Case l:14-cv-00914-UNA Document 4 Filed 07/11/14 Page 1 of 1 PagelD #: 125
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`for the District of Delaware
`filed in the U.S. District Court
`on the following
`( • the patent action involves 35 U.S.C. § 292.):
`
`Sf Patents.
`
`• Trademarks or
`
`DOCKET NO.
`
`DATE FILED
`7/11/2014
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`PLAINTIFF
`CUBIST PHARMACEUTICALS, INC.
`
`DEFENDANT
`FRESENIUS KABI USA, LLC
`
`PATEN T OR
`TRADEMARK NO.
`6,468,967
`
`DATE OF PATENT
`OR TRADEMARK
`10/22/2002
`
`2 6,852,689
`
`3 8,058,238
`
`4 8,129,342
`
`5
`
`2/8/2005
`
`11/15/2011
`
`3/6/2012
`
`HOLDER OF PATENT OR TRADEMARK
`
`Cubist Pharmaceuticals, Inc.
`
`Cubist Pharmaceuticals, Inc.
`
`Cubist Pharmaceuticals, Inc.
`
`Cubist Pharmaceuticals, Inc.
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PA TENT OR
`TRADEMARK NO.
`
`• Amendment
`DA TE OF PATENT
`OR TRADEMARK
`
`• Answer
`
`n Cross Bill
`
`• Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`2
`
`3
`
`4
`
`5
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`CLERK
`
`(BY) DEPU TY CLERK
`
`DATE
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
`
`
`1 of 319
`
`FRESENIUS-KABI, Exh. 1004
`
`

`
`Case l:13-cv-06016-NLH-JS Document 4 Filed 10/10/13 Page 1 of 1 PagelD: 126
`
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark
`Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`filed in the U.S. District Court for the District of New Jersey on the following:
`Trademarks or X Patents. (
`the patent action involves 35 U.S.C. § 292.)
`
`DOCKET NO.
`DATE FILED
`3:13-e v-06016-M AS-DE/A0/2013
`PLAINTIFF
`CUBIST PHARMACEUTICALS, INC.
`
`U.S. DISTRICT COURT
`TRENTON. NJ
`DEFENDANT
`STRIDES, INC.
`
`PATENT OR
`TRADEMARK NO.
`1 6,468,967
`
`DATE OF PATENT
`OR TRADEMARK
`10/22/2002
`
`2 6,852.68962
`
`3 8,058,238
`
`4 8,129,34262
`
`2/8/2005
`
`11/15/2011
`
`3/6/2012
`
`HOLDER OF PATENT OR TRADEMARK
`
`CUBIST PHARMACEUTICALS, INC
`
`CUBIST PHARMACEUTICALS, INC
`
`CUBIST PHARMACEUTICALS, INC
`
`CUBIST PHARMACEUTICALS, INC
`
`In the above—entitled case, the following patent(s)/ trademarkCs) have been included:
`DATE INCLUDED
`INCLUDED BY
`
`Amendment
`
`Answer
`
`Cross Bill
`
`Other Pleading
`
`PATENT OR
`TRADEMARK NO.
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`1
`
`3
`
`4
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`DECISION/JUDGEMENT
`
`CLERK
`William T. Walsh
`
`(BY) DEPUTY CLERK
`s/ KIM STILLMAN
`
`DATE
`10/10/2013
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`C'opj 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
`
`
`2 of 319
`
`

`
`Case 3:13-cv-06016-MAS-DEA Document 4 Filed 10/10/13 Page 1 of 1 PagelD: 126
`
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark
`Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`FILING ORD^ERMlNA/nON OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`filed in the U.S. District Court for the District of New Jersey on the following:
`the patent action involves 35 U.S.C. § 292.)
`Trademarks or X Patents. (
`
`DOCKET NO.
`DATE FILED
`3:13-cv-06016-MAS-t])E/A0/2013
`PLAINTIFF
`CUBIST PHARMACEUTICALS, INC.
`
`U.S. DISTRICT COURT
`TRENTON. NJ
`DEFENDANT
`STRIDES, INC.
