UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC. and PFIZER INC.,
`Petitioner,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`Case No. IPR2018-01676
`U.S. Patent No. 8,603,044 B21
`
`PATENT OWNER SANOFI-AVENTIS DEUTSCHLAND GMBH’S
`NOTICE OF APPEAL UNDER 37 C.F.R. § 90.2(a)
`
`1 Pfizer Inc. was joined as a petitioner in this proceeding.
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC. and PFIZER INC.,
`Petitioner,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`Case No. IPR2018-01676
`U.S. Patent No. 8,603,044 B21
`
`PATENT OWNER SANOFI-AVENTIS DEUTSCHLAND GMBH’S
`NOTICE OF APPEAL UNDER 37 C.F.R. § 90.2(a)
`
`1 Pfizer Inc. was joined as a petitioner in this proceeding.
`
`
`
`Pursuant to 35 U.S.C. §§ 141–144, 319 and 37 C.F.R. § 90.2(a), notice is
`
`hereby given that Patent Owner Sanofi-Aventis Deutschland GmbH (“Sanofi”)
`
`appeals to the United States Court of Appeals for the Federal Circuit from the Final
`
`Written Decision (Paper No. 84) (the “Final Written Decision”), in IPR2018-
`
`01676, entered on May 29, 2020, by the United States Patent and Trademark
`
`Office, Patent Trial and Appeal Board (the “Board”), and from all orders,
`
`decisions, rulings, and opinions antecedent to the Final Written Decision. This
`
`appeal is timely under 35 U.S.C. § 142 and Rule 15(a)(1) of the Federal Rules of
`
`Appellate Procedure. A copy of the Final Written Decision is attached hereto as
`
`Exhibit A.
`
`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), Sanofi further indicates that
`
`the issues on appeal may include, but are not limited to, the Board’s determination
`
`that claims 11, 14, 15, 18, and 19 of U.S. Patent Number 8,603,044 B2 have been
`
`shown to be unpatentable under 35 U.S.C. § 103 in view of the grounds of
`
`unpatentability identified in the Board’s Final Written Decision, challenges to any
`
`findings supporting the determination, the Board’s failure to properly consider
`
`evidence of record, the Board’s legal and factual errors in undertaking the
`
`obviousness analysis, the Board’s failure to consider Sanofi’s arguments in support
`
`of patentability, the Board’s procedural errors including its failure to strike and/or
`
`exclude certain of Petitioner’s arguments and evidence and the Board’s failure to
`
`2
`
`
`
`provide Sanofi an opportunity to offer rebuttal argument and evidence, the Board’s
`
`findings that conflict with the evidence of record and are not supported by
`
`substantial evidence, the Board’s failure to provide Sanofi with sufficient due
`
`process, the Board’s failure to provide Sanofi with just compensation, the
`
`constitutionality of the Administrative Patent Judges, and other issues decided
`
`adversely to Sanofi.
`
`Simultaneous with this submission, a copy of this Notice of Appeal is being
`
`filed through the Patent Trial and Appeal Board End to End (“PTAB E2E”)
`
`System. In addition, a copy of the Notice of Appeal, along with the required
`
`docketing fee, is being filed with the Clerk of Court for the United States Court of
`
`Appeals for the Federal Circuit.
`
`3
`
`
`
`Dated: July 15, 2020
`
`Respectfully submitted,
`
`/Elizabeth Stotland Weiswasser/
`Elizabeth Stotland Weiswasser
`Reg. No. 55,721
`Anish R. Desai
`Reg. No. 73,760
`Sudip K. Kundu
`Reg. No. 74,193
`Anna Dwyer
`Admitted Pro Hac Vice
`Andrew Gesior
`Reg. No. 76,588
`Kathryn M. Kantha
`Reg. No. 70,371
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`Phone: 212-310-8000
`elizabeth.weiswasser@weil.com
`anish.desai@weil.com
`sudip.kundu@weil.com
`anna.dwyer@weil.com
`andrew.gesior@weil.com
`kathryn.kantha@weil.com
`
`Adrian C. Percer
`Reg. No. 46,986
`Weil, Gotshal & Manges LLP
`201 Redwood Shores Parkway
`Redwood Shores, CA 94065
`Phone: 650-802-3124
`adrian.percer@weil.com
`
`Robert T. Vlasis
`Admitted Pro Hac Vice
`William S. Ansley
`Reg. No. 67,828
`Matthew D. Sieger
`Reg. No. 76,051
`
`4
`
`
`
`Weil, Gotshal & Manges LLP
`2001 M Street NW, Ste. 600
`Washington, D.C. 20036
`Phone: 202-682-7000
`sutton.ansley@weil.com
`matthew.sieger@weil.com
`
`W. Karl Renner
`Reg No. 41,265
`John S. Goetz
`Reg. No. 54,867
`Joshua A. Griswold
`Reg. No. 46,310
`Matthew S. Colvin
`Reg. No. 66,843
`Kenneth W. Darby, Jr.
