IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re application of:
`
`LUKASHEV et al.
`
`Confirmation No.: To be assigned
`
`Art Unit: To be assigned
`
`Appl. No.: To be assigned
`(Continuation of Appl. No. 12/526,296;
`§ 371 (c) Date: January 13, 2011)
`
`Filed: Herewith
`For: Treatment for Multiple Sclerosis
`(As Amended)
`
`Examiner: To be assigned
`
`Atty. Docket: 2159.3210002/JMC/MRG/U-S
`
`First Supplemental Irrformation Disdosure Statement
`
`Commissioner for Patents
`PO Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`Listed on accompanying IDS Forms PTO/SB/08a equivalent and/or PTO/SB/08b
`
`equivalent are documents that may be considered material to the patentability of this
`
`application as defined in 37 C.F.R. §1.56, and in compliance with the duty of disclosure
`
`requirements of 37 C.F.R. §§ 1.97 and 1.98.
`
`Where the publication date of a listed document does not provide a month of
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`publication, the year of publication of the listed document is sufficiently earlier than the
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`effective U.S. filing date and any foreign priority date so that the month of publication is
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`not in issue. Applicants have listed publication dates on the attached IDS Forms based
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`on information presently available to the undersigned. However, the listed publication
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`dates should not be construed as an admission that the information was actually
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`published on the date indicated.
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`Page 1 of 85
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`Biogen Exhibit 2017
`Mylan v. Biogen
`IPR2018-01403
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`

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`LUKASHEV et al.
`Appl. No. To be assigned
`
`Applicants reserve the right to establish the patentability of the claimed invention
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`over any of the information provided herewith, and/or to prove that this information may
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`not be prior art, and/or to prove that this information may not be enabling for the
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`teachings purportedly offered.
`
`This statement should not be construed as a representation that a search has been
`
`made, or that information more material to the examination of the present patent
`
`application does not exist. The Examiner is specifically requested not to rely solely on
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`the material submitted herewith.
`
`Applicants have checked the appropriate boxes below.
`
`D 1. Statement under 37 C.F.H .. l.704(d). Each item of information contained in this
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`Information Disclosure Statement was first cited in a communication from a
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`foreign patent office in a counterpart application and this communication was not
`
`received by any individual designated in 37 C.F.R. § l.56(c) more than thirty
`
`days prior to the filing of this information disclosure statement.
`
`~ 2. Filing under 37 C.F.R. § l.97(b). This Information Disclosure Statement is being
`
`filed within three months of the date of filing of a national application other than
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`a continued prosecution application (CPA), OR within three months of the date of
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`entry of the national stage as set forth in 3 7 C.F .R. § 1.491 in an international
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`application, OR before the mailing date of a first Office Action on the merits OR
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`before the mailing of a first Office Action after the filing of a request for
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`continued examination under 37 C.F.R. § 1.114. No statement or fee is required.
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`Atty. Dkt. No. 2159.3210002/JMC/MRG/U-S
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`Page 2 of 85
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`LUKASHEV et al.
`Appl. No. To be assigned
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`D 3. Filing under 37 C.F.R. § 1.97(c). This Information Disclosure Statement is being
`
`filed more than three months after the U.S. filing date AND after the mailing date
`
`of the first Office Action on the merits, but before the mailing date of a Final
`
`Rejection, or Notice of Allowance, or an action that otherwise closes prosecution
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`in the application.
`
`D a. Statement under 37 C.F.R. § 1.97(e)(l). I hereby state that each
`
`item of information contained in this Information Disclosure
`
`Statement was first cited in any communication from a foreign
`
`patent office in a counterpart foreign application not more than
`
`three months prior to the filing of this Information Disclosure
`
`Q
`
`Statement. 37 C.F.R. § l .97(e)(l).
`
`Db. Statement under 37 C.F.R. § l .97(e)(2). I hereby state that no item
`
`of information in this Information Disclosure Statement was cited
`
`in a communication from a foreign patent office in a counterpart
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`foreign application and, to my knowledge after making reasonable
`
`inquiry, was known to any individual designated in 3 7 C.F .R.
`
`§ 1.56( c) more than three months prior to the filing of this
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`Information Disclosure Statement. 37 C.F.R. § 1.97(e)(2).
`
`D c. Attached is our PTO-2038 Credit Card Payment Form in the
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`amount of $180.00 in payment of the fee under 37 C.F.R. §
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`l.17(p).
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`Atty. Dkt. No, 2159.3210002/JMC/MRG/U-S
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`Page 3 of 85
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`-4-
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`LUKASHEV et al.
