Filed: March 20, 2024
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TWI PHARMACEUTICALS INC.,
`Petitioner,
`v.
`MERCK SERONO SA,
`Patent Owner.
`
`IPR2023-00049 (Patent 7,713,947 B2)
`IPR2023-00050 (Patent 8,377,903 B2)1
`
`Before ULRIKE W. JENKS, ZHENYU YANG and TINA HULSE,
`Administrative Patent Judges.
`
`JENKS, Administrative Patent Judge.
`
`PETITIONER’S OBJECTIONS TO EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 The identical paper is filed in each proceeding identified in the caption.
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TWI PHARMACEUTICALS INC.,
`Petitioner,
`v.
`MERCK SERONO SA,
`Patent Owner.
`
`IPR2023-00049 (Patent 7,713,947 B2)
`IPR2023-00050 (Patent 8,377,903 B2)1
`
`Before ULRIKE W. JENKS, ZHENYU YANG and TINA HULSE,
`Administrative Patent Judges.
`
`JENKS, Administrative Patent Judge.
`
`PETITIONER’S OBJECTIONS TO EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 The identical paper is filed in each proceeding identified in the caption.
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1) and the Federal Rules of Evidence (FRE)
`
`Petitioner TWi Pharmaceuticals Inc. (“TWi”) objects to evidence submitted in
`
`connection with Patent Owner’s Response, IPR2024-00049, Paper 28 (Mar. 13,
`
`2024) (“PO Resp. ’947”) and Patent Owner’s Response, IPR2024-00050, Paper 27
`
`(Mar. 13, 2024) (“PO Resp. ’903”) filed by Patent Owner Merck Serona SA (“Merck
`
`Serona”).
`
`OBJECTIONS
`
`1.
`
`Exhibit 2004: Sipe 19942
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is. See
`
`Ex. 2019, Lublin ¶¶ 25, 137, 161, 179, 181, 188; PO Resp. ’947 at 35, 42, 52, 56;
`
`PO Resp. ’903 at 36, 43, 53, 57.
`
`2.
`
`Exhibit 2005: Greenberg 20093
`
`FRE 802, 803, hearsay to the extent offered as proof of the matter asserted
`
`and not for other purposes such as impeachment. Patent Owner offers Ex. 2005 for
`
`
`2 Ex. 2004 purports to be J. C. Sipe et al., Cladribine in Treatment of Chronic
`
`Progressive Multiple Sclerosis, 344 THE LANCET 9 (1994).
`
`3 Ex. 2005 purports to be B. M. Greenberg et al., Multiple Sclerosis, in
`
`
`
`– 1 –
`
`
`
`the proof of the matter asserted. See PO Resp.’947 at 26, 41, and 58; PO Resp.’903
`
`at 28, 42, and 60; Ex. 2019, Lublin Decl. ¶¶ 26, 117, 134, 157, 162.
`
`FRE 703, no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. See Ex. 2019,
`
`Lublin Decl. ¶¶ 26, 117, 134, 157, and 162.
`
`3.
`
`Exhibit 2006: Krishnan 20084
`
`FRE 802, 803, hearsay to the extent offered as proof of the matter asserted
`
`and not for other purposes such as impeachment. Patent Owner offers Ex. 2005 for
`
`the proof of the matter asserted. PO Resp.’947 at 30, 34, 39; PO Resp.’903 at 31, 35,
`
`40; Ex. 2019, Lublin Decl. ¶¶ 65, 67, 70, 126, n.5, 136, 152, 154.
`
`FRE 703, no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. Ex. 2019,
`
`Lublin Decl. ¶¶ 65, 67, 70, 126 & n.5, 136, 152, 154.
`
`
`PHARMACOLOGY AND THERAPEUTICS: PRINCIPLES TO PRACTICE 685 (S. A.
`
`Waldman & A. Terzic eds., 2009).
