`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`34103
`
`7590
`
`09/07/2011
`
`Intellectual Property Department
`Cubist Pharmaceuticals, Inc.
`65 Hayden Avenue
`Lexington, MA 02421
`
`KAM. CHIH MIN
`
`1656
`
`DATE MAILED: 09/07/201 1
`
`04/24/2007
`11/739,180
`TITLE OF INVENTION: HIGH PURITY LIPOPEPTIDES
`
`Thomas Kelleher
`
`C062—02/03 US
`
`8837
`
`
`
`
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`YES
`
`$755
`
`$300
`
`$0
`
`$1055
`
`12/07/2011
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON THE MERITS IS CLOSED. THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`THIS APPLICATION IS SUBJECT TO WITHDRAWAL FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
`
`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`THIS
`STATUTORY PERIOD CANNOT BE EXTENDED.
`SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION.
`IF AN ISSUE FEE HAS
`PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM
`WILL BE CONSIDERED A REQUEST TO REAPPLY THE PREVIOUSLY PAID ISSUE FEE TOWARD THE ISSUE FEE NOW
`DUE.
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`HOW TO REPLY TO THIS NOTICE:
`
`1. Review the SMALL ENTITY status shown above.
`
`If the SMALL ENTITY is shown as YES, verify your current
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`
`A. If the status is the same, pay the TOTAL FEE(S) DUE shown
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`and twice the amount of the ISSUE FEE shown above, or
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`B. If applicant claimed SMALL ENTITY status before, or is now
`claiming SMALL ENTITY status, check box 5a on Part B - Fee(s)
`Transmittal and pay the PUBLICATION FEE (if required) and 1/2
`the ISSUE FEE shown above.
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`11. PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office
`(USPTO) with your ISSUE FEE and PUBLICATION FEE (if required). If you are charging the fee(s) to your deposit account, section "4b"
`of Part B - Fee(s) Transmittal should be completed and an extra copy of the form should be submitted. If an equivalent of Part B is filed, a
`request to reapply a previously paid issue fee must be clearly made, and delays in processing may occur due to the difficulty in recognizing
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`
`111. All communications regarding this application must give the application number. Please direct all communications prior to issuance to
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`
`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenance fees. It is patentee's responsibility to ensure timely payment of maintenance fees when due.
`CUBIST 2008
`a e
`1
`P
`PTgL—85 (Rev. 02/11)
`
`AGILA v. CUBIST
`IPR2015-00144
`
`Page 1 of 3
`
`CUBIST 2008
`AGILA v. CUBIST
`IPR2015-00144
`
`Page 1
`
`

