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
`
`ATTORNEY DOCKET NO.
`
`CONF {MATION NO.
`
`11/739,180
`
`04/24/2007
`
`Thomas Kelleher
`
`C062—02/03 US
`
`8837
`
`Intellectual Property Department
`Cubist Pharmaceuticals, Inc.
`65 Hayden Avenue
`Lexington, MA 02421
`
`KAM, CHIH MIN
`
`1656
`
`MAIL DATE
`
`03/22/2010
`
`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)
`
`CUBIST 2212
`AGILA v. CUBIST
`IPR2015-00143
`
`

`
`Office Action Summary
`
`Application No.
`
`App|icant(s)
`
`11/739,180
`
`Examine,
`
`CHIH—MIN KAM
`
`KELLEHER ET AL.
`
`A,, Unit
`
`1656 -
`
`-- 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 13 November 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) 1-29 31-36 38-44 46-52 and 54-63 is/are pending in the application.
`
`4a) Of the above c|aim(s)
`
`is/are withdrawn from consideration.
`
`5)I:I C|aim(s) j is/are allowed.
`
`
`
`6)IXI C|aim(s) 1 8-29 38 46 54-58 and 60 is/are rejected.
`
`7)IZ C|aim(s) 2-7 31-36 39-44 47-52 59 and 61-63 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 24 April 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.
`
`Attachment(s)
`
`1) D Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) IXI Information Disclosure Statement(s) (PTO/SB/08)
`
`Paper No(s)/Mail Date 11/13/09 1/15/10.
`U.S. Patent and Trademark Office
`
`4) E Interview Summary (PTO-413)
`Paper N0(S)/IVI3” D3te- -
`5) I:I Notice of informal Patent Application
`6) D Other:
`.
`
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20100222
`
`Page 2
`
`Page 2
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`

`
`Application No.
`
`AppIicant(s)
`
`_
`Interview Summary
`
`11/739,180
`E
`_
`xamlner
`
`KELLEHER ET AL.
`M U _t
`nu
`
`CH|H—M|N KAM
`
`1656
`
`All participants (applicant, applicant's representative, PTO personnel):
`
`(1) CHlH-MIN KAM.
`
`(2) -
`
`Date of Interview: 07 Januag; 2010.
`
`(3)William D DeVaul.
`
`(4):-
`
`b)I:I Video Conference
`Type: a) Telephonic
`c)I:I Personal [copy given to: 1)I:I applicant
`
`2)I:I app|icant’s representative]
`
`Exhibit shown or demonstration conducted:
`If Yes, brief description:
`
`d)|:I Yes
`
`e)IZ No.
`
`C|aim(s) discussed: gending claims.
`
`
`Identification of prior art discussed: US RE39 071 E.
`
`Agreement with respect to the claims f)I:I was reached. 9) was not reached. h)I:I N/A.
`
`Substance of Interview including description of the general nature of what was agreed to if an agreement was
`reached, or any other comments: Discussing the reiection under 35 USC 102(e]/103[aI, the statement that was
`added to the sgecification regarding a joint research agreement and amendment to the claims agglicants will file part
`of [oint research agreement and assignment .
`
`(A fuller description, if necessary, and a copy of the amendments which the examiner agreed would render the claims
`allowable, if available, must be attached. Also, where no copy of the amendments that would render the claims
`allowable is available, a summary thereof must be attached.)
`
`THE FORMAL WRITTEN REPLY TO THE LAST OFFICE ACTION MUST INCLUDE THE SUBSTANCE OF THE
`
`If a reply to the last Office action has already been filed, APPLICANT IS
`INTERVIEW. (See MPEP Section 713.04).
`GIVEN A NON-EXTENDABLE PERIOD OF THE LONGER OF ONE MONTH OR THIRTY DAYS FROM THIS
`
`INTERVIEW DATE, OR THE MAILING DATE OF THIS INTERVIEW SUMMARY FORM, WHICHEVER IS LATER, TO
`FILE A STATEMENT OF THE SUBSTANCE OF THE INTERVIEW. See Summary of Record of Interview
`requirements on reverse side or on attached sheet.
