IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re application of:
`
`Confirmation No.: 5197
`
`LUKASHEV el‘ al. (as changed)
`
`Art Unit: 1649
`
`Appl. No.: 12/526,296
`
`Examiner: ULM, John D.
`
`§ 371(c) Date: January 13, 2011
`For: Treatment for Multiple Sclerosis
`(As Amended)
`
`a
`
`Atty. Docket: 2159.3210001/JMC/M-R/U-S
`
`Sappiementai Amendment and Remy Under 3‘? C.F.R.; § 1.111
`
`Matt Stop Amendment
`
`Commissioner for Patents
`PO Box 1450
`
`Alexandria, VA 22313 -1450
`
`Sir:
`
`Further to the Amendment and Reply Under 37 C.F.R. § 1.111 filed on October
`
`13, 2011, Applicants submit the following Amendment arid Remarks.
`
`Amendments to the Claims are reflected in the listing of claims which begins on
`
`page 2 of this paper.
`
`Remarks and Arguments begin on page 6 of this paper.
`
`It is not believed that extensions of time or fees for net addition of claims are
`
`required beyond those that may otherwise be provided for in documents accompanying
`
`this paper. However,
`
`if additional extensions of time are necessary to prevent
`
`abandonment of this application, then such extensions of time are hereby petitioned
`
`under 37 C.F.R. § 1.136(a), and any fees required therefor (including fees for net
`
`addition of claims) are hereby authorized to be charged to our Deposit Account No.
`
`19-0036.
`
`Page 1 0f 8
`
`Biogen Exhibit 2095
`Mylan v. Biogen
`IPR 2018-01403
`
`Biogen Exhibit 2095
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 8
`
`
`
`In re application of:
`
`Confirmation No.: 5197
`
`LUKASHEV el‘ al. (as changed)
`
`Art Unit: 1649
`
`Appl. No.: 12/526,296
`
`Examiner: ULM, John D.
`
`§ 371(c) Date: January 13, 2011
`For: Treatment for Multiple Sclerosis
`(As Amended)
`
`a
`
`Atty. Docket: 2159.3210001/JMC/M-R/U-S
`
`Sappiementai Amendment and Remy Under 3‘? C.F.R.; § 1.111
`
`Matt Stop Amendment
`
`Commissioner for Patents
`PO Box 1450
`
`Alexandria, VA 22313 -1450
`
`Sir:
`
`Further to the Amendment and Reply Under 37 C.F.R. § 1.111 filed on October
`
`13, 2011, Applicants submit the following Amendment arid Remarks.
`
`Amendments to the Claims are reflected in the listing of claims which begins on
`
`page 2 of this paper.
`
`Remarks and Arguments begin on page 6 of this paper.
`
`It is not believed that extensions of time or fees for net addition of claims are
`
`required beyond those that may otherwise be provided for in documents accompanying
`
`this paper. However,
`
`if additional extensions of time are necessary to prevent
`
`abandonment of this application, then such extensions of time are hereby petitioned
`
`under 37 C.F.R. § 1.136(a), and any fees required therefor (including fees for net
`
`addition of claims) are hereby authorized to be charged to our Deposit Account No.
`
`19-0036.
`
`Page 1 0f 8
`
`Biogen Exhibit 2095
`Mylan v. Biogen
`IPR 2018-01403
`
`Biogen Exhibit 2095
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 8
`
`
`
`Amendment dated October 28, 201 1
`
`- 2 -
`
`LUKASHEV et al.
`Appl. No. 12/526,296
`
`Amendments to the Claims
`
`This listing of claims will replace all prior versions, and listings, of claims in the
`
`application.
`
`1—17.
`
`(Cancelled)
`
`18.
`
`(Previously Presented)
`
`A method of treating a subject in need of treatment
`
`for multiple sclerosis comprising orally administering to the subject
`
`in need
`
`thereof
`
`a pharmaceutical
`
`composition
`
`consisting
`
`essentially of
`
`(a)
`
`a
`
`therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or
`
`a combination thereof, and (b) one or more pharmaceutically acceptable
`
`excipients, wherein the therapeutically effective amount of dimethyl fumarate,
`
`monomethyl fumarate, or a combination thereof is about 480 mg per day.
`
`19.
`
`(Previously Presented)
`
`The method
`
`of
`
`claim 18, wherein
`
`the
`
`pharmaceutical composition is administered in the form of a tablet, a suspension,
`
`or a capsule.
`
`20.
`
`QPreviously Presented)
`
`The method
`
`of
`
`claim 18, wherein
`
`the
`
`therapeutically effective amount is administered in separate administrations of 2,
`
`3, 4, or 6 equal doses.
