`571-272-7822
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` Paper No. 13
`Entered: September 8, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`GENENTECH, INC. and CITY OF HOPE,
`Patent Owner.
`____________
`
`Case IPR2016-00710
`Patent 6,331,415 B1
`____________
`
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`SUSAN L. MITCHELL, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
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`I.
`
`INTRODUCTION
`
`Mylan Pharmaceuticals Inc. (“Petitioner”) filed a Petition (Paper 2,
`“Pet.”), requesting institution of an inter partes review of claims 1–4, 11, 12,
`14, 18–20, and 33 of U.S. Patent No. 6,331,415 B1 (Ex. 1001, “the ’415
`patent”). Petitioner also filed a Motion for Joinder, seeking joinder with
`IPR2015-01624. Paper 3, 1. Genentech, Inc. and City of Hope
`(collectively, “Patent Owner”) did not file a Preliminary Response, but did
`file an Opposition to the Motion for Joinder. Paper 8. In addition,
`Petitioners in IPR2015-01624, Sanofi Aventis U.S. LLC and Regeneron
`Pharmaceuticals, Inc., filed an opposition to the Motion for Joinder in that
`proceeding (Paper 25). Institution of an inter partes review is authorized by
`statute when “the information presented in the petition . . . and any response
`. . . shows that there is a reasonable likelihood that the petitioner would
`prevail with respect to at least 1 of the claims challenged in the petition.” 35
`U.S.C. § 314(a); see 37 C.F.R. § 42.108.
`Upon consideration of the Petition, as well as the papers related to
`joinder, for the reasons explained below, we determine that Petitioner has
`shown that there is a reasonable likelihood that they would prevail with
`respect to at least one of the challenged claims. We, thus, institute an inter
`partes review of claims 1–4, 11, 12, 14, 18–20, and 33 of the ’415 patent.
`A.
`Related Proceedings
`Petitioner identifies IPR2015-01624, IPR2016-00383, and IPR2016-
`00460 as all challenging claims of the ’415 patent. Pet. 44. Note that
`IPR2015-01624, to which IPR2016-00460 was joined, has been terminated
`(Paper 43). The Board declined to institute trial in IPR2016-00383
`(Paper 16).
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`Patent Owner identifies U.S. patent applications, as well as issued
`patents, that relate to the ’415 patent. Paper 7, 2–3. In addition, Patent
`Owner identifies other proceedings before the Office, such as interferences
`and reexaminations, that may relate to the ’415 patent. Id. at 3. Patent
`Owner also identifies several district court proceedings that may relate to the
`’415 patent. Id. at 3–6.
`B. Motion for Joinder (Paper 25)
`Petitioner seeks joinder to IPR2015-01624, asserting that its Petition
`
`“raises the same grounds of unpatentability over the same prior art as those
`instituted by the Board in [IPR2015-01624].” Paper 3, 1. We note,
`however, that at the request of the involved parties, we terminated IPR2015-
`01624 on September 2, 2016 (Paper 43). Thus, Petitioner’s Motion for
`Joinder is moot. We do, however, for the reasons set forth below, as well as
`in the Decision on Institution in IPR2015-01624 (Paper 15), institute on the
`same grounds we instituted in IPR2015-01624.
`C.
`The ’415 Patent (Ex. 1001)
`The ’415 patent issued on December 18, 2001, and claims priority to
`an application filed on April 8, 1983. See Ex. 1001, Title Page. It names
`Shmuel Cabilly, Herbert L. Heyneker, William E. Holmes, Arthur D. Riggs,
`and Ronald B. Wetzel, as the inventors. Id.
`The ’415 patent relates generally to processes for producing
`immunoglobulin molecules in a host cell transformed with a first DNA
`sequence encoding the variable domain of the heavy chain and a second
`DNA sequence encoding the variable domain of the light chain, as well as
`vectors and transformed host cells used in such processes. More
`specifically, the first and second DNA sequences are present in either
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`different vectors or in a single vector, and independently expressed so that
`the immunoglobulin heavy and light chains are produced as separate
`molecules in the transformed single host cell. See id., cols. 1, 15, 18, 21, and
`33.
