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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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
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`WOCKHARDT BIO AG,
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`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________
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`Case IPR2016-01582
`________________
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`Patent No. 8,822,438 B2
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`PATENT OWNER’S REQUEST FOR REHEARING
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`Date Filed: February 16, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`WOCKHARDT BIO AG,
`
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________
`
`Case IPR2016-01582
`________________
`
`Patent No. 8,822,438 B2
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`
`
`PATENT OWNER’S REQUEST FOR REHEARING
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`
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`IPR2016-01582
`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 72) (the “Final Decision”) regarding
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`U.S. Patent 8,822,438 (the “’438 patent”) pursuant to 37 C.F.R. §42.71(d). The
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`Board misapprehended or overlooked evidence, and employed reasons not set forth
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`in the Petition or the Institution Decision (“ID”), to find claims 1-20 of the ‘438
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`patent obvious.
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`First, the Board misapprehended evidence in the record contradicting the
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`reason advanced in the Petition as to why a skilled person supposedly would have
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`found it obvious to administer prednisone with abiraterone acetate (“AA”) – that a
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`skilled person would have been motivated to provide “coadministration of
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`prednisone, as taught by Gerber, because prednisone was known to treat prostate
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`cancer on its own.” (Paper 29 (ID) at 9-10) (emphasis added). But that proposition
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`was refuted by testimony from Petitioner’s own expert that no treating physician
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`would prescribe prednisone alone as an “anti-cancer agent” to a patient with a
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`prostate cancer. (Ex. 1002 at ¶ 116). The Board thus should have found that
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`Petitioner has failed to establish by a preponderance of the evidence the predicate
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`of its obviousness challenge in the Petition.
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`In its Final Decision, the Board resorted to new evidence introduced for the
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`first time in Petitioner’s Reply, as well as new and entirely distinct reasons
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`advanced by neither party, to conclude that a skilled person supposedly would have
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`co-administered prednisone with AA. For example, the Board credited Petitioner’s
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`assertion, raised first in its Reply, that “‘modest’ increased survival rates” was
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`evidence of prednisone’s effectiveness in treating cancer. (Final Decision at 25,
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`citing Reply at 11). The Board also misapprehended Dr. Godley’s testimony,
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`finding his explanation that the “palliative” use of prednisone in a prostate cancer
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`patient to constitute not only evidence of prednisone’s “anti-prostate cancer”
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`activity but that such “palliative” use of prednisone treated cancer. Both were
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`theories never advanced by Petitioner. (Final Decision at 26-27). The Board also
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`misapprehended that Dr. Godley’s declaration testimony being cited to support
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`“palliative treatment” (Ex. 1002 at ¶116) was not presenting opinions about what
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`Sartor would have suggested to the skilled artisan at the time of the invention, but
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`instead was describing his contemporaneous opinions regarding whether the
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`combination of AA and prednisone had unexpected effects.
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` Second, the Board overlooked or misapprehended the evidence
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`demonstrating there was no motivation to combine AA with prednisone based on
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`the teachings of Sartor. This evidence included testimony from Petitioner’s expert
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`that (i) a skilled artisan would not use prednisone alone as an anti-cancer treatment,
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`despite the teachings of Sartor, and (ii) that the Sartor publication itself had
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`limitations that undermined a skilled artisan’s ability to rely on the results reported.
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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 reasoning, a skilled artisan would not have increased the dose of AA
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`from 500 mg to 1000 mg/day, as dependent claims 4, 11, 19, and 20 require,
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`because doing so would have been expected to cause more severe adverse effects
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`and no additional benefit, given that the lower dose was supposedly effective.
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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 single paper prior to the Final Decision. There is thus
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`no rational basis for finding claims 4, 11, 19 and 20 obvious on this record.
