626
`
` LUPIN
`EX. 1021
`(Part 6 of 6)
`
`

`
`M S"3'3375'
`
`Total in USD (S)
`
`1806
`
`|
`
`1
`
`l
`
`180
`
`|
`
`Miscellaneous:
`
`Submission- Information Disclosure Stmt
`
`627
`
`627
`
`

`
`PTOlSBlO8a (01-10)
`Doc code: "33
`th
`df
`A
`h 0713112012. OMB 0651-D031
`.
`.
`.
`.
`.
`U_S_ Patent and Traflggzfk O‘;E::eUg‘_"E,‘EPARTMENT OF COMMERCE
`Doc description: Information Disclosure Statement (IDS) Filed
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Number
`Fiinwate
`
`12350111
`
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Arwni
`
`Examiner Cite
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`Initial
`No
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`Patent Number
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`Kind
`Code1
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`Issue Date
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`Name of Patentee or Applicant Page5’C°|umnS’LineS Where
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`Relevant Passages or Relevant
`of cited Document
`.
`Figures Appear
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`FOREIGN PATENT DOCUMENTS
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`Examiner Cite Foreign Document
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`Code2 |
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`Publication
`Cocle4 Date
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`Name of Patentee or
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`NON-PATENT LITERATURE DOCUMENTS
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`Rem°Ve
`
`Examiner Cite
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`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc), date, pages(s), volume-issue number(s),
`publisher, city and/or country where published.
`
`EFSWeb2.1.1T
`
`628
`
`628
`
`

`
`_
`_
`(Not for submission under 37 CFR 1.99)
`
`Application Number
`
`12350111
`
`Filing Date
`
`2009-01-07
`
`First Named Inventor
`
`Bruce SCHARSCHMIDT
`
`Art Unit
`
`1651
`
`Tiffany Maureen GOUGH
`Attorney Docket Number
`79532.8001.US01
`
`DIAZ, G.A., et al., "Phase 3 Blinded, Randomized, Crossover Comparison of Sodium Phenylbutyrate (NaPBA) and
`Glycerol Phenylbutyrate (GPB): Ammonia (NH3) Control in Adults with Urea Cycle Disorders (UCDs)," Mol. Genet.
`Metab_ 1021276, Society of Inherited Metabolic Disease (SMID) Abstract.
`
`GHABRIL, M., et al., "Glycerol Phenylbutyrate (GPB) Administration in Patients with Cirrhosis and Episodic Hepatic
`Encephalopathy (HE)," accepted for presentation at Digestive Disease Week, 2012.
`
`LEE, B., et al., "Phase 2 Comparison of a Novel Ammonia Scavenging Agent with Sodium Phenylbutyrate in Patients
`with Urea Cycle Disorders: Safety, Pharmacokinetics and Ammonia Control," Mol. Genet. Metab_ 100:221—228 (2010).
`
`L|CHTER—KONECK|, U., et al., "Ammonia Control in Children with Urea Cycle Disorders (UCDs); Phase 2 Comparison
`of Sodium Phenylbutyrate and Glycerol Pheny|butyrate," Mol. Genet. Metab_ 103323-329 (2011).
`
`MCGUIRE, B. M., et al., "Pharmacology and Safety of Glycerol Phenylbutyrate in Healthy Adults and Adults with
`Cirrhosis," Hepatology 51 :2077-2085 (2010).
`
`If you wish to add additional non-patent literature document citation information please click the Add button Add
`
`EXAMINER SIGNATURE
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`‘EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a
`citation if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
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`2 Enter office that issued the document, by the two-letter code (WIPO
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`Standard ST.3). 3 For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document.
`4 Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST.‘l6 if possible.
`5 Applicant is to place a check mark here i
`English language translation is attached.
`
`EFSWeb2.1.1T
`
`629
`
`629
`
`