`Reg. No. 65,068
`Fish & Richardson P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Phone: 202-783-5070
`PTABInbound@fr.com
`
`5
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that, in addition to being filed electronically
`
`through the PTAB E2E System, the original version of Patent Owner Sanofi-
`
`Aventis Deutschland GmbH’s Notice of Appeal, has been sent via priority mail
`
`on July 15, 2020, to the Director of the United States Patent and Trademark
`
`Office, at the following address:
`
`Director of the United States Patent and Trademark Office
`c/o Office of the General Counsel
`United States Patent and Trademark Office
`Madison Building East, Room 10B20
`600 Dulany Street
`Alexandria, VA 22314-5793
`
`The undersigned also certified that a true and correct copy of Patent Owner
`
`Sanofi-Aventis Deutschland GmbH’s Notice of Appeal and the required filing fee
`
`were filed electronically via CM/ECF on July 15, 2020, with the Clerk of Court for
`
`the United States Court of Appeals for the Federal Circuit.
`
`The undersigned also certifies that a true and correct copy of Patent Owner
`
`Sanofi-Aventis Deutschland GmbH’s Notice of Appeal was served on July 15,
`
`2020, via electronic mail, upon the following counsel of record for Petitioners
`
`Mylan Pharmaceuticals Inc. and Pfizer Inc.:
`
`6
`
`
`
`Richard Torczon
`Wesley Derryberry
`Tasha Thomas
`Lora Green
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street NW, 5th Floor
`Washington, D.C. 20006
`rtorczon@wsgr.com
`wderryberry@wsgr.com
`tthomas@wsgr.com
`lgreen@wsgr.com
`
`Douglas H. Carsten
`Jeffrey W. Guise
`Arthur Dykhuis
`Elham F. Steiner
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real, Suite 200
`San Diego, CA 92130
`dcarsten@wsgr.com
`jguise@wsgr.com
`adykhuis@wsgr.com
`esteiner@wsgr.com
`
`Lorelei Westin
`WILSON SONSINI GOODRICH & ROSATI
`650 Page Mill Road
`Palo Alto, CA 94304
`lwestin@wsgr.com
`
`Nicole W. Stafford
`WILSON SONSINI GOODRICH & ROSATI
`900 South Capital of Texas Highway
`Las Climas IV, Fifth Floor
`Austin, TX 78746-5546
`nstafford@wsgr.com
`
`Jad Mills
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100
`
`7
`
`
`
`Seattle, WA 98104
`jmills@wsgr.com
`
`Jovial Wong
`Charles B. Klein
`WINSTON & STRAWN LLP
`1901 L Street, NW
`Washington, DC 20036
`jwong@winston.com
`cklein@winston.com
`
`Dan H. Hoang
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 6061-9703
`dhong@winston.com
`
`PfizerIPRs@winston.com
`
`Dated: July 15, 2020
`
`Respectfully submitted,
`
`/Timothy J. Andersen/
`Timothy J. Andersen
`Case Manager
`Weil Gotshal & Manges LLP
`2001 M Street, NW, Suite 600
`Washington, DC 20036
`timothy.andersen@weil.com
`
`8
`
`
`
`EXHIBIT A
`EXHIBIT A
`
`
`
`Paper 84
`Trials@uspto.gov
`571-272-7822 Entered: May 29, 2020
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`MYLAN PHARMACEUTICALS INC. and PFIZER INC.,
`Petitioner,
`
`v.
