`571-272-7822
`
`Paper 8
`Date: April 24, 2023
`
`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.
`
`IPR2023-00070
`Patent 7,541,179 B2
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, SHERIDAN K. SNEDDEN, and
`JAMES A. WORTH, Administrative Patent Judges.
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314, 37 C.F.R. § 42.4
`
`
`
`
`
`
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`IPR2023-00070
`Patent 7,541,179 B2
`
`INTRODUCTION
`I.
`Bluebird bio, Inc. (“Petitioner”) filed a Petition requesting an inter
`partes review of claims 1, 10, 19, and 22 of U.S. Patent No. 7,541,179 B2
`(Ex. 1001, “the ’179 patent”). Paper 1 (“Petition” or “Pet.”). Sloan
`Kettering Institute for Cancer Research (“Patent Owner”) filed a Preliminary
`Response to the Petition. Paper 5 (“Prelim. Resp.”). With our authorization,
`Petitioner filed a Reply (Paper 6, “Reply”) and Patent Owner filed a Sur-
`Reply (Paper 7, “Sur-reply”).
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314 (2018). Upon considering the parties’ arguments
`and evidence, we determine that Petitioner has established a reasonable
`likelihood that it would prevail in showing the unpatentability of at least one
`claim challenged in the Petition. Accordingly, we institute an inter partes
`review of all claims and all grounds asserted in the Petition.
`Real Parties in Interest
`A.
`Petitioner identifies itself and Third Rock Ventures, LLC as the real
`parties-in-interest. Pet. 2.
`Patent Owner identifies itself, San Rocco Therapeutics, LLC,
`formerly known as Errant Gene Therapeutics, LLC, and Memorial Sloan-
`Kettering Cancer Center as the real parties-in-interest. Paper 4, 1.
`Related Matters
`B.
`Petitioner and Patent Owner identify San Rocco Therapeutics, LLC v.
`bluebird bio, Inc., et al., No. 1-21-cv-01478 (D. Del.)1 as a related district
`court litigation. Pet. 2–3; Paper 4, 2–3. Patent Owner also identifies Errant
`
`
`1 Patent Owner captions this case “Errant Gene Therapeutics, LLC v.
`Bluebird Bio, Inc., 1-21-cv-01478, (D. Del. October 21, 2021).” Paper 4, 2.
`
`2
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`IPR2023-00070
`Patent 7,541,179 B2
`Gene Therapeutics, LLC v. Memorial Sloan-Kettering Cancer Center and
`Sloan Kettering Institute of Cancer Research, 1-21-cv-08206 (S.D.N.Y.) as
`a related litigation involving the ’179 patent. Paper 4, 3.
`The parties further identify IPR2023-00074, challenging certain
`claims of U.S. Patent No. 8,058,061 B2 (“the ’061 patent”), as a related
`matter. Pet. 2–3; Paper 4, 2–3. The ’061 patent issued from a divisional
`application of U.S. application number 10/188,221 (“the ’221 application”),
`which issued as the ’179 patent. Ex. 1001, code (21).
`The ’179 Patent
`C.
`The ’179 patent is directed to a recombinant vector, e.g., a lentiviral
`vector, incorporating a functional globin gene and large portions of the β-
`globin locus control region (“LCR”). Ex. 1001, 1:47–51. The Specification
`defines a “recombinant lentiviral vector” as “an artificially created
`polynucleotide vector assembled from a lentiviral-vector and a plurality of
`additional segments as a result of human intervention and manipulation.” Id.
`at 2:36–40. The Specification defines “functional globin gene” as “a
`nucleotide sequence the expression of which leads to a globin that does not
`produce a hemoglobinopathy phenotype, and which is effective to provide
`therapeutic benefits to an individual with a defective globin gene.” Id. at
`2:41–45. “The functional globin gene may encode a wild-type globin,” “a
`mutant form of globin,” “α-globin, β-globin, or γ-globin.” Id. at 2:45–53.
