`
`'
`
`-
`
`.
`
`/é/’/
`
`.
`
`Case S—7é-A
`
`App]. No. 10/197,077
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`) )
`
`RAJENDRA K. JOSH], ET AL.
`
`APPL. No.: 10/197,077
`
`FILED: JULY 17, 2002
`
`UTILIZATION OF DIALKYLFUMARATES
`
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`) GROUP ART UNIT: 1614
`)
`
`)EXAMINER: KEVIN E. WEDDINGTON
`)
`)
`
`SUPPLEMENTAL AMENDMENT
`
`Applicants desire to amend the above application by adding additional claims.
`
`Amendments to the claims begin on page 2 hereof.
`
`The Remarks commence on Page 7 hereof.
`
`A Second Supplemental Information Disclosure Statement is also enclosed with the
`appropriate fee and a copy ofthe translated document referred to therein. Also enclosed is a paper
`authorizing the payment of the fee for the additional claims presented hereinafter.
`
`11/29/2004 SHINQSSl 00000001 502768
`
`10197077
`
`01 FCHEOE
`02 FC:1201
`
`684.00 09
`352.00 00
`
`CERTIFICATE OF MAILING
`that in accordance with standard business practice, this pa er (along with any referred to as bein attached or enclosed) is to be
`I hereby certi
`de osited ont e date shown below with the United States Post Service as Irst class mail In an envelope addresse to: Commissioner for Patents,
`P.
`. Box 1450, Alexandria, VA 22313-1450.
`
` Deborah A. Brouillette
`
`Hfl- 'l 1, QOQQ
`Date
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 1
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`

`

`Case S—73 7-A
`
`App]. No. 10/197,077
`
`In the Claims:
`
`1 15.
`
`(New) A method for treating psoriasis comprising administering to a patient an effective
`
`amount of a pharmaceutical preparation which is in the form of microtablets or pellets and
`
`consists essentially of at least one dialkyl fumarate of the following formula
`
`COOR1
`
`H
`\_
`C—C
`
`RZOOC
`
`H
`
`wherein R1 and R2, which may be the same or different, independently represent a linear,
`
`branched or cyclic, saturated or unsaturated C,_20 alkyl radical which may be optionally
`
`substituted with halogen (Cl, F, 1, Br), C14 alkoxy, nitro or cyano and optionally
`
`conventional excipients.
`
`116. (New) A method as in claim 115, wherein said microtablets or pellets are contained in
`
`capsules.
`
`117. (New) A method as in claim 115, wherein said preparation contains an amount
`
`between 10 and 300 mg of dimethyl fiimarate.
`
`118. (New) A method as in claim 115, wherein said preparation contains an amount of
`
`about 120 mg dimethyl fumarate.
`
`'119. (New) A method as in claim 115, wherein the size or mean diameter of said
`
`microtablets or pellets is in the range of 300 to 2000 pm.
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 2
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 2
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`

`

`Case S—737-A
`_ Appl. No. 10/197,077
`
`1‘20.
`
`121.
`
`122.
`
`123.
`
`124.
`
`(New) A method as in claim 115, wherein the size or mean diameter of said
`
`microtablets or pellets is about 2000 pm.
`
`(New) A method as in claim 115, wherein said microtablets or pellets are enteric-
`
`coated and contained in capsules, and wherein said pharmaceutical preparation consists
`
`essentially of dimethyl fumarate in an amount between 10 and 300 mg.
`
`(New) A method as in claim 121 , wherein said pharmaceutical preparation consists
`
`essentially of dimethyl fumarate in an amount of about 120 mg.
`
`(New) A method as in claim 121, wherein the size or mean diameter of said
`
`microtablets or pellets is in the range of 300 to 2000 pm.
`
`(New) A method for treating multiple sclerosis comprising administering to a patient
`
`an effective amount of a pharmaceutical preparation which consists essentially of at least
`
`one dialkyl fumarate of the following formula
`
`coom
`
`H
`\ _
`C—C
`
`RZOOC
`
`H
`
`wherein R1 and R2, which may be the same or different, independently represent a linear, -
`
`branched or cyclic, saturated or unsaturated CL20 alkyl radical which may be optionally
`
`substituted with halogen (Cl, F, I, Br), C1_4 alkoxy, nitro or cyano and optionally
`
`conventional excipients.
`
`125.
`
`(New) A method as in claim 124, wherein said pharmaceutical preparation is in the
`
`form of microtablets or pellets.
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 3
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 3
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`