`
`4 Ex. 2006 purports to be C. Krishnan et al., Reduction of Disease Activity and
`
`Disability With High-Dose Cyclophosphamide in Patients With Aggressive
`
`Multiple Sclerosis, 65 ARCHIVES OF NEUROLOGY 1044 (2008).
`
`– 2 –
`
`
`
`4.
`
`Exhibit 2007: Greenberg and Frohman 20085
`
`FRE 802, 803, hearsay to the extent offered as proof of the matter asserted
`
`and not for other purposes such as impeachment. Patent Owner offers Ex. 2005 for
`
`the proof of the matter asserted. PO Resp ’947 at 46, 47, 49; PO Resp. ’903 at 47,
`
`49; Ex. 2019, Lublin Decl. ¶¶ 74. 139, 169, 171.
`
`FRE 703, no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. Ex. 2019,
`
`Lublin Decl. ¶¶ 74. 139, 169, 171.
`
`5.
`
`Exhibit 2008: Greenberg 20106
`
`FRE 802, 803, hearsay to the extent offered as proof of the matter asserted
`
`and not for other purposes such as impeachment. Patent Owner offers Ex. 2005 for
`
`the proof of the matter asserted. PO Resp ’947 at 59, 62; PO Resp. ‘903 at 60, 63;
`
`Ex. 2019, Lublin Decl. ¶¶ 200, 217.
`
`
`5 Ex. 2007 purports to be B. Greenberg & E. M. Frohman, Defining Success in
`
`Multiple Sclerosis: Treatment Failures and Nonresponders, 8 PROCEEDINGS, JOHNS
`
`HOPKINS ADVANCED STUDIES IN MEDICINE 274 (2008).
`
`6 Ex. 2008 purports to be B. M. Greenberg et al., Current and Emerging Multiple
`
`Sclerosis Therapeutics, 16 CONTINUUM 58 (2010).
`
`– 3 –
`
`
`
`FRE 703, no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. Ex. 2019,
`
`Lublin Decl. ¶¶ 200, 217.
`
`6.
`
`Exhibit 2009: Greenberg Tr.7
`
`Petitioner restates and reserves all objections as stated on the record of the
`
`transcript.
`
`7.
`
`Exhibit 2010: Miller 2000.8
`
`Patent Owner cites the exhibit not for its disclosure of prior art, but instead
`
`for the author’s commentary on other prior art.
`
`FRE 602, lack of personal knowledge, Patent Owner offers the hearsay
`
`statements from Exhibit 2010 without showing personal knowledge by the declarant
`
`author.
`
`
`7 Ex. 2009 purports to be Transcript of Benjamin Greenberg, M.D. (February 26,
`
`2024).
`
`8 Ex. 2010 purports to be A. E. Miller & R. M. Herndon, Treatment Issues, in
`
`MULTIPLE SCLEROSIS: THE QUESTIONS YOU HAVE—THE ANSWERS YOU NEED 43
`
`(R. C. Kalb ed., 2nd Ed. 2000).
`
`– 4 –
`
`
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, (i)
`
`because Patent Owner relies on the hearsay statements from Exhibit 2010 that would
`
`constitute expert opinion testimony without qualifying the hearsay declarant as an
`
`expert witness, (ii) because Patent Owner cites the exhibits for expert opinions that
`
`are conclusory, that do not disclose supporting facts or data, that are based on
`
`unreliable facts, data, or methods, and that include testimony outside the scope of
`
`the declarant’s specialized knowledge (to the extent declarant has any such
`
`knowledge), and/or that will not assist the trier of fact, and (iii) because Patent
`
`Owner provides no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. See also,
`
`Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, Paper 9, 2022 WL 3648989, at
`
`*6 (P.T.A.B. Aug. 24, 2022) (designated precedential Feb. 10, 2023).
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`See PO Resp. ’903 at ,1 5, 47, 57; PO Resp ’947 at 1, 5, 49, 59; Ex. 2019,
`
`Lublin Decl. ¶¶ 74, 79, 171, 172, 175, 196.
