Attorney Docket No. HOR0026—201TC2—US
`
`IN THE UNITED STATES PATENTAND TRADEMARK OFFICE
`
`Applicant:
`
`Bruce Scharschmidt et al.
`
`Title:
`
`METHODS OF THERAPEUTIC MONITORING OF
`NITROGEN SCAVENGING DRUGS
`
`Appl. N0.:
`
`To be assigned
`
`Filing Date:
`
`Herewith
`
`Examiner:
`
`To be assigned
`
`A1“: Unit:
`
`To be assigned
`
`Confirmation To be assigned
`Number:
`
`PRELIMINARY AMENDMENT UNDER 37 CFR I .1 15
`
`Mail Stop Amendment
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`Prior to examination, please amend the application as indicated on the following pages.
`
`This paper contains:
`
`Amendments to the Specification are reflected on page 2 of this document.
`
`Amendments to the Drawings are reflected on page 3 of this document.
`
`Amendments to the Claims are reflected on page 4 of this document.
`
`Remarks/Arguments follow the Amendments to the Claims.
`
`Please amend the application as follows:
`
`-1-
`
`LUPIN EX. 1025
`
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`Attorney Docket No. HOR0026—201TC2—US
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`Amendments to the Specification:
`
`Please amend paragraph [001] as follows:
`
`[0001] The present application is a continuation of U.S. Patent Application 14/816.674. filed
`
`August 3. 2015, which is a continuation of U.S. Patent Application 13/775000. filed February
`
`22, 2013 and now issued as U.S. Patent 9,095,559, which is a continuation
`
`of U.S.
`
`Patent Application No. 13/417,137. filed March 9. 2012, ane1—new pending issued as U.S. Patent
`
`8 404 215, which claims the benefit of U.S. Provisional Application No. 61/564,668, filed
`
`November 29, 2011, and U.S. Provisional Application No. 61/542,100, filed September 30,
`
`2011, the disclosures of which are incorporated by reference herein in their entirety, including
`
`drawing 3.
`
`2 of 238
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`Attorney Docket No. HOR0026—201TC2—US
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`Amendments to the Drawings:
`
`Please replace Figures 1-3 with the accompanying replacement formal drawing sheets for
`
`Figures 1-3.
`
`3 of 238
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`Attorney Docket No. HORO026—20 lTC2—US
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`Amendments to the Claims:
`
`This listing of claims replaces all prior versions and listings of claims in the application:
`
`Listing of Claims:
`
`1.—1 1.
`
`(Cancelled)
`
`12.
`
`(New) A method of treating a subject with a urea cycle disorder, the method comprising:
`
`administering to the subject in need thereof glyceryl tri—[4—phenylbutyrate] in an amount
`
`sufficient to produce a fasting plasma ammonia level that is less than half the upper limit of
`
`normal for plasma ammonia level,
`
`wherein the method further comprises restricting the subject’s dietary protein intake.
`
`13.
`
`(New) The method of claim 12, wherein the upper limit of normal for plasma ammonia
`
`level is 35 umol/L.
`
`14.
`
`(New) The method of claim 12, wherein the glyceryl tri—[4—phenylbutyrate] is
`
`administered orally.
`
`15.
`
`(New) A method of treating a subject with a urea cycle disorder, the method comprising:
`
`administering to the subject in need thereof glyceryl tri—[4—phenylbutyrate] in an amount
`
`sufficient to produce a fasting plasma ammonia level that is less than half the upper limit of
`
`normal for plasma ammonia level,
`
`wherein the method further comprises monitoring the subject’s ammonia levels if the
`
`glyceryl tri—[4—phenylbutyrate] is not being adequately digested by the subject’s pancreatic
`
`lipases.
`
`4 of 238
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`Attorney Docket No. HORO026—20 lTC2—US
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`16.
`
`(New) The method of claim 15, wherein the glyceryl tri—[4—phenylbutyrate] is
`
`administered orally.
`
`17.
