Case 1:18-cv-01363-CFC Document 1-14 Filed 09/04/18 Page 1 of 20 PageID #: 525
`Case 1:18-cv-01363-CFC Document1-14
`Filed 09/04/18
`Page 1 of 20 PagelD #: 525
`
`
`
`EXHIBIT N
`EXHIBIT N
`
`
`
`

`

`Case 1:18-cv-01363-CFC Document 1-14 Filed 09/04/18 Page 2 of 20 PageID #: 526
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`Illll Mllll Ill Illll Illll Ill Illll Illll Illll Illll Illll Illlll Illl Illl Illl
`
`US008440402B2
`
`(12) nited States Patent
`Mass
`
`(10) Patent No.:
`(45) Date of Patent:
`
`S 8,440,402 B2
`*May 14, 2013
`
`(54)
`
`(75)
`
`(73)
`
`GENE DETECTION ASSAY FOR IMPROVING
`THE LIKELIHOOD OF AN EFFECTIVE
`RESPONSE TO A HER2 ANTIBODY CANCER
`THERAPY
`
`Inventor: Robert D. Mass, Mill Valley, CA (US)
`
`Assignee: Genentech, Inc., South San Francisco,
`CA (US)
`
`(*)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis-
`claimer.
`
`(21)
`
`Appl. No.: 13/323,322
`
`(22)
`(65)
`
`(63)
`
`(60)
`
`(51)
`
`(52)
`
`(58)
`
`(56)
`
`Filed:
`
`Dec. 12, 2011
`
`Prior Publication Data
`
`US 2012/0093838 A1
`
`Apr. 19, 2012
`
`Related U.S. Application Data
`
`Continuation of application No. 11/690,304, filed on
`Mar. 23, 2007, now Pat. No. 8,076,066, which is a
`continuation of application No. 09/863,101, filed on
`May 18, 2001, now abandoned.
`
`Provisional application No. 60/205,754, filed on May
`19, 2000.
`
`(2006.01)
`(2006.01)
`
`Int. CI.
`C12Q 1/68
`GO1N 33/5 74
`U.S. CI.
`USPC
`........................................... 435/6.1; 435/7.23
`Field of Classification Search ........................ None
`See application file for complete search history.
`
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`
`Primary Examiner Laura B Goddard
`
`(74) Attorney, Agent, or Firm Diane Marschang; Ginger
`R. Dreger; Arnold & Porter LLP
`
`(57)
`
`ABSTRACT
`
`The invention provides a method for more effective treatment
`of patients susceptible to or diagnosed with tumors overex-
`pressing HER2, as determined by a gene amplification assay,
`with a HER2 antibody. Such method comprises administer-
`ing a cancer-treating dose of the HER2 antibody, preferably
`in addition to chemotherapeutic agents, to a subject in whose
`tumor cells her2 has been found to be amplified e.g., by
`fluorescent in situ hybridization.
`
`6 Claims, No Drawings
`
`

`

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`

`Case 1:18-cv-01363-CFC Document 1-14 Filed 09/04/18 Page 4 of 20 PageID #: 528
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