?- -7~ oc;
`
`/ bit',,,
`"O' l.'
`EXPRESS MAIL NO. EV475140930US ~u)
`
`IN THE UNITED ST ATES PATENT AND TRADEMARK OFFICE
`
`Application of: Jerome B. Zeldis
`
`Group Art Unit: 1614
`
`Serial No.:
`
`10/411,649
`
`Examiner: To be assigned
`
`Filed: April 11, 2003
`
`For: METHODS OF USING AND
`COMPOSITIONS COMPRISING
`IMMUNOMODULATORY
`COMPOUNDSFORTHETREATMENT
`AND MANAGEMENT OF
`MYELOYDYSLP ASTIC SYNDROMES
`
`Attorney Docket No.: 501872-999071
`(Formerly 9516-072-999)
`
`PRELIMINARY AMENDMENT
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Prior to examination on the merits, please enter the following amendments and
`
`remarks into the file of the above-captioned application.
`
`Amendments to the Claims are reflected in the listing of the claims that begins on
`
`page 2 of this paper.
`
`Remarks begin on page 4 of this paper.
`
`Page 1 of 4
`
`NYJD: 1524637.5
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 1
`
`

`

`This listing of claims will replace all prior versions, and listings, of claims in the
`
`application:
`
`Listing of the Claims:
`
`Claims 1-38. (canceled without prejudice)
`
`39. (new) A method of treating a myelodysplastic syndrome, which comprises
`
`administering to a patient in need thereof a therapeutically effective amount of a compound
`
`of formula (I):
`
`(I)
`
`or a pharmaceutically acceptable salt, solvate or stereoisomer thereof, wherein one of X and
`Y is C=O, the other of X and Y is C=O or CH2, and R2 is hydrogen or lower alkyl.
`
`40. (new) The method of claim 39, wherein R2 is hydrogen.
`
`41. (new) The method of claim 39, wherein the compound has formula (I):
`
`(I)
`
`wherein one of X and Y is C=O, the other of X and Y is C=O or CH2 • and R2 is hydrogen
`or lower alkyl.
`
`42. (new) The method of claim 39, wherein the compound is a pharmaceutically
`
`acceptable salt.
`
`43. {new) The method of claim 39, wherein the compound is a pharmaceutically
`
`acceptable solvate.
`
`44. (new) The method of claim 39, wherein the compound is a pharmaceutically
`
`acceptable stereoisomer.
`
`Page 2 of 4
`
`NYJD: 1524637.5
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 2
`
`

`

`45. (new) The method of claim 44, wherein the stereoisomer is an enantiomerically
`
`pure R isomer.
`
`46. (new) The method of claim 44, wherein the stereoisomer is an enantiomerically
`
`pure S isomer.
`
`47. (new) The method of claim 39, wherein the compound is 4-(amino)-2-(2,6-
`
`dioxo(3-piperidyl) )-isoindoline-1,3-dione.
`
`48. (new) The method of claim 39, wherein the compound is 3-(4-amino-
`
`1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione.
`
`49. (new) The method of claim 39, which further comprises administering a
`
`·'
`
`therapeutically or prophylactically effective amount of a second active agent.
`
`50. (new) The method of claim 49, wherein the second active agent is capable of
`
`improving blood cell production.
`
`51. (new) The method of claim 49, wherein the second active agent is a cytokine,
`
`hematopoietic growth factor, an anti-cancer agent, an antibiotic, a proteasome inhibitor, or
`
`an immunosuppressive agent.
`
`52. (new) The method of claim 51, wherein the second active agent is etanercept,
`
`imatinib, anti-TNF-a antibodies, infliximab, G-CSF, GM-CSF, EPO, topotecan,
`
`pentoxifylline, ciprofloxacin, irinotecan, vinblastine, dexamethasone, IL2, IL8, IL18, Ara(cid:173)
`
`C, vinorelbine, isotretinoin, 13-cis-retinoic acid, arsenic trioxide or a pharmacologically
`
`active mutant or derivative thereof.
`
`53.'(new) The method of claim 39, wherein the myelodysplastic syndrome is
`
`refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess
`
`blasts, refractory anemia with excess blasts in transformation, or chronic myelomonocytic
`
`leukemia.
`
`54. (new) The method of claim 39, wherein the compound or a pharmaceutically
`
`acceptable salt, solvate or stereoisomer thereof is administered before, during or after
`
`transplanting umbilical cord blood, placental blood, peripheral blood stem cell,
`
`hematopojetic stem cell preparation or bone marrow in the patient.
`
`Page 3 of 4
`
`NYJD: 1524637.5
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 3
`
`

