Exhibit 1021
`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1021
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01800
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`

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`UNITED STATES PATENT AND TRADEMARK OEEICE
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`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
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`APPLICATION NO.
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`FILING 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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`11/698.739
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`01/25/2007
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`S. George Kottayil
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`506950100
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`4756
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`SNELL&WILMER L.L.P. —
`One Arizona Center
`WEGERT, SANDRA L
`400 East Van Buren
`Phoenix, AZ 85004-2202
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`PAPER NUMBER
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`ART UNIT
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`1646
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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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`MAIL DATE
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`09/15/2010
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`DELIVERY MODE
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`PAPER
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`PTOI.—90A (Rev. 04/07)
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`

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`Office Action Summary
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`Application No.
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`Applicant(s)
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`11/698,739
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`KOTTAYIL ET AL.
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`Examine,
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`SANDRA WEGERT
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`Art Unit
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`1646 -
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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 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).
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`Status
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`1)IXI Responsive to communication(s) filed on 31 August 2010.
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`2a)I:I This action is FINAL.
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`2b)IZ 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 parie Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`4) C|aim(s) is/are pending in the application.
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`4a) Of the above c|aim(s) 5-8 12-19,24-29 and 33-138 is/are withdrawn from consideration.
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`5)I:I C|aim(s) j is/are allowed.
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`6)IZI C|aim(s) 1-4 10 11 20-23 31 and 32 is/are rejected.
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`7)I:I C|aim(s) j is/are objected to.
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`8)I:I C|aim(s) j 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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`is/are: a)I:I accepted or b)I:I objected to by the Examiner.
`10)IZ The drawing(s) filed on
`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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`Attachment(s)
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`1) E Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) X Information Disclosure Statement(s) (PTO/SB/08)
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`Paper No(s)/Mail Date 6/21/10 8/31/10.
`U.S. Patent and Trademark Office
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`4) I] Interview Summary (PTO-413)
`Papal N0(S)/IVIaII Data E
`5) I:I N0tICa 07 Informal Patent Application
`6) D Other: j.
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
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`Part of Paper No./Mail Date 20100907
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`

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`Application/Control Number: 11/698,739
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`Art Unit: 1646
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`Page 2
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`Detailed Action
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`Status ofApplication, Amendments, and/or Claims
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`Applicant's remarks and the Information Disclosure Statements sent 21 June 2010 and 31
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`August 2010, have been entered into the record.
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`Claims 1-8, 10-29 and 31-138 are pending. Claims 1 and 20 are amended. Claims 5-8,
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`12-19, 24-29 and 33-138 are withdrawn. Claims 9 and 30 are cancelled.
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`Claims 1-4, 10, 11, 20-23, 31 and 32 are under examination in the Instant Application.
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`Maintained/New Claim Rejections/Objections
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`Claim Rejections: Double Patenting
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`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
`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).
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`

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`Application/Control Number: 11/698,739
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`Art Unit: 1646
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`Page 3
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`Claims 1-4, 10, 11, 20-23, 31 and 32 are provisionally rejected on the ground of
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`nonstatutory obviousness-type double patenting as being unpatentable over claims 9-11, 30-32,
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`127, 128 and 139 of copending Application No. 12/221,333 (Pub No. 2009/0176834). Although
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`the conflicting claims are not identical, they are not patentably distinct from each other because
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`each application describes almost identical inventions, and the claims to those inventions use
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`nearly identical language in describing them.
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`This is a provisional obviousness-type double patenting rejection because the conflicting
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`claims have not in fact been patented.
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`Although the conflicting claims are not identical, they are not patentably distinct from
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`each other for the following reasons:
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`Instant claims 1-4, 10, 11, 20-23, 31 and 32 are directed to formulations of fentanyl and
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`fentanyl derivatives that are at least about 10 microns in diameter and produce Cmax blood
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`concentrations of 127pg/ml to about 213 pg/ml or 142pg/ml to 195pg/ml or 158pg/ml to 177
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`pg/ml after sublingual administration to humans. Claims 9-11, 30-32, 127, 128 and 139 of
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`copending application 12/221,333 are directed to formulations of fentanyl and fentanyl
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`derivatives that are at least about 10 microns in diameter— as recited in the independent claims
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`from which claims 9-11, 30-32, 127, 128 and 139 depend- and produce Cmax blood
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`concentrations of 127pg/ml to about 213 pg/ml or 142pg/ml-195pg/ml or 158pg/ml-177 pg/ml
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`after sublingual administration to humans.
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`

