Case 1:18-cv-01363-CFC Document 1-13 Filed 09/04/18 Page 1 of 20 PageID #: 505
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`Case 1:18-cv-01363-CFC Document1-13_Filed 09/04/18 Page 1 of 20 PagelD #: 505
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`
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`EXHIBIT M
`EXHIBIT M
`
`
`
`

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`Case 1:18-cv-01363-CFC Document 1-13 Filed 09/04/18 Page 2 of 20 PageID #: 506
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`Illll Mllll Ill Illll Illll Ill Illll Illll Illll Illll IM IMI Illl Illl Illl
`
`US008076066B2
`
`(12) nited States Patent
`Mass
`
`(10) Patent No.:
`(45) Date of Patent:
`
`S 8,076,066 B2
`*Dec. 13, 2011
`
`(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.: 11/690,304
`
`(22) Filed:
`
`Mar. 23, 2007
`
`(65)
`
`Prior Publication Data
`
`US 2007/0166753 A1
`
`Jul. 19, 2007
`
`5,726,023 A
`5,728,687 A
`5,736,137 A
`5,747,261 A
`5,770,195 A
`5,772,997 A
`5,776,427 A
`5,783,186 A
`5,783,404 A
`5,801,005 A
`5,804,396 A
`5,821,337 A
`5,824,311 A
`5,834,229 A
`5,837,243 A
`5,837,523 A
`5,840,525 A
`5,846,538 A
`5,846,749 A
`5,856,089 A
`5,856,110 A
`5,859,206 A
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`5,876,712 A
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`
`Related U.S. Application Data
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`FOREIGN PATENT DOCUMENTS
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`
`(60) Provisional application No. 60/205,754, filed on May
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`
`EP
`EP
`EP
`EP
`EP
`
`(51) Int. Cl.
`(2006.01)
`C12Q 1/68
`GO1N 33/5 74
`(2006.01)
`(52) U.S. CI ............................................ 435/6; 435/7.23
`(58) Field of Classification Search ........................ None
`See application file for complete search history.
`
`(56)
`
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`Primary Examiner Laura B Goddard
`(74) Attorney, Agent, orFirm Diane Marshang; 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
`
`

`

`Case 1:18-cv-01363-CFC Document 1-13 Filed 09/04/18 Page 3 of 20 PageID #: 507
`
`US 8,076,066 B2
`Page 2
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`U.S. PATENT
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`

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