Trials@uspto.gov
`571-272-7822
`
`Paper No. 20
`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 IPR2018-01676
`
`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
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`I.
`
`INTRODUCTION
`
`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”).
`
`Sanofi-Aventis Deutschland GmbH (“Patent Owner”) filed a Preliminary
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`Response (Paper 10). With prior authorization, Petitioner filed a Reply to
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`Patent Owner’s Preliminary Response (Paper 13; “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 15, “PR Sur-Reply”). Pursuant to 35 U.S.C. § 314, an inter
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`partes review may not be instituted “unless .
`
`.
`
`. there is a reasonable
`
`likelihood that the petitioner would prevail with respect to at least 1 of the
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`claims challenged in the petition.”
`
`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.
`
`B.
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`Related Proceedings
`
`The parties indicate that the ’044 patent has been asserted in Sanofi-
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`Avem‘is 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, N0. 1:16-cv-00812
`
`(D. Del); and Sanofi-Aventis US. LLC v. Eli Lilly and Co, No. 1:14-cv-
`
`00113 (D. Del.). Paper 8, 2; Paper 9, 1—2.
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`The parties state that the 5044 patent also is challenged in Case
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`IPR2018-01675. Paper 8, 2; Paper 9, 2. 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 8, 2—3;
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`Paper 9, 1—2.
`
`C.
`
`Real Parties in Interest
`
`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 8, 2. Patent Owner identifies
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`Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis US. LLC, and Sanofi
`
`Winthrop Industrie as real parties in interest. Paper 9, 1.
`
`D.
`
`The Asserted Grounds of Unpatentabilily
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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 (1) Steenfeldt—Jensen
`
`et al.‘ (Ex. 1014, “Steenfeldt-Jensen”) and (2) Moller2 (Ex. 1015) in
`
`combination with Steenfeldt-Jensen. Petitioner supports its challenge with a
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`declaration by Karl R. Leinsing, dated September 9, 2018 (Ex. 1011, “the
`
`Leinsing Declaration”).
`
`E.
`
`The ’044 Patent
`
`The ’044 patent “relates to pen-type injectors .
`
`.
`
`. where a user may set
`
`the dose.” Ex, 1002, 1:20—24. Figures 1 and 2 of the ’044 patent are
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`reproduced below.
`
`' US. Patent No. 6,235,004 B1, iss. May 22, 2001.
`
`2 US. Patent Application Pub. No. 2002/0052578 A1.
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
` r.
`E»
`
`FIG. 1
`
`me. 2
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`Figure 1 “shows a sectional View of a pen—type injector .
`
`.
`
`. in a first,
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`cartridge full, position,” and Figure 2 “shows a sectional view of the pen-
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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—5 1. 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
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`thread 19 that engages threaded circular opening 18. Id. at 3:56.
`
`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”).
`
`

