`
`Exhibit 1019
`
`‘688 Patent File History (“FH688”), Notice
`of Allowance
`
`

`
`
`
`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.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`75093
`
`7590
`
`09/1 l/2014
`
`McCarter & English, LLP / Salix Pharmaceuticals
`265 Franklin St.
`BOSTON. MA 02110
`
`FRAZIER, BARBARAS
`
`1611
`
`DATE MAILED: 09/1 1/2014
`
`122184—02804
`William Forbes
`10/02/2009
`12/573,081
`TITLE OF INVENTION: COMPOSITIONS AND METHODS FOR TREATMENT OF BOWEL DISEASES WITH GRANULATED MESALAMINE
`
`5308
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`SMALL
`
`$480
`
`$0
`
`$0
`
`$480
`
`12/1 1/2014
`
`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 THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`THIS
`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
`WILL 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 shown 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—85 (Rev. 02/11)
`
`Page-10f3
`
`MycoNovo, Inc.
`Foxhill Opportunity Fund, L.P.
`
`EX 1 Q1 9
`
`

`
`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 1 (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
`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`in 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.
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any Change Ofaddress)
`
`_
`09/ 1/2014
`75?0
`75093
`l\/ICCEIITGI‘ & E1’lgl1Sl’1, LLP / Sal1X Pharmaceuticals
`265 Franklin St
`BOSTON, MA 02110
`
`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 other accompanying
`fiapers. 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
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (571) 273-2885, on the date indicated below.
`(Depositofs name)
`(Signature)
`
`(Date)
`
`APPLICATION NO.
`
`FILING DATE
`
`F {ST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`122184-02804
`William Forbes
`10/02/2009
`12/573,081
`TITLE OF INVENTION: COMPOSITIONS AND METHODS FOR TREATMENT OF BOWEL DISEASES WITH GRANULATED MESALAMINE
`
`5308
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`SMALL
`
`FRAZIER, BARBARA S
`
`$480
`
`1611
`
`$0
`
`$0
`
`$480
`
`12/11/2014
`
`514- 166000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`
`3 Chan e of correspondence address (or Change of Correspondence
`Address orm PTO/SB/ 122) attached.
`
`3 "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.
`
`2
`
`3
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`If an assignee is identified below, the document has been filed for
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent.
`recordation 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) :
`
`'3 Individual
`
`'3 Corporation or other private group entity '3 Government
`
`4a. The following fee(s) are submitted:
`3 Issue Fee
`
`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`3 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 credits any
`overpayment, to Deposit Account Number
`(enclose an extra copy of this form).
`
`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.
`
`\IOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/ 15A and 15B), issue
`fee payment in the micro entity amount will not be accepted at the risk of application abandonment.
`\IOTE: 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.
`\IOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro
`entity status, as applicable.
`
`NOTE: This form must be signed in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 1.4 for signature requirements and certifications.
`
`Authorized Signature
`
`Typed or printed name
`
`Date
`
`Registration No.
`
`Page 2 of 3
`
`PTOL-85 Part B (10-13) Approved for use through 10/31/2013.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`

`
`
`
`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.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`F {ST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`12/573,081
`
`10/02/2009
`
`William Forbes
`
`122184—02804
`
`5308
`
`McCarter & English, LLP / Salix Pharmaceuticals
`265 Franklin St.
`BOSTON, MA 02110
`
`FRAZIER, BARBARAS
`
`1611
`
`DATE MAILED: 09/1 1/2014
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`
`(Applications filed on or after May 29, 2000)
`
`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
`
`to eliminate the
`Section l(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i)
`requirement that the Office provide a patent term adjustment determination with the notice of allowance. See
`Revisions to Patent Term Adjustment, 78 Fed. Reg. 19416, 19417 (Apr. 1, 2013). Therefore, the Office is no longer
`providing an initial patent term adjustment determination with the notice of allowance. The Office will continue to
`provide a patent term adjustment determination with the Issue Notification Letter that is mailed to applicant
`approximately three weeks prior to the issue date of the patent, and will include the patent term adjustment on the
`patent. Any request for reconsideration of the patent term adjustment determination (or reinstatement of patent term
`adjustment) should follow the process outlined in 37 CFR 1.705.
`
`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—85 (Rev. 02/11)
`
`Page 3 of 3
`
`

`
`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
`
`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and
`Budget approval before requesting most types of information from the public. When OMB approves an agency
`request to collect information from the public, OMB (i) provides a valid OMB Control Number and expiration
`date for the agency to display on the instrument that will be used to collect the information and (ii) requires the
`agency to inform the public about the OMB Control Number’s legal significance in accordance with 5 CFR
`1320.5(b).
`
`The information collected by PTOL-85 Part B is required by 37 CFR 1.311. The information is required 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. This collection is estimated to take 12 minutes to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary
`depending upon the individual case. Any comments on the amount of time you require to complete this form
`and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and
`Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
`SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box
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`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection witl1 your
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`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 purpose for which
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`
`The information provided by you in this form will be subject to the following routine uses:
`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 records
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`5. 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.
`6. 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.
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`8. A record from this system of records may be disclosed, as a routine use, to the public after either publication
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`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
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`inspection or an issued patent.
`9. 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 USPTO becomes aware of a violation or potential violation of law or regulation.
`
`

