Paper No. ___
`Date Filed: June 14, 2016
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`
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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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`________________
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`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner
`
`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
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`________________
`
`Case IPR2016-00286
`Patent 8,822,438 B2
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`________________
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`
`PATENT OWNER’S REQUEST FOR RECONSIDERATION
`PURSUANT TO 37 C.F.R. § 42.71(c)
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`
`
`
`
`
`
`
`Date Filed: June 14, 2016
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`
`________________
`
`Case IPR2016-00286
`Patent 8,822,438 B2
`
`________________
`
`
`PATENT OWNER’S REQUEST FOR RECONSIDERATION
`PURSUANT TO 37 C.F.R. § 42.71(c)
`
`
`
`
`
`
`
`
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`IPR2016-00286
`Patent 8,822,438
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`
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`TABLE OF CONTENTS
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`Page
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`SUMMARY ................................................................................................................ 1
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`LEGAL STANDARDS ............................................................................................ 4
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`I.
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`II.
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`III. ARGUMENT ............................................................................................................. 5
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`a.
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`The Decision to Institute Ignores Petitioner’s Admissions that the
`Prior Art Does Not Teach or Suggest the Claim Element “A
`Therapeutically Effective Amount of Prednisone” .................................. 5
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`
`b.
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`The Board Fails to Credit the Patent Office’s Prior Determination of
`Commercial Success and Petitioner’s Admission of Unexpected
`Results ............................................................................................................ 10
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`IV. CONCLUSION ........................................................................................................ 13
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`i
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`Patent 8,822,438
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`Cases
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`TABLE OF AUTHORITIES
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` Page(s)
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`Al-Site Corp. v. VSI Int’l, Inc.,
`174 F.3d 1308 (Fed. Cir. 1999) .......................................................................... 12
`
`Arnold P’ship v. Dudas,
`362 F.3d 1338 (Fed. Cir. 2004) ............................................................................ 5
`
`Coal. for Affordable Drugs V LLC v. Biogen MA Inc.,
`IPR2015-01136, 2015 WL 5169256 (Sept. 2, 2015) ............................................ 6
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`In re Cyclobenzaprine Hydrochloride,
`676 F.3d 1063 (Fed. Cir. 2012) ............................................................................ 7
`
`In re Glass,
`472 F.2d 1388 (C.C.P.A. 1973) ............................................................................ 5
`
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .......................................................................... 11
`
`In re Lowry,
`32 F.3d 1579 (Fed. Cir. 1994) .............................................................................. 5
`
`Medtronic, Inc. v. Nuvasive, Inc.,
`IPR2013-00504, 2014 WL 1253033 (Feb. 13, 2014) ........................................... 6
`
`Microsoft Corp. v. Secure Web Conference Corp.,
`IPR2014-00745, 2014 WL 4925718 (Sept. 29, 2014) .......................................... 6
`
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling
`USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) .......................................................................... 11
`
`ii
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`IPR2016-00286
`Patent 8,822,438
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`Statutes
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`35 U.S.C. § 282 ........................................................................................................ 12
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`35 U.S.C. § 311 ........................................................................................................ 12
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`35 U.S.C. § 311(b) ............................................................................................... 4, 10
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`35 U.S.C. § 314(a) ......................................................................................... 1, 2, 4, 6
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`Other Authorities
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`37 C.F.R. 42.71(c) .................................................................................................. 1, 5
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`37 C.F.R. § 42.108(c) ............................................................................................... 12
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`MPEP 716.01(b) ....................................................................................................... 13
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`iii
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`Patent Owner Janssen Oncology, Inc. (“Janssen”) hereby requests rehearing
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`pursuant to 37 C.F.R. § 42.71(c) of the Board’s decision to institute an inter partes
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`review of claims 1-20 of U.S. Patent No. 8,822, 438 (“the ‘438 patent”) (Paper No.
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`14) (“Decision”) on the basis that:
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`(1) the Decision overlooks the petitioner’s failure to proffer any evidence on
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`the necessary element of administering a “therapeutically effective amount of
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`prednisone,” as well as petitioner’s repeated admissions that this element, as
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`properly construed by the Board to require an anti-cancer effective amount of
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`prednisone, is neither taught nor suggested by the prior art; and
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`(2) the Decision fails to appropriately credit the Patent Office’s prior finding
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`of commercial success, instead inappropriately crediting petitioner’s declaration
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`refuting that finding, notwithstanding the statutory prohibition against instituting
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`an inter partes review based on anything other than prior art patents and
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`publications.