`The recombinant lentiviral vector is used as a gene therapy vector to provide
`“therapeutically meaningful levels of human globin for sustained periods of
`time.” Id. at 1:36–44.
`The Specification describes the recombinant vector as including
`“large portions of the locus control region (LCR) which include DNase I
`hypersensitive sites HS2, HS3 and HS4.” Id. at 2:54–56. The Specification
`
`3
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`IPR2023-00070
`Patent 7,541,179 B2
`defines “large portions” as “portions of the locus control region which
`encompass larger portions of the hypersensitive sites as opposed to
`previously tested fragments including only the core elements.” Id. at 2:60–
`64. In a specific vector, designated TNS9, the LCR is 3.2 kilobases (“kb”)
`in size and “consists of an 840 [base pair (‘bp’)] HS2 fragment (SnaBI-
`BstXI), a 1308 bp HS3 fragment (HindIII-BamHI) and a 1069 bp HS4
`fragment (BamHI-BanII).” Id. at 3:24–26. Figure 1, reproduced below,
`illustrates the TNS9 vector.
`
`
`
`Figure 1 illustrates the TNS9 vector with exons represented by filled boxes
`and introns represented by open boxes. Id. at 3:14–16. The TNS9 vector
`includes, from the 5ʹ end to the 3ʹ end, a splice donor (SD), packaging region
`(Ψ), rev-response element (RRE), splice acceptor (SA), 3'-β-globin enhancer
`(E), β-globin gene, human β-globin promoter (P), and LCR (including HS2,
`HS3, and HS4). Id. at 3:16–19. The 5ʹ and 3ʹ ends include long terminal
`repeat (LTR) sequences. See Fig. 1.
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`4
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`IPR2023-00070
`Patent 7,541,179 B2
`
`Illustrative Claim
`D.
`Petitioner challenges claims 1, 10, 19, and 22 of the ’179 patent.
`Claim 1, set forth below, is the only independent claim and is illustrative of
`the claimed subject matter.
`1. A recombinant vector comprising a nucleic acid encoding a
`functional globin operably linked to a 3.2-kb nucleotide fragment
`which consists essentially of three contiguous nucleotide
`fragments obtainable from a human β-globin locus control region
`(LCR), the three fragments being a BstXI and SnaBI HS2-
`spanning nucleotide fragment of said LCR, a BamHI and HindIII
`HS3-spanning nucleotide fragment of said LCR and a BamHI
`and BanII HS4-spanning nucleotide fragment of said LCR, said
`vector providing expression of the globin in a mammal in vivo.
`Ex. 1001, 11:55–65. Dependent claim 19 recites that the functional globin is
`β-globin, and dependent claim 10 recites that the functional globin is human
`β-globin. Id. at 13:4–5, 14:6–7. Dependent claim 22 recites that the vector
`is a lentiviral vector. Id. at 14:12–13.
`Asserted Grounds of Unpatentability
`E.
`Petitioner asserts that claims 1, 10, 19 and 22 would have been
`unpatentable on the following four grounds:
`Claims Challenged
`35 U.S.C. §2
`1, 19, 22
`102
`
`Reference/Basis
`May Thesis3
`
`
`2 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112–29, 125
`Stat. 284 (2011), amended 35 U.S.C. §§ 102 and 103, effective March 16,
`2013. Because the application from which the ’179 patent issued has an
`effective filing date before that date, the pre-AIA version of §§ 102 and 103
`apply.
`3 May, Therapeutic Hemoglobin Synthesis in Beta-Thalassemic Mice
`Expressing Lentivirus-Encoded Human Beta-Globin, Cornell University
`(2001) (Ex. 1004, “May Thesis”).
`
`5
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`IPR2023-00070
`Patent 7,541,179 B2
`Claims Challenged
`1, 19, 22
`1, 19, 22
`1, 10, 19, 22
`
`35 U.S.C. §2
`102
`103
`103
`
`Reference/Basis
`May Article4,5
`May Article
`May Abstract6
`
`Petitioner also relies upon the Declarations of Jörg Bungert, Ph.D.