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`The Board’s actions also are contrary to its obligations to recognize the
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`presumption of validity of the ’438 patent imposed by 35 U.S.C. § 282. The
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`statutory presumption of validity means that, in the absence of proof under the
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`applicable evidentiary standard, the court must find the claims valid. In these
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`proceedings, the Petitioner is required to establish the claims are unpatentable for
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`the reasons set forth in its Petition by a preponderance of the evidence. Where the
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`evidence before the Board on the Petitioner’s theory of unpatentability falls short
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`of that threshold – such as when a key fact underpinning the Petitioner’s theory has
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`been disproven – the presumption of validity compels the Board to affirm the
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`patentability of the claims.
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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 party may file a request for rehearing that “specifically identif[ies] all
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`matters the party believes the Board misapprehended or overlooked.” 37 C.F.R.
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`§42.71(d).
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`III. ARGUMENT
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`A. The Board Misapprehended or Overlooked that Petitioner’s
`Admissions Negated the Motivation to Combine in the Petition.
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`Petitioner’s sole obviousness ground asserted that the claims of the ’438
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`patent were unpatentable as obvious over Gerber, O’Donnell, and Sartor because
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`“a POSA reading Sartor would have had a reason to maintain Gerber’s co-
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`administration of prednisone when replacing Gerber’s ketoconazole with
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`O’Donnell’s abiraterone acetate” because “prednisone was known to treat prostate
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`cancer [based on Sartor].” (Paper 4 (Petition) at 22, 32, 34).
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`The Board relied on these representations to find a reasonable likelihood that
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`Petitioner would prevail in challenging the claims as obvious, stating:
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`[O]ne of ordinary skill in the art would have had a reason to maintain
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`coadministration of prednisone, as taught in Gerber, because
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`prednisone was known to treat prostate cancer on its own, as
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`demonstrated by Sartor…Sartor discloses that, even without a
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`concomitant anticancer therapy such as a CYP17 inhibitor, prednisone
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`as a monotherapy results in a PSA decline in patients with hormone-
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`refractory prostate cancer…We are persuaded, on this record, that a
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`person of ordinary skill in the art would have reasonably expected
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`each of abiraterone acetate and prednisone to treat prostate cancer
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`when co-administered and that, therefore, Petitioner has demonstrated
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`a reasonable likelihood of prevailing on its obviousness challenge to
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`claim 1.
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`ID at 9-10. (emphasis added)
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`In response, Patent Owner explained that the prior art relied upon by
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`Petitioner and the Board did not show that prednisone had an anti-prostate cancer
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`effect alone or in combination with other therapeutic agents. (PO Response at 26-
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`35). Petitioner’s expert, Dr. Godley, agreed with Patent Owner, testifying: “in my
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`experience no treating physician would prescribe prednisone alone as an anti-
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`cancer agent to a patient with a prostate cancer.” (Ex. 1002 at ¶ 116).
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`Dr. Godley also made other admissions that countered Petitioner’s
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`proposition that a skilled person would have believed prednisone was effective in
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`treating prostate cancer. These included: (i) that prednisone had not been
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`demonstrated to enhance the survival benefit of patients when administered in
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`combination with other anti-cancer drugs (Ex. 2161 at 19:21-25, cited in Paper 43
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`(PO Resp.) at 33); (ii) there was not much enthusiasm for combination therapies at
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`the time of the invention (Id. at 24:17-25:25; 26:2-11); and (iii) prior to the
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`patented invention it would be “unclear whether prednisone would have a
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`measureable cancer-treating effect when combined with abiraterone acetate…it’s
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`unclear what the prednisone impact would be when combined with abiraterone
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`acetate.” (Id. at 146:23-147:5). Dr. Godley additionally testified that even if
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`prednisone was combined with AA, he would expect the effect of prednisone
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`would be dwarfed by the effect of abiraterone acetate (Ex. 2185 at 184:9-20, cited
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`in Paper 64 (PO Mot. Obs.) at ¶ 13).
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`In its Final Decision, the Board overlooked or misapprehended the
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`preponderance of the evidence which demonstrated that Petitioner has failed to
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`meet its burden of proving that a skilled person would have been motivated to
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`combine AA with prednisone based on the results reported in Sartor.