`
`21.
`
`(Previously Presented)
`
`The method
`
`Of
`
`claim 20, wherein
`
`the
`
`therapeutically effective amount is administered in separate administrations of 2
`
`equal doses.
`
`Page 2 0f 8
`
`Atty. Dkt. No. 2159.3210001/JMC/M-R/U-S
`
`Page 2 of 8
`
`
`
`Amendment dated October 28, 2011
`
`- 3 —
`
`LUKASHEV er al.
`Appl. No. 12/526,296
`
`22.
`
`(Previously Presented)
`
`The method
`
`of
`
`claim 20, wherein
`
`the
`
`therapeutically effective amount is administered in separate administrations of 3
`
`equal doses.
`
`23.
`
`(Previously Presented)
`
`The method
`
`of
`
`claim 18, wherein
`
`the
`
`pharmaceutical composition consists essentially of dimethyl fumarate and one or
`
`more pharmaceutically acceptable excipients.
`
`24.
`
`(Previously Presented)
`
`The method
`
`of
`
`claim 18, wherein
`
`the
`
`pharmaceutical composition consists essentially of monomethyl fumarate and one
`
`or more pharmaceutically acceptable excipients.
`
`25.
`
`(Previously Presented)
`
`The method
`
`of
`
`claim 18, wherein
`
`the
`
`pharmaceutical composition is administered to the subject for at least 12 weeks.
`
`26.
`
`(Previously Presented)
`
`The method
`
`of
`
`claim 23, wherein
`
`the
`
`therapeutically effective amount is administered to the subject in 2 equal doses.
`
`27.
`
`(Previously Presented)
`
`The method
`
`of
`
`claim 26, wherein
`
`the
`
`therapeutically effective amount is administered to the subject for at least 12
`
`weeks.
`
`28.
`
`(Previously Presented) A method of treating a subject in need of treatment for
`
`multiple sclerosis consisting essentially of orally administering to tlee subject
`
`about 480 mg per day of dimethyl fumarate, monomethyl fumarate, or a
`
`combination thereof.
`
`Page 3 0f 8
`
`Atty. Dkt. N0. 2159.3210001/JMC/M-R/U-S
`
`Page 3 of 8
`
`
`
`Amendment dated October 28, 201 1
`
`— 4 —
`
`LUKASHEV er al.
`Appl. No. 12/526,296
`
`29.
`
`30.
`
`31.
`
`32.
`
`33.
`
`34.
`
`(Previously Presented) The method of claim 28, wherein about 480 mg of
`
`dimethyl fumarate per day is administered to the subject.
`
`(Previously Presented) The method of claim 29, wherein, the dimethyl fumarate is
`
`administered in separate administrations of 2 equal doses.
`
`(Previously Presented) The method of claim 29, wherein the dimethyl fumarate is
`
`administered in separate administrations of 3 equal doses.
`
`(Previously Presented)
`
`A method of treating a subject in need of treatment
`
`for multiple sclerosis comprising orally administering to the
`
`subject a
`
`pharmaceutical composition consisting essentially of (a)
`
`a therapeutically
`
`effective amount of dimethyl fumarate and (b) one or more pharmaceutically
`
`acceptable excipients, wherein the therapeutically effective amount of dimethyl
`
`fumarate is about 480 mg per day.
`
`(Previously Presented)
`
`The method of claim 32, wherein the dimethyl
`
`fumarate is administered in separate administrations of 2 equal doses.
`
`(New) The method of claim 18, wherein the expression level of NQO1 in the
`
`subject is elevated after administering to the subject the therapeutically effective
`
`amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof.
`
`35.
`
`(New) The method of claim 28, wherein the expression level of NQOl in the
`
`subject is elevated after administering to the subject about 480 mg per day of
`
`dimethyl fumarate, monomethyl fumarate, or a combination thereof.
`
`Page 4 0f 8
`
`Atty. Dkt. No. 2159.3210001/JMC/M-R/U-S
`
`Page 4 of 8
`
`
`
`Amendment dated October 28, 201 1
`
`— 5 —
`
`LUKASHEV et al.
`Appl. No. 12/526,296
`
`36.
`
`(New) The method of claim 32, wherein the expression level of NQOl in the
`
`subject is elevated after administering to the subject the therapeutically effective
`
`amount of dimethyl funéarate.
`
`Page 5 0f 8
`
`Atty. Dkt. No. 2159.3210001/JMC/M-R/U-S
`
`Page 5 of 8
`
`
`
`Amendment dated October 28, 2011
`
`- 6 —
`
`LUKASHEV er al.