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`As a result of these errors, the Board fails to properly apply the standard set
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`forth in 35 U.S.C. § 314(a). Accordingly, the Board should grant rehearing and
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`decline to institute inter partes review of claims 1-20 of the ‘438 patent.
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`I.
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`SUMMARY
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`The inventors of the ‘438 patent discovered that the combination of
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`administering a therapeutically effective amount of prednisone together with a
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`1
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`therapeutically effective amount of abiraterone acetate would provide an
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`unexpectedly enhanced treatment for advanced prostate cancer, i.e., that such a
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`combined administration would have an unexpectedly superior anti-cancer effect
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`compared to the use of either agent administered alone.
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`Based on the express disclosure in the ‘438 patent, the Decision properly
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`construes each of the claims of the ‘438 patent to require administration of a
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`therapeutically effective anti-cancer amount of prednisone. Decision at 6-7. The
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`Decision properly construes the claim element “a therapeutically effective amount
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`of prednisone” to be “an amount of prednisone effective for treating prostate
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`cancer.” Id. The Decision further properly construes the terms “treat,” “treating”
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`and “treatment” to “include the eradication, removal, modification, management or
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`control of a tumor or primary, regional, or metastatic cancer cells or tissue and the
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`minimization or delay of the spread of cancer.” Decision at 5. As such, the
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`Decision recognizes that each challenged claim of the ‘438 patent requires use of
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`“an amount of prednisone effective for eradicate[ing], remov[ing], modif[ying],
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`manag[ing] or control[ing] … a tumor or primary, regional or metastatic cancer
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`cells or tissue and … minimiz[ing] or delay[ing] … the spread of cancer,” i.e. an
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`anti-cancer effective amount of prednisone.
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`Having so construed the claims, this proceeding may not be instituted unless
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`the Board concludes that the petitioner has shown that it is likely to prevail in
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`2
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`demonstrating at trial that the prior art relied upon teaches or suggests an anti-
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`cancer effective amount of prednisone co-administered with an anti-cancer
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`effective amount of abiraterone acetate.
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`But the Board’s Decision does not, and indeed cannot, do so. The Decision
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`points to no prior art or other evidence proffered by petitioner that demonstrates
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`that such an anti-cancer effect of prednisone was ever known, suggested or in any
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`way obvious at the time of the ‘438 invention. Nor could it have. First, it is
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`undisputed that the prior art does not show that co-administration of prednisone
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`with abiraterone acetate had ever taken place prior to the ‘438 invention. Even
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`more importantly, as petitioner advocated (and thus admitted) multiple times,
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`before the priority date of the ‘438 patent, when prednisone was administered with
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`other anti-cancer drugs, it was solely for the purpose of treating potential side
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`effects of those drugs, and that “it was known that prednisone was not effective as
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`an anti-cancer agent for treating prostate cancer.” Petition at 14. Neither petitioner
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`nor the Board point to any prior art teaching which suggests that prednisone has an
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`anti-cancer effect on the prostate cancer.1 Accordingly, the Decision fails to apply
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`1 Nor does the mention by the Board that “co-administration of prednisone and
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`abiraterone acetate” would be “safe and effective” fill this void because it does not
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`3
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`the standard set forth in 35 U.S.C. § 314(a), which requires demonstration of a
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`reasonable likelihood that petitioner would prevail with respect to at least one
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`challenged claim.
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`As to Point 2, the Decision errs in weighing the petitioner’s declaration
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`relating to commercial success (Ex. 1017), as such a declaration is not of the kind
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`permitted to form the basis of a petition under 35 U.S.C. § 311(b). Because
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`Section 311(b) limits petitions to grounds “only on the basis of prior art consisting
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`of patents or printed publications,” petitioner’s commercial success declaration
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`should have been ignored, and the Board should have accorded full credit to the
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`PTO’s prior determination that the invention underlying the ‘438 patent is
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`commercially successful. As such, the Board erred in its conclusion that “[b]ased
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`on the record before us, we determine that Patent Owner’s evidence of secondary
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`considerations is insufficient to preclude trial.”
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`II. LEGAL STANDARDS
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`An inter partes review may not be instituted “unless…there is a reasonable
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`likelihood that the petitioner would prevail with respect to at least 1 of the claims
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`challenged in the petition.” 35 U.S.C. § 314(a).
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`address the claim limitation requiring an anti-cancer effective amount of
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`prednisone. Decision at 9-10.
