UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`BLUEBIRD BIO, INC.,
`Petitioner,
`
`v.
`
`SLOAN KETTERING INSTITUTE FOR CANCER RESEARCH,
`Patent Owner.
`____________
`Case No. IPR2023-00074
`Patent No. 8,058,061
`____________
`
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`PATENT OWNER’S OBJECTIONS TO PETITIONER’S
`EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(b)(1)
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`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`BLUEBIRD BIO, INC.,
`Petitioner,
`
`v.
`
`SLOAN KETTERING INSTITUTE FOR CANCER RESEARCH,
`Patent Owner.
`____________
`Case No. IPR2023-00074
`Patent No. 8,058,061
`____________
`
`
`
`
`PATENT OWNER’S OBJECTIONS TO PETITIONER’S
`EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(b)(1)
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`
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`Case IPR2023-00074
`Patent 8,058,061
`
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`Sloan Kettering Institute for Cancer Research (“SKI”) is the owner by
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`assignment of U.S. Patent No. 8,058,061 (“the ’061 Patent”). SKI has granted San
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`Rocco Therapeutics LLC (“SRT”) an exclusive but assignable license to — and for
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`the entire term of — the ’061 Patent, entitling SRT to make, use, and sell the claimed
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`invention, commence litigation for infringement, and defend any validity attack on
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`the ’061 Patent.
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`Pursuant to 37 C.F.R. § 42.64 and the Federal Rules of Evidence, as applied
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`by the Board, SRT (herein “Patent Owner”) provides the following objections to
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`evidence submitted by Petitioner bluebird bio, Inc. (“Petitioner”). These objections
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`are timely served within ten (10) business days. Patent Owner serves Petitioner with
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`these objections to provide notice that Patent Owner may move to exclude the
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`challenged evidence under 37 C.F.R. § 42.64(c) unless Petitioner cures the defects
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`associated with the challenged evidence identified below. In addition, Patent Owner
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`reserves the right to present further objections to this or additional evidence
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`submitted by Petitioner, as allowed by the applicable rules or other authority.
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`Exhibit 1002 – Declaration of Jörg Bungert, Ph.D.
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`Patent Owner objects to Exhibit 1002 as lacking authentication as required
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`under Fed. R. Evid. 901, which requires that “the proponent must produce evidence
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`sufficient to support a finding that the item is what the proponent claims it is.”
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`Petitioner has failed to provide any evidentiary foundation for portions of this
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`Case IPR2023-00074
`Patent 8,058,061
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`document. For example, neither Petitioner nor its declarant, Dr. Bungert, identifies
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`the source of certain images contained in this document or attempts to authenticate
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`them. See, e.g., Ex. 1002 at ¶¶ 152-154, 225-226. Dr. Bungert fails to provide a
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`citation to any source for these images or the discussions related thereto. See id.
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`Accordingly, this testimony is irrelevant, misleading, unduly prejudicial, and
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`confusing under Fed. R. Evid. 401-403.
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`Patent Owner also objects to Exhibit 1002 as including “[e]xpert testimony
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`that does not disclose the underlying facts or data on which the opinion is based” in
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`violation of 37 C.F.R. § 42.55(a) and Fed. R. Evid. 702-703 and 705. For example,
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`Dr. Bungert testifies that “[a] range of ± 20 bp would allow for minor changes in
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`fragment length that resulted from the process of inserting the HS2, HS3, or HS4
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`fragment into the vector; this may result in the reported lengths of the fragment in
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`the May Article being slightly different than the calculated length between
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`recognition sites.” (Ex. 1002 at ¶ 152, n. 6.) Dr. Bungert provides no citation
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`supporting this range or evidence that a POSA would consider it to be appropriate.
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`(See id.) Patent Owner further objects to other portions of Exhibit 1002 to the extent
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`it does not disclose the underlying facts or data on which statements and/or the
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`opinion is based. (See Ex. 1002 at ¶¶ 32, 37-38, 45, 56-59, 64, 68, 87, 93, 125-127,
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`139, 145-146, 149-156, 171, 178, 181, 184, 190-192, 194, 195, 201-203, 215, 218-
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`233, 235-236, 242, 245, 252, 256, 259-260, 262.) Similarly, Dr. Bungert identifies
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`Case IPR2023-00074
`Patent 8,058,061
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`various restriction sites, positions, and fragment lengths and then arbitrarily groups
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`said fragments in the Appendices to his declaration. (See Ex. 1002 at Appendices A,
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`B, and C.) No support is cited for the restriction site or position being known at the
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`time of the invention and no basis is given for how the fragment lengths were
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`determined and then grouped. (See id.)