`

`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: M_ail Mail Stop ISSUE FEE
`Commissioner for Patents
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`or m (571)-273-2885
`
`through 5 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1
`propriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`fpdjlcated 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 Blocklfor any change of addrCSS)
`
`34103
`
`7590
`
`09/07/2011
`
`Intellectual Property Department
`C b.
`t Ph
`t.
`1
`I
`11
`1S
`armaceu lea S, no.
`65 Hayden Avenue
`.
`Lexmgton, MA 02421
`
`Note: A certificate of mailin can only be used for domestic mailings of the
`Fee(()5)Transmittal. This certi icate cannot be used for any other accompanying
`fiapers. Each additional paper such as an assignment or formal drawing, must
`ave lts 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.
`(Depositors name)
`(Signature)
`(Date)
`
`
`
`
`
`
`
`04/24/2007
`11/739,180
`TITLE OF INVENTION: HIGH PURITY LIPOPEPTIDES
`
`Thomas Kelleher
`
`C062—02/03 US
`
`8837
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`KAM, CHIH MIN
`
`$755
`
`1656
`
`$300
`
`514—009000
`
`$1055
`
`12/07/2011
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`3 Change of correspondence address (or Change of Correspondence
`Address rom PTO/SB/122) attached.
`3 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03—02 or more recent) attached. Use of a Customer
`Vumber 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.
`
`
`
`
`
`2
`
`3
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`If an assignee is identified below, the document has been filed for
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent.
`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)
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) :
`
`'3 Individual
`
`'3 Corporation or other private group entity '3 Government
`
`4a. The following fee(s) are submitted:
`3 Issue Fee
`
`3 Publication Fee (No small entity discount permitted)
`P
`3 Advance Order — # of Co ies
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`
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`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`3 A check is enclosed.
`
`3 Payment by credit card. Form PTO—2038 is attached.
`:I The Director is hereby authorized to charge the required fee(s), any deficiency, or credit any
`overpayment, to Deposit Account Number
`(enclose an extra copy of this form).
`
`
`
`5. Change in Entity Status (from status indicated above)
`:I b. Applicant is no longer claiming SMALL ENTITY status. See 37 CFR 1.27(g)(2).
`:I a. Applicant claims SMALL ENTITY status. See 37 CFR 1.27.
`NOTE: The Issue Fee and Publication Fee (if required) will not be accepted from anyone other than the applicant; a registered attorney or agent; or the assignee or other party in
`interest as shown by the records of the United States Patent and Trademark Office.
`
`Authorized Signature
`
`Typed or printed name
`
`
`Date
`
`Registration No.
`
`This collection of informationls required by 37 CFR 1.311. The informationls re uired to obtain or retain a benefit by the public whichls to file (and by the USPTO to process)
`an application. Confidentialityls governedby 35 U.S.C. 122 and 37 CFR 1d14. T is collectionls estimated to take 12 minutes to complete, including gathering, preparlng, and
`submitting the completed application form to the USPTO. Time will v
`eendin upon the individual case. Any comments on the amount of time you require to complete
`this form and/or su gestions for reducillg this burden, should be sent toalfgedCCief In ormation Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O.
`Box 1450, Alexandgria, Virglnia 22313—1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 14,50
`Alexandria, Virginia 22313—1450.
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`
`Page 2
`PTOL—85 (Rev. 02/11) Approved for use through 08/31/2013.
`
`OMB 0651—0033
`
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`
`Page 2
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`APPLICATION NO.
`
`FILING DATE
`
`
`
`
`F {ST NAMED INVENTOR
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`11/739,180
`
`04/24/2007
`
`Thomas Kelleher
`
`C062—02/03 US
`
`8837
`
`34103
`
`7590
`
`09/07/2011
`
`Intellectual Property Department
`Cubist Pharmaceuticals, Inc.
`65 Hayden Avenue
`Lexington, MA 02421
`
`KAM, CHIH MIN
`
`ART UNIT
`1656
`
`PAPER NUMBER
`
`DATE MAILED: 09/07/201 1
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment to date is 0 day(s). If the issue fee is paid on the date that is three months after the
`mailing date of this notice and the patent issues on the Tuesday before the date that is 28 weeks (six and a half
`months) after the mailing date of this notice, the Patent Term Adjustment will be 0 day(s).
`
`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 Customer Service Center of the Office of Patent Publication at 1—(888)—786—0101 or (571)—272—4200.
`
`Page 3
`PTOL—85 (Rev. 02/11)
`
`Page 3 of 3
`
`Page 3
`
`

