Paper 91
`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.
`_____________
`
`IPR2018-01675
`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.
`
`
`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.
`_____________
`
`IPR2018-01675
`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.
`
`
`
`IPR2018-01675
`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 12). With prior authorization, Mylan filed a Reply to
`Patent Owner’s Preliminary Response (Paper 16) 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 19).
`Also with prior authorization, Mylan filed a Motion to Correct the Petition
`(Paper 15) and Patent Owner filed an Opposition to the Motion (Paper 18).
`We granted Mylan’s Motion to Correct (Paper 21), resulting in a citation
`change on page 25 of the Petition, which is shown in Exhibit 1037.2 We
`also granted Patent Owner’s request to file an Amended Preliminary
`Response, which Patent Owner filed as Paper 23, to respond to the corrected
`citation in the Petition. Paper 21, 4. Applying the standard set forth in 35
`U.S.C. § 314(a), we instituted an inter partes review of all challenged
`claims. Paper 28 (“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
`
`
`2 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.
`
`
`
`2
`
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`
`IPR2018-01675
`Patent 8,603,044 B2
`
`be joined as a petitioner in this case. Pfizer Inc. v. Sanofi-Aventis
`Deutschland GmbH, IPR2019-00977, 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).3
`Patent Owner filed a Patent Owner Response (Paper 38, “PO Resp.”),
`Petitioner4 filed a Reply to Patent Owner’s Response (Paper 53, “Pet.
`Reply”), and Patent Owner filed a Sur-reply (Paper 65, “PO Sur-reply”).
`With prior authorization, Patent Owner filed a List of Improper Reply
`Arguments that Patent Owner asserts exceed the scope of a reply under 37
`C.F.R. §§ 42.22 and 42.23 (Paper 63), and Petitioner filed a Response to
`Patent Owner’s List (Paper 64). Petitioner also filed a Motion to Exclude
`(Paper 71, “Mot.”), Patent Owner filed an Opposition to Petitioner’s Motion
`(Paper 72, “Opp.”), and Petitioner filed a Reply in support of its Motion
`(Paper 77, “Motion Reply” or “Mot. Reply”). Additionally, Patent Owner
`filed Observations on the Cross-Examination of Mr. Karl Leinsing
`(Paper 75) and Petitioner filed a Response to Patent Owner’s Observations
`(Paper 79). And, Petitioner filed Observations Regarding the Testimony of
`Alexander Slocum, Ph.D. (Paper 76), to which Patent Owner filed a
`Response (Paper 78). An oral hearing was held on January 15, 2020, and a
`copy of the transcript was entered in the record. Paper 85 (“Tr.”).
`
`
`3 This decision is entered in the record in this case as Paper 48.
`4 We refer to Mylan and Pfizer, collectively, as “Petitioner.”
`
`
`
`3
`
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`Patent 8,603,044 B2
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`
`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”);
`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 10, 2; Paper 11, 2–3; IPR2019-00977, Paper 2
`at 1–2, Paper 6 at 2.
`
`
`
`4
`
`
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`IPR2018-01675
`Patent 8,603,044 B2
`
`
`The parties state that the ’044 patent also is challenged in IPR2018-
`01676.5 Paper 10, 2; Paper 11, 3. The parties also state that 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 10, 2–3; Paper 11, 2–3; Pfizer, IPR2019-00977, 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 10, 2.
`Pfizer identifies itself and Hospira, Inc. as real parties in interest.
`Pfizer, IPR2019-00977, 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 11, 2.
`
`The Instituted Ground 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)
`
`Reference
`Burroughs6
`
`
`5 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).
`6 Exhibit 1013 (US 6,221,046 B1, iss. Apr. 24, 2001 (“Burroughs”)).
`
`
`
`5
`
`
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`IPR2018-01675
`Patent 8,603,044 B2
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`
`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”), and a
`declaration by Dr. William C. Biggs (Ex. 1049).
