Exhibit 1023
`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1023
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01800
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`

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`
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`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 22313-1430
`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
`
`S. George Kottayil
`
`5069510100
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`4756
`
`7590
`can Cummings
`IP Services Intake Coordinator
`
`05/02/2011
`
`Cooley LLP
`777 6th Street, Suite 1100
`Washington, DC 20001-3703
`
`WEGERT, SANDRAL
`
`1646
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`MAIL DATE
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`05/02/201 1
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`PAPER NUMBER
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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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`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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`App|icant(s)
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`11/698,739
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`KOTTAYIL ET AL.
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`Examiner
`SANDRA WEGERT
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`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 3 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions oftime may be available under the provisions of 37 CFR1.136(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 afterthe mailing date ofthis 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)IXl Responsive to communication(s) filed on 31 March 2011.
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`2a)I:l This action is FINAL.
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`2b)IZ This action is non—final.
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`3)I:l 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 Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`4) Claim(s) is/are pending in the application.
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`4a) Of the above claim(s) 5-8 12-19 24-29 and 33-138 is/are withdrawn from consideration.
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`5)I:| Claim(s) j is/are allowed.
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`6)IZl Claim(s) 1-4 10 11 20-23 31 32 and 139-143 is/are rejected.
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`7)I:I Claim(s) j is/are objected to.
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`8)I:I Claim(s) j are subject to restriction and/or election requirement.
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`Application Papers
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`9)I:l The specification is objected to by the Examiner.
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`10)IZ| The drawing(s) filed on 25 January 2007is/are: a)IZI 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).
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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:| 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)|:| All
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`b)I:| Some * c)|:| None of:
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`1.|:I 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. j
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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)
`Paper No(s)/Mail Date 2/15/11, 3/31/11.
`U.S. Patent and Trademark Office
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`4) El Interview Summary (PTO-413)
`Paper N°(5)/Ma” Date 2
`5) I:I NOIICG Of Informal Patel“ APPII°aII°n
`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./Mail Date 20110424
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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 of Application, Amendments, and/or Claims
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`Applicant's Remarks and the Information Disclosure Statements, sent 15 February 2011
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`and 31 March 2011, have been entered into the record.
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`Claims 1-8, 10-29 and 31-143 are pending. Claims 1 is amended. Claims 5-8, 12-19, 24-
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`29 and 33-138 are withdrawn. Claims 9 and 30 are cancelled. Claims 139-143 are new and read
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`on the examined invention.
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`Claims 1-4, 10, 11, 20-23, 31, 32 and 139-143 are under examination in the Instant
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`Application.
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`Withdrawn 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, eg, 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
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`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 l.32l(c) or l.32l(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.
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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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`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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`The rejection of claims 1-4, 10, 11, 20-23, 31 and 32 on the ground of nonstatutory
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`obViousness—type double patenting over copending Application No. 12/221,333 (Pub No.
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`2009/0176834), is withdrawn based on claim amendments in the co—pending application.
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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 pcrson shall bc cntitlcd to a patent unlcss —
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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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`The rejection of claims 1-4, 10, 11, 20-23, 31 and 32 under 35 U.S.C. § 102(b) for being
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`anticipated by Ross (2003, US 2003/0190290, Application No. 10/312,200), is withdrawn based
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`on applicant's arguments (15 February 2011, p. 20, part A: "Droplet size").
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`New Claim Rejections/Objections
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`Claim Rejections - 35 USC § 112- second paragraph
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`The following is a quotation of the second paragraph of 35 U.S.C. 112:
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`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
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`Claims 1-4, 10, 11, 20-23, 31, 32 and 139-143 are rejected under 35 U.S.C. 112, second
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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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`paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject
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`matter which applicant regards as the invention.
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`The independent claims recite that the discrete liquid droplets must have a mean diameter
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`of at least about 10 microns. Additional claims recite "20 microns," "5—500 microns," or "10-
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`200 microns." The claims are indefinite in that it is unclear how to achieve that particle size
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`using the formulation specified. Similarly, the claims are indefinite in that it is unclear how the
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`recited particle size relates to the effective concentrations recited, or how a particular droplet size
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`contributes to a particular recited Cmax.
