Trials@uspto.gov Paper No. 16
`571.272.7822
`
` Filed: July 13, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COHERUS BIOSCIENCES, INC.,
`Petitioner
`
`v.
`
`HOFFMANN-LAROCHE INC.,
`Patent Owner
`____________
`
`Case IPR2017-01916 (Patent 8,163,522 B1)
`Case IPR2017-02066 (Patent 8,063,182 B1)
`____________
`
`
`
`Before SUSAN L. C. MITCHELL, TINA E. HULSE, and
`WESLEY B. DERRICK, Administrative Patent Judges.
`
`DERRICK, Administrative Patent Judge.
`
`
`DECISION
`Denying Petitioner’s Requests for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
`
`
`
`
`571.272.7822
`
` Filed: July 13, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COHERUS BIOSCIENCES, INC.,
`Petitioner
`
`v.
`
`HOFFMANN-LAROCHE INC.,
`Patent Owner
`____________
`
`Case IPR2017-01916 (Patent 8,163,522 B1)
`Case IPR2017-02066 (Patent 8,063,182 B1)
`____________
`
`
`
`Before SUSAN L. C. MITCHELL, TINA E. HULSE, and
`WESLEY B. DERRICK, Administrative Patent Judges.
`
`DERRICK, Administrative Patent Judge.
`
`
`DECISION
`Denying Petitioner’s Requests for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2017-01916 (Patent 8,163,522 B1)
`IPR2017-02066 (Patent 8,063,182 B1)
`
`
`I. INTRODUCTION
`In IPR2017-02066, Coherus Biosciences, Inc. (“Petitioner”) filed a
`Petition (Paper 1 (“Pet.”)) to institute an inter partes review of claims 1–36
`of U.S. Patent No. 8,063,182 B1 (Ex. 1001 (“the ’182 patent”)). Hoffmann-
`LaRoche Inc. (“Patent Owner”) filed a Preliminary Response. Paper 7
`(“Prelim. Resp.”). In IPR2017-01916, Petitioner filed a Petition (Paper 1) to
`institute an inter partes review of claims 1–10 of U.S. Patent
`No. 8,163,522 B1. Hoffman-LaRoche Inc. filed a Preliminary Response.
`Paper 9. Having considered the Petitions, the Preliminary Responses, and
`the evidence in each record, and applying the standard set forth in 35 U.S.C.
`§ 314(a), which requires that Petitioner demonstrate a reasonable likelihood
`that it would prevail with respect to at least one challenged claim in a
`Petition, we denied Petitioner’s requests and did not institute inter partes
`review. IPR2017-02066, Paper 11, 20 (“Decision” or “Dec.”); IPR2017-
`01916, Paper 13, 24.
`Petitioner filed virtually identical Requests for Rehearing in each case
`(IPR2017-02066, Paper 13 (“Reh’g Req.”); IPR2017-01916, Paper 15),
`requesting reconsideration of the Decisions denying institution of inter
`partes review. Similar papers and exhibits were filed in both cases. For
`purposes of this decision, because the Requests for Rehearing set forth the
`same arguments and reasoning, we will treat both Requests in this single
`decision, discussing IPR2017-02066 as representative. Also, we will refer to
`the papers and exhibits in IPR2017-02066 in this decision. Similar papers
`and exhibits were filed in IPR2017-01916.
`Petitioner’s Requests are grounded on the claims encompassing both
`fusion proteins with a functional hinge, including two cysteine residues, and
`
`2
`
`
`
`IPR2017-01916 (Patent 8,163,522 B1)
`IPR2017-02066 (Patent 8,063,182 B1)
`
`fusion proteins with all of the amino acid sequence that is encoded by the
`corresponding hinge exon, including three cysteine residues. See, e.g.,
`Reh’g Req. 1, n.1, 14–15. Petitioner contends that we construed the phrase
`“all of the domains of the constant region . . .” so as to exclude a “functional
`hinge.” Id. at 1. Petitioner argues: (1) that we overlooked Patent Owner’s
`statements characterizing the hinge as a functional hinge, including
`admissions that the claims encompass a functional hinge; (2) that we
`improperly relied on a single prosecution history statement as a prosecution
`disclaimer; and (3) that nothing in the ’182 patent specification supports a
`construction excluding a functional hinge. Id. at 2–14.
