`Filed: March 31, 2016
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`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
`LUPIN LTD., and LUPIN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
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`_________________
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`Case IPR2015-00903 (Patent 8,129,431 B2)1
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`PATENT OWNER’S MOTION TO EXCLUDE
`UNDER 37 C.F.R. § 42.64(C)
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`1IPR2015-01871 has been joined with this proceeding.
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`Case IPR2015-00903 (Patent 8,129,431 B2)
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`TABLE OF CONTENTS
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`Dr. Laskar’s Opinions and Testimony Regarding any Issue of Organic
`or Medicinal Chemistry Should Be Excluded Under FRE 702....................... 2
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`A.
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`Senju Timely Objected to and Challenged Dr. Laskar’s
`Qualifications During Cross Examination ............................................ 2
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`B. Dr. Laskar Is Not Qualified to Offer Opinions on Organic or
`Medicinal Chemistry, or Challenge Those Opinions of Senju’s
`Qualified Expert .................................................................................... 2
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`I.
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`II.
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`Portions of the Reply Declaration of Dr. Laskar, and Eight New
`Accompanying Exhibits Should be Excluded Under FRE 402 and 403 ......... 8
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`A.
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`Senju Timely Objected to the Laskar Reply Declaration and
`Accompanying Exhibits, Upon Which Petitioner Relied in Its
`Reply...................................................................................................... 8
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`B. Dr. Laskar’s Reply Declaration and Supporting Exhibits
`Exceed the Proper Scope of Petitioner’s Reply under 37 C.F.R.
`§ 42.23(b) and Thus Lack Relevance under FRE 402 and Are
`Prejudicial Under FRE 403 ................................................................... 9
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`III. Allegedly Supporting Exhibits 1075, 1098, and 1076 Should Be
`Excluded Under FRE 402 and 403 ................................................................10
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`A.
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`B.
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`Senju Timely Objected to Exhibits 1075, 1098, and 1076 .................10
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`Exhibits 1075, 1098, and 1076 Allegedly Support an Argument
`that Exceeds the Proper Scope of Petitioner’s Reply under 37
`C.F.R. § 42.23(b) and Should Be Excluded Under FRE 402 and
`Are Prejudicial Under FRE 403 ..........................................................11
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`IV. Dr. Laskar’s Testimony on Redirect After Consultation with
`Petitioner’s Counsel Should Be Excluded .....................................................11
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`V.
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`Conclusion .....................................................................................................13
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`ii
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`Case IPR2015-00903 (Patent 8,129,431 B2)
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`Pursuant to 37 C.F.R. §§ 42.64(c) and 42.61(a), and the Federal Rules of
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`Evidence, Patent Owner Senju first moves to exclude the Reply Declaration of
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`Paul Laskar, Ph.D. (EX1104), specifically at least paragraphs 8, 10-13, and 17-19,
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`and the testimony of Dr. Laskar (EX2114 and EX2272), because Dr. Laskar
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`completely lacks expertise in organic or medicinal chemistry and, thus, Dr. Laskar
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`is not qualified by knowledge, skill, experience, training or education necessary to
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`form an opinion under FRE 702. Second, Senju moves to exclude paragraphs 4-34
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`of Ex. 1104, and allegedly supporting EX1089, 1092, 1093, 1105, 1106, 1091,
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`1094 and 1148, because these exhibits lack relevance under FRE 402, as they
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`exceed the proper scope of Petitioner’s Reply under 37 C.F.R. § 42.23(b), and
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`because they are prejudicial under FRE 403 to Senju, as Senju is unable to respond
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`to them. Third, Senju moves to exclude EX1075, EX1098 and EX1076 for lack of
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`relevance under FRE 402, because these exhibits were used in connection with a
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`new argument in Petitioner’s Reply (Paper 51), which exceeds the proper scope of
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`a Reply under 37 C.F.R. § 42.23(b) and their use is prejudicial to Senju under FRE
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`403. Senju further moves to exclude Dr. Laskar’s testimony at his first cross
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`examination on redirect, Ex. 2114, 258:14-263:1, because that testimony was
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`unreliable, having been elicited after consultation with Petitioner’s counsel during
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`a break, and in light of Dr. Laskar’s repeated refusal to provide responsive,
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`accurate answers on cross-examination during his cross examination.