`

`Case S-737-A
`
`App]. No. 10/197,077
`
`126. (New) A method as in claim 125, wherein said microtablets or pellets are contained in
`
`capsules.
`
`127. (New) A method as in claim 126, wherein said preparation contains an amount
`
`between 10 and 300 mg of dimethyl furnarate.
`
`128. (New) A method as in claim 126, wherein said preparation contains an amount of
`
`about 120 mg dimethyl furnarate.
`
`129. (New) A method as in claim 125, wherein the size or mean diameter of said
`
`microtablets or pellets is in the range of 300 to 2000 pm.
`
`130. (New) A method as in claim 125, wherein the size or mean diameter of said
`
`microtablets or pellets is about 2000 pm.
`
`131. (New) A method as in claim 125, wherein said microtablets or pellets are enteric-
`
`coated and are contained in capsules, and wherein said pharmaceutical preparation
`
`consists essentially of dimethyl fumarate in an amount between 10 and 300 mg.
`
`132. (New) A method as in claim 131, wherein said pharmaceutical preparation consists
`
`essentially of dimethyl fumarate in an amount of about 120 mg.
`
`133. (New) A method as in claim 131, wherein the size or mean diameter of said
`
`microtablets or pellets is in the range of 300 to 2000 pm.
`
`134. (New) A pharmaceutical preparation in the form of enteric-coated microtablets or
`
`pellets containing dimethyl fumarate in an amount effective for treating psoriasis.
`
`135. (New) The preparation of claim 134, wherein the microtablets or pellets are contained
`
`in capsules.
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 4
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 4
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`

`

`Case S-737-A
`
`Appl. No. 10/197,077
`
`136. (New) The preparation of claim 135, wherein each capsule contains an amount
`
`between 10 and 300 mg of dimethyl fumarate.
`
`137. (New) The preparation of claim 135, wherein each capsule contains an amount ofV
`
`about 120 mg dimethyl fumarate.
`
`138. (New) The preparation of claim 134, wherein the size or mean diameter of said
`
`microtablets or pellets is in the range of 300 to 2000 pm.
`
`139. (New) The preparation of claim 134, wherein the size or mean diameter of said
`
`microtablets or pellets is about 2000 pm.
`
`140. (New) The preparation of claim 134, wherein the microtablets or pellets contain
`
`dimethyl fumarate in an amount between 10 and 300 mg.
`
`141. (New) The pharmaceutical preparation of claim 140, wherein the microtablets or
`
`pellets contain dimethyl fumarate in an amount of about 120 mg.
`
`142. (New) The preparation of claim 140 wherein the size or mean diameter of said
`
`microtablets or pellets is in the range of 300 to 2000 pm.
`
`143. (New) A pharmaceutical preparation consisting essentially of dimethyl fumarate in an
`
`amount effective for treating multiple sclerosis.
`
`144. (New) The preparation of claim 143, wherein the preparation is in the form of enteric-
`
`coated microtablets or pellets.
`
`145. (New), The preparation of claim 144, wherein said microtablets or pellets are contained
`
`in capsules.
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 5
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 5
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 5
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`

`

`Case S-737-A
`
`App1.No. 10/197,077
`
`146. (New) The preparation of claim 145, wherein each capsule contains an amount
`
`between 10 and 300 mg of dimethyl fumarate.
`
`147. (New) The preparation of claim 145, wherein each capsule contains an amount of
`
`about 120 mg dimethyl fiimarate.
`
`148. (New) The preparation of claim 143, wherein the size or mean diameter of said
`
`microtablets or pellets is in the range of 300 to 2000 pm.
`
`149. (New)
`
`The preparation of claim 143, wherein the size or mean diameter of said
`
`microtablets or pellets is about 2000 pm.
`
`150. (New) The preparation of claim 143, wherein the microtablets or pellets contain
`
`dimethyl furnarate in an amount of 10 to 300 mg.
`
`151. (New) The preparation of claim 150, wherein the microtablets or pellets contain
`
`dimethyl filmarate in an amount of about 120 mg.
`
`152. (New) The preparation of claim 150 wherein the size or mean diameter of said
`
`microtablets or pellets is in the range of 300 to 2000 um.
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 6
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 6
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`