`

`REMARKS
`
`New claims 39-54 appear in the application for the Examiner's consideration.
`
`Claims 1-38 have been canceled without prejudice to Applicant's right to pursue them in
`
`one or more continuations, divisionals or continuations-in-part. The new claims are
`
`supported by canceled claims 1-38 and the originally filed specification. No new matter has
`
`been added.
`
`No fee is believed due for this Preliminary Amendment. However, if a fee is due,
`
`please charge such fee to Jones Day Deposit Account No. 503013.
`
`Date
`
`July 7, 2004
`
`Respectfully submitted,
`
`Y eahsil ~ (Reg. No. 52,042)
`Jones Day
`222 East 41 st Street
`New York, New York 10017
`
`For: Anthony M. Insogna
`Jones Day
`12750 High Bluff Drive, Suite 300
`San Diego, CA 92130
`
`(Reg. No. 35,203)
`
`Page4 of 4
`
`NYJD: 1524637.5
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 4
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`UNJTED STATES DEPARTMENT O COMMERCE
`United States Patent and Trademarli Office
`Address: COMMISSIONER FOR PA TENTS
`P.O. Box 1450
`Alc:wulria, Virginia 22313-1450
`www.uspto.gov
`
`I ATTORNEY DOCKET NO. I CONFIRMATION NO.
`
`10/411,649
`
`04/11/2003
`
`Jerome B. Zeldis
`
`501872-999071
`
`9157
`
`7590
`20583
`JONES DAY
`222 EAST 41 ST ST
`NEW YORK, NY 10017
`
`03/09/2005
`
`EXAMINER
`
`KIM, VICKIE Y
`
`ART UNIT
`
`1614
`
`PAPER NUMBER
`
`DA TE MAILED: 03/09/2005
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`PT0-90C (Rev. 10/03)
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 5
`
`

`

`'
`
`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`10/411,649
`
`Examiner
`
`ZELDIS, JEROME B.
`
`Art Unit
`
`1614
`Vickie Kim
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 1 MONTH(S) FROM
`THE MAILING DATE OF THIS COMMUNICATION.
`- Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely.
`-
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)0 Responsive to communication(s) filed on __ .
`2a)O This action is FINAL.
`2b)l2sl This action is non-final.
`3)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11,453 O.G. 213.
`
`Disposition of Claims
`
`4)12sl Claim(s) 39-54 is/are pending in the application.
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)0 Claim(s) __ is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)0 The specification is objected to by the Examiner.
`10)0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85{a).
`
`Replacement drawing sheet(s) induding the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`11 )0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
`
`Priority under 35 U.S.C. § 119
`
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some * c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ :
`3.0 Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`*Seethe attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`1) l2sJ Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) l2sJ Information Disclosure Statement(s) (PT0-1449 or PTO/SB/08)
`Paper No(s)/Mail Date 5 & 11/2004.
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 1-04)
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) D Notice of Informal Patent Application (PT0-152)
`6) 0 Other: __ .
`
`.....
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20050302
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 6
`
`

`

`Application/Control Number: 10/411,649
`Art Unit: 1614
`
`Page2
`
`DETAILED ACTION
`
`Claims 39-54 are pending and presented for examination
`
`Information Disclosure Statement(IDS)
`
`The information disclosure statement (IDS) is submitted on May 04,2004 and
`
`Nov. 12, 2004. The submission is in compliance with the provisions of 37 CFR 1.97.
`
`Accordingly, the information disclosure statement is being considered by the examiner.
`
`Please refer to applicants' copy of the 1449 submitted herewith.
`
`Claim Rejections - 35 USC§ 102
`
`1.
`
`The following is a quotation of the appropriate paragraphs .of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless -
`
`(e) the invention was described in (1) an application for patent, published under section 122(b), by
`another filed in the United States before the invention by the applicant for patent or (2) a patent
`granted on an application for patent by another filed in the United States before the invention by the
`applicant for patent, except that an international application filed under the treaty defined in section
`351 (a) shall have the effects for purposes of this subsection of an application filed in the United States
`only if the international application designated the United States and was published under Article 21 (2)
`of such treaty in the English language.
`
`2.
`
`Claims 39-54 are rejected under 35 U.S.C. 102(e) as being anticipated by Hariri
`
`et al(US2003/0235909) or Stein (US 2004/0067953).
`
`The claims are drawn to a method of treating a myelodysplastic syndrome using
`
`a therapeutically effective amount of a compound of formula (i) as recited in claim 39.
`
`a.
`
`Hariri et al(US'909, hereinafter) teach use of immunomodulatory compound
`
`such as amino-substituted isoindolines(e.g. Actimid ™ or Revimid™) for treating various
`
`diseases including myelodysplasia, see paragraphs 268-269 & 271, especially working
`
`examples at pages 27-33. US'909 also teaches that the compound used in the patent
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 7
`
`

