8299539
`
`September 28, 2022
`
`THIS IS TO CERTIFY THAT ANNEXED IS A TRUE COPY FROM THE
`RECORDS OF THIS OFFICE OF THE FILE WRAPPER AND CONTENTS
`OF:
`
`APPLICATION NUMBER: 12/766,173
`FILING DATE: April 23, 2010
`PATENT NUMBER: 8377903
`ISSUE DATE: February 19, 2013
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 1 of 207
`
`

`

`April 23, 2010
`
`CLAIM OF PRIORITY UNDER35 USC §119
`Patent Application
`Docket No. SER.125D1
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Applicants—: Giampiero De Luca, Arnaud Ythier, Alain Munafo, Maria Lopez-Bresnahan
`
`
`
`Docket No.—: SER.125D1
`
`For
`
`:
`
`Cladribine Regimen for Treating Multiple Sclerosis
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`CLAIM OF PRIORITY UNDER 35 USC 8119
`
`Applicants in the above-identified patent application hereby reaffirmstheir 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 ofthe
`
`foreign priority application be madeofrecord in the subject application pursuant to MPEP 201.14(b).
`
`Respectfully submitted,
`
`
`4
`ff
`
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`
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`
`f
`
`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/b
`
`JASER\I25DI\PTO-Mise\COP.doc/DNB/jb
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 2 of 207
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 2 of 207
`
`

`

`April 23, 2010
`
`INFORMATION DISCLOSURE
`STATEMENT
`Patent Application
`Docket No. SER.125D1
`
`IN THE UNITED STATES PATENT AND TRADEMARKOFFICE
`
`Applicants:
`
`Giampiero De Luca, Arnaud Ythier, Alain Munafo, Maria Lopez-Bresnahan
`
`Docket No.
`
`For
`
`:
`
`:
`
`SER.125D1
`
`Cladribine Regimen for Treating Multiple Sclerosis
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313
`
`
`INFORMATION DISCLOSURE STATEMENT
`UNDER37 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. 11/722,018, 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 ofthe filing date ofpatent 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.
`
`JASER\125DAPTO-Misc\[IDS.do/DNB/jb
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 3 of 207
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 3 of 207
`
`

`

`Docket No. SER.125D1
`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 of 37 CFR §§1.97 and 1.98 are
`met by the foregoing statements.
`
`Respectfully submitted,
`
`
`
`
`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
`
`JASER\L25D\PTO-Misc\IDS.doc/DNB/jb
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 4 of 207
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 4 of 207
`
`

