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`Paper No. ___
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`Date Filed: February 16, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________
`
`MYLAN PHARMACEUTICALS INC., ACTAVIS
`LABORATORIES FL, INC., AMNEAL PHARMACEUTICALS LLC,
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, INC.,
`TEVA PHARMACEUTICALS USA, INC., WEST-WARD
`PHARMACEUTICAL CORP., and HIKMA PHARMACEUTICALS, LLC,
`Petitioners,
`
`v.
`
`JANSSEN ONCOLOGY, INC.
`Patent Owner.
`
`_______________________
`
`Case IPR2016-013321
`Patent 8,822,438 B2
`
`_______________________
`
`
`
`PATENT OWNER’S REQUEST FOR REHEARING
`
`
`1 Case IPR2017-00853 has been joined with this proceeding.
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`IPR2016-01332
`U.S. Patent 8,822,438
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`I.
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`INTRODUCTION
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`Janssen Oncology, Inc. (“Patent Owner”) respectfully requests rehearing of
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`the Board’s Final Written Decision (Paper 84) (“Final Decision”) regarding U.S.
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`Patent 8,822,438 (the “’438 patent”) pursuant to 37 C.F.R. §42.71(d). The Board
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`misapprehended or overlooked evidence and improperly relied on theories and
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`evidence presented only in Petitioners’ Reply, to hold claims 1-20 obvious.
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`First, the Board misapprehended the evidence contradicting the sole reason
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`advanced in the Petition (which it adopted in its Institution Decision) as to why a
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`skilled person would have found it obvious to administer prednisone with
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`abiraterone acetate (“AA”) – that there supposedly was a need to treat the side
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`effects of mineralocorticoid excess caused by “CYP17 inhibitors.” But
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`ketoconazole – which the Board inaccurately portrayed as being equivalent to AA
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`because both were “CYP17 inhibitors” – does not cause mineralocorticoid excess.
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`As he stated in his opening declaration, Petitioners’ expert also confirmed that
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`cortisol reductions alone are not enough to justify glucocorticoid replacement
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`therapy and opined that such treatment is warranted only if cortisol reduction
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`results in mineralocorticoid excess. Consequently, Petitioners failed to show by a
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`preponderance of the evidence that a skilled person would have been motivated to
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`co-administer prednisone with an alleged “CYP17 inhibitor” like ketoconazole and
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`AA to treat symptoms of (non-existent) mineralocorticoid excess.
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`IPR2016-01332
`U.S. Patent 8,822,438
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`The Board compounded its errors by relying on new theories that Petitioners
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`raised for the first time in Reply to find a different motivation to combine
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`prednisone with AA, particularly because other evidence in the record contradicted
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`those new theories. More than a preponderance of the evidence in this record thus
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`refutes the obviousness grounds as they were set forth in the Institution Decision.
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`The Board’s decision also improperly disregards the presumption of validity
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`that patents – including those undergoing inter partes review – are entitled to under
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`35 U.S.C. § 282. The statutory presumption of validity means that, in the absence
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`of proof under the applicable evidentiary standard, the court must find the claims
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`valid. In these proceedings, the Petitioners are required to establish the claims are
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`unpatentable for the reasons set forth in their Petition by a preponderance of the
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`evidence. Where the evidence before the Board on the Petitioners’ theory of
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`unpatentability falls short of that threshold – such as when a key fact underpinning
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`the Petitioners’ theory has been disproven – the presumption of validity compels
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`the Board to affirm the patentability of the claims.
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`Finally, the Board misapprehended the logical consequence of its dual
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`findings that (i) O’Donnell taught that 500mg of AA effectively “treats” prostate
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`cancer but (ii) results in “unquestionably abnormal” cortisol side effects. Under
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`the Board’s own reasoning, a skilled artisan would not have increased the dose of
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`AA from 500 mg to 1000 mg/day, as dependent claims 4, 11, 19, and 20 require,
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`IPR2016-01332
`U.S. Patent 8,822,438
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`because doing so was unnecessary and would cause more severe side effects.
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`Patent Owner also could not have responded to the inconsistencies in the Board’s
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`reasoning with respect to these dependent claims because these two arguments
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`were not articulated in any paper prior to the Final Decision. There is thus no
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`rational basis for finding dependent claims 4, 11, 19 and 20 obvious on this record.