`
`
`
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`_____________
`
`IPR2018-01676
`Patent 8,603,044 B21
`_____________
`
`
`Before HYUN J. JUNG, BART A. GERSTENBLITH, and
`JAMES A. TARTAL, Administrative Patent Judges.
`
`GERSTENBLITH, Administrative Patent Judge.
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`Denying Petitioner’s Motion to Exclude
`35 U.S.C. § 318(a)
`
`
`
`
`1 Pfizer Inc. was joined as a petitioner in this proceeding.
`
`
`
`IPR2018-01676
`Patent 8,603,044 B2
`
`
`I.
`
`INTRODUCTION
`
`Background
`A.
`Mylan Pharmaceuticals Inc. (“Mylan”) filed a Petition (Paper 2,
`“Pet.”) requesting institution of an inter partes review of claims 11, 14, 15,
`18, and 19 of U.S. Patent No. 8,603,044 B2 (Ex. 1002, “the ’044 patent”).
`Sanofi-Aventis Deutschland GmbH (“Patent Owner”) filed a Preliminary
`Response (Paper 10). With prior authorization, Mylan filed a Reply to
`Patent Owner’s Preliminary Response (Paper 13) limited to 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 response (Paper 15).
`Applying the standard set forth in 35 U.S.C. § 314(a), we instituted an inter
`partes review of all challenged claims. Paper 20 (“Inst. Dec.”).
`After institution, Pfizer Inc. (“Pfizer”) filed (1) a petition challenging
`the same claims of the ’044 patent on the same grounds asserted by Mylan
`and instituted in this case and (2) a motion for joinder requesting that Pfizer
`be joined as a petitioner in this case. Pfizer Inc. v. Sanofi-Aventis
`Deutschland GmbH, IPR2019-00978, Papers 2 (Pfizer’s Petition), 3 (Pfizer’s
`Motion for Joinder) (May 2, 2019). For the same reasons set forth in our
`Institution Decision in this case, we instituted inter partes review on Pfizer’s
`petition and granted Pfizer’s motion for joinder. Id. at Paper 12 (Aug. 15,
`2019).2
`Patent Owner filed a Patent Owner Response (Paper 31, “PO Resp.”),
`Petitioner3 filed a Reply to Patent Owner’s Response (Paper 46, “Pet.
`Reply”), and Patent Owner filed a Sur-reply (Paper 56, “PO Sur-reply”).
`
`2 This decision is entered in the record in this case as Paper 41.
`3 We refer to Mylan and Pfizer, collectively, as “Petitioner.”
`
`
`
`2
`
`
`
`IPR2018-01676
`Patent 8,603,044 B2
`
`Petitioner filed a Motion to Exclude (Paper 64, “Mot.”), Patent Owner filed
`an Opposition to Petitioner’s Motion (Paper 65, “Opp.”), and Petitioner filed
`a Reply in support of its Motion (Paper 70, “Motion Reply” or “Mot.
`Reply”). Additionally, Patent Owner filed Observations on the Cross-
`Examination of Mr. Karl Leinsing (Paper 68) and Petitioner filed a Response
`to Patent Owner’s Observations (Paper 72). And, Petitioner filed
`Observations Regarding the Testimony of Alexander Slocum, Ph.D.
`(Paper 69), to which Patent Owner filed a Response (Paper 71). An oral
`hearing was held on January 15, 2020, and a copy of the transcript was
`entered in the record. Paper 78 (“Tr.”).
`We have jurisdiction pursuant to 35 U.S.C. § 6. This Decision is a
`Final Written Decision under 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73 as to
`the patentability of the claims on which we instituted trial. 35 U.S.C.
`§ 316(e); 37 C.F.R. § 42.1(d) (2017). Petitioner bears the burden of proving
`unpatentability of the challenged claims, and the burden of persuasion never
`shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must prove
`unpatentability by a preponderance of the evidence. See 35 U.S.C. § 316(e)
`(2012); 37 C.F.R. § 42.1(d). Having reviewed the arguments and the
`supporting evidence, we determine that Petitioner has shown, by a
`preponderance of the evidence, that challenged claims 11, 14, 15, 18, and 19
`of the ’044 patent are unpatentable. Additionally, for the reasons explained
`herein, we deny Petitioner’s motion to exclude.