`

`Substitute for form 1449A/PTO
`
`
`Complete if Known
`
`Application Number
`
`INFORMATION DISCLOSURE
`
`
`Filing Date
`April 23, 2010
`STATEMENTBY APPLICANT First Named Inventor|Giampiero De Luca
`
`
`
`
`(use as many sheets as necessary)
`
`Art Unit
`Examiner Name
`
`| SER.125D1
`
`
`
`
`
`U.S. PATENT DOCUMENTS
`«ati
`:
`:
`Document Number
`.
`Pages, Coiumns, Lines, Where
`Examiner
`Cite
`Publication Date
`Nameof Patentee or Applicant
`,
`’
`,
`Number- Kind Code‘
`Dn.
`Relevant Passages or Relevant
`“ae
`lai
`:
`(if
`Initials
`MM-DD-YYYY
`of Cited Document
`Figures Appear
`known
`
`Pout|US-4,964,848 10-23-1990 Bloom
`
`U1
`
`|u2_| US-5,506,214 04-09-1996 Beutler
`
`U2
`US-2010/0021429
`01-28-2010
`Brentzel et ai.
`pO
`US
`us po
`US
`US
`7 po
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`US
`US
`g Ld
`US-
`
`
`>|>|>
`
`
`
`Examiner
`“a
`initials
`
`Cite
`No.'
`
`FOREIGN PATENT DOCUMENTS
`Foreign Patent Document
`—
`PublicationPate
`
`Nameof Patentee or
`Applicant of Cited Document
`
`- Number * - Kind Gade®(if known
`Country Code?
`WO 04/087101 A2
`
`10/14/2004
`
`Pages, Columns, Lines
`Where Relevant Passages
`;or Relevant Figures Appear
`
`8
`PP
`
`
`
` Attorney Docket Number
`
`
`
`
`
`mnWw S|
`
`The Scripps
`7
`
`
`
`
`2 04/26/200|Research InstituteEP 0 626 853 B1 All
`
`||
`
`4
`F5
`1oO
`| mn ~I
`
`|||
`
`Examiner
`Signature
`
`Date
`Considered
`
`Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw fine through citation if not in conformance and not
`*EXAMINER:
`considered.
`include copy of this form with next communication to applicant. ' Applicant's unique citation designation number (optional),
`7 See Kind Codes of
`USPTO Patent Documents at www.uspto.gov or MPEP901.04.
`3 Enter Office that issued the document, by the two-letter code (WIPO Standard T.3).
`* For
`Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document.
`* Kind of document by
`the appropriate symbols as indicated on the document under WIPO Standard ST. 16 if possible.
`® 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 whichis 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 uponthe individual case. Any comments
`on the amountof 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:
`Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`if you need assistance in completing the farm, call 1-800-PTO-9199 (1-800-786-9199) and select option 2.
`
`JASER\L2SDI\PTO-Misc\IDS-form.doc/DNB/jb
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 5 of 207
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 5 of 207
`
`

`

`Substitute for form 1449B/PTO
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(use as many sheets as necessary)
`
`
`
`Application Number
`Fog ba
`ADDS 2010
`
`First Named Inventor
`Giampiero De Luca
`
`
`Group Art Unit
`Examiner Name
`
`
`
`Neurotherapeutics, May 2002, pp. 319-327, Vol. 2, No. 3.
`
`Attorney Docket Number|SER.125D1
`
`NON PATENT LITERATURE DOCUMENTS
`
`
`Examiner|Cite Include name of the author (in CAPITAL LETTERS),title of the article, (when appropriate),title of the
`Xe
`‘
`No.‘
`item (book, magazine,journal, serial, symposium, catalog, etc.), date, page(s}, volume-issue
`Initials
`0.
`publisher, city and/or country where published.
`
`BEUTLER, E. ef a/. “Marrow Suppression Produced by Repeated Doses of Cladribine’,
`Acta Haematol, 1994, pp. 10-15, Voi. 91.
`BEUTLER, E. et a/. “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 a/. “The treatmentof chronic progressive multiple sclerosis with
`cladribine”, Proc. Natl. Acad. Sci. USA, February 1996, pp. 1716-1720, Vol. 93.
`
`R5
`
`ELLISON, G. et a/. “Oral Cladribine for Multiple Sclerosis”, Neurology, March 1997,
`P03.070, pp. A174-A175, Vol. 48, No. 3, XP008047069.
`GRIEB, P. et a/. “Effect of Repeated Treatments with Cladribine (2-Chlorodeoxyadenosine)
`on Blood Counts in Multiple Sclerosis Patients’, Archivum Immunologiae et Therapiae
`Experimentalis, 1995, pp. 323-327, Vol. 43, No. 5-6.
`| KAZIMIERCZUK,Z.et a/. “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. ef a/. “Cladribine: A Review of its Use in Multiple Sclerosis”, Biodrugs, May
`1998, pp. 419-433, Vol. 9, No. 3.
`LASSMANN, H. et a/. “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. ef a/. “Defining the clinical course of multiple sclerosis: Results of an
`international survey”, Neurology, April 1996, pp. 907-911, Vol. 46.
`LUCCHINETT], C. ef a/. “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
`
`Date
`Examiner
`Considered
`Signature
`if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not
`Initial
`*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 whichis 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, PO. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS.
`SEND TO:
`Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`ff you need assistance in completing the form, call 1-800-PTO-9199 (1-800-786-9199) and select option 2.
`
`in conformance
`
`JASERM2SDI\PTO-Miso\IDS-form.doc/DNB/b
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 6 of 207
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 6 of 207
`
`