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`Because these statements and opinions in Exhibit 1002 are unsupported and
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`conclusory, Patent Owner further objects to this testimony as irrelevant, misleading,
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`unduly prejudicial, and confusing under Fed. R. Evid. 401-403.
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`Exhibit 1005 – May, et al., “Therapeutic Haemoglobin Synthesis in β-
`Thalassaemic Mice Expressing Lentivirus-Encoded Human β-globin,” Nature,
`406:82-86 (2000) (“the May Article”)
`
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`Patent Owner objects to Exhibit 1005 to the extent it contains hearsay. Exhibit
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`1005 contains a date of July 6, 2000. (Ex. 1005 at 1.) Petitioner and its experts rely
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`upon that date for the truth of the matter asserted, i.e., that the article was published
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`and publicly available on July 6, 2000. (See Pet. at 20; Ex. 1002 ¶ 64; see also
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`Ex. 1036 ¶¶ 44-45 (relying on similar evidence, including Appendix 1005D to
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`declaration).) Because these statements are being offered for the truth of the matter
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`asserted and do not fall under any exemption or exception, they are hearsay and
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`should be excluded under Fed. R. Evid. 801-802.
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`Case IPR2023-00074
`Patent 8,058,061
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`Exhibit 1006 – May, et al., “Lentiviral-Mediated Transfer of the Human β-
`Globin Gene and Large Locus Control Region Elements Permit Sustained
`Production of Therapeutic Levels of β-Globin in Long-Term Bone Marrow
`Chimeras,” Mol. Therapy, 1(5):S248-49 (2000) (“the May Abstract”)
`
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`Patent Owner objects to Exhibit 1006 to the extent it contains hearsay. Exhibit
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`1006 contains a date of May 2000. (Ex. 1006 at 1.) Petitioner and its experts rely
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`upon that date for the truth of the matter asserted, i.e., that the article was published
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`and publicly available in May 2000. (See Pet. at 22-23; Ex. 1002 ¶ 71; see also Ex.
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`1036 ¶¶ 46-52 (relying on Ex. 1006 and similar evidence in Appendices 1006A and
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`1006B to declaration).) Because these statements are being offered for the truth of
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`the matter asserted and do not fall under any exemption or exception, they are
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`hearsay and should be excluded under Fed. R. Evid. 801-802.
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`Exhibit 1036 – Declaration of Ingrid Hsieh-Yee, Ph.D.
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`Patent Owner objects to Exhibit 1036 as including “[e]xpert testimony that
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`does not disclose the underlying facts or data on which the opinion is based” in
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`violation of 37 C.F.R. § 42.55(a) and Fed. R. Evid. 702-703 and 705. For example,
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`Dr. Hsieh-Yee testifies that experts in the field would reasonably rely on the data
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`described herein to form their opinions. (See Ex. 1036 at ¶ 17; see also id. at ¶¶ 6,
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`21, 24, 29, 32, 40, 49, 56, 59, 66.) She provides no support or even example to
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`support such a statement. Patent Owner further objects to other portions of Exhibit
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`1036 to the extent it does not adequately disclose the underlying facts or data on
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`Case IPR2023-00074
`Patent 8,058,061
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`which statements and/or the opinion is based, either by (1) providing no citations or
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`(2) failing to cite where in a reference the disclosure supporting the statement and/or
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`opinion can be found, i.e., by providing pin cites. (See Ex. 1036 at ¶¶ 6-14, 17-26,
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`29, 31-32, 34-38, 40, 43, 44, 51.) Dr. Hsieh-Yee also testifies she requested various
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`information (Ex. 1036 at ¶¶ 18, 21) but did not provide those requests. She also
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`claims to have various understandings but does not identify where those came from
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`or what those understandings are. (See, e.g., id. at ¶¶ 22, 45.)
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`Patent Owner further objects to the extent Exhibit 1036 relies on evidence not
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`filed in this proceeding in violation of 37 C.F.R. § 42.63(a). (See Ex. 1036 at ¶¶ 7-
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`8, 13, 50 (referencing and quoting, e.g., the “Third Article, Amended Articles of
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`Incorporation of OCLC Online Computer Library Center, Inc.,” and the “RDA:
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`Resource Decision and Access cataloging standard,” without providing same).)