`
`(New) A method for adjusting the dosage of glyceryl tri—[4—phenylbutyrate] in a subject
`
`being treated for a urea cycle disorder who has previously been administered an initial dosage of
`
`sodium phenylbutyrate, the method comprising:
`
`administering an initial dosage of glyceryl tri—[4—phenylbutyrate], wherein the initial
`
`dosage is determined by the amount of the initial dosage of sodium phenylbutyrate, and
`
`administering to the subject in need thereof an adjusted dosage of glyceryl tri—[4—
`
`phenylbutyrate], wherein the adjusted dosage of glyceryl tri—[4—phenylbutyrate] is an amount
`
`sufficient to produce a fasting plasma ammonia level that is less than half the upper limit of
`
`normal for plasma ammonia level.
`
`18.
`
`(New) The method of claim 17, wherein the initial dosage of glyceryl tri—[4—
`
`phenylbutyrate] is administered orally.
`
`19.
`
`(New) The method of claim 17, wherein the adjusted dosage of glyceryl tri—[4—
`
`phenylbutyrate] is administered orally.
`
`20.
`
`(New) A method of treating a pediatric subject with a urea cycle disorder, the method
`
`comprising:
`
`administering to the pediatric subject glyceryl tri—[4—phenylbutyrate] in an amount
`
`sufficient to produce a fasting plasma ammonia level that is less than half the upper limit of
`
`normal for plasma ammonia level,
`
`wherein said administration results in an improvement in executive function in the
`
`pediatric subject.
`
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`Attorney Docket No. HOR0026—201TC2—US
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`21.
`
`(New) The method of claim 20, wherein the glyceiyl tri—[4—pheny1butyrate] is
`
`administered orally.
`
`6 of 238
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`Attorney Docket No. HORO026—20 lTC2—US
`
`REMARKS
`
`Applicant respectfully requests that the foregoing amendments be made prior to
`
`examination of the present application. In the specification, the priority paragraph has been
`
`added. In addition, the figures have been replaced with formal drawing sheets. Finally, claims 1-
`
`ll have been cancelled without prejudice or disclaimer. Claims 12-21 have been added. No new
`
`matter has been introduced by those amendments.
`
`Applicant believes that the present application is now in condition for allowance.
`
`Favorable consideration of the application as amended is respectfully requested.
`
`The Examiner is invited to contact the undersigned by telephone or email, if it is felt that
`
`a telephone interview would advance the prosecution of the present application.
`
`Respectfully submitted,
`
`By /Lauren L. STEVENS/
`
`Lauren L. Stevens
`
`Attorney for Applicant
`Registration No. 36,691
`lstevens @ globalpatentgroupcom
`
`7 of 238
`
`

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`Attorney Docket No.: HOR0026—201C1—US
`Sheet 1 of 3
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`Attorney Docket No.: HOR0026—201C1—US
`Sheet 2 of 3
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`9 of 238
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`Attorney Docket No.: HOR0026—201C1—US
`Sheet 3 of 3
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`10 of 238
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`

`

`Attorney Docket No.: HOR0026—201TC2—US
`
`PATENT APPLICATION
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Group Art Unit:
`
`) )
`
`Scharschmidt et al.
`
`To be assigned
`
`) To be assigned
`
`Examiner:
`
`)
`
`) )
`
`) To be assigned
`
`Herewith
`
`Applicant(s)
`
`Serial No.
`
`Filed
`
`:
`
`:
`
`:
`
`Title: METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING
`DRUGS
`
`INFORMATION DISCLOSURE STATEMENT UNDER 37 CFR §1.561
`
`ELECTRONICALLY VIA EFS —WEB
`
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Applicant submits herewith documents for the Examiner's consideration in accordance
`
`with 37 CFR §§1.56, 1.97 and 1.98.
`
`Applicant respectfully requests that each listed document be considered by the Examiner
`
`and be made of record in the present application and that an initialed copy of Form PTO/SB/08
`
`be retumed in accordance with MPEP §609.
`
`Applicant requests that, in accordance with 37 CFR §1.98(d), the Examiner review all
`
`applications relied on for an earlier effective filing date under 35 U.S.C. 120, including
`
`application no. 14/816,674, filed August 3, 2015, application no. 13/775,000, filed February 22,
`
`2013, now U.S. Patent 9,095,559, and application no. 13/417,137, filed March 9, 2012, now U.S.