`Petitioner further maintains that its “use of the term ‘hinge’ to refer to
`prior art fusion proteins comprising either a functional or genetic hinge was
`neither ‘unclear’ nor ‘inconsistent.’” Id. at 14 (citing Dec. 10–11). Noting
`that “[n]either the ’182 patent nor its prosecution history defines the
`boundaries of the hinge to include every amino acid in the genetically-
`encoded hinge,” Petitioner contends that “the Board abused its discretion by
`requiring Petitioner to show this level of specificity in the prior art.” Id. at
`14–15.
`We have considered Petitioner’s Requests for Rehearing, and, for the
`reasons set forth below, Petitioner’s Requests are denied.
`
`II. STANDARD OF REVIEW
`37 C.F.R. § 42.71(d) provides that:
`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
`
`3
`
`
`
`IPR2017-01916 (Patent 8,163,522 B1)
`IPR2017-02066 (Patent 8,063,182 B1)
`
`
`matter was previously addressed in a motion, opposition, or a
`reply.
`See also Office Trial Practice Guide, 77 Fed. Reg. 48756, 48768 (Aug. 14,
`2012). Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on
`petition, a panel will review the decision for an abuse of discretion.” An
`abuse of discretion occurs when a “decision was based on an erroneous
`conclusion of law or clearly erroneous factual findings, or . . . a clear error of
`judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co. Inc., 840
`F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).
`
`III. DISCUSSION
`Petitioner’s general argument that we misapprehended or overlooked
`matters in construing the claims does not address our reasoning set forth in
`the decision. Contrary to Petitioner’s contentions, we did not construe the
`claims to be limited to fusion proteins comprising a hinge having the full
`amino acid sequence encoded by the corresponding hinge exon, including
`three cysteine residues. Although we did construe the claims to exclude
`“any protein with less than all of the amino acid sequence of the hinge
`domain of human IgG (or IgG1) immunoglobulin heavy chain, even if
`functional,” see Dec. 7, we could not discern from Petitioner’s discussion of
`the claims and the art any consistent demarcation in the amino acid sequence
`of human IgG (or IgG1) concerning where the first domain ends and the
`hinge domain begins. As we explained, the phrase “all of the domains of the
`constant region . . . other than the first domain of said constant region”
`leaves unsettled “where in the constant region the divide lies between the
`first domain of the constant region and the hinge domain.” Dec. 7–8. What
`is settled, however, is that the ordinary and customary meaning of the terms
`
`4
`
`
`
`IPR2017-01916 (Patent 8,163,522 B1)
`IPR2017-02066 (Patent 8,063,182 B1)
`
`in the phrase requires that all constant region amino acid sequence that is not
`part of the first domain must be included in the fusion protein. Id. at 7.
`As made explicit in the Decision, Petitioner failed to define in a
`consistent manner where the divide lies between the first domain of the
`constant region and the hinge domain. It was in light of this deficiency that
`we determined that Petitioner had not met the requisite burden for instituting
`inter partes review. Id. at 8. As we further explained:
`[W]ith respect to Zettlmeissl, Petitioner appears to assert that
`“all of the hinge domain” requires the hinge segment encoded
`by the hinge exon, including three cysteine residues. But with
`respect to Watson, Petitioner appears to assert that “all of the
`hinge domain” simply requires a portion of sequence that
`includes the two cysteine residues involved in joining the heavy
`chains.