`
`U.S. Patent and Trademaik Office
`
`PTOL-413 (Rev. 04-03)
`
`Interview Summary
`
`Paper No. 20100222
`
`Page 3
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`Page 3
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`

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`Manual of Patent Examining Procedure (MPEP), Section 713.04, Substance of Interview Must be Made of Record
`A complete written statement as to the substance of any face-to—faoe, video conference, or telephone interview with regard to an application must be made of record in the
`application whether or not an agreement with the examiner was reached at the interview.
`
`Summary of Record of Interview Requirements
`
`Title 37 Code of Federal Regulations (CFR) § 1.133 Interviews
`Paragraph (b)
`
`In every instance where reconsideration is requested in view of an interview with an examiner, a complete written statement of the reasons presented at the interview as
`warranting favorable action must be filed by the applicant. An interview does not remove the necessity for reply to Office action as specified in §§ 1.111, 1.135. (35 U.S.C. 132)
`
`37 CFR §1.2 Business to be transacted in writing.
`All business with the Patent or Trademark Office should be transacted in writing. The personal attendance of applicants or their attorneys or agents at the Patent and
`Trademark Office is unnecessary. The action of the Patent and Trademark Office will be based exclusively on the written record in the Office. No attention will be paid to
`any alleged oral promise, stipulation, or understanding in relation to which there is disagreement or doubt.
`
`The action of the Patent and Trademark Office cannot be based exclusively on the written record in the Office if that record is itself
`incomplete through the failure to record the substance of interviews.
`It is the responsibility of the applicant or the attorney or agent to make the substance of an interview of record in the application file, unless
`the examiner indicates he or she will do so.
`It is the examiner’s responsibility to see that such a record is made and to correct material inaccuracies
`which bear directly on the question of patentability.
`
`Examiners must complete an Interview Summary Form for each interview held where a matter of substance has been discussed during the
`interview by checking the appropriate boxes and filling in the blanks. Discussions regarding only procedural matters, directed solely to restriction
`requirements for which interview recordation is otherwise provided for in Section 812.01 of the Manual of Patent Examining Procedure, or pointing
`out typographical errors or unreadable script in Office actions or the like, are excluded from the interview recordation procedures below. Where the
`substance of an interview is completely recorded in an Examiners Amendment, no separate Interview Summary Record is required.
`
`The Interview Summary Form shall be given an appropriate Paper No., placed in the right hand portion of the file, and listed on the
`“Contents" section of the file wrapper.
`In a personal interview, a duplicate of the Form is given to the applicant (or attorney or agent) at the
`conclusion of the interview.
`In the case of a telephone or video-conference interview, the copy is mailed to the applicant's correspondence address
`either with or prior to the next official communication. If additional correspondence from the examiner is not likely before an allowance or if other
`circumstances dictate, the Form should be mailed promptly after the interview rather than with the next official communication.
`
`The Form provides for recordation of the following information:
`— Application Number (Series Code and Serial Number)
`— Name of applicant
`— Name of examiner
`— Date of interview
`— Type of interview (telephonic, video-conference, or personal)
`— Name of participant(s) (applicant, attorney or agent, examiner, other PTO personnel, etc.)
`— An indication whether or not an exhibit was shown or a demonstration conducted
`— An identification of the specific prior art discussed
`— An indication whether an agreement was reached and if so, a description of the general nature of the agreement (may be by
`attachment of a copy of amendments or claims agreed as being allowable). Note: Agreement as to allowability is tentative and does
`not restrict further action by the examiner to the contrary.