`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.
`
`
`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-
`
`
`
`6
`
`
`
`IPR2018-01675
`Patent 8,603,044 B2
`
`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 4.7 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.
`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
`
`
`7 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”).
`
`
`
`7
`
`
`
`IPR2018-01675
`Patent 8,603,044 B2
`
`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.
`
`Illustrative Claim
`F.
`Claim 11, the sole independent claim challenged in this proceeding, is
`illustratve 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,
`
`wherein said dose dial sleeve extends
`circumferentially around at least a portion of said tubular
`
`
`
`8
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`
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`IPR2018-01675
`Patent 8,603,044 B2
`
`
`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
`degree, and approximately three years of experience in medical-device
`design” and “would have understood the basics of medical-device design
`and manufacturing, and the basic mechanical elements (e.g., gears, pistons)
`involved in drug-delivery devices.” Pet. 14 (citing Ex. 1011 ¶ 104). 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. 8. Patent Owner contends that additional
`experience beyond the bachelor’s degree is not required. Id. at 9. 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
`
`
`
`9
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`
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`IPR2018-01675
`Patent 8,603,044 B2
`
`petition.” Id. at 8–9 (citations omitted). Patent Owner further contends that
`“Mr. Leinsing testified that three years of experience is not required.” Id.
`at 9.8 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 8.
`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 9.
`In its Reply, Petitioner agrees with our preliminary finding from the
`Institution Decision that the art of record reflects the level of ordinary skill
`in the art. Pet. Reply 2. Petitioner also acknowledges that Patent Owner
`concedes that any differences in the level of ordinary skill proposed by the
`parties do not affect the outcome of this case. Id. at 1–2.
`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
`years of experience in medical-device design” and “would have understood
`the basics of medical-device design and manufacturing, and the basic
`mechanical elements (e.g., gears, pistons) involved in drug-delivery
`devices.” Inst. Dec. 12–13 (quoting Pet. 14). We also find that the outcome
`
`
`8 Patent Owner does not provide a citation to where Mr. Leinsing so
`testified.
`
`
`
`10
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`
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`IPR2018-01675
`Patent 8,603,044 B2
`
`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)
`(2017);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.,
`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
`
`
`9 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) (now codified at 37 C.F.R.
`§ 42.100(b) (2019)).
`
`
`
`11
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`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.
`Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the
`context of an inter partes review).
`Petitioner provides interpretations of six terms that were proffered by
`Patent Owner in related litigation—“drive sleeve,” “main housing,” “piston
`rod,” “threading,” “tubular clutch,” and “clicker.” Pet. 15–17 (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
`(Mylan’s Preliminary Claim Constructions in Sanofi-9105), 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 contends the only term that
`requires construction is “tubular clutch,” although Patent Owner also
`
`
`
`12
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`contests Petitioner’s assertion that “clicker” should be construed as a means-
`plus-function limitation. PO Resp. 10, 13.10
`
`“tubular clutch”
`1.
`Petitioner contends “tubular clutch” is “[a] tubular structure that
`couples and decouples a moveable component from another component.”
`Pet. 16. Petitioner acknowledges that in related litigation, Mylan “proffered
`[a] preliminary means-plus-function construction[] for ‘tubular clutch,’”
`where the functions are “that, during dose setting, it ‘clutch[es], i.e.,
`coupling and decoupling a moveable component from another component,’
`or it ‘operates to reversibly lock two components in rotation.’” Id. (citing
`Ex. 1028, 56). In that case, Petitioner identified the structure in the
`’044 patent that corresponds to those functions as “component 60.” Id.
`(citations omitted).
`Patent Owner contends that the plain and ordinary meaning of
`“clutch” is “a component that can operate to reversibly lock two components
`in rotation.” PO Resp. 12 (citing Ex. 2165 (Opinion and Order (D.I. 319)
`construing claim terms in Sanofi-9105, filed May 9, 2019), 13). Patent
`Owner asserts that this is the construction adopted by the district court in
`
`
`10 We decline to opine on the term “clicker” because resolving the parties’
`apparent dispute as to whether the term invokes 35 U.S.C. § 112, ¶ 6, is not
`necessary to resolve any controversy presented in this case. 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).
