UNITED STATES PATENT AND TRADEMARK OFFICE
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`——————————
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`——————————
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`FLATWING PHARMACEUTICALS, LLC,
`PETITIONER,
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`v.
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`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner
`
`——————————
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`Cases Nos. IPR2018-00168, -00169, -00170, and -00171
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`Patents Nos. 9,549,938, 9,566,289, 9,566,290, and 9,572,823
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`——————————
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`PETITONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE
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`——————————
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`——————————
`
`FLATWING PHARMACEUTICALS, LLC,
`PETITIONER,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner
`
`——————————
`
`Cases Nos. IPR2018-00168, -00169, -00170, and -00171
`
`Patents Nos. 9,549,938, 9,566,289, 9,566,290, and 9,572,823
`
`——————————
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`PETITONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE
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`Pursuant to 37 C.F.R. § 42.64, Petitioner hereby and herewith submits the
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`following objections to evidence. Petitioner submits the same set of objections in
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`all four related Inter Partes Review patent trials, IPR2018-0168 (for U.S. Patent
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`No. 9,459,938), IPR2018-0169 (for U.S. Patent No. 9,566,289), IPR2018-00170
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`(for U.S. Patent No. 9,566,290), and IPR2018–00171 (for U.S. Patent No.
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`9,572.823). Patent Owner made substantially the same arguments in each of its
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`four responses. (Patent Owner’s Response, IPR2018-00168, Paper #13; Patent
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`Owner’s Response, IPR2018-00169, Paper #13; Patent Owner’s Response,
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`IPR2018-00170, Paper #14; and Patent Owner’s Response, IPR2018-00171,
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`Paper #13.) Patent Owner’s Exhibits 2002–2012 and 2015–2045 are identical in
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`all four IPRs. The direct testimony of its witnesses differs primarily in
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`identifying the claims of the patents in each IPR, and does not differ in the
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`substance. (Cf., IPR2018-00168 Ex. 2013, Declaration of Paul J. Reider, Ph.D.
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`in Support of Patent Owner’s Response; IPR2018-00169 Ex. 2013, Declaration
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`of Paul J. Reider, Ph.D. in Support of Patent Owner’s Response; IPR2018-00170
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`Ex. 2013, Declaration of Paul J. Reider, Ph.D. in Support of Patent Owner’s
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`Response; IPR2018-00171 Ex. 2013, Declaration of Paul J. Reider, Ph.D. in
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`Support of Patent Owner’s Response; IPR201800168 Ex. 2014, Declaration of
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`Majella E. Lane, Ph.D. in Support of Patent Owner’s Response; IPR2018-00169
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`Ex. 2014, Declaration of Majella E. Lane, Ph.D. in Support of Patent Owner’s
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`
`
`2
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`
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`
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`Response; IPR2018-00170 Ex. 2014, Declaration of Majella E. Lane, Ph.D. in
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`Support of Patent Owner’s Response; IPR2018-00171 Ex. 2014, Declaration of
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`Majella E. Lane, Ph.D. in Support of Patent Owner’s Response.) Accordingly,
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`this single consolidated set of objections is submitted in all four IPRs, with
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`specific citations to each of the four responses and each of the four different
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`direct testimony papers as appropriate.
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`Petitioner’s objections are as follows:
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`Ex. 2002 is or purports to be the Murthy May-2016 Dep.1 marked at the
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`cross-examination deposition of Dr. Murthy (Ex. 2018 Murthy 20-Aug-2018
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`Dep. at 13:20–15:8). Pursuant to 37 C.F.R. § 42.64, Petitioner reserves all
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`objections made on the record at that deposition, including its objection under
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`Federal Rule of Evidence (“FRE”) 106. Also, as stated on the record (Ex. 2018,
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`Murthy 20-Aug-2018 Dep. at 7:24–8:23), the Petitioner agreed to allow the use
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`of these depositions in prior related proceedings to the extent relevant to the
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`issues in the current IPRs, but reserved the right to object on grounds including
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`relevance to the extent testimony in that deposition is not relevant in this
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`proceeding. Because Patent Owner cites only to Ex. 2002 at 88:12–89:16 and
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`91:4–11 (IPR2018-00168, Paper #13, at 20, 21; IPR2018-00169, Paper #13, at
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`20, 21; IPR2018-00170, Paper#14 at 20, 21; IPR2018-00171, Paper#13 at 20,
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`1 Transcript of Deposition of S. Narasimha Murthy, Ph.D. taken IPR2015-01776,
`IPR2015-01780, and IPR2015-01785 (May 4, 5, 6, and 12, 2016).
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` 3
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`
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`
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`21), Petitioner objects to the all other testimony in Ex. 2002 not cited in Patent
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`Owner’s response on grounds of relevance under FRE 402 and as exceeding the
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`scope of cross under 37 C.F.R. § 42.53.
