`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.
`and PFIZER INC.,
`Petitioners,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`————————————————
`Case IPR2018-01675
`Patent No. 8,603,044
`————————————————
`
`PETITIONERS’ REPLY TO PATENT OWNER RESPONSE
`37 CFR §42.23
`
`
`
`TABLE OF CONTENTS
`
`INTRODUCTION ........................................................................................... 1
`I.
`LEVEL OF SKILL .......................................................................................... 1
`II.
`III. CLAIM CONSTRUCTION ............................................................................ 2
`IV. GROUND 1: BURROUGHS .......................................................................... 5
`A.
`Burroughs suggests a “helical groove provided along an
`outer surface of said dose dial sleeve” .................................................. 5
`1.
`Sanofi’s “inconsistent” modification argument
`is a canard .................................................................................... 5
`The petition established a reason to modify ............................... 6
`2.
`Burroughs suggests different leads for the drive sleeve
`and the dose-dial sleeve ......................................................................... 9
`Burroughs suggests a tubular clutch located adjacent a
`distal end of, and operatively coupled to, the dose-dial
`grip ....................................................................................................... 11
`CONCLUSION .............................................................................................. 14
`
`
`B.
`
`C.
`
`V.
`
`
`
`-i-
`
`IPR2018-01675
`
`
`
`I.
`
`INTRODUCTION
`
`The patent owner (Sanofi) reads Burroughs (EX1013), not as a whole, but as
`
`disjoint teachings in a manner inconsistent with precedent and the understanding of
`
`a person of ordinary skill in the art (POSA). The preponderance of evidence of
`
`record—including testimony from pen designer Karl Leinsing (EX1011, EX1095)
`
`and cross examination testimony from Sanofi’s Professor Slocum (EX1053,
`
`EX1054)—contradicts Sanofi’s arguments.
`
`Claims not argued separately stand or fall together. In re Dillon, 919 F.2d
`
`688, 692 (Fed. Cir. 1990) (en banc). Sanofi only separately argues claim 11,1
`
`leaving the remaining claims to stand or fall with claim 11 from which they
`
`depend. For the reasons given in the petition alone and in light of the arguments
`
`below, all challenged claims are unpatentable.
`
`II. LEVEL OF SKILL
`
`Sanofi disputes the level of skill in the art and whether it requires any years
`
`of experience but concedes that any differences between the parties do not affect
`
`
`
`1 Sanofi only discusses claim 14 to deny a means-plus-function reading for
`
`clicker. POR 13.
`
`-1-
`
`
`
`
`
`this trial. POR 8-9. Petitioners agree with the Board that the art of record amply
`
`reflects the level of skill. Paper 28, 12-13.
`
`III. CLAIM CONSTRUCTION
`
`Claims have their ordinary and customary meaning, consistent with the
`
`specification. 37 CFR §42.100(b); Phillips v. AWH Corp., 415 F.3d 1303, 1312-13
`
`(Fed. Cir. 2005) (en banc). If it would make a difference, the Board will adopt the
`
`broadest reasonable interpretation in this trial. Paper 28, 13.
`
`Sanofi asserts that Petitioners have not settled on a meaning for tubular
`
`clutch and clicker, which the petition explained could be subject to a means-plus-
`
`function interpretation. POR 9. Claim construction is a question of law, and the
`
`tribunals regularly arrive at a final construction in their final decisions. Jack
`
`Guttman, Inc. v. Kopykake Enter., Inc., 302 F.3d 1352, 1361 (Fed. Cir. 2002)
`
`("District courts may engage in a rolling claim construction, in which the court
`
`revisits and alters its interpretation of the claim terms as its understanding of the
`
`technology evolves."). In fact, the Board will deny petitions for failing to address a
`
`foreseeable alternate construction. Ethicon Endo-Surgery, Inc. v. Covidien AG,
`
`IPR2016-00944, Paper 8, 5-6 (denying follow-on institution for claim construction
`
`not addressed in earlier petition). The Board was not confused when instituting this
`
`trial. Paper 28, 15-16.