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`4
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`Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a
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`panel will review the decision for an abuse of discretion.” 37 C.F.R. 42.71(c). An
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`abuse of discretion exists “if a decision is based on an erroneous interpretation of
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`law, if a factual finding is not supported by substantial evidence, or if the decision
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`represents an unreasonable judgment in weighing relevant factors.” Arnold P’ship
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`v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); citing In re Gartside, 203 F.3d
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`1305, 1315-16 (Fed. Cir. 2000).
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`III. ARGUMENT
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`a. The Decision to Institute Ignores Petitioner’s Admissions that
`the Prior Art Does Not Teach or Suggest the Claim Element
`“A Therapeutically Effective Amount of Prednisone”
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`Independent claim 1 of the ‘438 patent recites “a therapeutically effective
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`amount of prednisone.” The remaining claims challenged by petitioner, claims 2-
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`20, depend from claim 1. Thus, every challenged claim requires administering “a
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`therapeutically effective amount of prednisone.” Patent Owner Preliminary
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`Response at 16-17; Ex. 1001 at Col. 16-17.
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`In assessing whether petitioner has demonstrated a reasonable likelihood of
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`prevailing on its obviousness challenge of claims 1-20, the Board is required to
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`“consider all claim limitations when determining patentability of an invention over
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`the prior art.” In re Lowry, 32 F.3d 1579, 1582 (Fed. Cir. 1994); see also In re
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`Glass, 472 F.2d 1388, 1392 (C.C.P.A. 1973) (“It is error to ignore specific
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`limitations distinguishing over the references.”); Medtronic, Inc. v. Nuvasive, Inc.,
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`IPR2013-00504, 2014 WL 1253033, at *4-5 (Feb. 13, 2014); Microsoft Corp. v.
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`Secure Web Conference Corp., IPR2014-00745, 2014 WL 4925718, at *9 (Sept.
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`29, 2014); Coal. for Affordable Drugs V LLC v. Biogen MA Inc., IPR2015-01136,
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`2015 WL 5169256, at *6 (Sept. 2, 2015).
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`Therefore, in keeping with its claim construction, in order to conclude that
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`petitioner had demonstrated a reasonable likelihood of prevailing in its
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`obviousness challenge under 35 U.S.C. § 314(a), the Board was required to
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`determine if petitioner is likely to show at trial that the prior art patents and
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`publications relied upon teach or suggest the claimed co-administration including a
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`“therapeutically effective amount of abiraterone acetate,” and, separately, “an
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`amount of prednisone effective for treating [i.e., having an anti-cancer effect on]
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`prostate cancer.” Petitioner’s characterization of the claimed invention as
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`requiring nothing more than “co-administration of prednisone with abiraterone
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`[sic]” and finding an alleged expectation of a “safe and effective” treatment of
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`prostate cancer in the prior art (see, e.g., Decision at 8-10, 11, 13, 15) is
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`inconsistent with the Board’s claim construction because it reads out of the claims
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`entirely the requirement that the prednisone have an anti-cancer effect.
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`Stated differently, the Board was required to determine whether petitioner
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`has identified with particularity evidence supporting that “a skilled artisan would
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`have had a reasonable expectation that…[prednisone] would succeed in being
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`therapeutically effective.” In re Cyclobenzaprine Hydrochloride, 676 F.3d 1063,
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`1070 (Fed. Cir. 2012); see also Coalition for Affordable Drugs V LLC v. Biogen
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`MA Inc., IPR2015-01136, Decision Denying Institution of Inter Partes Review
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`(Sept. 2, 2015) at *4-*6.
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`But the Board’s Decision makes no such determination and indeed does not
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`address this issue. This is not surprising since petitioner never proffered any
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`evidence on this point. To the contrary, petitioner repeatedly argued that a skilled
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`artisan would not expect prednisone to have a therapeutic anti-cancer effect.
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`Specifically the Board fails to consider petitioner’s own admissions, which vitiate
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`a finding that the prior art teaches or suggests a “therapeutically effective amount
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`of prednisone” as that limitation was construed by the Board. Petitioner’s
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`submission openly admits – and Janssen fully agrees – that the prior art did not
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`teach “a therapeutically effective amount of prednisone” and that a person of
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`ordinary skill in the art would not have any expectation that prednisone had a
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`therapeutic, anti-cancer effect for the treatment of prostate cancer. See Petition at
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`14, 22-23, 27, 53; Ex. 1002 at ¶ 74. Indeed, the following admissions made by the
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`petitioner are overlooked and not considered by the Board:
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` “at the time of filing of the ‘438 patent, it was known that prednisone
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`was not effective as an anti-cancer agent for prostate cancer,”
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`Petition at 14 (emphasis added);
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` “it was known [in the prior art] that co-administering a glucocorticoid
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`such as prednisone with a CYP17 inhibitor was…not to enhance an
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`anti-cancer benefit,” Petition at 22-23 (emphasis added);
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` “[o]ne of skill in the art would therefore have appreciated that the co-
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`administration of prednisone with abiraterone [acetate] was not
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`intended to enhance the anti-cancer effect of abiraterone,” Petition at
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`27 (emphasis added); and
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` “one of skill would not expect the administration of the combination
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`of abiraterone acetate and prednisone to provide any additional
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`clinically significant anti-cancer benefit in treating prostate cancer
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`beyond the anti-cancer benefit obtained from the administration of
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`abiraterone acetate.” Petition at 53 (emphasis added).
