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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________
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`BLUEBIRD BIO, INC.
`Petitioner
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`v.
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`SLOAN KETTERING INSTITUTE FOR CANCER RESEARCH,
`Patent Owner
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`_________________
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`Case No. IPR2023-00074
`Patent No. 8,058,061
`_________________
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`PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE
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`IPR2023-00074
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`On February 10, 2023, the Board authorized Petitioner to file a five-page
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`Reply to address certain arguments raised in Patent Owner’s Preliminary Response
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`regarding the priority date of U.S. Patent No. 8,058,061 (“the ’061 patent”). In its
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`attempt to shore up deficient provisional applications, San Rocco Therapeutics
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`(“SRT”), who filed the preliminary response: (1) misinterprets the prosecution
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`record and provisional applications; (2) distorts the substance of Petitioner’s
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`argument; and (3) applies an incorrect legal standard.
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`I.
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`SRT’s Misinterpretation of the
`Prosecution History and Provisional Applications
`SRT argues that the Examiner “already addressed the priority date” during
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`prosecution of the related ’179 patent. (POPR, 22.) But SRT does not point to any
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`analysis of the priority date issue by the Examiner. Rather, SRT suggests the
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`Board may infer such an analysis because the Examiner treated the May Article as
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`35 U.S.C. § 102(a) prior art, and “accepted Katz declarations to traverse the
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`rejection.” (Id.) SRT draws the wrong inference from the Examiner’s silence,
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`which suggests only that the Examiner erred by failing to consider the priority date
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`issue. See PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1305 (Fed. Cir.
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`2008) (“In the absence of an interference or rejection which would require the PTO
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`to make a determination of priority, the PTO does not make such findings as a
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`matter of course in prosecution.”). Indeed, even if the Examiner silently
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`considered the priority issue, there is no analysis upon which the Board may
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`IPR2023-00074
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`discern whether the Examiner conducted a proper analysis. See Smith & Nephew,
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`Inc. v. Arthrex, Inc., IPR2016-00487, Paper 8 at 19 (P.T.A.B. July 27, 2016) (“We
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`are not apprised of any statements the examiner made regarding priority. Silence
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`is not a determination.”). And the record in fact shows that the Examiner missed
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`key issues (which SRT ignores), such as how, in response to repeated rejections
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`regarding the “functional globin gene” claim language on written description
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`grounds, Applicants pointed to specification passages from the full application that
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`were not present in the provisional applications. (Pet., 17-18.)
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`SRT alleges the provisional applications disclose “tetramers of two murine
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`α-globin and two human β-globin molecules.” (POPR, 20; Ex. 1034, 4; Ex. 1035,
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`5.) But this sentence simply reports that, when human β-globin is expressed in
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`mice from the vector, two of the human β-globin chains will bind to two of the
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`native murine α-globin chains to form hemoglobin. (Ex. 1002 ¶ 18.) It does not
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`indicate that the claimed vector can be used to express α-globin, as SRT alleges.1
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`1 SRT also adds its own language to the provisional applications: “The vector of
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`the invention is used in therapy for treatment of individuals suffering from
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`hemoglobinopathies [disorders resulted from mutations in globin (alpha, beta, or
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`gamma) genes].” (POPR, 20 (emphasis added, brackets in original).) But SRT
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`does not assert, nor could it, that the vector identified in the provisional
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`IPR2023-00074
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`II.
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`SRT’s Distortions of Petitioner’s Argument
`The preliminary response fails to engage with the substance of Petitioner’s
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`priority argument. For example, SRT incorrectly asserts that the only dispute is
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`over what it labels “Element 1.1” (the “functional globin gene”), and then
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`represents that the Parties are in agreement over all remaining claim limitations,
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`including what it terms “Element 1.8” (“said vector providing expression of the
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`globin in a mammal in vivo”). (POPR, 22-24.) Petitioner explained, however, that
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`the provisional applications do not inform a POSA that the alleged inventors
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`“possessed all recombinant vectors that can express a ‘functional globin’ from the
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`claimed 3.2-kb LCR in a mammal in vivo.” (Pet., 18 (emphasis added).) Notably,
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`SRT does not provide proper support for “Element 1.8.” Instead, it simply cites
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`the provisional applications and its expert’s conclusory assertion that these
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`applications disclose that the “TNS9 vector was capable of providing expression of
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`the globin in a mammal in vivo”—despite the provisional applications discussing
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`only expression of human β-globin in mammals in vivo. (Ex. 2002 ¶ 75.)
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`applications could be used to treat all hemoglobinopathies. Instead, the provisional
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`applications discuss “β-thalassemia and sickle-cell disease”—disorders that
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`specifically have mutations in human β-globin. (Ex. 1034, 1; Ex. 1035, 1; see also
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`Ex. 1002 ¶¶ 21, 23.)
