April 23, 2010
`
`Applicants
`
`Docket No.
`
`For
`
`CLAIMOFPRIORITYUNDER35USC §119
`Patent Application
`Docket No. SER.125Dl
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Giampiero De Luca, Arnaud Ythier, Alain Munafo, Maria Lopez-Bresnahan
`
`SER.125Dl
`
`Cladribine Regimen for Treating Multiple Sclerosis
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`CLAIM OF PRIORITY UNDER 35 USC §119
`
`Sir:
`
`Applicants in the above-identified patent application hereby reaffirms their claim to the right
`
`of priority granted pursuant to 35 USC §119 based upon European Application No. 04106909.7,
`
`filed December 22, 2004.
`
`A certified copy of the above European application can be found in the parent application,
`
`U.S. application Serial No. 11/722,018. Applicants respectfully request that the certified copy of the
`
`foreign priority application be made of record in the subject application pursuant to MPEP 201.14(6 ).
`
`Respµ@
`
`Frank C. Eisenschenk, Ph.D.
`Patent Attorney
`Registration No. 45,332
`Phone No.:
`352-375-8100
`Fax No.:
`352-372-5800
`Address:
`P.O. Box 142950
`Gainesville, FL 32614-2950
`
`FCE/jb
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`J \SER\125D1\PTO-Misc\COP.dociDNB/jb
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`Hopewell EX1025
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`1
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`

`

`April 23, 2010
`
`INFORlvIATION DISCLOSURE
`STATEMENT
`Patent Application
`Docket No. SER.125D1
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Giampiero De Luca, Arnaud Ythier, Alain Munafo, Maria Lopez-Bresnahan
`
`SER.125Dl
`
`Cladribine Regimen for Treating Multiple Sclerosis
`
`Applicants
`
`Docket No.
`
`For
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313
`
`INFORMATION DISCLOSURE STATEMENT
`UNDER 37 CFR §§1.97 AND 1.98
`
`Sir:
`
`In accordance with 37 CFR § 1.97 and§ 1.98, Applicants would like to bring to the attention
`
`of the Examiner, the references cited in the following patent application:
`
`U.S. Serial No. I 1/722,018, which entered the U.S. national stage on June 18, 2007, from
`
`international application No. PCT/EP2005/056954, filed December 20, 2005.
`
`The subject application claims the benefit under 35 USC§ 120 of the filing date of patent application
`
`Serial No. 11/722,018. Applicants respectfully request that the references cited in the Information
`
`Disclosure Statement submitted in the 11/722,018 application, as well as any references cited by the
`
`Patent Office during the prosecution thereof, be made of record in the subject application. As copies
`
`of the references made of record in the 11/722,018 application, and cited on the attached form
`
`PTO/SB/08, can be found in the 11/722,018 casefile, copies of those references are not provided
`
`herewith.
`
`J•ISER\125D1\PTO-Misc\IDS.doo'DNB/jb
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`2
`
`

`

`2
`
`Docket No. SER.125Dl
`Patent Application
`
`It is respectfully requested that the references cited on the attached form PTO/SB/08 be
`considered in the examination of the subject application and that their consideration be made of
`record.
`
`Applicants respectfully assert that the substantive provisions of37 CFR §§ 1.97 and 1.98 are
`met by the foregoing statements.
`
`Renbmitted,
`
`Frank C. Eisenschenk, Ph.D.
`Patent Attorney
`Registration No. 45,332
`Phone No.:
`352-375-8100
`Fax No.:
`352-372-5800
`Address:
`P.O. Box 142950
`Gainesville, FL 32614-2950
`
`FCE/jb
`Attachment: Form PTO/SB/08
`
`J:\SER\12501\PTO-Misc\TDS.doo'DNB/jb
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`3
`
`