`

`Case S—737-A
`
`App]. No. 10/197,077
`
`R E M A R K S
`
`By the above amendment, Applicants present for consideration Claims 115-152. Thus,
`the case now contains Claims 21-152. A paper authorizing the payment of the fees for the extra
`
`claims from a Deposit Account is enclosed.
`
`Claims 115-152 are based on and are believed to find support in the disclosure. For
`
`example, treatment of psoriasis with the present fumarates is referred to for example in
`
`paragraphs 0029 and 0030, and treatment of multiple sclerosis with the present fumarates is
`
`referred to for example in paragraphs 0003, 0014, and 0029. The presence in the preparations of
`
`optional conventional excipients appears for example in paragraph 0026. The preparations in the
`
`form of microtablets or pellets is referred to for example in paragraph 0025 and enteric coatings
`
`for the microtablets or pellets is referred to for example in paragraphs 0025, 0034, and 0035. The
`
`inclusion of such coated microtablets or pellets in capsules is referred to for example in
`
`paragraphs 0025 and 0034. Similarly, the range of 10 and 300 mg of dimethylfumarate is referred
`
`to for example in paragraph 0027, and the range of 300 to 2000 micron mean diameters is referred
`
`to for example in paragraph 0028. Also, a dosage level of 120 mg of dimethylfumarate is referred
`
`to for example in Examples 1 and 2.
`
`Favorable action on the claims is solicited.
`
`Accompanying this response is an Information Disclosure Statement in which there is
`
`provided a translation of DE 3834794 Al which has previously been cited in a prior Information
`
`Disclosure Statement, but without a translation.
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 7
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 7
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 7
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`

`

`Case S—737-A
`
`App]. No. 10/197,077
`
`If any matters remain requiring further consideration that may be expedited by discussion,
`
`the Examiner is requested to telephone the undersigned at the number given below so that such
`
`matters may be discussed and, if possible, promptly resolved.
`
`Respectfull
`
`submitted,
`
`/.
`
`\\ John F. Si berth
`
`Reg. No. 17,704
`Attorney of Record
`
`Telephone:
`Facsimile:
`
`225-291-4600
`225-291-4606
`
`’
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 8
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 8
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 8
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`

`

`Attorney Docket No. 08201 .0061—01000
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`
`Rajendra JOSHI et al.
`
`Group Art Unit: 1614
`
`Application No.: 10/197,077
`
`Examiner: Raymond J. Henley, Ill
`
`Filed: July 17, 2002
`
`Confirmation No.: 7489
`
`For: UTILIZATION OF
`
`DIALKYLFUMARATES
`
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313—1450
`
`Sir:
`
`AMENDMENT
`
`Please amend the above-identified application as follows:
`
`0 Amendments to the Claims begin at page 2;
`
`. Remarks begin at page 7.
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 9
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 9
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 9
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`

`

`USSN 10/197,077
`Attorney Docket No. 08201 .0061—01000
`
`AMENDMENTS TO THE CLAIMS
`
`This listing of claims will replace all prior versions and listings of claims in the
`
`application:
`
`Claims 1-165. (Canceled)
`
`166.
`
`(New) A method of treating multiple sclerosis comprising administering, to
`
`a patient in need of treatment for multiple sclerosis, an amount effective for treating said
`
`multiple sclerosis of a pharmaceutical preparation comprising dimethyl fumarate.
`
`167.
`
`(New) The method of claim 166, wherein the pharmaceutical preparation
`
`comprises from 10 to 300 mg of dimethyl fumarate.
`
`168.
`
`(New) The method of claim 167, wherein the pharmaceutical preparation
`
`is provided in one or more capsules.
`
`169.
`
`(New) The method of claim 166, wherein the pharmaceutical preparation
`
`comprises at least 50 mg of dimethyl fumarate.
`
`170.
`
`(New) The method of claim 169, wherein the pharmaceutical preparation
`
`comprises at least 110 mg of dimethyl fumarate.
`
`171.
`
`(New) The method of claim 170, wherein the pharmaceutical preparation
`
`comprises at least 120 mg of dimethyl fumarate.
`
`172.
`
`(New) The method of claim 166, wherein the pharmaceutical preparation
`
`comprises 50 mg of dimethyl fumarate.
`
`173.
`
`(New) The method of claim 166, wherein the pharmaceutical preparation
`
`comprises 110 mg of dimethyl fumarate.
`
`-2-
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 10
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 10
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`