`

`Application/Control Number: 10/411,649
`Art Unit: 1614
`
`Page 3
`
`include racemic, stereomerically enriched and pure and pharmaceutically acceptable
`
`salts, solvates , hydrates, stereoisomers and prodrugs thereof including pure R-isomer
`
`and S-isomers, see paragraph 159.
`
`US'909 also teaches use of additional active agent such as G-CSF to induce
`
`stimulate the proliferation or propagation of embryonic stem cells, see paragraphs 202-
`
`209. Thus, all the critical elements are well taught by the cited reference and the
`
`claimed subject matter is not patentably distinct over the prior art of the invention.
`
`As to claim 54, US'909 teaches that the methods of the invention are
`
`administered to a subject followed by transplantation of the differentiated cells(e.g.
`
`hematopoietic stem cells) to said subject, see paragraph 107-109 at p·age 10.
`
`It is noted that Actimid™ or RevimidTM is potent immunomodulatory thalidomide
`
`analogs which is same compound required by the instant claims 47 or 48, respectively.
`
`ActimidTM:
`
`Revimid™:
`
`b.
`
`Stein et al (US'953, hereinafter) teach methods and compositions for the
`
`treatment of cancers(e.g. leukemia, myelodysplastic syndrome), see paragraphs 108
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 8
`
`

`

`.. ·
`
`Application/Control Number: 10/411,649
`Art Unit: 1614
`
`Page 4
`
`and 559. US'953 discloses a preferred patented composition comprises Actimid™ or
`
`Revimid™ in combination with JNK inhibitor.see paragraphs 108 and 553. Since
`
`US'953 particularly emphasizes the use of the combination of JNK inhibitor and
`
`Actimid™ or Revimid™ for the said treatment, for instance chronic myelogenous
`
`leukemia is treated by blocking transformation of hematopoietic cells, see paragraphs 8
`
`at page 2. All the critical elements required by the instant claims, for instance,
`
`Actimid™ or Revimid™ as first ai;;tive agent and JNK inhibitor(IL-2) as second active
`
`agent, are well taught by the cited references. US'953 teaches that the patented
`
`invention encompasses not only direct inhibitors but also indirect JNK inhib.itors such as
`
`IL-2 or TNF-.alpha. activity modulators, see paragraphs 6 and 87-88. Thus, the claimed
`
`subject matter is not patentably distinct over the prior art of the record.
`
`As mentioned earlier, Actimid™ or Revimid™ is potent immunomodulatory agent
`
`which is required by the instant claims 47 or 48, respectively.
`
`3.
`
`Claims 39-54 are rejected under 35 U.S.C. 102(a) as being anticip·ated by, or
`
`alternatively being obvious over Zeldis et al(WO 01/87307 A2).
`
`Zeldis et al (W0'307 hereinafter) teach treatment of cancer including
`
`leukemia(e.g. chronic myelocytic leukemia) using a composition comprising thalidomide,
`
`or salts, solvate, hydrate, clathrate, analogs and derivatives thereof(e.g. EM-12) and
`
`anticancer drugs such as topoisomerase inhibitors(e.g. topotecan or irinotecan), see
`
`abstract; example 3; page 4; page 12, lines 4-15 and page 14, lines 5-25, especially
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 9
`
`