`

`Privacy Act Statement
`
`The Privacy Act of 1974 (PL. 93-579) requires that you be given certain information in connection with
`your submission of the attached form related to a patent application or patent. Accordingly, pursuant to
`the requirements of the Act, please be advised that: (l) the general authority for the collection of this
`information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the
`principal purpose for which the information is used by the US. Patent and Trademark Office is to process
`and/or examine your submission related to a patent application or patent. If you do not furnish the
`requested information, the US. Patent and Trademark Office may not be able to process and/or examine
`your submission, which may result in termination of proceedings or abandonment of the application or
`expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1. The information on this form will be treated confidentially to the extent allowed under the Freedom
`of Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of
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`A record from this system of records may be disclosed, as a routine use, in the course of presenting
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`U.S.C. 552a(m).
`. A record related to an International Application filed under the Patent Cooperation Treaty in this
`system of records may be disclosed, as a routine use, to the International Bureau of the World
`Intellectual Property Organization, pursuant to the Patent Cooperation Treaty.
`. A record in this system of records may be disclosed, as a routine use, to another federal agency for
`purposes of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy
`Act (42 U.S.C. 218(c)).
`to the Administrator,
`. A record from this system of records may be disclosed, as a routine use,
`General Services, or his/her designee, during an inspection of records conducted by GSA as part of
`that agency's responsibility to recommend improvements in records management practices and
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`with the GSA regulations governing inspection of records for this purpose, and any other relevant
`(i.e., GSA or Commerce) directive. Such disclosure shall not be used to make determinations about
`individuals.
`
`. A record from this system of records may be disclosed, as a routine use, to the public after either
`publication of the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35
`U.S.C. 151. Further, a record may be disclosed, subject to the limitations of 37 CFR 1.14, as a
`routine use, to the public if the record was filed in an application which became abandoned or in
`which the proceedings were terminated and which application is referenced by either a published
`application, an application open to public inspection or an issued patent.
`. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local
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`
`Page 4
`
`Page 4
`
`

`

`
`Application No.
`Applicant(s)
`
`Notice Of Allowability
`
`11/739,180
`Examiner
`
`KELLEHER ET AL.
`Art Unit
`
`CHIH-MIN KAM
`
`1656
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application.
`If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1. IX] This communication is responsive to 5/27/2011.
`
`2. IX] The allowed claim(s) is/are 2—29 31 -36 38-44 47-52 54-56 58-86 and 88-200.
`
`3. I] Acknowledgment is made of a claim for foreign priority under 35 U.S.C.§119( )-(d) or (f).
`a) DA”
`b) I] Some*c) I:I None
`of the:
`
`1. El Certified copies of the priority documents have been received.
`
`2. I] Certified copies of the priority documents have been received in Application No.
`
`3. 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( )).
`
`* Certified copies not received:
`
`Applicant has THREE MONTHS FROM THE “MAILING DATE” of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`4. El A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER’S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PTO-152) which gives reason(s) why the oath or declaration is deficient.
`
`5. El CORRECTED DRAWINGS ( as “replacement sheets”) must be submitted.
`(a) I] including changes required by the Notice of Draftsperson’s Patent Drawing Review ( PTO-948) attached
`
`1) I:Ihereto or 2) I] to Paper No./Mai| Date
`
`(b) I] including changes required by the attached Examiner’s Amendment / Comment or in the Office action of
`Paper No./Mai| Date
`.
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the front (not the back) of
`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).
`
`6. El DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner’s comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Primary Examiner, Art Unit 1656
`
`Attachment(s)
`1. El Notice of References Cited (PTO-892)
`
`2. El Notice of Draftperson‘s Patent Drawing Review (PTO-948)
`
`)
`3. El Information Disclosure Statements (PTO/SB/08 ,
`Paper No./Mai| Date
`4. El Examiner‘s Comment Regarding Requirement for Deposit
`of Biological Material
`
`/Chih-Min Kam/
`
`5. El Notice of Informal Patent Application
`
`6. El Interview Summary (PTO-413),
`Paper No./Mai| Date
`.
`7. E Examiners Amendment/Comment
`
`8 E Examiner‘s Statement of Reasons for Allowance
`
`9. I:IOther
`
`.
`
` US. Patent and Trademark Office
`PTOL-37 (Rev. 08-06)
`Notice of Allowability
`Part of Paper No./Mai| Date 20110808
`
`Page 5
`
`Page 5
`
`