`
`Patent 8,404,215, for copies of references of record therein that are not being provided here;
`
`11 of 238
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`Attorney Docket No.: HORO026—201TC2—US
`
`although Applicant would be pleased to provide copies of any such documents at the Examiner's
`
`request.
`
`The submission of any document herewith is not an admission that such document
`
`constitutes prior art against the claims of the present application or that such document is
`
`considered material to patentability as defined in 37 CFR §l.56(b). Applicants do not waive any
`
`rights to take any action which would be appropriate to antedate or otherwise remove as a
`
`competent reference any document submitted herewith. Authorization is hereby given to treat
`
`this and any future reply, which requires or might require a petition for an extension of time
`
`under 37 CFR § l.l36(a) for its timely submission or payment of fee, as incorporating a petition
`
`for extension of time for the appropriate length of time and an authorization to pay any required
`
`fees from Deposit Account No. 50-4297.
`
`Respectfully submitted,
`
`By /Lauren L. STEVENS/
`
`Lauren L. Stevens
`
`Attorney for Applicant
`Registration No. 36,691
`(650) 387-3813
`
`12 of 238
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`

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`DOC Code: TRACK1.REQ
`Document Description: TrackOne Request
`
`PTO/AIA/424 (04-14)
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`
`UNDER 37 CFR 1.102(e) (Page 1 of1)
`
`Scharschmldt ‘
`METHODS OF THERAPEUTIC MONITORING OF NITROGEN scAvENGING DRUGS
`APPLICANT HEREBY CERTIFIES THE FOLLOWING AND REQUESTS PRIORITIZED EXAMINATION FOR
`THE ABOVE-IDENTIFIED APPLICATION.
`
`1. The processing fee set forth in 37 CFR 1.17(i)(1) and the prioritized examination fee set forth in
`37 CFR 1.17(c) have been filed with the request. The publication fee requirement is met
`because that fee, set forth in 37 CFR 1.18(d), is Currently $0. The basic filing fee, search fee,
`and examination fee are filed with the request or have been already been paid.
`I understand
`that any required excess Claims fees or application size fee must be paid for the application.
`
`I understand that the application may not Contain, or be amended to Contain, more than four
`independent claims, more than thirty total claims, or any multiple dependent Claims, and that
`any request for an extension of time will cause an outstanding Track I request to be dismissed.
`
`3. The applicable box is Checked below:
`
`Ori
`
`inal A lication Track One - Prioritized Examination under ~ 1.102 e 1
`
`i.
`
`(a) The application is an original nonprovisional utility application filed under 35 U.S.C. 111(a).
`This certification and request is being filed with the utility application via EFS—Web.
`___OR___
`
`(b) The application is an original nonprovisional plant application filed under 35 U.S.C. 111(a).
`This certification and request is being filed with the plant application in paper.
`
`ii. An executed inventor’s oath or declaration under 37 CFR 1.63 or 37 CFR 1.64 for each
`
`inventor, g the application data sheet meeting the conditions specified in 37 CFR 1.53(f)(3)(i) is
`filed with the application.
`
`Re uest for Continued Examination - Prioritized Examination under
`
`A request for Continued examination has been filed with, or prior to, this form.
`If the application is a utility application, this certification and request is being filed via EFS—Web.
`The application is an original nonprovisional utility application filed under 35 U.S.C. 111(a), or is
`a national stage entry under 35 U.S.C. 371.
`. This certification and request is being filed prior to the mailing of a first Office action responsive
`to the request for continued examination.
`No prior request for continued examination has been granted prioritized examination status
`under 37 CFR1.102(e)(2).
`
`'
`
`siqmre/Lauren L. STEVENS/
`
`Name
`Print/T ed
`
`Lauren L. Stevens
`
`Da,e12—3—2O15
`
`F’raC““°“er
`Re istration Number
`
`36691
`
`This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d) for signature requirements and cerfifications.