`Id. at 14. Notwithstanding the apparent differences in amino acid sequence,
`unacknowledged in the Petition, “Petitioner relies on Zettlmeissl and Watson
`as teaching the use of the same, identical portion of the IgG heavy chain, and
`relies on that portion for use in the fusion protein.” Id. at 10 (citing Pet. 5);
`see also id. at 6, 12–14, Pet. 5 (stating “both [Watson and Zettlmeissl]
`reported optimal results by employing the identical portion of the IgG heavy
`chain as claimed in the ’182 patent”).
`Petitioner’s position set forth in the Request for Rehearing,
`nonetheless, is that the claims encompass both fusion proteins with a
`functional hinge, including two cysteine residues, and fusion proteins with
`all of the amino acid sequence that is encoded by the corresponding hinge
`exon, including three cysteine residues. Reh’g Req. 1, n.1, 3–4, 14–15.
`These two meanings of hinge not only differ as to how much sequence is
`included, they also lead to inconsistency as to the claims requiring “all of the
`
`5
`
`
`
`IPR2017-01916 (Patent 8,163,522 B1)
`IPR2017-02066 (Patent 8,063,182 B1)
`
`domains of the constant region . . . other than the first domain [CH1] of said
`constant region,” as explained in the Decision. If the hinge includes
`sequence encompassing all three cysteine residues encoded by the hinge
`exon, then the fusion protein including sequence having only two of the
`cysteine residues would not include all constant region amino acid sequence
`that is not part of the first domain. Dec. 13–14. Conversely, if the hinge
`does not require the third cysteine residue, but is nonetheless a “hinge” such
`that omitted sequence is only from the first domain of the constant region,
`then the fusion protein including sequence encompassing all three cysteine
`residues encoded by the hinge exon would not, as contended by Petitioner,
`have the included “receptor . . . attached directly to the hinge-CH2-CH3
`region” (emphasis added). Id. at 6. As emphasized in the Decision,
`“Petitioner cannot have it both ways, particularly without an explanation
`why” (id. at 14), and we are directed to nothing indicating that we
`overlooked or misapprehended any such explanation provided in the Petition
`(see generally Reh’g Req.).
`Turning to the specific matters Petitioner contends that we
`misapprehended or overlooked, we find none persuasive.
`Petitioner contends that we overlooked Patent Owner’s statements
`characterizing the hinge as a functional hinge. Id. at 5–10. In particular,
`Petitioner contends that we overlooked or misapprehended that Patent
`Owner was the source of the schematic and accompanying description
`included in Dr. Burton’s declaration. Id. at 5–7. Petitioner maintains that
`while we stated “that Dr. Burton’s schematic was ‘adapted from Ex. 1006,’
`which is an excerpt from the prosecution history, . . . we did not
`
`6
`
`
`
`IPR2017-01916 (Patent 8,163,522 B1)
`IPR2017-02066 (Patent 8,063,182 B1)
`
`acknowledge that [the] schematic . . . is a near identical reproduction of a
`schematic submitted by Patent Owner during prosecution.” Id. at 6.
`We did not, however, overlook or misapprehend the ultimate source
`of the schematic set forth in Dr. Burton’s declaration. Citing Dr. Burton’s
`declaration, we acknowledged that Dr. Burton “identified [the schematic] as
`‘[a] schematic depiction of an IgG immunoglobulin’ (Ex. 1006, 12)” and
`quoted Dr. Burton’s characterization of the schematic as “[a]dapted from Ex.
`1006, 12.”1 Dec. 11–12 (citing Ex. 1002 ¶ 36). Indeed, we cited the very
`same paragraph from Dr. Burton’s declaration that Petitioner cites as
`“specifically point[ing] out that this figure was from the prosecution
`history.” See Reh’g Req. 7 (citing Ex. 1002 ¶ 36).
