UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.goV
`
`APPLICATION NO.
`
`F ING DATE
`
`FIRST NAMED INVENTOR
`
`11/651,212
`
`01/09/2007
`
`Irit Pinchasi
`
`75667/JPW/GJG/ALW
`
`1141
`
`"90
`234”
`COOPER & DUNHAM, LLP
`30 Rockefeller Plaza
`20th Floor
`NEW YORK, NY 10112
`
`°3’°”°1°
`
`RUSSEL, JEFREY E
`
`ART UNIT
`
`1 654
`
`MAIL DATE
`
`03/09/2010
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL—90A (Rev. 04/07)
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 1
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 1
`
`

`
`Notice of Abandonment
`
`Application No.
`
`App|icant(s)
`
`11/651,212
`Examiner
`
`Jeffre E. Russel
`
`PINCHASI, IRIT
`Art Unit
`
`1654 ‘
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`
`This application is abandoned in view of:
`
`1. E App|icant’s failure to timely file a proper reply to the Office letter mailed on 20 July 2009.
`(a) I:I A reply was received on
`(with a Certificate of Mailing or Transmission dated
`period for reply (including a total extension oftime of
`month(s)) which expired on
`
`), which is after the expiration of the
`
`(b) I:I A proposed reply was received on
`
`, but it does not constitute a proper reply under 37 CFR 1.113 (a) to the final rejection.
`
`(A proper reply under 37 CFR 1.113 to a final rejection consists only of: (1) a timely filed amendment which places the
`application in condition for allowance; (2) a timely filed Notice of Appeal (with appeal fee); or (3) a timely filed Request for
`Continued Examination (RCE) in compliance with 37 CFR 1.114).
`
`but it does not constitute a proper reply, or a bona fide attempt at a proper reply, to the non-
`(c) I:I A reply was received on
`final rejection. See 37 CFR 1.85(a) and 1.111. (See explanation in box 7 below).
`
`(d) E No reply has been received.
`
`2. I:I Applicant’s failure to timely pay the required issue fee and publication fee, if applicable, within the statutory period of three months
`from the mailing date of the Notice of Allowance (PTOL—85).
`
`(with a Certificate of Mailing or Transmission dated
`(a) I:I The issue fee and publication fee, if applicable, was received on
`), which is after the expiration of the statutory period for payment of the issue fee (and publication fee) set in the Notice of
`Allowance (PTOL—85).
`
`(b) I:I The submitted fee of $
`
`is insufficient. A balance of $
`
`is due.
`
`The issue fee required by 37 CFR 1.18 is $
`
`. The publication fee, if required by 37 CFR 1.18(d), is $
`
`(c) I:I The issue fee and publication fee, if applicable, has not been received.
`
`3.|:| Applicant’s failure to timely file corrected drawings as required by, and within the three—month period set in, the Notice of
`Allowability (PTO—37).
`
`(a) I:I Proposed corrected drawings were received on
`after the expiration of the period for reply.
`
`(b) I:I No corrected drawings have been received.
`
`(with a Certificate of Mailing or Transmission dated
`
`j)
`
`, which is
`
`4. I:I The letter of express abandonment which is signed by the attorney or agent of record, the assignee of the entire interest, or all of
`the applicants.
`
`5. E] The letter of express abandonment which is signed by an attorney or agent (acting in a representative capacity under 37 CFR
`1.34(a)) upon the filing of a continuing application.
`
`6. |:| The decision by the Board of Patent Appeals and Interference rendered on
`of the decision has expired and there are no allowed claims.
`
`and because the period for seeking court review
`
`7. I:I The reason(s) below:
`
`/Jeffrey E. Russell
`Primary Examiner, Art Unit 1654
`
`Petitions to revive under 37 CFR 1.137(a) or (b), or requests to withdraw the holding of abandonment under 37 CFR 1.181, should be promptly filed to
`minimize an neative effects on atent term.
`U.S. Patent and Trademark Office
`
`PTOL-1432 (Rev. 04-01)
`
`Notice of Abandonment
`
`Part of Paper No. 20100302
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 2
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 2
`
`