`

`Application/Control Number: 11/739,180
`
`Page 2
`
`Art Unit: 1656
`
`DETAILED ACTION
`
`Status of the Claims
`
`1.
`
`Claims 2—29, 31—36, 38—44, 47—52, 54—56 and 58—200 are pending.
`
`Applicants’ amendment filed May 27, 2011 is acknowledged. Claims 2—4, 6, 7, 10, 54,
`
`55, 58, 62, 76, 82, 83, 85, 87-92, 94, 95, 108, 109 and 115 have been amended, claim 1 has been
`
`cancelled, and new claims 161—200 have been added. Therefore, claims 2—29, 31—36, 38—44, 47—
`
`52, 54—56 and 58—200 are examined.
`
`Withdrawn Claim Reiections - 35 USC § 112
`
`2.
`
`The previous rejection of claim 8—29, 31—36, 38—44, 47—52, 55—56, 58—1 14 and 116—160
`
`under 35 U.S.C.112, second paragraph, is Withdrawn in View of applicants’ amendment of the
`
`claims and applicants’ response at page 35 in the amendment filed May 27, 2011.
`
`Withdrawn Claim Reiections - 35 USC § 102
`
`3.
`
`The previous rejection of claims 1 and 54 under U.S.C. 102(e) as being as anticipated by
`
`Baker et al. (US RE39,071 E) is Withdrawn in View of applicants’ amendment to the claims,
`
`applicants’ cancellation of the claims, and applicants’ response at page 34 in the amendment
`
`filed May 27, 2011.
`
`Withdrawn Claim Reiections - Obviousness Twe Double Patenting
`
`4.
`
`The preVious rejection of claims 1 and 54 under the judicially created doctrine of
`
`obViousness—type double patenting as being unpatentable over claims 18—20, 26, 28 and 29 of
`
`US. Patent RE39,071 E is Withdrawn in View of applicants’ amendment to the claims,
`
`applicants’ cancellation of the claims, and applicants’ response at page 34 in the amendment
`
`filed May 27, 2011.
`
`Page 6
`
`Page 6
`
`

`

`Application/Control Number: 11/739,180
`
`Page 3
`
`Art Unit: 1656
`
`Specification
`
`5.
`
`Applicants’ amendment to the specification regarding “CROSS—REFERENCE TO
`
`RELATED APPLICATIONS” at page 1 lines 5—9 is acknowledged. Applicants’ petition filed
`
`May 27, 2011 under 37 CFR 1.78(a)(3),(6) to accept an unintentionally delayed priority claim
`
`has been granted.
`
`Examiner’s Amendment
`
`An Examiner's Amendment to the record appears below. Should the changes and/or
`additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR
`1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the
`
`payment of the issue fee.
`
`Authorization for this examiner's amendment was given in a telephone interview with
`Nicholas M. Boivin on August 16, 2011.
`
`Examiner’s Amendment to the Claims:
`
`Cancel claim 87.
`
`Claims 2—4, 6, 54—56, 58, 60, 62—76, 80, 89, 94—96, 98, 116—127, 129, 133, 142, 149-160,
`
`162, 171—179, 184, 189, 191—194 and 196—200 have been amended as follows:
`
`2. (Currently Amended)
`
`A composition comprising essentially pure daptomycin
`
`purified by a process comprising the steps of;
`
`(a) subjecting daptomycin to conditions forming a daptomycin aggregate; and
`
`(b) obtaining at—least—a—pertien—ef the essentially pure daptomycin from the
`
`daptomycin aggregate.
`
`3. (Currently Amended)
`
`A composition comprising daptomycin that is
`
`substantially free of anhydro—daptomycin and substantially free of [3—isomer of
`
`daptomycin, the daptomycin being purified by a process comprising the steps ofg
`
`Page 7
`
`Page 7
`
`