`
`– 5 –
`
`
`
`8.
`
`Exhibit 2011: Noseworthy 2005.9
`
`Patent Owner cites the exhibit not for its disclosure of prior art, but instead
`
`for the author’s commentary on other prior art.
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, (i)
`
`because Patent Owner relies on the hearsay statements from Exhibit 2010 that would
`
`constitute expert opinion testimony without qualifying the hearsay declarant as an
`
`expert witness, (ii) because Patent Owner cites the exhibits for expert opinions that
`
`are conclusory, that do not disclose supporting facts or data, that are based on
`
`unreliable facts, data, or methods, and that include testimony outside the scope of
`
`the declarant’s specialized knowledge (to the extent declarant has any such
`
`knowledge), and/or that will not assist the trier of fact, and (iii) because Patent
`
`Owner provides no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. See also,
`
`Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, Paper 9, 2022 WL 3648989, at
`
`*6 (P.T.A.B. Aug. 24, 2022) (designated precedential Feb. 10, 2023).
`
`
`9 Ex. 2011 purports to be J. Noseworthy et al., Disease-Modifying Treatments in
`
`Multiple Sclerosis, in MCALPINE’S MULTIPLE SCLEROSIS 729 (A. Compston et al.
`
`eds., 4th ed. 2005).
`
`– 6 –
`
`
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`See PO Resp. ’903 at 1, 40, 43, 50, 53, 55, 58; PO Resp ’947 at 1, 41, 45, 51,
`
`55, 57, 60; Ex. 2019, Lublin Decl. ¶¶ 77, 79, 80, 157, 162, 175, 183, 184, 187, 190,
`
`193, 198.
`
`9.
`
`Exhibit 2012: Miller 2008.10
`
`Patent Owner cites the exhibit not for its disclosure of prior art, but instead
`
`for the author’s commentary on other prior art.
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, (i)
`
`because Patent Owner relies on the hearsay statements from Exhibit 2010 that would
`
`constitute expert opinion testimony without qualifying the hearsay declarant as an
`
`expert witness, (ii) because Patent Owner cites the exhibits for expert opinions that
`
`are conclusory, that do not disclose supporting facts or data, that are based on
`
`unreliable facts, data, or methods, and that include testimony outside the scope of
`
`
`10 Ex. 2012 purports to be the H. El-Moslimany & A. E. Miller, Escape Therapies
`
`and Management of Multiple Sclerosis, in MULTIPLE SCLEROSIS: A
`
`COMPREHENSIVE TEXT 333 (C. S. Raine et al. eds., 2008).
`
`– 7 –
`
`
`
`the declarant’s specialized knowledge (to the extent declarant has any such
`
`knowledge), and/or that will not assist the trier of fact, and (iii) because Patent
`
`Owner provides no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. See also,
`
`Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, Paper 9, 2022 WL 3648989, at
`
`*6 (P.T.A.B. Aug. 24, 2022) (designated precedential Feb. 10, 2023).
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`See PO Resp ’947 at 1, 5, 25, 40, 43, 53, 55, 58; PO Resp. ’903 at 1, 5, 26,
`
`42, 45, 55, 57, 59, 60; Ex. 2019, Lublin Decl. ¶¶ 72, 73, 76, 79, 81, 85, 90, 117, 118,
`
`134, 157, 162, 168, 175, 183, 184, 187, 193, 196, 197.
`
`10. Exhibit 2013: Lublin 2005.11
`
`Patent Owner cites the exhibit not for its disclosure of prior art, but instead
`
`for the author’s commentary on other prior art.
`
`
`11 Ex. 2013 purports to be F. Lublin, History of Modern Multiple Sclerosis Therapy,
`
`252 JOURNAL OF NEUROLOGY III/3 (2005).