`Appl. No. To be assigned
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`D 4. Filing under 37 C.F.R. § 1.97(d) This Information Disclosure Statement is being
`
`filed more than three months after the U.S. filing date and after the mailing date
`
`of a Final Rejection or Notice of Allowance, but on or before payment of the
`
`Issue Fee. Enclosed find our PTO-2038 Credit Card Payment Form in the
`
`amount of $180.00 in payment of the fee under 37 C.F.R. § l.l 7(p); in addition:
`
`D a. Statement under 37 C.F.R. § 1.97(e)(l). I hereby state that each
`
`item of information contained in this Information Disclosure
`
`Statement was first cited in any communication from a foreign
`
`patent office in a counterpart foreign application not more than
`
`three months prior to the filing of this Information Disclosure
`
`Statement. 37 C.F.R. § 1.97(e)(l).
`
`Db. Statement under 37 C.F.R. § 1.97(e)(2). I hereby state that no item
`
`of information in this Information Disclosure Statement was cited
`
`in a communication from a foreign patent office in a counterpart
`
`foreign application and, to my knowledge after making reasonable
`
`inquiry, was known to any individual designated in 37 C.F.R. §
`
`1.56( c) more than three months prior to the filing of this
`
`Information Disclosure Statement. 37 C.F.R. § l.97(e)(2).
`
`D 5. The document(s) was/were cited in a search report by a foreign patent office in a
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`counterpart foreign application. Submission of an English language version of
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`the search report that indicates the degree of relevance found by the foreign office
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`Atty. Dkt. No. 2159.3210002/JMC/MRG/U-S
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`Page 4 of 85
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`LUK,ASHEV et al.
`Appl. No. To be assigned
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`is provided in satisfaction of the requirement for a concise explanation of
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`relevance. 1138 OG 37, 38 and MPEP 609.04(a)(III).
`
`~ 6. A concise explanation of the relevance of the non-English language documents
`
`appears below in accordance with 37 C.F.R. § l.98(a)(3).
`
`Document FPl, JP 54-80439 A. is in the Japanese language. An English
`
`language abstract of document FP1 is cited as document NPLl and submitted
`
`herewith.
`
`Document FP2, EP O 188 749 A2, is in the Gennan language. Document US3 is
`
`believed to be an English-language equivalent of document FP2.
`
`Document FP4, EP O 312 697 A2, is in the German language. Document US4 is
`
`believed to be an English-language equivalent of document FP4.
`
`Document FPS, DE 38 34 794 Al, is in the German language. An English
`
`language abstract of document FPS is cited as document NPL2 and submitted
`
`herewith.
`
`Document FP6, EP O 518 388 A2, is in the German language. Document US4 is
`
`believed to be an English-language equivalent of document FP6.
`
`Document FP7, .JP 6-345644 A, is in the Japanese language. An English
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`language abstract of document FP7 is cited as document NPL3 and submitted
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`herewith.
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`Atty. Dkt. No. 21593210002/JMC/MRG/U-S
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`Page 5 of 85
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`LUKASHEV et al.
`Appl. No. To be assigned
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`Document FP9, .JP 8-99906 A, is in the Japanese language. An English language
`
`abstract of document FP9 is cited as document NPL4 and submitted herewith.
`
`Document FP13, .JP 9-221428 A, is in the Japanese language. An English
`
`language abstract of document FP13 is cited as document NPLS and submitted
`
`herewith.
`
`Document FPlS, WO 97/48405 Al, is in the Russian language. An English
`
`language abstract of document FP 15 is cited as document NPL6 and submitted
`
`herewith.
`
`Document FP19, DE 197 21 099 Al, is in the German language. Document
`
`US 14 is believed to be an English-language equivalent of document FP 19.
`
`Document F.P:23, RU 2 189 813 Cl, is in the Russian language. An English
`
`language abstract of document FP23 is cited as document NPL 7 and submitted
`
`herewith.
`
`Document FP25, WO 2005/027899 Al, is in the German language. An English
`
`language abstract of document FP25 is cited as document NPL8 and submitted
`
`herewith.
`
`Document FP37, CN 1125141 A, is in the Chinese language. An English
`
`language abstract of document FP37 is cited as document NPL292 and submitted
`
`herewith.
`
`Atty. Dkt. No. 2159.3210002/JMC/MRG/U-S
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`Page 6 of 85
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`-7-
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`LUKASHEV et al.
`Appl. No. To be assigned
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`Document NPL28, Ducker and Pfeiff, is in the German language. An English
`
`language abstract of document NPL28 can be found on the face page of the
`
`publication.
`
`Document NPL31, Fliegner and Spiegel, is in the German language. An
`
`English language abstract of document NPL31 can be found on the face page of
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`the publication.
`
`Document NPL48, Hunziker and Schmidli, is in the German language. It is
`
`believed that document NPL4 7 is a partial English language translation of
`
`document NPL48.
`
`Document NPL163, Gutzmer et al., is in the German language. An English
`
`language abstract of Document NPL163 is cited as document NPL164 and
`
`submitted herewith.
