Coalition for Affordable Drugs IV LLC - Exhibit 1017
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`

`
`Applicant : Joseph J. Buggy, et al.
`Serial No. : 13/340,522
`December 29, 2011
`Filed
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`AMENDMENTS TO THE CLAIMS
`
`Attorney's Docket No.: 25922-819.301
`Preliminary Amendment and Response to
`Restriction Requirement
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`Please amend claims 131, 132, and 134-144. Please cancel claims 130 and 133. Please add
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`new claims 145-149. This listing of claims replaces all prior versions and listings of claims in the
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`above-referenced patent application. The following amendments do not constitute an admission
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`regarding the patentability of the amended subject matter and should not be so construed.
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`Applicants reserve the right to pursue the subject matter of the canceled claims in this or any other
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`appropriate patent application. Deletions are denoted by [ striketh-rough] and additions are denoted
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`by underline.
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`Listing of Claims
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`1. -129. (Cancelled)
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`130.
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`(Canceled).
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`131.
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`(Currently Amended) A method for treating a relapsed or refractory hematological
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`malignancy in an individual comprising administering to the individual an inhibitor ofBruton's
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`tyrosine kinase (Btk).
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`13 2.
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`(Currently Amended) [ [A]] The method for trea-tiRg a of claim 131, wherein the relapsed or
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`refractory hematological malignancy is a relapsed or refractory non-Hodgkin's lymphoma ffi.-aR
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`iRdividual comprisiRg admiRisteriRg to the iRdividual aR iRhibitor of BrutoR's tyrosme kiRase (Btk).
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`133.
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`(Canceled).
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`134.
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`(Currently Amended) The method of aay of claims 130 LB claim 131, wherein the inhibitor
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`of Btk is administered orally.
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`135.
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`(Currently Amended) The method of aay of claims 130 133 claim 131, wherein the inhibitor
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`ofBtk is administered once per day, twice per day, or three times per day.
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`136.
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`(Currently Amended) The method of aay of claims 130 133 claim 131, wherein the inhibitor
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`of Btk is administered daily or every other day.
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`137.
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`(Currently Amended) The method of aay of claims 130 133 claim 131, further comprising
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`administering a second cancer treatment regimen.
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`138.
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`(Currently Amended) The method of claim [[138]] 137, wherein the second cancer treatment
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`regimen comprises bendamustine, bortezomib, CAL- I 01, chlorambucil, cyclophosphamide,
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`-2-
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`

`
`Applicant : Joseph J. Buggy, et al.
`Serial No. : 13/340,522
`December 29, 2011
`Filed
`
`Attorney's Docket No.: 25922-819.301
`Preliminary Amendment and Response to
`Restriction Requirement
`
`dexamethasone,docetaxel, doxorubicin, endostatineverolimus, etoposide, fludarabine, fostamatinib,
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`hydroxydaunorubicin, ibritumomab, ifosphamide, lenalidomide, mesalazine, ofatumumab,
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`paclitaxel, pentostatin, prednisone, rituximab, temsirolimus, thalidomide, tositumomab, vincristine,
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`or a combination thereof.
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`139.
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`(Currently Amended) The method of any of claims 130 133 claim 131, wherein the amount
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`of the inhibitor ofBtk is between 1.25 -17.5 mg/kg/day.
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`140.
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`(Currently Amended) The method of claim [[133]] 131, wherein >95% of the Btk is
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`occupied by the inhibitor of Btk at 4 hours post dose.
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`141.
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`(Currently Amended) The method of any of claims 130 133 claim 131, wherein the inhibitor
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`of Btk is an irreversible inhibitor of Btk.
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`142. Currently Amended) The method of any of elaims 130 133 claim 131, wherein the inhibitor
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`of Btk forms a covalent bond to a Btk.
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`143.
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`(Currently Amended) The method of any of claims 130 133 claim 131, wherein the inhibitor
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`of Btk forms a covalent bond to a cysteine sidechain of a Bruton's tyrosine kinase (Btk).
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`144.
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`(Currently Amended) The method of Glaim claim 143, wherein the cysteine sidechain of the
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`Btk is cysteine 481.
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`145.
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`(New) The method of claim 131, wherein the inhibitor ofBtk is a compound having the
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`structure
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`'\,N
`N
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`l)~
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`0
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`146. The method of claim 132, wherein the relapsed or refractory non-Hodgkin's lymphoma is a
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`relapsed or refractory diffuse large B-cell lymphoma (DLBCL), relapsed or refractory mantle cell
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`lymphoma (MCL), relapsed or refractory follicular lymphoma (FL), relapsed or refractory chronic
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`-3-
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`