`— The signature of the examiner who conducted the interview (if Form is not an attachment to a signed Office action)
`
`It is desirable that the examiner orally remind the applicant of his or her obligation to record the substance of the interview of each case. It
`should be noted, however, that the Interview Summary Form will not normally be considered a complete and proper recordation of the interview
`unless it includes, or is supplemented by the applicant or the examiner to include, all of the applicable items required below concerning the
`substance of the interview.
`A complete and proper recordation of the substance of any interview should include at least the following applicable items:
`1) A brief description of the nature of any exhibit shown or any demonstration conducted,
`2) an identification of the claims discussed,
`3) an identification of the specific prior art discussed,
`4) an identification of the principal proposed amendments of a substantive nature discussed, unless these are already described on the
`Interview Summary Form completed by the Examiner,
`5) a brief identification of the general thrust of the principal arguments presented to the examiner,
`(The identification of arguments need not be lengthy or elaborate. A verbatim or highly detailed description of the arguments is not
`required. The identification of the arguments is sufficient if the general nature or thrust of the principal arguments made to the
`examiner can be understood in the context of the application file. Of course, the applicant may desire to emphasize and fully
`describe those arguments which he or she feels were or might be persuasive to the examiner.)
`6) a general indication of any other pertinent matters discussed, and
`7) if appropriate, the general results or outcome of the interview unless already described in the Interview Summary Form completed by
`the examiner.
`Examiners are expected to carefully review the applicant's record of the substance of an interview.
`accurate, the examiner will give the applicant an extendable one month time period to correct the record.
`
`If the record is not complete and
`
`Examiner to Check for Accuracy
`
`If the claims are allowable for other reasons of record, the examiner should send a letter setting forth the examiner’s version of the
`statement attributed to him or her.
`If the record is complete and accurate, the examiner should place the indication, “Interview Record OK" on the
`paper recording the substance of the interview along with the date and the examiner’s initials.
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`Page 4
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`Page 4
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`

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`Application/Control Number: 11/739,180
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`Page 2
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`Art Unit: 1656
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`DETAILED ACTION
`
`1.
`
`The Request for Continued Examination (RCE) filed on November 13, 2009 under 37
`
`CFR 1.114 is acknowledged. An action on the RCE follows.
`
`Status of the Claims
`
`2.
`
`Claims 1-29, 31-36, 38-44, 46-52 and 54-63 are pending.
`
`Applicants’ amendment filed November 13, 2009 is acknowledged. New claims 58-63
`
`have been added. Therefore, claims 1-29, 31-36, 38-44, 46-52 and 54-63 are examined.
`
`Withdrawn Claim Re °ecti0ns - 35 USC I 03
`
`3.
`
`The previous rejection of claims 2-5, 31-34, 39-42 and 47-50 under 35 U.S.C. 103(a) as
`
`being unpatentable over Baker et al. (US RE39,071 E) is withdrawn in view of applicants’
`
`statement added to the specification regarding a joint research agreement, and applicant’s
`
`response at pages 9-10 in the amendment filed November 13, 2009.
`
`Claim Rejections - 35 USC § 1 02
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the
`
`basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless —
`(e) the invention was described in a patent granted on an application for patent by another filed in the United
`States before the invention thereof by the applicant for patent, or on an international application by another who
`has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(0) of this title before the invention
`thereof by the applicant for patent.
`
`The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999
`
`(AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002
`
`do not apply when the reference is a U.S. patent resulting directly or indirectly from an
`
`international application filed before November 29, 2000. Therefore, the prior art date of the
`
`reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA
`
`35 U.S.C. 102(e)).
`
`Page 5
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`Page 5
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`

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`Application/Control Number: 11/739,180
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`Page 3
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`Art Unit: 1656
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`4.
`
`Claims 1, 8-29, 38, 46, 54-58 and 60 are rejected under 35 U.S.C. 102(e) as anticipated
`
`by Baker et al. (US RE39,071 E, reissue ofU.S. Patent 5,912,226, filed December 16, 1991).