`
`Document NPL165, Hagedorn et al., is in the German language. An English
`
`language abstract of document N :-L165 can be found on the face page of the
`
`publication.
`
`Document NPL187, Roodnat et al., is in the German language. An English
`
`language abstract of document NPL 187 can be found on the face page of the
`
`publication.
`
`Document NPL191, Schilling and Schopf, is in the German language. An
`
`English language abstract of document NPL191 can be found on the face page
`
`of the publication.
`
`Atty. Dkt. No. 2159.3210002/JMC/MRG/U-S
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`Page 7 of 85
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`LUKASHEV et al.
`Appl. No. To be assigned
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`Document NPL198, Van Loenen et al., is in the Dutch language. An English
`
`language abstract of document NPL 198 can be found on the face page of the
`
`publication.
`
`Document NPL202, Wanscher and Sorensen, is in the Danish language. An
`
`English language abstract of document NPL202 can be found on the page 6357
`
`of the publication.
`
`Document NPL210, Immunmodulation durch Fumaderm. Das richtungsweisende
`
`Konzept, is in the German language. It is believed that document NPL211 is a
`
`partial English language translation of document NPL210.
`
`Document NPL215, Bayard et al, is in the German language. An English
`
`language abstract of document NPL2 l 5 can be found on the face page of the
`
`publication.
`
`Document NPL234, "Klinische Studie mit Fumaderm® als magensaftresistente
`
`Mikrotabletten," the first three pages are in the German language. An English
`
`language translation of pages 1-3 of document NPL234 can be found on pages 4-
`
`6 of the same document.
`
`Document NPL247, Peeters et al, is in the Dutch language. An English
`
`language abstract of document NPL24 7 can be found on the last page of the
`
`publication.
`
`Atty. Dkt. No. 2159.3210002/JMC/MRG/U-S
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`Page 8 of 85
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`- 9 -
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`LUKASHEV et al.
`Appl. No. To be assigned
`
`Document NPL257, Stangel et al, is in the German language. An English
`
`language abstract of document NPL257 can be found on page 215 of the
`
`publication.
`
`Document NPL258, Stiihlinger et al, is in the German language. An English
`
`language abstract of document NPL258 can be found on the face page of the
`
`publication.
`
`D 7. Copies of the documents are submitted. However, in accordance with 3 7 C.F .R.
`
`§ l .98(a)(2), no copies of U.S. patents and patent application publications cited as
`
`documents US1-US40 on the attached IDS Forms are submitted.
`
`~ 8. Copies of documents FP1-FP50 and NPL1-NPL293 were cited by or submitted to
`
`the Office in an IDS that complies with 37 C.F.R. § l.98(a)-(c) in Application
`
`No. 12/526,296, with a§ 371(c) date of January 13, 2011, which is relied upon
`
`for an earlier filing date under 35 U.S.C. § 120. Thus, copies of these documents
`
`are not attached. 37 C.F.R. § l.98(d).
`
`~ 9.
`
`It is expected that the examiner will review the prosecution and cited art in the
`
`parent application no. 12/526,296 in accordance with MPEP 2001.06(b), and
`
`indicate in the next communication from the office that the art cited in the earlier
`
`prosecution history has been reviewed in connection with the present application.
`
`~ 10. In accordance with the Federal Circuit decision in Dayco Prods., Inc. v. Total
`
`Containment, Inc. 329 F.3d 1358 (Fed. Cir. 2003), Applicants submit herewith
`
`Office Actions from the co-pending U.S. Patent Application Nos. 09/194,862, §
`
`Atty. Dkt. No. 2159.3210002/JMC/MRG/U-S
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`Page 9 of 85
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`- 10 -
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`LUKASHEV et al.
`Appl. No. To be assigned
`
`371(c) date July 8, 1999; 09/402,103, § 371(c) date September 27, 1999;
`
`09/743,978, § 371(c) date January 17, 2001; 09/831,620, § 371(c) date May 10,
`
`2001; 10/148,858, § 371(c) date May 28, 2002; 10/197,077, filed July 17, 2002;
`
`11/765,563, filed June 20, 2007; 11/765,578, filed June 20, 2007; 12/405,661,
`
`filed March 17, 2009; and 12/405,665, filed March 17, 2009, as documents
`
`NPL269-NPL291.
`
`The identification of these Office Actions is not to be construed as a waiver of
`
`secrecy as to those applications now or upon issuance of the present application
`
`as a patent. The Examiner is respectfully requested to consider the cited
`
`applications and the art cited therein during examination.
`
`It is respectfully requested that the Examiner initial and return a copy of the
`
`enclosed IDS Forms, and indicate in the official file wrapper of this patent application
`
`that the documents have been considered.