`Appl. No. 12/526,296
`
`Remarks
`
`Reconsideration of this Application is respectfully requested.
`
`Upon entry of the foregoing amerzdment, claims 18-36 are pending in the
`
`application, with claims 18, 28, and 32 being the independent claims.
`
`New claims 34536 are sought to be added. Support for new claims 34456 can he
`
`found in the application, e. g., in original claims 5 and 11; page 2, paragraph [0006];
`
`pages 4-5, paragraph [0012]; page 18, paragraph [0080]; pages 22—23, paragraph [0092];
`
`page 25, paragraph [0104]; page 31, paragraph [0122], Example 1, Figure 1; and pages
`
`31-32, paragraph [0123], Example 2, Figure 2.
`
`These changes are believed to introduce no new matter, and their entry is
`
`respectfully requested.
`
`Based on the above amendment and the remarks of the Amendment and Reply
`
`Under 37 C.F.R. § 1.111 filed on October 13, 2011, Applicants respectfully request that
`
`the Examiner reconsider all outstanding objections and rejections and that they be
`
`withdrawn.
`
`Applicants submit as Exhibit A a copy of a press release issued on October 26,
`
`2011, by Biogen Idec MA Inc. ("Biogen Idec"), the assignee of the above-captioned
`
`application.
`
`In the press release, Biogen Idec announced "positive top-line results from
`
`CONFIRM, the second of two pivotal. Phase 3 clinical trials designed to evaluate the
`
`investigational oral compound BG-12 (dimethyl fumarate) in people with relapsing—
`
`rcmitting multiple sclerosis (RRMS).” Exhibit A, page 1. "Results showed that 240 mg
`
`of BG—12, administered either
`
`twice a day (BID) or
`
`three times a day (TID),
`
`demonstrated significant efficacy and favorable safety and tolerability profiles. Further
`
`analyses of the CONFIRM study are ongoing .
`
`.
`
`.
`
`..." Id.
`
`Page 6 0f 8
`
`Atty. Dkt. No. 2159.3210001/JMC/M-1VU-S
`
`Page 6 of 8
`
`
`
`Amendment dated October 28, 2011
`
`— 7 «
`
`LUKASHEV et al.
`Appl. No. 12/526,296
`
`Applicants submit that the CONFIRM study results, as well as the results from
`
`the first pivotal Phase 3 clinical trial, the DEFINE study, which Applicants provided in
`
`the Amendment and Reply Under 37 CPR. § 1.111 filed on October 13, 2011 (see e.g.,
`
`discussion of section 3.b), further support the patentability of the currently pending
`
`claims.
`
`Additionally, Applicants submit herewith a Request to Add an Inventor in a
`
`Nonprovisional Patent Application under 37 CFR. § 1.48(c) seeking to change the
`
`inventive entity from h/l'atvey E LUKASHEV to Mai‘vey El. LUKASHEV and Gilmore
`
`O'NEILL.
`
`Reconsideration of this Application is respectfully requested.
`
`Page 7 0f 8
`
`\\'\
`
`Atty. Dkt. No. 2159.3210001/JMC/M-R/U-S
`
`Page 7 of 8
`
`
`
`Amendment dated October 28, 2011
`
`— 8 —
`
`LUKASHEV et all.
`App]. No. 12/526,296
`
`Cendusitm
`
`Further to the Amendment and Reply tiled en October l3, 2011, all efthe stated.
`
`grounds of objection and rejection were properly traversed, accommodated, or rendered
`
`moot. Applicants therefore respectfully request
`
`that
`
`the Examiner reconsider all
`
`presently outstanding objections and rejections and that they be withdrawn. Applicants
`
`believe that
`
`the present application is in condition for allowance,
`
`if the Examiner
`
`believes, for any reason, that personal communication will expedite prosecution of this
`
`application,
`
`the Examiner
`
`is
`
`invited te telephone the undersigned at
`
`the number
`
`provided.
`
`Prompt and favorable consideration of this Amendment and Reply is respectfully
`
`requested.
`
`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & Fox P.L.L.C.
`}
`
`
`Marsha A. Rose
`
`Attorney for Applicants
`Registration No. 58,403
`
`
`
`1 100 New York Avenue, N.W.
`
`Washington, DC 20005-3934
`(202) 371-2600
`
`l43686l_l .docx
`
`Page 8 0f 8
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`Atty. Dkt. No. 2159,3210001/JMC/M-R/U-S
`
`Page 8 of 8
`
`
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