`
`– 8 –
`
`
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, (i)
`
`because Patent Owner cites the exhibits for expert opinions that are conclusory, that
`
`do not disclose supporting facts or data, that are based on unreliable facts, data, or
`
`methods, and that include testimony outside the scope of the declarant’s specialized
`
`knowledge (to the extent declarant has any such knowledge), and/or that will not
`
`assist the trier of fact, and (ii) because Patent Owner provides no foundation for use
`
`by an expert as inadmissible hearsay and no showing of probative value sufficient
`
`for use directly with trier of fact. See also, Xerox Corp. v. Bytemark, Inc., No.
`
`IPR2022-00624, Paper 9, 2022 WL 3648989, at *6 (P.T.A.B. Aug. 24, 2022)
`
`(designated precedential Feb. 10, 2023).
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`PO Resp ’947 at 1, 4, 5, 40, 43, 48, 53, 55, 58; PO Resp. ’903 at 1, 4, 5, 42,
`
`45, 49, 55, 57, 60; Ex. 2019, Lublin Decl. ¶¶ 15, 52, 54, 71, 72, 73, 74, 79, 90, 157,
`
`162, 168, 171, 175, 183, 184, 187, 193, 199.
`
`– 9 –
`
`
`
`11. Exhibit 2014: Goodin 200212
`
`Patent Owner cites the exhibit not for its disclosure of prior art, but instead
`
`for the author’s commentary on other prior art.
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, (i)
`
`because Patent Owner cites the exhibits for expert opinions that are conclusory, that
`
`do not disclose supporting facts or data, that are based on unreliable facts, data, or
`
`methods, and that include testimony outside the scope of the declarant’s specialized
`
`knowledge (to the extent declarant has any such knowledge), and/or that will not
`
`assist the trier of fact, and (ii) because Patent Owner provides no foundation for use
`
`by an expert as inadmissible hearsay and no showing of probative value sufficient
`
`for use directly with trier of fact. See also, Xerox Corp. v. Bytemark, Inc., No.
`
`IPR2022-00624, Paper 9, 2022 WL 3648989, at *6 (P.T.A.B. Aug. 24, 2022)
`
`(designated precedential Feb. 10, 2023).
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`
`12 Ex. 2014 purports to be the articles D. S. Goodin et al., Disease Modifying
`
`Therapies in Multiple Sclerosis, 58 NEUROLOGY 169 (2002).
`
`– 10 –
`
`
`
`PO Resp ’947 at 1, 5, 29, 39, 42, 43, 54; PO Resp. ’903 at 1, 5, 31, 40, 44, 55;
`
`Ex. 2019, Lublin Decl. ¶¶ 22, 52, 66, 72, 74, 124, 148, 151, 161, 162, 171, 175, 184
`
`& n.6
`
`12. Exhibit 2015: Giovannoni 2023.13
`
`FRE 701–703, 37 C.F.R. § 42.65, Patent Owner provides no foundation for
`
`use by an expert as inadmissible hearsay and no showing of probative value
`
`sufficient for use directly with trier of fact. See also, Xerox Corp. v. Bytemark, Inc.,
`
`No. IPR2022-00624, Paper 9, 2022 WL 3648989, at *6 (P.T.A.B. Aug. 24, 2022)
`
`(designated precedential Feb. 10, 2023).
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`PO Resp ’947 at 1, 60; PO Resp. ’903 at 1, 62; Ex. 2019, Lublin Decl. ¶¶ 97,
`
`103, 207.
`
`
`13 Ex. 2015 purports to be G. Giovannoni et al., Long-Term Follow-Up of Patients
`
`with Relapsing Multiple Sclerosis From the CLARITY/CLARITY Extension Cohort
`
`of CLASSIC-MS: An Ambispective Study, 29 MULTIPLE SCLEROSIS JOURNAL 719
`
`(2023).
`
`– 11 –
`
`
`
`13. Exhibit 2016: Filippi and Rice 2000.14
`
`Patent Owner cites the exhibit not for its disclosure of prior art, but instead
`
`for the author’s commentary on other prior art.
