IN THE UNETED STATES PATENT AND TRADEMARK OFFICE
`
`In re application of:
`
`E Confirmation No.: 5197
`
`LUKASHEV, Matvey E.
`
`Art Unit: 1614
`
`Appl. No.: 12/526,296
`
`Examiner: Ulm, 3ohn D.
`
`§ 371(c) Date: January 13, 2011
`For: Treatment for Multiple Sclerosis (As
`Amended)
`
`k Atty. Docket: 2159.3210001/JMC/M—R/KMH
`'
`t2
`
`Preliminary Amendment Under 37 C..FR. § 1.115
`
`Mail Stop Amendment
`
`Commissioner for Patents
`PO Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`In advance of prosecution, Applicants submit the following amendments and remarks.
`
`Amendments to the Title begin on page 2 of this paper.
`
`Amendments to the Claims are reflected in the listing of claims which begins on
`
`page 3 of this paper.
`
`Remarks 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 CPR. § 1.136(a),
`
`and any fees required (including fees for net addition of claims) are hereby authorized to be
`
`charged to our Deposit Account No. 19-0036.
`
`Page 1 0f 7
`
`Biogen Exhibit 2094
`
`Mylan v. Biogen
`IPR 2018-01403
`
`Biogen Exhibit 2094
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 7
`
`
`
`In re application of:
`
`E Confirmation No.: 5197
`
`LUKASHEV, Matvey E.
`
`Art Unit: 1614
`
`Appl. No.: 12/526,296
`
`Examiner: Ulm, 3ohn D.
`
`§ 371(c) Date: January 13, 2011
`For: Treatment for Multiple Sclerosis (As
`Amended)
`
`k Atty. Docket: 2159.3210001/JMC/M—R/KMH
`'
`t2
`
`Preliminary Amendment Under 37 C..FR. § 1.115
`
`Mail Stop Amendment
`
`Commissioner for Patents
`PO Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`In advance of prosecution, Applicants submit the following amendments and remarks.
`
`Amendments to the Title begin on page 2 of this paper.
`
`Amendments to the Claims are reflected in the listing of claims which begins on
`
`page 3 of this paper.
`
`Remarks 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 CPR. § 1.136(a),
`
`and any fees required (including fees for net addition of claims) are hereby authorized to be
`
`charged to our Deposit Account No. 19-0036.
`
`Page 1 0f 7
`
`Biogen Exhibit 2094
`
`Mylan v. Biogen
`IPR 2018-01403
`
`Biogen Exhibit 2094
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 7
`
`
`
`Amendments to the Claims
`
`LUKASHEV
`
`Appl. No. 12/526,296
`
`This listing of claims will replace all prior versions, and listings, of claims in the
`
`application.
`
`1.-17. Cancelled
`
`18.
`
`(new) 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.
`
`(new) The method of claim 18, wherein the pharmaceutical composition is
`
`administered in the form of a tablet, a suspension, or a capsule.
`
`20.
`
`(new) The method of claim 18, wherein the therapeutically effective amount
`
`is
`
`administered in separate administrations of 2, 3, 4, or 6 equal doses.
`
`21.
`
`(new) The method of claim 20, wherein the therapeutically effective amount is
`
`administered in separate administrations of 2 equal doses.
`
`22.
`
`(new) The method of claim 20, wherein the therapeutically effective amount
`
`is
`
`administered in separate administrations of 3 equal doses.
`
`Page 2 0f 7
`
`Atty. Dkt. No. 2159.3210001/JMC/M-R/KMH
`
`Page 2 of 7
`
`
`
`Appl. No. 12/526,296
`(new) The method of claim 18, wherein the pharmaceutical composition consists
`
`23.
`
`LUKASHEV
`
`essentially of dimethyl
`
`fumarate and one or more pharrnaceutically acceptable
`
`excipients.
`
`24.
`
`(new) The method of claim 18, wherein the pharmaceutical composition consists
`
`essentially of monomethyl fumarate and one or more pharmaceutically acceptable
`
`excipients.
`
`25.
`
`(new) The method of claim 18, wherein the pharmaceutical composition is
`
`administered to the subject for at least 12 weeks.
`
`26..
`
`(new) The method of claim 23, wherein the therapeutically effective amount
`
`is
`
`administered to the subject in 2 equal doses.
`
`27.
`
`(new) The method of claim 26, wherein the therapeutically effective amount
`
`is
`
`administered to the subject for at least 12 weeks.
`
`28.
`
`(new) A method of treating a subject in need of treatment for multiple sclerosis
`
`consisting essentially of orally administering to the subject about 480 mg per day of
`
`dimethyl fumarate, monomethyl fumarate, or a combination thereof.
`
`29‘.
