Trials@uspto.gov
`571-272-7822
`
`Paper 84
`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 US. C. § 318(a)
`
`‘ Pfizer Inc. was joined as a petitioner in this proceeding.
`
`

`

`IPR201 8-01676
`
`Patent 8,603,044 B2
`
`I.
`
`INTRODUCTION
`
`A.
`
`Background
`
`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 US. 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.”
`
`

`

`[PR201 8-01676
`
`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 (“TL”).
`
`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 CPR. § 42.73 as to
`
`the patentability of the claims on which we instituted trial. 35 U.S.C.
`
`§ 316(e); 37 CPR. § 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 ’1 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 CPR. § 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.
`
`B.
`
`Related Proceedings
`
`The parties indicate that the ’044 patent was asserted in Sanofi-Aventis
`
`US. LLC v. Mylan GmbH, No. 2:17-cv-09105 (D.N.J.) (“SanOfi-9105”);
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`Sanofi-Aventis US. LLC v. Merck Sharp & Dohme Corp, No. 1:16-cv-
`
`00812 (D. Del.); Sanofi-Aventis US. LLC v. Eli Lilly and Co., No. 1:14-cv—
`
`00113 (D. Del.); Sanofi-Aventis US. LLC v. Eli Lilly and Co, No. 1:14-cv-
`
`00884 (D. Del.); and Sanofi-Aventis US. 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, [PR2018-01679, IPR2018-01680,
`
`[PR2018-01682, IPR2018-01684, IPR2018-01696, IPR2019-00122, and
`
`[PR2019-00979. Paper 8, 2—3; Paper 9, 1—2; Pfizer, IPR2019-00978,
`
`Paper 6 at 2—4.
`
`'
`
`C.
`
`Real Parties in Interest
`
`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 US. 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-Ol676, Paper 41 (Aug. 15, 2019).
`
`

`

`IPR201 8—01676
`
`Patent 8,603,044 BZ
`
`D.
`
`The Instituted Grounds of Unpatentability
`
`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. §
`
`Reference(s)
`
`11, 14, 15, 18, 19
`
`11, 14, 15, 18, 19
`
`103(a)
`
`103(a)
`
`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).
`
`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
`
`reproduced below.
`
`5 Exhibit 1014 (U.S. Patent No. 6,235,004 B1, issued May 22, 2001).
`
`6 Exhibit 1015 (US. 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.
`'
`
`

`

`IPR20 1 8-0 1676
`
`Patent 8,603,044 B2
`
`
`
`FIG. 1
`
`FIG. 2
`
`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 3249—5 1. 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 3 256—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”).
`
`

`

`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 ofdrive 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 525—6,
`
`5:9—1 1. 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.
`
`

`

`IPR20 l 8-01676
`
`Patent 8,603,044 B2
`
`F.
`
`Illustrative Claim
`
`Claim 11, the sole independent claim challenged in this proceeding, is
`
`illustrative of the claimed subject matter and reproduced below:
`
`1 1. 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
`
`grlp9
`
`wherein
`
`said
`
`dose
`
`dial
`
`sleeve
`
`extends
`
`circumferentially around at least a portion of said tubular
`clutch, and wherein said helical groove of the dose dial
`sleeve has a first lead and said internal threading of said
`drive sleeve has a second lead, and wherein said first lead
`and said second lead are different.
`
`EX. 1002, 8:7—36.
`
`II.
`
`ANALYSIS
`
`A.
`
`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
`
`

`

`IPR201 8—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.”lo
`
`Pet. 14 (citing Ex. 1011 11 104—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 GPACInc., 57 F.3d 1573, 1579
`
`(Fed. Cir. 1995); In re OeIrich, 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 11 102). 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 1] 106.
`
`'0 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.
`
`

`

`IPR201 8-0 1676
`
`Patent 8,603,044 B2
`
`required.” Id. ” 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.
`
`B.
`
`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 CPR. § 42.100(b)
`
`” Patent Owner does not provide a citation to where Mr. Leinsing so
`testified.
`
`10
`
`