`

`IPR2018—01676
`
`Patent 8,603,044 B2
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`Piston rod 20 also includes pressure foot 22 that abuts piston 10 of
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`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, 4:18—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
`sleeve 30. Id. at 4260—62. Clutch 60 also has teeth 66 that engage dose—dial .
`
`sleeve 70. Id. at4:50—52.
`
`Dose dial sleeve 70 is outside of clutch 60 but within main housing 4.
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`Id. at 523—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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`529—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
`
`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
`
`threaded opening 18 to dispense medicine from cartridge 8. Id. at 6:45—47.
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`F.
`
`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:
`
`A housing part for a medication dispensing apparatus, said
`11.
`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
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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
`drive sleeve has a second lead, and wherein said first lead
`and said second lead are different.
`
`Id. at 827—36.
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`11.
`
`35 U.S.C. § 314(a)
`
`Patent Owner contends we should exercise our discretion under
`
`35 U.S.C. §§ 314(a) and 324(a)4 to deny the Petition, as instituting trial
`
`“would waste the Board’s finite resources and is fundamentally unfair and
`
`inefficient to require Patent Owner to expend resources on an IPR trial
`
`where the final written decision will issue only after the conclusion and
`
`resolution of the identical validity challenge in the related District Court
`
`case.” Prelim. Resp. 4. Patent Owner provides a procedural history leading
`
`to the related district court litigation and filing of the Petition in this
`
`proceeding. Id. at 6—8. Patent Owner indicates it initiated district court
`
`litigation as part of the Hatch-Waxman Act process, which was triggered by
`Petitioner’s submission of an application to the Food and Drug
`
`Administration (“FDA”) to market a follow-on insulin glargine product. Id.
`
`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.
`
`Patent Owner indicates it filed a patent infringement case against
`
`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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`Paper 6, 1. Patent Owner alleges the Petition “assert[s] substantially the
`
`same invalidity grounds” alleged in the district court case. Prelim. Resp. 7.
`
`4 35 U.S.C. § 324 applies to post-grant reviews, which this is not. Therefore,
`our focus is on § 314.
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`Patent Owner additionally indicates the parties in the district court
`
`case jointly requested trial for October 2019, to reach resolution before the
`
`end of the FDA’s 30—month stay. Id. at 8 (citing Ex. 2006 1] 8); see also PR
`
`Sur-Reply 1 (arguing Petitioner sought trial in advance of March 2020).
`
`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
`
`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.
`
`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
`
`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. 8—9 (citing Office Patent Trial Practice Guide,
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`August 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
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`exercised its discretion to deny institution in circumstances similar to those
`
`presented here. Id. at 9 (citing NHK Spring Co. v. Intri-Plex Techs., Inc,
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`Case IPR2018-00752 (PTAB Sept. 12, 2018) (Paper 8) (“NHK Spring”)).
`
`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.
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`Patent Owner contends the facts here are similar to the facts of NHK
`
`Spring because the parties are at an advanced stage in district court
`
`litigation, Petitioner relies on prior art in this proceeding that is at issue in
`
`the litigation, and the district court trial will conclude before a final written
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`decision is issued. Id at 9—13. 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
`
`case and engaged in gamesmanship that is highly prejudicial to Patent
`
`Owner. Id; see also PR Sur—Reply 5 n.1 (contending Petitioner “can still
`
`tailor its District Court invalidity grounds to address weaknesses identified
`
`in the Patent Owner’s Preliminary Response or the institution decision”).
`Patent/Owner also applies the factors discussed in General Plastic
`
`Industrial Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357 (PTAB
`
`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. 13—18.
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`Patent Owner argues, although those factors were articulated in the context
`
`of denying follow-on petitions, the underlying logic applies to the present
`
`proceeding. Id. at 14. 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
`
`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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`the district court case will be decided no later than March 18, 2020. See id.
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`at 14—18.
`
`

`

`IPR201 8-01676
`
`Patent 8,603,044 B2
`
`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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`Steenfeldt—Jensen or Moller in combination with thirty—three additional
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`references. PR Reply 1—2. Petitioner contends Patent Owner provides no
`
`evidence of its “detailed validity positions,” other than an email that
`
`demonstrates service of the contentions. Id. at 2.
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`Petitioner also contends that the number of patents asserted by Patent
`
`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
`
`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
`
`deadline. Id. Petitioner also contends Sanofi’s arguments run afoul of
`
`statute, case law, and the Administrative Procedure Act. Id. at 5—12.
`
`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
`
`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
`
`10
`
`