`

`
`
`Application Number
`
`Filing Date
`April 23, 2010
`First Named Inventor
`Giampiero De Luca
`
`Group Art Unit
`(use as many sheets as necessary)
`~
`—
`Examiner Name
`Attorney Docket Number|SER.125D1
`
`
`
`NON PATENT LITERATURE DOCUMENTS
`
`
`
`Include name of the author (in CAPITAL LETTERS), title of the article,
`(when appropriate), title of the
`nN
`Cite
`Examiner
`item (book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue
`Initials”
`No, '
`number(s), publisher, city and/or country where published.
`
`‘MCDONALD, W.ef 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 a/. “Therapeutic advances in ALS”, Neurology, 1996, pp. S217, Vol. 47,
`Suppl. 4.
`
`
`
`NOSEWORTHY,J. ef a/. “Multiple Sclerosis”, The New England Journal of Medicine,
`September28, 2000, pp. 938-952, Vol. 343, No. 13.
`
`
`
`R oa we
`
`az2 db
`
`a 5
`
`6
`
`POSER, C. et a/. “New Diagnostic Criteria for Multiple Sclerosis: Guidelines for Research
`Protocols”, Annals of Neurology, March 1983, pp. 227-231, Vol. 13, No. 3.
`
`
`aeeeee
`— 7
`
`Substitute for form 1449B/PTO
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`
`
`
`
`
`
`RICE, G. et al. “Cladribine and progressive MS: Clinical and MRI outcomesofa
`multicenter controlled trial’, Neurology, March 2000, pp. 1145-1155, Vol. 54.
`| ROMINE, J. ef af. “A Double-Blind, Placebo-Controlled, RandomizedTrial of Cladribine in
`Relapsing-Remitting Multiple Sclerosis”, Proceedings of the Association of American
`Rig|Physicians, January/February 1999, pp. 35-44, Vol. 111, No. 1.
`SCHUMACHER, G. ef a/. “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.
`
`BO9
`2 A Np
`R23Pe
`
`R20
`
`a8
`
`
`
`SELBY, R. et a/. “Safety and Tolerability of Subcutaneous Cladribine Therapyin
`Progressive Multiple Sclerosis”, Can. J. Neurol. Sci, 1998, pp. 295-299, Vol. 25.
`
`
`SIPE, J. ef af “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.
`
`
`
`
`
`Examiner
`Signature
`in conformance with MPEP 609.
`if reference considered, whether or not citation is
`Initial
`*EXAMINER:
`and not considered. Include copy of this form with next communication to applicant.
`' 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 whichis 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, inciuding
`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:
`Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1-800-PTO-9199 (1-800-785-9199) and select option 2.
`
`Date
`Considered
`Drawline through citation if not
`
`in conformance
`
`JASERMI25D1\PTO-Misc\lDS-form,doc/DNB/jb
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 7 of 207
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 7 of 207
`
`

`

`Electronic Patent Application Fee Transmittal
`
`Title of Invention:
`
`Cladribine Regimen for Treating Multiple Sclerosis
`
`omen
`
`
`
`First Named Inventor/Applicant Name:
`
`Giampiero De Luca
`
`Attorney Docket Number:
`
`SER.125D1
`
`Utility under 35 USC 111(a) Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
`
`Sub-Total in
`USD(S$)
`
`eee
`
`Miscellaneous-Filing:
`
`Petition:
`
`Inc.
`Petitioner TWi Pharms..,
`EX1004, Page 8 of 207
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 8 of 207
`
`

`

`wigs
`
`.
`
`Sub-Total in
`
`Patent-Appeals-and-Interference:
`
`1558
`
`Post-Allowance-and-Post-Issuance:
`
`Extension-of-Time:
`
`Total in USD (S$)
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 9 of 207
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 9 of 207
`
`

