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
`____________
`
`
`
`
`PATENT OWNER’S SUR-REPLY
`TO PETITIONER’S REPLY TO PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`____________
`
`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 SUR-REPLY
`TO PETITIONER’S REPLY TO PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`
`Case IPR2023-00074
`Patent 8,058,061
`
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`Petitioner’s Reply presents unauthorized arguments, fails to show that SRT
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`misinterpreted or misapplied the facts or the law, and confirms that the Petition
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`should be denied since it does not remedy Petitioner’s failure to demonstrate a
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`reasonable likelihood of prevailing on at least one challenged claim. The Board
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`authorized this Sur-Reply via email on February 10, 2023.
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`I.
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`ARGUMENT
`The Reply Presents Unauthorized Arguments and Should Be Struck.
`Under the guise that SRT misinterpreted the prosecution history and
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`provisional applications (“Provisionals”) or applied an incorrect legal standard,
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`Petitioner improperly presents new arguments. “Petitioner may not submit new []
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`argument in reply that it could have presented [in its Petition].” (PTAB Consolidated
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`Trial Practice Guide (Nov. 2019) at 73-74 (“[A] reply [] that raises a new issue or
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`belatedly presents evidence may not be considered.”).)
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`For the first time, Petitioner argues that (1) the “Examiner missed” that the
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`cited support for an amendment was not present in the Provisionals, (2) statements
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`in the Provisionals do not indicate the vector design could express other globins, and
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`(3) even if a POSITA substituted a different globin’s nucleotide sequence, there are
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`additional but unspecified changes to the vector needed to allow for the expression
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`of the other globins. (See Reply at 2, 4-5.) Petitioner also never requested (or was
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`granted) leave to address allegedly “categorical, unsupported statements.” (Id. at
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`1
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`Case IPR2023-00074
`Patent 8,058,061
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`4-5.) Because these arguments could have been presented in the Petition and were
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`not authorized by the Board, they should be rejected. See Intelligent Bio-Sys., Inc. v.
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`Illumina Cambridge Ltd., 821 F.3d 1359, 1369–70 (Fed. Cir. 2016) (affirming
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`refusal to consider reply raising new arguments).
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`II.
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`Petitioner Distorts Patent Owner’s Arguments to Erroneously Claim
`Patent Owner Misinterpreted the Prosecution History.
`Petitioner does not point to any actual misinterpretation, but claims SRT
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`simply drew the “wrong inference” from purported silence and Petitioner now
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`argues the correct inference is that “the Examiner erred by failing to consider the
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`priority date issue.” (Reply at 1.) There was no error here. The Office rejected the
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`claims as anticipated by the Nature Article, (published July 6, 2000), under § 102(a),
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`while simultaneously rejecting other art under § 102(b). (See POPR at 22 (citing
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`Ex. 1032 at 63, 83-90, 104).) Thus, the Office necessarily determined priority when
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`distinguishing between §§ 102(a) and 102(b) art. This was confirmed when the
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`Office accepted traversal of the § 102(a) rejection with Katz declarations, which
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`cannot traverse statutory bars, e.g., § 102(b). (Id.; see also MPEP § 716.10.) If the
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`claims were only entitled to the filing date of the ‘221 Application (July 1, 2002),
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`then the Nature Article would be § 102(b) prior art, preventing Katz declarations
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`from removing this reference as prior art. (See POPR at 13-14, 22, 31-33.)
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`Accordingly, the Office necessarily undertook the requisite priority analysis.
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`2
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`Case IPR2023-00074
`Patent 8,058,061
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`Petitioner makes two previously unpresented arguments. First, Petitioner
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`claims the Office missed that cited support is not present in the Provisionals. (Reply
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`at 2 (citing Pet. at 17-18 (not alleging this).) Not true. Like the cited non-provisional
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`support, the Provisionals explain that “large fragments” [i.e., nucleotide sequences]
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`of the globin gene along with the LCR fragments allow for the “treatment [i.e.,
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`therapeutic benefits] of severe haemoglobinopathies.” (Ex. 1032 at 4; Compare with
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`Ex. 1034 at 6 (explaining “the principles underlying inclusion of multiple genetic
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`elements within this vector provide a paradigm for any stem cell therapy requiring
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`stable and regulated expression of a [gene].”).)
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`Second, in rebuttal to SRT’s arguments, (POPR at 19-21), Petitioner attempts
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`to explain away the Provisionals’ disclosures. (See Reply at 2.) But the only support
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`for the alleged meaning of the α- and β-globin molecules provision is its expert’s
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`testimony, which does not interpret the Provisionals’ disclosures. (Id. (citing
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`Ex. 1002 ¶18).) This attorney argument should be rejected. In addition, SRT did not
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`add to the provisional but simply provided an uncontested understanding of
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`hemoglobinopathies, i.e., disorders resulting from mutations in (alpha, beta, or
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`gamma) genes fully supported by the known scientific literature. (See Reply at 2-3,
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`n.1; POPR at 20 (citations omitted).)