`
`Related Proceedings
`B.
`The parties indicate that the ’044 patent was asserted in Sanofi-Aventis
`U.S. LLC v. Mylan GmbH, No. 2:17-cv-09105 (D.N.J.) (“Sanofi-9105”);
`
`
`
`3
`
`
`
`IPR2018-01676
`Patent 8,603,044 B2
`
`Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., No. 1:16-cv-
`00812 (D. Del.); Sanofi-Aventis U.S. LLC v. Eli Lilly and Co., No. 1:14-cv-
`00113 (D. Del.); Sanofi-Aventis U.S. LLC v. Eli Lilly and Co., No. 1:14-cv-
`00884 (D. Del.); and Sanofi-Aventis U.S. LLC v. Mylan GmbH, No. 1:17-cv-
`00181 (N.D. W.Va.). Paper 8, 2; Paper 9, 1–2; IPR2019-00978, Paper 2 at
`1–2, Paper 6 at 2.
`The same five claims—claims 11, 14, 15, 18, and 19—of the
`’044 patent also are challenged in IPR2018-01675.4 Paper 8, 2; Paper 9, 2.
`Patents related to the ’044 patent are challenged in IPR2018-01670,
`IPR2018-01677, IPR2018-01678, IPR2018-01679, IPR2018-01680,
`IPR2018-01682, IPR2018-01684, IPR2018-01696, IPR2019-00122, and
`IPR2019-00979. Paper 8, 2–3; Paper 9, 1–2; Pfizer, IPR2019-00978,
`Paper 6 at 2–4.
`
`Real Parties in Interest
`C.
`Mylan identifies Mylan Pharmaceuticals Inc., Mylan Inc., Mylan
`GmbH, Biocon Research Ltd., Biocon Ltd., and Becton, Dickinson and
`Company as real parties in interest. Paper 8, 2.
`Pfizer identifies itself and Hospira, Inc. as real parties in interest.
`Pfizer, IPR2019-00978, Paper 2 at 1.
`Patent Owner identifies Sanofi-Aventis Deutschland GmbH, Sanofi-
`Aventis U.S. LLC, and Sanofi Winthrop Industrie as real parties in interest.
`Paper 9, 1.
`
`
`4 Pfizer also challenged the ’044 patent in IPR2019-00978 and was joined
`subsequently as a petitioner to IPR2019-01676. Pfizer Inc. v. Sanofi-Aventis
`Deutschland GmbH, IPR2019-01676, Paper 41 (Aug. 15, 2019).
`
`
`
`4
`
`
`
`IPR2018-01676
`Patent 8,603,044 B2
`
`
`The Instituted Grounds of Unpatentability
`D.
`Petitioner asserts claims 11, 14, 15, 18, and 19 of the ’044 patent are
`unpatentable as set forth in the chart below:
`Claims Challenged
`35 U.S.C. §
`11, 14, 15, 18, 19
`103(a)
`11, 14, 15, 18, 19
`103(a)
`
`Reference(s)
`Steenfeldt-Jensen5
`Moller6 and Steenfeldt-Jensen
`
`Petitioner supports its challenge with two declarations by Karl R.
`Leinsing, dated September 9, 2018 (Ex. 1011, “the Leinsing Declaration”),
`and September 18, 2019 (Ex. 1095, “the Leinsing Reply Declaration”).7
`Patent Owner supports its arguments with a declaration by Alexander
`Slocum, Ph.D. (Ex. 2107) and a declaration by Dr. Robin S. Golan
`(Ex. 2111).
`
`The ’044 Patent
`E.
`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
`reproduced below.
`
`
`5 Exhibit 1014 (U.S. Patent No. 6,235,004 B1, issued May 22, 2001).
`6 Exhibit 1015 (U.S. Patent Application Pub. No. 2002/0052578 A1,
`published May 2, 2002).