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`For example, the Board credited Petitioner’s argument that a skilled artisan
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`allegedly “would have had a reason to maintain coadministration of prednisone, as
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`taught in Gerber, because prednisone was known to treat prostate cancer on its
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`own, as demonstrated by Sartor.” (Final Decision at 12, citing Petition at 24)
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`(emphasis added). But in so doing, the Board overlooked that Dr. Godley admitted
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`that “no treating physician would prescribe prednisone alone as an anti-cancer
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`agent to a patient with prostate cancer,” (Ex. 1002 at ¶ 116) an admission entirely
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`at odds with the Board’s finding.
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`In addition, the Board stated in its Final Decision that “Sartor discloses that
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`administration of prednisone alone, as shown by its results, led to an average
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`decline of 33% in PSA responses after initiating prednisone; a majority of patients
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`had PSA progression-free survival for a matter of months following treatment.
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`[Ex. 1006] at 254, Table III.” (Final Decision at 11). The Board, however,
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`overlooked critical admissions from Petitioner’s expert, Dr. Godley, that Sartor did
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`not include results from an untreated control group, and therefore a skilled person
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`would not know if the “progression-free survival” (i.e. the length of time until a
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`patient experienced PSA progression) was increased, or if that increase was
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`because of prednisone. (PO Response at 29-30). The Board also overlooked
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`testimony from Petitioner’s expert that Sartor is “likely a retrospective chart review
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`that Sartor threw together” (Ex. 2161 at 123:8-20) and a skilled researcher would
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`“not bet[] the ranch on any of these results.” (PO Response at 29, citing Ex. 2161
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`at 118:20-119:25, 121:3-5). In other words, the Board improperly credited
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`Petitioner’s arguments over the contrary testimony of Petitioner’s expert.
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`In its Final Decision, the Board also found that the use of prednisone for
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`palliative purposes in a prostate cancer patient would have provided an alternative
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`motivation for a skilled person to co-administer prednisone with AA, reasoning
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`that “…palliative treatment, which, as we discuss herein, is a treatment permitted
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`by the language of the claims. Ex. 2162, 66:1–10, 66:17–67:1.” (Final Decision at
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`26-27). But here, the Board misapprehended or overlooked that Petitioner never
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`contended that use of prednisone for “palliation” would have been a motivation to
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`for a skilled person combine it with AA to treat cancer, in either the Petition or in
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`its Reply.1 Instead, the Board announced this supposed motivation to combine sua
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`sponte for the first time in its Final Decision.
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`The Board also misapprehended or overlooked the record of evidence in this
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`proceeding in presenting this new “palliation”-based motivation theory. For
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`example, the Board did not identify any portion of any of the three references used
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`in the obviousness grounds (O’Donnell, Gerber and Sartor) as supporting its new
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`theory that “palliative” use of prednisone would have provided a motivation for a
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`skilled person to combine prednisone with AA. In fact, the Board makes no
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`reference at all to the prior art in advancing this new rationale. The Board likewise
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`cited portions of Dr. Godley’s deposition testimony that were not cited in any paper
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`in this proceeding (e.g., Ex. 2162, 66:1-10).
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`1
`Petitioner’s Reply quoted Godley but omitted any reference to “palliation.”
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`(See Paper 54 (Reply) at 12 (“Indeed, the very quote Janssen provides directly
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`undermines its assertion: ‘in my experience no treating physician would prescribe
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`prednisone alone as an anti-cancer agent … except in those patients that had
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`progressed on all other available treatments.’ (Id., citing WCK1002, ¶116,
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`emphasis added.)”) (ellipses in original)).