`As to Dr. Burton’s description of the schematic, Petitioner maintains
`that we “clearly overlooked that Dr. Burton’s description of the hinge region
`is the same as Patent Owner’s description, because otherwise the Board
`could not have reached the conclusion that the claims exclude a functional
`hinge.” Id. at 7. Petitioner contends that Dr. Burton’s description “closely
`tracked Patent Owner’s description of the location of the cysteine residues.”
`Id. (citing Ex. 1002 ¶ 39, Ex. 1006, 12). Petitioner also contends that we
`overlooked “statements made during prosecution in which the Patent Owner
`explicitly characterized ‘the invention’ as including a hinge with only two
`disulfide bonds, and thus, requiring only two cysteine residues.” Id. at 8
`(emphasis omitted).
`
`
`1 Exhibit 1006 is not an excerpt of the prosecution history of the ’182 patent;
`it is an appeal brief from the prosecution history of patent application
`08/444,790, a divisional of the application from which the ’182 patent
`issued.
`
`7
`
`
`
`IPR2017-01916 (Patent 8,163,522 B1)
`IPR2017-02066 (Patent 8,063,182 B1)
`
`
`As explained above, the Decision is not grounded on the claims
`excluding a functional hinge; it is grounded on Petitioner’s inconsistent
`position on what constitutes the hinge. Thus, even if Dr. Burton’s
`description were identical to a description of an IgG immunoglobulin set
`forth at some point by Patent Owner, that fact would not overcome the
`underlying deficiency.
`As to the argument that we overlooked or misapprehended what
`happened in the CFAD IPR,2 Petitioner again relies on the misapprehension
`that the Decision is grounded on the conclusion that “hinge” excludes a
`functional hinge. Id. at 9–10. Petitioner’s argument, however, that the
`Board’s construction in the CFAD IPR necessarily encompassed a functional
`hinge is not persuasive. Petitioner, referring to the decision denying
`institution in the CFAD IPR (Ex. 1010), argues that CFAD contended “that
`prior art ‘defining hinge functionally’ was within the scope of the ’522
`patent claims” (Reh’g Req. 9 (quoting Ex. 1010, 12)) and that Patent Owner
`admitted as much in “cit[ing] Capon’s teaching of ‘fusion proteins
`retain[ing] at least functionally active hinge” (emphasis omitted) (id. (citing
`Ex. 1008, 31 (citing Ex. 1019, 10:10–12))). The offered construction, not
`contested by Patent Owner, however, was merely “that the claim phrase ‘all
`of the domains . . . other than the first domain of said constant region’
`should be interpreted as ‘-hinge-CH2-CH3’ region of . . . immunoglobulin
`heavy chain.’” Ex. 1010, 5–6. The Board did not need to reach, nor did the
`Board reach, whether the “hinge” was a functional hinge including sequence
`
`
`2 Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche Inc., Case
`IPR2015-01792 (PTAB) (“CFAD IPR”).
`
`8
`
`
`
`IPR2017-01916 (Patent 8,163,522 B1)
`IPR2017-02066 (Patent 8,063,182 B1)
`
`having only two of the cysteine residues or an exon-encoded hinge including
`sequence having all three cysteine residues. See generally id.
`Petitioner contends that we, overlooking other prosecution history
`statements, improperly relied on a single statement as a prosecution
`disclaimer. Reh’g Req. 10–12. Petitioner argues that despite a broad
`ordinary meaning for the term hinge (and domain), that our “claim
`construction narrows the claim scope to exclude functional hinge regions
`that lack even a single amino acid of the exon-encoded hinge.” Id. at 10–11
`(citing Dec. 7–8). As discussed above, however, we determined that “all of
`the constant region forming domains, i.e., CH1, hinge, CH2, and CH3
`domains, is included except that forming the first domain” (Dec. 7), and that
`Petitioner failed to define in a consistent manner where “the divide lies
`between the first domain of the constant region and the hinge domain” (id. at
`8). Not having construed the claims to require the full exon-encoded hinge,
`it follows that we also did not rely on the statements made by Patent Owner
`as a disclaimer that narrowed the claims.