`

`r Substitute for form 1449A/PTO
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`(use as many sheets as necessary)
`
`Complete if Known
`
`April 23, 2010
`Giampiero De Luca
`
`Application Number
`
`Filing Date
`
`First Named Inventor
`
`Art Unit
`
`Examiner Name
`
`Sheet
`
`I
`
`1
`
`3
`
`Attorney Docket Number
`
`i
`! SER.125D1
`
`Document Number
`Number - Kind Code (if
`known)
`
`US-4,964,848
`
`US-5,506,214
`
`US-2010/0021429
`
`U.S. PATENT DOCUMENTS
`
`Publication Date
`MM-DD-YYYY
`
`Name of Patentee or Applicant
`of Cited Document
`
`Pages, Coiumns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`10-23-1990
`
`04-09-1996
`
`01-28-2010
`
`Bloom
`
`Beutler
`
`Brentzel et al.
`
`All
`
`All
`
`All
`
`US-
`
`US-
`
`US-
`
`US-
`
`US-
`
`US-
`
`FOREIGN PATENT DOCUMENTS
`Foreign Patent Document
`
`Publication Date
`MM-DD-YYYY
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines,
`Where Relevant Passages
`or Relevant Figures Appear
`
`T''
`
`- Number' - Kind Code5 (if known)
`Country Code 3
`WO 04/087101 A2
`
`10/14/2004
`
`EP O 626 853 B1
`
`04/26/200
`
`Ivax Corporation
`The Scripps
`Research Institute
`
`All
`
`All
`
`Examiner
`Initials*
`
`Cite
`No. 1
`
`U1
`
`U2
`
`U3
`U4
`
`U5
`
`U6
`
`U7
`
`U8
`
`U9
`
`Cite
`No. 1
`
`F1
`
`F2
`F3
`F4
`F5
`F6
`F7
`
`Examiner
`Initials*
`
`[ Examiner
`Signature
`
`Date
`Considered
`
`Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`*EXAMINER:
`considered. Include copy of this form with next communication to applicant. 1 Applicant's unique citation designation number (optional) 2 See Kind Codes of
`3 Enter Office that issued the document, by the two-letter code (WIPO Standard T.3).
`4 For
`USPTO Patent Documents at www.uspto.goy or MPEP901.04.
`Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document. 5 Kind of document by
`the appropriate symbols as indicated on the document under WIPO Standard ST. 16 if possible. 6 Applicant is to place a check mark here if English language
`Translation is attached.
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by the
`USPTO to process) an application. Confidentiality is governed by 35 U.S.C 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete.
`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments
`on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent
`and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO:
`Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`ff you need assistance in completing the form, ca/11-800-PTO-9199 (1-800-786-9199) and select option 2.
`
`J \SER\125Dl IPTO-Misc\lDS-form.doc/DNB/jb
`
`4
`
`