`7 Petitioner filed a Declaration of Mr. William C. Biggs (Ex. 1049) and a
`Declaration of DeForest McDuff, Ph.D. (Ex. 1060), yet neither of these
`declarations includes this case number—IPR2018-01676—or the ’044 patent
`on the cover sheet. Accordingly, although we reference the declarations
`here, it appears that they do not address the issues before us in this
`proceeding.
`
`
`
`
`5
`
`
`
`IPR2018-01676
`Patent 8,603,044 B2
`
`
`
`Figure 1 “shows a sectional view of a pen-type injector . . . in a first,
`cartridge full, position,” and Figure 2 “shows a sectional view of the pen-
`type injector of FIG. 1 in a second, maximum first dose dialed, position.”
`Id. at 2:53–57. The pen-type injector includes first cartridge retaining part 2
`and second main housing part 4.8 Id. at 3:27–28. Insert 16 is at a first end of
`housing part 4 and is fixed rotationally and axially to main housing 4. Id.
`at 3:49–51. Insert 16 includes threaded circular opening 18, through which
`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 3:56–58.
`
`
`8 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”).
`
`
`
`6
`
`
`
`IPR2018-01676
`Patent 8,603,044 B2
`
`
`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
`rod 20, and second thread 24 of piston rod 20 engages internal helical
`groove 38 of drive sleeve 30. Id. at 3:61–62, 4:4, 4:13–14.
`Clutch or clutch means 60 is disposed about drive sleeve 30 adjacent
`its second end. Id. at 4:33–35, 4:49–50. Clutch 60 is keyed to drive
`sleeve 30 by splines to prevent relative rotation between clutch 60 and drive
`sleeve 30. Id. at 4:60–62. Clutch 60 also has teeth 66 that engage dose-dial
`sleeve 70. Id. at 4:50–52.
`Dose dial sleeve 70 is outside of clutch 60 but within main housing 4.
`Id. at 5:3–5. Dose dial sleeve 70 has helical groove 74 on its outer surface,
`and helical rib 46 of housing 4 is seated in helical groove 70. Id. at 5:5–6,
`5:9–11. Dose dial grip 76 is disposed about and secured to the second end
`of dose dial sleeve 70. Id. at 5:24–25, 5:27–28.
`In operation, a user rotates dose dial grip 76 to set a dose and cause
`dose-dial 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 turning dose dial grip 76 in the opposite direction. Id. at 6:19–20,
`Fig. 10. The user then presses button 82, which causes clutch 60 to
`disengage from dose dial sleeve 70 so that clutch 60 moves axially and dose
`dial sleeve 70 rotates back into main housing 4. Id. at 6:28–35, 6:38–40,
`Fig. 11. Drive sleeve 30 also moves axially and causes piston rod 20 to
`rotate through threaded opening 18 to dispense medicine from cartridge 8.
`Id. at 6:44–46.
`
`
`
`7
`
`
`
`IPR2018-01676
`Patent 8,603,044 B2
`
`
`Illustrative Claim
`F.
`Claim 11, the sole independent claim challenged in this proceeding, is
`illustrative of the claimed subject matter and reproduced below:
`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,
`
`extends
`sleeve
`dial
`dose
`said
`wherein
`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.
`Ex. 1002, 8:7–36.
`
`II. ANALYSIS
`Level of Ordinary Skill in the Art
`A.
`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
`
`
`
`8
`
`
`
`IPR2018-01676
`Patent 8,603,044 B2
`
`degree, and three-year’s experience”9 and would have “understood the
`basics of medical-device design and manufacturing, and the basic
`mechanical elements (e.g., gears, pistons) in drug-delivery devices.”10
`Pet. 14 (citing Ex. 1011 ¶ 104–06). In our Institution Decision, we found
`that Petitioner’s proposal was consistent with the level of ordinary skill in
`the art reflected by the prior art of record and we preliminarily adopted
`Petitioner’s unopposed position. Inst. Dec. 13 (citing Okajima v. Bourdeau,
`261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579
`(Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978)).
