IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re application of:
`
`Confirmation No.2 5197
`
`LUKASHEV et a[. (as changed)
`
`Art Urzit: 1649
`
`Appl. No.: 12/526,296
`
`Examiner: John D. ULM
`
`§ 371(c) Date: January 13, 2011
`For: Treatment for Multiple Sclerosis
`(As Amended)
`
`E
`
`Atty. Docket: 2159.3210001/JMC/M-R/U-S
`
`Reqaest to Add inventer in a Nonprevisienai Patent Appiieation
`Under 3'? Céfii’i. § mare)
`
`Commissioner for Patents
`PO Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`Applicants request that the United States Patent and Trademark Office correct
`
`inventorship in the above-captioned nonprovisional patent application for which an oath
`
`or declaration has already been filed. Specifically, Applicants request that the United
`
`States Patent and Trademark Office add Gilmore O'Neil
`
`to the inventive entity.
`
`Accordingly, upon entry of this request, the inventive entity would be changed from
`
`Matvey E. LUKASHEV to Matvey E. LUKASHEV and Gilmore O'NEILL.
`
`This request is accompanied by:
`
`(1)
`
`A statement under 37 CPR. § 148(c)(2) from the person to be added as
`
`an inventor stating that the amendment to the inventorship is necessitated
`
`by amendment of the claims and that the inventorship error occurred
`
`without deceptive iratention on his part;
`
`(2)
`
`An oath or declaration by the actual inventors as required by 37 C.F.R.
`
`§ 1.63 or as permitted by 37 CPR. §§ 1.42, 1.43 or 1.47;
`
`Page 1 0f 14
`
`Biogen Exhibit 2096
`Mylan v. Biogen
`IPR 2018-01403
`
`Biogen Exhibit 2096
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 14
`
`

`

`— 2 —
`
`LUKASHEV, et al.
`
`Appl. No. 12/526,296
`
`(3)
`
`The written consent of the assignee in accordance with § 148(c)(5); and
`
`(4)
`
`The processing fee as set forth under 37 CPR. § 1.17m,
`
`Applicants hereby authorize the US. Patent and Trademark Office to charge any
`
`fee deficiency, or credit any overpayment, to our Deposit Account No. 1943336.
`
`Respectfully submitted,
`
`STERNE, KLS‘wllR (3'0LDS'I‘ElN 8:: Fox ELLC.
`
`
`
`Marsha A. Rose
`
`Attorney for Applicants
`Registration No. 58,403
`
`
`
`l 100 New York Avenue, NW.
`
`Washington, DC. 20005-3934
`(202) 371-2600
`
`1401 175_1.D0CX
`
`Page 2 of 14
`
`Page 2 of 14
`
`

`

`EN TEE UNE'IEE') STATES PATENT AND TRADEMARK QFHCE
`
`in re application of:
`
`Confirmation Not: 5197
`
`LUKASHE‘V, er a5. {as changed)
`
`Art Unit: 1649
`
`Appl. No.: 12/526,296
`
`Examiner: John D. ULM
`
`§ 371(c) Date: January 13, 20] 1
`
`Atty. Docket: 2159.3210001/JMC/M-R/U—S
`
`For: Treatment for Multiple Sclerosis
`(As Amended)
`
`Statement Under 3’? GER. § E..48(a}(2) at“ a
`
`Person to be Added as an Enventer
`
`Commissioner for Patents
`PO Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`I am an inventor/coinventor of the invention of one or more claims in the above«
`
`captioned nonprovisional application for which an oath or declaration under 37 CPR.
`
`§ 1.63 has been filed.
`
`The addition of me as an inventor is necessitated by an
`
`amendment to the claims and an addition to the claims. The inventorship error occurred
`
`without deceptive intent on my part.
`
`I have read and understand 37 C.F.R. § 11.l8(b).
`
` Signedi._(f::iigixct,_ WDMGWQ
`Gilmore O'Neill
`
`M i
`
`l 4O4923WI .DOC
`
`Page 3 of 14
`
`Page 3 of 14
`
`