`

`IPR20 1 8-01 676
`
`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.
`
`‘2 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
`CPR. § 42.100(b) effective Nov. 13, 2018) (codified at 37 C.F.R.
`§ 42.100(b) (2019)).
`
`11
`
`

`

`IPR201 8-01676
`
`Patent 8,603,044 B2
`
`Mata], 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
`,, 6‘
`’9 “ '
`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.
`
`C.
`
`Legal Standards — 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 Co. of
`
`Kansas City, 383 US. 1, 17—18 (1966):
`
`12
`
`

`

`IPR20 1 8-01676
`
`Patent 8,603,044 B2
`
`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 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). “[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
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`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 § HA.
`
`2.
`
`Scope and Content of the Prior Art — Steenfeldt—Jensen
`
`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
`
`

`

`IPR201 8-0 1676
`
`Patent 8,603,044 B2
`
`
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`F615 Fl 16 F1617
`
`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 5:3 8—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
`
`
`
`
`
`
`
`
`
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`said bore.” Id. at 5255—5 8. 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 :3 5—3 8.
`
`“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—1 1. 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—5 1.
`
`“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
`
`

`

`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.” 1d. 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 1224—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.
`
`3.
`
`Diflerences Between the Prior Art and the Claims;
`Motivation to Modifi/
`
`Petitioner argues that “Steenfeldt—Jensen disclosed a single device
`
`comprising all claim 11 components, including the same structural
`
`limitations.” Pet. 21. Petitioner contends that “[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. Patent Owner disagrees.
`
`For the reasons below, we determine that Steenfeldt—Jensen teaches or
`
`suggests the limitations of claim 11 and that one of ordinary skill in the art
`
`would have had a reason to make Petitioner’s proposed modification with a
`
`reasonable expectation of success.
`
`17
`
`

`

`IPR20 1 8-01676
`
`Patent 8,603,044 B2
`
`a.
`
`Independent Claim 1 I
`
`i.
`
`“A housing partfor a medication dispensing
`apparatus, said housing part comprising: ”
`
`Petitioner contends that “[i]f the preamble is limiting, Steenfeldt-
`
`Jensen taught it.” Pet. 21. In particular, Petitioner asserts that “Steenfeldt-
`
`Jensen describes a medicine—dispensing syringe,” which “includes tubular
`
`housing 1.” Id. at 22 (citing Ex. 1014, 1:12—15, 5:38—44, Figs. 15—17;
`
`Ex. 1011 1111 261—263). Pointing to Figures 15 and 16 of Steenfeldt-Jensen,
`
`Petitioner argues that “tubular housing 1 holds the drive mechanism for
`
`dispensing medicine from the syringe.” Id. (citing Ex. 1011 1] 261). Patent
`
`Owner does not contest Petitioner’s argument that Steenfeldt—Jensen teaches
`
`the preamble of claim 11.
`
`For the reasons explained by Petitioner above, which we expressly
`
`adopt, we find that Petitioner has shown that Steenfeldt—Jensen teaches the
`
`preamble of claim 11.‘3
`
`ii.
`
`“a main housing, said main housing extending
`from, a distal end to a proximal end; ”
`
`Petitioner contends that Steenfeldt-Jensen teaches this limitation of
`
`claim 11 by disclosing “housing 1,” which “extends from button-end
`
`(proximal end) to needle-end (distal end) of the syringe.” Pet. 23 (citing
`
`Ex. 1011 11 263). Patent Owner does not contest Petitioner’s argument that
`
`Steenfeldt-Jensen teaches this limitation of claim 11.
`
`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 21 (Scheduling Order), 8 (“Patent Owner is cautioned that any
`arguments for patentability not raised in the response may be deemed
`waived”).
`
`18
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`For the reasons explained by Petitioner above, which we expressly
`
`adopt, we find that Petitioner has shown that Steenfeldt-Jensen teaches the
`
`main housing limitation of claim 11, recited above.14
`
`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
`ofsaid dose dial sleeve; ”
`
`Petitioner contends that Steenfeldt-Jensen’s scale drum 80 teaches the
`
`recited dose-dial sleeve of claim 11. Pet. 25 (citing Ex. 1014, 11:20—22).
`
`Pointing to Figures 15 and 16 of Steenfeldt—Jensen, Petitioner asserts that
`
`drum 80 is within housing 1. Id. (citing Ex. 1014, Figs. 15, 16; Ex. 1011
`
`111] 264—265). Petitioner argues that “[t]he drum includes a ‘helical groove
`
`provided along an outer surface’ as a helical track, extending along the
`
`drum’s outer wall,” and that the “helical track is ‘configured to engage a
`
`threading provided by’ housing 1 via helical rib 16, which extends along
`
`housing 1’s inner wall.” Id. at 25—26 (citing Ex. 1014, 11:20—22, Figs. 16,
`
`(17; Ex. 1011 1111 264—265). Patent Owner does not contest Petitioner’s
`
`argument that Steenfeldt—Jensen teaches this limitation of claim 11.
`
`For the reasons explained by Petitioner above, which we expressly
`
`adopt, we find that Petitioner has shown that Steenfeldt—Jensen teaches the
`
`dose dial sleeve limitation of claim 11, recited above.15
`
`14 Additionally, we find that Patent Owner has waived any argument for
`patentability directed to this limitation of claim 11. See Paper 21, 8.
`
`‘5 Additionally, we find that Patent Owner has waived any argument for
`patentability directed to this limitation of claim 11. See Paper 21, 8.
`
`19
`
`

