Exhibit 1028
`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1028
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01800
`
`

`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www usplo gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`WOOD, PHILLIPS, KATZ, CLARK & MORTIMER
`500 W. MADISON STREET
`SUITE 1130
`CHICAGO, IL 60661
`
`EXAMINER
`
`LANDSMAN, ROBERT S
`
`1647
`
`DATE MAILED: 04/15/2013
`
`APPLICATION NO.
`FILING DATE
`FIRST NAI\/IED INVENTOR
`A'I"I'()RNEY D()CKE'I' N0.
`C()NFIRMA'I'I()N N0.
`
`11/698,739
`01/25/2007
`S. George Kottayil
`INS 10763P00090US
`4756
`TITLE OF INVENTION: Sublingual fentanyl spray
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`IS SUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`SMALL
`
`$890
`
`$0
`
`$0
`
`$890
`
`07/15/2013
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON THE MERITS IS CLOSED. THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`THIS APPLICATION IS SUBJECT TO WITHDRAWAL FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
`
`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
`MAILING DATE OF TIIIS NOTICE OR TIIIS APPLICATION SIIALL BE REGARDED AS ABANDONED.
`TIIIS
`STATUTORY PERIOD CANNOT BE EXTENDED.
`SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION.
`IF AN ISSUE FEE HAS
`PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM
`VVILL BE CONSIDERED A REQUEST TO REAPPLY THE PREVIOUSLY PAID ISSUE FEE TOWARD THE ISSUE FEE NOW
`DUE.
`
`HOW TO REPLY TO THIS NOTICE:
`
`I. Review the ENTITY STATUS shown above. If the ENTITY STATUS is sl1ow11 as SMALL or MICRO, verify whether entitlement to that
`entity status still applies.
`
`If the ENTITY STATUS is the same as shown above, pay the TOTAL FEE(S) DUE shown above.
`
`If the ENTITY STATUS is changed from that shown above, on PART B — FEE(S) TRANSMITTAL, complete section number 5 titled
`"Change in Entity Status (from status indicated above)".
`
`For purposes of this notice, small entity fees are 1/2 the amount of undiscounted fees, and micro entity fees are 1/2 the amount of small entity
`fees.
`
`II. PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office
`(USPTO) with your ISSUE FEE and PUBLICATION FEE (if required). If you are charging the fee(s) to your deposit account, section "4b"
`of Part B - Fee(s) Transmittal should be completed and an extra copy of the form should be submitted. If an equivalent of Part B is filed, a
`request to reapply a previously paid issue fee must be clearly made, and delays in processing may occur due to the difficulty in recognizing
`the paper as an equivalent of Part B.
`
`III. All communications regarding this application must give the application number. Please direct all communications prior to issuance to
`Mail Stop ISSUE FEE unless advised to the contrary.
`
`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenance fees. It is patentee's responsibility to ensure timely payment of maintenance fees when due.
`
`PTOL—S5 (Rev. 02/11)
`
`Page I of 4
`
`

`
`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`or @ (571)-273-2885
`
`through 5 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1
`p(propriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`n icated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS" for
`maintenance fee notifications.
`
`a i
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1f0r any Chingt of address)
`
`7590
`32115
`WOOD, PHILLIPS,
`500 W» MADISON STREET
`SUITE 1130
`CHICAGO, IL 60661
`
`04/15/2013
`
`& MORTIMER
`
`Note: A certificate of mailin can only be used for domestic mailings of the
`Fee(s) Transmittal. This certi icate cannot be used for any ot ier accompanying
`papers. Each additional paper, such as an assignment or formal drawing, must
`ave its own certificate of mailing or transmission.
`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
`States Postal Service with sufficient postage for first class mail in an envelope
`?r‘1‘1§‘ii?3‘§d‘?o "L111: I13"iS"1;11"(S)t(()§)71§’S217"3]:7—21;'E§ 3311353a?§’?X(%c£Ed'°§é‘i§wfa°S”“‘1°
`‘
`_
`
`(Sigznature) (Date)
`
`1””)
`
`APPLICATION NO.
`
`FILING DATE
`
`F {ST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`01/25/2007
`11/698,739
`TITLE OF INVENTION: Sublingual fentanyl spray
`
`S. George Kottayil
`
`INS 10763P00090US
`
`4756
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`IS SUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`SMALL
`
`LANDSMAN, ROBERT S
`
`$890
`
`1647
`
`$0
`
`$0
`
`$890
`
`07/15/2013
`
`514—329000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`
`:1 Chan e of correspondence address (or Change of Correspondence
`Address orm PTO/SB/122) attached.
`
`:1 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Vumber is required.
`
`
`
`2. For printing on the patent front page, list
`(1) the names of up to 3 registered patent attorneys
`or agents OR, alternatively,
`(2) the name of a single firm (having as a member a
`registered attorney or agent) and the names of up to
`2 registered patent attorneys or agents. If no name is
`listed, no name will be printed.
`
`1
`
`2
`
`3
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent. If an assignee is identified below, the document has been filed for
`rccordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
`(A) NAME OF ASSIGNEE
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) : D Individual D Corporation or other private group entity D Government
`
`4a. The following fee(s) are submitted:
`:1 Issue Fee
`
`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`:1 A check is enclosed.
`
`3 Publication Fee (No small entity discount permitted)
`3 Advance Order — # of Copies
`
`3 Payment by credit card. Form PTO—2038 is attached.
`3 The Director is hereby authorized to charge the required fee(s), any deficiency, or credit any
`overpayment, to Deposit Account Number
`(enclose an extra copy of this form).
`
`PTOL—S5 (Rev. 02/11)
`
`Page 2 of 4
`
`