`
`-2-
`
`
`
`
`
`In any case, Sanofi rejects means-plus-function constructions for these
`
`terms. POR 10. Similarly, the institution decision provisionally adopted Sanofi’s
`
`broader constructions. Sanofi has waived any argument resting on a means-plus-
`
`function construction, including any separate argument that the art would not teach
`
`the invention with a means-plus-function construction. Accordingly, Petitioners
`
`will proceed with the broader plain and ordinary meaning for these terms.
`
`Other than contending clicker is not a means-plus-function limitation,
`
`Sanofi’s response only addresses the construction of tubular clutch, which Sanofi
`
`would construe as “a component that can operate to reversibly lock two
`
`components in rotation.” POR 10-12. While Sanofi challenges Petitioners’ means-
`
`plus-function construction for its use of the phrase “during dose setting”, Sanofi
`
`does not address the plain-meaning construction that the petition offered. The
`
`petition—relying on Sanofi’s own representations to the district court in the
`
`collateral proceeding—proposed the following construction: “A tubular structure
`
`that couples and decouples a moveable component from another component”
`
`Pet. 16, citing EX1019, 23. This construction does not restrict the claims to dose
`
`setting, rendering Sanofi’s argument moot.
`
`In an earlier proceeding, Sanofi proffered a similar construction of the term
`
`(“A first component that couples and decouples at least a second component to a
`
`third component.”), which the court construed as “[a] structure that couples and
`
`-3-
`
`
`
`
`
`decouples a moveable component from another component.” EX1030, 12. Sanofi
`
`proffered this construction in the collateral litigation, but the court rejected, “as
`
`inconsistent with the ordinary meaning, claim construction proposals that would
`
`have required a structure that ‘couples and decouples’ two components rather than
`
`reversibly locking two components in rotation.”2 POR 12, citing EX2165, 10-11.
`
`While the current court’s construction is evidence of the reasonable scope of the
`
`limitation, the earlier court’s construction and Sanofi’s subsequent proffer in the
`
`current court is evidence—an admission—about the reasonable scope of the
`
`limitation. Ex parte Schulhauser, Appeal No. 2013-007847, slip op. 9 (PTAB
`
`2016) (precedential). The broadest reasonable interpretation of this limitation
`
`would at least encompass both of these constructions absent a showing that either
`
`construction is unreasonable. Sanofi has made no such showing beyond noting the
`
`current court’s construction, and certainly has not stated that its construction
`
`proffered to the current court, and adopted by an earlier court, was unreasonable.
`
`
`
`2 Given that the contested patent uses the term “coupled” in the abstract and
`
`claims but does not use any variant of “lock” much less “reversibly locking”, it is
`
`not clear how Sanofi’s new construction is more reasonable in light of the
`
`specification. Phillips, 415 F.3d at 1315-17.
`
`-4-
`
`
`
`
`
`IV. GROUND 1: BURROUGHS
`
`A. Burroughs suggests a “helical groove provided along an outer
`surface of said dose dial sleeve”
`1. Sanofi’s “inconsistent” modification argument
`is a canard
`
`Sanofi argues that the petition presents a “convoluted” modification, while
`
`Petitioners’ expert, Karl Leinsing, provides an inconsistent modification. POR 21.
`
`Sanofi misapprehends the petition’s rationale and Mr. Leinsing’s testimony.
