`
`
`
`Paper No. ___
`
`Date Filed: Jan. 31, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`AMERIGEN PHARMACEUTICALS LIMITED and
`ARGENTUM PHARMACEUTICALS LLC
`
`Petitioners
`
`v.
`
`JANSSEN ONCOLOGY, INC.
`Patent Owner
`________________
`
`Case IPR2016-002861
`Patent No. 8,822,438 B2
`________________
`
`PATENT OWNER’S IDENTIFICATION OF NEW ARGUMENTS AND
`EVIDENCE IN PETITIONERS’ REPLY
`
`
`
`
`1 Case IPR2016-01317 has been joined with this proceeding.
`
`
`
`IPR2016-00286
`U.S. Patent 8,822,438
`
`
`
`
`Pursuant to the Board’s January 26, 2017 Order (Paper 68), Patent Owner
`
`Janssen Oncology, Inc. hereby submits an itemized list of what Patent Owner
`
`considers to be new arguments and evidence raised in Petitioners’ Reply, including
`
`paragraphs of the declarations of Drs. Ratain (Ex. 1091) and Dorin (Ex. 1093), as
`
`specifically identified below.
`
`1. New Argument and Evidence Regarding Motivation to Combine based
`on “Combined Congenital CYP 17 Deficiency”
`
`a. Pet. Reply, p. 4, l. 13 - p. 5, l. 3
`
`b. Pet. Reply, p. 10, l. 20 - p. 11, l. 5
`
`c. Ex. 1093 ¶¶ 15-19, 34-35, 61, 66
`
`2. New Arguments and Evidence Regarding Motivation to Combine Based
`on Adrenal Insufficiency, Concurrent Stress, or Adrenal Crisis
`
`a. Pet. Reply, p. 3, l. 20 - p. 4, l. 3
`
`b. Pet. Reply, p. 7, ll. 12-16
`
`c. Pet. Reply, p. 8, l. 7 - p. 9, l. 9
`
`d. Pet. Reply, p. 12, ll. 4-8
`
`e. Ex. 1091 ¶¶ 30, 35, 39; Ex. 1093 ¶¶ 20-24, 31-32, 36, 47-49, 53-54, 56,
`
`59-60, 62, 69
`
`3. New Argument Regarding Prednisone’s Safety Profile
`
`a. Pet. Reply, p. 10, ll. 5-13
`
`b. Ex. 1093 ¶ 30
`
`
`
`1
`
`
`
`IPR2016-00286
`U.S. Patent 8,822,438
`
`4. New Argument Regarding Glucocorticoids as Effective Anti-Cancer
`Agents
`
`a. Pet. Reply, p. 12, ll. 15-17
`
`b. Pet. Reply, p. 14, FN4
`
`c. Pet. Reply, p. 15, ll. 1-10
`
`d. Pet. Reply, p. 16, ll. 1-8
`
`e. Pet. Reply, p. 17, l. 5 - p. 18, l. 17
`
`f. Ex. 1091 ¶¶ 42-47, 54, 59-61, 63
`
`
`
`
`
`
`
`Dated: January 31, 2017
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`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)
`Bindu Donovan (pro hac vice)
`Paul J. Zegger (Reg. No. 33,821)
`Todd L. Krause (Reg. No. 48,860)
`
`2
`
`
`
`
`
`
`IPR2016-00286
`U.S. Patent 8,822,438
`
`
`
`
`
`
`
`S. Isaac Olson (pro hac vice)
`Alyssa B. Monsen (pro hac vice)
`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
`
`
`
`3
`
`
`
`IPR2016-00286
`U.S. Patent 8,822,438
`
`CERTIFICATE OF SERVICE
`
`
`
`The undersigned hereby certifies that a copy of the foregoing Patent
`
`Owner’s Identification of New Arguments and Evidence in Petitioner’s Reply was
`
`served on counsel of record on January 31, 2017 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 Petitioner and Patent Co-Owner at the following addresses:
`
`William Hare - bill@miplaw.com
`Gabriela Materassi - materassi@miplaw.com
`
`Teresa Stanek Rea - TRea@Crowell.com
`Shannon M. Lentz - SLentz@Crowell.com
`
`Anthony C. Tridico - anthony.tridico@finnegan.com
`Jennifer H. Roscetti - jennifer.roscetti@finnegan.com
`
`
`
`
`
`Date: Jan. 31, 2017
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`
`
`4
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