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`III. SRT Did Not Distort Petitioner’s Argument.
`Contrary to Petitioner’s false claims, (Reply at 3), SRT provided support for
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`Case IPR2023-00074
`Patent 8,058,061
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`a POSITA’s understanding from the Provisionals that a substituted globin is fully
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`capable of being expressed in vivo. (See POPR at 24-27.) A POSITA knew the β-
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`globin LCR was essential to expression of ε-, γ-, and β-globin genes and that
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`substituting in one of these would result in expression of said gene. (See id. (citing
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`Ex. 2011 at 1; Ex. 2002 at ¶61-68 (understanding of other globin expression));
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`Ex. 2009 at ¶¶14-15 (same); Ex. 2006 at ¶¶28-30 (explaining expectation of other
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`globin expression); Ex. 2007 at ¶15 (same); Ex. 2008 at ¶17 (same).)
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`IV. SRT Applied the Correct Legal Standard and Supported Its Statements.
`Contrary to Petitioner’s suggestions, (Reply at 4-5), SRT applied the correct
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`written description legal standard and fully supported its statements. (See POPR at
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`19-27.) Resorting to semantics, Petitioner suggests that just because SRT stated that
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`a POSITA would understand that the teachings of the Provisionals “could be used”
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`with other functional globins or that these other globin genes “would be expressed”
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`by the disclosed TNS9 vector system, this somehow means that SRT was arguing
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`obviousness instead of possession of the invention. Not so. A POSITA’s
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`understanding regarding the specification’s disclosure, including whether the POSA
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`would expect this disclosure to show possession of claimed embodiments, has
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`always been the proper test for written description. See Vas-Cath Inc. v.
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`Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991).
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`Written description requires only a showing that a POSITA would have
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`Case IPR2023-00074
`Patent 8,058,061
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`understood the inventors had possession of the invention, which does not require
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`examples, actual reduction to practice, or recitation of known structures. See Falk-
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`Gunter Falkner v. Inglis, 448 F.3d 1357, 1365-1368 (Fed. Cir. 2006) (finding claims
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`supported based, in part, on accessible literature not recited in specification but that
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`described known genetic material). Here, the invention is directed to a vector having
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`novel LCR fragments that results in expression of known globin genes. (POPR at 9,
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`14 (citing uncontested testimony that LCR material was the “most innovative” and
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`globin genes were well-known).) The Provisionals, which reproduce the Nature
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`Article in full, make clear that the disclosed principles could be extended to express
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`other globin genes, (Ex. 1005 at 6; Exs. 1034-35), which was well understood by
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`POSITAs. (See POPR at 24-27 (citing Ex. 1036 at 115-116 (industry publication
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`discussing Nature Article’s disclosure as a “giant leap” in globin gene therapy
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`research, generally, and that approach could be used with “beta-like globins”));
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`Ex. 2002 at ¶¶60-68 (understanding same and that substitution would result in
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`expression of substitute genes); Ex. 2009 at ¶¶14-15 (same).)
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`Finally, each of SRT’s statements are fully supported by the record. (See
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`POPR 23-26 (citing Exs. 2002, 2006, 2007, 2008, 2009, 2011, and 1036 in support
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`of said statements).) Petitioner’s arguments to the contrary should be rejected.
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`CONCLUSION
`For these reasons, the Board should not institute review of the ’061 Patent.
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`Case IPR2023-00074
`Patent 8,058,061
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`Dated: February 27, 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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`6
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`Case IPR2023-00074
`Patent 8,058,061
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`CERTIFICATE OF WORD COUNT
`Pursuant to 37 CFR § 42.24(d), the undersigned hereby certifies that the
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`foregoing Patent Owner’s Sur-Reply to Petitioner’s Reply to Preliminary Response
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`contains 1,165 words using the word count feature of Microsoft Word, and is 5 pages
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`long pursuant to the Board’s email on February 10, 2023.
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`Dated: February 27, 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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`7
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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
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`February 27, 2023, the foregoing Patent Owner’s Sur-Reply to Petitioner’s Reply to
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`Preliminary Response, was served via e-mail, as authorized by the Petitioner, at the
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`following email correspondence address of record:
`
`Naveen Modi
`Eric W. Dittmann
`Daniel Zeilberger
`Max H. Yusem
`Krystina L. Ho
`bluebird-IPR-PH@paulhastings.com
`
`PAUL HASTINGS LLP
`2050 M Street NW
`Washington, D.C. 20036
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`Dated: February 27, 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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`8
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