`
`According to the Specification of the ’415 patent, there were two
`major sources of vertebrate antibodies that could be generated in situ by the
`mammalian B lymphocytes or in cell culture by B-cell hybrids
`(hybridomas). Id. at 1:42–45. The Specification notes, however, that
`monoclonal antibodies produced by these two sources suffer from
`disadvantages, including contamination with other cellular materials,
`instability, production of an undesired glycosylated form, high cost, and an
`inability to manipulate the genome. Id. at 2:40–66. The Specification
`recognizes that “the use of recombinant DNA technology can express
`entirely heterologous polypeptides—so-called direct expression—or
`alternatively may express a heterologous polypeptide fused to a portion of
`the amino acid sequence of a homologous polypeptide.” Id. at 4:33–37.
`The Specification states that “[t]he invention relates to antibodies and
`to non-specific immunoglobulins (NSIs) formed by recombinant techniques
`using suitable host cell cultures,” which can “be manipulated at the genomic
`level to produce chimeras of variants which draw their homology from
`species which differ from each other.” Id. at 4:53–59. The Specification
`further indicates that “[t]he ability of the method of the invention to produce
`heavy and light chains or portions thereof, in isolation from each other offers
`the opportunity to obtain unique and unprecedented assemblies of
`immunoglobulins, Fab regions, and univalent antibodies.” Id. at 12:58–62.
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`D. Illustrative Claims
`Petitioner challenges claims 1–4, 11, 12, 14, 18–20, and 33 of the
`’415 patent. Independent claims 1 and 18, the only independent claims
`challenged, are illustrative, and reproduced below:
`
`1. A process for producing an immunoglobulin molecule or an
`immunologically functional immunoglobulin fragment comprising at
`least the variable domains of the immunoglobulin heavy and light
`chains, in a single host cell, comprising the steps of:
`
`(i) transforming said single host cell with a first DNA sequence
`encoding at least the variable domain of the immunoglobulin heavy
`chain and a second DNA sequence encoding at least the variable
`domain of the immunoglobulin light chain, and
`
`(ii) independently expressing said first DNA sequence and said
`second DNA sequence so that said immunoglobulin heavy and light
`chains are produced as separate molecules in said transformed single
`host cell.
`
`18. A transformed host cell comprising at least two vectors, at least
`one of said vectors comprising a DNA sequence encoding at least a
`variable domain of an immunoglobulin heavy chain and at least
`another one of said vectors comprising a DNA sequence encoding at
`least the variable domain of an immunoglobulin light chain.
`Ex. 1001, 28:35–49; 29:31–36.
`
`The Asserted Grounds of Unpatentability
`E.
`Petitioner challenges the patentability of the challenged claims of the
`’415 patent on the following grounds (Pet. 3):
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`References
`Bujard1 and Riggs & Itakura2
`
`Bujard and Southern3
`
`Basis
`§ 103(a)
`
`§ 103(a)
`
`Claims challenged
`1, 3, 4, 11, 12, 14, 19,
`and 33
`1, 2, 18, 20 and 33
`
`
`
`Petitioner relies also on the Declaration of Jefferson Foote, Ph.D. (Ex.
`1006), as well as the Declaration of Dr. Kathryn Calame, Ph.D. (Ex. 1059).
`Pet 3. Petitioner relies on the Declaration of Dr. Calame “to
`preserve its right to rely on expert testimony in the event that joinder is not
`granted or in the case that the Sanofi IPR is settled.” Id.
`II. DISCUSSION
`A. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are
`interpreted according to their broadest reasonable construction in light of the
`Specification of the patent in which they appear. See 37 C.F.R. §42.100(b);
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–2145 (2016)
`(upholding the use of the broadest reasonable interpretation standard).