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`Case IPR2015-00903 (Patent 8,129,431 B2)
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`I. Dr. Laskar’s Opinions and Testimony Regarding any Issue of Organic or
`Medicinal Chemistry Should Be Excluded Under FRE 702
`A.
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`Senju Timely Objected to and Challenged Dr. Laskar’s
`Qualifications During Cross Examination
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`Senju timely objected to Ex. 1104, specifically paragraphs 8, 10-13, and 17-
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`19, under FRE 702 and 37 C.F.R. § 42.65 in objections filed and served March 25,
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`2016. (Paper 54.) Further, during Dr. Laskar’s cross-examination on his
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`Declaration (Ex. 2114, 25:21-32:17; 257:14-18) and on his Reply Declaration
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`(EX2272, 14:10-25:7), Senju extensively challenged and objected to Dr. Laskar’s
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`lack of qualifications necessary to form an opinion under FRE 702.
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`B. Dr. Laskar Is Not Qualified to Offer Opinions on Organic or
`Medicinal Chemistry, or Challenge Those Opinions of Senju’s
`Qualified Expert
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`In his declarations in support of the petition and the reply, Dr. Laskar offers
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`opinions on, among other things, organic and medicinal chemistry issues to argue
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`that the instituted claims are allegedly obvious and to challenge the declarative
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`evidence on secondary considerations submitted by Patent Owner. Dr. Laskar,
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`however, completely lacks expertise in organic and medicinal chemistry—the
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`central technology of this proceeding. Accordingly, and as discussed below, Dr.
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`Laskar’s opinions should be excluded.
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`Dr. Laskar was cross-examined twice during this proceeding, and each time,
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`Patent Owner explored his complete lack of relevant expertise. At the outset, Dr.
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`Laskar held himself out to be an expert in “the field of formulations and drug
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`delivery, specifically pharmaceutical formulations for ophthalmic administration
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`including topical aqueous liquid preparations.” (EX2114, 24:3-14.) But Dr.
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`Laskar has never practiced medicine (EX2114, 28:4-23) and is no longer “an active
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`registered pharmacist” (EX2272, 14:22-15:2). In fact, Dr. Laskar has not
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`dispensed a drug since the mid-1970s, has never dispensed any bromfenac product,
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`and does not recall ever dispensing an ophthalmic product containing tyloxapol.
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`(EX2272, 14:13-15:22.) Since 1982, he has formulated drug products, but he has
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`never formulated products with bromfenac and has never formulated any NSAID
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`product containing tyloxapol. (EX2272, 22:1-13.) Nor has Dr. Lasker conducted
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`any research on bromfenac products. (EX2114, 28:25-29:5.)
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`Dr. Laskar’s formal education is in general science, pharmacy, and
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`pharmaceutical sciences, not in chemistry. (EX2272, 22:17-23-15.) He has never
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`held a faculty position in any chemistry department and never held any faculty
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`position at all beyond associate professor. (EX2272, 20:10-16.) Dr. Laskar has
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`only ever submitted two patent applications, and neither is relevant to the ’290 or
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`’431 patents. (EX2114, 26:3-27:1; EX2272, 16:1-18:7.) He has only authored
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`eight peer reviewed publications in his entire career, the last one in 1993 related to
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`sunscreen products, and the most recent one before that in 1977. (EX2272, 18:13-
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`19:15.) None of his publications relates to antioxidants, a topic on which he opines
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`extensively in his Reply Declaration. (EX2272, 19:11-15, 20:6-9.) Dr. Laskar is
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`not a member of the American Chemical Society and has never published anything
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`in the Journal of the American Chemical Society. (EX2272, 24:1-8.) To date, he
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`has only ever given four presentations—none on the use of antioxidants—and the
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`most recent was 24 years ago. (EX2272, 20:20-21:9.) After an extensive review
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`of his credentials during his cross examination on his Reply Declaration, Dr.