`In its Response, Patent Owner contends that one of ordinary skill in
`the art would have “a bachelor’s degree in mechanical engineering or an
`equivalent degree.” PO Resp. 12 (citing Ex. 2107 ¶ 102). Patent Owner
`contends that additional experience beyond the bachelor’s degree is not
`required. Id. at 13. In particular, Patent Owner asserts that Petitioner
`proposes inconsistent levels of skill across related cases, including that one
`of ordinary skill “would have had ‘design experience,’ ‘approximately three
`years of experience in medical-device design,’ or ‘three-year’s experience’
`depending on the petition.” Id. (citations omitted). Patent Owner further
`contends that “Mr. Leinsing testified that three years of experience is not
`
`
`9 Mr. Leinsing testifies the three years of practical experience would have
`been “with medical device design and manufacturing.” Ex. 1011 ¶ 106.
`10 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.
`
`
`
`9
`
`
`
`IPR2018-01676
`Patent 8,603,044 B2
`
`required.” Id.11 Patent Owner contends that what is important is that the
`level of skill include someone “who understands the mechanical elements
`(e.g., lead screws, clutches, gears) used in drug injection delivery devices as
`well as the principles governing the interactions of such mechanical
`elements, and further understands the basics of device design and
`manufacturing.” Id. at 12. Nonetheless, Patent Owner asserts that “the
`slight differences between Patent Owner and Petitioner’s level of ordinary
`skill do not affect the arguments” in this case. Id. at 13.
`We see no reason to disturb our preliminary finding regarding the
`level of ordinary skill in the art. Accordingly we maintain and reaffirm that
`one of ordinary skill in the art “would have ‘had at least a bachelor’s degree
`in mechanical engineering, or an equivalent degree, and approximately three
`year’s experience’” and “would have ‘understood the basics of medical-
`device design and manufacturing, and the basic mechanical elements (e.g.,
`gears, pistons) in drug-delivery devices.’” Inst. Dec. 12–13 (quoting
`Pet. 14). We also find that the outcome of this case is not dependent upon
`whether we adopt Petitioner’s or Patent Owner’s proposed level of skill.
`
`Claim Construction
`B.
`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)
`
`
`11 Patent Owner does not provide a citation to where Mr. Leinsing so
`testified.
`
`
`
`10
`
`
`
`IPR2018-01676
`Patent 8,603,044 B2
`
`(2017);12 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.,
`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
`patentee disavows the full scope of a claim term either in the specification or
`during prosecution.” Uship Intellectual Props., LLC v. United States, 714
`F.3d 1311, 1313 (Fed. Cir. 2013) (quoting Thorner v. Sony Comput. 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 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) (holding that “only those terms need be construed that
`are in controversy, and only to the extent necessary to resolve the
`controversy”); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co.
`
`
`12 An 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) (codified at 37 C.F.R.
`§ 42.100(b) (2019)).
`
`
`
`11
`
`
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`Patent 8,603,044 B2
`
`Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the
`context of an inter partes review).
`Petitioner provides interpretations of five terms that were proffered by
`Patent Owner in related litigation—“drive sleeve,” “main housing,” “piston
`rod,” “threading,” and “tubular clutch.” Pet. 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
`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.
`In our Institution Decision, we determined that none of the terms
`required an express construction for the purposes of determining whether
`Petitioner demonstrates a reasonable likelihood of prevailing in its
`challenged. Inst. Dec. 17.
`In its Response, Patent Owner agrees with our preliminary
`determination from the Institution Decision, arguing that “no express
`constructions are required.” PO Resp. 12. Petitioner does not contend
`otherwise in its Reply.
`Accordingly, we maintain and reiterate our preliminary determination
`that no claim terms require express construction to address the issues raised
`in this proceeding. Vivid Techs., 200 F.3d at 803.
`
`Legal Standards – Obviousness
`C.
`The U.S. Supreme Court set forth the framework for applying the
`statutory language of 35 U.S.C. § 103 in Graham v. John Deere Co. of
`Kansas City, 383 U.S. 1, 17–18 (1966):
`
`
`
`12
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`
`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.:
`
`Often, it will be necessary for a court to look to interrelated
`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 U.S. 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). “[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
`
`
`
`13
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`IPR2018-01676
`Patent 8,603,044 B2
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`Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063,
`1068–69 (Fed. Cir. 2012)).
