Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`Mail Stop: Patent Board
`Patent Trial and Appeal Board
`U.S. Patent And Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA(USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`
`v.
`
`ALKERMES PHARMA IRELAND LTD and
`ALKERMES CONTROLLED THERAPEUTICS, INC.,
`Patent Owners.
`
`Patent No. 6,667,061 to Ramstack et al.
`Issue Date: December 23, 2003
`Title: PREPARATION OF INJECTABLE
`SUSPENSIONS HAVING IMPROVED INJECTABILITY
`____________________________
`Inter Partes Review No. IPR2016-01096
`__________________________________________________________________
`
`OPPOSITION TO PATENT OWNERS’ MOTION TO EXCLUDE
`
`
`
`
`

`

`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES ..................................................................................... ii
`
`PETITIONERS’ EXHIBIT LIST .............................................................................. iv
`
`I.
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`ARGUMENT ................................................................................................... 2
`
`A. Petitioner’s Reply (Paper 40), Dr. DeLuca’s Declaration
`(Ex.1024), And Exhibits 1027, 1028, 1030, 1032,
`1034, 1036, 1037, And 1043 Should Not Be Excluded ........................... 2
`
`1. Luye’s Reply (Paper 40) And Dr. DeLuca’s Declaration
`(Ex.1024) Are Relevant And Alkermes Is Not Prejudiced ...................... 8
`
`2. Objections To Evidence Pursuant To 35 U.S.C. § 312(a)(3);
`37 C.F.R. §§ 42.23(b), 42.104(b)(5), And 42.123(b) Are Improper .....10
`
`B. Dr. DeLuca’s Declarations (Exs.1002 And 1024) Have
`Proper Factual Support And Should Not Be Excluded ..........................10
`
`C. The Tracy Declaration (Ex.1018) Should Not Be Excluded ..................11
`
`D. Portions Of Exs.1002 And 1024 And
`Exs.1019-1021 Should Not Be Excluded ...............................................13
`
`E. Exhibits 1014 And 1016-1022 Should Not Be Excluded .......................13
`
`II.
`
`CONCLUSION ..............................................................................................14
`
`
`
`
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`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`CASES
`Ariosa Diagnostics v. Bd. of Trs. of the Leland Stanford Junior Univ.,
`IPR2013-00308, Paper 20 (May 27, 2014) ........................................................... 3
`
`Blackberry Corp. v. Zipit Wireless, Inc.,
`IPR2014-01508, Paper 49 (Mar. 29, 2016) .......................................................... 2
`
`Ericsson Inc. v. Intellectual Ventures II LLC,
`IPR2014-00915, Paper No. 37 (Dec. 7, 2015) .................................................... 13
`
`Gulf States Utils. Co. v. Ecodyne Corp.,
`635 F.2d 517 (5th Cir. 1981) ................................................................................ 9
`
`Microsoft Corp. v. Parallel Networks Licensing, LLC,
`IPR2015-00483, Paper 81 (Aug. 11, 2016) .................................................... 9, 10
`
`Peshlakai v. Ruiz,
`39 F. Supp. 3d. 1264 (D.N.M. 2014) .................................................................... 8
`
`STATUTES, RULES & OTHER AUTHORITIES
`
`35 U.S.C. § 312(a)(3) ..................................................................................... 1, 10, 11
`
`37 C.F.R. § 42.20(c) ................................................................................................... 1
`
`37 C.F.R. § 42.23(b) ................................................................................ 1, 2, 3, 8, 10
`
`37 C.F.R. § 42.62(a) ................................................................................................. 10
`
`37 C.F.R. § 42.64(c) ................................................................................................... 1
