IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Application of: Jerome B. Zeldis
`
`Group Art Unit: To be assigned
`
`Serial No.:
`
`To be assigned (Continuation of Confirmation No.: To be assigned
`Serial No. 121777,765)
`
`Examiner: To be assigned
`
`Filed: March 24, 2011
`
`For: METHODS OF TREATING
`MYELODYSPLASTIC SYNDROMES
`USING LENALIDOMIDE (as amended)
`
`Attorney Docket No.: 12827-089-999
`(CAM 226269-999089)
`
`PRELIMINARY AMENDl\'IENT
`
`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 Title begin on page 2 of this paper.
`
`Amendments to the Specification begin on page 3 of this paper.
`
`Amendments to the Claims are reflected in the listing of the claims that begins on
`
`page 4 of this paper.
`
`Remarks begin on page 6 of this paper.
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 1
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`

`

`Amendment to the Title:
`
`Please amend the title of the application as follows:
`
`METHODS OF TREATING MYELODYSPLASTIC SYNDROMES WITH A
`
`COJ\fBil'L,\TION THERAPY USING LENALIDOMIDE AND AZACITIDINE
`
`- 2 -
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 2
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`

`

`Amendments to the Specification:
`
`Please replace the first paragraph after the title on Page I with the following amended
`
`paragraph:
`
`This application is a continuation application of U.S. Patent Application No.
`
`12/777,765, filed May 11, 2010, presently pending, which is a continuation-in-part of U.S.
`
`Patent Application No. 11/985,032, filed November 12, 2007, which is continuation of U.S.
`
`Patent Application No. 11/654,550 filed January 16, 2007, now issued U.S. Patent No.
`
`7,393,863, which is divisional of U.S. Patent Application No. 10/411,649 filed April 11,
`
`2003, now issued U.S. Patent No. 7,189,740, which claims the benefit of U.S. Provisional
`
`Patent Application No. 60/418,468 filed on October 15, 2002, the contents of each of which
`
`are incorporated by reference herein in their entireties.
`
`- 3 -
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 3
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`

`

`Amendment to the Claims:
`
`This listing of claims will replace all prior versions, and listings, of claims in the
`
`application:
`
`Listing of the Claims:
`
`Claims 1-37. (canceled)
`
`38.
`
`(New) A method of treating a patient having transfusion dependent anemia
`
`due to low to intermediate -1- risk myelodysplastic syndrome, which comprises administering
`
`to said patient about 5 to about 25 mg per day of 3-( 4-amino-l-oxo-1,3-dihydro-isoindol-2-
`
`yl)-piperidine-2,6-dione having the formula:
`
`or a pharmaceutically acceptable salt, solvate or stereoisomer thereof.
`
`39.
`
`(New) The method of claim 38, wherein the compound is administered in the
`
`amount of 5 mg per day.
`
`40.
`
`(New) The method of claim 38, wherein the compound is administered in the
`
`amount of 10 mg per day.
`
`41.
`
`(New) The method of claim 38, wherein the compound is administered in the
`
`amount of 15 mg per day.
`
`42.
`
`(New) The method of claim 38, wherein the compound is administered in the
`
`amount of 25 mg per day.
`
`43.
`
`(New) The method of claim 39, wherein the compound is administered orally
`
`in an amount of 5 mg as a capsule per day.
`
`44.
`
`(New) The method of claim 40, wherein the compound is administered orally
`
`in an amount of 10 mg as a capsule per day.
`
`- 4 -
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`DR. REDDY’S LABS., INC. EX. 1002 PAGE 4
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`

`

`45.
`
`(New) The method of claim 41, wherein the compound is administered orally
`
`in an amount of 15 mg as a capsule per day.
`
`46.
`
`(New) The method of claim 42, wherein the compound is administered orally
`
`in an amount of 25 mg as a capsule per day.
`
`47.
`
`(New) The method of claim 43, 44, 45 or 46, wherein the compound 3-(4-
`
`amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is as a free base.
`
`- 5 -
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 5
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`

