheduling order in the district court
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`litigation, the parties will not propose trial dates to the district court until
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`October 2019. See id. Adding to the uncertainty of when a trial may begin,
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`many of the district court schedule’s milestones are dependent on the
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`issuance of a claim construction order, which is not within the control of
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`either party. See id; see also PR Reply 4 (explaining that “most deadlines”
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`are tied to the issuance of a Markman order). In this proceeding, by statute,
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`6 In the district court case running parallel to NHK Spring, the court
`ultimately moved the trial date back six months, illustrating the uncertainty
`associated with litigation schedules. See Intri-Plex Techs. v. NHK Int ’1
`Corp, 3:17-cv-01097—EMC (N .D. Cal.) (docket entry 173 (providing new
`schedule), docket entry 175 (providing order granting new schedule)).
`
`11
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`

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`IPR2018-01675
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`Patent 8,603,044 B2
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`barring any good cause, review will be completed within one year of
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`institution. For these reasons, we are not persuaded instituting review in this
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`proceeding will be an inefficient use of Board resources.
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`Additionally, we are not persuaded to apply the factors enumerated in
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`General Plastic to the facts of this case. As Patent Owner notes, the
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`General Plastic factors were articulated in the context of follow-on petitions.
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`Prelim. Resp. 14. Here, in contrast, Patent Owner does not complain of a
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`follow-on petition. Rather, Patent Owner complains that Petitioner received
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`Patent Owner’s response to Petitioner’s invalidity contends in related
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`litigation before Petitioner filed the Petition. Id. at 14—18. We cannot
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`discern from Exhibit 2011, however, the substance of Patent Owner’s
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`response to the invalidity contentions, so it is unclear what, if any, tactical
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`advantage, Petitioner may have gained by receiving that response before
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`filing the Petition in this matter. Thus, we are not persuaded that Petitioner’s
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`receipt of Patent Owner’s response to the invalidity contentions amounts to a
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`petitioner receiving the benefit of a preliminary response or decision on
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`institution before filing a second petition challenging the same patent, the
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`circumstances addressed by the General Plastic factors. For the same
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`reasons, even if we were to apply the General Plastic factors, we would be
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`unable to ascertain the same information. Also, Petitioner filed the Petition
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`well within the timeframe allowed by statute, weighing heavily in
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`Petitioner’s favor. Accordingly, we do not exercise our discretion under 35
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`U.S.C. § 314(a) to deny the Petition.
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`III.
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`LEVEL OF ORDINARY SKILL IN THE ART
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`Petitioner asserts that one of ordinary skill in the art “would have had
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`at least a bachelor’s degree in mechanical engineering, or an equivalent
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`12
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`