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`Accordingly, the Board should vacate its Final Decision and confirm the
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`patentability of claims 1-20 of the ’438 patent.
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`II.
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`STANDARD OF REVIEW
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`A request for rehearing may be filed that “specifically identif[ies] all matters
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`the party believes the Board misapprehended or overlooked.” 37 C.F.R. §42.71(d).
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`III. ARGUMENT
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`A. The Board Misapprehended the Significance of Petitioners’
`Admission that Ketoconazole Does Not Cause Mineralocorticoid
`Excess
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`Mylan’s Petition articulated a single rationale why the challenged claims
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`were unpatentable:
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`… it was known in the art that administering ketoconazole, also a
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`CYP17 inhibitor like abiraterone acetate, to treat a prostate cancer
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`may result in significant side effects, such as hypertension,
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`hypokalemia and fluid retention as a result of a decrease in cortisol
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`levels and consequent ACTH drive.
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`Paper 1 (Petition) at 57-58, citing Ex. 1002 at ¶¶ 44, 78-80.
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`To support this assertion, Petitioners relied on their expert, Dr. Garnick who
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`testified:
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`[T]he administration of ketoconazole to treat prostate cancer was
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`known to reduce cortisol levels and potentially result in
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`mineralocorticoid excess, giving rise to side effects commonly
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`associated with mineralocorticoid excess, including hypertension,
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`hypokalemia, and fluid retention…These side effects reduced the
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`safety and tolerability of administering ketoconazole…To address
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`these side effects, it was standard practice in the art to co-administer a
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`glucocorticoid such as…prednisone with ketoconazole to improve the
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`safety and tolerability of administration of ketoconazole to treat
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`prostate cancer.”
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`Ex.1002 at ¶ 44 (emphasis added).
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`In its decision to institute trial, the Board relied on the same reasons given in its
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`Institution Decision in the Amerigen IPR (IPR2016-00286), stating:
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`Having reviewed the [Mylan] Petition and Janssen’s Preliminary
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`Response, we incorporate our analysis from our Institution Decision
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`in the Amerigen IPR. IPR2016-00286, Paper 14, 4-15. For the same
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`reasons given in the Institution Decision in the Amerigen IPR, we
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`determine that Mylan has demonstrated a reasonable likelihood that it
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`would prevail with respect to its challenge to claims 1-20 of the ’438
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`patent on the asserted grounds.
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`Paper 21 (ID) at 5.
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`In turn, the Amerigen Institution Decision found a reasonable likelihood that
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`Petitioners would prevail in challenging the claims as obvious because:
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`Our review of Dr. Serels’s declaration and supporting evidence leads
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`us to credit his testimony that “one of skill in the art would have
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`expected that the co-administration of prednisone with abiraterone
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`would improve the safety and tolerability of administering abiraterone
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`by reducing the potential for side effects associated with the
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`administration of a CYP17 inhibitor.” Pet. 27–28 (citing Ex. 1002 ¶
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`34).
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`See IPR2016-00286 Paper 14 (Amerigen ID) at 10 (emphasis added).
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`In its Response, Patent Owner explained that the prior art relied upon by
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`Petitioners (and the Board) did not show that ketoconazole caused
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`mineralocorticoid excess and, in fact, other prior art showed that ketoconazole
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`suppressed production of mineralocorticoids. (Paper 35 (Patent Owner Response)
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`at 18-19; Ex. 2163 at 815, cited in Paper 70 (PO Mot. Obs.) ¶ 6 (“it can be
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`expected that patients treated with [ketoconazole] will be free of side effects such
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`as mineralocorticoid excess”). Petitioners’ expert, Dr. Bantle, agreed with Patent
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`Owner: “So I would anticipate there would be some production [of
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`mineralocorticoids after ketoconazole administration], but the production [of
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`mineralocorticoids] would usually be deficient.” (Ex. 2188 at 37:20-22).
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`Amerigen’s expert, Dr. Serels, upon whom the Board relied in its Institution
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`Decision, also agreed with Bantle and Patent Owner: “I have reviewed the steroid
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`synthesis pathways…and now more fully appreciate…that mineralocorticoid
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`excess would not occur with ketoconazole.” (Ex. 2122 ¶10 (PO Response at 2).