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, (i)
`
`because Patent Owner relies on the hearsay statements from Exhibit 2010 that would
`
`constitute expert opinion testimony without qualifying the hearsay declarant as an
`
`expert witness, (ii) because Patent Owner cites the exhibits for expert opinions that
`
`are conclusory, that do not disclose supporting facts or data, that are based on
`
`unreliable facts, data, or methods, and that include testimony outside the scope of
`
`the declarant’s specialized knowledge (to the extent declarant has any such
`
`knowledge), and/or that will not assist the trier of fact, and (iii) because Patent
`
`Owner provides no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. See also,
`
`Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, Paper 9, 2022 WL 3648989, at
`
`*6 (P.T.A.B. Aug. 24, 2022) (designated precedential Feb. 10, 2023).
`
`
`14 Ex. 2016 purports to be M. Filippi et al., The Effect of Cladribine on T1 ‘Black
`
`Hole’ Changes in Progressive MS, 176 JOURNAL OF THE NEUROLOGICAL SCIENCES
`
`42 (2000).
`
`– 12 –
`
`
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`PO Resp ’947 at 2, 41, 46, 47, 53, 54; PO Resp. ’903 at 2, 43, 48, 55, 56; Ex.
`
`2019, Lublin Decl. ¶¶ 26, 72, 91, 158, 167, 170, 183, 185, 195.
`
`14. Exhibit 2017: Joy 2001.15
`
`Patent Owner cites the exhibit not for its disclosure of prior art, but instead
`
`for the author’s commentary on other prior art.
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, (i)
`
`because Patent Owner relies on the hearsay statements from Exhibit 2010 that would
`
`constitute expert opinion testimony without qualifying the hearsay declarant as an
`
`expert witness, (ii) because Patent Owner cites the exhibits for expert opinions that
`
`are conclusory, that do not disclose supporting facts or data, that are based on
`
`unreliable facts, data, or methods, and that include testimony outside the scope of
`
`the declarant’s specialized knowledge (to the extent declarant has any such
`
`knowledge), and/or that will not assist the trier of fact, and (iii) because Patent
`
`
`15 Ex. 2017 purports to be J. E. Joy & R. B. Johnston, Jr., MULTIPLE SCLEROSIS:
`
`CURRENT STATUS AND STRATEGIES FOR THE FUTURE 17 (2001).
`
`– 13 –
`
`
`
`Owner provides no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. See also,
`
`Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, Paper 9, 2022 WL 3648989, at
`
`*6 (P.T.A.B. Aug. 24, 2022) (designated precedential Feb. 10, 2023).
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`PO Resp ’947 at 3; PO Resp. ’903 at 3; Ex. 2019, Lublin Decl. ¶¶ 53, 44, 60.
`
`15. Exhibit 2018: Neuhaus 2003.16
`
`Patent Owner cites the exhibit not for its disclosure of prior art, but instead
`
`for the author’s commentary on other prior art.
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, (i)
`
`because Patent Owner relies on the hearsay statements from Exhibit 2010 that would
`
`constitute expert opinion testimony without qualifying the hearsay declarant as an
`
`expert witness, (ii) because Patent Owner cites the exhibits for expert opinions that
`
`
`16 Ex. 2018 purports to be O. Neuhaus et al., Immunomodulation in Multiple
`
`Sclerosis: From Immunosuppression to Neuroprotection, 24 TRENDS IN
`
`PHARMACOLOGICAL SCIENCES 131 (2003).
`
`– 14 –
`
`
`
`are conclusory, that do not disclose supporting facts or data, that are based on
`
`unreliable facts, data, or methods, and that include testimony outside the scope of
`
`the declarant’s specialized knowledge (to the extent declarant has any such
`
`knowledge), and/or that will not assist the trier of fact, and (iii) because Patent
`
`Owner provides no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. See also,
`
`Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, Paper 9, 2022 WL 3648989, at
`
`*6 (P.T.A.B. Aug. 24, 2022) (designated precedential Feb. 10, 2023).