`
`The petition notes that Burroughs describes flexible legs 102, 104 with
`
`outwardly extending threads 110, 112. Pet. 23-24, citing EX1013, 8:24-29. These
`
`threads fit into a helical groove 158 on the housing. Pet. 24. The petition with
`
`supporting testimony explains that the placement of threads and grooves are known
`
`to be interchangeable, and proposes to change the helical threads 110, 112 into “u-
`
`shaped protruding grooves”. Pet. 41. Contrary to Sanofi’s assertions, the petition
`
`says nothing about cutting into the threads to make this modification. In context,
`
`turning a single thread into “protruding grooves” indicates duplication of the
`
`thread. There is nothing convoluted about treating two threads as forming the
`
`groove for an engaging thread. The Board understood the proposed modification in
`
`its institution decision. Paper 28, 23-24. To the extent Sanofi was truly confused, it
`
`needed only consult the cited paragraph in the Leinsing declaration, which explains
`
`(EX1011, ¶170):
`
`-5-
`
`
`
`
`
`[T]he rotational operability between the components would be
`retained if the threads 110, 112 of the dial mechanism were
`configured as two, parallel ribs that form a discontinuous, helical
`groove for engaging the housing’s threading.
`
`What the petition expressly intends is two protruding ribs that form a
`
`groove. Sanofi adopts a strawman reading of the petition and declaration to create
`
`confusion where none exists. Sanofi’s arguments built on its misapprehension
`
`(POR 27-33) should be disregarded.
`
`Sanofi notes that Mr. Leinsing rejected its mischaracterization of the
`
`modification during his deposition. POR 27-28, citing EX2163, 193:22-194:11. Far
`
`from supporting Sanofi’s argument, Mr. Leinsing’s answer should have alerted
`
`Sanofi to its misapprehension of the proposed modification.
`
`2. The petition established a reason to modify
`
`Sanofi addresses the petition’s rationale as “Mr. Leinsing’s proposed
`
`modification” but dismisses it as “assertions [that] do no more than establish that a
`
`POSA could have performed the proposed modification.” POR 34 (original
`
`emphasis). Again, Sanofi misapprehends the argument. When known
`
`interchangeable solutions to a problem exist, the case law fully supports that
`
`swapping one solution for the other is well within the realm of the obvious.
`
`Pet. 41-42, citing KSR, 550 U.S. at 417; see also EX1095, ¶43. The Board
`
`-6-
`
`
`
`
`
`understood this to be Petitioners’ argument. Paper 28, 23-24. Again, Sanofi sets up
`
`a strawman argument that does not represent the actual argument and avoids
`
`addressing the actual rationale.
`
`Sanofi further argues that a POSA would have been deterred from making
`
`the proposed modification because two ribs would increase the stress and wear on
`
`Burroughs’ flexible legs 102, 104. POR 35-36. Sanofi concedes that one could
`
`have “reduce[d] the stress on the legs 102 and 104 by changing their dimensions,”
`
`but urges that the petition does not explain this and that a POSA would not have
`
`wanted to do it because it would increase the width of the pen. POR 36-37. Case
`
`law, however, consistently rejects treating modifications rigidly rather than
`
`appreciating that a POSA would use routine skill in implementing the change. For
`
`example, in Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC, the
`
`court affirmed a modification that might have disadvantages because (1) the
`
`possibility of disadvantages does not obviate the reason to change and (2) the
`
`further modification to mitigate the disadvantage was readily apparent. 825 F.3d
`
`1373, 1381 (Fed. Cir. 2016).
`
`Sanofi argues the further modification it suggests has the disadvantage of
`
`making the pen 10% wider. POR 37. Yet Dr. Biggs explains that “width is not
`
`necessarily a disadvantage because it can aid patients with grip or agility problems.
`
`For example, the Basaglar [KwikPen] is relatively bulky to enhance gripping.”
`
`-7-
`
`
`
`
`
`EX1048, ¶50. What Dr. Slocum, a professor with no pen design experience
`
`(EX1053, 13:2-6), sees as a disadvantage, Dr. Biggs explains is an advantage seen
`
`in insulin pens currently marketed against Sanofi’s insulin products.