`
`
`
`13
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`Sanofi-9105.11 Id. Patent Owner contends that, in construing the term, the
`district court disagreed with Mylan’s proposed construction. Id. (citing
`Ex. 2165, 10–11).
`In its Reply, Petitioner asserts that the Delaware court’s construction
`and Patent Owner’s proposed construction in New Jersey (i.e., “a tubular
`structure that couples and decouples a moveable component from another
`component”) are evidence of the reasonable scope of the limitation. Pet.
`Reply 4. Thus, Petitioner contends “[t]he broadest reasonable interpretation
`. . . would at least encompass both of these constructions absent a showing
`that either construction is unreasonable.” Id.
`In its Sur-reply, Patent Owner contends that the plain and ordinary
`meaning (i.e., “a component that can operate to reversibly lock two
`components in rotation”) should apply because there has been no express
`disavowal of claim scope and the Specification does not contain a
`lexicographic definition. PO Sur-reply 3. Patent Owner asserts that
`Petitioner thus lacks evidence to support any other construction. Id.
`
`
`11 “Tubular clutch” was construed by two different district courts. In Sanofi-
`9105, the U.S. District Court for the District of New Jersey, construed the
`term to mean “a component that can operate to reversibly lock two
`components in rotation.” Ex. 2165, 13. Previously, in Sanofi-Aventis U.S.
`LLC v. Eli Lilly & Co., 14-cv-113 (RGA) (D. Del.), the U.S. District Court
`for the District of Delaware construed “tubular clutch” to mean “a structure
`that couples and decouples a moveable component from another
`component.” See Ex. 2165, 10 (referring to the Delaware court’s
`construction).
`
`
`
`14
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`
`Although we are persuaded that “tubular clutch” does not invoke
`§ 112, ¶ 6,12 we need not decide which party’s proposed construction is the
`broadest reasonable construction because under either construction—“a
`tubular structure that couples and decouples a moveable component from
`another component” or “a component that can operate to reversibly lock two
`components in rotation”—we find that Petitioner sufficiently establishes that
`Burroughs discloses a “tubular clutch,” for the reasons discussed below. See
`infra § II.C.3.a.vii.
`Accordingly, we determine that no claim terms require express
`construction beyond the discussion above. 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):
`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.
`
`
`12 Petitioner fails to present any evidence or argument to overcome the
`presumption that “tubular clutch,” which does not recite the word “means,”
`is not a means-plus-function limitation. See Williamson v. Citrix Online,
`LLC, 792 F.3d 1339, 1349 (Fed. Cir. 2015) (when a claim limitation does
`not include the word “means,” there is a presumption that the term is not a
`means-plus-function limitation and § 112, ¶ 6 does not apply).
`
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`15
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`Patent 8,603,044 B2
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`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
`Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063,
`1068–69 (Fed. Cir. 2012)).
`
`Level of Ordinary Skill in the Art
`1.
`As discussed supra, 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
`
`
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`IPR2018-01675
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`
`years of experience in medical-device design” and “would have understood
`the basics of medical-device design and manufacturing, and the basic
`mechanical elements (e.g., gears, pistons) involved in drug-delivery
`devices.” See supra § II.A.
`
`Scope and Content of the Prior Art – Burroughs
`2.
`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
`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 the commencement of the dosing process.”
`Id. at 8:33–36, 8:62–9:1, Figs. 3, 5. “As a dosage is being set, outwardly
`extending threads 110 and 112 of dial mechanism 34 ride in helical
`groove 158 of housing parts 24 and 26.” Id. at 10:60–63.
`
`
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`17
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`IPR2018-01675
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`
`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 10:5–9.