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`Ex. 2003 is or purports to be the Murthy Sep-2016 Dep.2 marked at the
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`cross-examination deposition of Dr. Murthy (Ex. 2018, Murthy 20-Aug-2018
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`Dep. at 15:9–17:19). Pursuant to 37 C.F.R. § 42.64, Petitioner reserves all
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`objections made on the record at that deposition, including its objection under
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`FRE 106. Also, as stated on the record (Ex. 2018, Murthy 20-Aug-2018 Dep. at
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`7:24–8:23), the Petitioner agreed to allow the use of these depositions in prior
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`related proceedings to the extent relevant to the issues in the current IPRs, but
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`reserved the right to object on grounds including relevance to the extent
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`testimony in that deposition is not relevant in this proceeding. Because Patent
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`Owner does not cite Ex. 2003 in any of Patent Owner’s Responses, Petitioner
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`objects to the entirety of Ex. 2003 on grounds of relevance under FRE 402 and as
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`exceeding the scope of cross under 37 C.F.R. § 42.53.
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`Ex. 2004 is or purports to be an article Nair 2009a3 marked at the cross-
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`examination deposition of Dr. Murthy (Ex. 2018 at 36:9–41:8). Pursuant to 37
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`2 Transcript of Deposition of S. Narasimha Murthy, Ph.D. taken IPR2015-01776,
`IPR2015-01780, and IPR2015-01785 (Sept. 17, 2016)
`3 Nair, Anroop B., Srinivasa M. Sammeta, Hyun D. Kim, Bireswar Chakraborty,
`Phillip M. Friden, and S. Narasimha Murthy. “Alteration of the diffusional
`
` 4
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`
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`
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`
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`C.F.R. § 42.64, Petitioner reserves all objections made on the record at that
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`deposition. Petitioner objects as inadmissible hearsay under FRE 801 to the
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`quotations from and citations to Ex. 2004 in Patent Owner’s Responses.
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`(IPR2018-00168, Paper #13, at 2 & n.2, 4, 18, 34, and 41; IPR2018-00169, Paper
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`#13 at 2 & n.2, 4, 19, 35, and 42; IPR2018-00170, Paper #14 at 2 & n.2, 4, 19,
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`34, and 41; IPR2018-00171, Paper #13 at 2 & n.2, 4, 18, 34, and 41.) Petitioner
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`objects to the quotation from and citations to Ex. 2004 as inadmissible hearsay
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`under FRE 801 in the direct testimony of Dr. Lane. (IPR2018-00168 Ex. 2014,
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`Lane ’938 Decl. ¶ 55 n.3; IPR2018-00169 Ex. 2014, Lane ’289 Decl. ¶ 58 n.3;
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`IPR2018-00170 Ex. 2014, Lane ’290 Decl. ¶ 59 n.3; IPR2018-00171 Ex. 2014,
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`Lane ’823 Decl. ¶ 53 n.3.) Petitioner also objects under 37 C.F.R. § 42.53 to the
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`use of Ex. 2004 as uncompelled direct testimony from the authors of Ex. 2004
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`without providing an affidavit in the form required by that provision. Petitioner
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`also objects under FRE 703, to the use of Ex. 2004 as expert testimony from the
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`authors of Ex. 2004 without properly qualifying them as experts. Petitioner also
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`objects under 37 C.F.R. § 42.65, to the use of Ex. 2004 as expert testimony from
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`the authors of Ex. 2004 without providing an affidavit meeting the requirements
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`of that provision. Petitioner also objects under FRE 901, lack of authentication.
`
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`barrier property of the nail leads to greater terbinafine drug loading and
`permeation.” International journal of pharmaceutics 375, no. 1–2 (2009): 22–27.
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` 5
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`
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`
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`Ex. 2005 is or purports to be an article Nair 2009b4 marked at the cross-
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`examination deposition of Dr. Murthy (Ex. 2018 at 43:24–49:15). Pursuant to 37
`
`C.F.R. § 42.64, Petitioner reserves all objections made on the record at that
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`deposition. Petitioner objects as inadmissible hearsay under FRE 801 to the
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`quotations from and citations to Ex. 2005 in Patent Owner’s Responses.
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`(IPR2018-00168, Paper #13 at 2 & n.3; 4, and 19; IPR2018-00169, Paper #13 at
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`2 & n.3, 4, and 20; IPR2018-00170, Paper #14 at 2 & n.3, 4, and 20; IPR2018-
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`00171, Paper #13 at 2 & n.3, 4, and 19.) Petitioner objects to the quotation from
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`and citations to Ex. 2005 as inadmissible hearsay under FRE 801 in the direct
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`testimony of Dr. Lane. (IPR2018-00168 Ex. 2014, Lane ’938 Decl. ¶ 55 n.3;
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`IPR2018-00169 Ex. 2014, Lane ’289 Decl. ¶ 58 n.3; IPR2018-00170 Ex. 2014,
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`Lane ’290 Decl. ¶ 59 n.3; IPR2018-00171 Ex. 2014, Lane ’823 Decl. ¶ 53 n.3.)