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`Laskar readily admitted that he was not an expert in medicinal or organic
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`chemistry, including antioxidant chemistry. (EX2272, 20:17-21:5.) As a result,
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`with respect the central issues Dr. Laskar and Petitioners have raised in this
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`proceeding, Dr. Laskar has no experience whatsoever, and therefore he is
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`unqualified to provide expert testimony in this proceeding.
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`Dr. Laskar not only is unqualified to offer his own opinions but also is
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`unqualified to challenge the opinions of Patent Owner’s expert Dr. Davies. For
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`example, Dr. Laskar contends that the compound tyloxapol is an “alkylphenol,”
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`like those disclosed in the Doi patent (EX2025). (EX1104 at ¶ 17.) A phenol,
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`however, is by definition a compound having one or more hydroxy (-OH) groups
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`attached to a phenyl ring. Tyloxapol is therefore by definition not an alkylphenol
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`and is not taught by Doi, contrary to Dr. Laskar’s opinions.
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`In addition, Dr. Laskar agrees that polysorbate 80 is an oxidizing agent
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`because it degrades to produce peroxides and hydroperoxides, citing Dr. Davies’
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`declaration, but then contends that tyloxapol somehow is an antioxidant. (EX1104
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`at ¶¶ 8,10-11, n.6.) Contrary to Dr. Laskar’s opinion, the portion of Dr. Davies’
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`declaration to which Dr. Laskar cites establishes with literature support (see
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`EX2097) that both polysorbate 80 and tyloxapol degrade to produce peroxides and
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`hydroperoxides because they both contain polyoxyethylene chains. (EX2105 at ¶¶
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`71-74.) Dr. Laskar admits that tyloxapol is an “ethoxylated” surfactant which
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`contains a polyoxyethylene chain. (EX1104 at ¶ 2.) Given his agreement that
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`polysorbate 80 is an antioxidant rather than an oxidizing agent, and the fact
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`polysorbate 80 and tyloxapol share the same ethoxylated chain in common, Dr.
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`Laskar cannot credibly contend that tyloxapol somehow is an antioxidant rather
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`than an oxidizing agent. Dr. Laskar’s reliance on Dr. Davies’ opinion regarding
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`polysorbate 80’s polyoxyethylene chain, coupled with his unsupported rejection of
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`Dr. Davies’ opinion regarding tyloxapol’s polyoxyethylene chain, demonstrates
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`Dr. Laskar’s complete lack of expertise in this area and the unreliability of his
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`opinions.
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`Moreover, Dr. Laskar’s reliance on a series of wholly irrelevant references
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`that teach the use of tyloxapol in biological systems to prevent biologic injury (see
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`EX1092, EX1093, EX1094, EX1105, EX1148) further establishes that Dr. Laskar
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`is unqualified to offer opinions regarding organic or medicinal chemistry. As Dr.
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`Davies explained in the parallel district court litigation regarding the ’431 and ’290
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`patents, bromfenac is subject to oxidation in aqueous ophthalmic solutions in the
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`presence of oxygen (O2). (EX2267.) EX1092 and EX1093 cited by Dr. Laskar
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`study the ability of tyloxapol to prevent biologic injury from “partially reduced O2
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`species,” which Dr. Laskar agrees are not oxygen. (EX2267 at ¶ 29; EX2272,
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`130:4-8.) “Partially reduced O2 species” are simply not present in bromfenac
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`ophthalmic solutions. (Id.) Dr. Davies further explained that EX1094 similarly
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`studies the use of tyloxapol in biological systems to “inhibi[t] activation of the
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`transcription factor nuclear factor-kappa B . . .,” as well as tyloxapol’s ability to
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`serve as an antioxidant for hydroxyl radicals, generated in the presence of ferrous
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`ions, and hypochlorous acid, generated from ‘leukocyte myeloperoxidase.” (Id.)