`
`( Not for submission under 37 CFR 1.99)
`
`79532_8001_US01
`
`Tiffany Maureen GOUGH
`Attorney Docket Number
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate se|ection(s):
`
`CERTIFICATION STATEMENT
`
`|:|
`
`That each item of information contained in the information disclosure statement was first cited in any communication
`from a foreign patent office in a counterpart foreign application not more than three months prior to the filing of the
`information disclosure statement. See 37 CFR 1.9"/'(e)(1).
`
`OR
`
`That no item of information contained in the information disclosure statement was cited in a communication from a
`
`foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification
`after making reasonable inquiry, no item of information contained in the information disclosure statement was known to
`any individual designated in 37’ CFR 1.56(c) more than three months prior to the filing of the information disclosure
`statement. See 37' CFR 1.9"/'(e)(2).
`
`El
`
`:| See attached certification statement.
`
`XI Fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`
`:| None
`
`SIGNATURE
`
`A signature of the applicant or representative is required in accordance with CFR 1.33, 10.18. Please see CFR 1.4(d) for the
`form of the signature.
`
`Signature
`
`{Patrick D. Morris!
`
`Date (YYYY-MM-DD)
`
`2012-02-22
`
`Name/Print
`
`Patrick D. Morris
`
`Registration Number
`
`53,351
`
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`FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria,
`VA 22313-1450.
`
`EFSWeb2.1.1T
`
`630
`
`630
`
`

`
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`EFS Web 2.1.17
`
`631
`
`631
`
`

`
`
`
`UNIT]:-‘D S'1‘A'l'l:'S P/\'l‘l:‘N'[‘ AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF‘ ('.TOMM'ERCl'-I
`United States Patent and Tradcniark Ofliec
`Addres-a: (I()MM|SS|()N]‘.R I"()R 1’A'I'|iN'l'S
`P.(). Iiurx I450
`Alcxmidria. Virginia .'.‘.‘-3l3- I450
`www_11spIo._2m-
`
`;\|’|’l.I(.‘/\'I‘I()N N0.
`
`|"||.I!\'(i ])r\'|'I".
`
`1-'|RS'|' NAMILI) INN-'|iN'|'()R
`
`;\'I'I‘()RN|iY ])()t"K|'L'I' N0.
`
`(T()N1"|R!\-'Ix\'l'|().“€ N0.
`
`121350.11 I
`
`UIIUTIZUD9
`
`Bruutc SCIIARSCIIMIUI‘
`
`643982DO[JlU(J
`
`6290
`
`EEEKINS co1F“i". p
`
`Sl:lA'l'l‘Ll:', WA 931 1 I -I 208
`
`GOUGII. TIFFANY MAUREEN
`ART lJN|'l'
`l’A1’]'IR Nl.‘-MBER
`
`I65]
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`0.’-!23.I'2UI 2
`
`I_'Il-L".C'l'I{ON [C
`
`Please find below andfor attached an Office communication concerning this application or proceeding.
`
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`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e-mail address(es):
`
`palcnlprocurcmcnl @ perkiI1scoic.c0m
`
`PTOI.—9'0A (Rev. 0-H0?)
`
`632
`2
`
`