`
`Baker et al. teach an antibacterial composition comprising daptomycin (LY146032)
`
`obtained in substantially pure form, which refers to daptomycin that contains less than 2.5% of a
`
`combined total of anhydro-daptomycin and beta-isomer of daptomycin (column 8, lines 50-60;
`
`Examples 4 and 5; claim 1(g), 54, 58 and 60), where daptomycin is purified by a procedure using
`
`Diaion HP-20 resin column, followed by HPLC and another HP-20 resin column (Examples 1-5,
`
`claim 8). Baker et al. also teach the preparation of a pharmaceutical formulation comprising the
`
`purified daptomycin (LY146032) with pharmaceutical carriers or excipients (column 9, lines 47-
`
`59; claims 9, 38, 46 and 55-57). Baker et al. indicate the daptomycin (LY146032) is in
`
`substantially pure form and contains less than 2.5% of a combined total of anhydro-daptomycin
`
`and beta-isomer of daptomycin, thus claims 11-29 are not patentable because the product by
`
`process claims are limited by and defined by the process, determination of patentability is based
`
`on the product itself, and the patentability of a product does not depend on its method of
`
`production (see MPEP 2113). In the instant case, the composition comprising daptomycin
`
`(LY146032) that is in substantially pure form and contains less than 2.5% of a combined total of
`
`anhydro-daptomycin and beta-isomer of daptomycin as indicated in the patent is not different
`
`from the claimed composition comprising substantially pure daptomycin (>97% daptomycin),
`
`even though the daptomycin of reference is purified by a different process. Baker et al. also
`
`disclose an antibiotic composition comprised of a combination of a compound of formula 1 (i.e.,
`
`anhydro-A21978C; column 1, lines 14-21), a compound of formula 2 (isomer of A21978C) and a
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`Page 6
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`Page 6
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`

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`Application/Control Number: 11/739,180
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`Page 4
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`Art Unit: 1656
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`compound of formula 3 (the parent cyclic peptide of A21978C; LY146032) or pharrnaceutically
`
`acceptable salts (Reissue: claim 18; claim 10 of instant application).
`
`Resgonse to Arguments
`
`Applicants indicate that the purity of daptomycin in Baker can only be interpreted as
`
`defined by Baker, thus Baker can be interpreted to read that there is 97.5% of daptomycin over a
`
`daptomycin plus anhydro-daptomycin (“A”) plus beta isomer daptomycin (“B”) composition.
`
`The present application describes daptomycin purity relative to daptomycin plus anhydro-
`
`daptomycin (impurity No. 13) plus beta isomer daptomycin (impurity No. 8) plus 12 other
`
`impurities (impurities 1-7, 9-12 and 14) as described in Table 3 of the specification. Thus, Baker
`
`uses a different purity and does not teach purity over the 14 daptomycin impurities. Applicants
`
`also indicate that Baker had at best about 93% purity against the 14 daptomycin impurities, while
`
`comparing Baker’s later work in US 4,874,843 with Baker’s RE39,071, which use similar
`
`purification procedure. Applicants further assert that evidence of inherency and/or notice of
`
`facts to support the inherency of the present claims have not been provided. Furthermore, Baker
`
`does not specifically describe the following limitations:
`
`1. essentially pure daptomycin (i.e. at least 98% daptomycin in the present application),
`
`2. daptomycin substantially free of anhydro-daptomycin and substantially free of B-
`
`isomer of daptomycin (each no more than 1%),
`
`3. daptomycin essentially free of anhydro-daptomycin (no more than 0.5%) and
`
`substantially free of B-isomer of daptomycin (no more than 1%),
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`Page 7
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`Page 7
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`

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`Application/Control Number: 11/739,180
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`Page 5
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`Art Unit: 1656
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`4. daptomycin free of anhydro-daptomycin (no more than 0.1%) and substantially free of
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`B-isomer of daptomycin (no more than 1%), and
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`5. daptomycin that substantially or essentially free of each of impurities 1 to 14 defined
`
`by peaks 1-14 ofFIG. 12,
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`6. at least 95% pure daptomycin, and
`
`7. greater than about 93% pure daptomycin.