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`Hydroxyl radicals and hypochlorous acid are also not oxygen and are similarly not
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`present in bromfenac ophthalmic solutions. (Id.) These references cited by Dr.
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`Laskar are therefore not relevant to bromfenac’s oxidative degradation, and
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`nothing in these references establishes that tyloxapol would behave as an
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`antioxidant for O2 in an aqueous solution of bromfenac. (Id.) Indeed, if tyloxapol
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`did inhibit O2, its administration as a therapeutic agent by aerosol treatment to the
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`lungs as in EX1093 (see 3:2-5) would be potentially fatal in vivo. In sum, it is not
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`surprising that Dr. Laskar’s opinions in his reply declaration (EX1104) are
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`inconsistent with the opinions offered by Dr. Davies, an undisputed expert in
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`organic and medicinal chemistry.
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`To qualify as an expert, a witness must have “knowledge, skill, experience,
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`training, or education” relevant to the evidence or facts at issue. Fed. R. Evid. 702.
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`In addition, an expert must be more than simply “qualified” in any discipline. The
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`expert must be qualified in the subject matter about which he or she proposes to
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`testify. See Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1362
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`(Fed. Cir. 2008) (expert who may have been qualified to testify as to patent office
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`procedures not qualified to testify on patent validity because of a lack of
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`experience and training in the pertinent art). The Federal Circuit has stated that
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`“[a]dmitting testimony from a [witness], with no skill in the pertinent art, serves
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`only to cause mischief and confuse the factfinder.” Sundance, 550 F.3d at 1362.
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`Under Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 597 (1993) and
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`Fed. R. Evid. 702, courts and the Board are charged with a “gatekeeping role,” the
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`objective of which is to ensure that expert testimony admitted into evidence is both
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`reliable and relevant. Because Dr. Laskar, by his own admission, has no training or
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`experience in organic or medicinal chemistry, which is the very subject matter Dr.
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`Laskar and Petitioners have placed at issue in this proceeding, Dr. Laskar’s
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`opinions fail to comply with Fed. R. Evid. 702. Dr. Laskar plainly lacks both the
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`knowledge and experience required to express the opinions he provides in EX1003
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`and EX1104.
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`Dr. Laskar’s purported expertise in the fields of formulation and drug
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`delivery does not qualify him as an expert in the specific chemical technology at
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`issue. See Extreme Networks, Inc. v. Enterasys Networks, Inc., 395 F. App’x 709,
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`715 (Fed. Cir. 2010) (“General experience in a related field may not suffice when
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`experience and skill in specific product design are necessary to resolve patent
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`issues.”). And because he is unqualified, Dr. Laskar’s opinions expressed in
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`EX1104, specifically at least paragraphs 8, 10-13, and 17-19, 2114, and EX2272
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`regarding organic or medicinal chemistry are unreliable and cannot assist the trier
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`of fact as Fed. R. Evid. 702 requires. Accordingly, the Board should exclude his
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`testimony from evidence. Likewise, Dr. Laskar’s opinions expressed in his
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`opening declaration (EX1003) involving organic and medicinal chemistry should
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`be afforded no weight given Dr. Laskar’s admitted lack of expertise in these fields.
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`II. Portions of the Reply Declaration of Dr. Laskar, and Eight New
`Accompanying Exhibits Should be Excluded Under FRE 402 and 403
`A.
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`Senju Timely Objected to the Laskar Reply Declaration and
`Accompanying Exhibits, Upon Which Petitioner Relied in Its
`Reply
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`In objections filed and served March 25, 2016, Senju objected to EX1104,
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`specifically ¶¶ 4-34, and allegedly supporting EX1089, 1092, 1093, 1105, 1106,
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`1091, 1094 and 1148, under FRE 402 and 403 as being directed to improper new
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`testimony from Dr. Laskar that tyloxapol allegedly is an antioxidant. (Paper 54.)