`

`r
`
`Substitute for form 1449B/PTO
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`\.
`
`Sheet
`
`2
`
`3
`
`Examiner Cite
`No. 1
`Initials*
`
`R1
`
`R2
`
`R3
`
`c.;omptete 11 Known
`
`Application Number
`Filing Date
`First Named Inventor
`Group Art Unit
`Examiner Name
`Attorney Docket Number SER.125D1
`
`April 23, 2010
`Giampiero De Luca
`
`"
`
`.J
`
`T2
`
`(use as many sheets as necessary)
`I of I
`I
`NON PATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title of the article, (when appropriate), title of the
`item (book, magazine, journal, serial, symposium, catalog. etc.), date, page(s), volume-issue
`number(s), publisher. city and/or country where published.
`BEUTLER, E. et al. "Marrow Suppression Produced by Repeated Doses of Cladribine",
`ActaHaematol, 1994, pp.10-15, Vol. 91.
`BEUTLER, E. et al. "Treatment of Multiple Sclerosis and Other Autoimmune Diseases With
`Cladribine", Seminars in Hematology, January 1, 1996, pp. 45-52, Vol. 33, No. 1,
`Supplement 1.
`BEUTLER, E. et al. "The treatment of chronic progressive multiple sclerosis with
`cladribine", Proc. Natl. Acad. Sci. USA, February 1996, pp. 1716-1720, Vol. 93.
`
`ELLISON, G. et al. "Oral Cladribine for Multiple Sclerosis", Neurology, March 1997,
`P03.070, pp. A174-A175, Vol. 48, No. 3, XP008047069.
`GRIEB, P. et al. "Effect of Repeated Treatments with Cladribine (2-Chlorodeoxyadenosine)
`on Blood Counts in Multiple Sclerosis Patients", Archivum lmmunologiae et Therapiae
`Experimentalis, 1995, pp. 323-327, Vol. 43, No. 5-6.
`KAZIMIERCZUK, Z. et al. "Synthesis of 2'-Deoxytubercidin, 2'-Deoxyadenosine, and
`Related 2'-Deoxynucleosides via a Novel Direct Stereospecific Sodium Salt Glycosylation
`Procedure", J. Am. Chem. Soc., 1984, pp. 6379-6382, Vol. 106, No. 21.
`KURTZKE, J. "Rating neurologic impairment in multiple sclerosis: An expanded disability
`status scale (EDSS)", Neurology, November 1983, pp. 1444-1452, Vol. 33.
`
`LANGTRY, H. et al. "Cladribine: A Review of its Use in Multiple Sclerosis", Biodrugs, May
`1998, pp. 419-433, Vol. 9, No. 3.
`LASSMANN, H. et al. "Heterogeneity of multiple sclerosis pathogenesis: implications for
`diagnosis and therapy", TRENDS in Molecular Medicine, March 2001, pp. 115-121, Vol. 7,
`No. 3.
`LUBLIN, F. et al. "Defining the clinical course of multiple sclerosis: Results of an
`international survey", Neurology, April 1996, pp. 907-911, Vol. 46.
`LUCCHINETTI, C. et al. "Multiple sclerosis: recent developments in neuropathology,
`pathogenesis, magnetic resonance imaging studies and treatment", Current Opinion in
`Neurology, 2001, pp. 259-269, Vol. 14.
`MATTSON, D. "Update on the diagnosis of multiple sclerosis", Expert Review of
`Neurotherapeutics, May 2002, pp. 319-327, Vol. 2, No. 3.
`
`R4
`
`R5
`
`R6
`
`R7
`
`R8
`
`R9
`
`R10
`
`R11
`
`R12
`
`J Date
`Examiner
`[
`Considered
`Signature
`Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
`*EXAMINER:
`and not considered. Include copy of this form with next communication to applicant.
`1 Applicant's unique citation designation number (optional). 2 Applicant is to place a check mark here if English language Translation is attached.
`This collection of information is required by 37 CFR 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by the US PTO
`to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete, including
`gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the
`amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and
`Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS.
`SEND TO:
`Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`/fyou need assistance in completing the form, ca/11-800-PTO-9199 (1-800-786-9199) and select option 2 .
`
`J
`
`]
`
`.J :\SER\125D I \PTO-Misc\IDS-form.doc/DNB/jb
`
`5
`
`