`(Ex. 1002) and Ingrid Hsieh-Yee, Ph.D.7 (Ex. 1036). Patent Owner relies
`upon the Declarations of James Riley, Ph.D. (Ex. 2002); Michel Sadelain,
`M.D., Ph.D. (Ex. 2006); Chad May, Ph.D. (Ex. 2007); Stefano Rivella,
`Ph.D. (Ex. 2008); Lucio Luzzatto, M.D., Ph.D. (Ex. 2009).8
`II. ANALYSIS
`A. Discretionary Denial under 35 U.S.C. § 325(d)
`Patent Owner asserts that we should deny the Petition under 35 U.S.C.
`§ 325(d). Prelim. Resp. 38–44. We have discretion to deny review when
`“the same or substantially the same prior art or arguments previously were
`presented to the Office.” 35 U.S.C. § 325(d). In that respect, § 325(d)
`provides that the Director may elect not to institute a proceeding if the
`challenge to the patent is based on matters previously presented to the
`
`
`4 May, et al., Therapeutic Haemoglobin Synthesis in β-Thalassaemic Mice
`Expressing Lentivirus-Encoded Human β-globin, 406 NATURE 82–86 (2000)
`(Ex. 1005, “May Article”).
`5 In the Preliminary Response, Patent Owner refers to Exhibit 1005 as the
`“Nature Article.” See Prelim. Resp. 1.
`6 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, 1(5)
`MOL. THERAPY S248–49 (2000) (Ex. 1006, “May Abstract”).
`7 Petitioner relies on the declaration of Dr. Hsiey-Yee, a librarian, to address
`authenticity and public availability of the cited references. Ex. 1036 ¶ 16.
`8 Patent Owner relies on the declarations of Drs. Sadelain, May, Rivella, and
`Luzzatto to address inventorship and, in some instances, conception and
`reduction to practice allegations.
`
`6
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`IPR2023-00070
`Patent 7,541,179 B2
`Office.9 Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte
`GmbH, IPR2019-01469, Paper 6 at 7 (PTAB Feb. 13, 2020) (precedential)
`(“Advanced Bionics”).
`In evaluating matters under § 325(d), the Board uses the following
`two-part framework: (1) determining whether the same or substantially the
`same art previously was presented to the Office or whether the same or
`substantially the same arguments previously were presented to the Office;
`and (2) if either condition of the first part of the framework is satisfied,
`determining whether the petitioner has demonstrated that the Office erred in
`a manner material to the patentability of challenged claims. Advanced
`Bionics, Paper 6 at 8.
`In applying the two-part framework, we consider several nonexclusive
`factors, including:
`(a) the similarities and material differences between the asserted art
`and the prior art involved during examination;
`(b) the cumulative nature of the asserted art and the prior art evaluated
`during examination;
`(c) the extent to which the asserted art was evaluated during
`examination, including whether the prior art was the basis for rejection;
`(d) the extent of the overlap between the arguments made during
`examination and the manner in which petitioner relies on the prior art or
`patent owner distinguishes the prior art;
`(e) whether petitioner has pointed out sufficiently how the examiner
`erred in its evaluation of the asserted prior art; and
`
`
`9 “The Board institutes trial on behalf of the Director.” 37 C.F.R. § 42.4(a);
`Advanced Bionics, Paper 6 at 7 n.7.
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`7
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`Patent 7,541,179 B2
`(f) the extent to which additional evidence and facts presented in the
`petition warrant reconsideration of the prior art or arguments. Becton,
`Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at
`17–18 (PTAB Dec. 15, 2017) (precedential as to Section III.C.5, first
`paragraph) (“Becton, Dickinson”) (footnote omitted).