`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.
`
`Differences Between the Prior Art and the Claims;
`3.
`Motivation to Modify
`
`
`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 declarant testimony. Id.
`
`a.
`
`Independent Claim 11
`i. “A housing part for a medication dispensing
`apparatus, said housing part comprising:”
`Petitioner contends that, “[t]o the extent the preamble of claim 11 is
`limiting, Burroughs” teaches “injection medication device 20 for dispensing
`medicine,” including “mechanical housing 22 containing the device’s drive
`mechanism.” Pet. 20–21 (citing Ex. 1013, Abs., 7:15–19, Fig. 1; Ex. 1011
`¶ 156). Patent Owner does not contest Petitioner’s argument that Burroughs
`teaches the preamble of claim 11.
`
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`For the reasons explained by Petitioner above, which we expressly
`adopt, we find that Petitioner has shown that Burroughs teaches the
`preamble of claim 11.13
`
`ii. “a main housing, said main housing extending
`from a distal end to a proximal end;”
`Petitioner contends that Burroughs teaches this limitation of claim 11
`by disclosing “mechanism housing 22,” which “includes a first part 24 and a
`second part 26 that are secured together to house the drive mechanism.”
`Pet. 23 (citing Ex. 1013, 7:18–20, Figs. 1, 2, 3, 5; Ex. 1011 ¶ 158).
`Petitioner asserts that “the mechanism housing 22 extends from a button-end
`(referred to as the proximal end) to a needle-end (referred to as the distal
`end),” as shown in Figure 1 of Burroughs. Id. (citing Ex. 1013, 7:9–13;
`Ex. 1011 ¶ 160). Patent Owner does not contest Petitioner’s argument that
`Burroughs teaches this limitation of claim 11.
`For the reasons explained by Petitioner above, which we expressly
`adopt, we find that Petitioner has shown that Burroughs teaches the main
`housing limitation of claim 11, as recited above.14
`
`
`13 We need not determine whether the preamble of claim 11 is limiting as the
`parties have not raised that issue before us. Nonetheless, Patent Owner has
`waived any argument for patentability directed to the preamble of claim 11.
`See Paper 29 (Scheduling Order), 8 (“Patent Owner is cautioned that any
`arguments for patentability not raised in the response may be deemed
`waived.”).
`14 Additionally, we find that Patent Owner has waived any argument for
`patentability directed to this limitation of claim 11. See Paper 29, 8.
`
`
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`
`iii. “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;”
`Petitioner contends Burroughs teaches a dose dial sleeve, except that
`Burroughs’s sleeve includes helical threads along its outer surface as
`opposed to a helical groove, as recited above. Pet. 25–26. In particular,
`Petitioner asserts dial mechanism 34 of Burroughs teaches the recited dose
`dial sleeve. Pet. 25 (citing Ex. 1013, 7:31–32, Fig. 2; Ex. 1011 ¶¶ 162–165).
`Petitioner argues that Burroughs’s dial mechanism 34 “is positioned within
`housing 22, and includes, on its outer surface, threads 110, 112.” Id. (citing
`Ex. 1013, 7:65–67, 8:33–36, Figs. 1, 2, 6–9; Ex. 1011 ¶ 166). Petitioner
`contends threads 110, 112 of dial mechanism 34 “are configured to
`releasably engage a helical spiral groove 158 provided on an inner surface of
`the housing 22.” Id. (citing Ex. 1013, 8:62–9:1, Figs. 1–3, 5–9; Ex. 1011
`¶ 167).
`Petitioner asserts “[t]hreads 110, 112 are rib-like structures that fit
`into and move within helical spiral groove 158 of the housing parts 24, 26 to
`allow the dial mechanism to rotate and move axially away from the needle-
`end of the housing during the dose-setting phase.” Id. (citing Ex. 1013,
`Figs. 6–9; Ex. 1011 ¶ 164). R
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