`
`Therefore, Baker did not anticipate claims 1-5, 8-29, 31-34, 38-42, 46-50 and 54-57, the
`
`rejection under 35 U.S.C. 102 (e) should be withdrawn (pages 10-17 of the response).
`
`Applicants’ response has been fully considered. Regarding claims 1(a)-1(f), 2-5, 31-34,
`
`39-42 and 47-50, the arguments are found persuasive and the rejection is withdrawn. However,
`
`regarding claim 1(g) and its dependent claims, the arguments are not found persuasive because
`
`of the following reasons. Baker et al. teach an antibacterial composition comprising daptomycin
`
`(LY146032) obtained in substantially pure form, which refers to daptomycin that contains less
`
`than 2.5% of a combined total of anhydro-daptomycin and beta-isomer of daptomycin (column
`
`8, lines 50-60; Examples 4 and 5). Since Baker et al. do not indicate other impurities besides
`
`anhydro-daptomycin and beta-isomer of daptomycin are contained in the daptomycin
`
`(LY146032) in substantially pure form, it reads that the daptomycin has more than 97.5% purity.
`
`While Baker implies that other degradants are present, but are not predominant in the pH range
`
`that optimizes the transpeptidation reactions, the reference does not indicate other degradants are
`
`present E the purification procedure (column 8, lines 45-49). While Baker's later work (U.S.
`
`Patent 4,874,843) shows undetermined impurities at least as great as 7%, and daptomycin has at
`
`Page 8
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`Page 8
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`

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`Application/Control Number: 11/739,180
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`Page 6
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`Art Unit: 1656
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`best 93% purity, the ‘843 patent only use a single HP-20 resin column to purify daptomycin with
`
`a yield of 50-60% (Example 1-2), which is different from the purification procedure (i.e., Diaion
`
`HP-20 resin column, followed by HPLC and another HP-20 resin column) used by Baker et al. in
`
`the US RE39,071 E (e.g., with a very low yield in Example 3). Thus, even Baker (U.S. Patent
`
`4,874,843) shows undetermined impurities at least as great as 7%, and daptomycin has at best
`
`93% purity, it does not mean that the daptomycin purified by Baker et al. in the US RE39,071 E
`
`has at best 93% purity since the purification procedures used by two patents are different. As
`
`shown in Example 2 of the present application, the purity level of the daptomycin was 91% using
`
`the purification method from the '843 patent, and the daptomycin sample was further confirmed
`
`to contain fourteen impurities (Example 10), which does not mean the daptomycin purified by
`
`Baker et al. in the US RE39,071 E would have at best 93% purity when a different purification
`
`procedure is used. The daptomycin purified by Baker et al. in the US RE39,071 E is obtained in
`
`substantially pure form that contains less than 2.5% of a combined total of anhydro-daptomycin
`
`and beta-isomer of daptomycin as taught by Baker et al. is not different from the claimed
`
`composition as indicated in claim 1(g) because the claimed substantially pure daptomycin has
`
`also >97% purity without indicating the existence of other 14 impuritites. Therefore, the
`
`rejection of claim 1(g) and its dependent claims are maintained.
`
`Claim Rejections-Obviousness Type Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine
`grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or
`improper timewise extension of the "right to exclude" granted by a patent and to prevent possible
`harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed.
`Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686
`F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA
`1970);and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`Page 9
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`Page 9
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`

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`Application/Control Number: 11/739,180
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`Page 7
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`Art Unit: 1656
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`A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to
`overcome an actual or provisional rejection based on a nonstatutory double patenting ground
`provided the conflicting application or patent is shown to be commonly owned with this
`application. See 37 CFR 1.130(b).