`Petitioner also notes that “Patent Owner does not appear to dispute
`that a functional hinge is a ‘domain;’ [because] doing so would be
`inconsistent with the statement by Patent Owner’s expert [in] a related
`litigation.” Reh’g Req. 10, n.2 (citing Decl. of Dr. Wall, Immunex v. Sandoz
`Inc., No. 16-01118, Dkt. No. 133-3 (D.N.J. Dec. 1, 2016)). The issue,
`however, is not that there is an inconsistency with a position taken by Patent
`Owner in a related litigation, but rather the failure of Petitioner to define the
`divide between the first domain and the hinge domain in light of the
`apparent inconsistency between the two proffered grounds, which
`inconsistency is neither acknowledged, nor addressed in the Petition. See
`
`9
`
`
`
`IPR2017-01916 (Patent 8,163,522 B1)
`IPR2017-02066 (Patent 8,063,182 B1)
`
`generally Dec. We further note that Dr. Wall’s declaration cited by
`Petitioner is not evidence of record in this proceeding. See Reh’g Req. 10,
`n.2.
`
`Despite arguing we erred in limiting the claims to exclude a functional
`hinge, which is only at issue with regard to the ground based on Watson in
`view of Smith (see generally Dec.), Petitioner also contends that we
`“misapprehended [its] position regarding Watson” and states its position as
`“contend[ing] that Watson teaches fusion proteins with a complete genetic,
`exon-encoded hinge.” Reh’g Req. 15 n.4 (citing Pet. 29–30). Petitioner
`further maintains that any conclusion to the contrary constituted “an
`improper weighing of the evidence that should have been reserved for trial.”
`Id. (citing 37 C.F.R. § 42.108(c)); see also Paper 10 (Transcript of January
`3, 2018, Conference Call), 19:6–8, 28:6–9, 29:2–5.
`As an initial matter, we are not persuaded that we misapprehended
`Petitioner’s position as to Watson’s teaching as it was set forth in the
`Petition. Petitioner fails to explain how the cited pages constitute an
`argument that Watson teaches fusion proteins with a “complete genetic,
`exon-encoded hinge.” See Reh’g Req. 15 n.4 (citing Pet. 29–30). We
`cannot have misapprehended an argument that was never made. Regardless,
`it would not avail Petitioner’s position even if Watson did teach a complete
`genetic, exon-encoded hinge. The salient issue is not that the prior art does
`not disclose such a hinge, but rather that Petitioner failed to set forth a
`consistent, tenable position as to claim construction. As explained in the
`Decision, the use of the complete genetic, exon-encoded hinge is
`inconsistent with Dr. Burton’s definition of a hinge and would also not
`provide a fusion protein having, as contended by Petitioner, the included
`
`10
`
`
`
`IPR2017-01916 (Patent 8,163,522 B1)
`IPR2017-02066 (Patent 8,063,182 B1)
`
`“receptor . . . attached directly to the hinge-CH2-CH3 region” in accord with
`that definition. Dec. 6, 11–12. These deficiencies remain even if Watson
`did teach a complete genetic, exon-encoded hinge, such that the hinges
`taught by Watson and Zettlmeissl were identical.
`Petitioner contends that we overlooked or misapprehended that
`nothing in the ’182 patent specification supports our claim construction.
`Reh’g Req. 12–13. Petitioner contends that “[t]he Board’s claim
`construction also purports to rely on the ’182 patent specification” and
`highlights that “the Board’s opinion does not cite to the specification, but
`instead cites to Patent Owner’s interpretation of examples from the patent
`specification.” Id. (citing Dec. 7–8). Petitioner then contends that “nothing
`in the ’182 patent specification describes that the fusion protein must
`comprise a complete, exon-encoded genetic hinge” and that “Example 11,
`. . . is not relevant to the claimed subject matter . . . [because it] does not
`include the extracellular region of the 75 kD TNF receptor . . . [and] includes
`the constant region of an IgG3—not IgG1—as required by claims 4-6, 13-17,
`20-21 and 26-29 of the ’182 patent.” Id. at 13–14 (citing Ex. 1001, Ex. 1002
`¶¶ 44–46, 50).