`

`REMARKS
`
`The title has been amended to clearly define the subject matter of the invention. The
`
`specification has been amended to update the present application's Cross-Reference To
`
`Related Applications section.
`
`New claims 38-47 appear in the application for the Examiner's consideration. Claims
`
`1-37 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 the
`
`originally filed specification (e.g., pages 19, 24 and 30-31 of U.S. Patent Application No.
`
`12/777,765 filed May 11, 2010, and pages 16-17, 20-21, 26-27 and 34-37 of U.S. Patent
`
`Application No. 10/411,649 filed April 11, 2003). 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.
`
`Respectfully submitted,
`
`Date March 24, 2011
`
`Yeahf:Sil Moon /
`For: Anthony M. Insogna
`Jones Day
`222 East 41 st Street
`New York, New York 10017
`
`(Reg. No. 52,042)
`(Reg. No. 35,203)
`
`- 6 -
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 6
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`

`

`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STA TES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/070,761
`
`03/24/2011
`
`Jerome B. Zeldis
`
`12827-089-999
`
`2735
`
`84802
`7590
`05/09/2012
`JONES DAY for Celgene Corporation
`222 E. 41ST. STREET
`NEW YORK, NY 10017
`
`EXAMINER
`
`SAMALA, JAGADISHW AR RAO
`
`ART UNIT
`
`PAPER NUMBER
`
`1618
`
`MAILDATE
`
`DELIVERY MODE
`
`05/09/2012
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 7
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`

`

`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`13/070,761
`
`Examiner
`
`ZELDIS, JEROME B.
`
`Art Unit
`
`1618
`JAGADISHWAR SAMALA
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, 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 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)0 This action is FINAL.
`2b)[8] This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ;the restriction requirement and election have been incorporated into this action.
`4)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 G.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)[8] Claim(s) 38-47 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)[8] Claim(s) 38-47 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`
`10)0 The specification is objected to by the Examiner.
`11 )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) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`12)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
`
`13)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)).
`*See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment{s)
`1) [8] Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) [8] Information Disclosure Statement(s) (PTO/SB/08)
`Paper No( s )/Mai I Date 0312412011 and 0210812012.
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 03-11)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20120417
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 8
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`

`

`Application/Control Number: 13/070,761
`Art Unit: 1618
`
`Page 2
`
`DETAILED ACTION
`
`• Claims 38-47 are pending and presented for examination.
`
`Information Disclosure Statement
`
`The information disclosure statement (IDS) submitted on 03/24/2011 and
`
`02/08/2012 was noted and the submission is in compliance with the provisions of 37
`
`CFR 1.97. Accordingly, the information disclosure statement is being considered by the
`
`examiner.
`
`Claim Rejections - 35 USC§ 103
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
`
`USPQ 459 (1966), that are applied for establishing a background for determining
`
`obviousness under 35 U.S.C. 103(a) are summarized as follows:
`
`1.
`2.
`3.
`4.
`
`Determining the scope and contents of the prior art.
`Ascertaining the differences between the prior art and the claims at issue.
`Resolving the level of ordinary skill in the pertinent art.
`Considering objective evidence present in
`the application
`obviousness or nonobviousness.
`
`indicating
`
`Claims 38-47 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`Pellegrino Musto et al., Haematologica vol. 87(8), pages 884-886, August 2002 in view
`
`of Muller et al (US 5,635,517).
`
`Claims are drawn to a method of treating a patient having transfusion dependent
`
`anemia due
`
`to
`
`low to
`
`intermediate-1-risk myelodysplastic syndrome comprising
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 9
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`

`

`Application/Control Number: 13/070,761
`Art Unit: 1618
`
`Page 3
`
`administering to said patient about 5 to about 25 mg per day of 3-(4-amino-1-oxo-1,3-
`
`dihydro-isoindol-2-yl)-piperidine-2,6-dione.
`
`Pellegrino discloses a method of treating transfusion-dependent patients with
`
`myelodysplastic syndrome (MOS) administering thalidomide (abstract). Pellegrino also
`
`discloses that the therapeutic role of thalidomide in MOS may significantly increase
`
`hemoglobin levels in about one third of treated patient. Additional disclosure includes
`
`that, studies confirmed that thalidomide at a relatively low doses, may be a very
`
`effective therapy for treating anemia in a selected group of transfusion-dependent,
`
`younger MOS patients with a recent diagnosis normal karyotype and no excess of
`
`marrow blasts (pages 884 and 885).
`
`Pellegrino fails to teach thalidomide derivative comprising 3-(4-amino-1-oxo-1,3-
`
`dihydro-isoindol-2-yl)-piperidine-2,6-dione.
`
`Muller discloses a method of administering thalidomide analogs for reducing
`
`undesirable levels of TNFa in a mammal. The thalidomide analogs of the formula:
`
`wherein one of X and Y is C=O and the other of X and Y is C=O or CH2, is 3-(4-
`
`amino- 1-oxo-l,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione would read on as recited in
`
`the instant claim (Col. 4 lines 20-34). The compound can be administered orally in the
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 10
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`