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`The Board’s Decision to institute inter partes review relies on Dr. Serels’
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`declaration concerning “the knowledge of those of ordinary skill in the art at the
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`time of the invention” and “to demonstrate the presence of those elements [not
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`found in the prior art].” Decision at 10, 14. Petitioner’s expert Dr. Serels,
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`however, does just the opposite. He expressly confirms that the knowledge of one
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`of ordinary skill in the art would not supply a key claim element missing in the
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`prior art – the therapeutic anti-cancer effect of prednisone when administered
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`together with a therapeutically effective amount of abiraterone acetate. Indeed, Dr.
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`Serels expressly swears that this missing element would not be within the
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`knowledge of one of ordinary skill in the art. His declaration states that the prior
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`art did not teach or suggest “a therapeutically effective amount of prednisone” as
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`required by claims 1-20 of the ‘438 patent. Dr. Serels squarely admits that “in my
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`clinical experience, I would not expect that the addition of prednisone to a
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`treatment for prostate cancer that includes abiraterone [acetate] would result in any
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`clinically significant enhancement of the anti-cancer or anti-tumor effect… of
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`treatment.” Ex. 1002 at ¶ 74 (emphasis added).
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`Instead Dr. Serels states that it was known in the art that prednisone’s
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`contribution to ketoconazole treatment regimens was “to improve symptoms and/or
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`quality of life” and “to improve the safety and enhance the tolerability of
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`[ketoconazole] treatment.” Ex. 1002 at ¶ 68; see also id. at ¶ 34. But these
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`opinions and Dr. Serels’ understanding of the teachings of the prior art references
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`relied upon by petitioner and the knowledge of the person of skill in the art do not
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`satisfy the claim limitation “a therapeutically effective amount of prednisone”
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`because they ignore the portion of the Board’s claim construction that requires that
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`the prednisone have a therapeutic anti-cancer effect for treating prostate cancer. As
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`a result, Dr. Serels’ statements do not support the Board’s conclusion that
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`petitioner has met its burden of showing a reasonable likelihood of prevailing with
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`respect to at least one challenged claim because.
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`In sum, the undisputed evidence – which the Decision fails to address –
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`establishes that the prior art fails to teach or suggest a necessary element of claims
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`1-20 of the ‘438 patent. Petitioner has not and cannot demonstrate a reasonable
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`likelihood of prevailing on its obviousness challenge with respect to at least one
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`challenged claim. Accordingly, the Board must deny inter partes review as to each
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`ground of invalidity advanced in the petition as a matter of law.
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`b. The Board Fails to Credit the Patent Office’s Prior
`Determination of Commercial Success and Petitioner’s
`Admission of Unexpected Results
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`Congress established inter partes review proceedings to be proceedings of
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`limited scope that could be instituted only on Section 102 or 103 grounds, and then
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`only on the basis of prior art patents or publications. Inter partes reviews are thus
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`limited by statute in their scope, and not intended as vehicles to allow challenges of
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`other determinations made by the PTO during the original patent examination. 35
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`U.S.C. § 311(b). In this case, the PTO previously determined that the invention of
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`the ‘438 patent was commercially successful, citing that determination repeatedly
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`in the Examiner’s reasons for allowance. Patent Owner’s Preliminary Response at
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`48-49; Ex. 1013; Ex. 1014; Ex. 1015. And contrary to the Decision’s suggestion,
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`the preexisting record establishing commercial success is complete insofar as the
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`PTO issued three separate Notices of Allowance acknowledging the commercial
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`success of the patented invention as a basis for issuing the claims of the ‘438
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`patent. Decision at 15; Ex. 1013; Ex. 1014; Ex. 1015.