`

`r
`
`Substitute for form 1449B/PTO
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`\...
`
`Sheet
`
`I
`
`3
`
`3
`
`Examiner Cite
`No. 1
`Initials*
`
`R13
`
`R14
`
`c.;omplete it Known
`
`Application Number
`Filing Date
`First Named Inventor
`Group Art Unit
`Examiner Name
`Attorney Docket Number SER.125D1
`
`April 23, 2010
`Giampiero De Luca
`
`"
`
`,J
`
`T2
`
`(use as many sheets as necessary)
`I ot I
`NON PATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title of the article, (when appropriate), title of the
`item (book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue
`number(s), publisher, citv and/or countrv where published.
`MCDONALD, W. et al. "Recommended Diagnostic Criteria for Multiple Sclerosis: Guidlines
`from the International Panel on the Diagnosis of Multiple Sclerosis", Annals of Neurology,
`July 2001, pp. 121-127, Vol. 50, No. 1.
`MILLER, R. et al. "Therapeutic advances in ALS", Neurology, 1996, pp. S217, Vol. 47,
`Suppl. 4.
`
`NOSEWORTHY, J. et al. "Multiple Sclerosis", The New England Journal of Medicine,
`September 28, 2000, pp. 938-952, Vol. 343, No. 13.
`
`POSER, C. et al. "New Diagnostic Criteria for Multiple Sclerosis: Guidelines for Research
`Protocols", Annals of Neurology, March 1983, pp. 227-231, Vol. 13, No. 3.
`
`R15
`
`R16
`
`RICE, G. et al. "Cladribine and progressive MS: Clinical and MRI outcomes of a
`R17 multicenter controlled trial", Neurology, March 2000, pp. 1145-1155, Vol. 54.
`ROMINE, J. et al. "A Double-Blind, Placebo-Controlled, Randomized Trial of Cladribine in
`Relapsing-Remitting Multiple Sclerosis", Proceedings of the Association of American
`Physicians, January/February 1999, pp. 35-44, Vol. 111, No. 1.
`SCHUMACHER, G. et al. "Problems of Experimental Trials of Therapy in Multiple
`Sclerosis: Report by the Panel on the Evaluation of Experimental Trials of Therapy in
`Multiple Sclerosis", Annals New York Academy of Sciences, March 31, 1965, pp. 552-568,
`Vol. 122.
`SELBY, R. et al. "Safety and Tolerability of Subcutaneous Cladribine Therapy in
`Progressive Multiple Sclerosis", Can. J. Neural. Sci., 1998, pp. 295-299, Vol. 25.
`
`R18
`
`R19
`
`R20
`
`SIPE, J. et al. "A neurologic rating scale (NRS) for use in multiple sclerosis", Neurology,
`October 1984, pp. 1368-1372, Vol. 34.
`
`STELMASIAK, Z. et al. "A pilot trial of cladribine (2-chlorodeoxyadenosine) in remitting-
`relapsing multiple sclerosis", Med. Sci Monit., 1998, pp. 4-8, Vol. 4, No. 1.
`
`R21
`
`R22
`
`R23
`
`R24
`
`Examiner
`[
`Considered
`Signature
`Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
`*EXAMINER:
`and not considered. Include copy of this form with next communication to applicant.
`1 Applicant's unique citation designation number (optional). 2 Applicant is to place a check mark here if English language Translation is attached.
`This collection of information is required by 37 CFR 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO
`to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete, including
`gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the
`arnount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer. U S. Patent and
`Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS.
`SEND TO:
`Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1-B00-PTO-9199 (1-800-786-9199) and select option 2.
`
`I Date
`
`I
`
`)
`
`J:\SER\125D1\PTO-Misc\JDS-form.doc/DNB(jb
`
`6
`
`

`

`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`Title of Invention:
`
`Cladribine Regimen for Treating Multiple Sclerosis
`
`First Named Inventor/Applicant Name:
`
`Giampiero De Luca
`
`Filer:
`
`Frank Christopher Eisenschenk/Jenny Bedner
`
`Attorney Docket Number:
`
`SER.125D1
`
`Filed as Large Entity
`
`Utility under 35 USC 111 (a) Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USO($)
`
`Utility application filing
`
`Utility Search Fee
`
`Utility Examination Fee
`
`1011
`
`1111
`
`1311
`
`1
`
`1
`
`1
`
`330
`
`540
`
`220
`
`330
`
`540
`
`220
`
`Basic Filing:
`
`Pages:
`
`Claims:
`
`Claims in excess of 20
`
`1202
`
`9
`
`52
`
`468
`
`Miscellaneous-Filing:
`
`Petition:
`
`7
`
`

`

`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USO($)
`
`Patent-Appeals-and-Interference:
`
`Post-Allowance-and-Post-Issuance:
`
`Extension-of-Time:
`
`Miscellaneous:
`
`Total in USD ($)
`
`1558
`
`8
`
`

`

`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`7476036
`
`12766173
`
`International Application Number:
`
`Confirmation Number:
`
`1906
`
`Title of Invention:
`
`Cladribine Regimen for Treating Multiple Sclerosis
`
`First Named Inventor/Applicant Name:
`
`Giampiero De Luca
`
`Customer Number:
`
`23557
`
`Filer:
`
`Frank Christopher Eisenschenk/Jenny Bedner
`
`Filer Authorized By:
`
`Frank Christopher Eisenschenk
`
`Attorney Docket Number:
`
`SER.125D1
`
`Receipt Date:
`
`23-APR-2010
`
`Filing Date:
`
`Time Stamp:
`
`14:02:49
`
`Application Type:
`
`Utility under 35 USC 111 (a)
`
`Payment information:
`
`Submitted with Payment
`
`Payment Type
`
`Payment was successfully received in RAM
`
`RAM confirmation Number
`
`Deposit Account
`
`Authorized User
`
`yes
`
`Credit Card
`
`$1558
`
`271
`
`190065
`
`EISENSCHENK,FRANK C.
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.16 (National application filing, search, and examination fees)
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.17 (Patent application and reexamination processing fees)
`
`9
`
`