`
`5. Change in Entity Status (from status indicated above)
`3 Applicant certifying micro entity status. See 37 CFR 1.29
`
`3 Applicant asserting small entity status. See 37 CFR 1.27
`
`3 Applicant changing to regular undiscounted fee status.
`
`NOTE: Absent a valid certification of Micro Entity Status (see form PTO/SB/ 15A and 15B , issue
`fee payment in the micro entity amount will not be accepted at the risk of application aban onment.
`NOTE: If the application was previously under micro entity status, checking this box will be taken
`to be a notification of loss of entitlement to micro entity status.
`NOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro
`entity status, as applicable.
`
`NOTE: The Issue Fee and Publication Fee (if required) will not be accepted from anyone other than the applicant; a registered attorney or agent; or the assignee or other party in
`interest as shown by the records of the United States Patent and Trademark Office.
`
`Authorized Signature
`
`Typed or printed name
`
`Date
`
`Registration No.
`
`This collection of information is required by 37 CFR 1.311. The information is re uired to obtain or retain a benefit by the public which is to file (and by the USPTO to process)
`an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. T is collection is estimated to take 12 minutes to complete, including gathering, preparing, and
`submitting the completed application form to the USPTO. Time will v
`de endin upon the individual case. Any comments on the amount of time you require to complete
`this form and/or su gestions for reducing this burden, should be sent toafhle Cfiief In ormation Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O.
`Box 1450, Alexan r1a, Virginia 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450,
`Alexandria, Virginia 22313-1450.
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`
`PTOL—85 (Rev. 02/11) Approved for use through 08/31/2013.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`Page 3 of 4
`
`

`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISS ONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`www uspln gov
`
`11/698,739
`
`01/25/2007
`
`s. George Kottayil
`
`INS10763P00090US
`
`4756
`
`32116
`
`7590
`
`04/15/2013
`
`WOOD, PHILLIPS, KATZ, CLARK & MORTIMER
`500 W. MADISON STREET
`SUITE 1130
`CHICAGO, IL 60661
`
`LANDSMAN, ROBERT s
`
`1647
`
`DATE MAILED: 04/ 1 5/201 3
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment to date is 495 day(s). If the issue fee is paid on the date that is three months after the
`mailing date of this notice and the patent issues on the Tuesday before the date that is 28 weeks (six and a half
`months) after the mailing date of this notice, the Patent Term Adjustment will be 495 day(s).
`
`If a Continued Prosecution Application (CPA) was filed in the above-identified application,
`determines Patent Term Adjustment is the filing date of the most recent CPA.
`
`the filing date that
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information Retrieval
`(PAIR) WEB site (http://pair.uspto.goV).
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee payments should be
`directed to the Customer Service Center of the Office of Patent Publication at 1-(888)-786-0101 or (571)-272-4200.
`
`PTOL-S5 (Rev. 02/11)
`
`Page 4 of 4
`
`

`
`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with
`your submission of the attached form related to a patent application or patent. Accordingly, pursuant to
`the requirements of the Act, please be advised that: (1) the general authority for the collection of this
`information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the
`principal puipose for which the information is used by the U.S. Patent and Trademark Office is to process
`and/or examine your submission related to a patent application or patent. If you do not furnish the
`requested information, the U.S. Patent and Trademark Office may not be able to process and/or examine
`your submission, which may result in termination of proceedings or abandonment of the application or
`expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
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`1. The information on this form will be treated confidentially to the extent allowed under the Freedom
`of Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of
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`U.S.C. 552a(m).
`. A record related to an International Application filed under the Patent Cooperation Treaty in this
`system of records may be disclosed, as a routine use, to the International Bureau of the World
`Intellectual Property Organization, pursuant to the Patent Cooperation Treaty.
`. A record in this system of records may be disclosed, as a routine use, to another federal agency for
`purposes of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy
`Act (42 U.S.C. 218(c)).
`to the Administrator,
`. A record from this system of records may be disclosed, as a routine use,
`General Services, or his/her designee, during an inspection of records conducted by GSA as part of
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`with the GSA regulations governing inspection of records for this purpose, and any other relevant
`(i.e., GSA or Commerce) directive. Such disclosure shall not be used to make determinations about
`individuals.
`
`. A record from this system of records may be disclosed, as a routine use, to the public after either
`publication of the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35
`U.S.C. 151. Further, a record may be disclosed, subject to the limitations of 37 CFR 1.14, as a
`routine use, to the public if the record was filed in an application which became abandoned or in
`which the proceedings were terminated and which application is referenced by either a published
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`. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local
`law enforcement agency, if the USI’TO becomes aware of a violation or potential violation of law or
`regulation.
`
`

