Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
` Paper No. 15
`Entered: January 22, 2018
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ARAGEN BIOSCIENCE, INC.
`AND
`TRANSPOSAGEN BIOPHARMACEUTICALS, INC.,
`Petitioner,
`v.
`KYOWA HAKKO KIRIN CO., LTD.,
`Patent Owner.
`____________
`
`Case IPR2017-01262
`Patent 7,425,446 B2
`____________
`
`
`Before JAMES T. MOORE, ERICA A. FRANKLIN, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`
`Denying Petitioner’s Request for Rehearing
` 37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`
` Paper No. 15
`Entered: January 22, 2018
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ARAGEN BIOSCIENCE, INC.
`AND
`TRANSPOSAGEN BIOPHARMACEUTICALS, INC.,
`Petitioner,
`v.
`KYOWA HAKKO KIRIN CO., LTD.,
`Patent Owner.
`____________
`
`Case IPR2017-01262
`Patent 7,425,446 B2
`____________
`
`
`Before JAMES T. MOORE, ERICA A. FRANKLIN, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`
`Denying Petitioner’s Request for Rehearing
` 37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`IPR2017-01262
`Patent 7,425,446 B2
`
`
` INTRODUCTION
`I.
`Aragen Bioscience, Inc. and Transposagen Biopharmaceuticals, Inc.
`(“Petitioner”) filed a Petition requesting an inter partes review of claims 1–6
`of U.S. Patent No. 7,425,446 B2 (Ex. 1001, “the ’446 Patent”). Paper 1.
`Kyowa Hakko Kirin Co., Ltd. (“Patent Owner”) filed a Preliminary
`Response to the Petition. Paper 8. In our Decision (“Dec.”) dated October
`23, 2017 (Paper 12), we determined that the information presented in the
`Petition and accompanying evidence did not establish a reasonable
`likelihood that Petitioner would prevail in showing the unpatentability of at
`least one challenged claim of the ’446 patent. Accordingly, we denied the
`Petition and did not institute an inter partes review of the ’446 patent. Id. at
`23.
`
`Petitioner now requests rehearing of our decision not to institute trial
`on claims 1–6. Paper 13 (“Req. Reh’g”). For the following reasons, we
`deny Petitioner’s Request for Rehearing.
`
` STANDARD OF REVIEW
`II.
`The applicable standard for a request for rehearing is set forth in 37
`C.F.R. § 42.71(d), which provides in relevant part:
`A party dissatisfied with a decision may file a request for
`rehearing, without prior authorization from the Board. The
`burden of showing a decision should be modified lies with the
`party challenging the decision. The request must specifically
`identify all matters the party believes the Board misapprehended
`or overlooked, and the place where each matter was previously
`addressed in a motion, an opposition, or a reply.
`When reconsidering a decision on institution, we review the decision
`for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion
`may be determined if a decision is based on an erroneous interpretation of
`
`2
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`IPR2017-01262
`
`Patent 7,425,446 B2
`law, if a factual finding is not supported by substantial evidence, or if the
`decision represents an unreasonable judgment in weighing relevant factors.
`See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir.
`2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re
`Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).
`
` ANALYSIS
`III.
`As recited in independent claim 1, the challenged claims recite “[a]n
`isolated mammalian host cell” created “by deleting a gene encoding α1,6-
`fucosyltransferase or by adding a mutation to said gene to reduce or
`eliminate the α1,6-fucosyltransferase activity” In denying the Petition, we
`found that Petitioner did not establish that the prior art disclosed or rendered
`obvious the challenged claims because it failed to present sufficient evidence
`that one of ordinary skill in the art would have had access to the necessary
`genetic starting material. Dec. 16–21. In particular, we determined that
`“Petitioner fails to establish adequately that DNA encoding a mammalian
`α1,6-fucosyltransferase was either available, or could be routinely obtained
`by those of ordinary skill in the art.” Id. at 20. According to Petitioner, our
`finding is “clearly erroneous” and based on “misunderstandings about the
`record evidence, as well as a failure to weigh, in full, unrebutted expert
`testimony before the Board.” Req. Reh’g 1. We do not find Petitioner’s
`argument persuasive.
`First, pointing to “a critical portion of Example 12” of the
`Specification, Petitioner contends that we overlooked that the inventors
`cloned exon 2 of a mammalian FUT8 using “PCR primers based on ‘a
`mouse FUT8 cDNA sequence (GenBank, AB025198).’” Id. at 4–5. (citing
`Ex. 1001 at 98:30–35; Dec. 4, 18–19) (emphasis omitted). Petitioner further
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`3
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`IPR2017-01262
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`Patent 7,425,446 B2
`contends that, in light of this disclosure, the Board, in a parallel Institution
`Decision, “acknowledged that the FUT8 gene sequence was available as of
`the priority date.” Id. We do not agree with Petitioner’s characterization.