`

`Charge any Additional Fees required under 37 C.F.R. Section 1.19 (Document supply fees)
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.20 (Post Issuance fees)
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`Charge any Additional Fees required under 37 C.F.R. Section 1.21 (Miscellaneous fees and charges)
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New A~~lications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International A~~lication under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/EO/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International A~~lication Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 181 O), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/1 OS) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`11
`
`

`

`PTO/Sl3i01A
`Approved for use through 07/31/2006. OMl3
`U S Patent and Trademark Office; U.S. DEP,\RTMENT 01' COiv11v1EnCE
`Under the raeerwork Red\lc\iop Act of 1995 no oersons are remured to rest1ond to a ccllection or iqformation unless 1f disnlavs a valid 0MB control n,,mber.
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1.76)
`
`Title of
`lnvontion
`
`CLADRIBINE REGIMEN FOR TREATING MULTIPLE SCLEROSIS
`
`As the below named inventor(s), I/we declare that:
`
`This declaration is directed to:
`
`D
`0
`
`The attached application, or
`
`Application No. PCT/f':P2005105fi954
`fHed on DECEMBER 20, 2005
`[II as amended on _J;;.;.U;;.;N..;.E=-_-'-1"'"8"', 2"'0""0""l _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (if applicable);
`
`I/we believe that I/we am/are the original and first inventor(s) of the subject matter which is claimed and for which a patent is
`sought;
`
`I/we have reviewed and understand the contents of the above-identified application, including the claims, as amended by any
`amendment specifically referred to above;
`
`I/we acknowledge the duty to disclose to the United States F'aten! and Trademark Office all information known to me/us to be
`material to patentability as defined in 37 CFR 1.56, including for contrnuation-in-part applications, material information which
`became available between the filing date of the prior application and the national or PCT International filing date of the
`continuation-in-part application
`
`All statements made herein of my/own knowledge are true, alt statements rnade herein on informaHon and belief are believed
`to be true, and further that these statements were made with the knowledge that willful false statements and the Hke are
`punishable by fine or imprisonment, or both, under 18 U.S.C. 1001, and may jeopardize the validity of the application or any
`patent issuing thereon,
`
`r -_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Citizen of: SWITZERLAND
`
`Signature: ___________________ _
`
`. ______ ,_Citizen of: SWITZERLAND and FRANCE
`
`Inventor three: ALAIN MUNAFO
`
`Signature: ___________________________ Ci!izen of: _S_v_V1]:0_E.f:th~ND
`
`Inventor four: MARIA LOPEZ-BHESNAHAN
`
`Signature: ________________________ _
`
`Citizen of: _l:!_~!T.l::_Q,JT_A_TE_·S_' __
`
`D Additional inventors or a le al representative are bein named on
`___ additional form(s) attact:ecl hereto.
`This collection or ,nformat,on is required by 3& U.$.C. 115 ~nd 37 CFR 1.63. Tl1e information is requilcd to ct>:aln or retain a benefit by tile public which :s to file
`,and by the USPTO to pmcess) an ;ipplication. Confidentiality is governed by 35 U.S.G. 122 and 3i CFR · 11 and ·: 14. This collection is estimated to take 1
`minute 10 complete, inciading gatnering, preparing, and subrnilting the comµleled applica11on form to tile USPTO rime will vary clependmg upon tho ipdividu,,1
`this burden. siioulcl be s,1nt to lho C!1ief !nfornw!ion
`case. Any comments on the amount of time you require to complete this form and/or suggest,ons for
`DO NOT SEND l'EES OH COl'/IPLF:TED
`Officer. U.S. Patent and Trndemark Office, U.S. Department of Commerce, P.O. Box 1450, Alexan<lna, VA
`FORMS TO THIS ADDl~ESS SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`ff you need assistance m cornp!oting ihe form. ca!J 1p800~PTO~9199 Ctr.cl select option 2
`
`12
`
`