`
`Atty. Dkt. No. 2159.3210002/JMC/MRG/U-S
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`Page 10 of 85
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`- 11 -
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`LUKASHEV et al.
`Appl. No. To be assigned
`
`The U.S. Patent and Trademark Office is hereby authorized to charge any fee
`
`deficiency, or credit any overpayn1ent, to our Deposit Account No. 19-0036.
`
`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & Fox P.L.L.C.
`
`Marsha A. Rose
`Attorney for Applicants
`Registration No. 58,403
`
`Date:
`
`1100 New York A venue, N. W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`1476774 .. ).DOCX
`
`Atty. Dkt. No. 2159.3210002/JMC/MRG/U-S
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`Page 11 of 85
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`

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`Substitute for form 1449/PTO
`
`FIRST SUPPLEl\rlENTAL
`INFORL"\'IATION DISCLOSURE
`STATE1\r1ENT BY APPLICANT
`((]se as mat~}' sheets as necessaly)
`i 1
`7
`
`Sheet
`
`Equivatent of Form PTO!S8i08a (07-09)
`Complete if Known
`
`I
`
`_____ .._, ... ,.... --- --------1
`Application Number
`To be assigned··--·-·------
`Here"vith
`Filing Date
`First Nanied Im-,e~.!-lt_o_r __ ___,_tv_1atvev E-.. -. -L-l-JK_A_S_H_F_,-\;~,--
`r~A-r_t_u_· .,-n-i-t - - - - - - - -........ ..:..'J ... oc:.:..:..b ... e:,.,ac:.._.,~;S ... i~ ... <;=n~e::..:d==.::.::.::...:.:.:::...:... ........ .. ···-
`f----------················ .. ·Y"' ----........s·a...,.. __ _
`To be assigned
`Examiner Name
`Attorney Docket Number
`2159.3210002/JMC/MRG;U-S
`
`lJ.S. PATENT DOCUMENTS
`
`Pub1ic!!tion Date
`t,.fM-DD-YYYY
`
`Nam~ of Patentee or
`Applicant of Cited Document
`
`Pages 1 Cc-lu1n;,:;, Lines~ \V'11ere
`Rci~vant Passages or Ri;,lev:.mt Figure~ A .. ppear
`
`05-07-1985
`05-24-1988
`07-25-1989
`09-25-1990
`09-22-1992
`05-25-1993
`09-07-1993
`10-25-1994
`06-13-l 995
`09-19.,1995
`08-21-2001
`03-12-2002
`03-19-2002
`08-20-2002
`01-21-2003
`02-22-2005
`01-02-2007
`0 !-22-2008
`10-07-2008
`I J-03-2009
`
`Zecher et al.
`Sato et al.
`Speiser et al.
`Speiser et al.
`Speiser et al.
`Blank
`Blank
`Blank
`Speiser et al.
`Speiser et al.
`Joshi et al.
`Joshi et al.
`Joshi et al.
`Joshi et al.
`Joshi et al.
`Joshi et al.
`Joshi et al.
`Joshi et al.
`Joshi et al.
`Joshi et al.
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`FOREIGN PATENT uocuivn.:NTS
`
`Exruniner
`initia!s*
`
`Cite
`No.l
`
`US!
`TJS2
`US3
`US4
`USS
`US6
`US7
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`lJS9
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`No. 1
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`Document Number
`Nnmb~r-Kind Cvde 2 Or
`k.t1ov1n}
`4,515,974
`4,746,668
`4,851,439
`4,959,389
`5,149,695
`5,214,196
`5,242,905
`5,359,128
`5,424,332
`5,45 l ,667
`6,277,882 Bl
`6,355,676 Bl
`6,359,003 Bl
`6,436,992 B 1
`6,509,376 Bl
`6,858,750 B2
`7,157,423 B2
`7320,999 B2
`7,432,240 B2
`7,612,J 10 B2
`- . -. --· .- ----~~~~~--~-
`
`Foreign Patent Document
`
`Pubhcation
`Date
`1\,flvJ~DD-YYYY
`
`Nan,e of Patente--e er
`Applic;mt ofCitd Document
`
`P~ges~ Cohrrrm'.}, Line-~~
`\,Vhere Relevant Passages c,r
`Rd~viwt F\gun:~s. Appear
`
`-.r6
`
`Country Code3-Number4,Kind
`Code5 (if known)
`JP 54-80439 A
`Ogawa Hiroe
`FP1
`06-27-1979
`Speiser et al.
`EP O 188 749 A2
`07-30-1986
`FP2
`Dexter Biotechnics
`03-09-1989
`WO 89/01930 Al
`FP3
`04-26-1989
`Speiser et al.
`FP4
`EP O 312 697 A2
`Schiele in, F.
`DE 38 34 794 Al
`FPS
`04-19-1990
`12-16-1992
`Speiser et al.