`Note:
`Submit multile forms if more than one si nature is reuired. *
`
`E *Total of
`
`forms are submitted.
`
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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 with your
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`furnishing of the information solicited is voluntary; and (3) the principal purpose for which the information is used by the
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`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:
`
`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 may
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`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.
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`A record from this system of records may be disclosed, as a routine use, to the Administrator, General
`Services, or his/her designee, during an inspection of records conducted by GSA as part of that agency’s
`responsibility to recommend improvements in records management practices and programs, under authority of
`44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance 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 application, an application open to public inspection or an issued
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`enforcement agency, if the USPTO becomes aware of a violation or potential violation of law or regulation.
`
`14 of 238
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`‘
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`L
`
`DECLARATION (37 CFR 1.63) FQR UETILITY OR DESICN APPLECATIQN US1NG AN
`...«.-....«“...&§..x..i,
`
`APPLECATEGN DATA SHEET (3? CFR 1.76)
`
` ““““““““““ fi§Eii1‘“‘i*i3€E<ii§}éi§§Efii fiE‘i§i3‘i%ii§:i§iiEii*fSiW""““"“‘
`iriwsntirm
`SCAVENGING DRUGS
`‘mu-...~..._.
`
`As. the beicw named inventor, ii hareby declare that:
`
`This deciaratioii E] The attached appiication, or
`is direaztsd to:
`
`United States appiicatioii or PCT intemational application number 13./’775,0U!G
`
`filed on Febmag}g_g_2_;, 2013.
`
`The above-idcntified application was made or authorized to be inade by ma.
`
`I believe that I am the original iniventcr or an originai joint invemm: (if a ciaimsd invention in the
`appiicatimi.
`
`ihereby state thati have B.‘€‘.‘»Vi€W€3d
`including the claims.
`
`and 1.11'i(7ie:%1‘St21l'}.d the contents of the abovenidentified specification,
`
`I am aware of and acknowledge the duty to disciose to the USE Patesnt and Ti‘adeinari<: Gfficé aii
`informaticm known to me to be material to patentabiiity as defined in 37 CPR 1.56.,
`
`Ihereby acknowiedge that any wiiifui faise statanient maids in this declaration is punishable under 18
`UuS.C. 1001 by fine O‘i2‘imipfiSOI1m.@Y1‘iOfnOt1"flOXf3’£i'iaX‘i,fiV’$ (5; years, or both.
`
`::S\ i
`
`LEGAL NAME GE ENVENTQR:
`
`Masamai Makhtarani
`
`f,
`Signature?
`
`-"
`
`Date:
`
`W
`ii
`
`i
`
`. _...» 1’
`
`r’
`?"f7"‘3
`
`’r'f§53;£—8f}03US€33!LEGAL2607733 3 .1
`
`15 of 238
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`DECLARATIGN (37 CFR 1.63} FGR UTELETY OR DESIGN APPLICATEGN USING AN
`AP£PI.7{CATl(}N IDA".E‘A. SHE ET (37 CFR 1.76)
`
`l"Tii§l3Ei"‘"W'Wl"‘17t7ii<i;i‘ii0hS (BF THERAhiiiililiiimillfifil’ilEl?h§ifi§E§§‘l§i3il§fiE§Ei§
`nventiun
`SCAVENGING DRUGS
`
`As the helaw named inventor, {hereby declare that:
`
`This declaration B The attaclied applicatiohg or
`is directed to:
`V
`
`United States epplieatien 01“ PCT iriterhatienal applicaticm number £3/775,600
`
`filed. on Fehruagg 22, 2013.
`
`The al:=eve~ideii’iified application was made or authorized to be made by me.
`
`l believe that I am the original. inventor or an original joint im/ei1tei' of 2; claimed iiwentieii in the
`applicatiim.
`
`I hereby time that I have reviewed and understand the contents (if the ahm/eidentified specification;
`§ it1ehidingth.e claims"
`
`l am aware ofaind acknowledge the duty te disclose to the U33. Paiteht and Tiaileiiiarl; Office all
`ihfmmation known to me to be material to patentability as defined in 37 CPR L56.