`
`Applicant : Joseph J. Buggy, et al.
`Serial No. : 13/340,522
`December 29, 2011
`Filed
`
`Attorney's Docket No.: 25922-819.301
`Preliminary Amendment and Response to
`Restriction Requirement
`
`lymphocytic leukemia (CLL), relapsed or refractory small lymphocytic leukemia (SLL), or relapsed
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`or refractory multiple myeloma (MM).
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`147.
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`(New) A method for treating a relapsed or refractory non-Hodgkin's lymphoma in an
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`individual comprising administering to the individual an inhibitor of Bruton's tyrosine kinase (Btk),
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`having the structure
`
`~,N
`N
`
`()~
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`0
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`148.
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`(New) The method of claim 147, wherein the relapsed or refractory non-Hodgkin's
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`lymphoma is a relapsed or refractory diffuse large B-cell lymphoma (DLBCL), relapsed or
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`refractory mantle cell lymphoma (MCL), or relapsed or refractory follicular lymphoma (FL),
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`relapsed or refractory chronic lymphocytic leukemia (CLL), relapsed or refractory small
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`lymphocytic leukemia (SLL), or relapsed or refractory multiple myeloma (MM).
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`149.
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`(New) A method for treating a relapsed or refractory mantle cell lymphoma in an individual
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`comprising administering to the individual an inhibitor of Bruton's tyrosine kinase (Btk), having the
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`structure
`
`~,N
`N
`
`l)~
`
`0
`
`-4-
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`

`
`Applicant : Joseph J. Buggy, et al.
`Serial No. : 13/340,522
`December 29, 2011
`Filed
`
`Attorney's Docket No.: 25922-819.301
`Preliminary Amendment and Response to
`Restriction Requirement
`
`REMARKS
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`Any fees that may be due in connection with the filing of this paper or with this application
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`may be charged to Deposit Account No. 23-2415. If a Petition for Extension of time is needed, this
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`paper is to be considered such Petition.
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`Claims 131, 132, and 134-149 are pending. Claims 131, 132, and 134-144 are amended.
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`Claims 130 and 133 are canceled. New claims 145-149 are added. Claim 131 is amended to
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`provided proper antecedent basis for now dependent claim 132. Basis for the amendment can be
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`found, for example, in paragraphs [0004], [0047], and [0171], in the specification as filed. Claim
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`132 is amended to depend from claim 131. Claims 134-143 are amended to correct claim
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`dependency. Claim 144 is amended to correct a typographical error. Basis for new claims 144-149
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`can be found in the application and claims as originally filed. No new matter is added.
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`Restriction Requirement
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`The Examiner has required restriction among the following groups.
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`Group I: Claims 130, 133-146 directed towards a method for treating a
`lymphoma in an individual comprising administering to the individual an inhibitor
`ofBruton's tyrosine kinase (Btk), wherein the lymphoma is a Cutaneous B-Cell
`Lymphoma, Cutaneous Marginal Zone Lymphoma (MZL), Diffuse Mixed Small
`and Large Cell Lymphoma, Diffuse Small Cleaved Cell, Diffuse Small
`Lymphocytic Lymphoma, Endemic Burkitt's lymphoma, Follicular Large Cell
`(Grade 3), Follicular Mixed Small Cleaved and Large Cell (Grade 2), Follicular
`Small Cleaved Cell (Grade 1), immunoblastic large cell lymphoma, indolent
`lymphoma, intravascular large B cell lymphoma, Intravascular Lymphomatosis,
`Large Cell Immunoblastic Lymphoma, Large Cell Lymphoma (LCL), low-grade
`small B-cell lymphoma Lymphoblastic Lymphoma, lymphoplasmocytic
`lymphoma, Mediastinal Large B-Cell Lymphoma, precursor B-Iymphoblastic
`lymphoma, primary central nervous system (CNS) lymphoma, primary
`mediastinal B-cell lymphoma, or Sporadic Burkitt's Lymphoma, further
`comprising a second cancer treatment (claim 138) and dosage regimen ..
`Group II: Claims 131, 133-144, 147, and 148 directed towards a method
`for treating a refractory hematological malignancy in an individual comprising
`administering to the individual an inhibitor of Bruton's tyrosine kinase (Btk).
`Group III: Claims 131, 133-144, 149, and 150 directed towards a method
`for treating a relapsed or refractory non-Hodgkin's lymphoma in an individual
`comprising administering to the individual an inhibitor ofBruton's tyrosine kinase
`(Btk).
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`-5-
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`

