ELECTRONIC FILING
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Application of: Jerome B. Zeldis
`
`Continuation No.: 4802
`
`Serial No.: 10/438,213
`
`Filed: May 15, 2003
`
`For: METHODS FOR TREATMENT OF
`MULTIPLE MYELOMA USING 3-
`(4-AMINO-1-0X0-1,3-DIHYDRO-
`ISOINDOL-2-YL)-PIPERIDINE-2,6-
`DIONE (AS AMENDED)
`
`Group Art Unit: 1612
`
`Examiner: Simmons, Chris E.
`
`Attorney Docket No.: 9516-074-999
`(CAM: 501872-999073)
`
`RESPONSE AND STATEMENT OF INTERVIEW SUMMARY
`
`Mail Stop Amendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`In response to Office Action dated August 3, 2010, and further to Examiner
`interview held on November 29, 2010 and to Interview Summary dated December 1, 2010,
`Applicant submits the following amendment and remarks for the consideration by the
`Examiner and entry into the record of the above-captioned application. Submitted herewith
`is Supplemental Information Disclosure Statement with fee, and Petition for extension of
`term from November 3, 2010 to and including January 3, 2011 with fee.
`
`The listing of the claims begins on page 2 of this paper.
`Remarks begin on page 4 of this paper.
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`This listing of claims will replace all prior versions, and listings, of claims in the
`
`application:
`Listing of the Claims:
`
`Claims 1-23. (canceled)
`
`24. (currently amended) A method of treating multiple myeloma, which comprises
`
`cyclically administering to a patient having multiple myeloma about 5 to about [[50]] 25 mg
`
`per day of a compound of the formula:
`
`NH2
`
`or a pharmaceutically acceptable salt thereof, for 21 consecutive days followed by seven
`
`consecutive days of rest from administration of said compound during a 28 day cycle, and a
`
`therapeutiealiy effeetive-amount-ef-clexametliasene cyclically administering about 40 mg
`
`per day of dexamethasone during said 28 day cycle.
`
`25. (canceled)
`26. (previously presented) The method of claim 24, wherein the multiple myeloma
`
`is smoldering myeloma, indolent myeloma, chemotherapy responsive multiple myeloma,
`refractory myeloma, relapsed myeloma, or relapsed and refractory Dune-Salmon stage III
`multiple myeloma.
`
`27-28. (canceled)
`
`29. (previously presented) The method of claim 24, wherein the compound is a
`
`pharmaceutically acceptable salt.
`
`30-56. (canceled)
`
`57. (previously presented) The method of claim 24, wherein the multiple myeloma
`
`is relapsed, refractory or resistant to conventional therapy.
`
`58. (previously presented) The method of claim 24, wherein the compound and
`
`dexamethasone are administered orally.
`
`59. (previously presented) The method of claim 58, wherein the compound is
`
`administered in the form of a capsule or tablet.
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`60. (previously presented) The method of claim 24, wherein the compound is
`administered in an amount of from about 10 to about 25 mg per day.
`61. (currently amended) The method of claim 24, wherein the compound is
`administered in an amount of about 5, 10, 20, or 25, 30, or 50 mg per day.
`62. (canceled)
`63. (previously presented) The method of claim 60, wherein the compound is
`administered in an amount of about 25 mg per day.
`64-70. (canceled)
`71. (previously presented) The method of claim 24, wherein the compound is
`administered in an amount of 5 mg per day.
`72. (previously presented) The method of claim 60, wherein the compound is
`administered in an amount of 10 mg per day.
`73. (previously presented) The method of claim 24, wherein the compound is
`administered in a capsule of 5 mg, 10 mg, 15 mg or 25 mg.
`74. (canceled)
`75. (previously presented) A method of treating multiple myeloma, which
`comprises administering, on a 28 day cycle, to a patient having multiple myeloma:
`(a) about 25 mg per day of a compound of the formula:
`
`NH2
`
`or a pharmaceutically acceptable salt thereof, for 21 consecutive days followed by
`seven consecutive days of rest from administration of said compound, and; (b) about 40 mg
`per day of dexamethasone on days 1-4 every 28 days.
`76-79. (canceled)
`80. (previously presented) The method of claim 73, wherein the capsule comprises
`the compound, lactose anhydrous, microcrystalline cellulose, croscarmellose sodium and
`magnesium stearate.
`8 I . (canceled)
`82. (new) The method of claim 24, wherein said dexamethasone is administered on
`days 1 to 4.
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`I.
`
`REMARKS
`Applicant's Statement of the Substance of Interview and
`Response to the Examiner's Interview Summary of Record
`
`A telephonic interview with Supervisory Patent Examiner Frederick Krass, Patent
`Examiner Chris E. Simmons, and attorneys for Applicant (Anthony M. Insogna and Yeah-
`Sil Moon), was held on November 29, 2010. Applicant appreciates the Examiner interview.
`During the interview, the Examiners and attorneys for Applicant discussed the
`amendment to the claims and the pending rejections.
`First, the Examiners and attorneys for Applicant discussed claim amendment
`proposal that was submitted to the PTO by a fax on November 22, 2010. Attorneys for
`Applicant pointed out that all the obviousness rejections should be withdrawn in view of
`previous arguments submitted on March 9, 2010, and in view of the further amendments
`submitted herewith.
`In particular, attorneys for Applicant explained that Kyle et al. (Semin. Oncol.,
`2001), Davies et al. (Blood, 2001) and Corral et al. (Ann. Rheum. Dis., 1999), alone or in
`combination with other cited references, fail to suggest the claimed methods, which require
`the use of 3-(4-amino-l-oxo-1,3-dihydro-isoindo1-2-y1)-piperidine-2,6-dione and
`dexamethasone for treating multiple myeloma in specific amounts and specific dosing
`regimens.
`Further, attorneys for Applicant stressed that the obviousness rejections of record
`also can be overcome by unexpected results of the claimed invention. Attorneys for
`Applicant discussed articles previously submitted to evidence unexpected results of the
`claimed invention. See e.g, Gay, Blood, 2010: 115, 1343-1350, which was filed with March
`9, 2010 response. In addition, attorneys for Applicant explained that the claimed method as
`amended relates to an FDA approved use of lenalidomide (product named Revlimid®)
`(Exhibit 1 filed with March 9, 2010 response). This method has resulted in one of the
`newest and most effective treatments available for multiple myeloma. Finally, attorneys for
`Applicant stated that the commercial success of this approved use supports non-obviousness
`of the claimed invention (Exhibits 3-4 filed with March 9, 2010 response).
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`In view of the foregoing, all the outstanding rejections over the cited references are
`moot and the case should proceed to allowance.
`Conclusion
`II.
`
`Entry of the above amendment and remarks, and allowance of the pending claims
`are respectfully requested.
`
`Date:
`
`December 7 , 2010
`
`Respectfully sub tted,
`
`Yeah-Sil M on (Reg. No. 52,042)
`For Anthon M. Insogna (Reg. No. 35,203)
`JONES DAY
`222 East 41st Street
`New York, NY 10017
`Tel. (212) 326-3778
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