`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.goV
`
`APPLICATION NO.
`
`F ING DATE
`
`FIRST NAMED INVENTOR
`
`11/651,212
`
`01/09/2007
`
`Irit Pinchasi
`
`75667/JPW/GJG/ALW
`
`1141
`
`"90
`234”
`COOPER & DUNHAM, LLP
`30 Rockefeller Plaza
`20th Floor
`NEW YORK, NY 10112
`
`°“°”°09
`
`RUSSEL, JEFREY E
`
`ART UNIT
`
`1 654
`
`MAIL DATE
`
`07/20/2009
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL—90A (Rev. 04/07)
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 3
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 3
`
`

`
`Office Action Summary
`
`Application No.
`
`App|icant(s)
`
`11/651,212
`
`Examine,
`
`Jeffrey E. Russel
`
`PINCHASI, IRIT
`
`A,, Unit
`
`1654 ‘
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE Q MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`- Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)IXI Responsive to communication(s) filed on 07 July 2009.
`
`2a)I:I This action is FINAL.
`
`2b)IXI This action is non-final.
`
`3)I:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)IXI C|aim(s)i is/are pending in the application.
`
`4a) Of the above c|aim(s)
`
`is/are withdrawn from consideration.
`
`5)I:I C|aim(s)
`
`is/are allowed.
`
`6)IXI C|aim(s)i is/are rejected.
`
`7)I:I C|aim(s) j is/are objected to.
`
`8)I:I C|aim(s) j are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)I:I The specification is objected to by the Examiner.
`
`10)IZ The drawing(s) filed on 09 January 2007 is/are: a)IXI accepted or b)I:I objected to by the Examiner.
`
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`
`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`
`a)I:I All
`
`b)I:I Some * c)I:I None of:
`
`1.I:I Certified copies of the priority documents have been received.
`
`2.I:I Certified copies of the priority documents have been received in Application No.
`
`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
`
`application from the International Bureau (PCT Rule 17.2(a)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attach ment(s)
`
`1) E Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) |:| Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date
`.
`U.S. Patent and Trademark Office
`
`4) D Interview Summary (PTO-413)
`Paper N0(S)/IVI3” Data L
`5) I:I Notice Of Informal Patent Application
`6) D Other:
`.
`
`PTOL-326 (Rev. 08-06)
`
`EXHFialrii$a;ieigo./Ma:k($]fi0(2'00716
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 4
`
`

`
`Application/Control Number: l 1/65 l ,2l2
`
`Page 2
`
`Art Unit: l654
`
`1.
`
`In view of the new grounds of rejection set forth below, the finality of the Office action
`
`mailed April 2, 2009 is withdrawn. The amendment after final rejection filed July 7, 2009 is
`
`entered, and overcomes the objection and rejection under 35 U.S.C. ll2, first paragraph, set forth
`
`in sections l and 2 of the Office action mailed April 2, 2009.
`
`2.
`
`The text of those sections of Title 35, U.S. Code not included in this action can be found
`
`in a prior Office action.
`
`3.
`
`Claims 1, 2, 4, 5, and ll-l6 are rejected under 35 U.S.C. l03(a) as being obvious over
`
`the W0 Patent Application 2004/09l573. The WO Patent Application ‘573 teaches the
`
`subcutaneous administration of glatiramer acetate to patients with relapsing-remitting multiple
`
`sclerosis, whereby the frequency of relapses is reduced and/or the appearance of new lesions as
`
`detected by MRI is reduced. The WO Patent Application ‘573 teaches glatiramer acetate
`
`dosages of 300 mg/week, which is equivalent to a daily dosage of about 43 mg/day. The W0
`
`Patent Application ‘573 also teaches that the dosage amount can be in the range of l8 to 40 mg.
`
`The WO Patent Application ‘573 teaches administration of the glatiramer acetate in the form of a
`
`solution in water or saline. See, e.g., page 2, line 3l - page 3, line 2; page 5, lines 28-31; page 7,
`
`lines 30-32; page 8, lines l7-20; page 9, lines 3l - page l0, line l; page l0, lines 19-22; page l3,
`
`lines 3l-33; page l7, lines 6-13; and claims l, 2, 6-14, and 18. The WO Patent Application ‘573
`
`does not teach a glatiramer acetate concentration of 40 mg/ml in the pharmaceutical composition
`
`being administered to the patients. It would have been obvious to one of ordinary skill in the art
`
`at the time Applicant's invention was made to determine all operable and optimal concentrations
`
`for the glatiramer acetate administered by the W0 Patent Application ‘573, because
`
`concentration is an art-recognized result-effective variable which is routinely determined and
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 5
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 5
`
`