`
`37 C.F.R. §§ 42.65(a) ............................................................................................... 11
`
`37 C.F.R. § 42.104(b)(5) ................................................................................ 1, 10, 11
`
`ii
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`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
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`37 C.F.R. § 42.123(b) .......................................................................................... 1, 10
`
`77 Fed. Reg. 48756 (Aug. 14, 2012)...................................................................... 1, 4
`
`FRE 106 ............................................................................................................... 2, 13
`
`FRE 401 ..................................................................................................................... 9
`
`FRE 402 ........................................................................................................... passim
`
`FRE 403 ....................................................................................................... 2, 8, 9, 10
`
`FRE 702 ................................................................................................... 2, 10, 11, 12
`
`FRE 703 ................................................................................................... 2, 10, 11, 12
`
`FRE 801 ............................................................................................................. 10, 12
`
`FRE 802 ......................................................................................................... 2, 10, 11
`
`
`
`
`
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`iii
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`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`PETITIONERS’ EXHIBIT LIST
`Exhibit # Reference
`U.S. Patent No. 6,667,061 (“the Patent”)
`1001
`1002
`Declaration of Dr. Patrick P. DeLuca
`Curriculum Vitae of Dr. Patrick P. DeLuca
`1003
`1004
`Intentionally Left Blank
`1005
`International Publication No. WO 95/13799 (“Ramstack”)
`1006
`U.S. Pharmacopeia Entry re: CMC, viscosity at 274-75, 1840 (1994)
`1007
`EP Pharmacopoeia Entry re: CMC, at 547-48(3d ed. 1997)
`1008
`Handbook of Pharmaceutical Excipients at 78-81, 135-38, 294-95,
`329-330, 375-78, 420-21, 439-42, 477-80, 481-82 (2nd ed. 1994)
`U.S. Patent No. 5,654,010 (“Johnson”)
`U.S. Patent No. 5,656,299 (“Kino”)
`International Publication No. WO199714408 (“Gustafsson”)
`Intentionally Left Blank
`Intentionally Left Blank
`Herbert A. Lieberman et al. (eds.), Pharmaceutical Dosage Forms:
`Disperse Systems, Vol.2, at 26-35, 40, 43-46, 261, 285-318 (2nd ed.
`rev. expanded 1996)
`U.S. Patent No. 6,495,164 (“the ’164 Patent”)
`Serial No. 10/259,949, Office Action, Apr. 9, 2003
`Serial No. 10/259,949, Applicants’ Resp., May 14, 2003
`Serial No. 09/577,875, Declaration of Mark A. Tracy, May 17, 2002
`Serial No. 10/259,949, Notice of Allowability, July 24, 2003
`Kenneth E. Avis et al. (eds.), 1 (Chs.2, 4, 5) Pharmaceutical Dosage
`Forms:Parenteral Medications 17-25, 115-16, 140-43, 150-51,
`173-75, 190-212 (2nd ed. rev. expanded Marcel Dekker, Inc. 1992)
`Leon Lachman, PhD et al., The Theory and Practice of Industrial
`Pharmacy 642-44, 783-84 (Lea & Febiger 3rd ed. 1986)
`Herbert A. Lieberman et al., Pharmaceutical Dosage Forms:
`Disperse Systems, Vol.1, at 287-313 (2nd ed. rev. expanded 1996)
`Orange Book entries for RISPERDAL®
`Supplemental Declaration of Dr. Patrick P. DeLuca, June 9, 2017
`Intentionally left blank
`Stedman’s Medical Dictionary (26th ed. 1995)
`
`1015
`1016
`1017
`1018
`1019
`1020
`
`1023
`1024
`1025
`1026
`
`iv
`
`1009
`1010
`1011
`1012
`1013
`1014
`
`1021
`
`1022
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`