`

`PTO/SB/01A (09-04)
`Approved for use through 07i31/2006. 0MB 0651-0032
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Panerwork Reduction Act of 1995 no nersons are reauired to resoond to a collection of information unless if displavs a vaiid 0MB control number.
`
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1.76)
`
`Title of
`Invention
`
`CLADRIBINE REGIMEN FOR TREATING MULTIPLE SCLEROSIS
`
`As the below named inventor(s}, I/we declare that
`
`This declaration is directed to:
`
`D The attached application, or
`0
`
`. filed on DECEMBER 20, 2005
`
`Application No. PCT /E P2005/056954
`0
`I/we believe that I/we am/are the original and first inventor(s) of the subject matter which is claimed and for which a patent is
`sought;
`
`as amended on JUNE 18 2007
`
`{if applicable);
`
`I/we have reviewed and understand the contents of the above-identified application, including the claims, as amended by any
`amendment specifically referred to above;
`
`I/we acknowledge the duty to disclose to the United States Patent and Trademark Office all information known to me/us to be
`material to patentability as defined in 37 CFR 1.56, including for continuation-in-part applications, material information which
`became available between the filing date of the prior application and the national or PCT International filing date of the
`continuation-in-part application.
`
`All statements made herein of my/own knowledge are true, all statements made herein on information and belief are believed
`to be true, and further that these statements were made with the knowledge that willful false statements and the like are
`punishable by fine or imprisonment. or both, under 18 U.S.C. 1001, and may jeopardize the validity of the application or any
`patent issuing thereon.
`
`FULL NAME OF INVENTOR(S)
`
`Inventor one: GIAMPIERO DE LUCA
`
`Signature:
`
`_,,_ _ _.
`;'""~/ ~ __ .... ~--
`~·----- -7
`
`Inventor two: ARNAUD YTHIER
`
`Signature:
`
`,~
`1 "
`Inventor three: ALAIN MUNAFO
`
`Citizen of: SWITZERLAND
`
`Citizen of: SWITZERLAND and FRANCE
`
`Signature:
`
`Citizen of: SWITZERLAND
`
`Inventor four: MARIA LOPEZ-BRESNAHAN
`
`Signature:
`
`Citizen of: UNITED STATES
`
`D
`
`Additional inventors or a legal representative are being named on
`additional form(s) attached hereto.
`This collectIon of information Is required by 35 U.S.C. 115 and 37 CFR 1.63. The information is reqwred to obtain or retain a benefit by the public which Is to file
`(and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 1
`minute to complete. including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual
`case. Any comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information
`Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`If you need assistance in completing the form, call 1-800-P T0-9199 and select option 2.
`
`13
`
`