`
`PATENT OR
`TRADEMARK NO
`1 6,468,967
`
`DATE OF PATENT
`OR TRADEMARK
`10/22/2002
`
`2 6,852,689B2
`
`3 8,058,238
`
`4 8,129,342B2
`
`5
`
`2/8/2005
`
`11/15/2011
`
`3/6/2012
`
`HOLDER OF PATENT OR TRADEMARK
`
`CUBIST PHARMACEUTICALS, INC
`
`CUBIST PHARMACEUTICALS, INC
`
`CUBIST PHARMACEUTICALS, INC
`
`CUBIST PHARMACEUTICALS, INC
`
`In the above—entitled case, the following patentfsV trademarkfs) have been included:
`INCLUDED BY
`DATE INCLUDED
`
`Amendment
`
`Answer
`
`Cross Bill
`
`Other Pleading
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`PATENT OR
`TRADEMARK NO
`1
`2
`3
`
`4
`
`5
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`DECISION/JUDGEMENT
`
`CLERK
`William T. Walsh
`
`(BY) DEPUTY CLERK
`s/ KIM STILLMAN
`
`DATE
`10/10/2013
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
`
`
`3 of 319
`
`

`
`Case l:12-cv-01142-UNA Document 4 Filed 09/17/12 Page 1 of 1 Page ID #: 142
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`for the District of Delaware
`on the following
`filed in the U.S. District Court
`Ef Patents.
`( • the patent action involves 35 U.S.C. § 292.):
`• Trademarks or
`
`DOCKET NO.
`
`PLAINTIFF
`
`CUBIST PHARMACEUTICALS, INC.
`
`DATE FILED
`9/17/2012
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`DEFENDANT
`
`HOSPIRA, INC.
`
`PATENT OR
`TRADEMARK NO.
`
`1 6,568,967 B1
`
`2 6,852,689 B2
`
`3 RE39,071 E
`
`4 8,058,238 B2
`
`5 8,129,342 B2
`
`DATE OF PATENT
`OR TRADEMARK
`10/22/2002
`
`2/8/2005
`
`4/18/2006
`
`11/15/2011
`
`HOLDER OF PATENT OR TRADEMARK
`
`Cubist Pharmaceuticals, Inc.
`
`Cubist Pharmaceuticals, Inc.
`
`Cubist Pharmaceuticals, Inc.
`
`Cubist Pharmaceuticals, Inc.
`
`3/6/2012
`
`Cubist Pharmaceuticals, Inc.
`
`DATE INCLUDED
`
`INCLUDED BY
`
`In the above-
`
`:ntitled case, the following patent(s)/ trademark(s) have been included:
`
`• Amendment • Answer
`DATE OF PATENT
`OR TRADEMARK
`
`• Cross Bill • Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`PATENT OR
`TRADEMARK NO.
`
`1
`
`2
`
`4
`
`5
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`CLERK
`
`(BY) DEPUTY CLERK
`
`DATE
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
`
`
`4 of 319
`
`

`
`Case l:12-cv-00859-UNA Document 4 Filed 07/09/12 Page 1 of 1 PagelD #: 46
`
`AO 120 (Rev. 08/1 (i)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`for the District of Delaware
`on the following
`filed in the U.S. District Court
`( • the patent action involves 35 U.S.C. § 292.):
`• Trademarks or 0 Patents.
`
`DOCKET NO.
`
`DATE FILED
`3/21/2012
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`PLAINTIFF
`CUBIST PHARMACEUTICALS, INC.
`
`DEFENDANT
`HOSPIRA, INC.
`
`PATENT OR
`TRADEMARK NO.
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`1 8,129,342 82
`
`3/6/2012
`
`Cubist Pharmaceuticals, Inc.
`
`2
`
`3
`
`4
`
`5
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`• Amendment
`DATE OF PATENT
`ORTRADEMARK
`
`• Answer
`
`• Cross Bill • Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`I
`
`2
`
`3
`
`4
`
`5
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`DECISION/JUDGEMENT
`
`CLERK
`
`(BY) DEPUTY CLERK
`
`DATE
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
`
`
`5 of 319
`
`

`
`^ UNITED STATES PATENT AND TRADEMARK OFFICE
`1
`
`it
`1
`
`•AT OF CO
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Bo DX 1450
`dria, Virginia 22313-1450
`Alexan
`to.gov www.usp
`
`
`APPLICATION NO.
`
`12/888,233
`
`ISSUE DATE
`
`03/06/2012
`
`PATENT NO.
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`8129342
`
`C062-02/04 US
`
`4046
`
`34103
`02/15/2012
`7590
`Intellectual Property Department
`Cubist Pharmaceuticals, Inc.
`65 Hayden Avenue
`Lexington, MA 02421
`
`The projected patent number and issue date are specified above.
`
`ISSUE NOTIFICATION
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment is 0 day(s). Any patent to issue from the above-identified application will include
`an indication of the adjustment on the front page.