`
`Application/Control Number: 1 1/65 1 ,2l2
`
`Page 3
`
`Art Unit: 1654
`
`optimized in any art involving solutions, including the pharmaceutical arts. See In re
`
`Mostovych, 144 USPQ 38, 42 (CCPA 1964).
`
`4.
`
`Claims 1-5 and 11-16 are rejected under 35 U.S.C. l03(a) as being obvious over the W0
`
`Patent Application 2004/091573. Application of the W0 Patent Application ‘573 is the same as
`
`in the above rejection of claims 1, 2, 4, 5, and ll-l6. To the extent that the W0 Patent
`
`Application ‘573 does not teach a dose of 40 mg, it would have been obvious to one of ordinary
`
`skill in the art at the time Applicant's invention was made to determine all operable and optimal
`
`doses for the glatiramer acetate administered by the W0 Patent Application ‘573, because dose
`
`is an art-recognized result-effective variable which is routinely determined and optimized in the
`
`pharmaceutical arts. The significant overlap in doses between the disclosed dose ranges of the
`
`W0 Patent Application ‘573 and Applicant’s claimed dose is sufficient to establish prima facie
`
`obviousness of Applicant’s claimed dose. See MPEP 2l44.05(I). The W0 Patent Application
`
`‘573 does not teach administering glatiramer acetate on a schedule of every other day, although
`
`periodic administration is taught, ranging from twice a day up to once every 11 days. See page
`
`7, lines 3-6, and page 8, lines 22-30. It would have been obvious to one of ordinary skill in the
`
`art at the time Applicant's invention was made to determine all operable and optimal dosage
`
`schedules for the glatiramer acetate of the W0 Patent Application ‘862, because dosage schedule
`
`is an art-recognized result-effective variable which is routinely determined and optimized in the
`
`pharmaceutical arts.
`
`5.
`
`Claims 6-9 and 17-20 are rejected under 35 U.S.C. l03(a) as being obvious over the W0
`
`Patent Application 2004/091573 as applied against claims l-5 and ll-l6 above, and further in
`
`view of Ray et al (U.S. Patent Application Publication 2006/0154862). The W0 Patent
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 6
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 6
`
`