`
`Sanofi relies on Dr. Slocum’s testimony to contend that redesigning the pen
`
`as proposed would “significantly” increase injection force 15%. POR 37-38, citing
`
`EX2107, ¶192. Dr. Slocum pulls this “significant” percentage out of thin air. See
`
`EX2107, ¶192 (providing no basis for percentage); EX1095, ¶41 (noting analytical
`
`model “is based entirely on dimensions determined from the apparent relative size
`
`of components in Burroughs’s patent drawings and a rough sketch of the location
`
`of the additional thread” provided by Mr. Leinsing during deposition). Conclusory
`
`expert testimony is entitled to no weight. See, e.g., Phillips, 415 F.3d at 1318;
`
`37 CFR §42.65(b). At most, Dr. Slocum asserts that the redesign might increase
`
`injection force enough to disadvantage some patients. In re Kao, 639 F.3d 1057,
`
`1067 (Fed. Cir. 2011) ("conjecture does not supply the requisite substantial
`
`evidence") (original emphasis); cf. EX1048, ¶¶29-30 (neither Dr. Biggs nor Dr.
`
`-8-
`
`
`
`
`
`Goland identify any real-world case where injection force actually made a
`
`difference for a patient).3
`
`B. Burroughs suggests different leads for the drive sleeve and the
`dose-dial sleeve
`
`Sanofi contends the petition provides no reason for different leads on the
`
`drive sleeve and dose-dial sleeve. POR 40. As an initial matter, Burroughs does not
`
`address the leads on these different structures. Pet. 39-40. The petition explains
`
`that without this requirement, a POSA would have understood that either of the
`
`two choices (same or different)4 are available. Id., citing EX1011, ¶194. Sanofi’s
`
`response does not identify any criticality for this choice. POR 40-43. Dillon,
`
`919 F.2d at 695 (“since … no criticality is shown for these limitations, the subject
`
`matter of these claims has not been shown to have been nonobvious.”); see also
`
`Süd-Chemie Inc. v. Multisorb Techs. Inc., 554 F.3d 1001, 1004-05 (Fed. Cir. 2009)
`
`
`
`3 Even if these unsupported concerns were real, Sanofi does not address any
`
`of the routine options at the POSA’s disposal. EX1095, ¶¶42-43 (e.g., different rib
`
`heights, shifting of threading).
`
`4 Actually, there is only one “same” choice and far more “different” choices.
`
`-9-
`
`
`
`
`
`(affirming obviousness of “uncoated” films because the reference is silent on
`
`coating and no evidence requires coating).
`
`Indeed, Sanofi’s own specification does not mention that the leads are
`
`different, much less suggest that they should or can be different, except in the
`
`claims. EX1002, passim; see also EX1095, ¶52 (noting no dispute that the ’044
`
`patent “does not disclose that th[e] leads may be different and it does not describe
`
`how the device could be modified to have different leads while still remaining
`
`operable” (citing EX1011, ¶¶196-99)). Yet Sanofi does specify a relationship
`
`between the leads when it matters. E.g., id., 5:61-62 (“The helical groove 74 on the
`
`dose dial sleeve 70 and the helical groove 38 in the drive sleeve 30 have the same
`
`lead.”). Surely, if this distinction were more than a simple choice among known,
`
`limited options, Sanofi would have said so in its specification.
`
`The Leinsing declaration provides the example of a suggestion in the Møller
`
`reference used in related IPRs for choosing a larger lead for the dose-dialing sleeve
`
`to improve user perception of small changes in dose size. EX1011, ¶195, citing
`
`EX1015. Sanofi’s Dr. Slocum disagrees with this example without actually saying
`
`it would not work. POR 41-43 (simply arguing that the contexts in the two
`
`disclosures are different). Mr. Leinsing did not point to Møller as another reason to
`
`modify: he was just offering a simple illustration that a larger travel (from the
`
`larger lead) in the dose-dial sleeve is one way to improve user perception of small
`
`-10-
`
`
`
`
`
`dialing changes. See EX1095, ¶¶53-56 (noting larger lead of dose-dial sleeve
`
`relative to lead of drive sleeve is “a well-known type of gearing”). Dr. Slocum
`
`does not even attempt to show otherwise, instead focusing on apparent distinctions
`
`between the references and existing features of Burroughs that, as Mr. Leinsing
`
`explains, would not have impacted the POSA’s understanding that different leads
`
`would result in larger axial travel of the dose-dial sleeve relative to the axial travel
`
`of the drive sleeve during dose-setting (and relative to the axial travel of the piston
`
`rod during dose-dispensing). See EX1095, ¶¶56-59 (addressing Dr. Slocum’s
`
`misapprehension of POSA’s understanding of Møller in relation to Burroughs).