`

`IPR201 8-01676
`
`Patent 8,603,044 B2
`
`iv.
`
`“a dose dial grip disposed near a proximal end
`ofsaid dose dial sleeve; ”
`
`Petitioner contends that Steenfeldt-Jensen’s dose-setting button 81,
`
`which a user rotates to set a dose, teaches the recited dose dial grip of
`
`claim 11. Pet. 26 (citing Ex. 1014, 11:22—25, Figs. 15—17; Ex. 1011 11 266).
`
`Petitioner asserts that “[d]ose-setting button 81 is at the button-end of scale
`
`drum 80.” Id. at 26—27 (citing Ex. 1014, Figs. 15—17; Ex. 1011 11 266).
`
`Patent Owner does not contest Petitioner’s argument that Steenfeldt—Jensen
`
`teaches this limitation of claim 11.
`
`For the reasons explained by Petitioner above, which we expressly
`
`adopt, we find that Petitioner has shown that Steenfeldt-Jensen teaches the
`
`dose dial grip limitation of claim 11, recited above.l6
`
`v.
`
`“a piston rod provided within said housing,
`said piston rod is non-rotatable during a dose
`setting step relative to said main housing; ”
`
`Petitioner contends that Steenfeldt—Jensen teaches piston rod 6, which
`
`“is non-rotatable during a dose-setting step relative to housing 1 due to a
`
`pawl mechanism between driver tube 85 and member 40.” Pet. 29 (citing
`
`Ex. 1014, 5:55—58, 11:6—19, 11:52—62, Figs. 15—17;Ex. 10111111 268, 271).
`
`Petitioner asserts the following with respect to Steenfeldt-Jensen’s dose
`
`setting:
`
`The pawl mechanism bars clockwise rotation of driver tube 85
`relative to housing 1. When dose-setting button 81 rotates
`clockwise to dial-up a dose, corresponding rotation of scale
`drum 80 is not transmitted to driver tube 85. To dial—down a
`
`dose, dose-setting button 81 rotates anticlockwise, but
`corresponding rotation of scale drum 80 is still not transmitted
`
`‘6 Additionally, we find that Patent Owner has waived any argument for
`patentability directed to this limitation of claim 11. See Paper 21, 8.
`
`20
`
`

`

`IPR2018-01676
`
`Patent 8,603,044 B2
`
`to driver tube 85 due to the pawl mechanism’s “sufficient
`reluctan[ce]” against anticlockwise rotation. Because piston
`rod 6 is coupled to driver tube 85 in such a way that “rotation is
`transmitted,” and driver tube 85 does not rotate during dose
`setting, piston rod 6 also cannot rotate during a dose-setting
`
`step.
`
`Id. (citing Ex. 1014, 1126—19, 11:

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