`Factors (a), (b), and (d) of the Becton, Dickinson factors relate to
`whether the art or arguments presented in the Petition are the same or
`substantially the same as those previously presented to the Office. Advanced
`Bionics at 10. Factors (c), (e), and (f) “relate to whether the petitioner has
`demonstrated a material error by the Office” in its prior consideration of that
`art or arguments. Id. Only if the same or substantially the same art or
`arguments were previously presented to the Office do we then consider
`whether petitioner has demonstrated a material error by the Office. Id.
`“[T]his framework reflects a commitment to defer to previous Office
`evaluations of the evidence of record unless material error is shown.”
`Id. at 9.
`
`Part One of the § 325(d) Analysis
`1.
`We first consider whether Petitioner asserts the same or substantially
`the same art or arguments that previously were presented to the Office.
`Advanced Bionics, Paper 6 at 8.
`Petitioner contends that “neither the May Thesis nor the May Abstract
`were considered during the prosecution of the ’179 patent or any related
`patent.” Pet. 45 (citing Ex. 1001, code (56)). Although Petitioner
`acknowledges that the Examiner considered the May Article, Petitioner
`argues that the May Article was applied against the original claims of the
`application, and not the allowed claims reciting the specific LCR fragment.
`Id. at 45–46 (citing Ex. 1032, 19–24, 61–66). Petitioner further argues that
`
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`“the Applicants overcame the rejection not on substance, but by the filing of
`conclusory Katz declarations arguing that the May Article ‘reflects the work
`of the inventors of this application.’” Id. at 46 (citing Ex. 1032, 106, 109–
`116).
`Patent Owner argues that the “Examiner expressly considered the
`[May] Article during prosecution.” Prelim. Resp. 42. Patent Owner further
`argues that the May Abstract and the May Thesis “describe the same work
`by the same inventors to develop the vector claimed in the ’179 Patent.” Id.
`(citing Exs. 1004–1006). Accordingly, Patent Owner argues that the May
`Abstract and May Thesis do not qualify as prior art, and that “the Examiner
`has already considered the written description requirements related to the
`‘functional globin’ limitation,” which forms the basis of Petitioner’s
`argument for lack of priority to the provisional applications.10 Id. at 42–43;
`see also 29–38.
`Petitioner replies that Patent Owner “does not point to any analysis of
`the priority date issue by the Examiner.” Reply 1. Instead, Petitioner argues
`that “even if the Examiner silently considered the priority issue, there is no
`analysis upon which the Board may discern whether the Examiner
`conducted a proper analysis.” Id. at 1–2 (citing Smith & Nephew, Inc. v.
`Arthrex, Inc., IPR2016-00487, Paper 8, 19 (PTAB July 27, 2016).
`Based on our review of the record, we find that Petitioner has not
`shown persuasively that the Examiner did not consider the same or
`
`
`10 The ’221 application claims priority to provisional application no.
`60/301,861 (Ex. 1034) (“the ’861 provisional application”), filed June 29,
`2001, and provisional application no. 60/302,852 (Ex. 1035) (“the ’852
`provisional application”), filed on July 2, 2001, referred to, collectively, as
`“the provisional applications,” “the provisionals” and “the Provisionals.”
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`Patent 7,541,179 B2
`substantially the same art that Petitioner relies upon for its obviousness
`challenges. Petitioner’s grounds rely on three different “May” references,
`only one of which the Examiner considered during prosecution, i.e., the May
`Article. The additional references relied upon by Petitioner are the May
`Thesis, which provides a more detailed disclosure than the May Article, and
`the May Abstract, which provides less detail than the May Article, in terms
`of the HS2, HS3, and HS4 fragments used to generate the disclosed TNS9
`vector. Those differences are only material with respect to whether each
`reference discloses the fragments as recited in independent claim 1, or
`renders those fragments obvious. However, as discussed in Section II.D.2.,
`we determine that the May Thesis is not prior art.
