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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
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`NOTICE OF ALLOWANCE AND FEE(S) DUE
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`101325
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`03/08/2016
`
`GLOBAL PATENT GROUP - HOR
`1005 NORTH WARSON ROAD
`SUIT 4
`SAINT LOUIS, MO 63132
`
`RAO,SAVITHA M
`
`1621
`
`DATE MAILED: 03/08/2016
`
`Bruce Scharschmidt
`12/03/2015
`14/958,259
`TITLE OF INVENTION: METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS
`
`HORO026-201TC2-US
`
`3046
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`APPLN. TYPE PUBLICATION FEE DUE|PREV. PAID ISSUE FEEENTITY STATUS ISSUE FEE DUE TOTAL FEE(S) DUE DATE DUE
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`(ate)
`
`APPLICATION NO.
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`FILING DATE
`
`
`
`
`
` FIRST NAMED INVENTOR
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATION NO.
`
`Bruce Scharschmidt
`12/03/2015
`14/958,259
`TITLE OF INVENTION: METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS
`
`HORO0026-201TC2-US
`
`3046
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`APPLN. TYPE PUBLICATION FEE DUE|PREV. PAID ISSUE FEEENTITY STATUS ISSUE FEE DUE TOTAL FEE(S) DUE DATE DUE
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`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`RAO, SAVITHA M
`
`1621
`
`424-009200
`
`
`
`
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`LI Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/122) attached.
`LI "Fee Address" indication (or "Fee Address” Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Numberis required.
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT(printor 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) NAMEOF ASSIGNEE
`(B) RESIDENCE:(CITY and STATE OR COUNTRY)
`
`2. For printing on the patent front page,list
`:
`1
`(1) The namesofup to 3 registered patent attorneys
`or agents OR,alternatively,
`(2) The nameofa single firm (having as a member a
`registered attorney or agent) and the namesof up to
`2 registered patent attorneys or agents. If nonameis
`listed, no namewill be printed.
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`2
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`43
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`Please check the appropriate assignee category or categories (will not be printed on the patent) :
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`LV individual LJ Corporation or other private group entity (J Government
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`4a. The following fee(s) are submitted:
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`_] Publication Fee (No small entity discount permitted)
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`LIA checkis enclosed.
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`[I The directoris hereby authorized to charge the required fee(s), any deficiency, or credits any
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`5. Change in Entity Status (from status indicated above)
`| Applicantcertifying micro entity status. See 37 CFR 1.29
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` Lj Applicant changing to regular undiscounted fee status.
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`Lj Applicant asserting small entity status. See 37 CFR 1.27
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`NOTE:Absenta valid certification of Micro Entity Status (see forms PTO/SB/15A and 15B), issue
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`Authorized Signature
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`Date
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`Registration No.
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`PTOL-85 Part B (10-13) Approved for use through 10/31/2013.
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`OMB 0651-0033
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`Page 2 of 8
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`APPLICATION NO.
`
`FILING DATE
`
`
`
`
`FIRST NAMED INVENTOR
`
`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
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATION NO.
`
`14/958,259
`
`12/03/2015
`
`Bruce Scharschmidt
`
`HORO026-201TC2-US
`
`3046
`
`101325
`
`7590
`
`03/08/2016
`
`GLOBAL PATENT GROUP - HOR
`1005 NORTH WARSON ROAD
`SUITE 04
`SAINT LOUIS, MO 63132
`
`RAO,SAVITHA M
`
`1621
`
`DATE MAILED: 03/08/2016
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(Applicationsfiled 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 1(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
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`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.
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`proage 30 8
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`Page 3 of 8
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`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
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`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and
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`The information collected by PTOL-85 Part B is required by 37 CFR 1.311. The information is required to obtain
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`Page 40
`
`Page 4 of 8
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`
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`
`
`Notice of Allowability Examiner
`
`Application No.
`14/958,259
`
`SAVITHA RAO
`
`Applicant(s)
`SCHARSCHMIDT ET AL.
`Art Unit
`AIA (First Inventorto
`1621
`File) Status
`No
`
`-- The MAILING DATEof 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 GRANTOF 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. KJ This communication is responsive to 02/18/2016.
`LIA declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2. 1 An election was madeby the applicant in responseto a restriction requirementsetforth during the interview on
`requirement and election have been incorporated into this action.
`
`3. KJ The allowed claim(s)is/are 22-24,28,29 and 36-45. As a result of the allowed claim(s), you maybeeligible to benefit from the Patent
`Prosecution Highway program at a participating intellectual property office for the corresponding application. For more information,
`
`oh/index. is
`please see httoy/www.uspto.gov/patents/inif evenis/
`or send an inquiry to PPHfeedback@uspto gov.