`
`If a Continued Prosecution Application (CPA) was filed in the above-identified application, the filing date that
`determines Patent Term Adjustment is the filing date of the most recent CPA.
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information
`Retrieval (PAIR) WEB site (http://pair.uspto.gov).
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the
`Office of Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee
`payments should be directed to the Application Assistance Unit (AAU) of the Office of Data Management
`(ODM) at (571)-272-4200.
`
`APPLICANT(s) (Please see PAIR WEB site http://pair.uspto.gov for additional applicants):
`
`Thomas J. Kelleher, Thousand Oaks, CA;
`Jan-Ji Lai, Westborough, MA;
`Joseph P. DeCourcey, Boston, MA;
`Paul D. Lynch, Arlington, MA;
`Maurizio Zenoni, Ferentino Frosinone, ITALY;
`Auro R. Tagliani, Pavia, ITALY;
`
`IR103 (Rev. 10/09)
`
`
`6 of 319
`
`

`
`PTO/SB/O8a (01-10)
`Doc code: IDS
`Approved for use through 07/31/2012. OMB 0651-0031
`Doc description: Information Disclosure Statement (IDS) Filed
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`12888233
`
`2010-09-22
`
`First Named Inventor
`
`Thomas J. Kelleher
`
`Art Unit
`
`1656
`
`Examiner Name
`
`Chih-Min Kam
`
`Attorney Docket Number
`
`C062-02/04 US
`
`U.S.PATENTS
`
`Examiner Cite
`Initial*
`No
`
`Patent Number
`
`Kind
`Code1
`
`Issue Date
`
`Name of Patentee or Applicant
`of cited Document
`
`Pages,Columns,Lines where
`Relevant Passages or Relevant
`Figures Appear
`
`/GMKi' 1
`nge\,s_) applied
`C i a
`to d ocumen:
`
`/ D-AiMj 9
`1/50/2012z
`
`6468967
`
`2002-10-22
`
`6852689
`
`2005-02-08
`
`O^e s o n Jr., et al.
`
`O^e s o n Jr., et al.
`
`If you wish to add additional U.S. Patent citation information please click the Add button.
`U.S.PATENT APPLICATION PUBLICATIONS
`
`Examiner
`Initial*
`
`Cite No
`
`Publication
`Number
`
`Kind Publication
`Code1 Date
`
`Name of Patentee or Applicant
`of cited Document
`
`Pages,Columns,Lines where
`Relevant Passages or Relevant
`Figures Appear
`
`1
`
`If you wish to add additional U.S. Published Application citation information please click the Add button.
`FOREIGN PATENT DOCUMENTS
`
`Examiner Cite
`Initial*
`No
`
`Foreign Document
`Number3
`
`Country
`Code2i
`
`Kind Publication
`Code4 Date
`
`Name of Patentee or
`Applicant of cited
`Document
`
`Pages,Columns, Lines
`where Relevant
`Passages or Relevant
`Figures Appear
`
`T5
`
`icmj
`
`1
`
`WO 00/18419
`
`WO
`
`2000-04-06
`
`Cubist Pharmaceuticals,
`Inc.
`
`•
`
`If you wish to add additional Foreign Patent Document citation information please click the Add button
`NON-PATENT LITERATURE DOCUMENTS
`
`EFS Web2.1.17
`
`
`7 of 319
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`a
`1
`$
`3k
`
`VVTOFCO
`
`II
`'gj
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`DX 1450
`P.O. Bo
`dria, Virginia 22313-1450
`Alexan
`to.gov
`www.usp
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`12/888,233
`
`09/22/2010
`
`Thomas J. Kelleher
`
`C062-02/04 US
`
`4046
`
`02/06/2012
`7590
`34103
`Intellectual Property Department
`Cubist Pharmaceuticals, Inc.
`65 Hayden Avenue
`Lexington, MA 02421
`
`EXAMINER
`
`KAM, CHIH MIN
`
`ART UNIT
`
`PAPER NUMBER
`
`1656
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`02/06/2012
`
`ELECTRONIC
`
`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.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`patents @ cubist.com
`jodi.doherty@cubist.com
`colleen.lombard@cubist.com
`
`PTOL-90A (Rev. 04/07)
`
`
`8 of 319
`
`

`
`Response to Rule 312 Communication
`
`Application No.
`
`Applicant(s)
`
`12/888,233
`Examiner
`
`KELLEHER ET AL.