`EP O 513 388 A2
`FP6
`, - -~ - - i F--p-7-+!-JF-,-6-. --3-4_5_6_4_4-,-,\-----12-.• --2-0 ___ i_9_9_4_'-!~LJ-"1n-i-ti-.k-a-L-td-.. -----------+--------·---·-· ......... .
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`................... ~.FP8 ___ _j \V094/2888J _A 1 ............ J?.::??.::~2~_':~ ..... L ?~·(}\Vfl, Rax!.:::?!'_d ____ ...................... .
`
`Examiner
`Signature
`
`Date
`Considered
`
`*EXAMINER: Initial ifreference considered, whether or notcitation is in conformance with MPEP 609. Draw line through citation if not in conformance and
`not considered. Include copy of this form with next communication to applicant. 1 Applicant's unique citation designation number (optional). 2 See Kinds
`Codes of USPTO Patent Documents at www.uspto.gov or MPEP 901.04. 3 Enter Office that issued the document, by the two-letter code (WIPO Standard
`ST.3). 4 For 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.
`
`Page 12 of 85
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`Substilute for fom1 1449/PTO
`
`Equivalent of Form PTOiSB/OBa (07-U&)
`Complete if Known
`
`_FIRST SUPPLEIVIENT AL
`/ Application Number
`Filing Date
`INFORlVi:ATION DISCLOSURE
`First Named Inventor
`STATEJVIENT BY APPLICANT
`Art Unit
`! Exarniner Nmne
`(Ure as many sheets as necessary)
`~ .................. -,-----r--r-----------
`I 2
`........... TAtt~~~;-~y Docket Number
`! of i
`Sheet
`7
`! ----- --
`i
`
`U.S. PATENT DOCUMENTS
`--
`
`~
`
`( }7~-!~:.~,tshs, igned ....................................... .
`·i_-: -.:c,,·
`Matvey E. LUKASHEV
`To be assigned
`............................. .
`To he assiane,-f
`-"-
`.
`2159.32100!)2/JMC/MRG!U-S ·-
`
`•'-•-••••-•-•--•-••-••••-,,.,,.,.,,,.._,
`
`---
`
`- - - - -A·
`
`. - - - - - - · . - - - - - - .-..-...
`
`Examiner
`initials*
`
`Exwnine-r
`initi~ls*
`
`c;tc
`;s,1o_l
`
`Publication Date
`1'.1l'vi-DD--YYYY
`
`Name of Patenteic or
`Aµplic,i;;t of Cit;;od Document
`
`Document Number
`Number-Kind Code 2 (if
`knc,wn)
`US21
`7,619,001 B2
`11-17-2009
`Joshi et al.
`US22
`7,790,916 B2
`09-07-2010
`Josbi et al.
`7,803,840 B2
`US23
`09-28-2010
`Joshi et al.
`7,915,310 B2
`US24
`03-29-2011
`Joshi et al.
`2004/0054001 A1
`US25
`03-18-2004
`Joshi et al.
`US26
`09-25-2008
`2008/0233185 Al
`Joshi et al.
`2010/0130607 Al
`05-27-2010
`US27
`Gold
`US28
`07-23-1996
`5,538,968
`Chiesi et al.
`5,548,059
`08-20-1996
`US29
`Bayley et al.
`Clikeman et al.
`i0-26-1999
`5,972,363
`US30
`6,812,248 B2
`Zhang et al.
`US31
`11-02-2004
`Rath
`06-06-2006
`7,056,950 B2
`US32
`Black et al.
`10-09-2007
`7,279,331 B2
`US33
`Black et al.
`04-29-2008
`7,364,900 B2
`US34
`Anilkumar et al.
`08-26-2008
`7,417,045 B2
`US35
`12-29-2009
`Johnson et al.
`7,638, l 19 B2
`US36
`Rischer et al.
`Ol-l8-20l 1
`7,871,977 B2
`US37
`2003i0176365 A•
`Blass
`09-18-2003
`US38
`11-03-2005
`Blass
`2005/0245612 Al
`1.JS39
`04-17-2008
`Vlent et al.