`
`_
`_
`Advisory Action
`Before the Filing of an Appeai Brief
`
`Application No.
`12/350,111
`Examiner
`TIFFANY GOUGH
`
`Applicant(s)
`SCHARSCHMIDT, BRUCE
`
`--The MAILING DATE of this communication appears on the cover sheet with the correspondence address --
`THE REPLY FILED 21 February 2012 FAILS TO PLACE THIS APPLICATION IN CONDITION FOFI ALLOWANCE.
`NO NOTICE OF APPEAL FILED
`
`1. E The reply was filed after a final rejection. No Notice of Appeal has been filed. To avoid abandonment of this application, applicant must timely file
`one of the following replies: (1) an amendment, affidavit, or other evidence, which places the application in condition for allowance;
`(2) a Notice of Appeal (with appeal fee) in compliance with 37 CFR 41.31: or (3) a Request for Continued Examination {ROE} in compliance with
`3? CFFI 1.114 if this is a utility or plant application. Note that FtCEs are not pennitted in design applications. The reply must be filed within one of
`the following time periods:
`a} E The period for reply expires 1months from the mailing date of the final rejection.
`b) D The period for reply expires on: (1) the mailing date of this Advisory Action: or (2) the date set forth in the final rejection, whichever is later.
`In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of the final rejection.
`c} D A prior Advisory Action was mailed more than 3 months after the mailing date of the final rejection in response to a first after—final reply filed
`within 2 months of the mailing date of the final rejection. The current period for reply expires
`months from the mailing date of
`the prior Advisory Action or SIX MONTHS from the mailing date of the final rejection, whichever is earlier.
`Examiner Note: If box 1 is checked, check either box (at, (b) or (c). ONLY CHECK BOX (bl WHEN THIS ADVISORY ACTION IS THE
`FIRST RESPONSE TO APPL|CANT’S FIRST AFTER-FINAL REPLY WHICH WAS FILED WITHIN TWO MONTHS OF THE FINAL
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`NOTICE OF APPEAL
`
`. A brief in compliance with 37 CFFI 41.37 must be filed within two months of the date of filing the
`2. I] The Notice of Appeal was filed on
`Notice of Appeal (3? CFFI 41 .37(a)). or any extension thereof (3? CFFI 41 .3?(e)), to avoid dismissal of the appeal. Since a Notice of
`Appeal has been filed, any reply must be filed within the time period set forth in 3? CFR 41 .3?( }.
`AMENDMENTS
`
`3. E The proposed amendments filed after a final rejection, but prior to the date of filing a brief, will n_ot be entered because
`a) E They raise new issues that would require further consideration andior search (see NOTE below);
`b) D They raise the issue of new matter (see NOTE below);
`c} D They are not deemed to place the application in better form for appeal by materially reducing or simplifying the issues for
`appeal: andior
`d) El They present additional claims without canceling a corresponding number of finally rejected claims.
`NOTE:
`. (See 37 CFR 1.116 and 41 .33( I).
`4. E] The amendments are not in compliance with 3? CFR 1.121. See attached Notice of Non-Compliant Amendment (PTOL-324).
`5. El Applicant's reply has overcome the following rejection(s): j
`6. E] Newly proposed or amended claims) _ would be allowable it submitted in a separate, timely filed amendment canceling the non-
`allowable claimisj.
`7. X For purposes of appeal, the proposed amendmentisjt (a) B will not be entered. or (b) [I will be entered, and an explanation of how the
`new or amended claims would be rejected is provided below or appended.
`AFFIDAVIT OR OTHER EVIDENCE
`
`8. E The affidavit or other evidence filed after final action, but before or on the date of filing a Notice of Appeal will n_ot be entered because
`applicant failed to provide a showing of good and sufficient reasons why the affidavit or other evidence is necessary and was not earlier
`presented. See 37 CFFI 1.116[e).
`9. CI The affidavit or other evidence filed after the date of filing the Notice of Appeal. but prior to the date of filing a brief, will n_ot be entered
`because the affidavit or other evidence failed to overcome a_H rejections under appeal andior appellant fails to provide a showing of good
`and sufficient reasons why it is necessary and was not earlier presented. See 3? CFR 41 .33(d)(1).
`10. El The affidavit or other evidence is entered. An explanation of the status of the claims after entry is below or attached.
`REQUEST FOR FIECONSIDEFIATIONIOTHEFI
`
`1 1. E The request for reconsideration has been considered but does NOT place the application in condition for allowance because:
`See Continuation Sheet.
`
`12. El Note the attached Information Disclosure Statementisj. [PTOiSB.r‘08j Paper No( ).
`13. El Other:
`.
`TATUS OF CLAIMS
`
`14. The status of the c|aim(s) is (or will be) as follows:
`C|aim(s) allowed:
`.
`C|aim(s) objected to:
`Claim(s} rejected: 1,2,4,6-8.11.30-35.3?-39, 41-45.
`Claimis) withdrawn from consideration:
`
`US. Patent and Trademark Office
`PTOL-303 (Rev. 09-2010)
`
`Advisory Action Before t
`
`633
`
`ing of an Appeal Briet
`
`Pan of Paper No. 20120319
`
`iRuth A. Davis’
`
`Primary Examiner, Art Unit 1651
`
`