`

`Application/Control Number: 13/070,761
`Art Unit: 1618
`
`Page 4
`
`form of tablets, capsules, and similar shaped, compressed pharmaceutical forms
`
`containing from 1 to 100 mg of drug per unit dosage (Col. 5 lines 62+). Additional
`
`disclosure includes that the inhibition of NFkB binding can regulate transcription of
`
`cytokine gene(s) and through this modulation and other mechanisms be useful in the
`
`inhibition of a multitude of disease states.
`
`It would have been obvious to one of ordinary skill in the art at the time the
`
`invention was to incorporate 3-(4-maino-l-oxo-l,3-dihydro-isoindol-2-yl)-piperidine-2,6-
`
`dione into Pellgegrino's composition. The person of ordinary skill in the art would have
`
`been motivated to make those modifications because Muller teaches that administration
`
`of an amino substituted oxoisoindolines and dioxoisoindolines compounds are
`
`particularly useful to reduce the levels of tumor necrosis factor a (TNFa) and/or
`
`increasing cAMP
`
`levies thus constitutes a valuable therapeutic strategy for the
`
`treatment of many inflammatory, infectious, immunological or malignant (cancer)
`
`diseases (Col. 1 lines 5-10 and Col. 3 lines 59+) and would have a reasonable
`
`expectation of success because Pellegrino teaches that thalidomide at a relatively low
`
`doses, may be a very effective therapy for treating anemia in a selected group of
`
`transfusion-dependent, younger MOS patients and overall response rate being 20% on
`
`an intention-to-treat analysis, 5 out of 7 (71 .4%) patients with these characteristics
`
`responded to the treatment (page 885).
`
`The method of administering the compound (dosage regimen or dosing intervals
`
`is clearly a result effective parameter that a person of ordinary skill in the art would
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 11
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`

`

`Application/Control Number: 13/070,761
`Art Unit: 1618
`
`Page 5
`
`routinely optimize. Optimization of parameters is a routine practice that would be
`
`obvious for a person of ordinary skill in the art to employ and reasonably would expect
`
`success. It would have been customary for a practitioner/physician to determine the
`
`optimal amount of medicament in order to achieve the desired therapeutic results, such
`
`as
`
`for
`
`the
`
`treatment of
`
`transfusion-dependent anemia. Thus, absent some
`
`demonstration of unexpected results from the claimed parameters of dosage regimen or
`
`dosing intervals, this optimization of thalidomide compound would have been obvious at
`
`the time of Applicant's invention.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`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.
`
`A nonstatutory
`
`obviousness-type double patenting rejection is appropriate where the conflicting claims
`
`are not identical, but at least one examined application claim is not patentably distinct
`
`from the reference claim(s) because the examined application claim is either anticipated
`
`by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140
`
`F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29
`
`USPQ2d 2010 (Fed. Cir. 1993); In re Langi, 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
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 12
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`

`

`Application/Control Number: 13/070,761
`Art Unit: 1618
`
`Page 6
`
`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) or 1.321 (d)
`
`may be used to overcome an actual or provisional rejection based on a nonstatutory
`
`double patenting ground provided the conflicting application or patent either is shown to
`
`be commonly owned with this application, or claims an invention made as a result of
`
`activities undertaken within the scope of a joint research agreement.
`
`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).
`
`Claims 38-47 are rejected on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over claims 1, 16-17, 24-27 and 32-34 of U.S.
`
`Patent No. 7,189,740 ('740) in view of Pellegrino Musto et al., Haematologica vol. 87(8),
`
`pages 884-886, August 2002.
`
`Patent '7 40 teaches a method of treating a myelosdysplastic syndrome, which
`
`comprises administering to a patient in need thereof about 5 to about 50 mg per day of
`
`3-(4-amino- 1-oxo-l,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione of formula:
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 13
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`