`
`(new) The method of claim 28, wherein about 480 mg of dimethyl fumarate per day is
`
`administered to the subject.
`
`30.
`
`(new) The method of claim 29, wherein the dimethyl fumarate is administered in
`
`separate administrations of 2 equal doses.
`
`Page 3 0f 7
`
`Atty. Dkt. No. 2159.3210001/JMC/M—R/KMH
`
`Page 3 of 7
`
`
`
`Appl. No. 12/526,296
`(new) The method of claim 29, wherein the dimethyl fumarate is administered in
`
`31.
`
`-5-
`
`LUKASHEV
`
`separate administrations of 3 equal doses.
`
`32.
`
`(new) 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 filmarate
`
`and (b) one or more pharmaceutically acceptable
`
`excipients, wherein the
`
`therapeutically effective amount of dimethyl fumarate is about 480 mg per day.
`
`33.
`
`(new) The method of claim 32, wherein the dimet’hyl fumarate is administered in
`
`separate administrations of 2 equal doses.
`
`Page 4 0f 7
`
`Atty. Dkt. No. 215913210001/JMC/M-R/KMH
`
`Page 4 of 7
`
`
`
`Remarks
`
`LUKASHEV
`
`Appl. No. 12/526,296
`
`Upon entry ofthe forgoing amendment, Applicant has amended the title to correspond
`
`more clearly with.
`
`the claimed subject matter.
`
`Support for this amendment
`
`is found
`
`throughout the specification as originally filed. No new matter has been added.
`
`Claims 18-33 are pending in the application, with claims 18, 28, and 32 being the
`
`independent claims. Claims 1—17 have been cancelled without prejudice or disclaimer
`
`thereof. Support for new claims 18, 28, and 32 is found, inter alia, in the specification at
`
`page 6, paragraph [0017]; at page 13, paragraph [0063]; at page 25, paragraph [0104]; at
`
`pages 29-30, paragraph [0116]; and at page 30, paragraphs [0118] and [0119]. Support for
`
`new claim 19 is found, inter alia, in the specification at page 30, paragraph [0119]. Support
`
`for new claims 20-22, 26, 29-31, and 33 is found, inter alia, in the specification at pages 29-
`
`30, paragraph [0116].
`
`Support for new claims 23 and 24 is found,
`
`inter alia,
`
`in the
`
`specification at page 30, paragraph [0118]. Support for new claims 25 and 27 is found, inter’
`
`alia, in the specification at pages 13-14, paragraph [0064].
`
`These changes are believed to introduce no new matter, and their entry is respectfully
`
`requested.
`
`Claims 18-27, 32, and 33 are not limited to subjects exhibiting only symptoms of
`
`multiple sclerosis.
`
`Instead, claims 18—27, 32, and 33 encompass subjects that may be
`
`undergoing treatment for other diseases and/or disorders (e.g., depression). Additionally,
`
`claims 18-27, 32, and 33 encompass subjects receiving other treatments for multiple
`
`sclerosis, as well as treatments for other diseases and/or disorders (6. g. , depression).
`
`Claims 28-31 are not
`
`limited to subjects exhibiting only symptoms of multiple
`
`sclerosis, nor are they limited to the route of administration. For example, claims 28-31
`
`encompass administration of an oral composition containing one or more acceptable
`
`Atty. Dkt. No. 2159.3210001/JMC/M-R/KMH
`
`Page 5 0f 7
`
`Page 5 of 7
`
`
`
`_ 7 _
`
`LUKASHEV
`
`Appl. No. 12/526,296
`excipients. Additionally, claims 28—31 encompass subjects that may be undergoing treatment
`
`for other diseases and/or disorders (e.g., depression) However, claims 28-31 encompass
`
`administration of dimethyl fumarate, monomethyl fumarate, or a combination thereof as the
`
`only treatment for multiple sclerosis.
`
`Page 6 of 7
`
`Atty. Dkt. No. 2159.3210001/JMC/M—R/KMH
`
`Page 6 of 7
`
`
`
`_ 8 _
`
`Conclusion
`
`LUKASHEV
`
`Appl. No. 12/526,296
`
`Prompt and favorable consideration of this Preliminary Amendment is respectfully
`
`requested. Applicants believe 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 to telephone the undersigned at the number provided.
`
`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & Fox P.L.L.C.
`
`
`
`Marsha A. Rose
`
`Attorney for Applicant
`Registration No. 58,403
`
`
`
`
`
` Date: 5:523 p
`
`1100 New York Avenue, N.W.
`
`Washington, DC. 20005-3934
`(202) 371—2600
`
`1374453__1.doc
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`Page 7 0f 7
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`Atty. Dkt. No. 2159.3210001/JMC/M-R/KMH
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`Page 7 of 7
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