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`PO Resp ’947 at 3; PO Resp. ’903 at 3; Ex. 2019, Lublin Decl. ¶¶ 43, 44, 53.
`
`16. Exhibit 2019: Lublin Decl.17
`
`Petitioner objects to the admissibility of Exhibit 2019 under FRE 701-703,
`
`because they contain opinions that are conclusory, that do not disclose supporting
`
`facts or data, that are based on unreliable facts, data, or methods, and that include
`
`
`17 Ex. 2019 is titled Declaration Of Fred D. Lublin, M.D. Under 37 C.F.R. § 1.68.
`
`– 15 –
`
`
`
`testimony outside the scope of Dr. Lublin’s specialized knowledge (to the extent Dr.
`
`Lublin has any such knowledge) that will not assist the trier of fact.
`
`Petitioner objects to select paragraphs of Dr. Lublin’s declaration as described
`
`below:
`
`Throughout this paper Petitioner has objected to certain exhibits on the
`
`grounds that they have “no foundation for use by an expert as inadmissible hearsay
`
`and no showing of probative value sufficient for use directly with trier of fact.”
`
`Petitioner incorporates those objections by reference herein, and objects to each and
`
`every paragraph of Ex. 2019 that cites to or relies upon those exhibits.
`
`More generally, Petitioner further objects to any paragraph in Exhibit 2019
`
`that relies upon an exhibit objected to herein, for the reasons set forth in those
`
`objections.
`
`Petitioner objects to ¶¶ 195–200 as applying a legally incorrect understanding
`
`of “skepticism” as a secondary consideration for obviousness.
`
`Petitioner objects to ¶¶ 201–209 because while it purports to concern
`
`unexpected results to fails to explain why the results were unexpected or what would
`
`have been expected instead.
`
`Petitioner objects to ¶¶ 210–218 as purporting to address “long felt need,” it
`
`limits its comparison to FDA approved treatments instead of the closest prior art.
`
`– 16 –
`
`
`
`Petitioner objects to ¶¶ 219–232 as applying an incorrect standard for “nexus”
`
`in assuming that any method that practices the claims has a sufficient nexus, and
`
`further in that it fails to identify what alleged benefits have such a next to the
`
`different claims of the ’947 and ’903 patent, respectively.
`
`17. Exhibit 2020: Durelli 2003.18
`
`Patent Owner cites the exhibit not for its disclosure of prior art, but instead
`
`for the author’s commentary on other prior art.
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, (i)
`
`because Patent Owner relies on the hearsay statements from Exhibit 2010 that would
`
`constitute expert opinion testimony without qualifying the hearsay declarant as an
`
`expert witness, (ii) because Patent Owner cites the exhibits for expert opinions that
`
`are conclusory, that do not disclose supporting facts or data, that are based on
`
`unreliable facts, data, or methods, and that include testimony outside the scope of
`
`the declarant’s specialized knowledge (to the extent declarant has any such
`
`knowledge), and/or that will not assist the trier of fact, and (iii) because Patent
`
`Owner provides no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. See also,
`
`
`18 Ex. 2020 purports to be L. Durelli, Dose and Frequency of Interferon Treatment
`
`Matter, 250 JOURNAL OF NEUROLOGY IV/9 (2003).
`
`– 17 –
`
`
`
`Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, Paper 9, 2022 WL 3648989, at
`
`*6 (P.T.A.B. Aug. 24, 2022) (designated precedential Feb. 10, 2023).
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`PO Resp ’947 at 4, 28; PO Resp. ’903 at 4, 29; Ex. 2019, Lublin Decl. ¶¶ 58,
`
`59, 122, 212.
`
`18. Exhibit 2021: Rudick 2004.19
`
`Patent Owner cites the exhibit not for its disclosure of prior art, but instead
`
`for the author’s commentary on other prior art.