`
`Application/Control Number: 1 l/651,212
`
`Page 4
`
`Art Unit: 1654
`
`Application ‘573 does not teach the glatiramer acetate in the form of a sterile solution; and does
`
`not teach the glatiramer acetate in combination with mannitol or at a pH in the range of 5.5 to
`
`7.0. Ray et al teach that CopaXone®, i.e. glatiramer acetate, is a lyophilized powder also
`
`containing mannitol and supplied in single use vials for subcutaneous administration after
`
`reconstitution with sterile water. See paragraph [0003]. It would have been obvious to one of
`
`ordinary skill in the art at the time Applicant's invention was made to administer the glatiramer
`
`acetate of the W0 Patent Application ‘573 in combination with mannitol for reconstitution with
`
`sterile water, because Ray et al teach that this is a known formulation for glatiramer acetate, and
`
`it is routine in the pharmaceutical arts to administer therapeutic agents using excipients and
`
`formulations which are already known to be effective for administration of the therapeutic
`
`agents. Sterile water has a pH of 7.0, and neither the glatiramer acetate salt nor the mannitol will
`
`materially change the pH of the reconstituted solution.
`
`6.
`
`Claims 10 and 21 are rejected under 35 U.S.C. l03(a) as being obvious over the W0
`
`Patent Application 2004/091573 as applied against claims l-5 and ll-l6 above, and further in
`
`view of the Polin article (May 2003). The WO Patent Application ‘573 does not teach the
`
`glatiramer acetate in the form of a prefilled syringe administered by the patient. The Polin article
`
`teaches the use of prefilled syringes to administer drugs, including Copaxone®, and teaches
`
`prefilled syringes as having the benefits of ease of use, elimination of dosing errors, and reduced
`
`waste. It would have been obvious to one of ordinary skill in the art at the time Applicant's
`
`invention was made to administer the glatiramer acetate of the W0 Patent Application ‘573
`
`using the pref1lled syringes taught by the Polin article because the pref1lled syringes of the Polin
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 7
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 7
`
`

`
`Application/Control Number: l 1/65 l ,2l2
`
`Page 5
`
`Art Unit: l654
`
`article are known to be useful for administering Copaxone®, and because of the expected
`
`benefits of using prefilled syringes as taught by the Polin article.
`
`7.
`
`Applicant's arguments filed July 7, 2009 have been fully considered but they are not
`
`persuasive.
`
`The prior art rejections set forth in the Office action mailed April 2, 2009 have been
`
`modified somewhat, especially so as to address the new dosage limitation and to apply a new
`
`reference against claims 10 and 21 drawn to the use of prefilled syringes. However, the essence
`
`of the rejections is the same as before, and the examiner maintains his position for the reasons of
`
`record.
`
`Applicant contends that the results of daily administration of 40 mg glatiramer acetate
`
`could not be predicted based on the prior art or upon the results of administration of 30 mg per
`
`day. At page 12 of the response, Applicant also identifies three unexpected results observed with
`
`the 40 mg dosage.
`
`Firstly, an issue which has not been addressed by Applicant is whether or not the W0
`
`Patent Application 2004/091573 teaches a dosage of 40 mg/day. See in particular page 8, line
`
`19, of the reference. To the extent that the W0 Patent Application ‘573 teaches this dosage, an
`
`assertion of unexpected results due to a dosage of 40 mg/day is ineffective because dosage is not
`
`a difference between the claims and the closest prior art of record.
`
`Secondly, to the extent that Applicant asserts that unexpected results are present as a
`
`result of dosage of 40 mg/day, the asserted unexpected results would only be commensurate in
`
`scope with instant claim 2. Dependent claim 2 is the only pending claim which requires a daily
`
`dosage of 40 mg. Note that product claims 16-21 have not been amended to contain a daily
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 8
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 8
`
`

`
`Application/Control Number: 1 l/651,212
`
`Page 6
`
`Art Unit: 1654
`
`dosage limitation; and in any event, product claims can not be limited with a process limitation
`
`so as to require the product to be used in a particular method.
`
`Finally, with respect to the three asserted unexpected results, an “unexpected result”
`
`which is no difference compared to the prior art is not deemed to outweigh the strong evidence in
`
`favor of obviousness. “Unexpectedly not worse” is not deemed to outweigh the strong evidence
`
`in favor of the routine optimization and determination of concentration or dose. See Agrizap Inc
`
`v. Woodstream Corp., 520 F3d 1337, 86 USPQ2d 1110 (Fed. Cir. 2008). Concerning the second
`
`and third asserted unexpected results, the examiner agrees that a demonstration that the higher
`
`dosage resulted in an increased rate of efficacy (by 3 months) could be the basis for rebutting a
`
`prima facie case of obviousness. However, the showing of criticality for a single dosage within a
`
`range of dosages requires testing at more than two points within the range. See MPEP
`
`7l6.02(d)(II). The results of the 30 mg/day dosage discussed at page 20, lines 9-27, of the
`
`specification appear to concern a different variable, i.e. progression and/or survival rates, than
`
`the results discussed at page 20, lines 1-8, of the specification, and therefore are not comparable.
`
`Concerning the results of the FORTE trial, as evidenced by Reference 63 of the Information
`
`Disclosure Statement filed December 29, 2008 and by the Yong et al abstract cited in
`
`Applicant’s response, the differing interpretations presented in these two articles will have to be
`
`reconciled by one skilled in the art in an affidavit or declaration filed under 37 CFR l.l32. Note
`
`that the burden is on Applicant to establish unexpected results and to explain any proffered data.
`
`See MPEP 7l6.02(b). Because the assignee of the instant invention is the author of Reference
`
`63, Applicant is in the best position to make such a reconciliation.
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 9
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 9
`
`