`
`Sanofi’s contested limitation is not critical, and Dr. Slocum’s concerns about
`
`combining Møller with Burroughs (which the petition does not suggest) is no
`
`teaching away. In re Brandt, 886 F.3d 1171, 1177-78 (Fed. Cir. 2018) (lack of
`
`criticality is not a teaching away).
`
`C. Burroughs suggests a tubular clutch located adjacent a distal
`end of, and operatively coupled to, the dose-dial grip
`
`Sanofi relies on its claim construction (see section III, above) to contend that
`
`the petition fails to address this limitation. POR. 44-45. Because Sanofi has not
`
`contested unpatentability under the petition’s construction, Sanofi has waived any
`
`such argument. Paper 29, 8 (“any arguments for patentability not raised in the
`
`response may be deemed waived”); see also EX1095, ¶¶35-36, 45-47.
`
`-11-
`
`
`
`
`
`As explained above, Sanofi has already conceded the reasonableness of the
`
`construction the petition employed when it proffered the same construction
`
`adopted by the earlier court to the court in the collateral litigation. Schulhauser, 9.
`
`Sanofi’s response does not confess to misleading the current court about the
`
`reasonableness of the construction; hence, there is no basis in the record to hold
`
`that the construction Sanofi proffered in district court is now unreasonable.
`
`Accordingly, the construction of the limitation for this trial must be broad enough
`
`to include the petition’s construction. In any case, the different wording of the
`
`constructions does not make a practical difference in this case.
`
`Sanofi contends that the tubular clutch must be a component that “can
`
`operate to reversibly lock two components in rotation”. POR 44-46. Burroughs’
`
`button 32 does this. The petition explains that button 32 operates to engage and
`
`disengage dial mechanism 34 from the housing’s helical groove. Pet. 32-34;
`
`EX1095, ¶48 (citing EX1013 7:49-55). Moreover, when the user injects a dose,
`
`button 32 operates to disengage the splined connection between dial mechanism 34
`
`and nut 36, thus reversing the rotational locking of those two components.
`
`EX1095, ¶¶48-49; EX1013, 8:42-48, 10:21-26, 10:38-42, 11:27-30, FIGS. 9, 11;
`
`see also EX1011, ¶¶180, 182-83. Button 32 thus satisfies even Sanofi’s new
`
`construction.
`
`-12-
`
`
`
`
`
`Sanofi argues, based on its new claim construction, that Burroughs already
`
`has a “clutching device” and that the button 32 does not reversibly lock dial
`
`mechanism 34 and nut 36 because splines 144 on the dial mechanism and teeth 192
`
`on the nut do the locking, not button 32; and the splines and teeth are not tubular.
`
`POR 47-48, citing EX1013, 2:59-65; EX2107, ¶209. Here, Sanofi adopts an even
`
`narrower interpretation of its new construction, requiring the clutch to act directly
`
`on the locked components to “operate to reversibly lock two components in
`
`rotation”. Sanofi makes no effort to justify this even narrower construction.
`
`Moreover, Sanofi misapprehends how the clutching device also meets Sanofi’s
`
`new extra-narrow construction.
`
`Sanofi characterizes the clutching device as splines and teeth as not tubular.