`
`Notice of Allowability
`
`Application No.
`12/573,081
`EXEWEIJXS; FRAZER
`
`App|icant(s)
`FORBES, WILLIAM
`(*3 3""
`’F‘:{;,<;‘,;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 Response filed 20 June 2014.
`
`D A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2. I:l 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 14 17-19 23-31 70 73 and 74. As a result of the allowed cIaim(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 htt ‘://'w\.»vw.us
`to.‘ ov/ atents/inii: events/‘
`ta/index.is or send an inquiry to PF‘Hfé’-.‘edbEiCI(”ci)L.=S ‘to. ov .
`
`; the restriction
`
`4. I:l Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`
`Certified copies:
`
`a) I:l All
`
`b) D Some
`
`*c) I:I None of the:
`
`1. El 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. 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:
`
`Applicant has THREE MONTHS FROM THE “MAILING DATE” of this 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] CORRECTED DRAWINGS ( as “replacement sheets”) must be submitted.
`
`I:I
`
`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 front (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] 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. IX] Notice of References Cited (PTO—892)
`
`2. IX] Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date 6/9/14 (5)
`3. I] Examiner’s Comment Regarding Requirement for Deposit
`of Biological Material
`4. I] Interview Summary (PTO—413),
`Paper No./Mail Date
`
`5. IX Examiner’s Amendment/Comment
`
`6. IX Examiner’s Statement of Reasons for Allowance
`
`7. I:I Other
`
`.
`
`/B. F./
`
`EXam1“efaAf1U“111511
`
`/DAVID J BLANCHARD/
`
`Supervisory Patent Examiner, Art Unit 1619
`
`U.S. Patent and Trademark Office
`
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20140904
`
`

`
`Application/Control Number: 12/573,081
`
`Page 2
`
`Art Unit: 1611
`
`DETAILED ACTION
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`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.
`
`Authorization for this examiner’s amendment was given in a telephone interview
`
`with Mr. Jonathan Sparks on 3 September 2014.
`
`The application has been amended as follows:
`
`IN THE CLAIMS:
`
`Please cancel claim 20.
`
`Reasons for Allowance
`
`The following is an examiner’s statement of reasons for allowance: the closest
`
`prior art of record is Salix article (“Salix”, from Drugs. Com[online], published 5
`
`

`
`Application/Control Number: 12/573,081
`
`Page 3
`
`Art Unit: 1611
`
`September 2007, previously cited) as evidenced by Karlstadt Meyeroff et al. (“MeyerofF’,
`
`US 2010/0035850, previously cited) in view of Endonurse (cited by Applicants as
`
`reference CB in IDS filed 29 January 2010) and optionally further in view of “Asacol
`
`(Mesalazine)” by NetDoctor (“NetDoctor”, previously cited). The invention of the
`
`combined references is delineated in the previous Office action mailed 27 March 2014
`
`(see pages 3-10, incorporated herein by reference). The cited prior art is silent with
`
`respect to whether or not the mesalamine formulation is administered with or without
`
`food. One skilled in the art would reasonably expect the formulation to be administered
`
`with food, since similar mesalamine formulations are directed to be administered with
`
`food (see Lialda® information pamphlet, submitted by Applicants with response filed 20
`
`June 2014). Additionally, one skilled in the art would be motivated to administer the
`
`mesalamine formulation with food, since 5—aminosalicylate compounds, including
`
`mesalamine, are known to have increased bioavailability when administered with food.
`
`As evidence, see US 2007/0167416 (included with this Office action) at, e.g., abstract
`
`and claims 3-4. However, Applicant’s specification provides evidence that the claimed
`
`mesalamine formulation may be administered without food without loss of efficacy. See
`
`Examples 1 and 4 of specification. Therefore, it would not have been obvious to a
`
`person having ordinary skill in the art at the time the invention was made to administer
`
`granulated mesalamine without food for remission of ulcerative colitis as recited in the
`
`instant claims.
`
`Any comments considered necessary by applicant must be submitted no later
`
`than the payment of the issue fee and, to avoid processing delays, should preferably
`
`

`
`Application/Control Number: 12/573,081
`
`Page 4
`
`Art Unit: 1611
`
`accompany the issue fee. Such submissions should be clearly labeled “Comments on
`
`Statement of Reasons for Allowance.”
`
`Correspondence
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to BARBARA FRAZIER whose telephone number is
`
`(571)270-3496. The examiner can normally be reached on Monday—Friday 9am-2:30pm
`
`EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, John Mabry can be reached on (571)270-1967. The fax phone number for
`
`the organization where this application or proceeding is assigned is 571-273-8300.
`
`

`
`Application/Control Number: 12/573,081
`
`Page 5
`
`Art Unit: 1611
`
`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). 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.
`
`/B. F./
`
`Examiner, Art Unit 1611
`
`/DAVID J BLANCHARD/
`
`Supervisory Patent Examiner, Art Unit 1619