`2008i008986 l Al
`US40
`................. ---------- .... -.----····~~"----------------· ···-- ····------------ ··- .-.••.... ~.,.-~------ ---------· .......... ·-··-·--·---- .... · -·-·-••-~--···-------
`
`Pages, Columns. Lines, Where
`Relevant Passages or Relevant Figures Appear
`
`(
`
`:
`
`F!Jrdg:n Pat,;;nt Document
`
`Cite
`No. 1
`
`Cuunlry Code3-Nun1b€-r4-
`Kind Codt:5 (jfkrvJwu)
`JP 8-99906 A
`FP9
`FP10 WO 97 /09984 A 1
`FPll
`vVO 97/13504 Al
`FP12 CA 2,248,955 A 1
`JP 9-221428 A
`FP13
`FP14 WO 97/44054 A2
`FP15 WO 97/48405 _Al
`FPl 6 WO 98/04290 A2
`
`.Fages_ Column::,
`Lines_ WD.ere R_i;_;fevaut
`Pas:sages or Rdevanl
`Figrnes Appear
`
`_FOREIGN PATENT HOC1JIVIENTS
`Publication
`D,1te
`M?>,I-DD--YYYY
`
`N:1me vf P;;tentee or
`Appl!cant r;fCi'::ect Dcrnunent
`
`04-16-1996
`03-20-1997
`04-17-1997
`05-20-1997
`08-26-1997
`ll-27-1997
`12-24-1997
`02-05-1998
`
`Chugai Pharmaceutical Co., Ltd.
`Takeda Chemical Industries, Ltd.
`Medgene Limited
`Fmnaphann AG
`Fuj lsawa Pharmaceutical Co.
`University of Alberta
`Belyaev, Jury Evgenievich
`Perrine et al.
`
`Examiner
`Signature
`
`Date
`Considered
`
`*EXAMINER: Initial if reference considered. whether or notcitation is in conformance with MPEP 609. Draw line through citation if not in conformance and
`not considered. Include copy of this form with next communication to applicant. 1 Applicant's unique citation designation number (optional). 2 See Kinds
`Codes ofUSPTO Patent Documents at www.uspto.gov or MPEP 901.04. 3 Enter Office that issued the document, by the two-Jetter code (WIPO Standard
`ST.3). 4 For 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.
`
`Page 13 of 85
`
`

`

`Substitute for form 1449/PTO
`
`LApplicationNumber
`FIRST SUPPLElVlENTAL
`I Filing Date
`INFORl\/lATION DISCLOSURI:i:
`1 First Named Inventor
`STATEIVlENT BY APPLICANT
`L.~!:!.Y~.~!........
`(Use as many sheets as neces_,_a_"J_:) ______ \ Examiner Name
`nf i
`! 3
`j Attomeypocket Number
`7
`
`Sheet
`l ~,_, ___ _
`
`E1uivalent of Form PTO/SB/08a (07-09)
`Complete if Known
`To be assigned
`Her._e_w.-ith---'"'-----------4
`Mat~ey"iI"i:iJMSHEV
`------~
`To be assi[I'!.~A-... -.. -.-·-···----·--·----------~
`To be assi5<ned
`2159.3210002/JMC/MRG/U-S
`
`Examiner
`initials•
`
`Cite
`No. 1
`
`Document Number
`Number-Kind Code 2 (if
`known)
`
`Publication Date
`MM-DD-YYYY
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant Figures Appear
`
`U.S. PATENT DOCUMENTS
`
`/
`
`j
`
`·····-···· ..................................... _ ............................ L ....... , ................................................... ,,, ............................................. · . .-...... ,, ....... -
`
`................... •
`
`:;·· .. ----------------~«-••---· ·--·-------
`FOREIGN PATENT DOCUMENTS
`Publication
`Date
`MM-DD-YYYY
`
`~ Examiner
`1 initials*
`~--·-·
`
`' Foreign Patent Document
`~
`
`Cite
`No. 1
`
`Country Code3-Number4-
`Kind Code5 (if known)
`FP17 WO 98/27970 A2
`FP18 EP O 852 233 Al
`FP19 DE 197 21 099 Al
`FP20 WO 99/21565 Al
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines,
`Where Relevant Passages
`or Relevant Figures Appear
`
`T6
`
`07-02-1998 National Research Council of Canada
`07-08-1998 Nippon Shinyaku Company, Limited
`11-26-1998 Fumapharm AG
`05-06-1999 Cornell Research Foundation, Inc.
`Philadelphia Health and Education
`• Corporation; University of Medicine and
`Dentistt,' ofNew Jersev
`. ...... ,:-
`.
`Johns Hopkins School of Medicine
`Rossijskij NII Gematologii Transfuziologii
`National Research Council of Canada
`----~----------------············-------------- ----·- -·-·····~·-·--------------- .
`---------
`Date
`Considered
`
`t
`i
`1
`
`········------------ -----------···-•·-•· , ......... \
`
`!
`
`FP21
`
`WO O 1/59072 A 1
`
`08-16-2001
`
`l t FP22
`
`FP23
`FP24
`------------ -- --.. -.--,- -------
`Examiner
`Signature
`
`01-10-2002
`WO 02/02190 A2
`09-27-2002
`RU 2 189 813 Cl
`04-24-2003
`WO 03/032969 A2
`-----------···· .. ·--------------- ••••••••••••••••••h -------------·--- ...........