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`Petitioner also objects under 37 C.F.R. § 42.53 to the use of Ex. 2005 as
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`uncompelled direct testimony from the authors of Ex. 2005 without providing an
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`affidavit in the form required by that provision. Petitioner also objects under
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`FRE 703, to the use of Ex. 2005 as expert testimony from the authors of Ex. 2005
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`without properly qualifying them as experts. Petitioner also objects under 37
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`C.F.R. § 42.65, to the use of Ex. 2005 as expert testimony from the authors of Ex.
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`
`4 Nair, Anroop B., Srinivasa M. Sammeta, Siva Ram K. Vaka, and S. Narasimha
`Murthy. “A study on the effect of inorganic salts in transungual drug delivery of
`terbinafine.” Journal of Pharmacy and Pharmacology 61, no. 4 (2009): 431–437.
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` 6
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`2005 without providing an affidavit meeting the requirements of that provision.
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`Petitioner also objects under FRE 901, lack of authentication.
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`Ex. 2006 is or purports to be an article Shivakumar 20105 marked at the
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`cross-examination deposition of Dr. Murthy (Ex. 2018 Murthy 23-Aug-2018
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`Dep. at 49:16–53:24). Pursuant to 37 C.F.R. § 42.64, Petitioner reserves all
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`objections made on the record at that deposition. Petitioner objects as
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`inadmissible hearsay under FRE 801 to the quotations from and citations to Ex.
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`2006 in Patent Owner’s Responses. (IPR2018-00168, Paper #13 at 3 & n.4 and
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`4; IPR2018-00169, Paper #13 at 3 & n.4 and 4; IPR2018-00170, Paper #14 at 3
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`& n.4 and 4; IPR2018-00171, Paper #13 at 3 & n.4 and 4.) Petitioner also objects
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`under 37 C.F.R. § 42.53 to the use of Ex. 2006 as uncompelled direct testimony
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`from the authors of Ex. 2006 without providing an affidavit in the form required
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`by that provision. Petitioner also objects under FRE 703, to the use of Ex. 2006
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`as expert testimony from the authors of Ex. 2006 without properly qualifying
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`them as experts. Petitioner also objects under 37 C.F.R. § 42.65, to the use of Ex.
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`2006 as expert testimony from the authors of Ex. 2006 without providing an
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`affidavit meeting the requirements of that provision. Petitioner also objects under
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`FRE 901, lack of authentication.
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`5 Shivakumar, H. N., Siva Ram Kiran Vaka, NV Satheesh Madhav, Harish
`Chandra, and S. Narasimha Murthy. “Bilayered nail lacquer of terbinafine
`hydrochloride for treatment of onychomycosis.” Journal of pharmaceutical
`sciences 99, no. 10 (2010): 4267–4276.
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` 7
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`Ex. 2007 is or purports to be an article Shivakumar 20146 marked at the
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`cross-examination deposition of Dr. Murthy (Ex. 2018 Murthy 23-Aug-2018
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`Dep. at 63:6–75:9). Pursuant to 37 C.F.R. § 42.64, Petitioner reserves all
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`objections made on the record at that deposition. Petitioner objects as
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`inadmissible hearsay under FRE 801 to the quotations from and citations to Ex.
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`2007 in Patent Owner’s Responses. (IPR2018-00168, Paper #13 at 18–19, 20
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`(twice), 21, 22, 24, and 41; IPR2018-00169, Paper #13 at 19, 21 (twice), 22, 23,
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`25, and 42; IPR2018-00170, Paper #14 at 19, 21 (twice), 22, 23, 25, and 41;
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`IPR2018-00171, Paper #13 at 18–19, 20 (twice), 21, 22, 24, and 41.) Petitioner
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`objects to the quotation from and citations to Ex. 2007 as inadmissible hearsay
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`under FRE 801 in the direct testimony of Dr. Lane. (IPR2018-00168 Ex. 2014,
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`Lane ’938 Decl. ¶¶ 40, 43, 48, 55, and 79; IPR2018-00169 Ex. 2014, Lane ’289
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`Decl. ¶¶ 43, 46, 51, 58, and 82; IPR2018-00170 Ex. 2014, Lane ’290 Decl. ¶¶ 44,
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`47, 52, 59, and 83; IPR2018-00171 Ex. 2014, Lane ’823 Decl. ¶¶ 38, 41, 46, 53,
`
`and 77.) Petitioner also objects under 37 C.F.R. § 42.53 to the use of Ex. 2007 as
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`uncompelled direct testimony from the authors of Ex. 2007 without providing an
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`affidavit in the form required by that provision. Petitioner also objects under
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`FRE 703, to the use of Ex. 2007 as expert testimony from the authors of Ex. 2007
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`6 Shivakumar, H. N., M. A. Repka, and S. Narasimha Murthy. “Transungual drug
`delivery: an update.” Journal of Drug Delivery Science and Technology 24, no. 3
`(2014): 301–310.