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`B. Dr. Laskar’s Reply Declaration and Supporting Exhibits Exceed
`the Proper Scope of Petitioner’s Reply under 37 C.F.R. § 42.23(b)
`and Thus Lack Relevance under FRE 402 and Are Prejudicial
`Under FRE 403
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`In its Reply (Paper 51), Petitioner relies upon the Laskar Reply Declaration
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`(EX1104) for an entirely new argument for why a person of ordinary skill in the art
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`allegedly would have reason to modify Ogawa in view of Sallmann, relying on
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`eight new references. (Reply, Paper 51 at 11.) In EX1104, Dr. Laskar posits, for
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`the first time, that:
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`Knowing that polysorbate 80 was the cause of oxidative degradation, the
`skilled artisan would have replaced the polysorbate 80 with another non-
`ionic surfactant that did not share polysorbate 80’s liability. The skilled
`artisan would have known that tyloxapol, like polysorbate 80, is not only a
`non-ionic surfactant commonly used in ophthalmic formulations but, unlike
`polysorbate 80, it also has antioxidant properties.
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`(EX1104, ¶ 7 (emphasis added).) In Dr. Laskar’s opening declaration (EX1003),
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`his first deposition, and the Petition, however, not once did Dr. Laskar or Petitioner
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`argue that a person of ordinary skill in the art would replace polysorbate 80 with
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`tyloxapol because tyloxapol allegedly is an antioxidant. This is an entirely new
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`argument, to which Patent Owner has had no opportunity to respond. In
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`connection with this new argument, Dr. Laskar cites eight new references and
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`discusses each reference in detail, blatantly mischaracterizing each reference. (See
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`EX1089, EX1106, EX1091, EX1094, EX1080, EX1105, EX1148, EX1092,
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`EX1093.) In fact, Dr. Laskar devotes 30 paragraphs of his 39-paragraph reply
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`declaration to this entirely new argument. (EX1104, ¶¶ 4-34.)
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`These portions of EX1104 and the exhibits listed above should be excluded
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`because they lack relevance under FRE 402, as they exceed the proper scope of
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`Petitioner’s Reply under 37 C.F.R. § 42.23(b). Arguments in support of a reply
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`“may only respond to arguments raised in the corresponding . . . patent owner
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`response.” Id. As explained in the Trial Practice Guide, “new evidence necessary
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`to make out a prima facie case for [] unpatentability” and “new evidence that could
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`have been presented in a prior filing” are improper. 77 Fed. Reg. 48767. “[A]
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`reply that raises a new issue or belatedly presents evidence will not be considered
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`and may be returned.” Id. Moreover, these portions of EX1104 and the exhibits
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`listed above should be excluded under FRE 403 because they were first presented
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`at the Reply stage and Patent Owner is prejudiced by being unable to respond to
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`the untimely evidence and arguments therein.
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`III. Allegedly Supporting Exhibits 1075, 1098, and 1076 Should Be Excluded
`Under FRE 402 and 403
`A.
`In objections timely filed and served March 25, 2016, Senju objected to
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`Senju Timely Objected to Exhibits 1075, 1098, and 1076
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`EX1075, EX1098 and EX1076, under FRE 402 and 403, which Petitioner cites in
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`connection with a new argument alleging motivation to combine. (Paper 54.)
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`B.
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`Exhibits 1075, 1098, and 1076 Allegedly Support an Argument
`that Exceeds the Proper Scope of Petitioner’s Reply under 37
`C.F.R. § 42.23(b) and Should Be Excluded Under FRE 402 and
`Are Prejudicial Under FRE 403
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`In its Reply, Petitioner argues for the first time that a person of ordinary skill
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`in the art allegedly would expect that switching polysorbate 80 with tyloxapol
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`would improve preservative efficacy because polysorbate 80 allegedly was known
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`to neutralize BAC. (Paper 51 at 16.) Petitioner sets forth three new references in
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`connection this new argument. (See EX1075, EX1098, EX1076.) Patent Owner
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`has had no opportunity to respond to this entirely new argument relating to alleged
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`motivation to combine. As a result, these Exhibits should be excluded because
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`they lack relevance under FRE 402, and they exceed the proper scope of
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`Petitioner’s Reply under 37 C.F.R. § 42.23(b) and under FRE 403, as they were
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`first presented at the Reply stage, and Patent Owner is prejudiced because it is not
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`able to respond to the untimely evidence and arguments therein.