`
`POR 47. The dial mechanism 34 is “generally cylindrical in shape and is hollow
`
`throughout its axial length.” EX1013, 7:66-67. Burroughs teaches (8:43-48) that:
`
`a plurality of splines 144 extend[] circumferentially about the interior
`surface of intermediate portion 80 of dial mechanism 34. Splines 144
`extend 360° about the inner circumference of intermediate portion 80
`and engage with teeth 192 (FIGS. 10, 11) provided on nut 36 when
`the clutch is engaged to set a dosage.
`
`When engaged the splines 144 and teeth 192 define a tubular (“360°”) structure
`
`(clutching device) within the intermediate portion 80 of the dial mechanism 34.
`
`The intermediate portion 80 lies between the proximal portion 78 and distal
`
`-13-
`
`
`
`
`
`portion 82, together comprising the dial mechanism 34 (see Burroughs Fig. 8,
`
`right). EX1013, 8:2-4.
`
`Sanofi does point to any
`
`special definition for
`
`adjacent, and the contested
`
`patent does not appear to
`
`use the term in an
`
`unconventional way. Case law indicates that adjacent should not be given an
`
`unduly complicated meaning but should be understood to mean simply “next to”.
`
`MBO Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d 1323, 1333 (Fed. Cir. 2007)
`
`(reversing construction as too narrow). In any case, the intermediate portion 80 in
`
`which the clutching device is located is on the distal end of the proximal
`
`portion 78, and thus satisfies a reasonably broad interpretation of adjacent to the
`
`distal end of the proximal portion. Thus, even Sanofi’s proposed alternative
`
`reading of Burroughs satisfies Sanofi’s new, extra-narrow claim construction.
`
`Under either the petition’s or Sanofi’s construction of the “tubular clutch”
`
`limitations, whether considering the button 32 as the petition proposes or the
`
`clutching device as Sanofi proposes, Burroughs teaches a tubular clutch.
`
`V. CONCLUSION
`
`The challenged claims are unpatentable and should be canceled.
`
`-14-
`
`
`
`
`
`
`
`
`Date: 18 September 2019
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Richard Torczon/
`Richard Torczon, Reg. No. 34,448
`
`
`-15-
`
`
`
`
`
`
`
`CERTIFICATION UNDER 37 CFR §42.24(d)
`
`I certify that the word count for this reply totals 2933, which is less than the
`
`5,600 words allowed under 37 CFR §42.24(a)(i).
`
`
`Respectfully submitted,
`
`/Richard Torczon/
`Richard Torczon, Reg. No. 34,448
`
`
`
`
`
`Date: 18 September 2019
`
`
`
`
`
`
`
`
`
`-16-
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that this reply was served today on the Patent Owner at the email
`
`correspondence address of the Patent Owner as follows:
`
`Elizabeth Stotland Weiswasser
`
`elizabeth.weiswasser@weil.com
`
`Anish R. Desai
`
`Sundip K. Kundu
`
`Kathryn M. Kantha
`
`William S. Ansley
`
`Matthew D. Sieger
`
`Adrian C. Percer
`
`Brian C. Chang
`
`anish.desai@weil.com
`
`sundip.kundu@weil.com
`
`kathryn.kantha@weil.com
`
`sutton.ansley@weil.com
`
`matthew.sieger@weil.com
`
`adrian.percer@weil.com
`
`brian.chang@weil.com
`
`WEIL, GOTSHAL & MANGES LLP
`
`Sanofi.IPR.Service@weil.com
`
`John S. Goetz, Joshua A. Griswold,
`Matthew S. Colvin, Kenneth W. Darby
`and W. Karl Renner
`
`PTABInbound@fr.com
`
`
`
`
`
`Date: 18 September 2019
`
`
`
`
`
`Respectfully submitted,
`
`/Richard Torczon/
`Richard Torczon, Reg. No. 34,448
`
`-17-
`
`
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