`Art Unit
`
`CHIH-MIN KAM
`
`1656
`
`- The MAILING DATE of this communication appears on the cover sheet with the correspondence address -
`
`1. ^ The amendment filed on 26 January 2012 under 37 CFR 1.312 has been considered, and has been:
`
`a) • entered.
`
`b) ^ entered as directed to matters of form not affecting the scope of the invention.
`
`c) • disapproved because the amendment was filed after the payment of the issue fee.
`Any amendment filed after the date the issue fee is paid must be accompanied by a petition under 37 CFR 1.313(c)(1)
`and the required fee to withdraw the application from issue.
`
`d) • disapproved. See explanation below.
`
`e) • entered in part. See explanation below.
`
`U.S. Patent and Trademark Office
`PTOL-271 (Rev. 04-01)
`
`Reponse to Rule 312 Communication
`
`Part of Paper No. 20120131
`
`/Chih-Min Kam/
`Primary Examiner, Art Unit 1656
`
`
`9 of 319
`
`

`
`PART B - FEE(S) TRANSMITTAL
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`or Fax (571)-273-2885
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1 through 5 should be completed where
`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`indicated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS" for
`maintenance fee notifications.
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change of address)
`
`7590
`01/11/2012
`34103
`Intellectual Property Department
`Cubist Pharmaceuticals, Inc.
`65 Hayden Avenue
`Lexington, MA 02421
`
`Note: A certificate of mailing can only be used for domestic mailings of the
`Fee(s) Transmittal. This certificate cannot be used for any other accompanying
`papers. Each additional paper, such as an assignment or formal drawing, must
`have its own certificate of mailing or transmission.
`
`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
`States Postal Service with sufficient postage for first class mail in an envelope
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (571) 273-2885, on the date indicated below.
`
`(Depositor's name)
`
`(Signature)
`
`(Date)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`09/22/2010
`12/888,233
`TITLE OF INVENTION: HIGH PURITY LIPOPEPTIDES
`
`Thomas J. Kelleher
`
`C062-02/04 US
`
`4046
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`nonprovisional
`
`NO
`
`$1740
`
`$300
`
`$0
`
`$2040
`
`DATE DUE
`
`04/11/2012
`
`EXAMINER
`
`KAM, CHIH MIN
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`1656
`
`514-009000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`Q Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/122) attached.
`Q "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Number is required.
`
`2. For printing on the patent front page, list
`(1) the names of up to 3 registered patent attorneys
`or agents OR, alternatively,
`(2) the name of a single firm (having as a member a
`registered attorney or agent) and the names of up to
`2 registered patent attorneys or agents. If no name is
`listed, no name will be printed.
`
`Cubist Pharmaceuticals, Inc.
`
`1
`
`2-
`
`3
`"
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent. If an assignee is identified below, the document has been filed for
`recordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
`(A) NAME OF ASSIGNEE
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`Cubist Pharmaceuticals, Inc.
`Lexington, Massachusetts 02421
`
`Please check the appropriate assignee category or categories (will not be printed on the patent):
`
`Q Individual ^ Corporation or other private group entity Q Government
`
`4a. The following fee(s) are submitted:
`Qi Issue Fee
`Q Publication Fee (No small entity discount permitted)
`Q Advance Order - # of Copies
`
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`Authorized Signature
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`Typed or printed name
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`/Nicholas M. Boivin/
`Nicholas M. Boivin
`
`Date
`
`January 26, 2012
`
`Registration No.
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`45,650
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`Electronic Patent Application Fee Transmittal
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`Application Number:
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`Filing Date:
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`12888233
`
`22-Sep-2010
`
`Title of Invention:
`
`HIGH PURITY LIPOPEPTIDES
`
`First Named Inventor/Applicant Name:
`
`Thomas J. Kelleher
`
`Filer:
`
`Nicholas M.C. Boivin/Jodi Doherty
`
`Attorney Docket Number:
`
`C062-02/04 US
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`Filed as Large Entity
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`11 of 319
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`12 of 319
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`11924066
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`12888233
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`International Application Number:
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`Confirmation Number:
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`4046
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`Title of Invention:
`
`HIGH PURITY LIPOPEPTIDES
`
`First Named Inventor/Applicant Name:
`
`Thomas J. Kelleher
`
`Customer Number:
`
`34103
`
`Filer:
`
`Nicholas M.C. Boivin
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`Filer Authorized By:
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`Attorney Docket Number:
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`C062-02/04 US
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`26-JAN-2012
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`22-SEP-2010
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`10:46:33
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`13 of 319
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`File Listing:
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`C062_02_04_U S_20120126_A
`mdt_After_Allowance.pdf
`
`54590
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`481c824840f43de2151763bca6ee4cc65e7
`673c5
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`yes
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`1 1
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`Multipart Description/PDF files in .zip description
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`Document Description
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`Start
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`End
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`Amendment after Notice of Allowance (Rule 312)
`
`Claims
`
`Applicant Arguments/Remarks Made in an Amendment
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`1
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`2
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`1 1
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`1
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`1 0
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`1 1
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`2
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`Issue Fee Payment (PTO-85B)
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`C062_02_04_US_20120126Jss
`ue_Fee.pdf
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`192793
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`baaa2920d51ef106a5a85b9ea83e338a285
`e70f8
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`no
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`1
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`3
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`Fee Worksheet (SB06)
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`fee-info.pdf
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`32043
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`d3c4
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`279426
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`14 of 319
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`Serial No. : 12/888,233
`
`Attorney's Docket No. C062-02/04 US
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`12/888,233
`
`Confirmation No.