`
`Application/Control Number: 1 1/65 1 ,212
`
`Page 7
`
`Art Unit: 1654
`
`8.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Jeffrey E. Russel at telephone number (571) 272-0969. The
`
`examiner can normally be reached on Monday-Thursday from 8:00 A.M. to 5:30 P.M. The
`
`examiner can also be reached on alternate Fridays.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor Cecilia Tsang can be reached at (571) 272-0562. The fax number for formal
`
`communications to be entered into the record is (571) 273-8300; for informal communications
`
`such as proposed amendments, the fax number (571) 273-0969 can be used. The telephone
`
`number for the Technology Center 1600 receptionist is (571) 272-1600.
`
`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`applications is available through Private PAIR only. For more information about the PAIR
`
`system, see http://pair-direct.uspto. gov. Should you have questions on access to the Private PAIR
`
`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
`
`/Jeffrey E. Russel/
`Primary Examiner, Art Unit 1654
`
`JRussel
`
`July 17, 2009
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 10
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 10
`
`

`
`
`
`Application/Control No.
`
`11/651312
`Examiner
`
`Jeffrey E. Russel
`U.S. PATENT DOCUMENTS
`
`Applicant(s)/Patent Under
`Reexamination
`PINCHASI
`IRIT
`Art Unit
`
`1654
`
`Page 1 °f1
`
`Notice of References Cited
`
`Document Number
`Country Code-Number-Kind Code
`C ‘P
`
`E
`
`Classification
`
`C ‘P
`CCCCCCCCCCC‘P‘P‘P‘P‘P‘P‘P‘P‘P‘P‘P
`
`FOREIGN PATENT DOCUMENTS
`
`Document Number
`Country Code-Number-Kind Code
`
`UQ).-o-(D
`|v||v|-YYYY
`
`COUWY
`
`C'3SSl“C3“°"
`
`NON-PATENT DOCUMENTS
`
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`Polin. The Ins and Outs of Prefilled Syringes. May 2003, Pharmaceutical & Medical Packaging News/Medical Device Link.
`
`— U
`
`
`
`Immunological Response to Different Doses of Glatiramer Acetate in MS: Analyses from the FORTE Trial. April 28,
`Yong et al.
`2009, Poster Session I: Multiple Sclerosis: Immunology I (Abstract).
`
`*A copy of this reference is not being furnished with this Office action. (See MPEP § 707.05(a).)
`Dates in MM-YYYY format are publication dates. Classifications may be US or foreign.
`U.S. Patent and Trademark Office
`
`PTO-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20090716
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 11
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 11
`
`

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`2009/ 07/ 1 5
`
`1 7: 1 8
`
`2“0‘0‘§/0‘7/‘1‘é‘""""""‘
`1 7: 1 8
`
`7/15/09 5:19:30 PM
`
`C:\ Documents and Settings\ JRusse|\ My Documents\ EAST\ Workspaces\ defau|t.wsp
`L9, L11
`Checked L4, L6,
`
`/J7R/
`
`07/15/2009
`
`file:///Cl/D0cuments%20and%20Settings/JRussel/My%2OD0cume...11651212/EASTSearchHist0ry.11651212_AccessibleVersi0n.htm7/15/09 5:19:36 PM
`
`MYLAN PHARMS. INC. EXHIBIT 1 135 PAGE 12
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 12
`
`
`
`
`
`
`