`

`Application/Control Number: 11/739,180
`
`Page 4
`
`Art Unit: 1656
`
`(a) subjecting daptomycin to conditions forming a daptomycin aggregate; and
`
`(b) obtaining at—least—a—pertien—ef the daptomycin that is substantially free of
`
`anhydro—daptomycin and g substantially free of [3—isomer of daptomycin from the
`
`daptomycin aggregate.
`
`4. (Currently Amended)
`
`The composition according to claim 3 that is
`
`essentially free of anhydro—daptomycin, wherein the step of obtaining the daptomycin that
`
`is essentially free of anhydro—daptomycin from the daptomycin aggregate further
`
`comprises the steps of:
`
`(c) subjecting the daptomycin aggregate to conditions to form monomeric
`
`daptomycin; and
`
`(d) obtaining at—least—a—pertien—ef the daptomycin that is essentially free of
`
`anhydro—daptomycin from the monomeric daptomycin.
`
`6. (Currently Amended)
`
`A composition comprising purified daptomycin
`
`that is substantially free of each of impurities 1 to 14 defined by peaks 1—14 shown in FIG. 12,
`
`the purified daptomycin being obtained by a process comprising the steps of3
`
`(a) subjecting daptomycin to conditions forming a daptomycin aggregate;
`
`(b) subjecting the daptomycin aggregate to conditions forming monomeric
`
`daptomycin; and
`
`(c) obtaining at—least—a—portion—of the daptomycin from the monomeric
`
`daptomycin, the daptomycin aggregate or a combination thereof.
`
`54 (Currently amended)
`
`A pu-iqfied—daptomyein pharmaceutical composition
`
`comprising essentially pure daptomycin purified by a process comprising the steps of;
`
`(a) forming micelles comprising daptomycin;
`
`Page 8
`
`Page 8
`
`