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` 8
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`
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`without properly qualifying them as experts. Petitioner also objects under 37
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`C.F.R. § 42.65, to the use of Ex. 2007 as expert testimony from the authors of Ex.
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`2007 without providing an affidavit meeting the requirements of that provision.
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`Petitioner also objects under FRE 901, lack of authentication.
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`Ex. 2008 is or purports to be an article Murthy 20077 marked at the cross-
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`examination deposition of Dr. Murthy (Ex. 2018 Murthy 23-Aug-2018 Dep. at
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`79:14–80:22). Pursuant to 37 C.F.R. § 42.64, Petitioner reserves all objections
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`made on the record at that deposition. Petitioner objects as inadmissible hearsay
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`under FRE 801 to the quotations from and citations to Ex. 2008 in Patent
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`Owner’s Responses. (IPR2018-00168, Paper #13 at 1–2 & n.1, 3 & n.4, 4, 16,
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`17, 21 (twice), 22, 43, and 45; IPR2018-00169, Paper #13 at 2 & n.1, 3 & n.4, 4,
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`16, 17, 22 (twice), 23, 44, and 47; IPR2018-00170, Paper #14 at 1–2 & n.1, 3 &
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`n.4, 4, 16, 17, 22 (twice), 23, 44, and 46; IPR2018-00171, Paper #13 at 1–2 &
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`n.1, 3 & n.4, 4, 16, 17, 21 (twice), 22, 43, and 45.) Petitioner objects to the
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`quotation from and citations to Ex. 2008 as inadmissible hearsay under FRE 801
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`in the direct testimony of Dr. Reider. (IPR2018-00168 Ex. 2013, Reider ’938
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`Decl. ¶ 63; IPR2018-00169 Ex. 2013, Reider ’289 Decl. ¶ 66; IPR2018-00170
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`Ex. 2013, Reider ’290 Decl. ¶ 67; IPR2018-00171 Ex. 2013, Reider ’823 Decl.
`
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`7 Narasimha Murthy, S., Dora E. Wiskirchen, and Christopher Paul Bowers.
`“Iontophoretic drug delivery across human nail.” Journal of pharmaceutical
`sciences 96, no. 2 (2007): 305–311.
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` 9
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`
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`¶ 61.) Petitioner objects to the quotation from and citations to Ex. 2008 as
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`inadmissible hearsay under FRE 801 in the direct testimony of Dr. Lane.
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`(IPR2018-00168 Ex. 2014, Lane ’938 Decl. ¶¶ 43 (twice), 44, 46, 55, 74, 76, and
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`81; IPR2018-00169 Ex. 2014, Lane ’289 Decl. ¶¶ 46 (twice), 47, 49, 58, 77, 79,
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`and 84; IPR2018-00170 Ex. 2014, Lane ’290 Decl. ¶¶ 47 (twice), 48, 50, 59, 78,
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`80, and 85; IPR2018-00171 Ex. 2014, Lane ’823 Decl. ¶¶ 41 (twice), 42, 44, 53,
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`72, 74, and 79.) Petitioner also objects under 37 C.F.R. § 42.53 to the use of Ex.
`
`2008 as uncompelled direct testimony from the authors of Ex. 2008 without
`
`providing an affidavit in the form required by that provision. Petitioner also
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`objects under FRE 703, to the use of Ex. 2008 as expert testimony from the
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`authors of Ex. 2008 without properly qualifying them as experts. Petitioner also
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`objects under 37 C.F.R. § 42.65, to the use of Ex. 2008 as expert testimony from
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`the authors of Ex. 2008 without providing an affidavit meeting the requirements
`
`of that provision. Petitioner also objects under FRE 901, lack of authentication.
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`Ex. 2009 is or purports to be an article Gupta 20038 marked at the cross-
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`examination deposition of Dr. Murthy (Ex. 2018 Murthy 23-Aug-2018 Dep. at
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`69:10–74:2). Pursuant to 37 C.F.R. § 42.64, Petitioner reserves all objections
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`made on the record at that deposition. Petitioner objects as inadmissible hearsay
`
`
`8 Gupta, Aditya K., Jennifer E. Ryder, and Robert Baran. “The use of topical
`therapies to treat onychomycosis.” Dermatologic clinics 21, no. 3 (2003): 481–
`489.