`

`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
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`
`1033
`1034
`
`1040
`
`Exhibit # Reference
`Decapetyl components sheet
`1027
`1028
`International Publication No. WO 97/44039 (“Francois”)
`1029
`Intentionally left blank
`1030
`Nutropin Label (December 1999)
`1031
`Deposition Transcript of Cory J. Berkland, Ph.D., May 26, 2017
`1032 M.A. Macket et al., Tolerability of intramuscular injections of
`testosterone ester in oil vehicle, PubMed-NCBI, 10(4) Hum.
`Reprod. 862-5 (April 1995)
`Intentionally left blank
`USP 23 NF 18, Suspensions, The U.S. Pharmacopeia, The Nat’l
`Formulary, Jan. 1, 1995.
`Intentionally left blank
`Hawley’s Condensed Chemical Dictionary (12th ed. 1993)
`(Ch.19) Organic Chemistry (2nd ed. 1998)
`U.S. Patent No. 5,417,982
`Biochemicals and Reagents for Life Science Research,
`Sigma-Aldrich 1998
`Biochemicals and Reagents for Life Science Research,
`Sigma-Aldrich 1999
`Biochemicals and Reagents for Life Science Research,
`Sigma-Aldrich 2000/2001
`Lupron Label, Center for Drug Evaluation and Research, Application
`No. NDA 19732/S012
`International Publication No. WO 99/013780
`Deposition Transcript of Robson Storey, Ph.D., May 3, 2016
`
`
`1035
`1036
`1037
`1038
`1039
`
`1041
`
`1042
`
`1043
`1044
`
`v
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`