`Nowhere does the Petition point us to GenBank entry AB025198—let
`alone suggest that it is prior art to the instant Specification. Only belatedly
`does Petitioner describe Exhibit 10391 as providing evidence that the
`GenBank entry relates to a genetic sequence of mouse α1,6-
`fucosyltransferase that was publically available prior to the earliest priority
`date of the ’232 Patent. Id. at 4 & n. 3. Petitioner similarly argues that “the
`’446 patent specification also admits that ‘human FUT8 cDNA’ and ‘swine
`FUT8 cDNA’ were in the prior art,” belatedly submitting Exhibits 10422 and
`10433 in support of this new argument. Id. at 7–8 & n.5 (citing Ex. 1001,
`79:53–56).
`“In an [inter partes review], the petitioner has the burden from the
`onset to show with particularity why the patent it challenges is
`unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
`Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review
`petitions to identify “with particularity . . . the evidence that supports the
`grounds for the challenge to each claim”)). Because Petitioner raised none
`
`
`1 Genbank entry AB025198.1. “Mus musculus mRNA for alpha-1,6-
`fucosyltransferase, complete cds,” https://www.ncbi.nlm.nih.gov/nuccore
`/%20AB025198.
`2 Yanagidani et al., Purification and cDNA Cloning of GDP-i-Fuc:N-acetyl-
`β-d-glucosaminyl fucosyltransferase (α1-6FucT) from Human Gastric
`CancerMKN45 Cells, 121 J. Biol. Chem. 626-632 (1997).
`3 Naofumi Uozumi, Purification and cDNA Cloning of Porcine Brain
`GDPL-Fuc:N-Acetyl-β-D-Glucosaminide α1→6Fucosyltransferase, 271 J.
`Biol. Chem. 27810-27817 (1996).
`
`4
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`IPR2017-01262
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`Patent 7,425,446 B2
`of the above arguments in the Petition, nor timely submitted any of Exhibits
`1038, 1041, and 1042, Petitioner has not established that we misapprehended
`or overlooked this evidence. Cf. DeSilva v. DiLeonardi, 181 F.3d 865, 866–
`67 (Fed. Cir. 1999) (“A brief must make all arguments accessible to the
`judges, rather than ask them to play archeologist with the record.”).
`Petitioner also contends that we overlooked the disclosures of Oriol
`(Ex. 1040) and Breton (Ex. 1041). Req. Reh’g 6. Petitioner correctly notes
`that “[t]he Board did not analyze these references” and that they were first
`submitted with Petitioner’s Request for Rehearing. Id. at 10; see id. at 6,
`n.4. Petitioner asserts, however, that Patent Owner should have submitted
`them when it discussed Dr. Van Ness’s testimony. Id. at 10–11.
`We do not find this argument persuasive. “In an inter partes review,
`the burden of persuasion is on the petitioner to prove ‘unpatentability by a
`preponderance of the evidence,’ 35 U.S.C. § 316(e), and that burden never
`shifts to the patentee.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364,
`1375 (Fed. Cir. 2016) (quoting Dynamic Drinkware, LLC v. Nat’l Graphics,
`Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015)). Accordingly, it was Petitioner’s
`responsibility, not Patent Owner’s, to set forth arguments and submit
`evidence to support its Petition. And, in light of the arguments and evidence
`before us at the time of our Decision, Petitioner had not established that the
`prior art taught the availability of a mammalian FUT 8 gene sequence.
`Petitioner further argues that we improperly discounted the testimony
`of Drs. Van Ness and Jefferis. Req. Reh’g 12–14 (citing Ex. 1007 ¶¶ 18–20,
`40–43, 73; Ex. 1026 ¶¶ 38, 11–14). With respect to the latter, Petitioner
`points to Dr. Jefferis’s statement that a person of ordinary skill in the art
`“would have had knowledge of the scientific literature no later than October
`
`5
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`IPR2017-01262
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`Patent 7,425,446 B2
`6, 2000 concerning the means and methods for creating cells in which the
`gene for the fucose-adding enzyme fucosyltransferase was knocked out,
`resulting in a modified sugar chain giving improved antibodies.” See id. at
`12; Ex. 1026 ¶ 12. But Dr. Jefferis provides no definitive statement with
`respect to the availability of DNA encoding a mammalian α1,6-
`fucosyltransferase, focusing, instead, on the “basic enabling techniques
`described in the patent claims.” See Ex. 1026 ¶ 12; see also id. ¶ 14
`(discussing statement in prosecution history “that construction of gene
`constructs and knock-out CHO cells were ‘standard methods’ in the prior
`art”). Accordingly, we do not find Dr. Jefferis’s testimony relevant to the
`availability of a mammalian FUT 8 gene sequence.