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`
`10
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`
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`under FRE 801 to the quotations from and citations to Ex. 2009 in Patent
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`Owner’s Responses. (IPR2018-00168, Paper #13 at 24; IPR2018-00169, Paper
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`#13 at 25; IPR2018-00170, Paper #14 at 25; IPR2018-00171, Paper #13 at 24.)
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`Petitioner also objects under 37 C.F.R. § 42.53 to the use of Ex. 2008 as
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`uncompelled direct testimony from the authors of Ex. 2008 without providing an
`
`affidavit in the form required by that provision. Petitioner also objects under
`
`FRE 703, to the use of Ex. 2008 as expert testimony from the authors of Ex. 2008
`
`without properly qualifying them as experts. Petitioner also objects under 37
`
`C.F.R. § 42.65, to the use of Ex. 2008 as expert testimony from the authors of Ex.
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`2008 without providing an affidavit meeting the requirements of that provision.
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`Petitioner also objects under FRE 901, lack of authentication.
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`Ex. 2010 is or purports to be the Kahl Apr-2016 Dep.9 marked at the cross-
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`examination deposition of Dr. Kahl (Ex. 2017 Kahl 23-Aug-2018 Dep. at 12:15–
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`14:25). Pursuant to 37 C.F.R. § 42.64, Petitioner reserves all objections made on
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`the record at that deposition, including its objection under FRE 106. Also, as
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`stated on the record (Ex. 2017, Kahl 23-Aug-2018 Dep. at 12:20–13:23), the
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`Petitioner agreed to allow the use of these depositions in prior related
`
`proceedings to the extent relevant to the issues in the current IPRs, but reserved
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`the right to object on grounds including relevance to the extent testimony in that
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`9 Transcript of the Deposition of Stephen B. Kahl, Ph.D., taken in IPR2015-
`01776, IPR2015-01780, and IPR2015-01785 (April 7–8, 2016).
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`11
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`
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`deposition is not relevant in this proceeding. Because Patent Owner does not cite
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`Ex. 2010 in any of Patent Owner’s Responses, Petitioner objects to the entirety of
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`Ex. 2010 on grounds of relevance under FRE 402 and as exceeding the scope of
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`cross under 37 C.F.R. § 42.53.
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`Ex. 2011 is or purports to be the Kahl Sep-2016 Dep.10 marked at the
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`cross-examination deposition of Dr. Kahl (Ex. 2017 Kahl 23-Aug-2018 Dep. at
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`15:7–16:23). Pursuant to 37 C.F.R. § 42.64, Petitioner reserves all objections
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`made on the record at that deposition, including its objection under FRE 106. As
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`stated on the record (Ex. 2017, Kahl 23-Aug-2018 Dep. at 12:20–13:23),
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`Petitioner agreed to allow the use of these depositions in prior related
`
`proceedings to the extent relevant to the issues in the current IPRs, but reserved
`
`the right to object on grounds including relevance to the extent testimony in that
`
`deposition is not relevant in this proceeding. Because Patent Owner does not cite
`
`Ex. 2011 in any of Patent Owner’s Responses, Petitioner objects to the entirety of
`
`Ex. 2011 on grounds of relevance under FRE 402 and as exceeding the scope of
`
`cross under 37 C.F.R. § 42.53.
`
`Ex. 2012 is or purports to be a document Structural Diagrams11 marked at
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`the cross-examination deposition of Dr. Kahl (Ex. 2017, Kahl 23-Aug-2018 at
`
`
`10 Transcript of the Deposition of Stephen B. Kahl, Ph.D., taken in IPR2015-
`01776, IPR2015-01780, and IPR2015-01785 (Sep. 14, 2016).
`11 Previously marked as Exs. 15–75 in the Kahl Apr-2016 Dep. (Ex. 2010).
`
`12
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`
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`
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`66:10–95:7). Because Patent Owner does not cite Ex. 2012 in any of Patent
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`Owner’s Responses, Petitioner objects to the entirety of Ex. 2012 on grounds of
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`relevance under FRE 402 and as exceeding the scope of cross under 37 C.F.R.
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`§ 42.53. This exhibit is inadmissible as lacking relevance. The Patent Owner does
`
`not cite this exhibit at any point in its Patent Owner Response. Indeed, the
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`omission of any citation to this exhibit in the Patent Owner’s Response suggests
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`that Patent Owner believes that this exhibit has little if any probative value. As
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`such, this exhibit is inadmissible as evidence to be presented to the Board under
`
`FRE 402.
