IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`SAN ROCCO THERAPEUTICS, LLC,
`
`Plaintiff,
`
`v.
`
`BLUEBIRD BIO, INC. and THIRD ROCK
`VENTURES, LLC,
`
`Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. 21-1478-RGA
`
`HIGHLY CONFIDENTIAL
`
`PLAINTIFF’S INITIAL INFRINGEMENT CLAIM CHARTS
`
`BLUEBIRD EXHIBIT 1064
`bluebird v. SKI
`IPR2023-00074
`
`Page 1 of 5
`
`

`

`Appendix A – Initial Infringement Claim Chart For U.S. Patent No. 7,541,179 – HIGHLY CONFIDENTIAL
`
`U.S. Patent No. 7,541,179
`
`BB305
`
`As the HS2 fragment is located between BstXI and SnaBI, the HS2 fragment is a BstXI and SnaBI HS2-
`spanning nucleotide fragment of said LCR.
`
`Bluebird’s limited production also supports this element. See BBI-DEL-0000023-28, BBI-DEL-
`0000034. For example, bluebird’s HS2 sequence identified in versus the SnaBI-BstXI range is shown
`below:
`
`1.5
`
`[the three
`fragments
`being…] [(2)] a
`BamHI and
`HindIII HS3-
`spanning
`nucleotide
`fragment of said
`LCR, and
`
`BB305_HS2 obtained from BBI-DEL-0000023-28 and compared to SnaBI-BstXI within human HS2.
`
`The BB305 vector comprises the 3.2-kb fragment discussed above (see claim 1.2 supra), where the 3.2-
`kb fragment consists essentially of three contiguous nucleotide fragments obtainable from a human β-
`globin locus control region (LCR), wherein the HS3 fragment (see claim 1.3 supra) is a BamHI and
`HindIII HS3-spanning nucleotide fragment of said LCR.
`
`To the extent the HS3 in BB305 is not literally a BamHI and HindIII HS3-spanning nucleotide fragment
`of said LCR, it is present under the doctrine of equivalents. For example, the HS3 in BB305 is
`insubstantially different from a BamHI and HindIII HS3-spanning nucleotide fragment. In both cases,
`the HS3 fragment is a HS3 fragment and sufficiently sized to cause expression of the globin gene
`payload but not large enough to disrupt functioning of the vector. Alternatively, the HS3 in BB305
`performs substantially the same function, in substantially the same way, to achieve the same result as a
`BamHI and HindIII HS3-spanning nucleotide fragment of said LCR. For example, the function of the
`HS3 in BB305 and the BamHI and HindIII HS3-spanning nucleotide fragment of said LCR is to control
`expression of the globin gene payload. It performs that function in substantially the same way, which
`is through the use of part of a human-derived β-globin locus control region known as HS3 (which
`naturally controls β-globin expression). The HS3 in BB305 is sufficiently large to allow the expression
`but sufficiently small to fit the recombinant vector. This achieves the same result, which is the
`
`10
`
`Page 2 of 5
`
`

`

`Appendix A – Initial Infringement Claim Chart For U.S. Patent No. 7,541,179 – HIGHLY CONFIDENTIAL
`
`U.S. Patent No. 7,541,179
`
`BB305
`
`controlled expression of a replacement β-globin gene in the target cell. Notably, the HS3 in BB305 is
`approximately two-thirds the size of the full BamHI and HindIII region.
`
`Exemplary Support:
`
`The HS3 fragment in BB305 (denoted “HS3BB”) is a subset of the HS3 human β-globin locus control
`region (LCR) located between the restriction sites BamHI (3877) and HindIII (5172).
`
`11
`
`Page 3 of 5
`
`

`

`Appendix A – Initial Infringement Claim Chart For U.S. Patent No. 7,541,179 – HIGHLY CONFIDENTIAL
`
`U.S. Patent No. 7,541,179
`
`BB305
`
`As the HS3 fragment is located between BamHI and HindIII, the HS3 fragment is a BamHI and HindIII
`HS3-spanning nucleotide fragment of said LCR.
`
`Bluebird’s limited production also supports this element. See BBI-DEL-0000023-28, BBI-DEL-
`0000034. For example, bluebird’s HS3 sequence identified in versus the HindIII-BamHI range is shown
`below:
`
`BB305_HS3 obtained from BBI-DEL-0000023-28 and compared to HindIII-BamHI within human
`HS3.
`
`The BB305 vector comprises the 3.2-kb fragment discussed above (see claim 1.2 supra), where the 3.2-
`kb fragment consists essentially of three contiguous nucleotide fragments obtainable from a human β-
`globin locus control region (LCR), wherein the HS4 fragment (see claim 1.3 supra) is a BamHI and
`BanII HS4-spanning nucleotide fragment of said LCR.
`
`1.6
`
`[the three
`fragments
`being…] [(3)] a
`BamHI and BanII
`HS4-spanning
`
`12
`
`Page 4 of 5
`
`

`

`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that on August 10, 2023, a copy of the foregoing
`
`document was served, by email, on the counsel listed below:
`
`Jack B. Blumenfeld
`Jeremy A. Tigan
`MORRIS, NICHOLS, ARSHT
`& TUNNELL LLP
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`jtigan@morrisnichols.com
`
`Attorneys for bluebird bio, Inc. and
`Third Rock Ventures, LLC
`
`Eric W. Dittmann
`Max H. Yusem
`Joshua M. Bennett
`Krystina L. Ho, Ph.D.
`Naveen Modi
`PAUL HASTINGS LLP
`200 Park Avenue
`New York, NY 10166
`ericdittmann@paulhastings.com
`maxyusem@paulhastings.com
`joshuabennett@paulhastings.com
`krystinaho@paulhastings.com
`naveenmodi@paulhastings.com
`
`Attorneys for bluebird bio, Inc. and
`Third Rock Ventures, LLC
`
`YOUNG CONAWAY STARGATT
`& TAYLOR, LLP
`
`/s/ Anne Shea Gaza
`Anne Shea Gaza (No. 4093)
`Samantha G. Wilson (No. 5816)
`Rodney Square
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6600
`agaza@ycst.com
`swilson@ycst.com
`
`Attorneys for Plaintiff
`San Rocco Therapeutics, LLC
`
`Page 5 of 5
`
`