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`The Board also misapprehended that the portion of Dr. Godley’s declaration
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`(¶ 116) that Petitioner cited in its Reply and which the Board relied on extensively
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`in its Final Decision concerned an entirely unrelated issue – whether the
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`combination of AA with prednisone would have unexpected results. As Dr. Godley
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`stated in that paragraph of his declaration:
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`It is also my understanding that Janssen cited evidence demonstrating
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`that the claimed invention provided an unexpected survival benefit as
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`compared to prednisone alone… in my experience no treating
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`physician would prescribe prednisone alone as an anti-cancer agent to
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`a patient with a prostate cancer, except in those patients that had
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`progressed on all other available treatments, with the goal being
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`palliative treatment….
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`Ex. 1002 at ¶ 116. (emphasis added)
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`The Board also overlooked that in this passage, Dr. Godley was not
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`describing the teachings of the prior art or what that prior art would have conveyed
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`or suggested to a skilled artisan at the time of the invention. Importantly, Dr.
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`Godley’s opinions concerning palliation were expressed from a modern perspective
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`and were based on his personal experiences – they were not presented using a
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`perspective of a skilled artisan at the time of the invention and are not based on any
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`prior art. They were not, thus, evidence of why a skilled person based on Sartor,
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`O’Donnell or Gerber would have been motivated to treat prostate cancer patients
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`with a combination of AA and prednisone.
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`The Board’s reliance on a new rationale for obviousness announced for the
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`first time in its Final Decision causes significant prejudice to Patent Owner, who
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`had no opportunity to respond to it, given that it was never advanced by Petitioner
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`and appeared for the first time in the Board’s Final Written Decision. As the
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`Federal Circuit has held, “the Board must base its decision on arguments that were
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`advanced by a party, and to which the opposing party was given a chance to
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`respond.” In re Magnum Oil Tools International, 829 F.3d 1364, 1381 (Fed. Cir.
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`2016) (citing SAS Inst., Inc. v. ComplementSoft, LLC, 825 F.3d 1341, 1351 (Fed.
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`Cir. 2016) (“An agency may not change theories in midstream without giving
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`respondents reasonable notice of the change and the opportunity to present
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`argument under the new theory.”)). “Thus, while the PTO has broad authority to
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`establish procedures for revisiting earlier-granted patents in IPRs, that authority is
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`not so broad that it allows the PTO to raise, address, and decide unpatentability
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`theories never presented by the petitioner and not supported by record evidence.”
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`In re Magnum Oil Tools International, 829 F.3d at 1381. The Federal Circuit has
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`found reversible error in cases in which the Board supplies a motivation to
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`combine not articulated by Petitioner for the first time in its Final Written
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`Decision. Id.
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`Moreover, the Board’s decision to disregard admissions of Petitioner’s
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`expert that refute the theory of obviousness advanced in the Petition cannot be
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`reconciled with the presumption of validity that patents are entitled to under 35
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`U.S.C. § 282.2 Here, by disregarding evidence that refutes the predicate of its
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`obviousness finding in the Petition, the Board improperly shifted the burden to
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`Patent Owner to demonstrate nonobviousness, rather than requiring Petitioner to
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`prove the claims are unpatentable. Because the preponderance of the evidence
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`shows that Petitioner has not proven that the contested claims would have been
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`obvious to a skilled person for the reasons advanced in its Petition, the Board
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`should have found the claims patentable.
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`Further, the Board’s misapprehension of the teachings of Sartor, considered
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`with Dr. Godley’s admissions that refute the proposition that Sartor would have
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`provided a motivation to combine prednisone with AA, caused it to incorrectly
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`conclude that the claimed methods would have been obvious. The Board’s
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`decision cannot be sustained when Petitioner’s admissions are accepted, and when
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`2
`Importantly, that presumption exists independent of the evidentiary
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`standards used by the Board to assess whether predicate facts have been
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`established. It is also reflected in the standards the Board must follow before
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`instituting trial and in its final written decision, which require the Board to find by
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`a preponderance of the evidence that Petitioner has established that the claimed
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`invention would have been unpatentable. 35 USC §316(e).
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`the new theories advanced for the first time in the Final Decision are properly
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`excluded from the analysis.