`
`Notice of Allowability
`
`Application No.
`11/698,739
`'F5£:';it"f;ndSman
`
`Applicant(s)
`KOTTAYIL ET AL.
`'1°*gt4;J"“
`£‘i'f;)‘§I;if,'s"“°"‘°"°
`No
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application.
`If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1. IX This communication is responsive to the amendment dated 10/8/12.
`
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2. I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`requirement and election have been incorporated into this action.
`
`3. IX The allowed cIaim(s) is/are 144 145 and 148. As a result of the allowed c|aim(s), you may be eligible to benefit from the Patent
`Prosecution Highway program at a participating intellectual property office for the corresponding application. For more information,
`please see hit
`:/./wwwxsss ‘to. CV1’ atents/init events/" h/index.'s' or send an inquiry to PPHfeedback5’fz>usg;t0.qov .
`
`: the restriction
`
`4. I:I Acknowledgment is made of a claim forforeign priority under 35 U.S.C. § 119(a)—(d) or (f).
`
`Certified copies:
`
`a) [I All
`
`b) [I Some
`
`*c) I:I None of the:
`
`1. I:I Certified copies of the priority documents have been received.
`
`2. El Certified copies of the priority documents have been received in Application No. j
`3. El 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)).
`
`* Certified copies not received:
`
`Interim copies:
`
`a) D All
`
`b) D Some
`
`c) I:I None of the:
`
`Interim copies of the priority documents have been received.
`
`Applicant has THREE MONTHS FROM THE “MAILING DATE” ofthis communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5. I:I CORRECTED DRAWINGS (as “replacement sheets”) must be submitted.
`
`El
`
`including changes required by the attached Examiner’s Amendment / Comment or in the Office action of
`Paper No./Mail Date
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the from (not the back) of
`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).
`
`6. I:I DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner’s comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. I:I Notice of References Cited (PTO-892)
`
`2. IXI Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date 10/8/12
`3. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. El Interview Summary (PTO—413),
`Paper No./Mail Date
`.
`
`5. E Examiner's Amendment/Comment
`
`6. IXI Examiner‘s Statement of Reasons for Allowance
`
`7. El Other
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 03-13)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20130406
`
`

`
`Application/Control Number: 11/698,739
`
`Art Unit: 1647
`
`Page 2
`
`EXAMINER’S AMENDMENT
`
`An examiner’s amendment to the record appears below. Should the changes and/or additions be
`
`unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure
`
`consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
`
`In the claims:
`
`In claim 148, replace “masimum” with "maximum”
`
`

`
`Application/Control Number: 11/698,739
`
`Art Unit: 1647
`
`Page 3
`
`REASONS FOR ALLOWANCE
`
`In the most recent response, Applicants argued that the use of propylene glycol is a result-
`
`effective variable and that this was not appreciated by Ross et al. The Examiner has not found any
`
`evidence supporting the fact that propylene glycol is a result-effective variable (i.e. proper controls).
`
`However, even if propylene glycol Was not result effective,
`
`the fact that Applicants’ fonnulation is
`
`effective (onset of action) 5 minutes after administration, which is more rapid than any other formulation
`
`on the market (10 to 15 minutes at best), provides evidence that the formulation was not appreciated by
`
`Ross. Due to the nature of the pain being treated, there was a need in the art at the time of the instant
`
`invention for a fast—acting pain reliever. Until Applicants‘ invention,
`
`it does not appear that any other
`
`formulations Were able to act as quickly.
`
`Advisory information
`Any inquiry concerning this communication or earlier communications from the examiner should
`be directed to Robert Landsman, Ph.D. whose telephone number is (571) 272-0888. The examiner can
`normally be reached M-F 8 AM — 6 PM (eastern).
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
`Joanne Hama, can be reached at 571-272-2911. The fax phone 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 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).
`
`/Robert Lands111an/
`
`Primary Examiner, Art Unit 1647