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`These concessions entirely refute Petitioners’ theory of obviousness - a skilled
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`artisan thus would have had no reason to administer a glucocorticoid with AA,
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`given that AA (as a supposed “CYP17 inhibitor” like ketoconazole) would not
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`cause mineralocorticoid excess.
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`In its Final Decision, the Board noted that Petitioners’ Reply argued that
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`both “mineralocorticoid excess” and “adrenal insufficiency” could occur with
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`ketoconazole, stating:
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`Ketoconazole…[a] known treatment[] for prostate cancer, inhibited
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`production of testosterone and numerous other steroids such as
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`cortisol, resulting in conditions such as mineralocorticoid excess and
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`adrenal insufficiency and symptoms such as hypertension,
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`hypokalemia, fluid retention, fatigue, nausea and vomiting, weight
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`loss, and hypotension. Reply 4–5 (citing Ex. 1097 ¶¶ 32–33, 37–39,
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`41; Ex. 1104 ¶¶ 16–23). Abiraterone acetate, as a “next generation
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`steroid synthesis inhibitor,” is in the same class of treatment agents as
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`ketoconazole…and therefore, “a skilled artisan would have been
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`concerned that abiraterone acetate would induce similar side effects as
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`other steroid synthesis inhibitors.”
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`Final Decision at 17 (emphasis added).
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`The Board, however, focused its analysis on the fact that “ketoconazole
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`would inhibit production of cortisol.” (Final Decision at 18). But in so doing, the
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`Board misapprehended or overlooked that the Petition did not portray the supposed
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`inhibition of the production of cortisol as an “independent” reason to administer
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`prednisone with AA (i.e., other than to treat side effects supposedly caused by
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`mineralocorticoid excess). Instead, as Petitioners’ expert explained:
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`However, the administration of ketoconazole to treat prostate cancer
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`was known to reduce cortisol levels and potentially result in
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`mineralocorticoid excess, giving rise to side effects commonly
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`associated with mineralocorticoid excess, including hypertension,
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`hypokalemia, and fluid retention.
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`Ex. 1002 ¶ 44 (emphasis added).
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`In other words, according to Petitioners and their expert, while cortisol
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`deficiency could (but does not necessarily) lead to mineralocorticoid excess, it is
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`only mineralocorticoid excess that causes side effects like hypertension,
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`hypokalemia and fluid retention.2 In fact, as Petitioners and their expert admitted,
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`2
`Petition at 5 (“it was known that in using a CYP17 inhibitor to reduce
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`testosterone synthesis, the CYP17 inhibitor…caused adverse effects, including
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`hypertension, hypokalemia (decrease in circulating potassium levels), and fluid
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`retention.”) citing Ex. 1002 at ¶¶ 42, 44, 58; see also id. at 27 (“It was known that
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`CYP17 inhibition of cortisol increased ACTH drive…which resulted in a
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`corresponding increase in mineralocorticoids. An increased in mineralocorticoids
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`beyond normal levels, known as “mineralocorticoid excess,” was known to have
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`adverse effects, including hypertension, hypokalemia (decrease in circulating
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`potassium levels), and fluid retention.”) citing Ex. 1002 at ¶ 41.
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`“[i]nsufficient cortisol levels cause a condition known as adrenal insufficiency,
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`which is characterized by weakness, fatigue, weight loss, nausea, vomiting,
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`hypotension, and hyperpigmentation.” (Reply at 10-11). Further, the Board
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`overlooked Petitioners’ expert’s admission that “mineralocorticoid excess is rarely
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`due to a defect in cortisol biosynthesis.” (Ex. 2188 at 24:22-25:2). And
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`Petitioners’ expert likewise acknowledged that “mineralocorticoid excess” and
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`“adrenal insufficiency” are “opposite disorders producing opposite sorts of
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`problems.” (Ex. 2188 at 23:20-24, cited in PO Mot. Obs. at ¶ 9(b)).
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`Consequently, Petitioners’ assertion in their Reply that “[c]ortisol, a
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`glucocorticoid … is necessary for other biochemical cycles in the body … reduced
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`production . . . caused adverse effects, including hypertension, hypokalemia …,
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`and fluid retention’” – which the Board cited in its Final Decision (Final Decision
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`at 12-13, citing Ex. 1002 ¶¶ 42, 44, 58.) – is not only scientifically inaccurate, it
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`employs a materially different rationale for obviousness than what was set forth in
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`the Petition.