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`IV. Dr. Laskar’s Testimony on Redirect After Consultation with Petitioner’s
`Counsel Should Be Excluded
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`During cross examination, Dr. Laskar was generally non-responsive and
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`gave inconsistent testimony on even the most basic questions, requiring Patent
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`Owner to repeatedly impeach him with his prior sworn testimony. In some cases,
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`Dr. Laskar provided non-responsive comments that failed to actually answer the
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`question that was presented to him the first, second or even third time. (See, e.g.,
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`EX2114, 48:19-50:4; 98:4-22; 101:13-102:10; 103:12-24; 104-2-20; 115:24-
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`116:17; 134:11-135:9; 136:16-137:19; 220:14-25.) In other cases, he did not
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`answer questions presented to him about disclosures in references, but rather
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`admitted only that the “wording” referenced by Patent Owner’s counsel appeared
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`in the reference. (See, e.g., id., 53:1-13 (“I see that wording.”); 54:9-55:15 (“That’s
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`what’s stated there.”); 136:2:15.) In still other cases, Dr. Laskar gave testimony
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`inconsistent with his prior sworn testimony, and Patent Owner’s counsel repeatedly
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`was forced to impeach Dr. Laskar with that prior testimony to get an accurate
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`response. (See, e.g., id., 85:17-88:1; 172:7-173:4, 187:2-188:23; 253:18-254:17.)
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`On redirect, the opposite was true. When barely prompted by Petitioner’s
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`counsel, Dr. Laskar gave lengthy answers in a contrived attempt support his
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`statements in his Declaration. (Id., 258:14-263:1.) Yet on recross, Dr. Laskar
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`readily admitted that prior to redirect and during a break, he and Petitioner’s
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`counsel discussed “the areas in which [Petitioner’s counsel] would ask questions.”
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`(Id. at 264:16-20). Patent Owner timely objected to this improper tactic and
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`moved to strike the entirety of Dr. Laskar’s redirect testimony. (Id., 264:21-23.)
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`In light of Dr. Laskar’s repeated refusals on cross examination to provide
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`responsive, accurate answers, and in light of the discussions between Dr. Laskar
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`and Petitioner’s counsel prior to redirect, Dr. Laskar’s testimony elicited on
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`redirect should be excluded as unreliable. In sum, in light of Dr. Laskar’s evasive
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`tactics during his cross examination, Dr. Laskar’s redirect testimony should be
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`excluded as prejudicial, under FRE 403.
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`V. Conclusion
`For the reasons stated herein, Patent Owner respectfully requests that
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`EX1104, paragraphs 4-34, the testimony of Dr. Laskar (EX2114 and EX2272), and
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`EX1089, 1092, 1093, 1105, 1106, 1091, 1094 and 1148, and EX1075, EX1098 and
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`EX1076 be excluded from these proceedings.
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`By: /Bryan C. Diner/
`Bryan C. Diner, Lead Counsel
`Registration No. 32,409
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`Date: March 31, 2016
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`Case IPR2015-00903 (Patent 8,129,431 B2)
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing PATENT
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`
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`OWNER’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(C) was
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`served on March 31, 2016, via email directed to counsel of record for the Petitioner
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`at the following:
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`Jitendra Malik, Ph.D
`Jitty.malik@alston.com
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`Bryan Skelton, Ph.D.
`Bryan.skelton@alston.com
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`Lance Soderstrom
`Lance.soderstrom@alson.com
`
`Hitetada James Abe
`James.abe@alston.com
`
`Joseph M. Janusz
`Joe.janusz@alston.com
`
`Deborah Yellin
`dyellin@crowell.com
`
`Jonathan Lindsay
`jlindsay@crowell.com
`
`Shannon Lentz
`slentz@crowell.com
`
`
`
`/Bradley J. Moore/
`Bradley J. Moore
`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`Dated: March 31, 2016
`
`
`
`
`
`14