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`IPR2023-00074
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`In addition, SRT asserts that Petitioner does not dispute that the
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`“[p]rovisionals provide sufficient support for the limitations of Claims 2, 5-8, and
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`15 of the ’061 Patent.” (POPR, 23-24.) Although Petitioner does not dispute this
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`with respect to claims 8 and 15 (as they are limited to “human β-globin”),
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`Petitioner clearly argued that claims 1, 2, 5-7, and 11 are not entitled to claim
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`priority to the provisional applications. (Pet., 14 (“The Earliest-Possible Priority
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`Date for Claims 1, 2, 5-7, and 11 of the ’061 Patent Is July 1, 2002”).)
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`III. SRT Applies the Wrong Legal Standard and
`Makes Categorical, Unsupported Statements
`Finally, SRT makes a number of unsubstantiated categorical statements.
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`First, SRT argues that a POSA “would understand [the provisional applications] to
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`disclose an approach that could be used with different functional globin . . . to
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`similar effect.” (POPR, 24-25.) Here, SRT appears to apply an incorrect legal
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`standard. As Petitioner explained, “[o]bviousness simply is not enough; the
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`subject matter must be disclosed to establish possession,” and a single species may
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`be insufficient to demonstrate possession of a genus even if it would invalidate a
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`claim to that genus. (Pet., 15-16 (emphasis added).)
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`Second, SRT goes further in alleging that, “by substituting the nucleotide
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`sequence of said globin gene(s) during the construction of the vector(s), different
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`globin genes would be expressed” and “would result in increased expression of
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`said genes.” (POPR, 26 (emphasis added).) Again, SRT appears to apply an
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`IPR2023-00074
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`obviousness standard rather than one of possession; just because a POSA could
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`make this substitution, it does not mean that it would result in expression in vivo.
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`(See, e.g., Pet., 17-18 (citing Ex. 1002 ¶¶ 57-59).) If anything, SRT recognizes that
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`changes would need to be made to the vector for the possibility to allow for
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`expression of other globin—changes not described in the provisional applications.
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`(POPR, 24.) Instead, the only exemplary vectors identified in those applications
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`use human β-globin for in vivo expression. (Ex. 1035, 1-2; Ex. 1036, 1-2.)
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`Third, SRT attempts to distinguish AbbVie Deutschland GmbH & Company,
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`KG v. Janssen Biotech, Inc. by misconstruing the fundamental issue here. 759
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`F.3d 1285 (Fed. Cir. 2014). (POPR, 27-28.) SRT argues that the claims are
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`directed “to a vector containing nucleotide fragments from a known LCR that
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`served to regulate the expression of known functional globins.” (Id., 28.) It asserts
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`that the claims are not directed to a new genus, such as the anti-human IL-12
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`antibodies in AbbVie. (Id., 27-28.) Yet the claimed (purportedly “new”) vector
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`encodes a functional globin that is expressed in mammals in vivo; it is not simply
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`claiming the globin itself. Moreover, like in AbbVie, the claims here do require a
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`functional result. That is, the claims require expression of the functional globin in
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`mammals in vivo. (Pet., 18.) And like in AbbVie, the provisional applications fail
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`to establish a reasonable structure-function relationship between the claimed vector
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`and all possible functional globins. 749 F.3d at 1301.
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`5
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`Dated: February 15, 2023
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`IPR2023-00074
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`Respectfully submitted,
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`By: /Naveen Modi/
` Naveen Modi (Reg. No. 46,224)
` Counsel for Petitioner
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`6
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`IPR2023-00074
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`CERTIFICATE OF SERVICE
`I certify that I caused to be served on the counsel identified below a true and
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`correct copy of the foregoing Petitioner’s Reply to Patent Owner’s Preliminary
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`Response by electronic means on February 15, 2023:
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`FOR PATENT OWNER:
`Luke Toft (Reg. No. 75,311)
`ltoft@foxrothschild.com
`Fox Rothschild LLP
`33 South Sixth Street, Suite 3600
`Minneapolis, MN 55402
`Telephone: (612) 607-7000
`Facsimile: (612) 607-7100
`
`Joe Chen (Reg. No. 70,066)
`joechen@foxrothschild.com
`Fox Rothschild LLP
`997 Lenox Drive
`Lawrenceville, NJ 08648
`Telephone: (609) 844-3024
`Facsimile: (609) 896-1469
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`Respectfully submitted,
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`By: /Naveen Modi/
` Naveen Modi (Reg. No. 46,224)
` Counsel for Petitioner
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