`

`Application/Control Number: 10/411,649
`Art Unit: 1614
`
`Page 5
`
`example 3 at page 32. W0'307 further teaches pure diastereomers( optically pure or
`
`pure enantiomer), see page 11, lines 10-30
`
`As mentioned earlier in 102( e) rejection, it is well known in the art that Actimid ™
`
`or Revimid™ is potent immunomodulatory thalidomide analogs, and thus, the
`
`substitution of Actimid™ or Revimid™ would have been readily envisaged or obvious by
`
`the skilled artisan, see page 12, line 4. Use of R-and S- isomer is also readily
`
`envisaged by skilled artisan with the information provided by patentee and thus, the
`
`claimed subject matter is not patentably distinct over the prior of the record.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
`4.
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`unjustified or improper timewise extension of the "right to exclude" granted by a patent
`and to prevent possible harassment by multiple assignees. See In re Goodman, 11
`F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887,225
`USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F .2d 937, 214 USPQ 761 (CCPA
`1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970);and, In re Thorington,
`418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be
`used to overcome an actual or provisional rejection based on a nonstatutory double
`patenting ground provided the conflicting application or patent is shown to be commonly
`owned with this application. See 37 CFR 1.130(b ).
`·
`Effective January 1, 1994, a registered attorney or agent of record may sign a
`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with
`37 CFR 3. 73(b ).
`
`5.
`
`Claims 39-54 are provisionally rejected under the judicially created doctrine of
`
`obviousness-type double patenting as being unpatentable over claims 1-12 of
`
`copending Application No. 10/438213. Although the conflicting claims are not identical,
`
`they are not patentably distinct from each other because both applications relates to a
`
`method of treating myelodysplastic syndromes such as myeloplastic leukemia using the
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 10
`
`

`

`.. ,
`
`J'
`
`..
`
`Application/Control Number: 10/411,649
`Art Unit: 1614
`
`Page 6
`
`immunomodulatory compound having same general formula. Thus, the scope of the
`
`claims are substantially conflicting each other.
`
`This is a provisional obviousness-type double patenting rejection because the
`
`conflicting claims have not in fact been patented.
`
`Conclusion
`
`1.
`
`2.
`
`No claim is allowed.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Vickie Kim whose telephone number is 571-272-0579.
`
`The examiner can normally be reached on Tuesday-Friday.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Chris Low be reached on 571-272-0953. The fax phone number for the
`
`organization where this application or proceeding is assigned is 703-872-9306.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free).
`
`im
`Vic·
`March 3, 2005
`Art unit 1614
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 11
`
`

`

`EXPRESS MAIL NO.: EV475141419y
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Application of: Jerome B. Zeldis
`
`Serial No.:
`
`10/411,649
`
`Confirmation
`No.:
`Art Unit:
`
`9157
`
`1614
`
`Filed:
`
`For:
`
`April 11, 2003
`
`Examiner:
`
`Kim, Vickie Y
`
`Attorney Dkt No.: 9516-072-999
`(CAM: 501872-
`999071)
`
`METHODS OF USING
`IMMUNOMODULATORY
`COMPOUNDS FOR THE
`TREATMENT AND
`MANAGEMENT OF
`MYELOYDYSPLASTIC
`SYNDROMES (as amended)
`
`RESPONSE
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`Sir:
`
`In response to Office Action dated March 9, 2005, please consider and enter
`
`the amendments and remarks provided below into the file of the above-captioned application.
`
`Petition for extension of time is submitted herewith with authorization to charge any required
`
`fee to extend the time for a response for three months to and including September 9, 2005.
`
`Applicant submits concurrently herewith a Supplemental Information Disclosure Statement
`
`with authorization to charge any required fee.
`
`The Commissioner is hereby authorized to charge any required fees for extra
`
`claims to Jones Day Deposit Account No. 50-3013.
`
`Amendment to the Title begins on page 2 of this response.
`Amendments to the Claims are reflected in the listing of the claims that
`
`begins on page 3 of this paper.
`
`Remarks begin on page 8 of this paper.
`
`1
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 12
`
`