`
`; the restriction
`
`4. 1 Acknowledgmentis madeof a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`
`Certified copies:
`*c) [J None of the:
`a) All
`b)(JSome
`1. (1 Certified copies ofthe priority documents have been received.
`2. C] Certified copies of the priority documents have been received in Application No.
`3. [1] Copiesofthe certified copies of the priority documents have been receivedin 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 ofthis application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5. DJ CORRECTED DRAWINGS( as “replacement sheets”) must be submitted.
`
`C1
`
`including changes required by the attached Examiner's Amendment / Commentor 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 drawingsin 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. [] DEPOSIT OF and/or INFORMATIONaboutthe deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`
`
`5. (] Examiner's Amendment/Comment
`6. XJ Examiner's Statement of Reasons for Allowance
`
`
`
`Attachment(s)
`1. [J Notice of References Cited (PTO-892)
`2. (J Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date
`3. DJ Examiner's Comment Regarding Requirementfor Deposit
`of Biological Material
`4. ZF Interview Summary (PTO-413),
`
`Paper No./Mail Date .
`/SAVITHA RAO/
`Primary Examiner, Art Unit 1621
`
`7. Other
`
`.
`
`U.S. Patent and Trademark Office
`
`PTOL-37(Rev. 08-13)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20160302
`
`Page 5 of 8
`
`Page 5 of 8
`
`
`
`Application/Control Number: 14/958 ,259
`Art Unit: 1621
`
`Page 2
`
`The present application is being examined underthe pre-AlA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`Claims 22-24, 28-29 and 36-45 and are pending in the instant application.
`
`Applicants present new claims 42-45 with their response on 02/18/2016.
`
`The terminal disclaimerfiled on 02/18/2016 disclaiming the terminal portion of
`
`any patent granted on this application which would extend beyondthe expiration date of
`
`US patent nos. 9,254,278, 8,404,215, 9,095,559 and 8,642,012 has been reviewed and
`
`is accepted. The terminal disclaimer has been recorded.
`
`REASONS FOR ALLOWANCE
`
`In view of the applicants argumentsfiled on 1 and terminal disclaimerfiled on
`
`02/18/2016 and the following examiners statement of reasonsfor allowance, claims 22-
`
`24, 28-29 and 36-41 are found to be allowable. Upon further review, new claims 42-45
`
`are also foundto free of art and do not consist of any 112 issues and are supported in
`
`the original specification. Accordingly, new claims 42-45 are also found to be allowable
`
`along with originally presented claims.
`
`Following a diligent search it was determined that the prior art neither teaches
`
`nor provides adequate motivation to arrive at the instantly claimed 22.
`
`(Previously
`
`presented) A methodof treating a subject with a urea cycle disorder who has
`
`previously been administered aninitial dosage of glyceryl tri-[4-phenylbutyrate] and who
`
`Page 6 of 8
`
`Page 6 of 8
`
`
`
`Application/Control Number: 14/958 ,259
`Art Unit: 1621
`
`Page 3
`
`has a fasting plasma ammonia level less than the upperlimit of normal for plasma
`
`ammonia level, the method comprising: (a) measuring a fasting plasma ammonia level
`
`for the subject; (6) comparing the fasting plasma ammonia level to the upperlimit of
`
`normal for plasma ammonia level; and (c) administering an adjusted dosage of glyceryl
`
`tri-[4-phenylbutyrate] that is greater than the initial dosage if the fasting plasma
`
`ammonia level is greater than half the upperlimit of normal for plasma ammonia level,
`
`wherein the upperlimit of normal for plasma ammonia levelis in the range of 26-64
`
`pmol/L.
`
`Claims 22-24, 28-29 and 36-45 (renumbered 1-15) are allowed.
`
`Conclusion
`
`Any comments considered necessary by applicant must be submitted no later
`
`than the paymentof the issue fee and, to avoid processing delays, should preferably
`
`accompany the issue fee. Such submissions should be clearly labeled “Comments on
`
`Statement of Reasons for Allowance.”
`
`Anyinquiry concerning this communication or earlier communications from the
`
`examiner should be directed to SAVITHA RAO whosetelephone numberis (571)270-
`
`5315. The examiner can normally be reached on Mon-Fri 7.00 am to 4.00 pm.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Melanie McCormick can be reached at 571-272-8037. The fax phone
`
`numberfor the organization wherethis application or proceeding is assignedis 571-
`
`273-8300.
`
`Page 7 of 8
`
`Page 7 of 8
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`
`
`Application/Control Number: 14/958 ,259
`Art Unit: 1621
`
`Page 4
`
`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.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`USPTO Customer Service Representative or access to the automatedinformation
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`
`/SAVITHA RAO/
`
`Primary Examiner, Art Unit 1621
`
`Page 8 of 8
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`Page 8 of 8
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`