`

`
`
`a i
`
`Electronic AcknowledgementReceipt
`
`tis
`
`Title of Invention:
`
`Cladribine Regimen for Treating Multiple Sclerosis
`
`ee
`
`ee
`
`Paymentinformation:
`
`Submitted with Payment
`
`Payment Type
`
`RAM confirmation Number
`
`Deposit Account
`
`Authorized User
`
`yes
`
`Credit Card
`
`271
`
`190065
`
`EISENSCHENK,FRANK C.
`
`}
`
`TheDirector of the USPTO is hereby authorized to charge indicated fees and credit any overpaymentas follows:
`
`ChargeanyAdditional Fees required under37 C.F.R.Section 1.16(National application IBSfiflorand Ti n fees)
`itioner
`hatins., Inc.
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.17 (Patent application and reexamina
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 10 of 207
`
`

`

`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)
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.21 (Miscellaneous fees and charges)
`
`File Listing:
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`Document
`
`Information:
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`gs
`
`File Size(Bytes)/
`
`Multi
`
`Pages
`
`Oath or Declaration filed
`
`executed-Dec-POA.pdf
`
`1226254
`
`d3dc201e3e69a9761 77f6b2ee3b0300478e|
`774ea
`
`177233
`
`df861bbdfb1 bfdf540e391b42e196598ab6a
`d25e
`
`Transmittal Letter
`
`ee
`
`Application Data Sheet
`
`This is not an USPTO supplied ADS fillable form
`
`as-filed.pdf
`
`2518006
`
`dcf85330afeeffa49f41 16e5dccb02b77f549
`810
`
`Multipart Description/PDF files in .zip description
`
`Information:
`
`Information:
`
`Request for USPTO to retrieve priority
`docs
`
`525 1f42b81ac54492d6c14f5¢33a2e2ecAbal
`6208
`
`673900
`
`b5eac3a5ca339072a9a2d03e99cc15b682b
`02eb3
`
`Multipart Description/PDF files in .zip description
`
`EX1004, Page 4 of 207
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 11 of 207
`
`

`

`— InformationDisclosureStatement(IDS)Filed(SB/08)
`
`Information:
`
`Fee Worksheet (PTO-875)
`
`fee-info.pdf
`
`25a2c4f1 08ceeccc23fc7b8dbaa956b63c48
`5577
`
`the application.
`
`New International Application 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 1810), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/105)will be issued in due course, subject to prescriptions concerning
`national security, and the date shownon this AcknowledgementReceiptwill establish the international filing date of
`
`This AcknowledgementReceipt evidences receipt on the noted date by the USPTOofthe 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 Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary componentsfora 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 shownonthis
`AcknowledgementReceiptwill establish thefiling date of the application.
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`National Stage of an International Application 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/903indicating acceptanceof 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.
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 12 of 207
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 12 of 207
`
`