`

`Amendment to the Title:
`
`Please amend the title of the application as follows: METHODS OF USING
`
`A~JD CO:MJ>QSITI@JS COMPRISD>lG IMMUNOMODULATORY COMPOUNDS FOR
`
`THE TREATMENT AND MANAGEMENT OF MYELOYDYSPLASTIC SYNDROMES
`
`2
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 13
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`EXPRESS MAIL NO.: EV475141419US
`
`Application of:
`
`Zeldis
`
`Confirmation No.: 9157
`
`Application No: 10/411,649
`
`Group Art Unit: 1614
`
`Filed:
`
`April 11, 2003
`
`Examiner: Kim, Vickie Y
`
`For: METHODS OF USING
`IMMUNOMODULATORYCOMPOUNDS
`FOR THE TREATMENT AND
`MANAGEMENT OF MYELOYDYSLP ASTIC
`SYNDROMES (as amended)
`
`Jones Day Docket No.: 9516-072-999
`(CAM: 501872-999071)
`
`CLAIM FEE SHEET
`
`Mail Stop Amendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`For the prosecution of the subject application, Applicants hereby direct the
`
`Examiner's attention to the fact that claims 39 to 80 (1 independent claim and 41 dependent
`
`claims) are pending in the application after the entry of the amendment filed submitted
`
`herewith.
`
`The application fee sheet was submitted to charge the filing fee of $2,752 for total 69
`
`claims and 13 independent claims at the time of filing the application on April 11, 2003.
`
`Accordingly, no fee is believed to be due for the submission of the amendment to the claims.
`
`However, should any fee be required, please charge such fee to Jones Day Deposit Account
`
`No. 50-3013.
`
`Date: August 19, 2005
`
`Enclosures
`
`Respectfully submitted,
`
`Y e~ -
`For: Anthony M. Insogna
`JONES DAY
`222 East 41 st Street
`New York, New York 10017
`(212) 790-9090
`
`(Reg. No.)
`52,042
`35,203
`
`NYJD: 1588985.1
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 14
`
`

`

`Amendments to the Claims:
`This listing of claims will replace all prior versions, and listings, of claims in
`
`the application:
`
`Listing of the Claims:
`
`Claims 1-38 (canceled.)
`
`39. (previously presented) A method of treating a myelodysplastic syndrome, which
`
`comprises administering to a patient in need thereof a therapeutically effective amount of a
`
`compound of formula (I):
`
`(I)
`
`or a pharmaceutically acceptable salt, solvate or stereoisomer thereof, wherein one of X and
`Y is C=O, the other ofX and Y is C=O or CH2, and R2 is hydrogen or lower alkyl.
`
`40. (previously presented) The method of claim 39, wherein R2 is hydrogen.
`
`41. (currently amended) The method of claim 39, wherein the compound has,
`
`administered is a compound of the formula (I):
`
`(I)
`
`wherein one of X and Y is C=O, the other of X and Y is C=O or CH2 , and R 2 is hydrogen or
`lower alkyl.
`42. (previously presented) The method of claim 39, wherein the compound is a
`
`pharmaceutically acceptable salt.
`
`43. (previously presented) The method of claim 39, wherein the compound is a
`
`pharmaceutically acceptable solvate.
`
`44. (previously presented) The method of claim 39, wherein the compound is a
`
`pharmaceutically acceptable stereoisomer.
`
`3
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`DR. REDDY’S LABS., INC. EX. 1002 PAGE 15
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`

`

`45. (previously presented) The method of claim 44, wherein the stereoisomer is an
`
`enantiomerically pure R isomer.
`
`46. (previously presented) The method of claim 44, wherein the stereoisomer is an
`
`enantiomerically pure S isomer.
`
`47. (currently amended) The method of claim 39, wherein the compound is 4-
`
`( amino )-2-(2,6-dioxo(3-piperidyl) )-isoindoline-1,3-dione having the formula:
`
`48. ( currently amended) The method of claim 39, wherein the compound is
`
`3-( 4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione having the formula:
`
`49. (previously presented) The method of claim 39, which further comprises
`
`administering a therapeutically or prophylactically effective amount of a second active agent.
`
`50. (previously presented) The method of claim 49, the second active agent is capable
`
`of improving blood cell production.
`
`51. (previously presented) The method of claim 49, wherein the second active agent
`
`is a cytokine, hematopoietic growth factor, an anti-cancer agent, an antibiotic, a proteasome
`
`inhibitor, or an immunosuppressive agent.
`
`52. (previously presented) The method of claim 51, wherein the second active agent
`
`is etanercept, imatinib, anti-TNF-a antibodies, infliximab, G-CSF, GM-CSF, EPO, topotecan,
`
`pentoxifylline, ciprofloxacin, irinotecan, vinblastine, dexamethasone, IL2, IL8, IL 18, Ara-C,
`
`vinorelbine, isotretinoin, 13-cis-retinoic acid, arsenic trioxide or a pharmacologically active
`
`mutant or derivative thereof.
`
`4
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`DR. REDDY’S LABS., INC. EX. 1002 PAGE 16
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`

