Trials@uspto.gov
`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.
`
`IPR2023-00074
`Patent 8,058,061 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
`
`
`
`
`
`
`
`
`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.
`
`IPR2023-00074
`Patent 8,058,061 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
`
`
`
`
`
`
`
`
`
`IPR2023-00074
`Patent 8,058,061 B2
`
`INTRODUCTION
`I.
`Bluebird bio, Inc. (“Petitioner”) filed a Petition requesting an inter
`partes review of claims 1, 2, 5–8, 11, and 15 of U.S. Patent No. 8,058,061
`B2 (Ex. 1001, “the ’061 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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`IPR2023-00074
`Patent 8,058,061 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 ’061 patent. Paper 4, 3.
`The parties further identify IPR2023-00070, challenging certain
`claims of U.S. Patent No. 7,541,179 B2 (“the ’179 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 10/188,22 (“the ’221 application”),
`which issued as the ’179 patent. Ex. 1001, code (62).
`The ’061 Patent
`C.
`The ’061 patent relates 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, 1:50–53. The Specification
`defines the “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 2:40–43. 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
`2:44–48. “The functional globin gene may encode a wild-type globin,” “a
`mutant form of globin,” “α-globin, β-globin, or γ-globin.” Id. at 2:48–56.
`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 1:41–46.
`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 2:57–59. The Specification
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`3
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`Patent 8,058,061 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 2:63–
`67. 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 3:26–28. Figure 1, reproduced below,
`illustrates the TNS9 vector.
`
`
`
`Figure 1 illustrates the TNS9 vector with the exons represented by filled
`boxes and the introns represented by open boxes. Id. at 3:16–18. 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 3:18–21. The 5ʹ and 3ʹ ends include
`long terminal repeat (LTR) sequences. See Fig. 1.
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`4
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`Patent 8,058,061 B2
`
`Illustrative Claims
`D.
`Petitioner challenges claims 1, 2, 5–8, 11, and 15 of the ’061 patent.
`Claims 1 and 11, set forth below, are the only independent claims and are
`illustrative of the claimed subject matter.
`1. An isolated mammalian hematopoietic progenitor cell or an
`isolated mammalian stem cell comprising a recombinant
`lentiviral vector which comprises 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.
`11. A method for making a mammalian hematopoietic progenitor
`cell or a mammalian stem cell composition which comprises
` (a) preparing a recombinant lentiviral 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; and
` (b) obtaining hematopoietic progenitor cells or stem cells from
`the mammalian individual, and transducing the cells with
`the recombinant vector.
`Ex. 1001, 11:56–67, 12:61–13:10. Dependent claim 2 recites the
`hematopoietic progenitor cell or stem cell of claim 1 being a human cell. Id.
`at 12:1–2. Claims 5–8 recite that the functional globin of claim 1 is a mutant
`
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`Patent 8,058,061 B2
`globin (claim 5), wild-type globin (claim 6), β-globin (claim 7), and human
`β-globin (claim 8 depending from claim 7). Id. at 12:10–15, 55–56. Claim
`15 recites that the functional globin of claim 11 is human β-globin. Id. at
`14:7–8.
`
`Reference(s)/Basis
`May Thesis3
`May Thesis, Himanen4
`May Article5,6
`May Article
`May Article, Himanen
`May Abstract7
`May Abstract, Himanen
`
`Asserted Grounds of Unpatentability
`E.
`Petitioner asserts that claims 1, 2, 5–8, 11, and 15 would have been
`unpatentable on the following seven grounds:
`Claims Challenged
`35 U.S.C. §2
`1, 2, 6, 7, 11
`102
`5
`103
`1, 2, 6, 7, 11
`102
`1, 2, 6, 7, 11
`103
`5
`103
`1, 2, 6–8, 11, 15
`103
`5
`103
`
`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 ’061 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”).
`4 Himanen, et al., A Recombinant Sickle Hemoglobin Triple Mutant With
`Independent Inhibitory Effects on Polymerization, 271(41) J. BIOL. CHEM.
`25152–56 (1996) (Ex. 1047, “Himanen”).
`5 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”).
`6 In the Preliminary Response, Patent Owner refers to Exhibit 1005 as the
`“Nature Article.” See Prelim. Resp. 1.
`7 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”).
`
`6
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`Patent 8,058,061 B2
`Petitioner also relies upon the Declarations of Jörg Bungert, Ph.D.
`(Ex. 1002) and Ingrid Hsieh-Yee, Ph.D.8 (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).9
`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. 40–45. 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
`Office.10 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,
`
`
`8 Petitioner relies on the declaration of Dr. Hsiey-Yee, a librarian, to address
`authenticity and public availability of the cited references. Ex. 1036 ¶ 16.
`9 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.