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, (i)
`
`because Patent Owner relies on the hearsay statements from Exhibit 2010 that would
`
`constitute expert opinion testimony without qualifying the hearsay declarant as an
`
`expert witness, (ii) because Patent Owner cites the exhibits for expert opinions that
`
`are conclusory, that do not disclose supporting facts or data, that are based on
`
`
`19 Ex. 2021 purports to be R. Rudick & A. Sandrock, Natalizumab: α4-Integrin
`
`Antagonist Selective Adhesion Molecule Inhibitors for MS, 4 EXPERT REVIEW OF
`
`NEUROTHERAPEUTICS 571 (2004).
`
`– 18 –
`
`
`
`unreliable facts, data, or methods, and that include testimony outside the scope of
`
`the declarant’s specialized knowledge (to the extent declarant has any such
`
`knowledge), and/or that will not assist the trier of fact, and (iii) because Patent
`
`Owner provides no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. See also,
`
`Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, Paper 9, 2022 WL 3648989, at
`
`*6 (P.T.A.B. Aug. 24, 2022) (designated precedential Feb. 10, 2023).
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`PO Resp ’947 at 4; PO Resp. ’903 at 4; Ex. 2019, Lublin Decl. ¶¶ 54, 56, 58,
`
`60, 122.
`
`19. Exhibit 2022: Alberts 1985.20
`
`Patent Owner cites the exhibit not for its disclosure of prior art, but instead
`
`for the author’s commentary on other prior art.
`
`
`20 Ex. 2022 purports to be D. S. Alberts et al., Disposition of Mitoxantrone in
`
`Cancer Patients, 45 CANCER RESEARCH 1879 (1985).
`
`– 19 –
`
`
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, (i)
`
`because Patent Owner relies on the hearsay statements from Exhibit 2010 that would
`
`constitute expert opinion testimony without qualifying the hearsay declarant as an
`
`expert witness, (ii) because Patent Owner cites the exhibits for expert opinions that
`
`are conclusory, that do not disclose supporting facts or data, that are based on
`
`unreliable facts, data, or methods, and that include testimony outside the scope of
`
`the declarant’s specialized knowledge (to the extent declarant has any such
`
`knowledge), and/or that will not assist the trier of fact, and (iii) because Patent
`
`Owner provides no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. See also,
`
`Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, Paper 9, 2022 WL 3648989, at
`
`*6 (P.T.A.B. Aug. 24, 2022) (designated precedential Feb. 10, 2023).
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`PO Resp ’947 at 4, 28; PO Resp. ’903 at4, 30; Ex. 2019, Lublin Decl. ¶¶ 23,
`
`61, 123, 150.
`
`– 20 –
`
`
`
`20. Exhibit 2023: Rammohan 2020.21
`
`Patent Owner cites the exhibit not for its disclosure of prior art, but instead
`
`for the author’s commentary on other prior art.
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, (i)
`
`because Patent Owner relies on the hearsay statements from Exhibit 2010 that would
`
`constitute expert opinion testimony without qualifying the hearsay declarant as an
`
`expert witness, (ii) because Patent Owner cites the exhibits for expert opinions that
`
`are conclusory, that do not disclose supporting facts or data, that are based on
`
`unreliable facts, data, or methods, and that include testimony outside the scope of
`
`the declarant’s specialized knowledge (to the extent declarant has any such
`
`knowledge), and/or that will not assist the trier of fact, and (iii) because Patent
`
`Owner provides no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. See also,
`
`Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, Paper 9, 2022 WL 3648989, at
`
`*6 (P.T.A.B. Aug. 24, 2022) (designated precedential Feb. 10, 2023).
`
`
`21 Ex. 2023 purports to be K. Rammohan et al., The Development of Cladribine
`
`Tablets for the Treatment of Multiple Sclerosis: A Comprehensive Review, 80
`
`DRUGS 1901 (2020).
`
`– 21 –
`
`
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`PO Resp ’947 at 4, 61, 63; PO Resp. ’903 at 4, 63, 64; Ex. 2019, Lublin Decl.
`
`¶¶ 86, 212, 213.