`

`Application/Control Number: 13/070,761
`Art Unit: 1618
`
`Page 7
`
`wherein Y is C=O; R=H; R6=H; and R4 is NHR5 and R5=H, would read on as
`
`recited in the instant claim (Col. 4 lines 20-34).
`
`Patent '740 does not teach using drug compound for treating transfusion-
`
`dependent anemia.
`
`Pellegrino teaches a method of treating transfusion-dependent patients with
`
`myelodysplastic syndrome (MOS) administering thalidomide (abstract).
`
`It would have been obvious to the person of ordinary skill in the art at the time the
`
`invention was made to incorporate the teachings of Pellegrino into Patent '740. The
`
`person of ordinary skill
`
`in
`
`the art would have been motivated to make those
`
`modifications and reasonably would have expectation of success because Pellegrino
`
`teaches that thalidomide at a relatively low doses, may be a very effective therapy for
`
`treating anemia in a selected group of transfusion-dependent, younger MOS patients
`
`and overall response rate being 20% on an intention-to-treat analysis, 5 out of 7
`
`(71.4%) patients with these characteristics responded to the treatment (page 885).
`
`This is a provisional obviousness-type double patenting rejection.
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 14
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`

`

`Application/Control Number: 13/070,761
`Art Unit: 1618
`
`Page 8
`
`Conclusion
`
`No claims are allowed at this time.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to JAGADISHWAR SAMALA whose telephone number is
`
`(571 )272-9927. The examiner can normally be reached on 8.30 A.M to 5.00 P.M.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Michael G. Hartley can be reached on (571 )272-0616. The fax phone
`
`number for the organization where this application or proceeding is assigned is 571-
`
`273-8300.
`
`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). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Jake M. Vu/
`Primary Examiner, Art Unit 1618
`
`/J. S./
`Examiner, Art Unit 1618
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 15
`
`

`

`Application/Control Number: 13/070,761
`Art Unit: 1618
`
`Page 9
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 16
`
`

`

`APPLICATION NUMBER
`13/070,761
`
`FILING OR 3 71 (C) DATE
`03/24/2011
`
`84802
`JONES DAY for Celgene Corporation
`222 E. 41 ST. STREET
`NEW YORK, NY 10017
`
`Ul\TfED STATES DEPA RTME'IT OF COMMERCE
`United States Patent and Trademark Office
`Adm"'· COMMISSIO'JER FOR PATENTS
`PO Box 1450
`Alexandria, Virgmia 22313-1450
`\VVi\V.USpto.gov
`
`FIRST NAMED APPLICANT
`Jerome B. Zeldis
`
`ATTY. DOCKET NO./TITLE
`12827-089-999
`CONFIRMATION NO. 2735
`POA ACCEPTANCE LETTER
`
`111111111111111111111111]~!l]~~1~~1~~HU~~u1111111111111111111111111
`
`Date Mailed: 09/10/2012
`
`NOTICE OF ACCEPTANCE OF POWER OF ATTORNEY
`
`This is in response to the Power of Attorney filed 09/05/2012.
`
`The Power of Attorney in this application is accepted. Correspondence in this application will be mailed to the
`above address as provided by 37 CFR 1.33.
`
`/stlam/
`
`Office of Data Management, Application Assistance Unit (571) 272-4000, or (571) 272-4200, or 1-888-786-0101
`
`page 1of1
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 17
`
`

`

`Doc Code: DIST.E.FILE
`Document Description: Electronic Terminal Disclaimer - Filed
`
`PTO/SB/26
`U.S. Patent and Trademark Office
`Department of Commerce
`
`Electronic Petition Request
`
`TERMINAL DISCLAIMER TO OBVIATE A DOUBLE PATENTING REJECTION OVER A
`"PRIOR" PATENT
`
`Application Number
`
`13070761
`
`Filing Date
`
`24-Mar-2011
`
`First Named Inventor
`
`Jerome Zeldis
`
`Attorney Docket Number
`
`12827-089-999
`
`Title of Invention
`
`METHODS OF TREATING MYELODYSPLASTIC SYNDROMES USING LENALIDOMIDE
`
`l'VI Filing of terminal disclaimer does not obviate requirement for response under 37 CFR 1.111 to outstanding
`i.c:,J Office Action
`
`~ This electronic Terminal Disclaimer is not being used for a Joint Research Agreement.
`
`Owner
`
`Percent Interest
`
`Celgene Corporation
`
`100%
`
`The owner(s) with percent interest listed above in the instant application hereby disclaims, except as provided below, the
`terminal part of the statutory term of any patent granted on the instant application which would extend beyond the expiration
`date of the full statutory term of prior patent number(s)
`
`7189740
`
`as the term of said prior patent is presently shortened by any terminal disclaimer. The owner hereby agrees that any patent so
`granted on the instant application shall be enforceable only for and during such period that it and the prior patent are commonly
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`DR. REDDY’S LABS., INC. EX. 1002 PAGE 18
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`I certify, in accordance with 37 CFR 1.4(d)(4), that the terminal disclaimer fee under 37 CFR 1.20(d)
`required for this terminal disclaimer has already been paid in the above-identified application.
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`Applicant is no longer claiming SMALL ENTITY status. See 37 CFR 1.27(g)(2).
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`@ An attorney or agent registered to practice before the Patent and Trademark Office who is of record in
`this application
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`Q A sole inventor
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`Form PTO/SB/96 may be used for making this certification. See MPEP § 324.
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`DR. REDDY’S LABS., INC. EX. 1002 PAGE 19
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`