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`Application/Control Number: 11/698,739
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`Art Unit: 1646
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`Page 4
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`The specifications and drawings of each co—pending application are nearly identical.
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`Application 12/221,333 has several additional tables of fentanyl concentration measurements
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`(pages 101-110); however, data found in Tables 1-49 in both disclosures are the same.
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`Applicants did not argue the Double-Patenting rejection presented in the Office action of
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`9 June 2010, correctly suggesting that the examiner may issue a patent on the earlier of the
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`copending applications (see Remarks 21 June 2010). However, since additional rejections are
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`pending (see below) the Double-Patenting rejection is maintained in this Office action.
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`-Claim Rejections-Prior art
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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
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`(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or
`on sale in this country, more than one year prior to the date of application for patent in the United States.
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`Claims 1-4, 10, 11, 20-23, 31 and 32 are rejected under 35 U.S.C. § 102(b) as being
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`anticipated by Ross (2003, US 2003/0190290, Application No. 10/312,200), referred to as "Ross
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`2003" as compared to Ross, et al, 2006, below. Ross 2003 teaches compositions and dispensing
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`devices for improved administration of fentanyl (Abstract) and also teaches that sublingual spray
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`delivery is preferred over other types of drug delivery (paragraph 0015). Liquid carriers, such as
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`oils and alcohols, are discussed in paragraphs 0038-0042 (page 3). Administration to human
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`beings is discussed throughout (for example, paragraph 0003).
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`

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`Application/Control Number: 11/698,739
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`Art Unit: 1646
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`Page 5
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`The device used for atomizing the liquid fentanyl formulation is shown in Figure 1.
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`Figure 5 shows the spray nozzle having three orifices in order to regulate spray droplet diameter.
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`The bottle and actuator used were the Purgard Schott bottle and the Bespak BK357 actuator,
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`respectively, which together form a typical "lil" atomizer. Such atomizers or inhalers
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`produce droplet sizes from about 6 um to approximately 200 um (Smyth, et al, 2003, Figure 1; see
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`related application, also by Ross, et al, 2006, application 2006/0062812, examples 2 and 6; and
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`the Bespak industry website at: http://wwwbespak.com/dde1_resp_v_a.asp). Ross 2003 teaches
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`that the orifices of the device are further adapted to dispense particles of chosen size (paragraph
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`0066) for optimum passage across the oral mucosa.
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`The recitation "provides a mean maximum plasma concentration (Cmax) of fentanyl of
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`"about 127 pg/ml to about 213 pg/ml," " 142 pg/ml to about 195 pg/ml" and "158 pg/ml to about
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`177 pg/ml" (as recited in claims 1, 10, 11, 31 and 32) are examples of intended use and therefore
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`do not receive patentable weight. Note that the same formulation is intended to be used to
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`produce the three claimed plasma concentration ranges.
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`Conclusion: Claims 1-4, 10, 11, 20-23, 31 and 32 are rejected for the reasons recited above.
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`Advisory information
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Sandra Wegert whose telephone number is (571) 272-0895. The
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`examiner can normally be reached Monday - Friday from 9:00 AM to 5 :00 PM (Eastern Time).
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`

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`Application/Control Number: 11/698,739
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`Art Unit: 1646
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`Page 6
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`If attempts to reach the examiner by telephone are unsuccessful, the Examiner's supervisor, Gary
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`Nickol, can be reached at (571) 272-0835.
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`The fax number for the organization where this application or proceeding is assigned is
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`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
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`PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you
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`would like assistance from a USPTO Customer Service Representative or access to the
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`automated information system, call 800-786-9199 (in USA or CANADA) or 571-272-1000.
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`/SLW/
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`1 September 2010
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`/Dong Jiang/
`Primary Examiner, Art Unit 1646