UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`www.usplo.gov
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`“1/
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`11/739,180
`
`04/24/2007
`
`Thomas Kcllchcr
`
`C062-02/03 US
`
`8837
`
`EXAMINER
`Intellectual Property Department _
`”W“ _
`759°
`34“”
`Cubist Pharmaceuticals, Inc.
`KAM, CHIH MIN
`’
`65 Hayden Avenue
`PAPER NUMBER
`Lexington, MA 02421
`
`ART UNIT
`_1656
`
`MA1L DATE
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`02/19/2008
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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 2109
`AGILA V. CUBIST
`IPR2015-00142
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`Page 1
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`CUBIST 2109
`AGILA v. CUBIST
`IPR2015-00142
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`\|
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`Application No.
`
`Applicant(s)
`
`Office Action Summary .
`
`11/739,180
`Examine,
`
`CHIH—MIN KAM
`
`KELLEHER‘ET AL.
`An 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 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 CF R 1.136(a).
`In no event however may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`II 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)D Responsive to communication(s) filed on
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`2a)[] This action is FINAL.
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`2mm This action is non-final.
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`3)Ij 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 Quay/e, 1935 CD. 11, 453 O.G. 213.
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`
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`Disposition of Claims
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`ME Claim(s) fl is/are pending in the application.
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`4a) Of the above claim(s) __ is/are withdrawn from consideration.
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`5)[:] Claim(s) __ is/are allowed.
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`SHE Claim(s) 1 8 9 11-30 37 38 45 46 and 53 is/are rejected.
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`DIE Claim(s) 2—7 10 31-36 39-44 and 47-52 is/are objected to.
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`8)l:] Claim(s) __ are subject to restriction and/or election requirement.
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`Application Papers
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`9)I:] The specification is objected to by the Examiner.
`10M The drawing(s)Ifiled on24AQril 2007 is/are: a))IZ accepted or b)lj objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be heldIn 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)l:l 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):] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)[] All
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`b)[:] Some * c)|:l None of:
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`11:! Certified copies of the priority documents have been received.
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`2|] Certified copies of the priority documents have been received in Application No. _
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`3.|:I Copies of the certified copies of the priority documents have been received in this National Stage
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`1 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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`Attachment(s)
`1) 1:] Notice of References Cited (PTO-892)
`'2) E] Notice of Draftsperson’s Patent Drawing Review (PTO~948)
`3) E Information Disclosure Statement(s) (PTO/$3108)
`Paper No(s)/Mai| Date 8/14/07.
`US. Patent and Trademark Office
`
`.
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`4) D Interview Summary (PTO-413)
`Paper No(s)/Mail Date. _
`5) D Notice of Informal Patent Application
`6) |:] Other:
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
`Page 2
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`Part of Paper No./MaiI Date 20080214
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`Page 2
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`

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`Application/Control Number: 11/739,180
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`Art Unit: 1656
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`Page 2
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`DETAILED ACTION
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`Status of the Claims
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`1.
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`Claims 1-53 are pending and examined.
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`Information Disclosure Statement (IDS)
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`i 2.
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`The references on IDS filed August 14, 2007 have been considered and signed.
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`Claim Rejections - 35 USC § 102
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the
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`basis for the rejections under this section made in this Office action:
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`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
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`(AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002
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`do not apply when the reference is a US. patent resulting directly or indirectly from an
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`international application filed before November 29, 2000. Therefore, the prior art date of the
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`reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA
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`35 U.S.C. 102(e)).
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`3.
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`Claims 1, 8, 9, 11-30, 37, 38, 45-46 and 53 are rejected under 35 U.S.C. 102(e) as
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`anticipated by Baker et al. (US RE39,071 E, reissue of US. Patent 5,912,226, filed December
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`16, 1991).
`
`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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`Page 3
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`Page 3
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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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`claims 1(g), 30), where daptomycin is purified by a procedure using Diaion PIP-20 resin column
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`and HPLC (Examples 1-3, claim 8). A pharmaceutical formulation comprising the purified
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`daptomycin (LY146032) with pharmaceutical carriers or excipients can also be prepared
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`(column 9, lines 47-59; claims 9, 37, 38, 45-46 and 53). The reference also anticipates claims
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`11-29 because although the product by process claims are limited by and defined by the process,
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`determination of patentability is based on the product itself, and the patentability of a product
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`does not depend on its method of production (see MPEP 2113). In the instant case, the
`composition comprising daptomycin that is substantially free of anhydro-daptomycin and beta—
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`isOmer of daptomycin (< 2.5%) as indicated in the patent is the same as the claimed composition
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`comprising substantially pure daptomycin (>95% daptomycin), even though the daptomycin of
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`reference is purified by a different process.
`3
`Claim Objections
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`4.
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`Claims 2-7, 10, 31-36, 39-44 and 47—52 are objected to because the claims are dependent
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`from a rejected claim.
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`Conclusion
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`5.
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`Claims 1, 8, 9, 11-30, 37, 38, 45—46 and 53 are rejected; and claims 2-7, 10, 31-36, 39—44
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`and 47-52 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 800-4230, Mon—Fri.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Kathleen Bragdon can be reached at 571-272-0931. 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 4
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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
`system, contact the Electronic Business Center (EBC) at 866-21 7-9197 (toll-free).
`
`Chih-Min Kam, Ph. D.
`Primary Patent Examiner
`
`CAL/aw.
`
`CHlH-MIN KAM
`PRIMARY EXAMINER
`
`CMK
`
`February 14, 2008
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`Page 5
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