`

`IPR2018—01676
`
`Patent 8,603,044 B2
`
`not apply necessarily to all Hatch-Waxman litigants. Id. at 3—4. Rather,
`
`Patent Owner points to the alleged duplicate grounds in the district court and
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`this proceeding and timing issues that Patent Owner contends are “unique
`
`issues” to the facts presented here. Id.
`
`In view of the arguments presented, we are not persuaded to exercise
`
`our discretion under 35 U.S.C. § 314(a) to deny the Petition. We understand
`
`that the facts in NHK Spring and the circumstances of this case may seem
`
`similar. The record, however, does not indicate that trial in the related
`
`district court case will occur in October 2019 or even in January 2020, in
`
`light of the latest schedule.6 See Ex. 3001. Although the record indicates
`
`that the district court and the parties are working together toward resolving
`
`the litigation before the end of the FDA’s 30-month stay, there are no
`
`assurances that the related litigation will in fact be resolved before then.
`
`Indeed, as indicated in the latest scheduling order in the district court
`
`litigation, the parties will not propose trial dates until October 2019. See id.
`
`Adding to the uncertainty of when a trial may begin, many of the district
`
`court schedule’s milestones are dependent on the issuance of a claim
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`construction order, which is not within the control of either party. See id.;
`
`see also PR Reply 4 (explaining that “most deadlines” are tied to the
`
`issuance of a Markman order). In this proceeding, by statute, barring any
`
`good cause, review will be completed within one year of institution. For
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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’l
`Corp, 3:17-cv—01097-EMC (ND. Cal.) (docket entry 173 (providing new
`schedule), docket entry 175 (providing order granting new schedule)).
`
`11
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`these reasons, we are not persuaded instituting review in this proceeding will
`
`be an inefficient use of Board resources.
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`Additionally, we are not persuaded the circumstances of this case
`
`warrant review according to the factors enumerated in General Plastic. As
`
`Patent Owner notes, the General Plastic factors were articulated in the
`
`context of follow-on petitions. Prelim. Resp. 14. Here, in contrast, Patent
`
`Owner does not complain of a follow-on petition. Rather, Patent Owner
`complains that Petitioner received Patent Owner’s response to Petitioner’s
`
`invalidity contentions in related litigation before Petitioner filed the Petition.
`
`Id. at 14—18. We cannot discern from Exhibit 2011, however, the substance
`
`of Patent Owner’s response to the invalidity contentions, so it is unclear
`
`what, if any, tactical advantage, Petitioner may have gained by receiving that
`
`response before filing the Petition in this matter. Thus, we are not persuaded
`
`that Petitioner’s receipt of Patent Owner’s response to the invalidity
`
`contentions amounts to a petitioner receiving the benefit of a preliminary
`
`response or decision on institution before filing a second petition
`
`challenging the same patent, the circumstances addressed by the General
`
`Plastic factors. For the same reasons, even if we were to apply the General
`
`Plastic factors, we would be unable to ascertain the same information. Also,
`
`Petitioner filed the Petition well within the timeframe allowed by Statute,
`
`weighing heavily in Petitioner’s favor. Accordingly, we do not exercise our
`
`discretion under 35 U.S.C. § 314(a) to deny the Petition.
`
`III.
`
`LEVEL OF ORDINARY SKILL IN THE ART
`
`Petitioner asserts that one of ordinary skill in the art would have “had
`
`at least a bachelor’s degree in mechanical engineering, or an equivalent
`
`12
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
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`degree, and approximately three-year’s experience”7 and would have