`

`{N Tl‘iE UNITE-313 STATES PATENT AND TRADEMARK (EFFKCE
`
`in re application of:
`
`Confirmation No.: 5197
`
`LUKASHEV, et :25. (as changed)
`
`Art Unit: 1649
`
`Agpfi. No; 121526396
`
`Examiner: John D. ULM
`
`{:3 37m; Date: January 33, 20%}
`
`Atty. Docket: 2159.3210001/JMC/M—R/U-S
`
`For: Treatment for Multigfie Siclemsis
`(AS Amended}
`
`'
`
`Consent. of the Assignee tinder 3'7 (ERR. § Ls§${a){5}
`
`Commissioner for Patents
`PO Box. 1450
`
`Alexandria, VA 223 l3~ 3456
`
`Sir:
`
`Biogen Idec MA Inc, assignee of the entire right,
`
`title and interest of the
`
`originally named inventor of the above-captioned application, consents to the change in
`
`inventorship from Matvey E. LUKASHEV to Matvey E. LUKASHEV and Gilmore
`
`Q'NEELL
`
`Ihave read and understand 3'7 (LE-ZR. § 11.28%).
`
`
`“
`’
`‘
`
`
`For: Biogen Ides; MA {tic
`
`/f
`.
`3"
`
`Signature:____a
`i.) _
`
`V1‘.e-
`Type or Print namezwww
`
`'I‘it§.e:“}§_,{§‘§§c E“!
`ff} sf ‘ ‘«§@§:3“mw;
`
`Date:
`
`E4632 iS-S‘l DOC
`
`Page 4 of 14
`
`Page 4 of 14
`
`

`

`Am‘my’b“ Becket Na: sensitivities/as
`
`‘ '{TSfiMfiiN‘ififi“EEECEARA'HQN"ANEE”?§3§‘§-’Ei§“fl?ATTG‘RNE‘Y
`
`As a below named inventor, I hereby declare that:
`
`My residence, post office address and citizenship are as stated below next to my name.
`
`I believe i am the original, first and sole inventor (if only one name is listed below) or an original, first and
`joint inventor (if plural names are listed below) of the subject matter which is claimed and for which a patent is
`\WM
`sought on the invention entitled Treatment forMultiple“SCIe-rosis g‘as anagmndedg the specification of which:
`
`is attached hereto.
`[j
`as Appiicaiion No _____________________________
`was filed on
`{i
`{a} was filed as FCI international Application No l‘C”WUS’FOU8’iit‘lio02, tiled on February 7, 2808 ani
`as amended herewithin U. S Application No iii/526296, whichis the national stag entry of
`PClLSZGdb’UQlGOZ and having a §3 I'lt't} date ol'ianuary l3 EGli
`
`l hereby state that l have reviewed and tandem/and the contents of the above‘identir’ied specification,
`incinding the claims, as amended by any amendment referred to above,
`
`l ackraowledge the duty to disclose all information I know to be material to patentability in accordance with
`Title 37, Code of Federal Regulations, §l.56.
`
`I hereby claim the benefit under Title 35, United States Code, §l 29(e)(l) of any United States provisional
`application(s) listed below:
`
`M1891,
`60/888,921
`
`Film” PateWWW,
`February 8, 2087
`
`
`
`mmn§t§ta§...........................
`Expired
`
`I hereby claim the benefit under Title 35, United States Code, §l20 of any United States applicat%0n(s)
`listed below and, insofar as the subject matter of each of the claims of this application is not disclosed in the prior
`United States application in the manner provided by the first paragraph of Title 35, United States Code, §l.12, I
`acknowledge the duty to disclose all information I know to be material to patentability as defined in Title 37, Code
`of Federal Regulations, §l.56(a) which became available between the filing date of the prior application, and the
`national or PCT international filing date of this application:
`
`USSerlflmeQWMW
`
`“imam“? WW
`
`I hereby claim foreign priority benefits under Title 35, United States Code, §l 19 of any foreign
`application(s) for. patent or inventor’s certificate or of any PCT international application(s) designating at least one
`country other than the United States of America listed below and have also identified below any foreign application
`for patent or inventor’s certificate or any PCT international application(s) designating at least one country other than
`the United States of America filed by me on the same subject matter having a filing date before that of the
`application(s) of which priority is claimed:
`
`Country
`
`M _......,r,.,ill-£3.ifiiiidfiiihfifizww.
`‘
`
`Filing bate
`
`Priority Claimed
`[ ] Yes
`[ ] No
`
`Page 5 of 14
`
`Page 5 of 14
`
`