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`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`13070761
`
`24-Mar-2011
`
`Title of Invention:
`
`METHODS OF TREATING MYELODYSPLASTIC SYNDROMES USING
`LENALIDOMIDE
`
`First Named Inventor/Applicant Name:
`
`Jerome B. Zeldis
`
`Filer:
`
`Attorney Docket Number:
`
`Filed as Large Entity
`
`Utility under 35 USC 111 (a) Filing Fees
`
`Yeahsil Moon
`
`12827-089-999
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USO($)
`
`Statutory or terminal disclaimer
`
`1814
`
`1
`
`160
`
`160
`
`Basic Filing:
`
`Pages:
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`Claims:
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`Miscellaneous-Filing:
`
`Petition:
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`Patent-Appeals-and-Interference:
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`Post-Allowance-and-Post-Issuance:
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`Extension-of-Time:
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`DR. REDDY’S LABS., INC. EX. 1002 PAGE 20
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`

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`Description
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`Fee Code
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`Quantity
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`Amount
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`Sub-Total in
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`Miscellaneous:
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`Total in USO($)
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`160
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`DR. REDDY’S LABS., INC. EX. 1002 PAGE 21
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`

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`Doc Code: DISQ.E.FILE
`Document Description: Electronic Terminal Disclaimer -Approved
`
`Application No.: 13070761
`
`Filing Date:
`
`24-Mar-2011
`
`Applicant/Patent under Reexamination:
`
`Zeldis et al.
`
`Electronic Terminal Disclaimer filed on September 10, 2012
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`C8J
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`APPROVED
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`This patent is subject to a terminal disclaimer
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`D
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`DISAPPROVED
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`Approved/Disapproved by: Electronic Terminal Disclaimer automatically approved by EFS-Web
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`U.S. Patent and Trademark Office
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`DR. REDDY’S LABS., INC. EX. 1002 PAGE 22
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`

`

`IN THE UNITED ST ATES PATENT AND TRADEMARK OFFICE
`
`Application of: Jerome B. Zeldis
`
`Group Art Unit: 1618
`
`Application No.: 13/070,761
`
`Confirmation No.: 2735
`
`Filed: March 24, 2011
`
`Examiner: Samala, Jagadishwar Rao
`
`For: METHODS OF TREATING
`MYELODYSPLASTIC SYNDROMES
`USING LENALIDOMIDE (as amended)
`
`Attorney Docket No.: 12827-089-999
`(CAM 226269-999089)
`
`RESPONSE
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`In response to the non-final Office Action mailed May 9, 2012, Applicant respectfully
`
`submits the following remarks for consideration by the Examiner and entry into the record of the
`
`above-identified application. Also submitted herewith is a Petition for Extension of Time for
`
`one month from August 9, 2012 to and including September IO, 2012 (September 9, 2012 being
`
`a Sunday).
`
`A listing of the claims begins on page 2 of this paper.
`
`Remarks begin on page 4 of this paper.
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 23
`
`

`

`U.S. Patent Application No. 13/070,761
`Attorney Docket No. 12827-089-999
`Response to Office Action dated May 9, 2012
`Filed September 5, 2012
`
`Listing of the Claims:
`
`1-37. (canceled)
`
`38.
`
`(Previously Presented) A method of treating a patient having transfusion
`
`dependent anemia due to low to intermediate -1- risk myelodysplastic syndrome, which
`
`comprises administering to said patient about 5 to about 25 mg per day of 3-( 4-amino- l-oxo- l ,3-
`
`dihydro-isoindol-2-yl)-piperidine-2,6-dione having the formula:
`
`or a pharmaceutically acceptable salt, solvate or stereoisomer thereof.
`
`39.
`
`(Previously Presented) The method of claim 38, wherein the compound is
`
`administered in the amount of 5 mg per day.
`
`40.
`
`(Previously Presented) The method of claim 38, wherein the compound is
`
`administered in the amount of 10 mg per day.
`
`41.
`
`(Previously Presented) The method of claim 3 8, wherein the compound is
`
`administered in the amount of 15 mg per day.
`
`42.
`
`(Previously Presented) The method of claim 38, wherein the compound is
`
`administered in the amount of 25 mg per day.
`
`(Previously Presented) The method of claim 39, wherein the compound is
`
`administered orally in an amount of 5 mg as a capsule per day.
`
`44.
`
`(Previously Presented) The method of claim 40, wherein the compound is
`
`administered orally in an amount of 10 mg as a capsule per day.
`
`- 2 -
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 24
`
`