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`“understood the basics of medical—device design and manufacturing, and the
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`basic mechanical elements (e.g., gears, pistons) in drug-delivery devices.”8
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`Pet. 14 (citing Ex. 1011 11 104—06). Patent Owner does not propose a level
`
`of ordinary skill in the Preliminary Response.
`
`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
`
`of record, see Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001);
`
`In re GPACInc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re OeIrich, 579
`
`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.
`
`IV.
`
`CLAIM CONSTRUCTION
`
`In an inter partes review based on a petition filed prior to
`
`November 13, 2018, claim terms in an unexpired patent are construed
`
`according to their broadest reasonable interpretation in light of the
`
`specification of the patent in which they appear. See 37 C.F.R. § 42.100(b)
`
`7 Mr. Leinsing testifies the three years of practical experience would have
`been “with medical device design and manufacturing.” Ex. 1011 11 106.
`
`8 The articulated level of ordinary skill in the Petition differs slightly from
`the level of ordinary skill proposed in the petition for IPR2018-01675, which
`challenges the same patent. Each petition references the same paragraph of
`Mr. Leinsing’s Declaration, which was filed in each case.
`
`13
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`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`(2018);9 Cuozzo Speed Techs, LLC v. Lee, 136 S. Ct. 2131, 2144—46 (2016).
`
`There is a presumption that claim terms are given their ordinary and
`
`customary meaning, as would be understood by a person of ordinary skill in
`
`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
`
`“reveal[s] a special definition given to a claim term by the patentee that
`
`differs from the meaning it would otherwise possess[,] .
`
`.
`
`. the inventor’s
`
`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
`
`1359, 1366 (Fed. Cir. 2002)). Another exception to the general rule that
`
`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
`
`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
`
`Am., LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012)). Additionally, only terms
`
`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.,
`
`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 C0., 868 F.3d 1013, 1017
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`(Fed. Cir. 2017) (applying Vivid Techs. in the context of an inter partes
`
`review).
`
`9 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 C.F.R. § 42.100(b) effective Nov. 13, 2018) (to be codified at
`37 C.F.R. pt. 42).
`
`14
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`Petitioner states, “[flor this petition, claim terms may be given their
`
`ordinary and accustomed meaning, consistent with the specification and how
`
`a [person of ordinary skill in the art] understood them.” Pet. 14 (citing 37
`
`C.F.R. § 42.100,(b); Phillips v. AWH Corp, 415 F.3d 1303, 1312—13 (Fed.
`
`Cir. 2005) (en banc)). Petitioner contends “the grounds rely on the ordinary
`
`and customary meaning of the claim terms.” Id. at 16.
`
`Petitioner provides interpretations of five terms that were proffered by
`$9 6‘
`'
`9, 6‘
`Patent Owner in related litigation—“drive sleeve, main housing,
`p1ston
`
`rod,” “threading,” and “tubular clutch.” Id. at 15 (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
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`reiterates those interpretations here. Id. at 15—16 (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 grounds presented “also address the ‘tubular clutch’ and
`
`‘clicker’ limitations as means-plus-function limitations.” Id. at 16.
`
`Patent Owner responds that Petitioner does not state what the plain
`
`and ordinary meaning is for any term. Prelim. Resp. 23. 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 67—70.
`
`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
`
`15
`
`