`Effective January 1, 1994, a registered attorney or agent of record may sign a terminal
`disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37
`CFR 3.73(b).
`
`5.
`
`Claims 1, 8-9, 46, 54-55, 57, 58 and 60 are rejected under the judicially created doctrine
`
`of obviousness-type double patenting as being unpatentable over claims 18-20, 26, 28 and 29 of
`
`U.S. Patent RE39,071 E. Although the conflicting claims are not identical, they are not
`
`patentably distinct from each other because claims 1, 8-9, 46, 54-55, 57, 58 and 60 in the instant
`
`application disclose a composition comprising substantially pure daptomycin (i.e., >97% purity
`
`daptomycin); or a pharmaceutical composition comprising the composition and a
`
`pharrnaceutically acceptable carrier or excipient. This is obvious variation in view of claims 18-
`
`20, 26, 28 and 29 of the patent which disclose an antibiotic composition comprised of a
`
`combination of a compound of formula 1 (i.e., anhydro-daptomycin), a compound of formula 2
`
`(i.e., beta-isomer of daptomycin) and a compound of formula 3 (i.e., daptomycin, A21978C), or
`
`pharrnaceutically acceptable salts thereof, wherein the total amount of the compound of formula
`
`1 and the compound of formula 2 or salts thereof, in the combination is less than 6 weight
`
`percent; or a pharmaceutical formulation comprising a combination of a compound of formula 1
`
`(i.e., anhydro-daptomycin), a compound of formula 2 (i.e., beta-isomer of daptomycin) and a
`
`compound of formula 3 (i.e., daptomycin, A21978C), or pharrnaceutically acceptable salts
`
`thereof, wherein the total amount of the compound of formula 1 and the compound of formula 2
`
`or salts thereof, in the combination is less than 6 weight percent and the pharmaceutical
`
`formulation further comprises from about 0.1 to about 90 weight percent of the A21978C. Both
`
`Page 10
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`Page 10
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`Application/Control Number: 11/739,180
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`Page 8
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`Art Unit: 1656
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`claims of instant application and the patent are directed to a composition comprising
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`substantially pure daptomycin (i.e., >97% purity daptomycin); or a pharmaceutical composition
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`comprising the composition and a pharrnaceutically acceptable carrier or excipient. Thus, claims
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`1, 8-9, 46, 54-55, 57, 58 and 60 in present application and claims 18-20, 26, 28 and 29 of the
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`patent are obvious variations of a composition comprising substantially pure daptomycin (i.e.,
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`>97% purity daptomycin); or a pharmaceutical composition comprising the composition and a
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`pharrnaceutically acceptable carrier or excipient.
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`Claim Objections
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`6.
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`Claims 2-7, 31-36, 39-44, 47-52, 59 and 61-63 are objected to because the claims are
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`dependent from a rejected claim, but would be allowable if rewritten in independent form
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`including all of the limitations of the base claim and any intervening claims.
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`Conclusion
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`7.
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`Claims 1, 8-29, 38, 46, 54-58 and 60 are rejected; and claims 2-7, 31-36, 39-44, 47-52, 59
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`and 61-63 are objected to.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Chih-Min Kam whose telephone number is (571) 272-0948. The
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`examiner can normally be reached on 8.00-4:30, Mon-Fri.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the
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`organization where this application or proceeding is assigned is 571-273-8300.
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`Application/Control Number: 11/739,180
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`Page 9
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`Art Unit: 1656
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`Information regarding the status of an application may be obtained from the Patent
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`Application Information Retrieval (PAIR) system. Status information for published applications
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`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
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`applications is available through Private PAIR only. For more information about the PAIR
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`system, see http://pair-direct.uspto. gov. Should you have questions on access to the Private PAIR
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`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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`/Chih-Min Kam/
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`Primary Examiner, Art Unit 1656
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`CMK
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`February 22, 2010
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