`

`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`I.
`
`INTRODUCTION
`
`Petitioners (“Luye”) respectfully submit this opposition to Patent Owners’
`
`(“Alkermes”) motion to exclude certain evidence. As the movant, Alkermes has
`
`the burden of proof to establish that it is entitled to the requested relief. 37 C.F.R.
`
`§ 42.20(c). As an initial matter, Alkermes’ motion to exclude does not clearly
`
`indicate the bases for which it seeks to exclude each exhibit as it did not follow the
`
`procedures set forth in 37 C.F.R. § 42.64(c) and the Patent Office Trial Practice
`
`Guide, 77 Fed. Reg. 48756, 48767 (Aug. 14, 2012). Therefore, Luye responds to
`
`the extent it understands the objections set forth in Alkermes’ motion to exclude.
`
`Nonetheless, Alkermes failed to meet this burden, having (i) offered merely
`
`unsupported conclusory attorney arguments that contradict the evidence, the
`
`Federal Rules of Evidence (“FRE”), and this Board’s prior decisions regarding
`
`admissibility of similar exhibits on similar facts or (ii) improperly requested
`
`exclusion of evidence. Alkermes asserts a number of objections to Luye’s Reply
`
`(Paper 40) and Dr. DeLuca’s Declaration (Ex.1024), most of which are improper
`
`bases of objections. 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.23(b), 42.104(b)(5),
`
`and 42.123(b). Alkermes asserts that its own Tracy Declaration should similarly be
`
`excluded. Alkermes further alleges that Paper 40, Exhibit 1024, and Exhibits 1027,
`
`
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`
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`

`

`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
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`1028, 1030, 1032, 1034, 1036, 1037, and 1043 are all irrelevant and prejudicial
`
`under FRE 402/403. With respect to both the Tracy Declaration (Ex.1018) and
`
`DeLuca’s Declarations (Exs.1002, 1024), Alkermes alleges that they should also
`
`be excluded under FRE 802, 703, 702, 402, and 403 as lacking evidentiary
`
`foundation. Finally, Alkermes asserts that Exhibits 1014 and 1016-1022 should be
`
`excluded as incomplete under FRE 106. None of Alkermes’ objections have merit,
`
`and the Board should deny Alkermes’ motion to exclude in full.
`
`I.
`
`ARGUMENT
`A.
`
`Petitioner’s Reply (Paper 40), Dr. DeLuca’s
`Declaration (Ex.1024), And Exhibits 1027, 1028, 1030,
`1032, 1034, 1036, 1037, And 1043 Should Not Be Excluded
`Alkermes makes a number of objections specific to its allegation that Luye’s
`
`Reply (Ex.1040) and Dr. DeLuca’s Declaration (Ex.1024) present arguments that
`
`are outside of the scope of Reply pursuant to 37 C.F.R. § 42.23(b). As a threshold
`
`matter, the Board has held that “a motion to exclude is not a proper vehicle for a
`
`party to raise the issue of arguments exceeding the permissible scope of a reply.”
`
`Blackberry Corp. v. Zipit Wireless, Inc., IPR2014-01508, Paper 49, at 40 (Mar. 29,
`
`2016). “Whether a reply contains arguments or evidence that are outside of a
`
`proper reply under 37 C.F.R. § 42.23(b) is left to our determination.” Id. at 40.
`
`Even so, Luye submits that both its Reply and Dr. DeLuca’s Declaration and the
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`2
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`