`

`USSN 10/197,077
`Attorney Docket No. 08201 .0061—01000
`
`174.
`
`(New) The method of claim 166, wherein the pharmaceutical preparation
`
`comprises 120 mg of dimethyl fumarate.
`
`175.
`
`(New) The method of claim 166, wherein the pharmaceutical preparation
`
`is formulated for oral administration.
`
`176.
`
`(New) The method of claim 166, wherein the pharmaceutical preparation
`
`is formulated as a solid dosage form.
`
`177.
`
`(New) The method of claim 166, wherein the pharmaceutical preparation
`
`is in the form of microtablets.
`
`178.
`
`(New) The method of claim 177, wherein the microtablets are enteric—
`
`coated .
`
`179.
`
`(New) The method of claim 178, wherein the microtablets have a mean
`
`diameter in the range of 0.3 mm to 2.0 mm, exclusive of any coating on the
`
`microtablets.
`
`180.
`
`(New) The method of claim 179, wherein the microtablets have a mean
`
`diameter of 2.0 mm, exclusive of any coating on the microtablets.
`
`181.
`
`(New) A method of treating multiple sclerosis comprising administering, to
`
`a patient in need of treatment of multiple sclerosis, an amount effective for treating said
`
`multiple sclerosis of a pharmaceutical preparation consisting essentially of dimethyl
`
`fumarate.
`
`182.
`
`(New) The method of claim 181, wherein the pharmaceutical preparation
`
`consists essentially of dimethyl fumarate in an amount from 10 to 300 mg.
`
`-3-
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 11
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 11
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`

`

`USSN 10/197,077
`Attorney Docket No. 08201.0061-01000
`
`183.
`
`(New) The method of claim 182, wherein the pharmaceutical preparation
`
`is provided in one or more capsules.
`
`184.
`
`(New) The method of claim 181, wherein the pharmaceutical preparation
`
`consists essentially of dimethyl fumarate in an amount of at least 50 mg.
`
`185.
`
`(New) The method of claim 184, wherein the pharmaceutical preparation
`
`consists essentially of dimethyl fumarate in an amount of at least 110 mg.
`
`186.
`
`(New) The method of claim 185, wherein the pharmaceutical preparation
`
`consists essentially of dimethyl fumarate in an amount of at least 120 mg.
`
`187.
`
`(New) The method of claim 181, wherein the pharmaceutical preparation
`
`consists essentially of dimethyl fumarate in an amount of 50 mg.
`
`188.
`
`(New) The method of claim 181, wherein the pharmaceutical preparation
`
`consists essentially of dimethyl fumarate in an amount of 110 mg.
`
`189.
`
`(New) The method of claim 181, wherein the pharmaceutical preparation
`
`consists essentially of dimethyl fumarate in an amount of 120 mg.
`
`190.
`
`(New) The method of claim 181, wherein the pharmaceutical preparation
`
`is formulated for oral administration.
`
`191.
`
`(New) The method of claim 181, wherein the pharmaceutical preparation
`
`is formulated as a solid dosage form.
`
`192.
`
`(New) The method of claim 181, wherein the pharmaceutical preparation
`
`is in the form of microtablets.
`
`-4-
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 12
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 12
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 12
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`