`

`Attorney’s Docket No.2 $22132“:onetime/M«R/U-s
`
`Cemhined fieeisrstien and Fewer ofAttnrney
`F’age 2’. of 2 Pages
`
`I hereby appoint the following attorneys and/or agents to prosecute this application and to transact all
`business in the Patent and Trademark Office connected therewith:
`
`All Attorneys and Agents associated with
`
`53644
`91% Custmner Nemher
`
`’7
`Direct all telephone calls to John M. Covert at telephone number (292) 7, 28673.
`
`mime: all correspondence to the feilewéng:
`
`53644
`PT0 Customer Number
`
`E] For Assigned Inventions: ] understand that the purpose of making this appointment is to permit
`prosecution of patent applications for the aboveidentified invention for the benefit of my assignee, and that. this
`appointment does not create a personal attemey-client relationship between me and these appointees.
`
`I hereby declare that all statements made herein of my own knowledge are true and that all statements made
`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 so made are punishable by fine or imprisonment, or both, under Section
`1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the
`application or any patents issued thereon.
`
`Full Name of Inventor: Matvey E. LUKAEsLiiEV
`
`Inventor’s Signature:
`Residence Address:
`Citizenship:
`Post Office Address:
`
`‘ WWWW
`35i"
`Tewksbury‘,“l‘;la‘ssaehiisett‘sw
`Russian Federation
`3 Louis Road, Tewksbury, MA 01876
`
`
`
`Full Name of Inventor:
`
`Giln'nri'ewtii'NtiilLL
`5"
`f
`3‘
`“
`
`/’
`
`i
`1‘
`
`‘1'.
`
`Residence Address:
`Citizenship:
`Post Office Address:
`
`Medford, Massachusettsm
`USA
`17 Grove Street, Medford, MA 02155
`
`1404943~moc
`
`Y W\x--------------------------------
`
`
`' Wis 93‘ mmseesm
`
`
`My Wessex: Wee
`a:
`
`1 35, 2313
`Newer:
`‘
`
`Page 6 of 14
`
`Page 6 of 14
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re appiica‘ticm of:
`
`Confirmation No,.: 5197
`
`‘illKASl-iEV (a? 521’. (as changed)
`
`Art Unit: 1649
`
`Appl. No: 12/526,296
`
`Examiner: ULM, John D.
`
`k 371(c) Bate:
`
`.iam.1ary 13, 201.1
`
`Atty. Docket: 2159.3210001/JMCM—R/U—S
`
`For; ’i‘reatment for Moitipie Sclerosis
`{As Am en tied)
`
`Second Snppiernentai information fiisciosnre Statement
`
`.Maié’ Stag} Amendment
`
`Commissioner for Patents
`PO Box 1450
`
`Alexandria, VA 22313 - l 450
`
`Sir:
`
`Listed on accompanying IDS Forms PTO/SB/08a equivalent and 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.
`
`The numbering on this Second
`
`Supplemental InformatiOn Disclosure Statement is a continuation of the numbering in the
`
`First Supplemental Information Disclosure Statement filed on {)ctober 21, 2011, in
`
`connection with tlee above-captioned application.
`
`Applicants bring to the Examiner's attention document NPL294, which is a
`
`Memorandum of Meeting Minutes
`
`for
`
`a meeting held on August 30, 2006
`
`("memorandum"), attended by US. Food and Drug Administration (FDA) and Biogen
`
`Idec MA Inc. (assignee of the current application) representatives. The memorandum
`
`(page 3, bottom line to page 4, line 2) contains a reference to a BG00012 (dimethyl
`
`fumarate) dose of 240 mg bid. (240 mg twice daily) corresponding to a 480 mg/day
`
`dose. Prior to the meeting of August 30, 2006, Matvey E. Lukashev and Gilmore
`
`Page 7 of 14
`
`Page 7 of 14
`
`