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`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
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`exhibits referred to therein are fully within the scope of reply under 37 C.F.R.
`
`§ 42.23(b). On its face, 37 C.F.R. § 42.23(b) permits Petitioner to “respond to
`
`arguments raised in the corresponding . . . patent owner response.” Luye may
`
`support its reply with new evidence, including the second Dr. Deluca Declaration
`
`(Ex.1024). Ariosa Diagnostics v. Bd. of Trs. of the Leland Stanford Junior Univ.,
`
`IPR2013-00308, Paper 20, at 2 (May 27, 2014).
`
`With respect to paragraphs 31-36, 40-46, 50-52, 56-60, and 86-89 of
`
`Exhibit 1024 and pages 8-11 and 13-15 of Luye’s Reply (Paper 40), Alkermes
`
`alleges Luye is seeking to “retroactively alter their inherency argument” by arguing
`
`that 3% CMC solution is within the claimed viscosity range for low viscosity
`
`CMCs. (Mot. 5.) In its Petition, Luye relied on the Tracy Declaration to support its
`
`assertion that Johnson’s and Gustafsson’s vehicles uses 3% CMC, which results in
`
`a viscosity within the range claimed in the ‘061 Patent. (Paper 5 pp.26, 39-40.) The
`
`paragraphs of Exhibit 1024 and the pages of Luye’s Reply that Alkermes seeks to
`
`exclude, however, are not outside the scope of reply. Instead, these paragraphs and
`
`pages are in response to Alkermes’ arguments that Johnson and Gustafsson do not
`
`specify viscosity of the injection vehicle, the particular grade or type of CMC used,
`
`or how the injection vehicle or CMC is prepared (Paper 33 pp.20-23, 26, 36) and
`
`their statements regarding testing data included in Exhibit 2059 (id. 37-38).
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`3
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`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`With respect to paragraphs 106-112 of Exhibit 1024 and pages 23-26 of
`
`Luye’s Reply (Paper 40), Alkermes asserts that Luye, for the first time, argues that
`
`the active ingredient of Ramstack can be combined with the microparticles and
`
`injection vehicle of Gustafsson to arrive at the claimed invention of claims 20-21.
`
`(Mot. 5-6.) Alkermes also argues that it is legally irrelevant whether a POSA could
`
`combine the active ingredient of Ramstack with Gustafsson’s microparticles and
`
`injection vehicle as Dr. Deluca testified. (Id. 6.) Motions to exclude, however,
`
`“may not be used to challenge the sufficiency of the evidence to prove a particular
`
`fact.” Trial Practice Guide, 77 Fed. Reg. at 49767. Further, in its Petition Luye
`
`argued that Gustafsson teaches that any active may be used in its formulation.
`
`(Paper 5 pp.39, 45-47.) The Board agreed. (Paper 13 p.30.) Both the paragraphs of
`
`Exhibit 1024 and the pages of Luye’s Reply that Alkermes seeks to exclude are not
`
`outside the scope of reply, but rather in response to Alkermes’ argument that there
`
`is no motivation to combine Gustafsson and Ramstack (Paper 33 pp.52-57), and
`
`that Gustafsson’s reservoir-type microparticles containing BSA differ from
`
`Ramstack’s PLGA-matrix-type microparticles containing risperidone (id. at 56).
`
`With respect to paragraphs 25-30, 91-97, 100-102, and 104 of Exhibit 1024,
`
`pages 6-8 and 17-26 of Luye’s Reply (Paper 40), and Exhibits 1036, 1037,
`
`and 1043, Alkermes asserts that Luye has changed its prima facie argument by
`
`4
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`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
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`relying on the PLGA coating of Gustafsson as satisfying the microparticle and
`
`polymeric binder limitations of claims 1-3, 6-9, 12-13, 20-21, and 22-33.
`
`(Mot. 6-7.) Alkermes also argues that Luye attempts to “reconcile the clear
`
`definition of microparticle” and “newly argue[s] that the starch in Gustafsson
`
`satisfies the microparticle and polymeric binder limitations of the claims.” (Id. 7.)
`
`In its Petition, Luye argued that Gustafsson teaches PGLA is a useful polymeric
`
`binder (Paper 5 p.45) and teaches any active may be used in its formulation (id.
`
`pp.39, 45-47). The Board agreed. (Paper 13 p.30.) The paragraphs of Exhibit 1024,
`
`the pages of Luye’s Reply, and Exhibits 1036, 1037, and 1043 that Alkermes seeks
`
`to exclude are not outside the scope of reply. Instead, the aforementioned
`
`paragraphs, pages, and exhibits are in response to Alkermes’ arguments that the
`
`active agent in Gustafsson is not dispersed or dissolved (i.e., entrapped) in a
`
`polymer (Paper 33 p.40) and that “starches are not polymers” (id. p.42).
`
`With respect to paragraphs 101-102 of Exhibit 1024, Alkermes alleges that
`
`Luye argues new combinations of references for claims 17-19, specifically, (1) the
`
`combination of the microparticles of Ramstack and the injection vehicle of
`
`Gustafsson and (2) the combination of the microparticles of WO 90/13780,
`
`incorporated by reference in Gustafsson, and the injection vehicles of Gustafsson.
`
`(Mot. 8.) First, Luye does not argue any new combinations, but relies on
`
`5
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`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
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`WO 90/13780 to show that Gustafsson is not as limited as Alkermes’ asserts, but
`
`should be considered for all that it teaches. Second, Luye asserts in its Petition that
`
`a POSA would expect to combine risperidone microspheres of Ramstack with the
`
`injection vehicle of Gustafsson with respect to claims 17-21. (Paper 5 pp.46-47.)
`
`Luye further argues that Gustafsson teaches that any active may be used in its
`
`formulation (id. pp.39, 46). The Board agreed. (Paper 13 p.30.) The paragraphs of
`
`Exhibit 1024 that Alkermes seeks to exclude are not outside the scope of reply but
`
`were offered in response to Alkermes’ argument that a POSA would not have
`
`selected Gustafsson for delivering risperidone particles (Paper 33 pp.49-52), that
`
`there was no reason to combine Gustafsson and Ramstack (id. pp.52-57), and that
`
`Gustafsson taught away from the claimed invention (id. pp.39-44).
`
`With respect to paragraphs 76 and 103-112 of Exhibit 1024 and pages 17
`
`and 22-26 of Luye’s Reply (Paper 40), Alkermes argues that Luye has advanced
`
`new arguments by asserting that “a POSA would have combined Johnson and Kino
`
`to minimize the difference between densities of the particles.” (Mot. 9.) Alkermes
`
`also asserts Luye’s argument that a POSA would combine Gustafsson with
`
`Ramstack to meet the limitations of claims 20-21 is a new argument. (Id.) Luye,
`
`however, put forward both of these arguments in its Petition. (Paper 5 pp.27, 39,
`
`45-47.) The paragraphs of Exhibit 1024 and the pages of Luye’s Reply that
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`6
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`