`Under the broadest reasonable construction standard, claim terms are
`presumed to have their ordinary and customary meaning, as would be
`understood by one of ordinary skill in the art in the context of the entire
`
`
`1 Bujard et al., US 4,495,280, issued Jan. 22, 1985 (Ex. 1002) (“Bujard”).
`2 Arthur D. Riggs and Keiichi Itakura, Synthetic DNA and Medicine, 31 AM.
`J. HUM. GENET. 531–538 (1979) (Ex. 1003) (“Riggs & Itakura”).
`3 P.J. Southern and P. Berg, Transformation of Mammalian Cells to
`Antibiotic Resistance with a Bacterial Gene Under Control of the SV40
`Early Region Promoter, 1 J. MOLECULAR AND APPLIED GENETICS327–341
`(1982) (Ex. 1004) (“Southern”).
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`disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007). “Absent claim language carrying a narrow meaning, the PTO should
`only limit the claim based on the specification . . . when [it] expressly
`disclaim[s] the broader definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed
`Cir. 2004). “Although an inventor is indeed free to define the specific terms
`used to describe his or her invention, this must be done with reasonable
`clarity, deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480
`(Fed. Cir. 1994).
`Petitioner states it “does not believe that any special meanings apply
`to the claim terms in the ‘415 patent.” Pet. 18. Petitioner notes that the term
`“immunoglobulin” is interchangeable with “antibodies.” Pet., 4 n.1.
`Moreover, for purposes of this decision and consistent with our Decision on
`Institution in IPR2015-01624 (Paper 15, 6–7), with respect to the term
`“independently expressing” recited in claims 1 and 33, we construe that term
`as not requiring that either the heavy or light chain is capable of being
`expressed without the concomitant expression of the other chain.
`We determine that no explicit construction of any other claim term is
`necessary to determine whether to institute a trial in this case. See, e.g.,
`Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011)
`(“[C]laim terms need only be construed ‘to the extent necessary to resolve
`the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795, 803 (Fed. Cir. 1999)). At this stage of the proceeding, we
`have not made a final determination as to the construction of any claim term.
`B. Principles of Law
`An inter partes review may be instituted only if “the information
`presented in the [Petition and Preliminary Response] shows that there is a
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`reasonable likelihood that the petitioner would prevail with respect to at
`least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). We
`analyze the proposed grounds of unpatentability in accordance with the
`following stated principles.
`The legal question of obviousness is resolved on the basis of
`underlying factual determinations, including: (1) the scope and content of
`the prior art; (2) any differences between the claimed subject matter and the
`prior art; (3) the level of skill in the art; and (4) objective evidence of
`nonobviousness, i.e., secondary considerations. See Graham v. John Deere
`Co., 383 U.S. 1, 17–18 (1966).
`In KSR International Co. v. Teleflex Inc., the Supreme Court stated
`that, under certain circumstances, an invention may be found obvious if
`trying a course of conduct would have been considered obvious to a person
`having ordinary skill:
`When there is a design need or market pressure to solve a
`problem and there are a finite number of identified, predictable
`solutions, a person of ordinary skill has good reason to pursue
`the known options within his or her technical grasp. If this leads
`to the anticipated success, it is likely the product not of
`innovation but of ordinary skill and common sense. In that
`instance the fact that a combination was obvious to try might
`show that it was obvious under § 103.
`550 U.S. 398, 421 (2007). In this regard, “[o]bviousness does not require
`absolute predictability of success . . . all that is required is a reasonable
`expectation of success.” In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009)
`(citing In re O'Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988)).
`As the court noted in Kubin, “[t]he Supreme Court’s admonition
`against a formalistic approach to obviousness in this context actually
`resurrects this court’s own wisdom in In re O'Farrell . . . .” Id. In
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`O’Farrell, the court outlined two classes of situations where “obvious to try”
`is erroneously equated with obviousness under § 103. First, obviousness is
`not shown when
`what would have been “obvious to try” would have been to vary
`all parameters or try each of numerous possible choices until one
`possibly arrived at a successful result, where the prior art gave
`either no indication of which parameters were critical or no
`direction as to which of many possible choices is likely to be
`successful.