`Because the May Abstract shares a similar disclosure as the May
`Article, but in less detail, the May Abstract may be considered cumulative to
`the May Article. Because the May Thesis provides more explicit details
`regarding the fragments disclosed in the May Article, it may not be
`considered to be cumulative to the May Article. However, as discussed in
`Section II.D.2., we determine that the May Thesis is not prior art.
`When considering the extent of the overlap between the arguments
`made during examination and the manner in which Petitioner relies on the
`May Article or Patent Owner distinguishes the May Article, we note that
`Patent Owner alleged during prosecution and here that the May Article is not
`prior art for a number of reasons, including that it is the work of the
`inventors and that it was published one year or less before the priority date
`asserted by Patent Owner for the challenged claims. We note also that
`Petitioner contends that the challenged claims are not entitled to the priority
`date asserted by Patent Owner, and recognized by the Examiner.
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`10
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`Based on the foregoing, we conclude that substantially the same prior
`art that Petitioner relies upon was previously presented to the Examiner
`during prosecution. The first part of the § 325(d) framework is, therefore,
`met. Accordingly, we turn to the second part of the § 325(d) and determine
`whether error by the Office has been shown. See Advanced Bionics at 8.
`Part Two of the § 325 Analysis
`2.
`We next consider whether Petitioner has demonstrated a material error
`by the Office. Material error may be demonstrated by showing that an
`examiner “misapprehend[ed] or overlook[ed] specific teachings of the
`relevant prior art where those teachings impact patentability of the
`challenged claims.” Advanced Bionics at 8 n.9.
`Petitioner asserts that “during the prosecution of the ’221 application,
`the Examiner did not consider the appropriate priority date, nor did they
`consider the inventors’ own prior art regarding the TNS9 vector disclosed
`and claimed in the ’179 patent published more than one year prior to the
`earliest possible priority date.” Pet. 46–47 (citing Ex. 1032). Petitioner
`further asserts that “[t]he Office plainly erred by not considering prior art up
`to the appropriate priority date and, therefore, not substantively engaging
`with the May Article and failing to consider the May Thesis or the May
`Abstract at all.” Id. at 47.
`Patent Owner argues that “Petitioner fails to identify any additional
`disclosures or art overlooked, or any material error made, by the Examiner
`that would negate or call into question the Examiner’s findings.” Prelim.
`Resp. 43. Patent Owner argues that “everything suggests the Examiner fully
`evaluated art and arguments and reconsideration is not warranted.” Id. at
`43–44.
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`Petitioner replies that the Examiner’s silence on priority “suggests
`only that the Examiner erred by failing to consider the priority date issue.”
`Reply 1. Petitioner further argues that the Examiner “missed key issues,”
`particularly where Applicants cited to the passages for written description
`support that were not present in the provisional applications. Id. at 2 (citing
`Pet. 16–17).
`In response to Petitioner’s argument about Examiner error, Patent
`Owner argues that “the Office necessarily determined priority when
`distinguishing between §§ 102(a) and 102(b) art.” Sur-reply 2. Patent
`Owner argues that the Office determined that the claims were entitled to the
`provisional filing date because Appellant was able to traverse the May
`article as § 102(a) art with Katz declarations from the inventors. Id.
`Otherwise, the Office would have treated the May Article as § 102(b) art and
`applied a statutory bar. See id.
`Patent Owner further argues that Petitioner raises new argument in the
`Reply that could have been presented in the Petition, namely that “the
`‘Examiner missed’ that the cited support for an amendment was not present
`in the Provisionals.” Sur-reply 3.11 Instead, Patent Owner argues that “the
`Provisionals explain that ‘large fragments’ [i.e., nucleotide sequences] of the
`globin gene along with the LCR fragments allow for the ‘treatment [i.e.,
`therapeutic benefits] of severe haemoglobinopathies.’” Id. at 3, citing (Ex.
`1032, 4).