`

`USSN 10/197,077
`Attorney Docket No. 08201 .0061-01000
`
`193.
`
`(New) The method of claim 192, wherein the microtablets are provided in
`
`one or more capsules, each capsule containing at least 50 mg of dimethyl fumarate.
`
`194.
`
`(New) The method of claim 193, wherein each capsule contains at least
`
`110 mg of dimethyl fumarate.
`
`195.
`
`(New) The method of claim 194, wherein each capsule contains at least
`
`120 mg of dimethyl fumarate.
`
`196.
`
`(New) The method of claim 192, wherein the microtablets are enteric~
`
`coated.
`
`197.
`
`(New) The method of claim 196, wherein the microtablets have a mean
`
`diameter in the range of 0.3 mm to 2.0 mm, exclusive of any coating on the
`
`microtablets.
`
`198.
`
`(New) The method of claim 197, wherein the microtablets have a mean
`
`diameter of 2.0 mm, exclusive of any coating on the microtablets.
`
`199.
`
`(New) A method of treating multiple sclerosis comprising administering, to
`
`a patient in need of treatment for multiple sclerosis, a pharmaceutical preparation
`
`consisting essentially of 120 mg of dimethyl fumarate in the form of enteric—coated
`
`microtablets.
`
`200.
`
`(New) A method of treating multiple sclerosis comprising administering, to
`
`a patient in need of treatment for multiple sclerosis, a capsule containing a
`
`pharmaceutical preparation consisting essentially of 120 mg of dimethyl fumarate in the
`
`form of enteric~coated microtablets having a mean diameter in the range of 0.3 mm to
`
`2.0 mm, exclusive of any coating on the microtablets.
`
`-5-
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 13
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 13
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 13
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`

`

`USSN 10/197,077
`Attorney Docket No. 08201 .0061-01000
`
`201.
`
`(New) A method of treating multiple sclerosis comprising treating a patient
`
`in need of treatment for multiple sclerosis with an amount effective for treating said
`
`multiple sclerosis of dimethyl fumarate and, optionally, methyl hydrogen fumarate.
`
`-5-
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 14
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 14
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 14
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`

`

`USSN 10/197,077
`Attorney Docket No. 08201 .0061—01000
`
`REMARKS
`
`Claims 1—165 have been canceled and new claims 166-201 have been added by
`
`the present amendment. Support for the new claims is found in the specification,
`
`including the original claims (see, e.g., paragraphs [0014], [0015], [0018], [0022],
`
`[0023] - [0030], [0033] — [0036] and Examples 1 ~ 4).
`
`No new matter has been added.
`
`In view of the foregoing amendments and remarks, Applicants respectfully
`
`request consideration and the timely allowance of the pending claims. Should the
`
`Examiner have any questions, the Examiner is welcome to call the Applicants’
`
`representative at the number listed below.
`
`No fees are believed to be is due with this Amendment.
`
`If any fee is due, please
`
`charge it to Deposit Account No. 06-0916.
`
`Dated: March 2, 2007
`
`Respectfully submitted,
`
`FlNNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`
`By:
`
`.
`.
`5?
`gig?
`.5"? WM...
`
`Konstantin M. Linnik
`
`Reg. No. 56,309
`Tel. (617) 452-1626
`
`-7-
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 15
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`

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`Customer Number 65,779
`Attorney Docket No. 08201 .0061-01000
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Group Art Unit: 1614
`
`Examiner: Raymond J. HENLEY lll
`
`Confirmation No.: 7489
`
`vvvvvvvvvvv
`
`In re Application of:
`
`Rajendra Kumar JOSHI et al.
`
`Application No.: 10/197,077
`
`Filed: July17, 2002
`
`For: DIMETHYL FUMARATE FOR THE
`
`TREATMENT OF MULTIPLE
`
`SCLEROSIS (As Amended)
`
`Mail Stop Amendment
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`AMENDMENT AND RESPONSE UNDER 37 C.F.R. 81.111
`
`This communication responds to the non-final Office Action mailed May 15, 2007.
`
`Please amend the specification and reconsider the pending claims in view of the
`
`arguments herein.
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 16
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 16
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 16
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`

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`US. Patent Application No. 10/197,077
`Attorney Docket No. 08201 .0061-01000
`
`AMENDMENTS TO THE SPECIFICATION
`
`Please replace the current title, “UTILIZATION OF DIALKYLFUMARATES,” with
`
`the following title: --D|METHYL FUMARATE FOR THE TREATMENT OF MULTIPLE
`
`SCLEROSIS--
`
`Please amend the specification at page 1, line 2 of paragraph [0001] by inserting
`
`--now US. Patent No. 6,509,376, -- after “May 10, 2001".
`
`—2
`
`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 17
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 17
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`MYLAN PHARMS. INC. EXHIBIT 1112 PAGE 17
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`