`
`4046
`
`Thomas Kelleher
`
`September 22, 2010
`
`1656
`
`Chih-Min Kam
`
`Appl. No.
`
`Applicant
`
`Filed
`
`TC/A.U.
`
`Examiner
`
`Docket No.
`
`C062-02/04 US
`
`Customer No. :
`
`34103
`
`MAIL STOP ISSUE FEE
`Commissioner for Patents
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`
`AMENDMENT AFTER ALLOWANCE PURSUANT TO 37 C.F.R. § 1.312
`
`Please amend the application as indicated on the following pages. This amendment is
`being filed concurrently with the payment of the issue fee.
`
`Page 1 of 11
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`Serial No. : 12/888,233
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`Attorney's Docket No. C062-02/04 US
`
`AMENDMENTS TO THE CLAIMS
`
`This listing of claims replaces all prior versions and listings of claims in the
`application:
`
`(Currently Amended) A composition obtained by a process comprising the step
`1.
`of forming a daptomycin aggregate, the composition comprising daptomycin of greater than or
`about 93% purity relative to impurities 1-14 defined by peaks 1-14 shown in FIG. 12 and less
`than 4% of anhydro-daptomycin and having less than 4% of PJsomer of daptomycin.
`
`2-5.
`
`(Canceled)
`
`6.
`(Original) The composition according to claim 1 that is free of each of impurities
`1 to 14 defined by peaks 1-14 shown in FIG. 12.
`
`(Previously Presented). The composition according to claim 1 that is essentially
`free of at least one of impurities 1 to 14 defined by peaks 1-14 shown in FIG. 12.
`
`g
`
`(Original) The composition of claim 1, wherein daptomycin purity is measured
`
`by HPLC.
`
`9.-22. (Canceled)
`
`(Previously Presented) The composition according to claim 1 wherein the process
`23.
`comprises the steps of:
`i) providing a daptomycin solution under conditions in which the daptomycin is in a
`monomelic and nonmicellar state;
`ii) filtering the daptomycin solution under conditions in which the daptomycin passes
`through the filter but pyrogens do not pass through the filter;
`iii) subjecting the daptomycin solution to conditions forming a daptomycin aggregate;
`
`Page 2 of 11
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`Serial No. : 12/888,233
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`iv) filtering the daptomycin aggregate under conditions in which the daptomycin
`aggregate is retained on the filter; and
`v) collecting the daptomycin aggregate.
`
`(Previously Presented) The composition according to claim 23, wherein the
`24.
`process further comprises the step of lyophilizing daptomycin.
`
`25.-31. (Canceled).
`
`(Previously Presented) The composition of claim 1 comprising daptomycin
`32.
`having less than 1% of P-isomer of daptomycin.
`
`33.-53. (Canceled).
`
`(Previously Presented) The composition of claim 1, comprising daptomycin
`54.
`having greater than 93% purity.
`
`(Previously Presented) The composition of claim 1, comprising daptomycin
`55.
`having less than 1% of the lactone hydrolysis product of daptomycin.
`
`(Currently Amended) The composition of claim 1, comprising daptomycin that is
`56.
`substantially free of beta^isomer of daptomycin.
`
`(Previously Presented) The composition of claim 56, comprising daptomycin of
`57.
`greater than 93% purity.
`
`(Previously Presented) The composition of claim 1, comprising daptomycin of at
`58.
`least 95% purity.
`
`(Previously Presented) The composition of claim 1, comprising daptomycin with
`59.
`a purity of about 94 to 96%.