`
`l hereby acknowledge that any willful false statement made in this declaration is punishable under 18
`U.S.C. 1901 by fine or impriscmnient ofriot more than five (5) years, 01° both.
`
`LEGAL NAME OF INVEN'.E'0R.:
`
`Briiee Scharschmidt
`
`Slgiiat11re:.«-
`
`79S32n8{)G3.U S03/LEGAL26l}772lS.l
`
`16 of 238
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`i hereby revoke all previeus powers er attorney given in the appiieaticxn identified in either the attached transmittal letter er
`
`.Ofi is pioviéiéifan ieiE?E?6?£§iZ}§2A.;
`iiioi駑“%‘i{é"iSS§;§;‘i§;%§;}?£§é;}E$€iéEEié}}i{iili?iiS}}}ia
`i hereby appoint the Patent Fractitioner(s) associated with the following Customer Number as my/eur ai.torney(s) or egentis), and
`in transact all business in the United States Patent and Trademark Office connected therewith ter the application referenced in
`the attached transmittal ietier (form PTO./AiA/82A) or identified abeve:
`““““““““““““““““““““““““““““““““““““““““““
`QR
`’i 01 325
`H i hereby appoint Prectitioner(s) named
`the attached list (form PTO/AiA/823) as my/our ettorney(s) or agentlsi, and in transact
`ail business in the United States Patent and Traeemark Office cennaeted therewith for the patent appiication referenced in the
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`(Note: Complete ferrn PTO/AiA/82$.)
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`3
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`——j‘ l
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`1 Teieuhcne
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`i am the Applicant (ifihe Applicant is e juristic entity. list the Applicant name in the box):
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`lHQriZOi"l Therapeutics, inc.
`5
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`Electronic Patent Application Fee Transmittal
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`Title of Invention:
`
`METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING
`DRUGS
`
`First Named Inventor/Applicant Name:
`
`Bruce Scharschmidt
`
`Filer:
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`Lauren StevensNicki Truman
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`Attorney Docket Number:
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`HOR0026-201TC2-US
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`280
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`600
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`720
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`4000
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`1
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`1
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`1
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`1311
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`6
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`140
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`Electronic Acknowledgement Receipt
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`24255987
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`Title of Invention:
`
`METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING
`DRUGS
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`First Named Inventor/Applicant Name:
`
`Bruce Scharschmidt
`
`Customer Number:
`
`101325
`
`Filer Authorized By:
`
`Lauren Stevens
`
`Attorney Docket Number:
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`HOR0026—201TC2—US
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`15:52:55
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`20151203_ADS.pdf
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`1819419
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`Document Description
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`Specification
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`Claims
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`Drawings-only black and white line drawings
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`20151203,Pre|iminary,Amend
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`53id378a5l373b:aB45c60df09ee47b7aad
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`Multipart Description/PDF files in .zip description
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`Document Description
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`Start
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`Transmittal Letter
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`232781
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`051':
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`Internet Communications Authorized
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`156713
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`Application Data Sheet 37 CFR 1.76
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`Application Number
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`Title of Invention
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`METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS
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`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
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`Inventor Information:
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`Legal Name
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`1
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`‘
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`Prefix Given Name
`Middle Name
`Family Name
`2— Scharschmidt
`Residence Information (Select One) @ US Residency 0 Non US Residency 0 Active US Military Service
`San Francisco
`StateIProvince
`CA
`country of Residence i
`I US
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`city
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`2
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`Masoud
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`45 St. Francis Boulevard
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`Midd'eName
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`Fam"vName
`Mokhtarani
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`Walnut Creek
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`Address 1
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`Address 2
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`725 Castle Rock Road
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`Walnut Creek
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`I StateIProvince
`City
`I Country i
`I US
`I 94598
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`PTOIAIAI14 (OT-14)
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`Application Data Sheet 37 CFR 1.76
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`HORO026—201TC2-US
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`Title Of Invention
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`METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS
`
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`METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS
`
`Attorney Docket Number HOR0026-201TC2-US
`
`Small Entity Status Claimed
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