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`IPR2018-01675
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`Patent 8,603,044 B2
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`degree, and approximately three years of experience in medical-device
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`design” and “would have understood the basics of medical-device design
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`and manufacturing, and the basic mechanical elements (e.g., gears, pistons)
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`involved in drug-delivery devices.”7 Pet. 14 (citing Ex. 1011 fl 104). Patent
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`Owner does not propose a level of ordinary skill in the Preliminary
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`Response.
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`At this stage of the proceeding, we find Petitioner’s proposal
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`consistent with the level of ordinary skill in the art reflected by the prior art
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`ofrecord, see Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001);
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`In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re OeIrz'ch, 579
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`F.2d 86, 91 (CCPA 1978), and, therefore, we preliminarily adopt Petitioner’s
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`unopposed position as to the level of ordinary skill in the art.
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`IV.
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`CLAIM CONSTRUCTION
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`In an inter partes review based on a petition filed prior to
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`November 13, 2018, claim terms in an unexpired patent are construed
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`according to their broadest reasonable interpretation in light of the
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`specification of the patent in which they appear. See 37 CPR. § 42.100(b)
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`(2018);8 Cuozzo Speed Techs, LLC v. Lee, 136 S. Ct. 2131, 2144—46 (2016).
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`7 The articulated level of ordinary skill in the Petition differs slightly from
`the level of ordinary skill proposed in the petition for IPR2018-01676, which
`challenges the same patent. Each petition references the same paragraph of
`Mr. Leinsing’s Declaration, which was filed in each case.
`
`8 A recent amendment to this rule does not apply here because the Petition
`was filed before November 13, 2018. See Changes to the Claim
`Construction Standard for Interpreting Claims in Trial Proceedings Before
`the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018)
`(amending 37 CPR. § 42.100(b) effective Nov. 13, 2018) (to be codified at
`37 C.F.R. pt. 42).
`
`13
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`IPR2018-01675
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`Patent 8,603,044 B2
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`There is a presumption that claim terms are given their ordinary and
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`customary meaning, as would be understood by a person of ordinary skill in
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`the art in the context of the specification. See In re Translogic Tech. Inc. ,
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`504 F.3d 1249, 1257 (Fed. Cir. 2007). Nonetheless, if the specification
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`“revea1[s] a special definition given to a claim term by the patentee that
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`differs from the meaning it would otherwise possess[,] .
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`.
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`. the inventor’s
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`lexicography governs.” Phillips v. AWH Corp, 415 F.3d 1303, 1316 (Fed.
`Cir. 2005) (en banc) (citing CCS Fitness, Inc. v. Brunswick Corp, 288 F.3d
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`1359, 1366 (Fed. Cir. 2002)). Another exception to the general rule that
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`claims are given their ordinary and customary meaning is “when the
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`patentee disavows the full scope of a claim term either in the specification or
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`during prosecution.” Uship Intellectual Props, LLC v. United States, 714
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`F.3d 1311, 1313 (Fed. Cir. 2013) (quoting Thorner v. Sony Computer Entm ’t
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`Am., LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012)). Additionally, only terms
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`that are in controversy need to be construed, and these need be construed
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`only to the extent necessary to resolve the controversy. See Vivid Techs.,
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`Inc. v. Am. Sci. & Eng ’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); Nidec
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`Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017
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`(Fed. Cir. 2017) (applying Vivid Techs. in the context of an inter partes
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`review).
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`Petitioner states, “[fjor this petition, claim terms may be given their
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`ordinary and accustomed meaning, consistent with the specification and how
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`a [person of ordinary skill in the art] would have understood them.” Pet. 15
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`(citing 37 CPR. § 42.100(b); Phillips v. AWH Corp, 415 F.3d 1303, 1312—
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`13 (Fed. Cir. 2005) (en banc)). Petitioner contends “[t]he ground presented
`
`14
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`

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`IPR2018-01675
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`Patent 8,603,044 B2
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`below relies on the ordinary and customary meaning of the claim terms.” Id.
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`at 17.
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`Petitioner provides interpretations of five terms that were proffered by
`39 6‘
`,3 6‘
`'
`Patent Owner in related litigation—“drive sleeve, main housing,
`p1ston
`
`rod,” “threading,” and “tubular clutch.” Id at 15—16 (citing Ex. 1019, 19,
`
`21, 23, 27, 30). Petitioner also explains it proffered means-plus-function
`
`interpretations for “tubular clutch” and “clicker” in related litigation and
`
`reiterates those interpretations here. Id. (citing Ex. 1028, 54—59, 62—63, 65—
`
`68; Ex. 1002, 2:16—18, 4:49—62, 4:63—65, 6:33—43). Petitioner states that
`
`the ground presented “also addresses the ‘tubular clutch’ and ‘clicker’
`
`limitations to the extent that those terms may be construed as means-plus-
`
`function limitations.” Id. at 17.
`
`Patent Owner responds that Petitioner does not state what the plain
`
`and ordinary meaning is for any term. Prelim. Resp. 24. Patent Owner also
`
`contends that Petitioner fails to comply with 37 C.F.R. § 42.104(b) by not
`
`asserting clearly how the claims are construed for purposes of the Petition.
`
`Id at 47—50.
`
`By providing Patent Owner’s proposed interpretations from related
`
`litigation, we understand Petitioner to contend that the broadest reasonable
`
`interpretation in view of the specification and the plain and ordinary
`
`meanings of these terms would, at a minimum, encompass Patent Owner’s
`
`proposed interpretations. Also, as discussed further below, Petitioner’s
`
`arguments provide sufficient indication as to how Petitioner interprets the
`
`challenged claims in its application of Burroughs to the claim limitations.
`
`Patent Owner also disputes that “tubular clutch” and “clicker” are
`
`means—plus-function limitations. Id. at 28-29. Patent Owner argues that,
`
`15
`
`