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`The Board thus overlooked or misapprehended the consequences of the now
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`undisputed fact that ketoconazole does not cause mineralocorticoid excess (Ex.
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`2188 at 37:20-22, Ex. 2163 at 815). First, that fact refutes the proposition that a
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`skilled artisan would have been motivated to administer prednisone to an
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`individual being treated with ketoconazole (and by extension, AA). Second, it
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`confirms that Petitioners advanced a new and different obviousness ground in their
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`Reply, which the Board improperly relied upon to hold the claims obvious.
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`(Petition at 57-58, Amerigen ID3 at 10, Final Decision at 13, 17-18).
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`The Board compounded its error by overlooking or misapprehending
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`evidence showing that AA was not known to cause side effects characteristic of
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`mineralocorticoid excess. Petitioners’ expert, Dr. Bantle, admitted: “I don’t see
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`any suggestion in the data presented or the discussion subsequently [in O’Donnell]
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`that mineralocorticoid excess was present or a problem.” (Ex. 2188 at 102:20-
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`103:4). Additionally, the evidence showed that, in O’Donnell, patients treated with
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`AA retained normal cortisol levels. (PO Response at 20-24, citing Ex. 1003 at
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`2320-23; Ex. 2038 ¶ 130; Ex. 2040 ¶¶ 30-35, Ex. 20137 at 185:10-24). The Board
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`also overlooked or misapprehended evidence showing that the body naturally
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`offsets modest decreases in cortisol production by increased production of
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`corticosterone and admissions from Petitioners’ expert that “corticosterone could
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`prevent adrenal insufficiency.” (PO Response at 21, citing Ex. 2038 ¶¶ 109-116;
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`Ex. 2040 ¶¶26, 30-35; Ex. 2037 at 181:6-183:20; see also Ex. 2188 at 26:8-16
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`(cited in PO Mot. Obs. at ¶ 15)).
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`The Board likewise misapprehended O’Donnell’s Synacthen test results,
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`3
`Portions of the Amerigen ID (pages 4-15) were incorporated by reference in
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`the Mylan ID. See ID at 5.
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`stating that the skilled artisan would know from them that “something was amiss
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`with the O’Donnell Study C patients’ cortisol levels following administration of
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`abiraterone acetate.” (Final Decision at 21). But, critically, the Board identified no
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`evidence suggesting that AA was known to cause the side effects associated with
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`mineralocorticoid excess at the time of the invention – the only rationale advanced
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`in the Petition as to why a skilled person would have considered it obvious to
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`administer prednisone with AA.
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`The Board also improperly credited a reply declaration from Petitioners’
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`expert that, according to the Board, showed “low adrenal reserve, which is closely
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`related to adrenal insufficiency and can be fatal, is likely when abnormal
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`Synacthen results and otherwise normal cortisol levels and few symptoms are
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`present” and was “significant enough to merit further investigation of
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`administration of abiraterone acetate with glucocorticoids.” (Final Decision at 22).
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`That hindsight-driven speculation is not evidence demonstrating a skilled person at
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`the time of the invention would have believed there was a need for co-
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`administration of a glucocorticoid with AA.
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`The evidence before the Board thus conclusively refutes Petitioners’
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`supposed motivation for administering prednisone with AA – namely, to treat side
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`effects caused by mineralocorticoid excess that result from use of ketoconazole
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`(and by extension AA).
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`The Board’s decision to credit an expert’s speculation and to disregard
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`admissions by Petitioners’ experts that refute the premise of Petitioners’
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`obviousness ground improperly shifted the burden of proof to Patent Owner. That
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`cannot be reconciled with the presumption under 35 U.S.C. § 282. It also cannot
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`be reconciled with the standards the Board must follow before instituting trial and
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`in its final written decision, both requiring the Board to find by a preponderance of
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`the evidence that Petitioners have established that the claimed invention would
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`have been unpatentable. See, e.g., 35 U.S.C. § 316(e). In other words, in the
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`absence of such evidence, the patent claims are presumed to satisfy the relevant
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`patentability requirements (i.e., they are not anticipated or obvious).
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`B.
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`The Board Overlooked the Evidence that AA Does Not Cause
`Adrenal Insufficiency.