`
`App|icationIContro| No.
`
`App|icant(s)IPatent Under
`Reexamination
`
`Seafch NOTES
`
`11651212
`
`PINCHASI, IRIT
`
`
`
`Examiner
`
`Jeffrey E Russel
`
`
`
`Art Unit
`
`1654
`
`Class Examiner Subclass Date
`
`NONE
`
`
`
`
`
`SEARCHED
`
`SEARCH NOTES
`
`EAST (US-PGPUB, USPAT) — See Search History Printout
`424/78.08, 78.37; 514/2,12 (text search only - see search history printout)
`
`07/15/2009
`07/15/2009
`
`Search Notes
`
`Examiner
`
`INTERFERENCE SEARCH
`
`US Patent and Trademark office
`
`MYLAN PHARMS. INC. EXHIBIT 11a5omectIE= 10390716
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 13
`
`

`
`OK TO ENTER:
`
`/JER.’
`
`Q7/15/Qg RESPONSE TO
`FINAL OFFICE ACTION
`EXPEDITED PROCEDURE
`GROUP ART UNIT 1654
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Dkt. 2609/75667/JPW/GJG/JR
`
`Applicants
`
`: Irit Pinchasi
`
`Serial No.
`
`: 11/651,212
`
`Examiner: J. E. Russel
`
`Filed
`
`For
`
`: January 9, 2007
`
`Art Unit: 1654
`
`: METHOD OF TREATING MULTIPLE SCLEROSIS
`
`30 Rockefeller Plaza, 20th Fl.
`New York, New York 10112
`
`July 1, 2009
`
`Mail Stop Amendment
`Commissioner for Patents
`P.O. BOX 1450
`
`Alexandria VA 22313-1450
`
`Sir:
`
`AMENDMENT UNDER 37 C.F.R. §1.116
`
`IN RESPONSE TO APRIL 2, 2009 FINAL OFFICE ACTION
`
`This is an Amendment
`
`in Response to the Final Office Action
`
`issued April 2,
`
`2009 in connection with the above-identified
`
`application. A response to the .April 2,
`
`2009 Final Office
`
`Action.
`
`is due July’ 2,
`
`2009. Accordingly;
`
`this .Amendment
`
`is
`
`being timely filed.
`
`Please amend the subject application as follows:
`
`Amendments to the specification begin on page 2 of this paper.
`
`Amendments to the claims begin on page 3 of this paper.
`
`Remarks begin on page 6 of this paper.
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 14
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 14
`
`

`
`RESPONSE TO
`FINAL OFFICE ACTION
`EXPEDITED PROCEDURE
`GROUP ART UNIT 1654
`
`
`
`Dkt. 2609/75667/JPW/GJG/JR
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicants
`
`: Irit Pinchasi
`
`Serial No.
`
`: 11/651,212
`
`Examiner: J. E. Russel
`
`Filed
`
`For
`
`: January 9, 2007
`
`Art Unit: 1654
`
`: METHOD OF TREATING MULTIPLE SCLEROSIS
`
`30 Rockefeller Plaza, 20th Fl.
`New York, New York 10112
`
`July 1, 2009
`
`Mail Stop Amendment
`Commissioner for Patents
`P.O. BOX 1450
`
`Alexandria VA 22313-1450
`
`Sir:
`
`AMENDMENT UNDER 37 C.F.R. §1.116
`
`IN RESPONSE TO APRIL 2, 2009 FINAL OFFICE ACTION
`
`This is an Amendment
`
`in Response to the Final Office Action
`
`issued April 2,
`
`2009 in connection with the above-identified
`
`application. A response to the .April 2,
`
`2009 Final Office
`
`Action.
`
`is due July’ 2,
`
`2009. Accordingly;
`
`this .Amendment
`
`is
`
`being timely filed.
`
`Please amend the subject application as follows:
`
`Amendments to the specification begin on page 2 of this paper.
`
`Amendments to the claims begin on page 3 of this paper.
`
`Remarks begin on page 6 of this paper.
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 15
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 15
`
`