`

`IPR2018—01675
`
`Patent 8,603,044 B2
`
`although Petitioner requests means-plus—function interpretations for these
`
`terms, Petitioner applies different interpretations or does not apply means-
`
`plus-function interpretations in its analysis, thereby prejudicing Patent
`
`Owner’s ability to defend its patent. Id. at 47—50.
`
`We do not view Petitioner’s reproduction of its means-plus-function
`
`interpretations from the related litigation as alternative constructions for
`
`these terms as somehow rendering the Petition defective. To the extent
`
`Petitioner’s approach results in a failure to explain how the claims are
`
`construed, it is addressed in the context of our consideration of Petitioner’s
`
`challenge. The parties may address this issue further during trial.
`
`Aside from contesting Petitioner’s application of means—plus-function
`
`claim construction, as discussed above, Patent Owner proposes only one
`
`term for construction—“helical groove.” Id. at 24—28. Patent Owner
`
`proposes “helical groove” means “a groove formed in the shape of a spiral.”
`Id. at 25. Patent Owner provides citations to the ’specification of the
`
`’044 patent and several dictionary definitions. Id. at 25—28 (citing Ex. 1002,
`
`525—6, Figs. 12—14; Ex. 2013, 10; Ex. 2014; Ex. 2015, 4—5).
`
`Based on the arguments and evidence at this stage, we adopt Patent
`
`Owner’s proposed construction for the purposes of this Decision. During
`
`trial, we may revisit the construction of this term and Petitioner’s arguments
`
`regarding Burroughs related thereto. With respect to the other claim terms
`
`discussed above, we determine that no express interpretation is required for
`
`purposes of determining whether Petitioner demonstrates a reasonable
`
`likelihood of prevailing in its challenge based on Burroughs. Vivid Techs.,
`
`200 F.3d at 803 (construing explicitly only those claim terms in controversy
`
`and only to the extent necessary to resolve the controversy).
`
`16
`
`

`

`IPR2018-01675
`
`Patent 8,603,044 B2
`
`V.
`
`ANALYSIS
`
`A.
`
`Obviousness over Burroughs
`
`The US. Supreme Court set forth the framework for applying the
`
`statutory language of 35 U.S.C. § 103 in Graham v. John Deere C0. of
`
`Kansas City, 383 US. 1, 17—18(1966):
`
`Under § 103, the scope and content of the prior art are to be
`determined; differences between the prior art and the claims at
`issue are to be ascertained; and the level of ordinary skill in the
`pertinent art resolved. Against this background, the obviousness
`or nonobviousness of the subject matter is determined. Such
`secondary considerations as commercial success, long felt but
`unsolved needs, failure of others, etc., might be utilized to give
`light to the circumstances surrounding the origin of the subject
`matter sought to be patented.
`
`As explained by the Supreme Court in KSR International Co. v. Teleflex
`
`Inc. :
`
`it will be necessary for a court to look to interrelated
`Often,
`teachings of multiple patents; the effects of demands known to
`the design community or present in the marketplace; and the
`background knowledge possessed by a person having ordinary
`skill in the art, all in order to determine whether there was an
`apparent reason to combine the known elements in the fashion
`claimed by the patent at issue. To facilitate review, this analysis
`should be made explicit. _
`
`550 US. 398, 418 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir.
`
`2006) (“[R]ejections on obviousness grounds cannot be sustained by mere
`
`conclusory statements; instead, there must be some articulated reasoning
`
`with some rational underpinning to support the legal conclusion of
`
`obviousness.”)).
`
`“Whether an ordinarily skilled artisan would have been motivated to
`
`modify the teachings of a reference is a question of fact.” WBIP, LLC v.
`
`17
`
`