`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`Alkermes seeks to exclude are not outside the scope of reply. Instead, the
`
`paragraphs and pages are in response to Alkermes’ arguments that (1) the prior art
`
`taught away from increasing the density of an injection formulation and (2) there is
`
`no motivation to combine Ramstack and Gustafsson. (Paper 33 pp.7, 31, 41, 56.)
`
`With respect to paragraphs 73-76 of Exhibit 1024 and pages 12 and 17 of
`
`Luye’s Reply (Paper 40), Alkermes argues that Luye asserts a new theory on how
`
`Kino satisfies the density enhancing agent limitations of claims 4, 5, 10, and 11 by
`
`arguing that the sorbitol of Kino will dissolve into the injection vehicle. (Mot. 10.)
`
`Luye, in its Petition, asserted that “[a] POSA, reading Kino, would appreciate that
`
`sorbitol would increase the density of an injectable suspension” and that this
`
`increase would stabilize the formulation. (Paper 5 p.27.) The paragraphs of
`
`Exhibit 1024 and the pages of Luye’s Reply that Alkermes seeks to exclude are not
`
`outside the scope of reply, but were offered in response to Alkermes’ arguments
`
`that Kino taught including sorbitol before freezing to stabilize the microsphere.
`
`(Paper 33 p.30.)
`
`Finally with respect to paragraphs 7-24 of Exhibit 1024, pages 2-3 and 27-28
`
`of Luye’s Reply (Paper 40), and Exhibits 1027, 1028, 1030, 1032, and 1034,
`
`Alkermes argues that Luye introduced new art to support its position that
`
`viscosities within the claimed range were known and that Decapeptyl fulfills the
`
`7
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`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
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`viscosity limitation through the formulation’s margins of error. (Mot. 10.) In its
`
`Petition, Luye argues that the claimed viscosities are within ranges known in the
`
`prior art for injectable suspensions. (Paper 5 pp.6, 7, 9, 15.) The paragraphs of
`
`Exhibit 1024 and pages of Luye’s Reply that Alkermes seeks to exclude are not
`
`outside the scope of reply. Instead, the argument and exhibits respond to
`
`Alkermes’ arguments that “in direct contrast to ‘conventional teachings that an
`
`increase in the viscosity hinders injectability and syringeability[,]’” the “inventors’
`
`in vivo injectability studies showed ‘a dramatic improvement in injectability with
`
`increased injection vehicle viscosity.’” (Paper 33 pp.6-7 (emphasis in original).)
`
`Luye’s Reply and Dr. DeLuca’s Declaration (Ex.1024), in whole or in part,
`
`and Exhibits 1027, 1028, 1030, 1032, 1034, 1036, 1037, and 1043 were submitted
`
`within the proper scope of reply pursuant to 37 C.F.R. § 42.23(b), and thus, should
`
`not be excluded.
`
`1.
`
`Luye’s Reply (Paper 40) And Dr. DeLuca’s Declaration
`(Ex.1024) Are Relevant And Alkermes Is Not Prejudiced
`Alkermes seeks to exclude Luye’s Reply and Dr. DeLuca’s Declaration as
`
`irrelevant under FRE 402/403. The Federal Rules of Evidence set a low bar for
`
`relevance. Peshlakai v. Ruiz, 39 F. Supp. 3d. 1264, 1338 (D.N.M. 2014). Evidence
`
`is relevant if it has a tendency to make a fact of consequence more or less probable
`
`8
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`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`than it would be without the evidence. FRE 401. “Irrelevant evidence is not
`
`admissible.” FRE 402. Alkermes has failed to indicate why Luye’s Reply and
`
`Dr. DeLuca’s Declaration do not tend to make any fact of consequence more or
`
`less probable. Thus, Alkermes has failed to meet its burden of showing how Luye’s
`
`Reply and Dr. DeLuca’s Declaration are irrelevant.
`
`Alkermes also alleges that it is prejudiced by Luye’s Reply and
`
`Dr. DeLuca’s Declaration because it is precluded from “responding properly to
`
`these new arguments.” (Mot. 4.) Alkermes, however, requested a conference with
`
`the Board to address the very issues it alleges were outside of the scope of reply in
`
`its motion to exclude. Alkermes proposed an agreed upon procedure to address
`
`such issues, which the Board accepted. Thus, Alkermes asked for and was given an
`
`opportunity to address Luye’s arguments it takes issue with here.
`
`Further, with respect to FRE 403, the Board has taken the position that
`
`“[p]roceedings before the Board . . . are not jury trials; in the absence of a jury, the
`
`risk of unfair prejudice against which Rule 403 guards is diminished, if not
`
`eliminated entirely.” Microsoft Corp. v. Parallel Networks Licensing, LLC,
`
`IPR2015-00483, Paper 81, at 25 (Aug. 11, 2016); see Gulf States Utils. Co. v.
`
`Ecodyne Corp., 635 F.2d 517, 519 (5th Cir. 1981) (“[t]he exclusion of evidence
`
`under Rule 403’s weighing of probative value against prejudice . . . has no logical
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`9
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`