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`IPR2018-00168 Ex. 2013 is or purports to be the Reider ’938 Decl.12
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`direct testimony. Petitioner objects to ¶ 5 in that it seeks to reserve the right to
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`supplement the opinions offered, which in general is not permissible in direct
`
`testimony in a patent trial. Petitioner also objects to the offering of expert opinion
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`testimony in IPR2018-00168 Ex. 2013 because while the exhibit does recite parts
`
`of the declarants’ background, it fails to state a proffer of the scope of his area of
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`expertise on which he will opine pursuant to FRE 703. Petitioner objects to ¶¶ 39,
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`40, 51, 52, 66, 67 pursuant to FRE 702 that the declarant (Dr. Reider) purports to
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`offer expert opinions that are not based on sufficient facts or data, and are
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`therefore unreliable and unhelpful to the fact-finder, as mischaracterizing the
`
`12 Declaration of Paul J. Reider, Ph.D. in Support of Patent Owner’s Response,
`Case No. IPR2018-00168, Patent No. 9,549,938 (Sept. 7, 2018).
`
`13
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`
`
`
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`disclosures of the prior art of record, speculating as to the composition and
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`properties of compounds disclosed in the prior art of record, particularly without
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`any testing to support such conjecture, and speculating as to how a person of
`
`ordinary skill in the art would have interpreted disclosures in the prior art of
`
`record. For example, Dr. Reider does not describe any testing of the mixture
`
`disclosed in Brehove to support his statement that the active compounds would
`
`hydrolyze in an environment where water is present. (See, e.g., IPR2018-00168
`
`Ex. 2013 ¶¶ 51, 52, 66, 67.) By way of further example, Dr. Reider does not
`
`provide any support for his statements that the active ingredient in VELCADE®
`
`became more stable by lyophilizing borteomib in the presence of mannitol. (See,
`
`e.g., id. ¶¶ 39, 40.) Petitioner objects pursuant to FRE 402 that, for the same
`
`reasons, the declarant’s testimony is irrelevant to any material issue in these
`
`proceedings. Petitioner further objects to ¶¶ 68–71 on the basis that the opinions
`
`are not relevant because they are not directed to the correct standard of a
`
`reasonable expectation of success and do not account
`
`for
`
`routine
`
`experimentation, such as dose finding studies. Petitioner objects pursuant to 37
`
`C.F.R. § 42.65(b) that the declarant does not sufficiently disclose the facts or data
`
`upon which his opinions are based, and does not describe any testing. See also,
`
`FRE 702 objection, supra. Petitioner further objects pursuant to FRE 801 on the
`
`basis that citations to technical articles for the truth of the matter asserted are
`
`
`14
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`
`
`
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`inadmissible hearsay. (See, e.g., IPR2018-00168 Ex. 2013 ¶¶ 25, 30, 33, 37, 38,
`
`41, 42, 44, 45, 48, 51, 52, 59, 60, 61 & n.1, 62, 63, 65, 66, 67, 68, and 69.)
`
`Petitioner also objects to Patent Owner’s use of Ex. 1020, Ex. 1022, Ex. 1032,
`
`and Ex. 1037 in Patent Owner’s Response as hearsay in that those exhibits are
`
`out of court statements by the authors of those documents which are there cited,
`
`quoted, and/or used for the truth of the matters asserted. (IPR2018-00168, Paper
`
`# 13 at 3 n.5, 4 n.6, 9, 14 n.12, 15 n.14, 18, 20, 22, 34, 40 n.19.) Petitioner also
`
`objects that IPR2018-00168 Ex. 2013 ¶ 72 is in the form similar to that for an
`
`inventor’s oath under 35 U.S.C. § 115, but is neither an affidavit sworn before a
`
`person authorized to administer oaths nor an unsworn declaration under penalty
`
`of perjury in the form required 28 U.S.C. § 1745, and therefore not admissible as
`
`evidence on direct testimony in this proceeding. (IPR2018-00168 Ex. 2013 ¶ 72.)
`
`IPR2018-00169 Ex. 2013 is or purports to be the Reider ’289 Decl.13
`
`direct testimony. Petitioner objects to ¶ 5 in that it seeks to reserve the right to
`
`supplement the opinions offered, which in general is not permissible in direct
`
`testimony in a patent trial. Petitioner also objects to the offering of expert opinion
`
`testimony in IPR2018-00169 Ex. 2013 because while the exhibit does recite parts
`
`of the declarants’ background, it fails to state a proffer of the scope of his area of
`
`expertise on which he will opine pursuant to FRE 703. Petitioner objects to ¶¶ 42,
`
`13 Declaration of Paul J. Reider, Ph.D. in Support of Patent Owner’s Response,
`Case No. IPR2018-00169, Patent No. 9,566,289 (Sept. 7, 2018).