`

`IPR2018-01675
`
`Patent 8,603,044 B2
`
`Kohler Co., 829 F.3d 1317, 1327 (Fed. Cir. 2016) (citations omitted).
`
`“[W]here a party argues a skilled artisan would have been motivated to
`
`combine references, it must show the artisan ‘would have had a reasonable
`9”
`expectation of success from doing so. Arctic Cat Inc. v. Bombardier
`
`Recreational Prods. Inc, 876 F.3d 1350, 1360—61 (Fed. Cir. 2017) (quoting
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent
`
`Litig, 676 F.3d 1063, 1068—69 (Fed. Cir. 2012)).
`
`Petitioner asserts that Burroughs would have rendered the subject
`
`matter of claims 11, 14, 15, 18, and 19 obvious to one of ordinary skill in the
`
`art at the time of the invention. Pet. 19—48.
`
`1.
`
`Level of Ordinary Skill in the Art
`
`As discussed supra, we adopt Petitioner’s unopposed position as to
`
`the level of ordinary skill in the art for purposes of this Decision. See supra
`
`Section III.
`
`2.
`
`Scope and Content ofthe Prior Art — Burroughs
`
`Burroughs relates to “medical dispensing devices .
`
`.
`
`. that permit
`
`selectively measured dosages of a liquid to be dispensed.” Ex. 1013, 1:13—
`
`16. Figure 2 of Burroughs is reproduced below.
`
`
`
`Figure 2 shows an exploded View of injection medication device 20. Id. at
`
`6:42—43, 7:15—16. Medication device 20 includes mechanism housing 22
`
`18
`
`

`

`IPR2018-01675
`
`Patent 8,603,044 B2
`
`made from housing parts 24 and 26, button 32, dial mechanism 34, nut 36,
`
`and leadscrew 38 that forms a drive stem. Id. at 7:17—18, 7:32—34, 9:12—13.
`
`Dial mechanism 34 engages button 32. Id. at 8: 9—14, Figs. 6, 8. Dial
`
`mechanism 34 also includes outwardly extending threads 110, 112 that
`
`“enter helical groove 158 during commencement of the dosing process.” Id.
`
`at 8:33—36, 8262—921, Figs. 3, 5. “As a dosage is being set, outwardly
`
`extending threads 110 and 112 of dial mechanism 34 ride in helical
`
`groove 158 ofhousing parts 24 and 26.” Id. at 10:60—63.
`
`When button 32 is depressed, dial mechanism 34 travels axially
`
`towards cartridge 40. Id. at 8:15—20. Splines 144 on the interior of dial
`
`mechanism 34 engage teeth 192 of nut 36 when the clutch is engaged to set a
`
`dosage. Id. at 8:42—48, Fig. 9. A series of numerals are printed on dial
`
`mechanism 34 to indicate a desired dosage. Id. at 1025—9.
`
`Rotating dial mechanism 34 causes nut 36 to rotate and move relative
`
`to housing 20, but rotation of leadscrew 38 is prevented. Id. at 10:25—27.
`
`Once a desired dosage has been set, button 32 is pushed to move dial
`
`mechanism 34, nut 36, and leadscrew 38 forward to deliver the set dosage.
`
`Id. at 11:13—19, 11:31—34.
`
`3.
`
`Differences Between the Prior Art and the Claims;
`Motivation to Modifi/
`
`Petitioner contends claims 11, 14, 15, 18, and 19 would have been
`
`obvious over Burroughs. Pet. 19—48. Petitioner provides claim charts and
`
`arguments with citations to where Burroughs allegedly teaches the
`
`limitations of the claims and citations to supporting declara‘nt testimony. Id.
`
`19
`
`

`

`IPR2018-01675
`
`Patent 8,603,044 B2
`
`0.
`
`Independent Claim 1 1
`
`Petitioner contends independent claim 11 recites six components:
`
`(1) a main housing; (2) a dose dial sleeve; (3) a dose dial grip; (4) a piston
`
`rod; (5) a drive sleeve; and (6) a tubular clutch. Id. at 6. Petitioner asserts
`
`Burroughs teaches each of the six components Petitioner’s identifies as
`
`recited in claim 11. Id. at 19. In particular, Petitioner contends Burroughs’s
`
`housing 22, dial mechanism 34, proximal portion 78, leadscrew 38, nut 36,
`
`and button 32 teach, respectively, claim 11’s main housing, dose dial sleeve,
`
`dose dial grip, piston rod, drive sleeve, and tubular clutch.

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