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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwusptogov
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`APPLICATION NO.
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` F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONF {MATION NO.
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`11/739,180
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`04/24/2007
`
`Thomas Kelleher
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`C062—02/03 US
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`8837
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`Intellectual Property Department
`Cubist Pharmaceuticals, Inc.
`65 Hayden Avenue
`Lexington, MA 02421
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`KAM, CHIH MIN
`PAPER NUMBER
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`ART UNIT
`1656
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`MAIL DATE
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`11/17/2008
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`DELIVERY MODE
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`PAPER
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`PTOL—90A (Rev. 04/07)
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`Page 1
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`CUBIST 2310
`AGILA V. CUBIST
`IPR2015—00141
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`CUBIST 2310
`AGILA v. CUBIST
`IPR2015-00141
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`Page 1
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`Application No.
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`Applicant(s)
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`11/739,180
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`KELLEHER ET AL.
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`Office Action Summary
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`Examiner
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`CHIH-MIN KAM
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`Art Unit
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`1656 -
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`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 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).
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`Status
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`1)IXI Responsive to communication(s) filed on 18 August 2008.
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`2a)I:I This action is FINAL.
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`2b)IZI This action is non-final.
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`3)I:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under EX parte Quayle, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims
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`4)IZI Claim(s) 1-29 31-36 38-44 and 46-52 is/are pending in the application.
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`4a) Of the above Claim(s)
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`is/are withdrawn from consideration.
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`5)I:I Claim(s) _ is/are allowed.
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`6)IXI Claim(s) 1-5 8-29 31 -34 38-42 and 46-50 is/are rejected.
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`7)IZI Claim(s) 6 7 35 36 43 44 51 and 52 is/are objected to.
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`8)I:I Claim(s) _ are subject to restriction and/or election requirement.
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`Application Papers
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`9)I:I The specification is objected to by the Examiner.
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`
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`10)IZ The drawing(s) filed on 24 April 2007 is/are: a)IZI accepted or b)I:I objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
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`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
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`a)I:I All
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`b)I:I Some * c)I:I None of:
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`1.I:I Certified copies of the priority documents have been received.
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`2.I:I Certified copies of the priority documents have been received in Application No.
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`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attach ment(s)
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`1) D Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) |:| Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mai| Date
`.
`U.S. Patent and Trademark Office
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`4) D Interview Summary (PTO-413)
`Paper No(s)/Mai| Date. _
`5) I:I Notice of Informal Patent Application
`6) D Other:
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20081029
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`Page 2
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`Page 2
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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
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`Status of the Claims
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`1.
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`Claims 1-29, 31-36, 38-44 and 46-52 are pending.
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`Applicants’ amendment filed August 18, 2008 is acknowledged. Claim 1 has been
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`amended, and claims 30, 37, 45 and 53 have been cancelled. Therefore, claims 1-29, 31-36, 38-
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`44 and 46-52 are examined.
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`Withdrawn Claim Obiections
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`2.
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`The previous objection to claims 2-7, 10, 31-34, 39-42 and 47-50 is withdrawn in view of
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`a new ground of rejection made on these claims.
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`Withdrawn Claim Re 'ections - 35 USC 102
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`3.
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`The previous rejection of claims 1, 8, 9, 11-30, 37, 38, 45-46 and 53 under 35
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`USC. 102(e) as being anticipated by Baker et al. (US RE39,071 E, reissue of US. Patent
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`5,912,226), is withdrawn in view of applicants’ amendment to the claim, and applicant’s
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`response at pages 8-9 in the amendment filed August 18, 2008.
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`New Claim Rejections - 35 USC § 103
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`The following is a quotation of 35 USC. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in
`section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are
`such that the subject matter as a whole would have been obvious at the time the invention was made to a person
`having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the
`manner in which the invention was made.
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`Page 3
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`Page 3
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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.