`
`O’Farrell, 853 F.2d at 903. Second, obviousness is also not shown when
`what was “obvious to try” was to explore a new technology or
`general approach that seemed to be a promising field of
`experimentation, where the prior art gave only general guidance
`as to the particular form of the claimed invention or how to
`achieve it.
`
`
`Id.
`
`C. Prior Art Relied Upon
`Petitioner relies upon the following prior art in its challenges.
`1.
`Bujard (Ex. 1002)
`Bujard relates to a process for producing polypeptides in a
`transformed host cell using a plasmid vector that is optimized to have a high
`signal strength T5 phage promoter and a balanced terminator. Ex. 1002,
`Abstract. More particularly, the structure of the vector taught by Bujard is
`“a strong promoter, followed by a DNA sequence of interest, optionally
`followed by one or more translational stop codons in one or more reading
`frames, followed by a balanced terminator, followed by a marker allowing
`for selection of transformants.” Id. at 2:8–13.
`Bujard explains that the plasmid vector may have the strong promoter
`and terminator separated by “more than one gene, that is, a plurality of
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`genes, including multimers and operons.” Id. at 3:45–48. Further, Bujard
`indicates that “[d]esirably, the gene is followed by one or a plurality of
`translational stop codons e.g. oop or nonsense codons, or preferably a
`plurality, usually up to about six, more usually from about two to five, where
`there is at least one stop codon in each reading frame.” Id. at 3:15–19.
`These stop codons aid in the efficiency of termination at both the
`transcription and expression levels. Id. at 3:19–21. Bujard also states:
`For hybrid DNA technology it would be useful to have a plasmid
`having a unique restriction site between a T5 promoter and a
`terminator, desirably having at least one stop codon on the
`upstream side of the terminator. In this manner, one or more
`structural genes may be introduced between the promoter and
`terminator.
`Id. at 7:57–63. The strategy described in Bujard “provides a vehicle which
`can be used with one or more hosts for gene expression.” Id. at 8:1–3. The
`host cells employed for Bujard’s process may be either bacterial or
`mammalian cells. Id. at 6:23–35.
`Bujard indicates that a “wide variety of structural genes are of interest
`for production of proteins,” and that “[t]he proteins may be prepared as a
`single unit or as individual subunits and then joined together in appropriate
`ways.” Id. at 4:14–21. Among the “proteins of interest,” Bujard includes
`“immunoglobulins e.g. IgA, IgD, IgE, IgG and IgM and fragments thereof,”
`and further spells out the “Mol. formula” for each of those
`immunoglobulins. Id. at 4:30–5:27. For example, Bujard identifies
`immunoglobulin G (IgG) as having the formula γ2λ2 or γ2κ2, which
`corresponds to the two light chains and two heavy chains of the antibody
`molecule. Id. at 5:11–14. Bujard also lists “Free light chains” separately.
`Id. at 5:27.
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`Riggs & Itakura (Ex. 1003)
`2.
`Riggs & Itakura discusses the bacterial production of human insulin.
`Ex. 1003, 531. Specifically, Riggs & Itakura made two E. coli strains, each
`constructed by cloning vectors containing chemically synthesized genes
`encoding the insulin A chain or B chain, and further showed that the
`separately purified chains can be joined by air oxidation in vitro to produce
`active insulin. Id. at 532 (FIG. 1). Among the potential practical
`applications, Riggs & Itakura states that the recombinant DNA techniques
`discussed therein can be used to produce antibodies from hybridoma, stating
`“[h]ybridoma will provide a source of mRNA for specific antibodies.
`Bacteria may then be used for the production of the antibody peptide chains,
`which could be assembled in vitro and used for passive immunization.” Id.
`at 537–38.
`
`Southern (Ex. 1004)
`3.