`
`Continuation Sheet (PTOL-303)
`
`Application No. 12!350,1 11
`
`Continuation of 11. does NOT place the application in condition for allowance because: Applicants claim amendments , particularly claims
`1, 6, 7. 8 and 38 require further search and consideration as the new claim amendments have not been previously considered. The claim
`amendments significantly alter applicants previously claimed invention. While applicants affidavit and other evidence has been considered,
`the newly claimed invention requires a new search and consideration.
`
`634
`
`634
`
`

`
`DO NOT ~'.NT «IR
`
`/ TMG Examiner lx§a§ri1e/y D1-ct. No. 79532.8(}{)l.US{)l
`3 / 1 9 / 2 O 1 2
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re the Application of:
`
`SCHARSCHMIDT, Bruce
`
`Serial No.: l2.’350,lll
`
`Filed: January 7, 2009
`
`F01’:
`
`Examiner: GOUGH, Tiffany Maureen
`
`Group Art Unit: 1651
`
`Docket No.: 795328001 .US0l
`
`I hereby certify that [his correspondence [along with any referred
`to as being altached or enclosnidl is being deposited wilh the
`US. Palenl and Trademark (_)”-[IE6 this 2 I sl day of Fehmary
`2011 via L-Ll-S—Wcb ]_-Llcctronic 1-'iling.
`
`."(follccn Kirchner!
`Cullccn Kirchncr
`
`AMENDMENT AND RESPONSE
`
`Mail Stop Amendment
`Commissioner fo1' Patents
`
`P.0. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`The following is in response to the Final Office Action mailed November 18, 2011
`
`for the above-identified application.
`
`Amendments to the claims begin on page 2.
`
`Remarks begin on page 6.
`
`Conclusion begins on page 16.
`
`99999—0396fl.EGAl 2'."-1.350493 _l
`
`635
`6 3 5
`
`

`
`Electronic Acknowledgement Receipt
`
`Application Number:
`
`12350111
`
`International Application Number:
`
`Confirmation N um ber:
`
`Title of Invention:
`
`METHODS OF TREATMENT USING AMMONIA-SCAVENGING DRUGS
`
`First Named |nventor!Applicant Name:
`
`Bruce SCHARSCHNIIDT
`
`Customer Number:
`
`34055
`
`Filer:
`
`Patrick D. Morris/Colleen Kirchner
`
`Filer Authorized By:
`
`Patrick D. Morris
`
`Attorney Docket Number:
`
`643982000100
`
`Receipt Date:
`
`11—APR—201 2
`
`Filing Date:
`
`07-JAN-2009
`
`Time Stamp:
`
`13:15:51
`
`Application Type:
`
`Utility under 35 USC 111(a]
`
`Payment information:
`
`Submitted with Payment
`
`yes
`
`Payment Type
`
`Deposit Accou nt
`
`10338 Deposit Accou nt
`
`Payment was successfully received in RAM
`
`5745
`
`RAM confirmation Number
`
`502586
`
`Authorized User
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`Charge any Additional Fees required under 37 C.F.Fi. Section 1.17 [Patent application and reexamination processing fees)
`
`Charge any Additional Fees required under 37 CFR. Section6.36lMiscel|aneous fees and charges]
`
`636
`
`