`

`
`
`PTOISBIOTA (09-04)
`Approved for use through 07/31/2506. OMB 9854-9032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERGE
`red to respond to.a collection of informationunless if displays a valid OMB control number.
`
`
`
`
`_inderthe Paperwork Reduction Act of 1995, no persons are redu:
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1.76)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`NG MULT
`Title of
`EN FOR TRE
`Invention
`
`
`
`As the below namedinventar(s), ive declare that:
`
`This declaration is ditected to:
`[| The attached application, or
`
`Application No. _PCT/EP2005/056954
`
`pied
`
`filed on DECEMBER 20, 2005
`
`,
`
`iv}
`
`as amended'on JUNE 18,2007
`
`.
`
`(if applicable).
`
`lave believe that [Ave am/are the original and first Inventor(s} of the subject matter which is claimed and for which a patent is
`sought;
`
`lave have reviewed and understand the contents of the above-identified. application, inchiding the claims, as amended by any
`amendment specifically referred to above;
`
`lwe 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 1.86, including for continuation-in-part applications, material information which
`became available between the filling date of the prior application and. the national or PCT International filing date of the
`continuatior-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 of imprisonment, or both, under 18 U.S.C. 1001, and may jeopardize the validity of the application or any
`
`FULL NAME OF INVEN FOR(S)
` Jy
`inventor one: GIAMMIE a9 DE oA
`
`roy
`‘
`
`
`
`_Citizen of SWITZERLAND
`
`
`
`
`
`Signature:
`
`inventor three: ALAINMUNAFO
`
`
`
`
`Signature:
`
`
`
`
`Inventor four: MARIA LOPEZ-BRESNAHAN.
`
`Signature:
`
`
`Additional Inventors or a legal representative are being
`named on
`<x
`
`
`hereto.
`
`
`
`This collection of information is required by 35 U:S.C. 115.and 37 CFR 1.63. The.
`information
`is required
`to cbtain or retain a benefit by the public whichIs to fle
`land py the USPTO-to process} an appiication. Confidentiality is governed by 35 U.S.C. 122 and: 37 CFR.1.11 and 1.14. This collection i$ estimated to take 1
`minute to complete, including gathering, preparing, and submilting the completed application farmto the USPTO. Time will vary depending upon the individual
`cage. Any coniments on the amount of time you requite te complete this form and/or suggestions for reducing this burden, should be sent to the Chief Informatio
`Officer, US. Patent and Trademark Office, U.S. Department of Commerce, P.O, Box 1450, Alexandria, VA 22313-1490. DO NOT SEND FEES OR COMPLE
`FORMS TO THIS ADDRESS. SEND Ta: Commissionertor Patents, P.O: Box 1450, Alexandria, VA 22349-1460,
`
`
`
`if you need assistance in completing ife form, call 1-800-PTO-9199 and select aption 2
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 13 of 207
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 13 of 207
`
`

`

`PTO/SB/01A (09-04)
`Approved for use through 07/31/2006, OMB 0651-0032
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reditiction Act of 1995 no persons are required to respond to a collection of information unlessif displays a valid OMB control number.
`
`
`
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1.76)
`
`patent issuing thereon.
`
`Title of
`| Invention
`
`
`
`EN FOR TR
`NG MULT
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`As the below named inventor(s), I/we declare that:
`
`This declaration is directed to:
`
`[J The attached application, or
`
`Application No.
`
`_PCT/EP2005/056954
`
`+
`, filed on DECEMBER 20, 2006
`
`as amended on JUNE 18, 2007
`
`(if applicable);
`
`we believe that I/we am/are the original and first inventor(s) of the subject matter which is claimed and for which a patentis
`sought;
`
`lve have reviewed and understand the contents of the above-identified application, including the claims, as amended by any
`amendmentspecifically referred to above;
`
`Wwe 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 thefiling 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 aretrue, all statements made herein on information and belief are believed
`to be true, and further that these statements were made with the knowledge thatwillful 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
`
`FULL NAME OF INVENTOR(S)
`
`Inventor one: GIAMPIERO DE LUCA
`
`Signature:
`
`Citizen of: SWITZERLAND
`
` Inventor two: ARNAU
`Signature:
`iid At
`Z
`f
`iti
`:
`[SWITZERLAND and FRANCE
`
`rrr}
`Inventor three: ALAIN MUNAFO
`
`Signature:
`
`
`Citizen of: SWITZERLAND
`
`Inventor four; MARIA LOPEZ-BRESNAHAN
`
`Signature:eeeCitizen Of. UNITED STATES
`
`Additional inventors or a legal representative are being named onditional form(s) attached hereto,
`L]
`This collection 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 whichis tofile
`{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 amountof 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. Bax 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`if you need assistance in completing the form, call 1-800-P-TO-9199 and select option 2.
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 14 of 207
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 14 of 207
`
`