`
`Applicants
`
`Serial NO.
`
`:
`
`:
`
`Irit Pinchasi
`
`ll/651,212
`
`January 9, 2007
`Filing Date :
`Page 2 of 15 of Amendment Under 37 C.F.R. §1.116 in Response
`to April 2, 2009 Final Office Action
`
`Amendments to the specification
`
`Please amend the specification pursuant
`
`to 37 C.F.R. §1.121(b)
`
`as indicated below:
`
`Please
`
`amend
`
`the
`
`specification by replacing the paragraph
`
`starting on page 2,
`
`line 6 and ending on line 31 with the
`
`following:
`
`Benign multiple sclerosis is a retrospective diagnosis which
`
`is characterized by 1-2 exacerbations with complete recovery,
`
`no lasting disability' and no disease progression.
`
`for 10-15
`
`years after the initial onset. Benign multiple sclerosis may,
`
`however, progress
`
`into other
`
`forms of multiple
`
`sclerosis.
`
`Patients suffering from RRMS experience sporadic exacerbations
`
`or
`
`relapses,
`
`as well
`
`as periods of
`
`remission. Lesions
`
`and
`
`evidence of axonal
`
`loss may or may not be visible on MRI
`
`for
`
`patients with RRMS.
`
`SPMS may
`
`evolve
`
`from RRMS. Patients
`
`afflicted. with.
`
`SPMS have relapses,
`
`a diminishing degree of
`
`recovery during remissions,
`
`less frequent remissions and more
`
`pronounced neurological deficits than RRMS patients. Enlarged
`
`ventricles, which
`
`are markers
`
`for
`
`atrophy of
`
`the
`
`corpus
`
`callosum, midline center and spinal cord, are visible on MRI
`
`of patients with SPMS.
`
`PPMS
`
`is characterized by a
`
`steady
`
`progression.
`
`of
`
`increasing
`
`neurological
`
`deficits without
`
`distinct
`
`attacks or
`
`remissions. Cerebral
`
`lesions,
`
`diffuse
`
`spinal cord damage and evidence of axonal
`
`loss are evident on
`
`the MRI of patients with PPMS.
`
`PRMS has periods of acute
`
`exacerbations while proceeding along a course of
`
`increasing
`
`neurological deficits without
`
`remissions. Lesions are evident
`
`on MRI of patients suffering from PRMS
`
`(Multiple sclerosis:
`
`its
`
`diagnosis,
`
`symptoms,
`
`types
`
`and
`
`stages,
`
`2003
`
`+heep+%%www—albany—fiet%—e3e%muleiple—
`
` AGE 16
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 16
`
`