`
`15
`
`
`
`
`
`43, 54, 55, 69, and 70 pursuant to FRE 702, that the declarant (Dr. Reider)
`
`purports to offer expert opinions that are not based on sufficient facts or data, and
`
`are therefore unreliable and unhelpful to the fact-finder, as mischaracterizing the
`
`disclosures of the prior art of record, speculating as to the composition and
`
`properties of compounds disclosed in the prior art of record, particularly without
`
`any testing to support such conjecture, and speculating as to how a person of
`
`ordinary skill in the art would have interpreted disclosures in the prior art of
`
`record. For example, Dr. Reider does not describe any testing of the mixture
`
`disclosed in Brehove to support his statement that the active compounds would
`
`hydrolyze in an environment where water is present. (See, e.g., IPR2018-00169
`
`Ex. 2013 ¶¶ 54, 55, 69, 70.) By way of further example, Dr. Reider does not
`
`provide any support for his statements that the active ingredient in VELCADE®
`
`became more stable by lyophilizing borteomib in the presence of mannitol. (See,
`
`e.g., id. ¶¶ 42, 43.) Petitioner objects pursuant to FRE 402 that, for the same
`
`reasons, the declarant’s testimony is irrelevant to any material issue in these
`
`proceedings. Petitioner further objects to ¶¶ 71–74 on the basis that the opinions
`
`are not relevant because they are not directed to the correct standard of a
`
`reasonable expectation of success and do not account
`
`for
`
`routine
`
`experimentation, such as dose finding studies. Petitioner objects pursuant to 37
`
`C.F.R. § 42.65(b) that the declarant does not sufficiently disclose the facts or data
`
`
`16
`
`
`
`
`
`upon which his opinions are based, and does not describe any testing. See also,
`
`FRE 702 objection, supra. Petitioner further objects pursuant to FRE 801 on the
`
`basis that ipr2018-00169 Ex. 2013 includes citations to technical articles for the
`
`truth of the matter asserted. Such citations are inadmissible hearsay. (See, e.g.,
`
`IPR2018-00169 Ex. 2013 ¶¶ 28, 33, 36, 40, 41, 44, 45, 47, 48, 51, 54, 55, 62, 63,
`
`64 & n.1, 65, 66, 68, 69, 70, 71, and 72.) Petitioner also objects to Patent
`
`Owner’s use of Ex. 1020, Ex. 1022, Ex. 1032, and Ex. 1037 in Patent Owner’s
`
`Response as hearsay in that those exhibits are out of court statements by the
`
`authors of those documents which are there cited, quoted, and/or used for the
`
`truth of the matters asserted. (IPR2018-00169, Paper # 13 at 3 n.5, 4 n.6, 9, 14
`
`n.12, 16 n.14, 19, 21, 23, 35, 41 n.20.) Petitioner also objects that IPR2018-
`
`00169 Ex. 2013 ¶ 75 is in the form similar to that for an inventor’s oath under 35
`
`U.S.C. § 115, but is neither an affidavit sworn before a person authorized to
`
`administer oaths nor an unsworn declaration under penalty of perjury in the form
`
`required 28 U.S.C. § 1745, and therefore not admissible as evidence on direct
`
`testimony in this proceeding. (IPR2018-00169 Ex. 2013 ¶ 75.)
`
`IPR2018-00170 Ex. 2013 is or purports to be the Reider ’290 Decl.14
`
`direct testimony. Petitioner objects to ¶ 5 in that it seeks to reserve the right to
`
`supplement the opinions offered, which in general is not permissible in direct
`
`14 Declaration of Paul J. Reider, Ph.D. in Support of Patent Owner’s Response,
`Case No. IPR2018-00170, Patent No. 9,566,290 (Sept. 7, 2018).