`

`Application/Control Number: 11/739,180
`
`Page 5
`
`Art Unit: 1656
`
`(b) converting the micelles to a non—micellar daptomycin composition comprising
`
`daptomycin in a non—micellar state; and
`
`(c) obtaining at—least—a—pottion—of the purified daptomycin from the micelles, the
`
`non—micellar daptomycin composition, or a combination thereof.
`
`55. (Currently Amended)
`
`The pharmaceutical composition of claim 54 comprising
`
`daptomycin of at least about 98% purity measured relative to daptomycin impurities 1—14
`
`defined by peaks 1—14 shown in FIG. 12.
`
`56. (Currently Amended) The method pharmaceutical composition of claim 54 wherein
`
`the oomposition—is daptomycin of i_s at least about 99% purity pure.
`
`58. (Currently Amended)
`
`A now composition comprising daptomycin of greater than
`
`g about 93% purity relative to daptomycin impurities that arise in fermentation or purification of
`
`daptomycin, and wherein the daptomycin impurities comprise impurities 1— 14 defined by peaks
`
`1—14 shown in FIG. 12, and the daptomycin is obtained by a process comprising the step of
`
`forming a micelle comprising daptomycin.
`
`60. (Currently Amended)
`
`daptomycin is at least 95% 93%.
`
`The composition of claim 58, wherein the purity o_f
`
`62. (Currently Amended)
`
`A purified daptomycin composition comprising
`
`daptomycin of greater than g about 93% purity relative to impurities 1—14 defined by peaks 1—14
`
`shown in FIG. 12, the daptomycin being obtained by a process comprising the step of forming an
`
`aggregate comprising daptomycin.
`
`63. (Currently Amended)
`
`The daptomyei—n composition of claim 62, wherein the
`
`purity of daptomycin is at least 95% 93%.
`
`64. (Currently Amended)
`
`The composition of claim 58 wherein impurity 1 is present
`
`in an amount no more than about 1%.
`
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`Application/Control Number: 11/739,180
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`Art Unit: 1656
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`65. (Currently Amended)
`
`The composition of claim 58 wherein impurity 2 is present
`
`in an amount no more than about 0.5%.
`
`66. (Currently Amended)
`
`The composition of claim 58 wherein impurity 3 is present
`
`in an amount no more than about 1%.
`
`67. (Currently Amended)
`
`The composition of claim 58 wherein impurity 4 is present
`
`in an amount no more than about 0.5%.
`
`68. (Currently Amended)
`
`The composition of claim 58 wherein impurity 5 is present
`
`in an amount no more than about 0.5%.
`
`69. (Currently Amended)
`
`The composition of claim 58 wherein impurity 6 is present
`
`in an amount no more than about 1%.
`
`70. (Currently Amended)
`
`The composition of claim 58 wherein impurity 7 is present
`
`in an amount no more than about 1%.
`
`71. (Currently Amended)
`
`The composition of claim 58 wherein impurity 9 8 is
`
`present in an amount no more than about—05% %.
`
`72. (Currently Amended)
`
`The composition of claim 58 fl wherein impurity -1-0 8 is
`
`present in an amount no more than about—05% fl.
`
`73. (Currently Amended)
`
`The composition of claim 58 3 wherein impurity -1—1- 8 is
`
`present in an amount no more than about—05% fl.
`
`74. (Currently Amended)
`
`The composition of claim 58 wherein impurity 12 is
`
`present in an amount no more than about 0.5%.
`
`75. (Currently Amended)
`
`The composition of claim 58 wherein impurity 14 is
`
`present in an amount no more than about 0.1%.
`
`76. (Currently Amended)
`
`The composition of claim 62, wherein the daptomycin is
`
`obtained by a process comprising;
`
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`Application/Control Number: 11/739,180
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`Art Unit: 1656
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`a) subjecting a daptomycin solution to conditions forming a daptomycin aggregate;
`
`
`b) separating the daptomycin aggregate from low molecular weight contaminants; and
`
`c) subjecting the daptomycin aggregate to conditions in which the daptomycin aggregate
`
`dissociates into daptomycin monomers.
`
`80. (Currently Amended)
`
`The composition of claim 79, wherein the daptomycin
`
`monomers ea? are separated from the high molecular weight contaminants by a size selection
`
`technique.
`
`89. (Currently Amended)
`
`micelle eonsisting consists of daptomycin.
`
`The composition of claim 82, wherein the aggregateis—a
`
`94. (Currently Amended)
`
`The composition of claim 93, wherein the micelle
`
`comprising daptomycin preparation of step a) that comprises micelle is—at @ a pH of 2.5 to 4.7,
`
`and the preparation further comprises 300 to 500 mM NaCl and is at a temperature of 2—15
`
`degrees C.
`
`95. (Currently Amended)
`
`The composition of claim 62, wherein the daptomycin is
`
`obtained by a process further comprising;
`
`
`
`b) a) separating the daptomycin aggregate from low molecular weight contaminants; w
`
`c—) b) subjecting the daptomycin aggregate to conditions in which the daptomycin
`
`aggregate dissociates into daptomycin monomers.
`
`96. (Currently Amended)
`
`The composition of claim 95, wherein the daptomycin
`
`aggregate of step b) a) is separated from the low molecular weight contaminants by a size
`
`selection technique.
`
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`Application/Control Number: 11/739,180
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`98. (Currently Amended)
`
`The composition of claim 97 further comprising separating