`Southern describes the transformation of mammalian host cells to
`confer resistance to neomycin-kanamycin antibiotics. Ex. 1004, 327
`(Summary). In particular, Southern utilized known selection markers for co-
`expressing the bacterial genes gpt and neo using two separate vectors—
`pSV2-gpt and pSV2-neo—within a single host cell. Id. at 337, Table 3.
`Southern teaches that “vectors containing these markers provide a way to
`cotransduce other genes whose presence and/or expression can not be
`selected.” Id. at 338. Southern concludes that “[c]otransformation with
`nonselectable genes can be accomplished by inserting genes of interest into
`vector DNAs designed to express neo or gpt,” and further states that “[t]he
`schemes used to select for the expression of gpt and neo [described therein]
`
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`are complementary and experiments that exploit the possibilities of a double
`and dominant selection are now in progress.” Id. at 339.
`D. Analysis of Petitioner’s Patentability Challenges
`Obviousness of Claims 1, 3, 4, 11, 12, 14, 19, and 33
`Based on Bujard and Riggs & Itakura
`Petitioner contends that claims 1, 3, 4, 11, 12, 14, 19, and 33 are
`obvious based on the combined teachings of Bujard and Riggs & Itakura.
`Pet. 34–38. In addition to the teachings of the references, Petitioner also
`relies upon the Declarations of Dr. Foote and Dr. Calame in support of this
`challenge. For this obviousness challenge, Petitioner focuses on those
`claims of the ’415 patent that require (or allow for) the first and second
`DNA sequences to be present in a single vector within a host cell. Pet. 34–
`35.
`Petitioner relies on Bujard as teaching the production of a protein of
`
`interest, including an immunoglobulin, “in a transformed host cell using a
`plasmid vector that is optimized to increase the efficiency of expression.”
`Pet. 35 (citing Ex. 1002, 2:1–20, 3:9–14, 3:61–62, 4:14–16, 4:30–36, 5:11–
`27; Ex. 1006 ¶ 91; Ex. 1059 ¶ 16). In particular, Petitioner notes that Bujard
`teaches that the protein may be produced in a single cell transformed with a
`single plasmid that contains a plurality of genes. Id. (citing Ex. 1002, 3:46–
`48, 3:61–62, 6:23–37; Ex. 1006 ¶ 91; Ex. 1059 ¶ 16).
`
`According to Petitioner, the ordinary artisan “would have been
`motivated to combine Bujard with the in vitro assembly disclosures in Riggs
`& Itakura, with a reasonable expectation of success in achieving the
`purported invention of the challenged claims, thus rendering the claims
`obvious.” Id. at 36 (reference omitted) (citing Ex. 1003, 537–38; Ex. 1006
`¶ 99; Ex. 1059 ¶ 16).
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`In particular, based on Bujard’s suggestion that “‘individual [protein]
`subunits’ can be ‘joined together in appropriate ways,’” Petitioner relies
`upon Riggs & Itakura as teaching a specific in vitro assembly technique that
`is applicable to Bujard. Id. at 36–37 (citing Ex. 1002, 4:20–21; Ex. 1003,
`537–38; Ex. 1006 ¶¶ 100–101; Ex. 1059 ¶ 16). Although Riggs & Itakura
`demonstrated the in vitro assembly of insulin A and B chains, and not
`immunoglobulin heavy and light chains, Petitioner asserts that the reference
`is nonetheless relevant because it “addresses the same problem of joining
`unassociated [polypeptide] chains separately produced in microorganism
`host cells.” Id. at 36–37. Petitioner also points to the statement in Riggs &
`Itakura that the in vitro recombinant DNA techniques disclosed therein are
`applicable for antibodies, wherein hybridomas would be a source of mRNA
`for the antibody peptide chains (i.e., heavy and light chains) that are
`produced in bacteria and assembled in vitro. Id. at 37 (citing Ex. 1003, 531–
`32, 537–38; Ex. 1006 ¶ 101; Ex. 1059 ¶ 16).