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`The Board overlooked or misapprehended the evidence in the record
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`refuting Petitioners’ new theory, presented for the first time in their Reply, that a
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`skilled person would have been motivated to combine AA with prednisone because
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`AA might cause “adrenal insufficiency” and/or a “low adrenal reserve.”4 (Final
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`Decision at 17, 20-22).
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`4
`Patent Owner identified these as new arguments in Paper 65 at p. 1, ll. 5-6;
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`p. 3, ll. 2-4; p. 5, ll. 5-9; p. 10, l. 6 – p. 11, l. 5; p. 11, l. 9-p. 12, l. 2; p. 13, ll. 4-11;
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`and FN7, ll. 3-6.
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`“Adrenal insufficiency” and “low adrenal reserve” are phenomena distinct
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`from “mineralocorticoid excess” and present different clinical manifestations. For
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`example, one side effect caused by mineralocorticoid excess is hypertension
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`(Petition at 27, 57), while, as Petitioners state in their Reply, “[i]nsufficient cortisol
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`levels casue a condition known as adrenal insufficiency, which is characterized by
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`weakness, fatigue, weight loss, nausea, vomiting, hypotension, and
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`hyperpigmentation.” (Reply at 10-11) (emphasis added). Obviously, different
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`therapeutic interventions are needed to address these contrary symptoms.
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`“[N]ew evidence that could have been presented earlier to support the
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`movant’s motion” is not permitted on reply under 37 C.F.R. §§ 42.22 (a)(2) and
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`42.23(b). See Baxter Healthcare Corp. v. Millenium Biologix, LLC, IPR2013-
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`00582, Paper 39, at 3-4 (Oct. 30, 2014). When a petitioner raises an entirely new
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`rationale to explain why one of skill in the art would have been motivated to
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`combine prior art references, it is appropriate to refuse the entire reply brief as
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`improper. Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359,
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`1369-70 (Fed. Cir. 2016). The Board’s obviousness conclusion cannot stand
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`without consideration of this improper evidence.
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`The Board overlooked or misapprehended that the phenomena of “adrenal
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`insufficiency” and “low adrenal reserve” do not provide a motivation to combine
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`AA with prednisone, based on O’Donnell or any other prior art, and thus cannot
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`support the rationale for obviousness adopted by the Board in its Final Decision.
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`The Board compounded its error by overlooking or misapprehending
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`evidence demonstrating that skilled artisans did not interpret the Synacthen test
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`results in O’Donnell as Petitioners contended. Just one year after the O’Donnell
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`publication, skilled artisans reviewing its Synacthen test results concluded that
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`while “[a]ll six patients had a reduced cortisol response to ACTH stimulation on
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`the 11th day after dosing…there were no clinical manifestations of adrenocortical
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`insufficiency.” (Ex. 1023 at 1245 (emphasis added), cited in PO Response at 41).
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`The Board overlooked that contemporaneous observations such as these are
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`entitled to more weight than the testimony of a paid expert. See, e.g., Union
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`Carbide Corp. v. Am. Can Co., 724 F.2d 1567, 1571-72 (Fed. Cir. 1984).
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`The Board also overlooked or misapprehended the evidence showing that
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`skilled artisans, after considering the data reported in O’Donnell, proceeded to
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`undertake studies based on AA monotherapy. For example, Attard 2005 indicated
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`that its next planned study of AA would not include co-administration of
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`prednisone: “[a] safety and efficacy evaluation of abiraterone acetate administered
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`daily and continuously to castrate men with advanced prostate cancer progressing
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`despite hormone treatment is planned.” (Ex. 1023 at 1245, cited in PO Response at
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`41). That evidence, which was not discussed by the Board, refutes Petitioners’
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`assertion that a skilled artisan would have been motivated by the alleged “adrenal
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`insufficiency” data in O’Donnell to administer AA with prednisone.
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`The prior art, including Attard 2005, when properly considered with the
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`presumption of validity, confirms that claims 1-20 are not obvious.
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`C. The Board Misapprehended that the Prior Art Does Not Teach or
`Suggest a 1000 mg Abiraterone Acetate Dose.