`

`U.S. Patent Application No. 13/070,761
`Attorney Docket No. 12827-089-999
`Response to Office Action dated May 9, 2012
`Filed September 5, 2012
`
`45.
`
`(Previously Presented) The method of claim 41, wherein the compound is
`
`administered orally in an amount of 15 mg as a capsule per day.
`
`46.
`
`(Previously Presented) The method of claim 42, wherein the compound is
`
`administered orally in an amount of 25 mg as a capsule per day.
`
`47.
`
`(Previously Presented) The method of claim 43, 44, 45 or 46, wherein the
`
`compound 3-( 4-amino-1-oxo-l ,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is as a free base.
`
`- 3 -
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 25
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`

`

`U.S. Patent Application No. 13/070,761
`Attorney Docket No. 12827-089-999
`Response to Office Action dated May 9, 2012
`Filed September 5, 2012
`
`REMARKS
`
`Claims 38-47 are pending in the application. Reconsideration of the pending claims in
`
`view of the remarks below is respectfully requested.
`
`I.
`
`Claim Rejection Under 35 U.S.C. § 103 Should Be Withdrawn
`
`Claims 38-47 are rejected under 35 U.S.C. § 103(a) as allegedly being obvious over
`
`Pellegrino et al. (Haematologica 87(8): 884-886, August 2002) in view Muller et al. (U.S.
`
`Patent No. 5,635,517). The Examiner states that Pellegrino discloses a method of treating
`
`transfusion-dependent patients with myelodysplastic syndrome (MOS) by administering
`
`thalidomide. (Office Action at 3). The Examiner acknowledges that Pellegrino does not teach
`
`the compound 3-( 4-amino-1-oxo-l ,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione recited in the
`
`instant claims, but asserts that Muller discloses a method of administering thalidomide analogs
`
`for reducing undesirable levels of tumor necrosis factor a (TNF-a), and that the formula for the
`
`thalidomide analogs in Muller would read on the instant compound. Id. Based on these, the
`
`Examiner alleges that it would have been obvious to one of ordinary skill in the art to incorporate
`
`the 3-( 4-amino- l-oxo-l ,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione into Pellegrino' s
`
`composition. (Id. at 4). For the following reasons, Applicant respectfully disagrees with this
`
`rejection.
`
`Claim 38 recites a method of treating a patient having transfusion dependent anemia due
`
`to low to intermediate -1- risk myelodysplastic syndrome, comprising administering about 5 to
`
`about 25 mg per day of 3-( 4-amino- l-oxo-l ,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione
`
`(hereafter referred to as ''lenalidomide"). Claims 39-47 depend on claim 38 directly or indirectly,
`
`and therefore incorporate all of its elements. Thus, the claimed methods do not require
`
`incorporating lenalidomide into Pellegrino' s composition, as the PTO alleged. Office Action at
`
`Applicant respectfully points out that the Examiner bears the burden of establishing a
`
`case ofprimafacie obviousness against the claims as a whole. That is, all the claim elements
`
`must be considered in a 103 rejection and the Examiner must show how the references render
`
`such obviousness. In re Royka, 490 F.2d 81 (CCPA 1974). Here. the cited references would not
`
`- 4 -
`
`DR. REDDY’S LABS., INC. EX. 1002 PAGE 26
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`

`

`U.S. Patent Application No. 13/070,761
`Attorney Docket No. 12827-089-999
`Response to Office Action dated May 9, 2012
`Filed September 5, 2012
`
`have provided any reason for one of skill in the art specifically to select administering the
`
`specific compound lenalidomide for treating a patient having transfusion dependent anemia due
`
`to low to intermediate -1- risk myelodysplastic syndrome, much less the claimed methods using
`