`
`
`11 We need not reach Patent Owner’s allegation that Petitioner’s Reply
`exceeds the scope authorized, as our determination regarding likely
`Examiner error is based upon our consideration of Petitioner’s arguments
`presented in the Petition, as opposed to what was presented in the Reply.
`
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`IPR2023-00070
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`As set forth below in Section II. D.1., we determine, at this stage in the
`proceeding that Petitioner has shown persuasively that claims 1, 19, and 22
`of the ’179 patent are not entitled to receive benefit of the filing date for
`either provisional application relied upon by Patent Owner. In particular, we
`find persuasive Petitioner’s arguments that the provisional applications do
`not satisfy the written description requirements of 35 U.S.C. § 112 for those
`claims. Thus, we explain that for purposes of this Decision, claims 1, 19,
`and 22 have a priority date of July 1, 2002, the filing date of the ’221
`application. The Examiner did not provide an analysis of the priority date
`for the challenged claims. Thus, we are unable to analyze the Examiner’s
`position regarding that issue. Based on the current record, we are
`constrained to consider that the Examiner likely misapprehended or
`overlooked the relevant facts regarding the proper priority date for the
`challenged claims.
`Similarly, as set forth in Section II.D.2., we determine at this stage in the
`proceeding that the May Article is eligible as prior art under Section 102(b).
`As we explain, based upon the undisputed July 6, 2000 public availability
`date, although the May Article is the work of the inventor, it represents a
`disclosure made more than one year before the effective filing date, i.e., July
`1, 2002, for claims 1, 19, and 22 challenged with this reference.
`Finally, as set forth in Section II.G.2, we determine, based on the current
`record, that Petitioner has shown a reasonable likelihood of establishing that
`the challenged claims are rendered obvious by the May Article.
`Thus, based on the current record, we determine that the Examiner
`likely erred in failing to consider the May Article as prior art. This apparent
`error, along with the testimony of Petitioner’s expert, Dr. Bungert regarding
`the teachings and suggestions provided by the May Article to a person of
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`skill in the art at the time of the invention, which was not before the
`Examiner, persuades us that the Office’s reconsideration of the prior art is
`justified.
`
`Conclusion on § 325
`3.
`Based on the foregoing analysis, we determine that the Petition does
`not implicate § 325(d) in a manner sufficient to warrant discretionary denial.
`Accordingly, we decline to exercise our discretion to deny the Petition under
`§ 325(d).
`
`Person of Ordinary Skill in the Art
`B.
`The level of skill in the art is a factual determination that provides a
`primary guarantee of objectivity in an obviousness analysis. Al-Site Corp. v.
`VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing Graham v. John
`Deere Co., 383 U.S. 1, 17–18 (1966); Ryko Mfg. Co. v. Nu-Star, Inc.,
`950 F.2d 714, 718 (Fed. Cir. 1991)).
`Petitioner asserts that a person of ordinary skill in the art (“POSA”)
`“at the time of the alleged invention would have had: (1) at least an
`advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, biotechnology,
`protein chemistry, genetics, molecular and structural biology,
`bioengineering, or similar disciplines.” Pet. 17 (citing Ex. 1002 ¶¶ 14–15).
`Petitioner further asserts that a POSA would have had “(2) several years of
`post-graduate training or related experience in one or more of these areas”
`and “(3) an understanding of vector design and the effect of LCR fragments
`on gene expression, including experience with how the LCR regulates gene
`expression.” Id.
`At this stage in the proceeding, Patent Owner does not dispute
`Petitioner’s description of the level of ordinary skill in the art. See Prelim.
`Resp. Because Petitioner’s uncontested definition of one of ordinary skill in
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`the art is reasonable and consistent with the ’179 patent and the prior art of
`record, we adopt Petitioner’s definition for purposes of this Decision.
`Claim Construction
`C.
`The Board applies the same claim construction standard that would be
`used to construe the claim in a civil action under 35 U.S.C. § 282(b).
