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