`Petitioner again misapprehends that the Decision is grounded on the
`conclusion that “hinge” excludes a functional hinge. As explained above,
`however, the Decision rests on the unacknowledged inconsistency between
`the two proffered grounds and the lack of any clarifying explanation in the
`Petition.3 As to Petitioner’s further argument, the cited declaration
`
`3 Further, if Watson did teach the use of a complete, exon-encoded hinge as
`Petitioner now contends, there would be an unacknowledged inconsistency
`between Dr. Burton’s definition of hinge and both grounds, without any
`clarifying explanation.
`
`11
`
`
`
`IPR2017-01916 (Patent 8,163,522 B1)
`IPR2017-02066 (Patent 8,063,182 B1)
`
`testimony—discounted by Petitioner as “Patent Owner’s interpretation” (id.
`at 12–13)—is, as we stated, “evidence in the record that the Specification of
`the ’182 patent is consistent with [Patent Owner’s] interpretation” (emphasis
`added) (Dec. 8). Petitioner’s various arguments, contending that the ’182
`patent specification is not limited to the use of a complete, exon-encoded
`hinge, are inapposite to whether it is open to such.
`Petitioner contends that the Board abused its discretion by requiring a
`greater level of specificity as to the hinge than the ordinary meaning, which
`includes both a functional and a genetic hinge. Id. at 14–15. Petitioner,
`however, did not simply rely on the ordinary meaning of the term hinge in
`its Petition. See generally Pet. Rather, as explained above, Petitioner set
`forth a definition by way of Dr. Burton’s declaration, and also by contending
`that Watson and Zettlmeissl teach the use of the identical portion of the IgG
`heavy chain, without acknowledging the apparent differences in the portions
`used (or explaining how they are nonetheless “identical”). Petitioner’s
`argument, thus, falls short because it is contrary to the challenge as defined
`by its Petition, even if the incompatible, inconsistent definitions effectively
`proffered by its challenge might fall within the scope of the ordinary
`meaning of the term hinge raised now in the Request for Rehearing.
`On this record, Petitioner neither persuades us that we overlooked or
`misapprehended any matter, nor sufficiently shows that denying inter partes
`review of claims 1–36 of the ’182 patent or claims 1–10 of the ’522 patent
`represents an abuse of discretion.
`
`
`12
`
`
`
`IPR2017-01916 (Patent 8,163,522 B1)
`IPR2017-02066 (Patent 8,063,182 B1)
`
`
`IV. ORDER
` Accordingly, it is hereby:
`ORDERED that Petitioner’s Requests for Rehearing in IPR2017-
`01916 and IPR2017-02066 are denied.
`
`
`13
`
`
`
`IPR2017-01916 (Patent 8,163,522 B1)
`IPR2017-02066 (Patent 8,063,182 B1)
`
`PETITIONER:
`Joseph A. Hynds
`Seth E. Cockrum, Ph.D.
`Jennifer P. Nock
`Brett A. Postal
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`jhynds@rfem.com
`scockrum@rfem.com
`jnock@rfem.com
`bpostal@rfem.com
`
`PATENT OWNER:
`Jeffrey P. Kushan
`Peter S. Choi
`SIDLEY AUSTIN LLP
`jkushan@sidley.com
`Peter.choi@sidley.com
`
`David I. Berl
`Aaron P. Mauer
`Thomas S. Fletcher
`WILLIAMS & CONNOLLY LLP
`dberl@wc.com
`amauer@wc.com
`tfletcher@wc.com
`
`
`
`
`
`14
`
`
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