`

`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`application to bench trials”). “The Board is capable of hearing relevant evidence
`
`and weighing its probative value, including determining the weight to be given” to
`
`the evidence. Microsoft, IPR2015-00483, Paper 81, at 25-26. Thus, Luye’s Reply
`
`and Dr. DeLuca’s Declaration should not be excluded.
`
`2. Objections To Evidence Pursuant To
`35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.23(b),
`42.104(b)(5), And 42.123(b) Are Improper
`Alkermes seeks to exclude Luye’s Reply and Dr. DeLuca’s Declarations
`
`(Exs.1024, 1002), in whole or in part, pursuant to 35 U.S.C. § 312(a)(3); 37 C.F.R.
`
`§§ 42.23(b), 42.104(b)(5), and 42.123(b). (Mot. 2, 11.) The cited statutes and rules
`
`are directed to the weight of evidence, not its admissibility. Further, the
`
`admissibility of exhibits submitted in a PTAB proceeding is governed by the
`
`Federal Rules of Evidence. 37 C.F.R. § 42.62(a). Thus, Luye’s Reply and
`
`Dr. DeLuca’s Declaration (Ex.1024) should not be excluded under such bases.
`
`B. Dr. DeLuca’s Declarations (Exs.1002 And 1024) Have
`Proper Factual Support And Should Not Be Excluded
`Alkermes seeks to exclude both of Dr. DeLuca’s Declarations (Exs.1002,
`
`1024) under FRE 802, 702, 703, 402, and 403 as lacking factual support (Mot. 11).
`
`As an initial matter, Dr. DeLuca’s Declarations are direct testimony in this case,
`
`and thus, are not hearsay under FRE 801. Next, Alkermes has failed to indicate any
`
`testimony that is not based on facts or data or that use unreliable methods or
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`10
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`

`

`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`principles. The paragraphs Alkermes cites
`
`in Dr. DeLuca’s Exhibit 1024
`
`Declaration are all addressing the fact that Alkermes’ evidence, on its face, does not
`
`establish that CMCs were available at the time of invention. These paragraphs also
`
`cite to the Declaration of Mark Tracy, a declarant for Alkermes in the Patent Office
`
`and an admission by Alkermes, which was relied upon by the Examiner in granting
`
`the ‘061 Patent. Thus, the portions of Dr. DeLuca’s testimony that Alkermes takes
`
`issue with actually explain why Alkermes’ evidence is factually insufficient.
`
`Accordingly, Dr. DeLuca’s Declarations (Exs.1002, 1024) should not be excluded.
`
`C. The Tracy Declaration (Ex.1018) Should Not Be Excluded
`Alkermes seeks to exclude the Tracy Declaration (Ex.1018) and portions of
`
`Luye’s argument and DeLuca’s opinions that rely on the Tracy Declaration.
`
`(Mot. 12.) It is not clear what the basis is for Alkermes’ request to exclude the
`
`sworn statement of its own declarant and those portions of Luye’s arguments and
`
`expert opinions that rely on it. Elsewhere in its motion to exclude, Alkermes
`
`indicates that the Tracy Declaration should be excluded as lacking evidentiary
`
`foundation under 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.65(a), 42.104(b)(5);
`
`FRE 702, 703, 802.
`
`As discussed above, 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.65(a), and
`
`42.104(b)(5) are not proper grounds for exclusion of evidence. Further, FRE 802
`
`11
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`

`

`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`does not apply here as the Tracy Declaration was submitted by Alkermes during the
`
`prosecution of the ’061 Patent as evidence of patentability over the prior art. Since
`
`Luye is offering the Tracy Declaration to support its position, the Tracy
`
`Declaration is not hearsay because it is an opposing party’s statement under
`
`FRE 801(d)(2). With respect to FRE 702/703, Alkermes has not identified
`
`anything in the Tracy Declaration that is not based on sufficient facts or data or
`
`that uses unreliable methods. In fact, it was sufficiently reliable for Alkermes’
`
`purposes in getting the ‘061 Patent allowed. It is similarly reliable here. Thus, the
`
`Tracy Declaration is admissible under the FRE 702/703.
`
`Alkermes’ only allegation is that the Tracy Declaration should be excluded
`
`as “a de facto prior art reference” because Luye relies on it for its inherency
`
`argument. (Mot. 12.) Alkermes’ alleges that Luye “overhauled” this argument in
`
`its Reply because it “improperly adopted the assumptions of Dr. Tracy.” (Id. 13.)
`
`First, The Tracy Declaration is not a “de facto prior art reference” but an admission
`
`from Alkermes as to what the prior art references teach. Alkermes’ submission of
`
`the Tracy Declaration to overcome prior art during the prosecution of the
`
`’061 Patent resulted in a Notice of Allowability. (Paper 5 pp.17-28; Ex.1019 p.2.)
`
`Further, the Board agreed with Luye that the Tracy Declaration is an admission
`
`and came to the same conclusion as to its use in determining validity. (Paper 13
`
`12
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`