`Dr. Van Ness, in contrast, referenced “the known genetic sequence of
`the α1,6-fucosyltransferase gene,” after asserting that “[t]he human
`fucosyltransferase gene sequence had been cloned in 1994 by Sasaki et al.
`(269(20) J. BIOL. CHEM. 14730–37 (1994)).” Ex. 1007 ¶¶ 40, 73. As
`discussed in our Decision, Sasaki does not disclose a mammalian α1,6-
`fucosyltransferase recited in claim 1, but an α1,3-fucosyltransferase. Dec.
`17. As such, Sasaki fails to support Dr. Van Ness’s generic reference to “the
`known genetic sequence of the α1,6-fucosyltransferase gene.” Because
`neither Dr. Van Ness nor Petitioner presented any evidence demonstrating
`how that the nucleotide sequence of an α1,3-fucosyltransferase teaches or
`suggests that of α1,6-fucosyltransferase recited in claim 1, we accorded little
`weight to Dr. Van Ness’s opinion. Id.
`Petitioner also contends that we overlooked “key aspects” of the
`prosecution history “demonstrating that structural motifs important for
`fucosyltransferase activity could be predicted from known DNA sequences.”
`
`6
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`IPR2017-01262
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`Patent 7,425,446 B2
`Req. Reh’g 7–12 (citing Ex. 1036, Aug. 12, 2004 Amendment at 34; Paper
`1, 13–16; Ex. 1007 ¶¶ 18–20). Petitioner similarly argues that we
`misapprehended Dr. Van Ness’s testimony regarding this portion of the
`prosecution history. See id. at 5–6.
`We do not find these arguments persuasive for the reasons set forth on
`pages 17–21 of the Decision on Institution. In sum, we determined that
`Dr. Van Ness’s testimony was unsupported by the record then before us
`because:
`the “structures” Applicants reference in the prosecution history
`are not DNA sequences but protein-based motifs; Dr. Van Ness
`does not establish with credible evidence or persuasive argument
`that one of ordinary skill in the art could have derived any portion
`of the gene sequence for α1,6-fucosyltransferase from protein-
`based “structures,” irrespective of whether they were important
`to the activity of fucosyltransferases generally.
`Because Dr. Van Ness cites no other persuasive evidence for
`the proposition that one of ordinary skill in the art would have
`“independently and routinely” determined the DNA sequence of
`α1,6-fucosyltransferase, we accord his opinion little weight and
`are unpersuaded by it in view of the documentary evidence of
`record.
`Dec. 20 (citing Ex. 1007 ¶ 41).4
`Rather than address the merits of our reasoning, Petitioner argues that
`two of the references cited in the prosecution history (references (i) and (ii),
`now identified as Oriol and Breton, respectively), “conclusively demonstrate
`
`
`4 We do not find persuasive Petitioner’s reliance on In re Taylor Made, in
`which patentee’s declarant “quoted a Wikipedia article.” Req. Reh’g 7; In
`re Taylor Made Golf Co. 589 F.App’x 967, 970–71 (Fed. Cir. 2014). Had
`Dr. Van Ness quoted the relevant portions of Oriol and Breton we might
`well have arrived at a different result in our Decision.
`7
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`IPR2017-01262
`
`Patent 7,425,446 B2
`that the FUT8 gene sequence was already known and published.” Req.
`Reh’g 8. As indicated above, Petitioner did not make Oriol or Breton of
`record prior to our Decision denying institution of an inter partes review;
`nor did Dr. Van Ness discuss the contents of these references with any
`degree of specificity as Petitioner now does in the Request for Rehearing.
`Compare Ex. 1007 ¶¶ 19, 40 with Req. Reh’g 8–10 (noting that Oriol and
`Breton identify the human FUT8 gene sequence by GenBank number and
`literature reference). Accordingly, we do not agree that we misapprehended
`or overlooked any matter identified in Petitioner’s Request for Rehearing.
`
`IV. CONCLUSION
`Upon consideration of Petitioner’s Request for Rehearing, our
`Decision, and the evidence of record as of the date of our Decision, we
`determine that Petitioner has not demonstrated an abuse of discretion in our
`Decision. Accordingly, we deny the request for rehearing.
`
`V. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that Petitioner’s Request for Rehearing is denied.
`
`
`
`
`
`
`
`8
`
`
`
`IPR2017-01262
`Patent 7,425,446 B2
`PETITIONER:
`Bryan Vogel
`Miles Finn
`JONES DAY
`bvogel@robinskaplan.com
`mfinn@robinskaplan.com
`
`
`PATENT OWNER:
`Anthony Insogna
`Sean Christian Platt
`Astrid Spain
`ROBINS KAPLAN LLP
`aminsogna@jonesday.com
`cplatt@jonesday.com
`arspain@jonesday.com
`
`
`
`
`
`9
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`
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