Case 1:18-cv-00924-CFC-SRF Document 3-1 Filed 06/21/18 Page 1 of 330 PageID
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`EXHIBIT O
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`

`

`(12) Ulllted States Patent
`Mass
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 7,993,834 B2
`Aug. 9, 2011
`
`US007993834B2
`
`(54) DETECTION OF ERBB2 GENE
`AMPLIFICATION TO INCREASE THE
`LIKELIHOOD OF THE EFFECTIVENESS OF
`ERBB2 ANTIBODY BREAST CANCER
`THERAPY
`
`.
`(75) Inventor: Robert D. Mass, Mill Valley, CA (US)
`
`(73) 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(1)) by 276 days_
`
`_
`(21) APPl' NO" 11/942’449
`_
`(22) Flledi
`
`Nov- 19, 2007
`
`(65)
`
`prior publication Data
`
`US 2008/0112958 A1
`
`May 15, 2008
`
`Related US. Application Data
`
`On
`Continuation Of
`May 26, 2006, noW abandoned, Which is a division of
`application No. 09/863,101, ?led on May 18, 2001,
`noW abandoned.
`
`EP
`
`3/1998 Cheever et a1.
`5,726,023 A
`3/1998 Bissery
`5,728,687 A
`‘V1998 Anderson et a1‘
`5,736,137 A
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`i
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`(Continued)
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`0 332 865 A2
`9/1989
`(Continued)
`
`OTHER PUBLICATIONS
`
`(60)
`
`(51)
`
`(52)
`(58)
`
`(56)
`
`Provisional application No. 60/205,754, ?led on May
`19, 2000.
`
`Int. Cl.
`(2006.01)
`C12Q 1/68
`(2006.01)
`G01N 33/5 74
`US. Cl. ......................................... .. 435/6; 435/7.23
`
`Field of Classi?cation Search ...................... .. None
`See application ?le for complete search history.
`
`References Cited
`
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`#: 706
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`(Continued)
`
`Primary Examiner * Laura B Goddard
`(74) Attorney, Agent, or Firm * Arnold & Porter LLP;
`Diane Marschang; Ginger R. Dreger
`
`ABSTRACT
`
`(57)
`The invention provides a method for more effective treatment
`of patients susceptible to or diagnosed With tumors overex
`pressing ErbB, as determined by a gene ampli?cation assay,
`With an ErbB antagonist. Such method comprises adminis
`tering a cancer-treating dose of the ErbB antagonist, prefer
`ably in addition to chemotherapeutic agents, to a subject in
`Whose tumor cells ErbB has been found to be ampli?ed e. g.,
`by ?uorescent in situ hybridization. ErbB antagonists
`described include an anti-HER2 antibody. Pharmaceutical
`packaging for providing the components for such treatment is
`also provided.
`
`6 Claims, N0 Drawings
`
`

`

`US 7,993,834 B2
`Page 2
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`US. PATENT DOCUMENTS
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`JP
`5;
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`W0
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`2007/0166753 A1* 7/2007 Mass ............................... .. 435/6
`Case 1:18-cv-00924-CFC-SRF Document 3-1 Filed 06/21/18 Page 3 of 330 PageID
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`FOREIGN PATENT DOCUMENTS
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`EP
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`EP
`EP
`EP
`EP
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`JP
`JP
`JP
`JP
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`0616 812 B1
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`0 412116
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`0 711 565
`0 554 441
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`1 006 194
`0444 181
`3-240498
`5-117165
`5-170667
`5-213775
`
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`

`

`US 7,993,834 B2
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`
`

`

`US 7,993,834 B2
`Page 4
`
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