`
`*EXAMINER: Initial if reference considered, whether or notcitation is in conformance with MPEP 609. Draw line through citation if not in conformance and
`not considered. Include copy of this form witt, next communication to applicant. 1 Applicant's unique citation designation number (optional). 2 See Kinds
`Codes of USPTO Patent Documents at www.uspto.gov or MPEP 901.04. 3 Enter Office that issued the document, by the two-letter code (WIPO Standard
`ST.3). 4 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. 6 Applicant is to place a check mark here if
`English language Translation is attached.
`
`Page 14 of 85
`
`

`

`Substitute for form 1449/PTO
`
`FIRST SUPPLEMENTAL
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Equivalent of Form PTO/SS/08a (07-09}
`Complete if Known
`··:\i:,i;ii~;t1~;;;·N~i;;b~;:··············T··;;~;·:~;~··~;;;·;g~~~i···································-·····
`l H~~~~v·iili
`··--········-"----------
`.. Yiling Date
`Matvey E. LUK.A.S:HEV
`-First Named Inventor
`Art Unit
`To be assigned
`
`U.S. PATENT DOCUMENTS
`
`Exatniuer
`1niiials~
`
`Cite
`No. 1
`
`Docurn.ent Number
`Number-Klnd Codt~ 2 {if
`known)
`
`Public.mien Date
`MM-DD-YYYY
`
`Name of P;,tenk;e or
`AppLcant of Cited Document
`
`Pages, Cnfo:mns~ Lines, Wh<:re
`Rdev;;nt Passages or Rckvanl Figures Appear
`
`-----------t-----,1------------+-------+------------+-------------~---'
`
`r ~-----+--------~------+--------1---~--------------~------------
`
`............. L ···----------·--.
`
`.. FOREIGN PATENT DOCUMENTS
`
`. .................... , .......... "._ ......................................................................... ,
`------···--·········••-.
`
`Exammer
`initials·'-
`
`.Pubhcatiurr
`Date
`:tvIM·-DD-YYYY
`
`Foreign Patent Document
`Cite No 1 Country Code3-Number4-Kin<l
`Code5 (if known)
`FP25 WO 2005/027899 Al 03-3 l-2005
`FP:26 WO 2006/037342 A2 04- i 3-2006
`\VO 2006/050730 Al 05-18-2006
`FP27
`FP28 WO 2006/055871 A2 05-26-2006
`,~----1
`.FP29 WO 2007/006307 A2 Ol-18-2007
`FP30 WO 2007 /042035 A2 04- l 9-2007
`FP31 WO 2008/0%271 A2 I 08-14-2008
`FP32 WO 2008/097596 A2 l 08-14-2008
`
`< . . . . . . . . . . . . . . . . . . . . -.~ •••••• ______________ ------····•• .. ·········------------- - ---- ••••••• ~~--~
`
`Nan,~ 0f Patent,;;;e er
`i\.pp1:Canr of C~ted Docrnnent
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`T6
`
`Heidland, August
`Aditech Pharma AB
`Aditech Phanna AB
`Biogen Idec MA Inc.
`Aditech Pharma AB
`Aditech Pham,a AB
`Gold, Ralf
`
`.Biogen. Idec J\,1A.Inc ... _ ........................................... "· ··•• .. •····---··--·--·•----·
`
`Examiner
`Signature
`
`Date
`Considered
`
`*EXAl\1INER: Initial if reference considered, whether or notcitation is in conformance with MPEP 609. Draw line through citation If not in conformance and
`not considered. Include copy of this form with next communication to applicant. 1 Applicant's unique citation designation number (optional). 2 See Kinds
`Codes of USPTO Patent Documents at wv.w uspto.gov or MPEP 901.04. 3 Enter Office that issued the document, by the two-letter code (WIPO Standard
`ST.3). 4 For 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 languag'<' Translatioo is attached.
`
`Page 15 of 85
`
`

`

`Substitute for form 1449/PTO
`
`:FIRST SUPPLI(J'VIENTAL
`INFOR1VlATION DISCLOSURE
`S'l'ATEIV[ENT BY APPLICANT
`
`..
`Filing Date
`First Named Inventor
`! Art Unit
`·
`,·--··
`
`. ... .
`
`Equivalent of Form PTO/SB/08a (07-09)
`Complete if Known
`r--:A_p_p_l_ic_a_t-io_n_N_u_m_b_er-----,,!-T._o_b_e_a_s_s~ig_n_e_d_~~-------·------------···--
`l Herewith
`l Matv_e_'i_" -E-. _L_UE_KA __ S_H_E_V-------1
`7 To be ~ssigned
`~S_h_e_e_t----T~ as m7:t7sas ;:::_si_;::._-,:i_'J _______ ._: ~!~~:;!.~~~=t Number ... ~--~~ 5~~3a;:~i~~-;-d-/JM--C-/M--R-G_/U __ -s~·-·--··
`
`'
`
`~ - - - - - - - - - - -1
`
`r-· Examiner
`
`initials*
`
`Cite No. I
`
`Document Number
`Number-Kind Code 2 (if
`known)
`
`U.S. PATENT DOCUMENTS
`
`Publication Date
`MM-DD-YYYY
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant Figures Appear
`
`, ........................ , ................................................... •················ ................................. ····•··········· ................................ ·······•·· ........ ·········. ···········•··••••·························
`- ----~-
`...