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`The Petition contended a skilled person would have been motivated to
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`increase the dose of AA disclosed in O’Donnell and/or Barrie to 1000 mg because
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`“O’Donnell reported that a dose of 800 mg of abiraterone acetate can successfully
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`suppress testosterone levels to the castrate range, but this level of suppression may
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`not be sustained in all patients due to compensatory hypersecretion of LH
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`(luteinizing hormone).” (Petition at 43, citing Ex. 1003 at Abstract; see also id. at
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`29, 31).5 Without any analysis, the Board adopted Petitioners’ assertion. (Final
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`Decision at 11). But elsewhere in its Final Decision, the Board held that “[w]e are
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`persuaded that one of ordinary skill in the art would understand the results of [the
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`Synacthen test] to be an indicator that something was amiss with the O’Donnell
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`Study C patients’ cortisol levels following administration of [500mg or 800mg of]
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`abiraterone acetate” and that the results were “significant enough” to cause a
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`5
`Patent Owner showed that the doses of AA tested in the O’Donnell study did
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`not establish clinical efficacy of AA (see, e.g., Ex. 2005 ¶ 8; Ex. 2006 at 2, cited in
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`Paper 12 at 8; Ex. 1023 at 1245, cited in Paper 12 at 19-20).
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`POSA concern that abiraterone acetate at these doses could result in “low adrenal
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`reserve.” (Final Decision at 21-22).
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`The Board overlooked or misapprehended that these two findings cannot be
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`reconciled or support a conclusion that increasing the 500/800 mg dose of AA
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`specified in O’Donnell and in Barrie would have been obvious to a skilled artisan.
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`Under the former finding (that doses of AA reported in O’Donnell are sufficient for
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`“treating” prostate cancer), there would be no motivation for a skilled artisan to
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`increase the AA dose beyond 500mg or 800mg. Under the latter finding, a skilled
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`person would have been motivated to maintain or reduce, but not increase the AA
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`dose. The Board’s finding that claims 4, 11, 19, and 20 would have been obvious
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`is not supported by a rational articulation of obviousness, and is not consistent with
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`the evidence of record. Considered in light of the presumption of validity, claims
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`4, 11, 19 and 20 of the ’438 patent are not obvious, and are patentable.
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`IV. Conclusion and Relief Requested
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`For the reasons described above, Patent Owner respectfully requests that the
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`PTAB vacate its Final Decision with respect to claims 1-20 and/or claims 4, 11, 19
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`and 20 of the ’438 patent, and confirm the patentability of these claims.
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`Dated: February 16, 2018
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`Respectfully Submitted,
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`By: /Dianne B. Elderkin/
`Dianne B. Elderkin (Reg. No. 28,598)
`delderkin@akingump.com
`Barbara L. Mullin (Reg. No. 38,250)
`bmullin@akingump.com
`Ruben H. Munoz (Reg. No. 66,998)
`rmunoz@akingump.com
`AKIN GUMP STRAUSS HAUER &
`FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel: (215) 965-1200
`Fax: (215) 965-1210
`
`David T. Pritikin (pro hac vice)
`dpritikin@sidley.com
`Bindu Donovan (pro hac vice)
`bdonovan@sidley.com
`Paul Zegger (Reg. No. 33,821)
`pzegger@sidley.com
`Todd Krause (Reg. No. 48,860)
`tkrause@sidley.com
`Alyssa B. Monsen (pro hac vice)
`amonsen@sidleyaustin.com
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
`ZytigaIPRTeam@sidley.com
`Counsel for Patent Owner
`
`
`
`
`
`
`
`- 16 -
`
`
`
`IPR2016-01332
`U.S. Patent 8,822,438
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent
`
`Owner’s Request for Rehearing was served on counsel of record on February 16,
`
`2018 by filing this document through the End-to-End System, as well as delivering
`
`a copy via electronic mail to counsel of record for the Petitioners at the following
`
`addresses:
`
`Brandon M. White – bmwhite@perkinscoie.com
`Crystal R. Canterbury – ccanterbury@perkinscoie.com
`Bryan D. Beel – bbeel@perkinscoie.com
`Shannon Bloodworth – sbloodworth@perkinscoie.com
`Emily J. Greb – egreb@perkinscoie.com
`Robert D. Swanson – rswanson@perkinscoie.com
`
`Samuel S. Park – spark@winston.com
`Ryan B. Hauer – rhauer@winston.com
`Jovial Wong – jwong@winston.com
`
`
`
`Date: Feb. 16, 2018
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`
`
` Counsel for Patent Owner
`Janssen Oncology, Inc.
`
`- 17 -
`
`
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