Trials@uspto.gov
`571-272-7822
`
`
`
`
` Paper 13
`
`
` Entered: August 30, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`BIOEQ IP AG,
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01608
`Patent 6,716,602 B2
`____________
`
`
`Before TONI R. SCHEINER, ERICA A. FRANKLIN, and
`MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`
`
`
`
`
`
`
`
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`

`

`IPR2016-01608
`Patent 6,716,602 B2
`
`
`INTRODUCTION
`
`bioeq IP AG (“Petitioner”) requests a rehearing of the Decision
`Denying Institution of an inter partes review of claims 1, 3–4, 6–16, 18, 20,
`22–25, 27–28, and 30–39 of U.S. Patent No. 6,716,602 B2 (Ex. 1001, “the
`’602 patent”) entered on February 22, 2017 (Paper 11, “Dec.”). Paper 12
`(“Reh’g Req.”). In the Petition (Paper 3; “Pet.”), Petitioner raised the
`following challenges to the claims:
`
`Reference(s)
`Seeger1
`
`Seeger
`
`Basis
`§ 102(b)
`
`§ 103(a)
`
`Claim(s) challenged
`1, 3–4, 6, 9, 15–16, 20–22, 24–25,
`27–28, 30, 33, 39
`7–8, 31–32
`
`Seeger and Markie’s2
`
`§ 103(a)
`
`10, 12, 23, 34, 36
`
`Seeger and Cabilly3
`
`§ 103(a)
`
`11, 13–14, 18, 35, 37–38
`
`
`Petitioner also relied on the declaration of Dr. Morris Z. Rosenberg, DSc.
`(Ex. 1002). Genentech, Inc. (“Patent Owner”) filed a Preliminary Response
`to the Petition. Paper 9 (“Prelim. Resp.”). We authorized Petitioner to file a
`Reply to Patent Owner’s Preliminary Response, Paper 10 (“Reply”), to
`
`
`1 Anke Seeger et al., Comparison of temperature- and isopropyl-ß-D-
`thiogalacto-pyranoside-induced synthesis of basic fibroblast growth factor
`in high-cell-density cultures of recombinant Escherichia coli, 17 ENZYME &
`MICROBIAL TECH. 947–53 (1995) (Ex. 1010).
`2 Savvas C. Makrides, Strategies for Achieving High-Level Expression of
`Genes in Escherichia coli, 60 MICROBIOLOGICAL REVIEWS 512–38 (1996)
`(Ex. 1023).
`3 Shmuel Cabilly, Growth at sub-optimal temperatures allows the
`production of functional, antigen-binding Fab fragments in Escherichia coli,
`85 GENE 553–57 (1989) (Ex. 1032).
`
`2
`
`

`

`IPR2016-01608
`Patent 6,716,602 B2
`address corrections to the ’602 patent claims requested by Patent Owner in
`its Request for Certificate of Correction submitted to the Director of the
`Patent Office after the filing of the Petition.
`Upon consideration of the Petition, Preliminary Response, Reply, and
`evidence of record, we determined that Petitioner failed to demonstrate a
`reasonable likelihood that it would prevail in showing the unpatentability of
`at least one challenged claim. Dec. 2. In the Rehearing Request, Petitioner
`seeks reconsideration of that determination. Reh’g Req. 1.
` ANALYSIS
`“When rehearing a decision on petition, a panel will review the
`decision for an abuse of discretion.” 37 C.F.R. § 42.71(c). “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.” Id.
`§ 42.71(d). Because Petitioner has not met its burden, as discussed below,
`the Rehearing Request is denied.
`Claim 1 is representative of the challenged claims and is reproduced
`below:
`
`1. A method for increasing the product yield of a properly
`folded polypeptide of interest produced by recombinant host
`cells, wherein expression of
`the polype[]ptide by
`the
`recombinant host cells is regulated by an inducible system, which
`method comprises
`(a) culturing the recombinant host cells under conditions of
`high metabolic growth rate; and
`(b) reducing the metabolic rate of the cultured recombinant
`host cells at the time of induction of polypeptide expression,
`wherein reducing the metabolic rate comprises reducing the feed
`
`3
`
`

`

`IPR2016-01608
`Patent 6,716,602 B2
`rate of a carbon/energy source, or reducing the amount of
`available oxygen, or both, and wherein the reduction in
`metabolic rate result in increase yield of properly folded
`polypeptide.
`Ex. 1001, 18:11–24.
`
`
`In the Rehearing Request, Reh’g Req. 1, Petitioner challenges our
`determination that “Petitioner has not shown persuasively that a person of
`skill in the art would have understood Seeger’s method to have included
`reducing the metabolic rate of the cultured recombinant host cells at the time
`of expression induction,” Dec. 11. Petitioner asserts that we “(i)
`misapprehended the science underlying the claimed methods; and (ii)
`overlooked that Dr. Rosenberg’s GUR calculation in fact accounted for the
`change in temperature at induction in Seeger, and conclusively showed a
`reduction in metabolic rate.” Reh’g Req 1. In particular, Petitioner asserts
`that we “failed to appreciate that GUR provides a direct read-out of
`metabolism in Seeger, such that any variable that may affect metabolism is
`accounted for,” including temperature. Id. at 2.
`In the Reply to Patent Owner’s Preliminary Response, Petitioner
`addressed Patent Owner’s argument distinguishing Seeger’s method from
`the method of the challenged claims and critiquing Dr. Rosenberg’s GUR
`calculation. See, e.g., Reply 2–3. We presented that argument in the
`Decision as follows:
`In the Reply, Petitioner acknowledges that temperature is one of
`the “external factors that influence[s] the metabolic rate,” along
`with amount of glucose and oxygen supplied. Reply 2.
`According to Petitioner, Dr. Rosenberg’s GUR calculation is a
`“‘read-out’ of the cells’ metabolic rate,” and accounts for each of
`those external factors, including temperature. Id. In support of
`that contention, Petitioner states, “Dr. Rosenberg calculated
`GUR throughout Seeger’s fed-batch phases, i.e., before and after
`
`4
`
`