`----~-
`...
`..
`··------------
`FOREIGN PATENT DOCUMENTS
`Publication
`Date
`tvfM-DD-YYYY
`
`~~~-
`
`~H -
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`Foreign Patent Document
`Cite No.I Country Code3-Number4-Kind
`Codes (if known)
`FP33 WO 95/25102 Al
`FP34 WO 96/01122 Al
`FP35 GB2 291422 A
`
`r·
`'
`
`Examiner
`initials*
`
`'
`:
`1
`'
`
`l
`
`I
`
`T6
`
`I
`
`' '
`---~
`
`09-21-1995 Novo Nordisk A/S
`01-18-1996
`Dana-Farber Cancer Institute
`j Fujisawa Pharmaceutical Co., Ltd
`01-24-1996
`! The Trustees of the University of
`Pennsylvania; Apollon, Inc.
`Zhongmei Huadong Pharmaceutic~
`06-26-1996
`09-10-1997 Hanmi Phannaceutical Co., Ltd.
`·····
`Massachusetts Institute of
`Technolo~;.? ____
`08-22-2002
`WO 02/064129 A2
`, Rath,. Matthias ... --------····~------------------···· ........
`--.-........
`····--------------- ------···•·-•·-·----------------· -------------------- --
`Date
`Considered
`
`FP36 WO 96/08970 A 1
`
`03-28-1996
`
`CN 1125141 A
`EP O 793 966 Al
`
`WO 02/38142 A2
`
`05-16-2002
`
`FP37
`FP38
`
`FP39
`
`·------- ...JFP40·····
`
`Examiner
`Signature
`
`. ..
`
`------------ ------.--------·······----------·········· ...
`
`..... i
`
`*EXAMlNER: Initial if refi.,rence considered, v,hether or notcitation is in confonnance with MPEP 609. Dra,v Ent· through citation if not in conforniance and
`not considered. Indude copy of this form with next communication to applicant. ' Applicant's unique citation designation number (optional), 1 See Kinds
`Codes of USPTO Patent Documents at www.uspto.gov or MPE.P 901.04. ' Enter Office foat issued the document, by the two-letter code {VVlPO Standard
`ST.3). 4 For Japan est patent documents, the indication of the yt>ar of the reign of the Emperor must precede the s\:rial nutt0ber of the patent document. ; Kind
`of docmn\:m by th1;; appropriate syrnhois as indicated on the document under V1,'IPO Standard ST. l6 ifpossibk. "Applicant is to place a check mark here if
`English language Tnu'sliltion is attached.
`
`Page 16 of 85
`
`

`

`Substitute for form 1449/PTO
`
`l
`
`Equivalent of Form PTO/SB/08a (07-09)
`Complete if Known
`! To b;,-::rssigned ----------------------
`__ Applic~ti._o_n_N_u_m_b_e_r___
`FIRST SUPPLEMENTAL
`l --H~rewith
`__ Filing Date
`------,~------
`INFORMATION DISCLOSURE
`First Named _!~y-~ntor
`::MatveyE_ (QKASI-IEv··::------i
`STATEMENT BY APPLICANT
`Art Unit
`To be assigned
`(Use as many sheets as necessary)
`--------·----E_x_am __ in_e~-N~me
`~ - - - - - - -
`l of !
`Sheet
`6
`7
`[ Attorney Docket Number
`
`··-:: Jo be assig_~-e-d----·--::::: ... ___ _,
`
`2159.3210002/JMC/MRG/U-S
`
`Examiner
`initials*
`
`Cite No_ I
`
`Document Number
`Number-Kind Code 2 (if
`known)
`
`Publication Date
`MM-DD-YYYY
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant Figures Appear
`
`U.S. PATENT DOCUMENTS
`
`=•-----------'""--•-•---•------'------'------••••••••••••• .. • .. •<•«•••••••••••••••••• • • • • - - - - -~ - - - - - - • • • • • • • • • •-••••••••·•···•···•··•···•••Y>>>"->>>> • • • • • • • • • • • - - - - - - - - - - • · • · • • • • • • • • '
`.......
`FOREIGN PATENT DOCUMENTS
`Publication
`Date
`MM-DD-YYYY
`
`---
`
`Examiner
`initials*
`
`Cite
`No. 1
`
`For