`
`File Listing:
`
`Document
`Number
`
`Warnings:
`
`Info rmation:
`
`Warnings:
`
`Info rmation:
`
`Warnings:
`
`Info rmation:
`
`Warnings:
`
`Info rmation:
`
`Document Description
`
`File Name
`
`Miscellaneous Incoming Letter
`
`SEAssertion.pdf
`
`Request for Continued Examination
`[RC E)
`
`File Size(Bytesli'
`Message Digest
`16285
`
`IEKSO 3-! 51 ifIJ'J8(:rII-Ir1LM|?§3c:r1i’tIIt-Ifaflfi
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`62?091
`
`b«I.iJU2d8}' 34113 |L|:.LII.i-L-l‘.l2:_-81'6dL|fu(:aIr_-.1‘.-‘I
`I1-'1I7h
`
`I
`
`Extension of 1"ime
`
`ExtofTime.pdf
`
`lab;-';Il]dli'.!I£l]2LI';‘.i|9i.".€b51.!lt_-dlJci:92lJ1
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`Fee Worksheet [SB06]
`
`fee—info.pdf
`
`b1d12i';n‘)f>-lfJfl.i-'I1‘JL’%!5J2b41¢1r1LJ61l2II‘J|
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`Total Files Size (in bytes]
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`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
`Ifa new application is being filed and the application includes the necessary components for a filing date {see 37 CFR
`1.53{b)-{d} and MPEP 506], a Filing Receipt (37 CFR 1.54] will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date ofthe application.
`
`National Stage of an International Application under 35 U.S.C. 371
`Ifa timely submission to enter the national stage ofan international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT!DO!E0!903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International Application Filed with the USPTO asa Receiving Office
`Ifa new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP1810], a Notification of the International Application Number
`and ofthe International Filing Date (Form PCTi‘RO!105) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`637
`
`637
`
`

`
`Attorney Docket No. 79532.8001.USO1
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of: Bruce SCHARSCHMIDT
`
`Confirmation No.: 6290
`
`Application No.: 12/350,111
`
`Art Unit: 1651
`
`Filed: January 7, 2009
`
`Examiner: Tiffany Maureen
`GOUGH
`
`For: METHODS OF TREATMENT USING
`
`AMMONIA-SCAVENGING DRUGS
`
`PETITION FOR TWO-MONTH EXTENSION OF TIME
`
`Commissioner for Patents
`
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`Applicant petitions for a Two-Month Extension of Time in which to respond to the
`outstanding Final Office Action mailed November 18, 2011, extending the period for
`response to April 19, 2012.
`
`I2
`
`E
`
`IZ
`
`IZ
`
`Fee (37 CFR § 1.17(a) (2)):
`
`E] Small Entity: $280.00.
`
`The Commissioner is hereby authorized to charge the requisite fee to Deposit
`Account No. 50-2586.
`
`Applicant petitions for an additional Extension of Time if necessary for timely
`filing of this petition and enclosures.
`
`Please charge any underpayment for
`Deposit Account No. 50-2586.
`
`timely consideration of
`
`this paper to
`
`Respectfully submitted,
`Perkins Coie LLP
`
`/Patrick D. Morris/
`Patrick D. Morris, Ph.D.
`Registration No. 53,351
`
`Date: April 11, 2012
`
`Correspondence Address:
`Customer No. 34055
`
`Perkins Coie LLP
`Patent — LA
`
`P.O. Box 1208
`
`Seattle, WA 98111-1208
`Phone: (310) 788-9900
`Fax:
`(206) 332-7198
`
`?'9532-3001.US01ILEGAL23363330.1
`
`63 8
`
`638
`
`