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`53. (previously presented) The method of claim 39, wherein the myelodysplastic
`
`syndrome is refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia
`
`with excess blasts, refractory anemia with excess blasts in transformation, or chronic
`
`myelomonocytic leukemia.
`
`54. (previously presented) The method of claim 39, wherein the compound or a
`
`pharmaceutically acceptable salt, solvate or stereoisomer thereof is administered before,
`
`during or after transplanting umbilical cord blood, placental blood, peripheral blood stem
`
`cell, hematopoietic stem cell preparation or bone marrow in the patient.
`
`55. (new) The method of claim 52, wherein the second active agent is dexamethasone.
`
`56. (new) The method of claim 39, wherein the patient is not previously treated for a
`
`myelodysplastic syndrome.
`
`57. (new) The method of claim 39, wherein the patient has been previously treated for
`
`a myelodysplastic syndrome.
`
`58. (new) The method of claim 39, 47 or 48, wherein the compound is administered in
`
`an amount of from about 0.10 to about 150 mg per day.
`
`59. (new) The method of claim 47, wherein the compound is administered in an
`
`amount of from about 0.10 to about 1 mg per day.
`
`60. (new) The method of claim 47, wherein the compound is administered in an
`
`amount of about 5 mg every other day.
`
`61. (new) The method of claim 39, wherein the compound is administered orally.
`
`62. (new) The method of claim 61, wherein the compound is administered in the form
`
`of a capsule or tablet.
`
`63. (new) The method of claim 39, wherein the compound is administered cyclically.
`
`64. (new) The method of claim 63, wherein the compound is administered once or
`
`twice every day for sixteen or twenty-four weeks.
`
`65. (new) The method of claim 63, wherein one cycle comprises the administration of
`
`the compound and at least one, two, or three weeks of rest.
`
`5
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`DR. REDDY’S LABS., INC. EX. 1002 PAGE 17
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`

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`66. (new) The method of claim 63, wherein the number of cycle is from one to twelve
`
`cycles.
`
`67. (new) The method of claim 63, wherein 3-(4-amino-1-oxo-1,3-dihydro(cid:173)
`
`isoindol-2-yl)-piperidine-2,6-dione is administered in an amount of from about 5 to about 25
`
`mg per day for 21 days every 28 days for sixteen or twenty-four weeks.
`
`68. (new) The method of claim 43 wherein said solvate is a hydrate.
`
`69. (new) The method of claim 39 wherein R2 is hydrogen and X and Y are C = 0.
`
`70. (new) The method of claim 39 wherein R2 is hydrogen and one ofX and Y are
`C = 0 and the other is CH2.
`
`71. (new) The method of claim 48, wherein the compound is administered in an
`
`amount of from about 0.10 mg per day to about 25 mg per day.
`
`72. (new) The method of claim 48, wherein the compound is administered in an
`
`amount of from about 0.10 mg per day to about 150 mg per day.
`
`73. (new) The method of claim 48, wherein the compound is administered in an
`
`amount of from about 5 mg per day to about 25 mg per day.
`
`74. (new) The method of claim 48, wherein the compound is administered in an
`
`amount of 10 mg per day.
`
`75. (new) The method of claim 48, wherein the compound is administered in an
`
`amount of 15 mg per day.
`
`76. (new) The method of claim 48, wherein the compound is administered in an
`
`amount of 25 mg per day.
`
`77. (new) The method of claim 48, wherein the compound is administered in an
`
`amount of from about 25 mg every other day to about 50 mg every other day.
`
`78. (new) The method of claim 48, wherein the compound is administered in a cycle
`
`of about 16 weeks and about once or twice every day.
`
`79. (new) The method of claim 78, wherein said cycle comprises at least one (1), two
`
`(2), or three (3) weeks of rest.
`
`6
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`DR. REDDY’S LABS., INC. EX. 1002 PAGE 18
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`

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`80. (new) The method of claim 48, wherein the compound is administered in an
`
`amount of IO mg per day or 15 mg per day for 21 days out of a block of 28 days.
`
`7
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`DR. REDDY’S LABS., INC. EX. 1002 PAGE 19
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`