`

`PTO/SB/0iA (09-04)
`Approved for use through 07131/2006. 0MB 0651-0032
`U S. Patent and Trademark Office; U S DEPARTMENT OF COMMERCE
`Under the Paoer,vork Reduction Act of 1995, no oersons are reauired tc resoond to a collection of information unless if disolavs a valid 0MB control number.
`
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DAT A SHEET (37 CFR 1. 76)
`
`Title of
`Invention
`
`CLADRIBINE REGIMEN FOR TREATING MULTIPLE SCLEROSIS
`
`As the below named inventor(s), I/we declare that:
`
`This declaration is directed to:
`
`D The attached application, or
`[Z] Application No. PCT/EP2005/056954
`0
`I/we believe that I/we am/are the original and first inventor(s) of the subject matter which is claimed and for which a patent is
`sought;
`
`as amended on _J_U_N_E_1_8~, 2_0_0_7 ________________ (if applicable);
`
`, filed on DECEMBER 20, 2005
`
`I/we have reviewed and understand the contents of the above-identified application, including the claims, as amended by any
`amendment specifically referred to above;
`
`I/we acknowledge the duty to disclose to the United States Patent and Trademark Office all information known to me/us to be
`material to patentabiiity as defined in 37 CFR 1 .56, including for continuation-in-part applications, material information which
`became available between the filing date of the prior application and the national or PCT International filing date of the
`continuation-in-part application.
`
`All statements made herein of my/own knowledge are true, all statements made herein on information and belief are believed
`to be true, and further that these statements were made with the knowledge that willful false statements and the like are
`punishable by fine or imprisonment, or both, under 18 U.S.C. 1001, and may jeopardize the validity of the application or any
`patent issuing thereon.
`
`FULL NAME OF INVENTOR(S)
`
`Inventor one: GIAMPIERO DE LUCA
`
`Signature:
`
`Inventor two: ARNAUD YTHIER
`
`Signature:
`
`Inventor three: ALAIN MUNAFO
`
`/}
`
`Jla,L r 1 ,~_J?
`.,
`Inventor four: MARIA LOPEZ-BRESNAHAN r
`I
`
`Signature:
`
`I
`
`,I
`
`Citizen of: SWITZERLAND
`
`Citizen of: SWITZERLAND and FRANCE
`
`Citizen of: SWITZERLAND
`
`Signature:
`
`Citizen of: UNITED STATES
`
`D
`
`Additional inventors or a legai representative are being named on
`additional form(s) attached hereto.
`This collecl1on of 1nformat1on 1s requ11ed by 35 U.S.C. 115 ano 37 CFR 1.63. Tne 1mormatlon 1s required to obtain or retain a benefit by the public wh1cr 1s to file
`(and by the USPTO to process) an application. Confidentiality is governed by 35 USC 122 and 37 CFR 1 11 and 1 14. Tris collec!'on is est,mated to take 1
`minute lo complete, including gathenng. preparing, and submitting the completed app1,cat1on form to the USPTO. Time w1l! vary deperidiC1g upon the ,naividual
`case Any con,mer::s on the amount of time you require to complete this form and/or suggestions 'or reducing this burden. should be sent to the Chief lnforma,ion
`O:f1cer. U.S Patent and Trader.1ark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLFTED
`FORMS TO THIS ADDRESS SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`if you need assistance in completing the form, call 1-B00-PTO-9199 and select optfo,1 2.
`
`14
`
`

`

`PTO/SB/01A (09-04)
`Approved for use through 07/31/2006. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paoerwork Reduction Act of 1995 no nersons are renuired to resnond to a collection of information unless if disnlavs a valid 0MB control number.
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1.76)
`
`Title of
`Invention
`
`CLADRIBINE REGIMEN FOR TREATING MULTIPLE SCLEROSIS
`
`As the below named inventor(s), I/we declare that:
`
`This declaration is directed to:
`D The attached application, or
`0
`Application No. PCT/EP2005/056954
`, filed on DECEMBER 20 2005
`[Z] as amended on -'J""U:.:.N.:.:E::....:..:18"'--"2"'"00"'7 _______________ (if applicable);
`I/we believe that I/we am/are the original and first inventor(s) of the subject matter which is claimed and for which a patent is
`sought;
`
`I/we have reviewed and understand the contents of the above-identified application, including the claims, as amended by any
`amendment specifically referred to above;
`
`I/we acknowledge the duty to disclose to the United States Patent and Trademark Office all information known to me/us to be
`material to patentability as defined in 37 CFR 1.56, including for continuation-in-part applications, material information which
`became available between the filing date of the prior application and the national or PCT International filing date of the
`continuation-in-part application.
`
`All statements made herein of my/own knowledge are true, all statements made herein on information and belief are believed
`to be true, and further that these statements were made with the knowledge that willful false statements and the like are
`punishable by fine or imprisonment, or both, under 18 U.S.C. 1001, and may jeopardize the validity of the application or any
`patent issuing thereon.
`
`FULL NAME OF INVENTOR(S)
`
`Inventor one: GIAMPIERO DE LUCA
`
`Signature:
`
`Inventor two: ARNAUD YTHIER
`
`Signature:
`
`Inventor three: ALAIN MUNAFO
`
`Signature:
`
`Inventor four: MARIA LOPEZ-BRESNAHAN
`
`Citizen of: SWITZERLAND
`
`Citizen of: SWITZERLAND and FRANCE
`
`Citizen of: SWITZERLAND
`
`Signature:
`
`At/.~ /~ - - -
`/
`(J
`/
`D Additional inventors or a leqal representative are beinq named on
`additional form/s) attached hereto.
`This collect,on of information Is required by 35 U.S.C. 115 and 37 CFR 1.63. The information Is required to obtain or retain a benefit by the public which Is to file
`(and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 1
`minute to complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary dependi