`

`IPR2016-01608
`Patent 6,716,602 B2
`temperature change induced bFGF expression, thus accounting
`for temperature.” Id. at 2–3 (citing Ex. 1002 ¶ 56) (emphasis
`omitted).
`
`Dec. 12. Petitioner reiterates that argument in the Rehearing Request.
`Reh’g Req. 6–10. As we explained in the Decision, Petitioner’s argument is
`unpersuasive because it is not supported by evidence. Dec. 12–13.
`Specifically, we stated,
`Petitioner’s assertion is not supported by the evidence of record.
`Dr. Rosenberg’s discussion of his calculation for the GUR in the
`paragraph cited by Petitioner explains only that Seeger increased
`the temperature, without describing or suggesting that he
`considered that temperature increase in his calculation or
`conclusions. Ex. 1002 ¶ 56. Moreover, as Patent Owner has
`asserted, Dr. [Rosenberg’s] calculation set forth in Appendix A
`does not include a variable accounting for the temperature shift.
`Ex. 1002, App. A. Thus, Petitioner has not shown persuasively
`that a person of skill in the art would have understood Seeger’s
`method to have included reducing the metabolic rate of the
`cultured recombinant host cells at the time of expression
`induction. See MEHL/Biophile Int'l. Corp., 192 F.3d at 1365.
`
`Id. 4 Thus, Petitioner has not established that we overlooked or
`misapprehended its argument as to this issue.
`With regard to the claim recitation “wherein the reduction in
`metabolic rate results in increased yield of properly folded polypeptide,”
`Petitioner argued in the Petition that such reduction is an intended result of
`
`
`4 Contrary to Petitioner’s assertion in the Rehearing Request, the rationale set
`forth in the Decision does not rely upon “Herendeen” teaching anything
`about “the effect of temperature on metabolic rate.” See Reh’g Req. 3–6
`(citing Sherrie L. Herendeen et al., Levels of Major Proteins of Escherichia
`coli During Growth at Different Temperatures, 139 J. BACTERIOLOGY 185–
`94 (1979) (Ex. 2002). Rather, the Decision is appropriately based upon the
`insufficient showing of Dr. Rosenberg relied upon by Petitioner.
`
`5
`
`

`

`IPR2016-01608
`Patent 6,716,602 B2
`the positively-recited method steps. Pet. 28, 36. In the Rehearing Request,
`Petitioner challenges our determination that, even if we accept Petitioner’s
`position that such reduction is an intended result of the positively-recited
`method steps, Petitioner has not shown “persuasively that Seeger discloses
`the positive step of reducing the metabolic rate so as to achieve that result.”
`Reh’g Req. 10 (citing Dec. 13). Petitioner’s argument here relies again upon
`its assertion that we misapprehended Dr. Rosenberg’s GUR calculation. Id.
`at 11–12. That argument remains unavailing because, as set forth above, the
`Decision explains that Dr. Rosenberg has not described or demonstrated
`adequately that his GUR calculation accounts for a temperature variable.
`Dec. 12–13.
`Petitioner asserts that “[t]o the extent the Board believes that the
`arguments [in the Rehearing Request] were not sufficiently presented in
`either the Petition or Dr. Rosenberg’s Declaration, Petitioner respectfully
`requests consideration of these arguments.” Reh’g Req. 13. That request is
`not well taken. As explained in the Decision, the insufficiency of the
`arguments presented in the Petition is the basis for the denying Petitioner’s
`request for an inter partes review of the challenged claims. Dec. 2–14. A
`rehearing request provides a party with an opportunity to identify a
`previously raised matter that the party believes the Board misapprehended or
`overlooked. See 37 C.F.R. § 42.71(d). Here, Petitioner has not done so.
` CONCLUSION
`For the foregoing reasons, we conclude that Petitioner has not shown
`that the Board abused its discretion in denying institution of the challenged
`claims. See 37 C.F.R. § 42.71(d).
`
`6
`
`

`

`IPR2016-01608
`Patent 6,716,602 B2
`
`ORDER
`In consideration of the foregoing, it is hereby ordered that the
`Petitioner’s Rehearing Request is denied.
`
`
`
`
`PETITIONER:
`
`Deborah Sterling
`Jeremiah Frueauf
`Olga Partington
`Timothy Shea
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C
`dsterlin@skgf.com
`jfrueauf-ptab@skgf.com
`opartington-ptab@skgf.com
`tshea-ptab@skgf.com
`
`
`PATENT OWNER:
`
`David J. Ball, Jr.
`Jennifer Gordon
`Steven M. Balcof
`PAUL, WEISS, RIFKIND, WHARTON & GARRISON LLP
`dball@paulweiss.com
`jgordon@paulweiss.com
`sbalcof@paulweiss.com
`
`
`7
`
`