`We determine that Petitioner has sufficiently demonstrated a
`reasonable likelihood of prevailing with respect to this obviousness
`challenge. That is, we determine that Petitioner has made a sufficient
`showing of obviousness for purposes of our institution of inter partes review
`when Bujard’s teachings are combined with the in vitro assembly technique
`taught by Riggs & Itakura and applied to produce an immunoglobulin
`molecule.
`
`2.
`
`Obviousness of Claims 1, 2, 18, 20 and 33
`Based on Bujard and Southern
`Petitioner contends that claims 1, 2, 18, 20 and 33 are obvious based
`on the combined teachings of Bujard and Southern. Pet. 39–41. In addition
`to the teachings of the references, Petitioner also relies upon Dr. Foote’s and
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`Dr. Calame’s Declarations in support of this challenge. For this obviousness
`challenge, Petitioner focuses on those claims of the ’415 patent that require
`(or allow for) the first and second DNA sequences to be present in different
`vectors within the same host cell. Pet. 39.
`Petitioner asserts that the ordinary artisan would “have been
`motivated to combine (1) Bujard’s teaching of a mammalian host cell
`transformed with two DNA sequences (for heavy and light chains), both in a
`single vector with (2) the co-transformation approach taught in Southern,
`i.e., a mammalian host cell transformed with two vectors, each with a
`different selectable marker and gene of interest.” Id. at 39 (citing Ex. 1006
`¶ 103; Ex. 1059 ¶ 16). Petitioner asserts further that the skilled artisan
`would have had a reason “to modify Bujard accordingly by splitting the
`heavy and light chain DNA sequences into two separate vectors to be
`transformed in a single mammalian host cell.” Id. at 39–40. Petitioner
`contends that the skilled artisan “would have known that the expression
`machinery in cells works universally, regardless of any difference in genes
`(heavy/light chain versus non-immunoglobulin polypeptides) or whether
`they are on separate vectors (instead of one).” Id. at 40–41 (citing Ex. 1006
`¶ 104; Ex. 1059 ¶ 16).
`Based on the foregoing, we determine that Petitioner has sufficiently
`demonstrated a reasonable likelihood of prevailing with respect to this
`obviousness challenge.
`
`III. CONCLUSION
`For the foregoing reasons and the reasons set forth in the institution
`
`decision in IPR2015-01624 (Paper 15), we determine that the Petition
`demonstrates that there is a reasonable likelihood that Petitioner would
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`prevail in proving the unpatentability of claims 1–4, 11, 12, 14, 18–20, and
`33 of the ’415 patent for obviousness.
`
`At this stage of the proceeding, we have not made a final
`determination as to the patentability of any challenged claim or any
`underlying factual or legal issue.
`IV. ORDER
`
`Accordingly, it is:
`ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes
`review is hereby instituted as to claims 1–4, 11, 12, 14, 18–20, and 33 of
`U.S. Patent No. 6,331,415 (Ex. 1001) based on the following grounds of
`unpatentability:
`A.
`Claims 1, 3, 4, 11, 12, 14, 19, and 33 under 35 U.S.C. § 103(a)
`as obvious over Bujard and Riggs & Itakura; and
`B.
`Claims 1, 2, 18, 20 and 33 under 35 U.S.C. § 103(a) as obvious
`over Bujard and Southern.
`FURTHER ORDERED that inter partes review commences on the
`entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.
`§ 42.4, notice is hereby given of the institution of a trial; and
`FURTHER ORDERED that the trial is limited to the grounds of
`unpatentability listed above, and no other grounds of unpatentability are
`authorized for inter partes review.
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`PETITIONER:
`Deanne Mazzochi
`dmazzochi@rmmslegal.com
`
`Paul Molino
`paul@rmmslegal.com
`
`
`PATENT OWNER:
`David Cavanaugh
`david.cavanaugh@wilmerhale.com
`
`Heather Petruzzi
`heather.petruzzi@wilmerhale.com
`
`Adam Brausa
`abrausa@durietangri.com
`
`Jeffrey Kushan
`jkushan@sidley.com
`
`
`
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