`
`Applicant : Joseph J. Buggy, et al.
`Serial No. : 13/340,522
`December 29, 2011
`Filed
`
`Attorney's Docket No.: 25922-819.301
`Preliminary Amendment and Response to
`Restriction Requirement
`
`Applicants hereby elect with traverse Group II. Claims 131, 132, and 134-149, as
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`presented herein, read on the elected Group.
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`Applicants respectfully traverse the restriction requirement as between Group II and Group
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`III claims. Applicants submit that a relapsed or refractory non-Hodgkin's lymphoma is a species of
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`relapsed or refractory hematological malignancy. The claims Group III overlap and are
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`encompassed by the genus relapsed or refractory hematological malignancy. Thus, the claims of
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`Group II are not patentably distinct from the claims of Group III. For clarity, Applicants have
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`amended claim 132 to depend from claim 131. Accordingly, claims 131, 132, and 134-149 as
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`presented herein read on elected Group II. Withdrawal of restriction requirement as between Group
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`II and Group III respectfully is requested.
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`Election of Species
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`The Examiner has requested that Applicants restrict the application to one of the following
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`species under 35 U.S.C. §§ 121:
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`(1)
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`(2)
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`(3)
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`Btk inhibitor
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`type of lymphoma
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`second cancer treatment agent
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`Applicants hereby elect for search purposes (1) the species of Btk inhibitor having the
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`structure:
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`(2) the species oflymphoma that is mantle cell lymphoma (MCL), and (3) the species of second
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`cancer agent that is rituximab. Applicants respectfully note that claims 131, 132, 134-136, and 139-
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`144 do not require administration of a second cancer agent.
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`-6-
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`

`
`Applicant : Joseph J. Buggy, et al.
`Serial No. : 13/340,522
`December 29, 2011
`Filed
`
`Attorney's Docket No.: 25922-819.301
`Preliminary Amendment and Response to
`Restriction Requirement
`
`CONCLUSION
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`Applicants respectfully solicit the Examiner to expedite prosecution of this patent application
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`to issuance. Should the Examiner have any questions, the Examiner is encouraged to telephone the
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`undersigned at (858) 350-2306. The Commissioner is hereby authorized to charge any additional
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`fees that may be required, or credit any overpayment to Deposit Account No. 23-2415 (Attorney
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`Docket No. 25922-819.301).
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`Respectfully submitted,
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`WILSON SONSINI GOODRICH & ROSATI
`Professional Corporation
`
`/Michael Hostetler/
`By:
`Michael J. Hostetler, Ph.D.
`Reg. No. 47,664
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`Date: February 4, 2013
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`650 Page Mill Road
`Palo Alto, CA 94304
`Direct Dial: (858) 350-2306
`Customer No. 021971
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