`

`US. Patent Application No. 10/197,077
`Attorney Docket No. 08201 .0061-01000
`
`AMENDMENTS TO THE CLAIMS
`
`This listing of claims will replace all prior versions and listings of claims in the
`
`application:
`
`Claims 1-200. (Canceled)
`
`201.
`
`(Amended) A method of treating multiple sclerosis comprising treating a
`
`patient in need of treatment for multiple sclerosis with an amount of a pharmaceutical
`
`preparation effective for treating said multiple sclerosis, wherein the only active
`
`ingredient for the treatment of multiple sclerosis present in said pharmaceutical
`
`preparation is at dimethyl fumarate-andreptienallyrnmhyl-hydregen—fiemarate.
`
`202.
`
`(New) The method of claim 201, wherein 10 to 300 mg of dimethyl
`
`fumarate is present in said pharmaceutical preparation.
`
`203.
`
`(New) The method of claim 202, wherein said pharmaceutical preparation
`
`is provided in one or more capsules.
`
`204.
`
`(New) The method of claim 201, wherein at least 50 mg of dimethyl
`
`fumarate is present in said pharmaceutical preparation.
`
`205.
`
`(New) The method of claim 204, wherein at least 110 mg of dimethyl
`
`fumarate is present in said pharmaceutical preparation.
`
`206.
`
`(New) The method of claim 205, wherein at least 120 mg of dimethyl
`
`fumarate is present in said pharmaceutical preparation.
`
`207.
`
`(New) The method of claim 201, wherein 50 mg of dimethyl fumarate is
`
`present in said pharmaceutical preparation.
`
`-3
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`

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`US. Patent Application No. 10/197,077
`Attorney Docket No. 08201 .0061-01000
`
`208.
`
`(New) The method of claim 201, wherein 110 mg of dimethyl fumarate is
`
`present in said pharmaceutical preparation.
`
`209.
`
`(New) The method of claim 201, wherein 120 mg of dimethyl fumarate is
`
`present in said pharmaceutical preparation.
`
`210.
`
`(New) The method of claim 201, wherein the pharmaceutical preparation
`
`is formulated for oral administration.
`
`211.
`
`(New) The method of claim 201, wherein the pharmaceutical preparation
`
`is formulated as a solid dosage form.
`
`212.
`
`(New) The method of claim 201, wherein the pharmaceutical preparation
`
`is in the form of microtablets.
`
`213.
`
`(New) The method of claim 212, wherein the microtablets are enteric—
`
`coated.
`
`214.
`
`(New) The method of claim 213, wherein the microtablets have a mean
`
`diameter in the range of 0.3 mm to 2.0 mm, exclusive of any coating on the
`
`microtablets.
`
`215.
`
`(New) The method of claim 214, wherein the microtablets have a mean
`
`diameter of 2.0 mm, exclusive of any coating on the microtablets.
`
`216.
`
`(New) The method of claim 201, wherein the pharmaceutical preparation
`
`is in the form of a capsule containing 120 mg of dimethyl fumarate in the form of enteric—
`
`coated microtablets having a mean diameter in the range of 0.3 mm to 2.0 mm,
`
`exclusive of any coating on the microtablets.
`
`.4-
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`

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`US. Patent Application No. 10/197,077
`Attorney Docket No. 08201 .0061—01000
`
`217.
`
`(New) The method of claim 201, wherein the pharmaceutical preparation
`
`comprises one or more carriers.
`
`218.
`
`(New) The method of claim 201, wherein the pharmaceutical preparation
`
`comprises one or more excipients.
`
`-5
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`