`
`21. Exhibit 2024: Kurtzke 1983.22
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, (i)
`
`because Patent Owner relies on the hearsay statements from Exhibit 2010 that would
`
`constitute expert opinion testimony without qualifying the hearsay declarant as an
`
`expert witness, (ii) because Patent Owner cites the exhibits for expert opinions that
`
`are conclusory, that do not disclose supporting facts or data, that are based on
`
`unreliable facts, data, or methods, and that include testimony outside the scope of
`
`the declarant’s specialized knowledge (to the extent declarant has any such
`
`knowledge), and/or that will not assist the trier of fact, and (iii) because Patent
`
`Owner provides no foundation for use by an expert as inadmissible hearsay and no
`
`
`22 Ex. 2024 purports to be J. F. Kurtzke, Rating Neurologic Impairment in Multiple
`
`Sclerosis: An Expanded Disability Status Scale (EDSS), 33 NEUROLOGY 1444
`
`(1983).
`
`– 22 –
`
`
`
`showing of probative value sufficient for use directly with trier of fact. See also,
`
`Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, Paper 9, 2022 WL 3648989, at
`
`*6 (P.T.A.B. Aug. 24, 2022) (designated precedential Feb. 10, 2023).
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`PO Resp ’947 at 5; PO Resp. ’903 at 5; Ex. 2019, Lublin Decl. ¶ 71.
`
`22. Exhibit 2025: Tullman 2002.23
`
`Patent Owner cites the exhibit not for its disclosure of prior art, but instead
`
`for the author’s commentary on other prior art.
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, (i)
`
`because Patent Owner relies on the hearsay statements from Exhibit 2010 that would
`
`constitute expert opinion testimony without qualifying the hearsay declarant as an
`
`expert witness, (ii) because Patent Owner cites the exhibits for expert opinions that
`
`are conclusory, that do not disclose supporting facts or data, that are based on
`
`
`23 Ex. 2025 purports to be M. J. Tullman et al., Immunotherapy of Multiple
`
`Sclerosis—Current Practice and Future Directions, 39 JOURNAL OF
`
`REHABILITATION RESEARCH AND DEVELOPMENT 273 (2002).
`
`– 23 –
`
`
`
`unreliable facts, data, or methods, and that include testimony outside the scope of
`
`the declarant’s specialized knowledge (to the extent declarant has any such
`
`knowledge), and/or that will not assist the trier of fact, and (iii) because Patent
`
`Owner provides no foundation for use by an expert as inadmissible hearsay and no
`
`showing of probative value sufficient for use directly with trier of fact. See also,
`
`Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, Paper 9, 2022 WL 3648989, at
`
`*6 (P.T.A.B. Aug. 24, 2022) (designated precedential Feb. 10, 2023).
`
`FRE 801, 802, hearsay, Patent Owner uses the exhibit’s contents as out of
`
`court statements offered for the truth of the matter asserted.
`
`FRE 901, authentication, Patent Owner as proponent produced no evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.
`
`PO Resp ’947 at 10, 43, 53, 55; PO Resp. ’903 at 42, 45, 55, 57; Ex. 2019,
`
`Lublin Decl. ¶¶ 52–55, 157, 168, 184, 187, 193.
`
`23. Exhibit 2026: Giovannoni 2010.24
`
`FRE 701–703, 37 C.F.R. § 42.65, lack of basis for expert testimony, because
`
`Patent Owner provides no foundation for use by an expert as inadmissible hearsay
`
`
`24 Ex. 2026 purports to be G. Giovannoni et al., A Placebo-Controlled Trial of Oral
`
`Cladribine for Relapsing Multiple Sclerosis, 362 NEW ENGLAND JOURNAL OF
`
`MEDICINE 416 (2010).
`
`– 24 –
`
`
`
`and no showing of probative value sufficient for use directly with trier of fact. See
`
`also, Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, Paper 9, 2022 WL
`
`3648989, at *6 (P.T.A.B. Aug. 24, 2022) (designated precedential Fe
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