`

`Under the Paperwork Reduction Act of 1995
`
`PTO/SB/O1A (09-04}
`Approved for use through 07/31/2006. OMB 0657-0032
`U_S. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`persons are required to respond to_a collection of information unless /f displays a valid OMB control number.
`
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET(37 CFR 1.76)
`
`Title of|CLADRIBINE REGIMEN FOR TREATING MULTIPLE SCLEROSIS
`Invention
`
`As the below namedinvenior(s), Ave declare that:
`
`This declarationis directed to:
`
` L| Additional inventors or a legal representative are being named on ————CSCsCnedtionnaal form(s) attached hereto.
`
`Application No.
`
`_PCT/EP2005/056954
`
`, filed on
`
`
`_DECEMBER 20, 2005
`
`:
`
`as amended on _JUNE 18, 2007
`
`(if applicable);
`
`l‘we believe that lAve am/are the original and first inventor(s) of the subject matter which is claimed and for which a patent is
`sought:
`
`lfwe have reviewed and understand the contents of the above-identified application, including the claims, as amended by any
`amendment specifically referred to above;
`
`lAwe 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 aretrue, all statements made herein on information and belief are believed
`to be true, and further that these statements were made with the knowledge thatwillful false statements and the like are
`punishable by fine ar 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:
`
`
`Citizen of: SWITZERLAND
`
`Inventor two: ARNAUD YTHIER
`
`Signature:
`
`
`Citizen of: SWITZERLAND and FRANCE
`
`
`
`
`Signature:
`1 hewn
`td”
`
`Citizen of: SWITZERLAND
`
`
`Inventor four. MARIA LOPEZ-BRESNAHAN
`
`Signature:
`
`Citizen of: UNITED STATES
`
`This collection of information is required by 35 U.S.C. 115 and 37 CFR 1.83. The information is required to obtain or retain a benefit by the public whichis 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 22813-1450. 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-PTO-9199 andselect aption2.
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 15 of 207
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 15 of 207
`
`

`

`PTO/SB/O01A (08-04)
`Approved for use through 07/31/2006. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respondto a collection of information unlessif displays a valid OMB control number.
`
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET(37 CFR 1.76)
`
`
`
`Title of
`Invention
`
`
`
`
`
`
`
`
`
`
`I
`;
`;
`
`
`
`
`
`
`
`
`
`;
`NG MULT
`
`As the below named inventor(s), I/we declare that:
`
`| This declaration is directed to:
`
`[] The attached application, or
`
`
`
`Application No.
`
`_PCT/EP2005/056954
`
`, filed on _DECEMBER20, 2005
`
`,
`
`as amended on _JUNE 18, 2007
`(if applicable).
`lwe believe that IMwe am/are the original and first inventor(s) of the subject matter which is claimed and for which a patent is
`sought:
`
`liwe have reviewed and understand the contents of the above-identified application, including the claims, as amended by any
`amendmentspecifically referred to above:
`
`live 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 thatwillful 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
`
`Citizen of: SWITZERLAND
`
`Signature:
`
`Citizen of: SWITZERLAND and FRANCE
`
`Inventor three: ALAIN MUNAFO
`
`Signature:
`
`
`
`Citizen of: SWITZERLAND
`
`
`Inventor four: MARIA LOPEZ-BRESNAHAN
`.
`a
`LPO gt ane ge
`be
`
`Signature:
`
`Citizen of UNITED STATES
`
`
`
`__ additional form(s) attached hereto.
`epee os
`Additional inventors or a legal representative are being named on
`
`This collection of information is required by 35 U.S.C, 115 and 37 CFR 1.63. Theinformation is required to obtain or retain a benefit by the public whichis tofile
`(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 amountof time you require to complete this form and/or suggestions for reducing this burden, shoufd be sent to the ChiefInformation
`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: Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`
`
`/f you need assistance in completing the form, call 1-800-PTO-9199 and select option 2.
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 16 of 207
`
`Petitioner TWi Pharms., Inc.
`EX1004, Page 16 of 207
`
`

`

`PTO/SB/81 (04-05)
`Approved for use through 11/30/2005. OMB 0651-0035
`U.S. Patent and Trademark Office; U.S. DE