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`US. Patent Application No. 10/197,077
`Attorney Docket No. 08201 .0061-01000
`
`I.
`
`Claim Status
`
`REMARKS
`
`Claims 166-200 have been cancelled without prejudice to their prosecution in
`
`another application. Claims 202-218 have been added. Support for the new claims is
`
`found in the specification, including the original claims (see, e.g., paragraphs [0014],
`
`[0015], [0018], [0022], [0023] - [0030], [0033] - [0036] and Examples 1 - 4). No new
`
`matter has been added. With entry of this amendment, claims 201-218 are currently
`
`pending.
`
`ll.
`
`Interview
`
`Applicants’ undersigned representative expresses her gratitude to the Office for
`
`the courtesies extended in the interview of August 7, 2007. As noted in the Interview
`
`Summary, during that interview, agreement was reached with regard to a proposed
`
`amendment to claim 201. Specifically, the Office indicated that amendment of the claim
`
`to include the phrase “wherein the only active ingredient in said preparation for the
`
`treatment of MS is dimethyl fumarate” would overcome the pending double patenting
`
`rejection and further, that such amended claim would be allowable. Applicants have
`
`amended that claim accordingly.
`
`The Interview Summary further indicates that such a claim “would be allowable
`
`because the ‘992 claims reguirel | an active ingredient in addition to dimethyl fumarate."
`
`Clearly, the Examiner was using shorthand, but the Applicants would like to clarify for
`
`the record the scope of the ‘992 claims. Specifically, to the extent that claim 15 of the
`
`“992 patent, for example, encompasses the use of dimethyl fumarate (an example of the
`
`certain dialkyl fumarates recited in claim 15) for the treatment of multiple sclerosis, claim
`
`15 also recites the use of an effective amount of either (i) a sodium, potassium, calcium,
`
`magnesium, zinc, or iron salt of certain fumaric acid monoalkyl esters or (ii) at least one
`
`of certain alkyl hydrogen fumarates. Accordingly, claim 15 of the ‘992 patent recites the
`
`use of an effective amount of those fumaric acid derivatives (either (i) a sodium,
`
`potassium, calcium, magnesium, zinc, or iron salt of certain fumaric acid monoalkyl
`
`esters or (ii) at least one of certain alkyl hydrogen fumarates) and does not broadly
`
`—6-
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`US. Patent Application No. 10/197,077
`Attorney Docket No. 08201 .0061-01000
`
`recite any active ingredient, in addition to the optional presence of dimethyl fumarate,
`
`one example of the certain dialkyl fumarates recited.
`
`And of course, while claim 201 recites that “the only active ingredient for the
`
`treatment of multiple sclerosis present in said pharmaceutical preparation is dimethyl
`
`fumarate”, that pharmaceutical preparation can contain impurities, carriers and/or
`
`excipients.
`
`III.
`
`Objection to the Specification
`
`The Examiner objected to the title stating that “[t]he title of the invention is not
`
`descriptive” and requests that a new title “that is clearly indicative of the invention to
`
`which the claims are directed" be submitted. To that end, Applicants have replaced the
`
`current title with “DIMETHYL FUMARATE FOR THE TREATMENT OF MULTIPLE
`
`SCLEROSIS." Applicants assert that this title is fully descriptive of the claimed
`
`invention and request that the Examiner withdraw this objection.
`
`In addition the Examiner, requested that the specification be amended to include
`
`the phrase, “now US. Patent No. 6,509,376". Applicants have amended the
`
`specification herein to include that phrase. Accordingly, Applicants respectfully request
`
`that this objection be withdrawn.
`
`IV.
`
`Double Patenting Rejection
`
`Claims 166-201 have been “rejected on the ground of nonstatutory obviousness-
`
`type double patenting as being unpatentable over claims 15-23 of US. Patent No.
`
`6,436,992” to Joshi et al. (“the ‘992 patent"). Office Action at 3. As explained at the
`
`interview, Applicants believe that rejection is improper. However, solely to expedite
`
`prosecution and without in any way conceding to the propriety of the rejection,
`
`Applicants respectfully submit that the amendment of claim 201 and the cancellation of
`
`claims 161-200 without prejudice herein moots the rejection of those claims and no
`
`further discussion is necessary. Applicants request, therefore, that the rejection be
`
`withdrawn.
`
`.7-
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`

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`U.S. Patent Application No. 10/197,077
`Attorney Docket No. 08201 .0061-01000
`
`V.
`
`Conclusion
`
`In view of the foregoing amendments and remarks, Applicants respectfully
`
`request reconsideration and reexamination of this application and the timely allowance
`
`of the pending claims.
`
`Please grant any extensions of time required to enter this response and charge
`
`any additional required fees to our Deposit Account No. 06-0916.
`
`Respectfully submitted,
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`
` Dated: August 15, 2007
`
`Lauren L. Stevens
`
`Reg. No. 36,691
`
`Tel: (650) 849-6614
`Email:
`lauren.stevens@finnegan.com
`
`-8
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`