`10 “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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`Patent 8,058,061 B2
`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
`(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
`
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`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 ’061 patent or any related
`patent.” Pet. 63 (citing Ex. 1001, code (56); Ex. 1033). Although Petitioner
`acknowledges that the Examiner considered the May Article during
`prosecution of the parent ’221 application, 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. (citing Ex. 1032, 19–
`24, 61–66). Petitioner further argues that “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. (citing Ex. 1032, 106, 109–116).
`Patent Owner argues that the “Examiner expressly considered the
`[May] Article during prosecution.” Prelim. Resp. 43. 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 ’061 Patent.” Id.
`at 43–44 (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
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`Patent 8,058,061 B2
`related to the ‘functional globin’ limitation,” which forms the basis of
`Petitioner’s argument for lack of priority to the provisional applications. 11
`Id. at 44, see also id. at 19–29.
`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
`substantially the same art that Petitioner relies upon for its obviousness
`challenges. Petitioner’s grounds primarily rely on three different “May”
`references, only one of which the Examiner considered during prosecution,
`i.e., the May Article. The additional primary 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. As discussed in
`Section II.D.2., however, we determine that the May Thesis is not prior art.
`
`
`11 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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`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.
`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.
`
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`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 ’061 patent published more than one year prior to the
`earliest possible priority date.” Pet. 64 (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.
`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. 44. Patent Owner argues that “everything suggests the Examiner fully
`evaluated the art and arguments, foreclosing reconsideration.” Id. at 45.
`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. 17–18).
`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.
`
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`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 news 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 3.12 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).
`As set forth above in Section II. D.1., we determine, at this stage in the
`proceeding that Petitioner has shown persuasively that claims 1, 2, 5–7, and
`11, of the ’061 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, 2, 5–
`7, and 11, 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
`
`
`12 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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`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, 2, 5–7, and 11 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
`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, 1323 (Fed. Cir. 1999) (citing Graham v. John
`
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`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. 18–19 (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
`the art is reasonable and consistent with the ’061 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
`
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`Patent 8,058,061 B2
`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 “that no term of the ’061 patent requires
`construction to resolve the challenges in this Petition.” Pet. 25 (citing Ex.
`1002 ¶¶ 50–51) (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.”).
`Priority and Prior Art Status
`D.
`1.
`The ’061 Patent Priority Date
`As noted above, the ’061 patent issued from U.S. application no.
`12/433,412 that is a division of 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, 2, 5–7, and 11 of the ’061
`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. 14 (citing In re NTP, Inc., 654 F.3d
`1268, 1277 (Fed. Cir. 2011)). As a result, Petitioner asserts that that “the
`earliest date to which these claims of the ’061 patent may claim priority is
`July 1, 2002, the filing date of the [’221] application.” Id. at 15.
`
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`Patent 8,058,061 B2
`Petitioner asserts particularly that the provisional applications do not
`provide written description support for a “nucleic acid encoding a functional
`globin,” recited by independent claims 1 and 11 of ’061 patent. Id. at 16
`(citing Ex. 1002 ¶¶ 52–60). Petitioner asserts that the provisional
`applications disclose only wild-type human β-globin. Id. (citing Ex. 1034,
`1; Ex. 1035, 1; Ex. 1002 ¶ 55). Petitioner contrasts that disclosure with the
`’061 patent, which Petitioner asserts describes a “‘functional globin’ genus
`that includes ‘mutant forms of globin’ as well as multiple different globin
`types (i.e., α, β, or γ-globin).” Id. (citing Ex. 1001, 2:44–56; Ex. 1002 ¶ 54).
`Petitioner contends that human β-globin 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 17–18 (citing Ex. 1002 ¶¶ 57–59;
`AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285,
`1299–1300 (Fed. Cir. 2014)). According to Petitioner, the provisional
`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 18 (citing
`Ex. 1024, 107, 109; Ex. 1025, 305; Ex. 1002 ¶¶ 57–59); see Reply 3.
`Patent Owner argues that the provisional applications “disclose
`‘functional’ globin genes.” Prelim. Resp. 24 (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
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`IPR2023-00074
`Patent 8,058,061 B2
`stem cells could be a powerful approach to treat β-thalassemia and sickle-
`cell disease,” and exemplifies a “recombinant virus [that] enables efficient
`transfer and faithful integration of the human b-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 25 (citing Ex. 2002 ¶¶ 61–68; Ex. 2009 ¶¶ 14–
`15; Ex. 1036, 128–129).
`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.
`(quoting Ex. 2011, 1). Based on that knowledge, Patent Owner argues 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 . . . genes.” Reply 4 (citing
`Prelim. Resp. 24–26). Petitioner argues that instead Patent Owner
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`IPR2023-00074
`Patent 8,058,061 B2
`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 ’061 patent claims from those i
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