`
`17
`
`
`
`
`
`testimony in a patent trial. Petitioner also objects to the offering of expert opinion
`
`testimony in IPR2018-00170 Ex. 2013 because while the exhibit does recite parts
`
`of the declarants’ background, it fails to state a proffer of the scope of his area of
`
`expertise on which he will opine pursuant to FRE 703. Petitioner objects to ¶¶ 43,
`
`44, 55, 56, 70, and 71 pursuant to FRE 702 that the declarant (Dr. Reider)
`
`purports to offer expert opinions that are not based on sufficient facts or data, and
`
`are therefore unreliable and unhelpful to the fact-finder, as mischaracterizing the
`
`disclosures of the prior art of record, speculating as to the composition and
`
`properties of compounds disclosed in the prior art of record, particularly without
`
`any testing to support such conjecture, and speculating as to how a person of
`
`ordinary skill in the art would have interpreted disclosures in the prior art of
`
`record. For example, Dr. Reider does not describe any testing of the mixture
`
`disclosed in Brehove to support his statement that the active compounds would
`
`hydrolyze in an environment where water is present. (See, e.g., IPR2018-00170
`
`Ex. 2013 ¶¶ 55, 56, 70, 71.) By way of further example, Dr. Reider does not
`
`provide any support for his statements that the active ingredient in VELCADE®
`
`became more stable by lyophilizing borteomib in the presence of mannitol. (See,
`
`e.g., id. ¶¶ 43, 44.) Petitioner objects pursuant to FRE 402 that, for the same
`
`reasons, the declarant’s testimony is irrelevant to any material issue in these
`
`proceedings. Petitioner further objects to ¶¶ 72–75 on the basis that the opinions
`
`
`18
`
`
`
`
`
`are not relevant because they are not directed to the correct standard of a
`
`reasonable expectation of success and do not account
`
`for
`
`routine
`
`experimentation, such as dose finding studies. Petitioner objects pursuant to 37
`
`C.F.R. § 42.65(b) that the declarant does not sufficiently disclose the facts or data
`
`upon which his opinions are based, and does not describe any testing. See also,
`
`FRE 702 objection, supra. Petitioner further objects pursuant to FRE 801 on the
`
`basis that IPR2018-00170 Ex. 2013 includes citations to technical articles for the
`
`truth of the matter asserted. Such citations are inadmissible hearsay. (See, e.g.,
`
`IPR2018-00170 Ex. 2013 ¶¶ 29, 34, 37, 41, 42, 45, 46, 48, 49, 52, 55, 56, 63, 64,
`
`65 & n.1, 66, 67, 69, 70, 71, 72, and 73.) Petitioner also objects to Patent
`
`Owner’s use of Ex. 1020, Ex. 1022, Ex. 1032, and Ex. 1037 in Patent Owner’s
`
`Response as hearsay in that those exhibits are out of court statements by the
`
`authors of those documents which are there cited, quoted, and/or used for the
`
`truth of the matters asserted. (IPR2018-00170, Paper # 14 at 3 n.5, 4 n.6, 9, 14
`
`n.12, 16 n.14, 19, 21, 23, 35, 41 n.19.) Petitioner also objects that IPR2018-
`
`00170 Ex. 2013 ¶ 76 is in the form similar to that for an inventor’s oath under 35
`
`U.S.C. § 115, but is neither an affidavit sworn before a person authorized to
`
`administer oaths nor an unsworn declaration under penalty of perjury in the form
`
`required 28 U.S.C. § 1745, and therefore not admissible as evidence on direct
`
`testimony in this proceeding. (IPR2018-00170 Ex. 2013 ¶ 76.)
`
`
`19
`
`
`
`
`
`IPR2018-00171 Ex. 2013 is or purports to be the Reider ’823 Decl.15
`
`direct testimony. Petitioner objects to ¶ 5 in that it seeks to reserve the right to
`
`supplement the opinions offered, which in general is not permissible in direct
`
`testimony in a patent trial. Petitioner also objects to the offering of expert opinion
`
`testimony in IPR2018-00171 Ex. 2013 because while the exhibit does recite parts
`
`of the declarants’ background, it fails to state a proffer of the scope of his area of
`
`expertise on which he will opine pursuant to FRE 703. Petitioner objects to ¶¶ 37,
`
`38, 49, 50, 64, 65 pursuant to FRE 702, that the declarant (Dr. Reider) purports to
`
`offer expert opinions that are not based on sufficient facts or data, and are
`
`therefore unreliable and unhelpful to the fact-finder, as mischaracterizing the
`
`disclosures of the prior art of record, speculating as to the composition and
`
`properties of compounds disclosed in the prior art of record, particularly without
`
`any testing to support such conjecture, and speculating as to how a person of
`
`ordinary skill in the art would have interpreted disclosures in the prior art of
`
`record. For example, Dr. Reider does not describe any testing of the mixture
`
`disclosed in Brehove to support his statement that the active compounds would
`
`hydrolyze in an environment where water is present. (See, e.g., IPR2018-00171
`
`Ex. 2013 ¶¶ 49, 50, 64, 65.) By way of further example, Dr. Reider does not
`
`provide any support for his statements that the active ingredient in VELCADE®
`
`15 Declaration of Paul J. Reider, Ph.D. in Support of Patent Owner’s Response,
`Case No. IPR2018-00171, Patent No. 9,572,823 (Sept. 7, 2018).
`
`20
`
`
`
`
`
`became more stable by lyophilizing borteomib in the presence of mannitol. (See,
`
`e.g., id. ¶¶ 37, 38.) Petitioner objects pursuant to FRE 402 that, for the same
`
`reasons, the declarant’s testimony is irrelevant to any material issue in these
`
`proceedings. Petitioner further objects to ¶¶ 66–69 on the basis that the opinions
`
`are not relevant because they are not directed to the correct standard of a
`
`reasonable expectation of success and do not account
`
`for
`
`routine
`
`experimentation,
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