Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 1 of 522 PageID #:
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`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 2 of 522 PageID #:
`3009
`
`JA00001454
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 3 of 522 PageID #:
`3010
`
`JA00001455
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 4 of 522 PageID #:
`3011
`
`JA00001456
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 5 of 522 PageID #:
`3012
`
`JA00001457
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 6 of 522 PageID #:
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`3092
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`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 128 of 522 PageID #:
`3135
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant:
`
`Mass, Robert D.
`
`Docket No.:
`
`GNE-0330 D2C 1
`
`Serial No.:
`
`11/942,449
`
`Group A1i Unit:
`
`1642
`
`Filing Date:
`
`11/19/2007
`
`Examiner:
`
`Goddard, Laura B.
`
`Customer No.
`
`35489
`
`Confirmation No.
`
`1617
`
`For:
`
`DETECTION OF ErbB2 GENE AMPLIFICATION TO INCREASE
`THE LIKELIHOOD OF THE EFFECTIVENESS OF ErbB2
`ANTIBODY BREAST CANCER THERAPY
`
`FILED VIA EFS -NOVEMBER 29, 2010
`
`SUPPLEMENTAL AMENDMENT AND RESPONSE TO OFFICE ACTION
`
`MS:AF
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`In response to the Office Action mailed on June 23, 2010 in connection with the above(cid:173)
`
`identified patent application, setting a three-month shortened statutory term for response,
`
`please enter the following Supplemental Amendment and consider the following arguments. A
`
`Notice of Appeal was filed on November 23, 2010, and an Advisory Action was mailed on
`
`November 24, 2010.
`
`Amendments to the claims begin on page .£ of this paper.
`
`Remarks/ Arguments begin on page ~ of this paper.
`
`30708610vl
`
`1
`Supplemental Response to Office Action Dated June 23, 2010
`U.S. Patent Application No. 11/942,449
`Attorney Docket No. GNE-0330-D2Cl
`
`JA00001580
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 129 of 522 PageID #:
`3136
`
`Amendments to the Claims:
`
`This listing of claims replaces all prior listings, and versions, of claims in this
`
`application.
`
`1.
`
`(Currently amended) A method for increasing likelihood of effectiveness of
`
`breast cancer treatment with humanized anti-ErbB2 antibody huMAb4D5-8, which method
`
`comprises administering a cancer treating dose of said antibody to a human subject diagnosed
`
`with breast cancer, wherein an erbB2 gene amplification in breast cancer cells in a tissue
`
`sample from the subject has been detected, and wherein the breast cancer cells from the human
`subject has-have been found to have a 0 or 1 + score of ErbB2 protein expression by
`
`immunohistochemistry.
`
`2-3.
`
`(Canceled)
`
`4.
`
`(Currently amended) The method according to claim 1, wherein the breast
`
`cancer cells from the human subject has-have been found to have a 0 or 1+ score ofErbB2
`
`protein expression by immunohistochemistry on a formaldehyde-fixed tissue sample.
`
`5-6.
`
`(Canceled)
`
`7.
`
`(Previously presented)
`
`The method according to claim 1 wherein the
`
`erbB2 gene amplification is detected by detecting fluorescence of a fluorescent-labeled nucleic
`
`acid probe hybridized to the gene.
`
`8.
`
`9.
`
`(Canceled)
`
`(Original)
`
`The method according to claim 1, which further comprises
`
`administering a cancer treating dose of a chemotherapeutic drug.
`
`10.
`
`(Previously presented)
`
`The method according to claim 9, wherein the
`
`chemotherapeutic drug is a taxoid.
`
`30708610vl
`
`2
`Supplemental Response to Office Action Dated June 23, 2010
`U.S. Patent Application No. 11/942,449
`Attorney Docket No. GNE-0330-D2Cl
`
`JA00001581
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 130 of 522 PageID #:
`3137
`
`11.
`
`(Original)
`
`The method according to claim 1 wherein the likelihood of
`
`effectiveness increases by about 30%.
`
`12-17. (Canceled)
`
`30708610vl
`
`3
`Supplemental Response to Office Action Dated June 23, 2010
`U.S. Patent Application No. 11/942,449
`Attorney Docket No. GNE-0330-D2Cl
`
`JA00001582
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 131 of 522 PageID #:
`3138
`
`Remarks/Arguments
`
`Claims 1, 4, 7, and 9-11 are pending in this application. Claims 1and4 have been
`
`amended. The amendments are of formal nature, are fully supported by the specification as
`
`originally filed, and do not add new matter. The amendments were made without prejudice or
`
`disclaimer. Applicants explicitly reserve the right to pursue any deleted or unclaimed subject
`
`matter in one or more continuing applications. According to the Advisory Action mailed on
`
`November 24, 2010 the amendments filed on October 25, 2010 will be entered for the purposes
`
`of an appeal. When making the present amendments, it is assumed that the amendments filed
`
`on October 25, 2010 have been entered.
`
`According to the Advisory Action, amendment of the claims to recite the 0or+1 score
`
`is found in breast cancer cells from the human subject would obviate their rejection under 35
`
`USC§ 112. Accordingly, in view of the current amendments the rejection under 35 U.S.C.
`
`§ 112, first paragraph should be withdrawn.
`
`As a result, the only remaining rejection will be the provisional rejection of claims 1, 4,
`
`7 and 9-11 on the ground of nonstatutory obviousness-type double patenting as allegedly being
`
`unpatentable over claims 1-6 of copending application no. 11/690,304. Since upon entry and
`
`consideration of the previous and present amendments and arguments this will be the only
`
`rejection remaining in the present case, the Examiner is respectfully requested to withdraw this
`
`rejection, and repeat it, if appropriate, in copending application 11/690,304.