`
`D. Obviousness over Steenfeldt-Jensen
`1.
`Level of Ordinary Skill in the Art
`As discussed above, we find that one of ordinary skill in the art at the
`time of the invention “would have had at least a bachelor’s degree in
`mechanical engineering, or an equivalent degree, and approximately three
`year’s experience” and “would have understood the basics of medical-device
`design and manufacturing, and the basic mechanical elements (e.g., gears,
`pistons) in drug-delivery devices.” See supra § II.A.
`
`Scope and Content of the Prior Art – Steenfeldt-Jensen
`2.
`Steenfeldt-Jensen “relates to injection syringes of the kind
`apportioning set doses of a medicine from a cartridge containing an amount
`of medicine sufficient for the preparation of a number of therapeutic doses”
`Ex. 1014, 1:12–15. Figures 15–17 of Steenfeldt-Jensen are reproduced
`below.
`
`
`
`14
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`
`
`Figures 15 and 16 show side sectional views of a syringe, and
`Figure 17 shows an exploded view of the syringe of Figures 15 and 16. Id.
`at 5:23–28. The syringe of Steenfeldt-Jensen includes tubular housing 1 that
`is partitioned so that a first division has ampoule holder 2. Id. at 5:38–40;
`see also id. at 14:11(reciting in claim 11 “a housing having proximal and
`distal ends”).
`“The end of the ampoule holder 2 inserted in the housing 1 is closed
`by a wall 4 having a central bore with an internal thread 5” and “piston rod 6
`having an external thread 7 mating the thread 5 of said bore extends through
`
`
`
`15
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`said bore.” Id. at 5:55–58. Driver tube 85 is disposed about piston rod 6.
`See id. at Figs. 15–17. “[E]nd wall 4 with the internal thread 5 is provided in
`a separate member 40 which is mounted in an end of the housing.” Id. at
`8:35–38.
`“To maintain a clockwise rotation of a dose setting button for
`increasing the set dose the pawl mechanism working between the driver tube
`and the housing . . . bars clockwise rotation . . . of the driver tube.” Id.
`at 11:6–11. The “thread of the piston rod and the thread in the end wall of
`the housing [are] so designed that an anticlockwise rotation of the piston will
`screw the piston rod through said end wall and into the cartridge holder
`compartment,” and “[t]he 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 11:11–19.
`Within housing 1 is scale drum 80, and “scale drum 80 is in its outer
`wall provided with a helical track which is engaged by a helical rib 16 along
`the inner wall of the housing 1.” Id. at 11:20–22. “At its proximal end the
`scale drum 80 has a diameter exceeding the inner diameter of the housing to
`form a dose setting button 81 which on its cylindrical outer wall is knurled
`to ensure a good finger grip,” Id. at 11:22–25.
`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 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 11:49–51.
`“When a dose is set by rotating the dose setting button 81 in a
`clockwise direction, the scale drum is screwed out of the housing and the
`
`
`
`16
`
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`IPR2018-01676
`Patent 8,603,044 B2
`
`dose setting button is lifted away from the proximal end of the housing.” Id.
`at 11:52–54. “[I]f a set dose is reduced by rotating the dose setting
`button 81 in an anticlockwise direction the pawl mechanism working
`between the driver tube and the housing . . . prevent[s] the bushing 82 from
`following this anticlockwise rotation.” Id. at 11:57–62.
`“When the injection button 88 is pressed to inject the set dose,” “the
`thread engagement between the helical track of the scale drum 80 and the
`rib 16 in the housing when the scale drum 80 is pressed back into said
`housing” induces “anticlockwise rotation of the dose setting button 81,” and
`bushing 82 follows that rotation. Id. at 12:4–9. “The bushing will rotate the
`driver tube 85 in an anticlockwise direction which the pawl mechanism
`reluctantly allows,” and “the piston rod is thereby screwed further into an
`ampoule 89 in the ampoule holder 2.” Id. at 12:9–12.
`
`Differences Between the Prior Art and the Claims;
`3.
`Motivation to Modify
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