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`The Examiner’s decision to grant the claims of the ‘438 patent is supported
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`by the Federal Circuit standards governing an obviousness determination. In re
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`Kao, 639 F.3d 1057, 1067 (Fed. Cir. 2011) (“To start, when secondary
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`considerations are present, though they are not always dispositive, it is error not to
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`consider them.”); Transocean Offshore Deepwater Drilling, Inc. v. Maersk
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`Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012) (“Objective evidence of
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`nonobviousness is an important component of the obviousness inquiry because
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`‘evidence of secondary considerations may often be the most probative and cogent
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`evidence in the record. It may often establish that an invention appearing to have
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`been obvious in light of the prior art was not.’”).
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`Nonetheless, the petition now before this Board is erroneously grounded in
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`part on an attack against the PTO’s prior commercial success determination. In
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`doing so, petitioner misleadingly argues that “most importantly…any commercial
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`success of Zytiga® is not shown to derive from the claimed invention” and, with
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`rhetorical sleight of hand, attempts to persuade the Board that the finding of
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`commercial success should be discounted because there is allegedly “no evidence
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`to suggest that the claimed invention, rather than the prior art abiraterone acetate,
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`was responsible for any commercial success of Zytiga®,” when the un-rebutted
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`evidence of record establishes that Zytiga® is approved only for concomitant use
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`with prednisone. Patent Owner Preliminary Response at 49-50; Ex. 1018; Ex.
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`1065. Moreover, the contentions advanced by petitioner do not meet the standard
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`for rebutting a finding of nexus in the commercial success context, and this does
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`not meet petitioner’s burden to demonstrate that there is “a reasonable likelihood
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`that at least one of the claims challenged in the petition is unpatentable” as
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`required by 37 C.F.R. § 42.108(c) for institution of an inter partes review. 2 Patent
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`Owner Preliminary Response at 50-51. The presumption of validity under 35
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`U.S.C. § 282 carries with it a presumption that the Examiner did his duty and knew
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`what claims he was allowing. Al-Site Corp. v. VSI Int’l, Inc., 174 F.3d 1308, 1323
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`(Fed. Cir. 1999). As part of his assessment of patentability, “the examiner must
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`2 Even assuming, arguendo, that the McDuff Declaration (Ex. 1017) and the
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`exhibits he cites are properly considered evidence, which they cannot be because,
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`inter alia, they are not “prior art consisting of patents or printed publications” as
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`required by 35 U.S.C. § 311, Dr. McDuff’s assessment of the nexus between the
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`commercial success of ZYTIGA® and the patented invention focuses on Patent
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`Owner’s alleged lack of evidence of nexus. Ex. 1017 at ¶ 32-35.
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`determine whether there is a nexus between the merits of the claimed invention and
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`the evidence of secondary considerations.” MPEP 716.01(b). The Examiner made
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`a full assessment of Patent Owner’s evidence of commercial success, which
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`necessarily includes an assessment of nexus, and found the evidence to support the
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`nonobviousness and patentability of the ‘438 patent claims.
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`As for unexpected results, the petitioner has repeatedly admitted that the
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`inventors’ discovery of the therapeutic anti-cancer effects of prednisone when used
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`in combination with a therapeutically effective amount of abiraterone acetate for
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`treating prostate cancer were unexpected and no further fact finding is needed.
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`Patent Owner’s Preliminary Response at 47-48; Ex. 1002 at ¶ 74.
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`IV. CONCLUSION
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`For the foregoing reasons, the Board should grant Patent Owner’s request
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`for reconsideration and deny institution of an inter partes review of claims 1-20 of
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`the ‘438 patent based on Amerigen’s Petition.
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`Date: June 14, 2016
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`Respectfully submitted,
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`By: /Dianne B. Elderkin/
`Dianne B. Elderkin (Lead Counsel)
`Reg. No. 28,598
`Barbara L. Mullin (Back-up Counsel)
`Reg. No. 38,250
`Ruben H. Munoz (Back-up Counsel)
`Reg. No. 66,998
`AKIN GUMP STRAUSS HAUER
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`& FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel.: (215) 965-1340
`Fax: (215) 965-1210
`
`David T. Pritikin (pro hac vice)
`Bindu Donovan (pro hac vice)
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
`
`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 RECONSIDERATION PURSUANT TO 37
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`C.F.R. § 42.71(c) was served on counsel of record on June 14, 2016 by filing this
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`document through the Patent Review Processing System, as well as delivering a
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`copy via electronic mail to counsel of record for the Petitioner at the following
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`William Hare
`Gabriela Materassi
`McNeeley Hare & War LLP
`bill@miplaw.com
`materassi@miplaw.com
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`Respectfully submitted,
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`By: /Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
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`addresses:
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`Date: June 14, 2016
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