`

`IPR2018—01676
`
`Patent 8,603,044 B2
`
`challenged claims in its application of the asserted references to the claim
`
`limitations.
`
`Patent Owner also disputes that “tubular clutch” and “clicker” are
`
`means—plus-function limitations. Id at 26—27. Patent Owner argues that,
`
`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 69—70.
`
`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—“main housing.” Id. at 23—26. Patent Owner
`
`proposes “main housing” means “an exterior unitary or multipart component
`
`configured to house, fix, protect, guide, and/or engage with one or more
`
`inner components.” Id. at 24. Patent Owner contends its proposed
`
`interpretation is derived from lexicography in a related patent (Ex. 1005,
`
`2:66—3:12). Id. at 24—25. Patent Owner also cites to a decision in a prior
`
`district court case. Id. at 25—26 (citing Ex. 2013, 7—9). Patent Owner asserts
`
`Petitioner’s plain and ordinary meaning is so broad that it includes an
`
`interior housing. Id. at 26 (citing Pet. 52—54).
`
`16
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`Based on the arguments and evidence at this stage and for the reasons
`
`discussed below, Petitioner sufficiently shows for purposes of institution that
`
`the asserted references teach the claimed “main housing,” even under Patent
`
`Owner’s proposed interpretation. After the record has been developed at
`
`trial, we may further analyze Patent Owner’s proposed interpretation of
`
`“main housing” and, as discussed infia, whether Moller teaches this
`
`limitation of the claims. At this stage, for the reasons given aboVe, we
`
`determine that no express interpretation is required for any claim term for
`
`the purposes of determining whether Petitioner demonstrates a reasonable
`
`likelihood of prevailing in its challenges. 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).
`
`V.
`
`ANALYSIS
`
`A.
`
`Law of Obviousness
`
`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.
`
`l7
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`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.
`
`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
`
`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)).
`
`B.
`
`Obviousness over Steenfeldt-Jensen
`
`Petitioner asserts that Steenfeldt-Jensen 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. 21—49.
`
`18
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`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 — Steenfeldt-Jenserz
`
`Steenfeldt-Jensen “relates to injection syringes of the kind
`
`apportioning set doses of a medicine from a cartridge.” Ex. 1014, 1:12—13.
`
`Figures 16 and 17 of Steenfeldt-Jensen are reproduced below.
`
`,,.:e:
`
`
`.____/WVA'I/IWI...._./..
`
`
` /it;
` J...
`
`Figure 16 shows a side sectional View of a syringe, and Figure 17
`
`shows an exploded View of that same syringe. Id. at 5:25—28. The syringe
`
`of Steenfeldt-Jensen includes tubular housing 1 that is partitioned so that a
`
`first division has ampoule holder 2. Id. at 5:3 8—40. Ampoule holder 2 has a
`
`central bore with thread 5 that engages external thread 7 of piston rod 6. Id.
`
`at 5:55—58. Driver tube 85 is disposed about piston rod 6. See id. at
`
`19
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`Figs. 15—17. “The piston rod has a not round cross-section and fits through
`
`the driver tube bore which has a corresponding not round cross-section” so
`
`that “rotation is transmitted” and “the piston rod is allowed to move
`
`longitudinally through the driver tube.” Id. at 11:15—19.
`
`Within housing 1 is scale drum 80, and scale drum 80 has on its outer
`
`wall a helical track that engages a helical rib on the inner wall of housing 1.
`
`Id. at 11:20—22. One end of scale drum 80 has a larger diameter so as to
`
`form dose setting button 81. Id. at 11:22-24. Bushing 82 fits within scale
`
`drum 80 and over driver tube 85. Id. at 11:26—29. Bushing 82 is coupled to
`
`driver tube 85 so that both bushing 82 and driver tube 85 can rotate but not
`
`longitudinally move. Id. at 11:30—33. Injection button 88 is rotatably
`
`mounted at an end of bushing 82. Id. at 49-51.
`
`A dose is set by rotating dose setting button 81, which causes scale
`
`drum 80 to rotate out of housing 1. Id. at 11:52—55. Injection button 88 is
`
`pressed to inject the set dose, and bushing 82 rotates with dose setting
`
`button 81 because of the engagement of the helical track of scale drum 80
`
`with the rib of housing 1 when scale drum 80 is pressed into housing 1. Id.
`
`at 1224—10. The rotation of bushing 82 rotates driver tube 85, which causes
`
`piston rod 6 to rotate and screw into ampoule 89 in ampoule holder 2. Id. at
`
`12:10—13.
`
`3.
`
`Differences Between the Prior Art and the Claims;
`Motivation to Modifi/
`
`a.
`
`Independent Claim 1 1
`
`Petitioner argues Steenfeldt—Jensen teaches all the structural
`
`limitations of claim 11. Pet. 21. Petitioner alternatively argues “[i]f
`
`Steenfeldt-Jensen does not disclose a ‘drive sleeve,’ it would have been
`
`routine to modify the Steenfeldt-Jensen device to include one.” Id.
`
`20
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`Petitioner provides a claim chart in which it asserts Steenfeldt-Jensen
`
`teaches or suggests all the limitations of claim 11. Id. at 21—39. Petitioner
`
`points to Steenfeldt-Jensen’s housing 1, scale drum 80, dose setting
`
`button 81, p

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