Reply to Office Action of November 27, 2017
`
`Application No. 15/121,623
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`- 12 -
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`GEUIJEN er a].
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`comprising: administering to the subject the antibody of claim 1 or the pharmaceutical
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`composition of claim 35.
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`37-39.
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`(Canceled)
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`40.
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`(Withdrawn and Previously Presented) A method for the treatment of a subject having a
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`ErbB-2, ErbB-3 or ErbB-2/ErbB-3 positive tumor or at risk of having the tumor, the method
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`comprising:
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`administering to the subject:
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`- the bispecif1c antibody of claim 1, and
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`- one or more compounds selected from the group consisting of an inhibitor of a
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`component of the PI3Kinase pathway, an inhibitor of a component of the MAPK pathway, a
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`microtubule disrupting drug and an HDAC inhibitor.
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`41-48.
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`(Canceled).
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`49.
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`(Withdrawn and Previously Presented) A method for counteracting the formation of a
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`metastasis in a subject having a ErbB-2, ErbB-3 or ErbB-2/ErbB-3 positive tumor, wherein
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`the ErbB-2, ErbB-3 or ErbB-2/E.rbB-3 positive tumor cell has a heregulin expression level
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`that is at least 60 of the heregulin expression level of BXPC3 or MCF7 cells, the method
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`comprising:
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`administering to the subject the bispecif1c antibody of claim 1.
`
`50-57.
`
`(Canceled)
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`58.
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`(Currently Amended) The bispecif1c antibody of claim 11, wherein the affinity (KD) of the
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`second binding arm antigen—bmd-i-ng—si-te for an ErbB-3 positive cell is lower than or equal to
`
`1.39 nM.
`
`Atty. Dkt. No. 4096.0100002/DAS/PAC/E-H
`
`
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`Reply to Office Action of November 27, 2017
`
`Application No. 15/121,623
`
`- 13 -
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`GEUIJEN er a].
`
`59.
`
`60.
`
`61.
`
`62.
`
`63.
`
`64.
`
`65.
`
`66.
`
`67.
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`(Currently Amended) The bispecific antibody of claim 11, wherein the affinity (KD) of the
`
`second binding arm antigen—bmdi—ng—si—te for an ErbB-3 positive cell is lower than or equal to
`
`0.99 nM.
`
`(Currently Amended) The bispecific antibody of claim 12, wherein the affinity (KD) of the
`
`first binding arm antigen—bmdi—ng—si—te for an ErbB-2 positive cell is lower than or equal to
`
`4.5 nM.
`
`(Currently Amended) The bispecific antibody of claim 12, wherein the affinity (KD) of the
`
`first binding arm antigen—bmd-i-ng—si-te tor an ErbB-2 positive cell is lower than or equal to
`
`4.0 nM.
`
`(Previously Presented) The bispecific antibody of claim 13, wherein the affinity of the
`
`bispecific antibody for SK-BR 3 cells is lower than or equal to 3.0 nM.
`
`(Previously Presented) The bispecific antibody of claim 13, wherein the affinity of the
`
`bispecific antibody for SK-BR 3 cells is lower than or equal to 2.0 nM.
`
`(Previously Presented) The bispecific antibody of claim 13, wherein the affinity of the
`
`bispecific antibody for BT-474 cells is lower than or equal to 4 nM.
`
`(Previously Presented) The bispecific antibody of claim 64, wherein the affinity of the
`
`bispecific antibody for SK-BR 3 cells is lower than or equal to 3.0 nM.
`
`(Previously Presented) The bispecific antibody of claim 64, wherein the affinity of the
`
`bispecific antibody for SK-BR 3 cells is lower than or equal to 2.0 nM.
`
`(Previously Presented) The bispecific antibody of claim 13, wherein the affinity of the
`
`bispecific antibody for BT-474 cells is lower than or equal to 3.2 nM.
`
`Atty. Dkt. No. 4096.0100002/DAS/PAC/E-H
`
`
`
`Reply to Office Action of November 27, 2017
`
`Application No. 15/121,623
`
`- l4 -
`
`GEUIJEN er a].
`
`68.
`
`69.
`
`70.
`
`71.
`
`72.
`
`73.
`
`74.
`
`75.
`
`76.
`
`77.
`
`(Previously Presented) The bispecific antibody of claim 67, wherein the affinity of the
`
`bispecific antibody for SK-BR 3 cells is lower than or equal to 3.0 nM.
`
`(Previously Presented) The bispecific antibody of claim 67, wherein the affinity of the
`
`bispecific antibody for SK-BR 3 cells is lower than or equal to 2.0 nM.
`
`(Previously Presented) The bispecific antibody of claim 33, wherein the germline light chain
`
`is a rearranged germline human kappa light chain comprising the IgVKl-39 gene segment
`
`(Previously Presented) The bispecific antibody of claim 33, wherein the germline light
`
`chain is a rearranged germline human kappa light chain IgVKI-39*01/IGJK1*01.
`
`(Previously Presented) The method according to claim 40, wherein at least one of the one or
`
`more compounds is selected from the group consisting of a tyrosine kinase inhibitor, a
`
`PI3Ka inhibitor, an Akt inhibitor, an mTOR inhibitor, an Src inhibitor, vorinostat and
`
`paclitaxel.
`
`(Previously Presented) The method according to claim 49, wherein the heregulin expression
`
`level is at least 70% of the heregulin expression level of BxPC-3 or MCF7 cells.
`
`(Previously Presented) The method according to claim 49, wherein the heregulin expression
`
`level is at least 80% of the heregulin expression level of BxPC-3 or MCF7 cells.
`
`(Previously Presented) The method according to claim 49, wherein the heregulin expression
`
`level is at least 85% of the heregulin expression level of BxPC-3 or MCF7 cells.
`
`(Previously Presented) The method according to claim 49, wherein the heregulin expression
`
`level is at least 90% of the heregulin expression level of BxPC-3 or MCF7 cells.
`
`(Previously Presented) The method according to claim 49, wherein the heregulin expression
`
`level is at least 95% of the heregulin expression level of BxPC-3 or MCF7 cells.
`
`Atty. Dkt. No. 4096.0100002/DAS/PAC/E-H
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