Exhibit 1018
`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1018
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01800
`
`

`
`
`
`UNITED STATES PATENT AND TRADEMARK OEEICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trzuleinark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www usplo gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONF MATION NO.
`
`11/698.739
`
`01/25/2007
`
`S. George Kottayil
`
`506950100
`
`4756
`
`SNELL&WILMER L.L.P. —
`One Arizona Center
`WEGERT, SANDRA L
`400 East Van Buren
`Phoenix, AZ 85004-2202
`
`PAPER NUMBER
`
`ART UNIT
`
`1646
`
`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.
`
`MAIL DATE
`
`06/09/2010
`
`DELIVERY MODE
`
`PAPER
`
`PTOI.—90A (Rev. 04/07)
`
`

`
`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`11/698,739
`
`KOTTAYIL ET AL.
`
`Examine,
`
`SANDRA WEGERT
`
`Art Unit
`
`1646 -
`
`-- 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 12 April 2010.
`
`2a)I:I This action is FINAL.
`
`2b)IZ 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 parie Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4) C|aim(s) 1-8 10-29 and 31-138 is/are pending in the application.
`
`4a) Of the above c|aim(s) 5-8 12-19,24-29 and 33-138 is/are withdrawn from consideration.
`
`5)I:I C|aim(s) j is/are allowed.
`
`6)IZI C|aim(s) 1-4 10 11 20-23 31 and 32 is/are rejected.
`
`7)I:I C|aim(s) j 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 25 January 2007 is/are: a)IZ 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) E Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) D Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date j.
`U.S. Patent and Trademark Office
`
`4) I] Interview Summary (PTO-413)
`Papal N0(S)/IVIaII Data E
`5) I:I N0tICa 07 Informal Patent Application
`6) D Other: j.
`
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20100602
`
`

`
`Application/Control Number: 11/698,739
`
`Art Unit: 1646
`
`Page 2
`
`Detailed Action
`
`Status ofApplication, Amendments, and/or Claims
`
`Applicants‘ election of Invention IV (claims 9-11 and 30-32), without traverse, in the
`
`election of 12 April 2010, is acknowledged. In addition, applicants amended claims 1 and 20
`
`such that they are also part of the elected invention; correspondingly, applicants cancelled claims
`
`9 and 30.
`
`The restriction requirement is deemed proper and is therefore made FINAL.
`
`Claims 5-8, 12-19, 24-29 and 33-138 are Withdrawn from further consideration pursuant
`
`to 37 CFR 1.142(b), as being drawn to nonelected Inventions, there being no allowable generic
`
`or linking claim.
`
`Claims 1-4, 10, 11, 20-23, 31 and 32 are under examination in the Instant Application.
`
`Claim Rejections/Objections
`
`Claim Rejections: 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. A nonstatutory obviousness-type double patenting rejection
`is appropriate where the conflicting claims are not identical, but at least one examined
`application claim is not patentably distinct from the reference claim(s) because the examined
`application claim is either anticipated by, or would have been obvious over, the reference
`
`

`
`Application/Control Number: 11/698,739
`
`Art Unit: 1646
`
`Page 3
`
`claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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).
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may
`be used to overcome an actual or provisional rejection based on a nonstatutory double patenting
`ground provided the conflicting application or patent either is shown to be commonly owned
`with this application, or claims an invention made as a result of activities undertaken within the
`scope of a joint research agreement.
`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).
`
`Claims 1-4, 10, 11, 20-23, 31 and 32 are provisionally rejected on the ground of
`
`nonstatutory obviousness-type double patenting as being unpatentable over claims 9-11, 30-32,
`
`127, 128 and 139 of copending Application No. 12/221,333 (Pub No. 2009/0176834). Although
`
`the conflicting claims are not identical, they are not patentably distinct from each other because
`
`each application describes almost identical inventions, and the claims to those inventions use
`
`nearly identical language in describing them.
`
`This is a provisional obviousness-type double patenting rejection because the conflicting
`
`claims have not in fact been patented.
`
`Although the conflicting claims are not identical, they are not patentably distinct from
`
`each other for the following reasons:
`
`Instant claims 1-4, 10, 11, 20-23, 31 and 32 are directed to formulations of fentanyl and
`
`fentanyl derivatives that are at least about 10 microns in diameter and produce Cm. blood
`
`concentrations of 127pg/ml to about 213 pg/ml or 142pg/ml to 195pg/ml or 158pg/ml to 177
`
`pg/ml after sublingual administration to humans. Claims 9-11, 30-32, 127, 128 and 139 of
`
`copending application 12/221,333 are directed to formulations of fentanyl and fentanyl
`
`

`
`Application/Control Number: 11/698,739
`
`Art Unit: 1646
`
`Page 4
`
`derivatives that are at least about 10 microns in diameter— as recited in the independent claims
`
`from which claims 9-11, 30-32, 127, 128 and 139 depend- and produce Cmax blood
`
`concentrations of 127pg/ml to about 213 pg/ml or 142pg/ml-195pg/ml or 158pg/ml-177 pg/ml
`
`after sublingual administration to humans.
`
`The specifications and drawings of each co-pending application are nearly identical.
`
`Application 12/221,333 has several additional tables of fentanyl concentration measurements
`
`(pages 101-110); however, data found in Tables 1-49 in both disclosures are the same.
`
`Conclusion: Claims 1-4, 10, 11, 20-23, 31 and 32 are rejected for the reasons recited above.
`
`Advisory information
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Sandra Wegert whose telephone number is (571) 272-0895. The
`
`examiner can normally be reached Monday — Friday from 9:00 AM to 5 :00 PM (Eastern Time).
`
`If attempts to reach the examiner by telephone are unsuccessful, the Examiner's supervisor, Gary
`
`Nickol, can be reached at (571) 272-0835.
`
`The fax number for the organization where this application or proceeding is assigned is
`
`571-273-8300.
`
`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`applications is available through Private PAIR only. For more information about the PAIR
`
`

`
`Application/Control Number: 11/698,739
`
`Art Unit: 1646
`
`Page 5
`
`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 866-217-9197 (toll-free). If you
`
`would like assistance from a USPTO Customer Service Representative or access to the
`
`automated information system, call 800-786-9199 (in USA or CANADA) or 571-272-1000.
`
`/SLW/
`
`1 June 2010
`
`/Dong Jiang/’
`Primary Examiner, Art Unit 1646