`
`the daptomycin monomers obtained from step c—) b) from high molecular weight contaminants.
`
`116. (Currently Amended)
`
`The composition of claim 62 wherein impurity 1 is present
`
`in an amount no more than about 1%.
`
`117. (Currently Amended)
`
`The composition of claim 62 wherein impurity 2 is present
`
`in an amount no more than about 0.5%.
`
`118. (Currently Amended)
`
`The composition of claim 62 wherein impurity 3 is present
`
`in an amount no more than about 1%.
`
`119. (Currently Amended)
`
`The composition of claim 62 wherein impurity 4 is present
`
`in an amount no more than about 0.5%.
`
`120. (Currently Amended)
`
`The composition of claim 62 wherein impurity 5 is present
`
`in an amount no more than about 0.5%.
`
`121. (Currently Amended)
`
`The composition of claim 62 wherein impurity 6 is present
`
`in an amount no more than about 1%.
`
`122. (Currently Amended)
`
`The composition of claim 62 wherein impurity 7 is present
`
`in an amount no more than about 1%.
`
`123. (Currently Amended)
`
`The composition of claim 62 wherein impurity 9 § is
`
`present in an amount no more than about—05% %.
`
`124. (Currently Amended)
`
`The composition of claim 62 E wherein impurity -1—0 § is
`
`present in an amount no more than about—05% fl.
`
`125. (Currently Amended)
`
`The composition of claim 62 Q wherein impurity -1—1- § is
`
`present in an amount no more than about—06% E.
`
`126. (Currently Amended)
`
`The composition of claim 62 wherein impurity 12 is
`
`present in an amount no more than about 0.5%.
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`Application/Control Number: 11/739,180
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`127. (Currently Amended)
`
`The composition of claim 62 wherein impurity 14 is
`
`present in an amount no more than about 0.1%.
`
`129. (Currently Amended)
`
`The composition of claim 63, wherein the daptomycin is
`
`obtained by a process comprising3
`
`a) subjecting a daptomycin solution to conditions forming a daptomycin aggregate;
`
`b) separating the daptomycin aggregate from low molecular weight contaminants; @
`
`c) subjecting the daptomycin aggregate to conditions in which the daptomycin aggregate
`
`dissociates into daptomycin monomers.
`
`133. (Currently Amended)
`
`The composition of claim 132, wherein the daptomycin
`
`monomers ot are separated from the high molecular weight contaminants by a size selection
`
`technique.
`
`142. (Currently Amended)
`
`The composition of claim —1—35 A, wherein the aggregate
`
`is a micelle.
`
`149. (Currently Amended)
`
`The composition of claim 63 wherein impurity 1 is present
`
`in an amount no more than about 1%.
`
`150. (Currently Amended)
`
`The composition of claim 63 wherein impurity 2 is present
`
`in an amount no more than about 0.5%.
`
`151. (Currently Amended)
`
`The composition of claim 63 wherein impurity 3 is present
`
`in an amount no more than about 1%.
`
`152. (Currently Amended)
`
`The composition of claim 63 wherein impurity 4 is present
`
`in an amount no more than about 0.5%.
`
`153. (Currently Amended)
`
`The composition of claim 63 wherein impurity 5 is present
`
`in an amount no more than about 0.5%.
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`Application/Control Number: 11/739,180
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`154. (Currently Amended)
`
`The composition of claim 63 wherein impurity 6 is present
`
`in an amount no more than about 1%.
`
`155. (Currently Amended)
`
`The composition of claim 63 wherein impurity 7 is present
`
`in an amount no more than about 1%.
`
`156. (Currently Amended)
`
`The composition of claim 63 wherein impurity 9 § is
`
`present in an amount no more than about—05% %.
`
`157. (Currently Amended)
`
`The composition of claim 63 m wherein impurity -1—0 § is
`
`present in an amount no more than about—06% E.
`
`158. (Currently Amended)
`
`The composition of claim 63 m wherein impurity -1—1- § is
`
`present in an amount no more than about—06% E.
`
`159. (Currently Amended)
`
`The composition of claim 63 wherein impurity 12 is
`
`present in an amount no more than about 0.5%.
`
`160. (Currently Amended)
`
`The composition of claim 63 wherein impurity 14 is
`
`present in an amount no more than about 0.1%.
`
`162. (Currently Amended)
`
`The composition of claim 161, wherein the daptomycin is
`
`purified by a process comprising the steps of:
`
`(a) subjecting a daptomycin solution to conditions forming the daptomycin aggregate;
`
`
`(b) separating the daptomycin aggregate from low molecular weight contaminants; and
`
`(c) subjecting the daptomycin aggregate to conditions in which the daptomycin micelle
`
`dissociates into daptomycin monomers.
`
`171. (Currently Amended)
`
`A purified daptomycin composition of greater than g about
`
`93% purity relative to impurities 1—14 defined by peaks 1—14 shown in FIG. 12, the purified
`
`daptomycin composition obtained by a process comprising the steps of;
`
`(a) subjecting daptomycin to conditions forming daptomycin micelles and
`
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`Application/Control Number: 11/739,180
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`(b) obtaining at—least—a—pertien—ef the purified daptomycin from the daptomycin
`
`micelles.
`
`172. (Currently Amended)
`
`The purified daptomycin composition of claim 171,
`
`wherein the step of obtaining the purified daptomycin from the daptomycin micelles
`
`further comprises the steps of:
`
`(c) subjecting the daptomycin micel