`
`Applicants
`Serial No.
`
`Irit Pinchasi
`
`ll/651,212
`
`Filing Date
`January 9, 2007
`Page 3 of 15 of Amendment Under 37 C.F.R. §1.116 in Response
`to April 2, 2009 Final Office Action
`
`Amendments to the Claims
`
`Please replace all previous listing of claims with the listing
`
`of claims which follows pursuant to 37 C.F.R. §1.121:
`
`Listing of Claims
`
`1.
`
`(Currently Amended) A method of alleviating a symptom of a
`
`patient
`
`suffering from a
`
`relapsing
`
`form of multiple
`
`sclerosis
`
`which
`
`comprises periodically administering to
`
`the patient by subcutaneous injection a sifigle—4O mg dose
`
`of
`
`a pharmaceutical composition
`
`comprising 40 mg/ml of
`
`glatiramer acetate so as to thereby alleviate the symptom
`
`of the patient.
`
`(Original) The method. of
`
`clain1 1, wherein.
`
`the periodic
`
`administration is daily.
`
`(Original) The method of claint 1,
`
`,wherein.
`
`the periodic
`
`administration is every other day.
`
`(Original) The method of claim 1, wherein.
`
`the relapsing
`
`form of nmltiple sclerosis is relapsing—remittingTnultiple
`
`sclerosis.
`
`(Previously Presented) The method of claim 1, wherein in
`
`thesymptom is the frequency of relapses.
`
`(Previously’ Presented) The method of clainl
`
`1 wherein.
`
`the
`
`pharmaceutical
`
`composition is in the form. of
`
`a sterile
`
`solution.
`
`(Previously Presented) The method of claim 1 wherein the
`
`pharmaceutical composition further comprises mannitol.
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 17
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 17
`
`

`
`Applicants
`Serial No.
`
`Irit Pinchasi
`
`11/651,212
`
`January 9, 2007
`Filing Date .
`Page 4 of 15 of Amendment Under 37 C.F.R.
`2009 Final Office Action
`to April 2,
`
`§1.116 in Response
`
`8.
`
`(Previously Presented) The method of claim 1, wherein the
`
`pharmaceutical composition has a pH in the range of 5.5to
`
`8.5.
`
`(Original)
`
`The
`
`method
`
`of
`
`claim 8,
`
`wherein
`
`the
`
`pharmaceutical composition has a pH in the range of 5.5 to
`
`7.0.
`
`10.
`
`ll.
`
`12.
`
`13.
`
`14.
`
`15.
`
`(Previously Presented) The method of claim 1, wherein the
`
`pharmaceutical composition is in a prefilled syringe and
`
`is self—administered by the patient.
`
`(Currently Amended)
`
`A method of
`
`reducing MRI—monitored
`
`disease activity" and burden. of
`
`a patient
`
`suffering from
`
`multiple
`
`sclerosis
`
`which
`
`comprises
`
`periodically
`
`administering to the patient by subcutaneous injection a
`
`sifigle——4O
`
`mg
`
`dose
`
`of
`
`a
`
`pharmaceutical
`
`composition
`
`comprising 40mg/ml of glatiramer acetate.
`
`(Original) The method. of claint 11, wherein.
`
`reducirg; MRI-
`
`monitored disease activity and burden is reducing the mean
`
`cumulative number of Gd—enhancing lesions in the brain of
`
`the patient.
`
`(Original) The method of claim 11, wherein reducing MRI-
`
`monitored disease activity and burden is reducing the mean
`
`cumulative number of new T2
`
`lesions in the brain of
`
`the
`
`patient.
`
`(Currently Amended) The nethod of clamn 11, wherein the
`
`periodic administration to the patient of the siagle—4O mg
`
`dose of a pharmaceutical composition comprising 40 mg/ml
`
`of glatiramer acetate further reduces a symptom of MS.
`
`(Original) The method of claim 14, wherein the symptom is
`
`the frequency of relapses.
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 18
`
`MYLAN PHARMS. INC. EXHIBIT 1135 PAGE 18
`
`

`
`Applicants
`Serial No.
`
`Irit Pinchasi
`
`ll/651,212
`
`January 9, 2007
`Filing Date .
`Page 5 of 15 of Amendment Under 37 C.F.R.
`2009 Final Office Action
`to April 2,
`
`§l.116 in Response
`
`16.
`
`(Previously Presented)
`
`Ix pharmaceutical composition jJ1 a
`
`unit
`
`dosage
`
`injectable
`
`form comprising
`
`40 mg/ml
`
`of
`
`glatiramer
`
`acetate
`
`and
`
`a
`
`pharmaceutically
`
`acceptable
`
`carrier.
`
`17.
`
`(Original)
`
`The pharmaceutical
`
`composition of
`
`claim