`

`~ 2 —
`
`LUKASHEV er al.
`
`Appl. No. 12/526,296
`
`O'Neill, employees of Biogen Idec MA Inc., conceived of the subject matter presently
`
`claimed in this application. A declaration executed by Matvey E. Lukashev and Gilmore
`
`O'Neill is filed separately herewith.
`
`Where the publication date of a listed document does not provide a month of
`
`publication, the year of publication of the listed document is sufficiently earlier than the
`
`effective U.S. filing date and any foreign priority date so that the month of publication is
`
`not in issue. Applicants have listed publication dates on the attached IDS Forms based
`
`on information presently available to the undersigned. However, the listed publication
`
`dates should not be construed as an admission that
`
`the information was actually
`
`published on the date indicated.
`
`Applicants reserve the right to establish the patentability of the claimed invention
`
`over any of the information provided herewith, and/or to prove that this information may
`
`not be prior art, and/or to prove that this information may not be enabling for the
`
`teachings purportedly offered.
`
`This statement should not be consteued 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
`
`the material submitted herewéth.
`
`Applicants have checked the appropriate boxes below.
`
`[:I 1. Statement under 37 C.F.R. 1.704(d). Each item of information contained in this
`
`Information Disclosure Statement was first cited in a communication from a
`
`Page 8 of 14
`
`Atty. Dkt. No. 2159.3210001/JMC/M—R/U-S
`
`Page 8 of 14
`
`

`

`— 3 —
`
`LUKASHEV et al.
`
`Appl. No. 12/526,296
`
`foreign patent office in a counterpart application and this communication was not
`
`received by any individual designated in 37 C.F.R. § 1.56(c) more than thirty
`
`days prior to the filing of this information disclosure statement.
`
`I: 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
`
`a continued prosecution application (CFA). OR within three months of the date of
`
`entry of the national stage as set forth in 37 C.F.R. § 1.491 in an international
`
`application, OR before the mailing date of a first Office Action on the merits OR
`
`before the mailing of a first Office Action after the filing of a request for
`
`continued examination under 37 CPR. § 1.1 14. No statement or fee is required.
`
`g 3. Filing under 37 C.F.R. § 1.97(c). This Information Disclosure Statement is being
`
`filed more than three months after the US. 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
`
`in the application.
`
`1:] a. Statement under 37 C.F.R. § l.97(e)(1). 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 CPR. § l.97(e)(1).
`
`Page 9 of 14
`
`Atty. Dkt. No. 2159.3210001/JMC/M-R/U-S
`
`Page 9 of 14
`
`

`

`- 4 —
`
`LUKASHEV et al.
`
`Appl. No. 12/526,296
`
`I:I b. 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. § 1.97(e)(2).
`
`E c. The required fee is provided through online credit card payment
`
`authorization in the amount of $180.00 in payment of the fee
`
`under 37 C.F.R. § l.l7(p).
`
`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. The required fee is provided through online credit card payment
`
`authorization in the amount of $180.00 in payment of the fee under 37 C.F.R. §
`
`1.17(p); in addition:
`
`[:1 a. Statement under 37 C.F.R. § 197(c)(1). 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).
`
`Atty. Dkt. No. 2159.3210001/JMC/M—R/U—S
`
`Page 10 of 14
`
`Page 10 of 14
`
`