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`Claims 1-5, 8-29, 31-34, 38-42 and 46-50 are rejected under 35 U.S.C. 103(a) as being
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`unpatentable over Baker et al. (US RE39,071 E, reissue of US. Patent 5,912,226, filed
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`December 16, 1991).
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`Baker et al. teach an antibacterial composition comprising daptomycin (LY146032) in
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`substantially pure form, which refers to daptomycin that contains less than 2.5% of a combined
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`total of anhydro-daptomycin and beta-isomer of daptomycin (column 8, lines 50-60; Example 4),
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`where daptomycin is purified by a procedure using Diaion HP-20 resin column and HPLC
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`(Examples 1-3, claim 8). Baker et al. also teach a pharmaceutical formulation comprising the
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`purified daptomycin (LY146032) with pharmaceutical carriers or excipients can also be prepared
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`(column 9, lines 47-59; claims 9, 38, 46). Although Baker et al. do not specifically disclose the
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`daptomycin (LY146032) that is essentially pure (i.e., at least 98% of a sample being daptomycin
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`as defined at page 11, lines 23-26 of the instant specification); that is substantially free of
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`anhydro-daptomycin (no more than 1%; page 11, lines 27-29) and substantially fiee of [3-isomer
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`of daptomycin (no more than 1%); that is essentially fiee of anhydro-daptomycin (no more than
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`0.5%; page 12, lines 1-3) and substantially free of [3-isomer of daptomycin (no more than 1%);
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`that is free of anhydro-daptomycin (no more than 0.1%; page 12, lines 4-6) and substantially free
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`of [3-isomer of daptomycin (no more than 1%), the reference does indicate the daptomycin
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`(LY146032) contains less than 2.5% of a combined total of anhydro-daptomycin and beta-isomer
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`of daptomycin, thus it is obVious that LY146032 is at least 97.5% pure, which encompass the
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`embodiments at least 98% pure (claims 1(a), 2, 31, 39, 47), the embodiments of substantially free
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`of anhydro-daptomycin (no more than 1%) and substantially free of [3-isomer of daptomycin (no
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`more than 1%; claims 1(b), 3, 32, 40, 48), the embodiments of essentially free of anhydro-
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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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`daptomycin (no more than 0.5%) and substantially free of [3-isomer of daptomycin (no more than
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`1%; claims 1(c), 4, 33, 41, 49), and the embodiments of free of anhydro-daptomycin (no more
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`than 0.1%) and substantially free of [3-isomer of daptomycin (no more than 1%; claims 1(d), 5,
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`34, 42, 50). It is also obvious that claims 11-29 are not patentable because the product by
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`process claims are limited by and defined by the process, determination of patentability is based
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`on the product itself, and the patentability of a product does not depend on its method of
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`production (see MPEP 2113). In the instant case, the composition comprising daptomycin that is
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`substantially free of anhydro-daptomycin and beta-isomer of daptomycin (less than 2.5%
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`impurity, or at least 97.5% pure) as indicated in the patent is the similar to the claimed
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`composition comprising essentially pure daptomycin (>98% daptomycin), even though the
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`daptomycin of reference is purified by a different process. Baker et al. also disclose an antibiotic
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`composition comprised of a combination of a compound of formula 1 (i.e., anhydro-A21978C;
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`column 1, lines 14-21), a compound of formula 2 (isomer of A21978C) and a compound of
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`formula 3 (the parent cyclic peptide of A21978C; LY146032) or pharmaceutically acceptable
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`salts (Reissue:claim 18; claim 10 of instant application).
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`Claim Objections
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`5.
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`Claims 6-7, 35-36, 43-44 and 51-52 are objected to because the claims are dependent
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`from a rejected claim.
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`Page 5
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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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`Conclusion
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`6.
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`Claims 1-5, 8-29, 31-34, 38-42 and 46-50 are rejected; and claims 6-7, 35-36, 43-44 and
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`51-52 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 8.00-4230, Mon-Fri.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Jon Weber can be reached at 571-272-0925. 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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`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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`November 12, 2008
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