`

`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`pp.13-14.) Luye, did not “overhaul” its argument. The Tracy Declaration did not
`
`consider anything other than the amount of CMC used by Kino, and Luye utilized
`
`the Tracy Declaration in the same manner as Alkermes’ did during prosecution.
`
`Luye may rely on Alkermes’ admission to the Patent Office and the public
`
`regarding the prior art in making any of its arguments related to invalidity,
`
`including inherency. Accordingly, the Tracy Declaration should not be excluded.
`
`D.
`
`Portions Of Exs.1002 And 1024 And
`Exs.1019-1021 Should Not Be Excluded
`Alkermes alleges
`that portions of Exhibits 1002 and 1024 and
`
`Exhibits 1019-1021 should be excluded as irrelevant because they “go uncited in
`
`the Petition and in the Petitioners’ Reply.” (Mot. 13.) Exhibit 1019 is cited in
`
`Exhibit 1031, at 188:16-191:5 and Exhibits 1020-1021 are cited in Exhibit 1002
`
`¶ 17. There is no requirement that every paragraph of a declaration must be
`
`expressly cited in the Petition or the Reply. Ericsson Inc. v. Intellectual Ventures II
`
`LLC, IPR2014-00915, Paper No. 37, at 11-12 (Dec. 7, 2015). Thus, portions of
`
`Exhibits 1002 and 1024 and Exhibits 1019-1021 should not be excluded.
`
`Exhibits 1014 And 1016-1022 Should Not Be Excluded
`E.
`Alkermes seeks to exclude Exhibits 1014 and 1016-1022 as being
`
`incomplete under FRE 106. As an initial matter, FRE 106 only provides direction
`
`to make the evidence complete, not exclude it. (FRE 106.) Nonetheless, the
`
`13
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`

`

`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`evidence Alkermes seeks to exclude as incomplete relates to a treatise and to the
`
`prosecution history of the ’061 Patent. Upon receiving the objection as to PTO
`
`filings, Luye called the PTAB and asked whether the entire prosecution history
`
`should be submitted into evidence. The PTAB advised that such submission would
`
`not be necessary. Luye, in an abundance of caution, however, served Alkermes
`
`with a certified copy of the prosecution history. Furthermore, the prosecution
`
`history is a public document and was within Alkermes’ possession during the
`
`entire proceeding as Alkermes is the owner of the ’061 Patent. To the extent
`
`Alkermes believed that other portions of the prosecution history were relevant,
`
`Alkermes had every opportunity to rely on such portions and identify their
`
`relevance in their Patent Owners’ Response. Accordingly, Exhibits 1014 and
`
`1016-1022 should not be excluded.
`
`II. CONCLUSION
`For
`the
`reasons stated above, Petitioner’s Reply
`
`(Paper 40) and
`
`Exhibits 1002, 1014, 1016-1022, 1024, 1027, 1028, 1030, 1032, 1034, 1036, 1037,
`
`and 1043 should not be excluded.
`
`Dated:
`
`August 7, 2017
`
`5074271_1.docx
`
`
`
`
`
`
`
`Respectfully submitted,
`By:
`s/ Paul H. Kochanski /
`Paul H. Kochanski
`Reg. No. 29,660
`
`
`
`
`
`
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`14
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`

`Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certifies
`that a copy of
`
`the
`
`foregoing
`
`OPPOSITION TO PATENT OWNERS’ MOTION TO EXCLUDE, was
`
`served on August 7, 2017, as follows.
`
`VIA E-MAIL
`
`Scott K. Reed, Esq.
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: 212.218.2100
`E-mail:
`sreed@fchs.com
`
`
`Dated:
`
`5074271_1.docx
`
`August 7, 2017
`
`
`
`By:
`
`
`
`
`
`s/ Paul H. Kochanski /
`Paul H. Kochanski
`Reg. No. 29,660
`
`
`15
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`