`37 C.F.R. § 100(b) (2019). Under that standard, claim terms “are generally
`given their ordinary and customary meaning” as understood by a person of
`ordinary skill in the art at the time of the invention. Phillips v. AWH Corp.,
`415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp.
`v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). “In determining
`the meaning of the disputed claim limitation, we look principally to the
`intrinsic evidence of record, examining the claim language itself, the written
`description, and the prosecution history, if in evidence.” DePuy Spine, Inc.
`v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006)
`(citing Phillips, 415 F.3d at 1312–17).
`Petitioner states that “no term of the ’179 patent requires construction
`to resolve the challenges in this Petition.” Pet. 22 (citing Ex. 1002 ¶¶ 49–
`50) (footnote omitted). Patent Owner does not argue for any express claim
`constructions. See Prelim. Resp.
`Based upon our review of the current record, we determine that no
`claim terms require express construction for purposes of deciding whether to
`institute an inter partes review of the challenged claims. See Nidec Motor
`Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed.
`Cir. 2017) (Only those terms that are in controversy need be construed, “and
`only to the extent necessary to resolve the controversy.”).
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`Priority and Prior Art Status
`D.
`The ’179 Patent Priority Date
`1.
`As noted above, the ’179 patent issued from the ’221 application filed
`on July 1, 2002. Ex. 1001, code (22). The ’221 application claims priority
`to the ’861 provisional application, filed June 29, 2001, and the ’852
`provisional application, filed on July 2, 2001. Id. code (60).
`Petitioner asserts that “at least claims 1, 19, and 22 of the ’179 patent
`cannot claim priority to either provisional because [the provisional
`applications] do not satisfy at least the written description requirements of
`35 U.S.C. § 112 for these claims.” Pet. 13; see Reply 4. As a result,
`Petitioner asserts that that “the earliest date to which these claims of the ’179
`patent may claim priority is July 1, 2002, the filing date of the [’221]
`application.” Id.
`Petitioner asserts particularly that the provisional applications do not
`provide written description support for “a nucleic acid encoding a functional
`globin,” recited by independent claim 1 of ’179 patent. Id. at 14 (citing Ex.
`1002 ¶¶ 51–59). Petitioner asserts that the provisional applications disclose
`only wild-type human β-globin. Id. (citing Ex. 1034, 1; Ex. 1035, 1;
`Ex. 1002 ¶ 54). Petitioner contrasts that disclosure with the ’179 patent,
`which Petitioner asserts describes a “‘functional globin’ genus [including]
`‘mutant forms of globin’ as well as multiple different globin types (i.e., α, β,
`or γ-globin).” Id. (citing Ex. 1001, 2:41–53; Ex. 1002 ¶ 53). Petitioner
`contends that human β-globin species is “merely a ‘corner’ of the vast
`‘functional globin’ genus” and “is not representative of the other types of
`globin (i.e., α and γ) or of mutants.” Id. at 16 (quoting AbbVie Deutschland
`GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1299–1300 (Fed. Cir.
`2014)); Ex. 1002 ¶¶ 56–58. According to Petitioner, the provisional
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`applications, therefore, “would not inform a [POSA] that the named
`inventors possessed all recombinant vectors that can express a ‘functional
`globin’ from the claimed 3.2-kb LCR in a mammal in vivo.” Id. at 16 (citing
`Ex. 1024, 107, 109; Ex. 1025, 305; Ex. 1002 ¶¶ 56–58); see Reply 3.
`Patent Owner argues that the provisional applications “disclose
`‘functional’ globin genes.” Prelim. Resp. 23 (citing Ex. 2002 ¶¶ 60–68).