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of 35 U.S.C. 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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`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459
`(1966), that are applied for establishing a background for determining obviousness under 35
`U.S.C. 103(a) are summarized as follows:
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`Determining the scope and contents of the prior art. 2. Ascertaining the differences
`between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the
`pertinent art. 4. Considering objective evidence present in the application indicating obviousness
`or nonobviousness.
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`This application currently names joint inventors. In considering patentability of the
`claims under 35 U.S.C. l03(a), the examiner presumes that the subject matter of the various
`claims was commonly owned at the time any inventions covered therein were made absent any
`evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out
`the inventor and invention dates of each claim that was not commonly owned at the time a later
`invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c)
`and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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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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`Claims 1-4, 10, 11, 20-23, 31, 32 and 139-143 are rejected under 35 U.S.C. 103(a) as
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`being unpatentable over Ross (2006, US 2006/0062812, Application No. 11/224,383; referred to
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`herein as "R0ss").
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`Instant claims 1-4, 10, 11, 20-23, 31, 32 and 139-143 are directed to an oral liquid
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`fentanyl formulation comprising discrete liquid droplets of fentanyl and pharmaceutically
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`acceptable liquid carriers. The formulation provides a mean maximum plasma concentration
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`(Cmax) of 127pg/ml to 21 3pg/ml per l00ug of fentanyl. New claims 139-143 more precisely
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`describe the concentrations of the active ingredient and the other excipients within the
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`formulation: 0.001% to about 15% fentanyl; 5% to 90% ethanol; and 0.1% to about 40% of
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`propylene glycol.
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`Ross teaches compositions of a liquid fentanyl formulation for sublingual administration
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`to treat breakthrough pain (Abstract) and also teaches that sublingual spray delivery is preferred
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`over other types of drug delivery (paragraph 0014). Liquid carriers, such as oils and alcohols, are
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`discussed in paragraphs 0018-0021 (page 2). Fentanyl concentrations of about 10% (.1 mg/ml)
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`are recited in paragraph 0036. Use of ethanol in the formulation, in the range of 6 to 50%, is
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`recited at paragraph 0037, while propylene glycol is discussed at paragraph 0055. Both are
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`described as preferred solvents (paragraphs 0038 and 0040). Sublingual administration of the
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`formulation to human beings is discussed throughout (see for example the results in Table 1).
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`Ross also obtained Cmax values of about 127pg/ml to 213pg/ml per 100ug of fentanyl after
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`sublingual administration of the formulation (for example, 370pg/ml per 200ug of fentanyl is the
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`same as 185pg/ml per 100ug of fentanyl- Table 1).
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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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`Ross does not specifically teach a liquid droplet size of at least about 10 microns.
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`However, the broad teachings of Ross cure this deficiency, since Ross teaches every aspect of
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`the claimed instant invention, including the resulting blood concentrations.
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`It would have been prima facie obvious to a person of ordinary skill in the art at the time
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`of the invention to have used the teachings of Ross to optimize the droplet size of the
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`formulation to achieve the blood concentrations of fentanyl that are sufficient to treat acute
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`breakthrough pain, specifically Cmaxvs of 127 to 213pg/ml of 100ug fentanyl. They in fact did use
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`a dispenser to administer the discrete liquid droplets sublingually (paragraph 0077); however the
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`size of the drops is not given.
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`Since the formulation of Ross comprises the same ingredients as the instant formulation,
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`and produces the same Cmax, the invention as claimed is not structurally distinguishable from that
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`of Ross. Since the Patent and Trademark Office does not have the facilities for examining and
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`comparing the claimed formulation with the formulation of Ross, the burden of proof is upon the
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`applicants to show an unobvious distinction between the structural and functional
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`characteristics of the claimed formulation and the formulation of the prior art. See In re Best, 562
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`F.2d 1252, 195 U.S.P.Q. 430 (CCPA 197) and EX parte Gray, 10 USPQ 2d 1922 1923 (PTO Bd.
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`Pat. App. & Int.).
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`Conclusion: Claims 1-4, 10, 11, 20-23, 31, 32 and 139-143 are rejected for the reasons recited
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`above.
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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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`Advisory information
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`Page 7
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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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`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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`21 April 2011
`
`/Dong .l_iai'1g./'
`Primary Examiner, Art Unit 1646