`

`— 5 —
`
`LUKASHEV er (:1.
`
`App}. No. 9,526,295
`
`I:I b. Statement under 37 CPR. § 197(c)(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. §
`
`l.56(c) more than three months prior
`
`to the filing of this
`
`Information Disclosure Statement. 37 CPR. § 1.97(e)(2).
`
`[:I 5. The document(s) was/were cited in a search report by a foreign patent office in a
`
`counterpart foreign application. Submission of an English language version of
`
`the search report that indicates the degree of relevance found by the foreign office
`
`is provided in satisfaction of the requirement for a concise explanation of
`
`relevance. 1138 0G 37, 38 and MPEP 609.04(a)(III).
`
`g 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 FP51, DE 25 30 372 A1,
`
`is in the German language. An English
`
`language translation of document FP51 is cited as document NPL311 and
`
`submitted herewith.
`
`Document FP52, DE 26 21 214 A1, is in the German language. An English
`
`language translation of document FP52 is cited as document NPL312 and
`
`submitted herewith.
`
`Page 11 of 14
`
`Atty. Dkt. No. 2159.3210001/JMC/M—R/U-S
`
`Page 11 of 14
`
`

`

`- 6 -
`
`LUKASHEV et al.
`
`Appl. No. 12/526,296
`
`Document FP53, DE 28 40 498 B1,
`
`is in the German language. An English
`
`language translation of document FP53 is cited as document NPL313 and
`
`submitted herewith.
`
`Document NPL295, Altmeyer and Niichel (1996), is in the German language.
`
`An English language translation of document NPL295 is cited as document
`
`NPL296 and submitted herewith.
`
`Document NPL297, Altmeyer and Niichel (1997), is in the German language.
`
`An English language translation of document NPL297 is cited as document
`
`NPL298 and submitted herewith.
`
`Document NPL304, Mrowietz, is in the German language. An English language
`
`translation of document NPL304 is cited as document NPL305 and submitted
`
`herewith.
`
`Document NPL309, Sadjak et al.,
`
`is in the German language. An English
`
`language translation of document NPL309 is cited as document NPL310 and
`
`submitted herewith.
`
`E 7. Copies of documents FPSl—FP53 and NPL294-NPL327 are submitted.
`
`I: 8. Copies of the
`
`,,
`
`documents 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.
`
`, filed
`
`, 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. § 1.98(d).
`
`Atty. Dkt. No. 2159.3210001/JTMC/M—R/U-S
`
`Page 12 of 14
`
`Page 12 of 14
`
`

`

`- 7 -
`
`LUKASHEV er al.
`
`Appl. No. 12/526,296
`
`|:|9.
`
`It is expected that the examiner will review the prosecution and cited art in the
`
`parent application no(s)._ V 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.
`
`. 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 US. Patent Application No.
`
`,
`
`filed _______, as documents ________ to
`
`The identification of these Office Actions is not to be construed as a waiver of
`
`secrecy as 10 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.
`
`Page 13 of 14
`
`Atty. Dkt. No. 2159.32IOOOl/JMC/M-R/U-S
`
`Page 13 of 14
`
`

`

`- 8 -
`
`LUKASHEV et al.
`
`Appl. No. 12/526,296
`
`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.
`
`The US. Patent and Trademark Office is hereby authorized to charge any fee
`
`deficiency, or credit any overpayment, 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 Avenue, N.W.
`Washington, DC. 20005-3934
`(202) 371-2600
`
`1434656_1.DOCX
`
`Page 14 of 14
`
`Atty. Dkt. No. 2159.3210001/JMC/M-R/U-S
`
`Page 14 of 14
`
`