`
`30708610vl
`
`4
`Supplemental Response to Office Action Dated June 23, 2010
`U.S. Patent Application No. 11/942,449
`Attorney Docket No. GNE-0330-D2Cl
`
`JA00001583
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 132 of 522 PageID #:
`3139
`
`Conclusion
`
`All claims pending in this application are believed to be in prima facie condition for
`
`allowance, and an early action to that effect is respectfully solicited.
`
`Although no fees are believed to be due at this time, the Commissioner is hereby
`
`authorized charge any fees due, including any fees for additional extension of time, or credit
`
`overpayment to Deposit Account 50-2387 (Attorney Docket No. GNE-0330D2Cl
`
`(24126.550)).
`
`Respectfully submitted,
`
`Date: November 29, 2010
`
`By Electronic Signature: /GINGER R. DREGER/
`Ginger R. Dreger, Esq., Reg. No. 33,055
`
`ARNOLD & PORTER LLP
`1400 Page Mill Road
`Palo Alto, CA 94304
`Telephone:+ 415-356-3000
`Facsimile:+ 415-356-3099 (fax)
`
`30708610vl
`
`5
`Supplemental Response to Office Action Dated June 23, 2010
`U.S. Patent Application No. 11/942,449
`Attorney Docket No. GNE-0330-D2Cl
`
`JA00001584
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 133 of 522 PageID #:
`3140
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`JA00001585
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`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 134 of 522 PageID #:
`3141
`
`JA00001586
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`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 135 of 522 PageID #:
`3142
`
`JA00001587
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`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 136 of 522 PageID #:
`3143
`
`JA00001588
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`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 137 of 522 PageID #:
`3144
`
`JA00001589
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 138 of 522 PageID #:
`3145
`
`JA00001590
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 139 of 522 PageID #:
`3146
`
`JA00001591
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 140 of 522 PageID #:
`3147
`
`JA00001592
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 141 of 522 PageID #:
`3148
`
`JA00001593
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 142 of 522 PageID #:
`3149
`
`JA00001594
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 143 of 522 PageID #:
`3150
`
`JA00001595
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 144 of 522 PageID #:
`3151
`
`JA00001596
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 145 of 522 PageID #:
`3152
`
`JA00001597
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 146 of 522 PageID #:
`3153
`
`JA00001598
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 147 of 522 PageID #:
`3154
`
`JA00001599
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 148 of 522 PageID #:
`3155
`
`JA00001600
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 149 of 522 PageID #:
`3156
`
`JA00001601
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 150 of 522 PageID #:
`3157
`
`JA00001602
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 151 of 522 PageID #:
`3158
`
`JA00001603
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 152 of 522 PageID #:
`3159
`
`JA00001604
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 153 of 522 PageID #:
`3160
`
`JA00001605
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 154 of 522 PageID #:
`3161
`
`JA00001606
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 155 of 522 PageID #:
`3162
`
`JA00001607
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 156 of 522 PageID #:
`3163
`
`JA00001608
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 157 of 522 PageID #:
`3164
`
`JA00001609
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 158 of 522 PageID #:
`3165
`
`JA00001610
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 159 of 522 PageID #:
`3166
`
`JA00001611
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 160 of 522 PageID #:
`3167
`
`JA00001612
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 161 of 522 PageID #:
`3168
`
`JA00001613
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 162 of 522 PageID #:
`3169
`
`JA00001614
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 163 of 522 PageID #:
`3170
`
`JA00001615
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 164 of 522 PageID #:
`3171
`
`JA00001616
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 165 of 522 PageID #:
`3172
`
`JA00001617
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`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 166 of 522 PageID #:
`3173
`
`JA00001618
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`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 167 of 522 PageID #:
`3174
`
`JA00001619
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`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 168 of 522 PageID #:
`3175
`
`JA00001620
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`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 169 of 522 PageID #:
`3176
`
`JA00001621
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 170 of 522 PageID #:
`3177
`
`JA00001622
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 171 of 522 PageID #:
`3178
`
`JA00001623
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 172 of 522 PageID #:
`3179
`
`JA00001624
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 173 of 522 PageID #:
`3180
`
`JA00001625
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 174 of 522 PageID #:
`3181
`
`JA00001626
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 175 of 522 PageID #:
`3182
`
`JA00001627
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 176 of 522 PageID #:
`3183
`
`JA00001628
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 177 of 522 PageID #:
`3184
`
`JA00001629
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 178 of 522 PageID #:
`3185
`
`JA00001630
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 179 of 522 PageID #:
`3186
`
`JA00001631
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 180 of 522 PageID #:
`3187
`
`JA00001632
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 181 of 522 PageID #:
`3188
`
`JA00001633
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 182 of 522 PageID #:
`3189
`
`JA00001634
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 183 of 522 PageID #:
`3190
`
`JA00001635
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 184 of 522 PageID #:
`3191
`
`JA00001636
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 185 of 522 PageID #:
`3192
`
`JA00001637
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 186 of 522 PageID #:
`3193
`
`JA00001638
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`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 187 of 522 PageID #:
`3194
`
`JA00001639
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`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 188 of 522 PageID #:
`3195
`
`JA00001640
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`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 189 of 522 PageID #:
`3196
`
`JA00001641
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`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed 12/11/18 Page 190 of 522 PageID #:
`3197
`
`JA00001642
`
`
`
`Case 1:18-cv-01363-CFC Document 48-5 Filed
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