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`Patent Owner further objects to the extent Exhibit 1036 includes hearsay.
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`Most of Dr. Hsieh-Yee’s opinions rely on taking statements in the documents and
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`accepting them as true. (See Ex. 1036 at ¶¶ 19, 22-23, 25, 27-28, 33-37, 42, 44-46,
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`50-51, 54, 57; see also id. at ¶¶ 20, 31, 48, 58 (accepting statements as true because
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`nothing “creates [] suspicion about its authenticity”).) Further, attached to Exhibit
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`1036 are several appendices: Appendix 1004A (ProQuest affidavit); Appendix
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`1004B (ProQuest database record); Appendix 1005A (Publisher Copy of the May
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`Article); Appendix 1005B (Bibliographic and MARC records for Nature); Appendix
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`Case IPR2023-00074
`Patent 8,058,061
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`1005C (Pubmed metadata record); Appendix 1005D (Citations to the May Article
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`from Google Scholar); Appendix 1006A (Publisher’s copy of May Abstract);
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`Appendix 1006B (Publisher webpage containing May Abstract); 1047A (Publisher
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`copy of Himanen); Appendix 1047B (Bibliographic and MARC records); Appendix
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`1047C (PubMed metadata record). (See Ex. 1036 at ¶ 17, pp. 87-142.) These are
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`each relied upon for the truth of the matter asserted, i.e., when the references were
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`purportedly published and publicly available. (See generally Ex. 1036.) Because
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`these statements are being offered for the truth of the matter asserted and do not fall
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`under any exemption or exception, they are hearsay and should be excluded under
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`Fed. R. Evid. 801-802. All opinions that rely upon such information should also be
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`excluded. (See Ex. 1036 at ¶¶ 22, 26, 34, 39, 43, 45, 51-52, 61, 65, 69-71.) Patent
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`Owner therefore objects to all of this evidence and opinion as hearsay under Fed. R.
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`Evid. 801-802 and as misleading, prejudicial, and confusing the issues under Fed.
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`R. Evid. 401–403. Patent Owner further objects to the extent any documents or
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`evidence are mischaracterized by Dr. Hsieh-Yee.
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`In addition, both Appendices 1006A and 1006B are from cell.com, which is
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`not and was not the Publisher of the May Abstract at the time of the invention.
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`Accordingly, this evidence is misleading, confusing, and prejudicial under Fed. R.
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`Evid. 401-403.
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`Case IPR2023-00074
`Patent 8,058,061
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`Dated: May 8, 2023
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`By: /s/ Luke Toft
`Luke Toft (Reg. No. 75,311)
`FOX ROTHSCHILD LLP
`33 South Sixth Street, Suite 3600
`Minneapolis, MN 55402
`Telephone: (612) 607-7000
`Facsimile: (612) 607-7100
`ltoft@foxrothschild.com
`
`Joe Chen, Ph.D. (Reg. No. 70,066)
`FOX ROTHSCHILD LLP
`997 Lenox Drive
`Lawrenceville, NJ 08648
`Telephone: (609) 844-3024
`Facsimile: (609) 896-1469
`joechen@foxrothschild.com
`
`Attorneys for San Rocco Therapeutics,
`LLC, Responding on Behalf of Patent
`Owner Sloan Kettering Institute for
`Cancer Research
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`Case IPR2023-00074
`Patent 8,058,061
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`CERTIFICATE OF SERVICE
`Pursuant to 37 CFR § 42.6(e), the undersigned hereby certifies that on May 8,
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`2023, the foregoing Patent Owner’s Objections to Petitioner’s Evidence Pursuant to
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`37 C.F.R. § 42.64(b)(1), was served via e-mail, as authorized by the Petitioner, at
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`the following email correspondence address of record:
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`Naveen Modi
`Daniel Zeilberger
`PAUL HASTINGS LLP
`2050 M Street NW
`Washington, D.C. 20036
`bluebird-IPR-PH@paulhastings.com
`
`Eric W. Dittmann
`Max H. Yusem
`Krystina L. Ho
`PAUL HASTINGS LLP
`200 Park Avenue
`New York, NY 10166
`bluebird-IPR-PH@paulhastings.com
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`Dated: May 8, 2023
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`/s/ Luke Toft
`Luke Toft (Reg. No. 75,311)
`Counsel for San Rocco Therapeutics, LLC,
`Responding on Behalf of Patent Owner
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`
`
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`8
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