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`REMARKS
`
`Amendments to the Title and Claims
`
`The title of the application has been amended to more accurately reflect the
`
`subject matter of the present claims. Claims 47-48 have been amended to clearly define the
`
`subject matter of the invention. New claims 55-80 have been added. The new claims are
`
`supported by the originally filed specification. For example, claims 56-57 are supported by
`
`page 21, lines 7-10. Claims 58-62 and 71-77 are supported by page 21, lines 25-32, and page
`
`24, lines 16-26. Claims 63-67 and 78-80 are supported by page 23, lines 23-34 and page 34,
`
`line 1 to page 38, line 3. Claim 68 is supported by claim 1 and page 17, lines 6-12. Claims
`
`69-70 are supported by page 13, lines 1-3. No new matter has been added. Claims 39-80
`
`will be pending in this application after the entry of this amendment.
`
`In connection with the filing of new claims, a claim fee sheet with
`
`authorization to charge any required fee is attached.
`
`The Invention
`
`Independent claim 39 recites a method of treating a myelodysplastic syndrome
`
`comprising administering a compound of formula (I):
`
`(I)
`
`or a pharmaceutically acceptable salt, solvate or stereoisomer thereof, wherein one ofX and
`Y is C=O, the other ofX and Y is C=O or CH2, and R2 is hydrogen or lower alkyl. In other
`words, the invention relates to the use of specific compounds to treat specific diseases in a
`
`specific patient population. See, also claims 47, 48, 53, 56 and 57. The claims also relate to
`
`methods further employing specific doses, claims 58-60 and 71-77; specific dosing regimens,
`
`claims 63-67 and 78-80; and a specific combination therapy, claims 49-52 and 55. As
`
`discussed below, none of the cited references, each of which is Assignee's or its subsidiary's,
`
`is prior art against the claims, or disclose or suggest the specific methods claimed herein.
`
`8
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`DR. REDDY’S LABS., INC. EX. 1002 PAGE 20
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`

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`The Claimed Invention Is Not Anticipated Under 35 U.S.C. § 102(e)
`
`Claims 39-54 are rejected under 35 U.S.C. § 102(e) as allegedly anticipated by
`
`Hariri et al (US2003/0235909, hereinafter US '909) or Stein (US 2004/0067953, hereinafter
`
`US '953). (Office Action, page 2). Applicant respectfully traverses these rejections.
`
`The present application claims priority to U.S. provisional patent application
`
`no. 60/418,468, filed October 15, 2002. The pending claims of the present application are
`
`supported by that provisional application. See, e.g., page 12 and claim 15 of the provisional
`
`application. Therefore, the pending claims are entitled to a priority date at least as early as
`
`October 15, 2002.
`
`US '909 was filed on April 11, 2003, several months after the filing of the
`
`provisional application to which the instant application claims priority. US '909 claims
`
`priority to U.S. provisional patent application nos. 60/372,348, filed April 12, 2002,
`
`60/437,348, filed December 31, 2002 and 60/437,350, filed December 31, 2002. However,
`
`the disclosure relied upon by the Examiner was filed only as early as April 11, 2003. In other
`
`words US '909 is not prior art to the instant claims as the particular disclosure relied upon by
`
`the Examiner is entitled to the benefit of a date no earlier than April 11, 2003 while the
`
`pending claims are entitled to the benefit of a date at least as early as October 15, 2002.
`
`While Applicant reserves the right to present alternate evidence that US '909 is not prior art
`
`to the pending claims or arguments demonstrating that the disclosure of US '909 is distinct
`
`from that claimed herein, Applicant respectfully submits that, for at least the reasons outlined
`
`above, the rejection of the pending claims in view of US '909 must be withdrawn.
`
`Next, the Examiner alleges that US '953 teaches methods and compositions
`
`for the treatment of cancers ( e.g., leukemia and myelodysplastic syndrome) at paragraphs l 08
`
`and 559, and the use of a composition comprising Actimid™ or Revimid® in combination
`
`with JNK inhibitor at paragraphs 108, 553 and 8, and that all the critical elements required by
`
`the instant claims are well taught by the cited reference. (Office Action, pages 3-4).
`
`Applicant respectfully traverses the rejection.
`
`US '953 relates, inter alia, to methods of treating cancers using JNK inhibitors
`-- an essential element -- and other chemotherapeutic agents in combination. See, e.g.,
`paragraph 18, 105, 108 and 109. The Examiner correctly recognized that the '953 discloses
`that the essential JNK inhibitors may be used with other agents such as Actimid™ or
`Revimid®. See, e.g., paragraph 108. However, the reference is not av