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`Moreover, because the Petition advanced a single ground of obviousness
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`based on all three references (Gerber, O’Donnell and Sartor), the Board cannot
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`properly find an alternative basis for obviousness based on a different combination
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`of references, such as Gerber and O’Donnell alone. As the Federal Circuit has
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`found, “IPR proceedings are formal administrative adjudications subject to the
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`procedural requirements of the Administrative Procedure Act…One such APA
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`provision is that ‘persons entitled to notice of an agency hearing shall be timely
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`informed of…the matters of fact and law asserted.’ 5 U.S.C. §554(b)(3).” SAS
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`Institute, Inc. v. ComplementSoft, LLC, 825 F.3d 1341, 1351 (Fed. Cir. 2016). The
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`Federal Circuit has likewise held that, in the IPR context, “an agency may not
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`change theories in midstream without giving respondents reasonable notice of the
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`change and the opportunity to present argument under the new theory.” Id.
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`(internal citations omitted). As such, the Board cannot alter the basis of its finding
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`of obviousness without seriously prejudicing Patent Owner, as this would represent
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`an impermissible midstream change in theory under Federal Circuit precedent. Id.
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`B.
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`The Board Misapprehended that the Prior Art Did Not Teach or
`Suggest a 1000 mg Abiraterone Acetate Dose as Required by
`Claims 4, 11, 19 and 20
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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 to 1000 mg because “O’Donnell
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`discloses administering 200, 500, and 800 mg/day of abiraterone acetate …
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`However, O’Donnell also discloses that the dose of abiraterone acetate may need to
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`be increased to reliably maintain sufficient suppression of testosterone production
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`in some patients.” (Petition at 37, citing Ex. 1005 at 2320-2321, 2324; Ex. 1002 at
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`¶ 89).3 Without any analysis, the Board adopted Petitioner’s assertion. (Final
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`Decision at 9-10). But elsewhere in its 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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`POSA concern that abiraterone acetate at these doses could result in “chronic
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`cortisol deficiency.” (Final Decision at 22-23).
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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 would have been obvious to a skilled artisan. Under the
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`3
`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., PO Resp. at 48, citing Ex. 1008 at
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`1245; Ex. 2161 at 100:1-11, 103:15-104:1; Ex. 2038 ¶ 92; Ex. 2016 at 145:3-9,
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`150:11-14; Ex. 2124 at 72:9-21).
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`former finding (that doses of AA reported in O’Donnell are sufficient for “treating”
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`prostate cancer), there would no motivation for a skilled artisan to increase the AA
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`dose beyond 500mg or 800mg. Under the latter finding, a skilled person would
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`have been motivated to maintain or reduce, but not increase the AA dose. The
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`Board’s finding that claims 4, 11, 19, and 20 would have been obvious is not
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`supported by a rational articulation of obviousness, and is not consistent with the
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`evidence of record. Patent Owner was denied an opportunity to respond to these
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`inconsistent findings in the Final Decision with respect to the dependent claims
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`requiring 1000mg of AA because these two arguments were not articulated by
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`Petitioner in any single paper prior to the Final Decision. Considered in light of
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`the presumption of validity, claims 4, 11, 19 and 20 of the ’438 patent are not
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`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
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Request for Rehearing was served on counsel of record on February 16,
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`2018 by filing this document through the End-to-End System, as well as delivering
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`a copy via electronic mail to counsel of record for the Petitioner and Patent Co-
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`Owner at the following addresses:
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`Dennies Varughese – dvarughe-PTAB@skgf.com
`Deborah A. Sterling – dsterlin-PTAB@skgf.com
`Lestin L. Kenton Jr. – lkenton-PTAB@skgf.com
`Ralph W. Powers III – tpowers-PTAB@skgf.com
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`Anthony C. Tridico – anthony.tridico@finnegan.com
`Jennifer H. Roscetti – jennifer.roscetti@finnegan.com
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`Date: Feb. 16, 2018
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`Respectfully submitted,
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`By: /Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
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`Counsel for Patent Owner
`Janssen Oncology, Inc.
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`- 16 -
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