`
`Page 3 of 11
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`Serial No. : 12/888,233
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`Attorney's Docket No. C062-02/04 US
`
`(Previously Presented) The composition of claim 1, comprising daptomycin with
`60.
`a purity of at least 97% purity.
`
`(Previously Presented) The composition of claim 1, comprising lyophilized
`61.
`daptomycin having greater than 93% purity relative to impurities 1-14 defined by peaks 1-14
`shown in FIG. 12, and having less than 1% of the lactone hydrolysis product of daptomycin.
`
`(Currently Amended) The composition of claim 61, wherein the daptomycin is
`62.
`substantially free of beta|3-isomer of daptomycin.
`
`(Previously Presented) A pharmaceutical composition compatible with a
`63.
`pharmaceutically acceptable carrier for the treatment of an infection of the blood, skin or soft
`tissue, the composition comprising daptomycin obtained by a process comprising the step of
`forming a daptomycin aggregate, the composition having daptomycin with greater than or about
`93% purity relative to impurities 1-14 defined by peaks 1-14 shown in FIG. 12.
`
`(Previously Presented) The pharmaceutical composition of claims 63, wherein
`64.
`the daptomycin has greater than 93% purity and less than 4% anhydro daptomycin.
`
`(Currently Amended) The pharmaceutical composition of claims 63, wherein the
`65.
`[[the]] pharmaceutically acceptable carrier is selected from the group consisting of physiological
`saline and Ringer's solution for reconstitution for administration as a single daily dose to the
`subject.
`
`(Previously Presented) The pharmaceutical composition of claims 63, wherein
`66.
`the pharmaceutical composition is compatible with the pharmaceutically acceptable carrier for
`the treatment of an infection of the blood, skin or soft tissue by administration in a daily dose of
`1 to 12 mg/kg of the daptomycin in a reconstituted solution of the composition in the
`pharmaceutically acceptable carrier.
`
`Page 4 of 11
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`Serial No. : 12/888,233
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`Attorney's Docket No. C062-02/04 US
`
`(Currently Amended) The pharmaceutical composition of claim 66, wherein
`67.
`a) the pharmaceutically acceptable carrier is selected from the group consisting of
`physiological saline and Ringer's solution for intravenous administration as a single daily dose to
`the subject;
`b) the daptomycin has greater than 93% purity, less than 4% anhydro daptomycin and
`less than 4% beta|3-isomer of daptomycin; and
`c) the composition comprising daptomycin is obtained by a purification process
`comprising the steps of forming a daptomycin aggregate and obtaining the daptomycin from the
`daptomycin aggregate.
`
`(Previously Presented) The pharmaceutical composition of claim 67, wherein the
`68.
`process for obtaining the daptomycin includes a purification process comprising the steps of
`a) subjecting daptoymycin to anion exchange chromatography to obtain an enriched
`daptomycin preparation;
`b) forming the daptomycin aggregate comprising a daptomycin micelle in the enriched
`daptomycin preparation or a composition obtained from the enriched daptomycin preparation;
`and
`
`c) obtaining daptomycin from the daptomycin aggregate.
`
`(Currently Amended) The pharmaceutical composition of claim 68, wherein the
`69.
`daptomycin is obtained from the daptomycin aggregate by a method comprising the steps of
`a) filtering the daptomycin aggregate under conditions in which the daptomycin
`aggregate is retained on the filter; and
`b) collecting the daptomycin aggregate.
`
`(Previously Presented) The pharmaceutical composition of claim 69, wherein the
`70.
`daptomycin is obtained from the daptomycin aggregate by a method further comprising the steps
`of
`
`a) subjecting a composition comprising the daptomycin is obtained from the daptomycin
`aggregate to hydrophobic interaction chromatography to obtain a semi-purified daptomycin
`preparation; and
`
`Page 5 of 11
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`Attorney's Docket No. C062-02/04 US
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`b) obtaining the daptomycin from the semi-purified daptomycin preparation.
`
`(Previously Presented) A pharmaceutical composition for the treatment of an
`71.
`infection, the composition comprising daptomycin having greater than 93% purity relative to
`impurities 1-14 defined by peaks 1-14 shown in FIG. 12, the daptomycin purified by a process
`comprising the formation of micelles comprising daptomycin.
`
`(Previously Presented) The pharmaceutical composition of claim 71, wherein the
`72.
`daptomycin is a lyophilized powder comprising daptomycin purified by process comprising the
`steps of forming a daptomycin micelle and obtaining the daptomycin from the micelles.
`
`(Currently A