`Specifically, Patent Owner points to the disclosure in the provisional
`applications that “the vector of the invention is used in therapy for treatment
`of individuals suffering from hemoglobinopathies [disorders resulted from
`mutations in globin (alpha, beta, or gamma) genes].” Id. (quoting Ex. 1034,
`3; Ex. 1035, 4) (bracketed portion added by Patent Owner). Additionally,
`Patent Owner notes that, for one embodiment, the provisionals state that
`“[t]he stable introduction of a functional β-globin gene in haematopoietic
`stem cells could be a powerful approach to treat β-thalassemia and sickle-
`cell disease,” and exemplifies a “recombinant lentivirus [that] enables
`efficient transfer and faithful integration of the human β-globin gene
`together with large segments of its locus control region.” Id. (citing Ex.
`1034, 4; Ex. 1035, 5). Patent Owner argues that a POSA “would understand
`this to disclose an approach that could be used with different functional
`globin (e.g., epsilon, gamma, or other beta) genes as well as one specific
`example with regard to a successfully tested vector, i.e., the TNS9 vector,
`using a human β-globin gene.” Id. at 23–24 (citing Ex. 2002 ¶¶ 61–68; Ex.
`2009 ¶¶ 14–15; Ex. 1036, 115–116).
`Moreover, Patent Owner argues that “it was understood in the 1990s
`that ‘the human beta-globin locus control region (LCR) is essential for high-
`level expression of human epsilon-, gamma-, and beta-globin genes.’” Id. at
`24 (quoting Ex. 2011, 1). Based on that knowledge, Patent Owner asserts
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`that “a POSITA would understand that the human β-globin LCR region
`described in the Provisionals could be used with an epsilon-, gamma-, or
`other beta-globin gene — which had little variation in their common
`structure and characteristics — to similar effect.” Id. (citing Ex. 2002 ¶ 63;
`Ex. 2009 ¶¶ 14–15).
`Petitioner replies that Patent Owner appears to incorrectly apply an
`obviousness standard to show possession by asserting that a POSA would
`understand that the provisional applications disclose “an approach that could
`be used with different functional globin . . . to similar effect,” and that “by
`substituting the nucleotide sequence of said globin gene(s) during the
`construction of the vector(s), different globin genes would be expressed,”
`and “would result in increased expression of said genes.” Reply 4 (quoting
`Prelim. Resp. 23–24). Petitioner asserts that Patent Owner’s argument
`“recognizes that changes would need to be made to the vector for the
`possibility to allow for expression of other globin,” and those changes are
`“not described in the provisional applications.” Id. at 5 (citing Prelim. Resp.
`24).
`
`Patent Owner distinguishes the ’179 patent claims from those in
`Abbvie, in which “the challenged claims were directed to a genus of new
`anti-human IL-12 antibodies,” defined only by their functions. Prelim.
`Resp. 26 (citing AbbVie, 759 F.3d at 1292). Patent Owner contends that
`“[u]nlike Abbvie, the claims here are not directed to a new ‘functional
`globin’ but rather to a vector containing nucleotide fragments from a known
`LCR that served to regulate the expression of known functional globins.” Id.
`(citing Ex. 1001, 11:54–14:28; Ex. 2002 ¶¶ 60–68).
`Petitioner replies that Patent Owner does not distinguish Abbvie.
`Reply 5. Rather, Petitioner argues that the claims do not merely recite a
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`globin, but a vector that encodes a functional globin expressed in mammals
`in vivo. Id. In other words, Petitioner argues that, “like in Abbvie, the
`claims here do require a functional result.” Id. (citing Pet. 16). Petitioner
`assert that also similar to Abbvie, “the provisional applications fail to
`establish a reasonable structure-function relationship between the claimed
`vector and all possible functional globins.” Id. (citing Abbvie, 749 F.3d at
`1301).
`Patent Owner responds that “the invention is directed to a vector
`having novel LCR fragments that results in expression of known globin
`genes.” Sur-reply 5 (citing Prelim. Resp. 9, 13). According to Patent
`Owner, [t]he Provisionals, which reproduce the Nature Article in full, make
`clear that the disclosed principles could be extended to express other globin
`genes, (Ex. 1005 at 6; Exs. 1034–35), which was well understood by
`POSITAs.” Id.
`In addition t