`
`PTO.I'SBI'06 (0?-06‘:
`Approved for use through ‘II‘31I200?. OMB 0651-0032
`U.S. Patent and Trademark Office: US. DEPARTMENT OF COMMERCE
`Under the Pa rwork Reduction Act of 1995. no ersons are re uired to res ond to a collection of information unless it dis la 5 a valid OMB control number.
`
`PATENT APPLICATION FEE DETERMINATION FIECOFID
`Substitute for Form PTO—8?'5
`
`Appllcallo” OI D°°l‘el l‘l”ml3e'
`13350.1 T1
`
`l:l"”9 Dale
`01 307112009 D T0 be Mailed
`
`OTHEFI THAN
`
`SMALL ENTITY
`
`APPLICATION AS FILED — PART I
`
`{Column 1)
`
`(
`
`M NUMBER EEED
`3 BASIC FEE
`NyA
`STCFFI 1.163. b_0l' C
`
`NUMBER EXTRA
`NIA
`
`III
`
`sEARcH FEE
`. or mI'
`I
`3? CFR 1.16 K .
`D EXAMINATION FEE
`3?CFR 1.160.
`0 .or 3
`TOTAL CLAIMS
`3? CFR l.l6i
`INDEPENDENT CLAIMS
`3? CFR 1.16 h
`
`DAPPLICATION SEE FEE
`(37 CPR Halslq
`
`NTA
`
`NIIIA
`
`If the specification and drawings exceed 100
`sheets of paper, the application size fee due
`is $250 ($125 for small entity) for each
`additional 50 sheets or fraction thereof. See
`35 U.S.C. 41 a 1 G and 37 CFFI1.16 5.
`
`El MULTIPLE DEPENDENT CLAIM PREsENT (:3? cFR 1.150)}
`' II the GIITBTBTIOQ in COIUl"l'II"I 1
`is I983 than ZQTO. enter "0" in COIIJl"l'II"I 2.
`
`APPLICATION AS AMENDED — PART II
`
`(Column 1‘;
`CLAIMS
`REMAINING
`AFTER
`AMENDMENT
`
`(Column 2)
`HIGHEST
`NUMBER
`PREVIOUSLY
`PAID FOFI
`
`0431132012
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`(Column 3}
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`SMALL ENTITY
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`ADD T ONA
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`
`FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM (3? CFR 1
`
`‘I6[j}]
`
`CLAIMS
`REMAINING
`Al-TIER
`AMENDMENT
`
`(Column 3}
`
`(Column 2)
`HIGHEST
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`PREVIOUSLY
`PAID FOR
`
`ADDITIONAL
`FEE ($}
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`
`AMENDMENT E FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM I3? CFR1 16tj}J
`
`El Application Size Fee (3? CFR 1.16{s‘IJ
`
`* If the entry in column 1 is less than the entry in column 2. write "0" in column 3.
`" If the “Highest Number Previously Paid For" IN THIS sPACE is less than 2:]. enter '20".
`""“ If the “Highest Number Previously Paid Fof' IN THIS SPACE is Iess than 3. enter "3".
`The “Highest Number Previously Paid For" (Total or Independent) is the highest number found in the appropriate box in column 1.
`This collection of information is required by 3? CFR 1.16. 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 3? 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 andlor suggestions for reducing this burden. should be sent to the Chief Information Officer. U.S. Patent and Trademark Office. US.
`Department of Commerce. P.O. Box 1450. Alexandria. VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS
`ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`tfyou need assistance in completing the font}. call t—800—PTO—9t99 and select option 2‘.
`
`Legal Instrument Examiner:
`FLORENCE PMTERSONI
`
`639
`
`639
`
`

`
`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`12350111
`
`07-Jan-2009
`
`Title of Invention:
`
`METHODS OF TREATMENT USING AMMONIA-SCAVENGING DRUGS
`
`First Named lnventormpplicant Name:
`
`Bruce SCHARSCHMIDT
`
`Attorney Docket Number:
`
`643982000100
`
`Filed as Small Entity
`
`Utility under 35 USC 1 1 1(a) Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Su b-Tota I in
`Usms}
`
`Basic Filing:
`
`Miscellaneous-Filing:
`
`Petition:
`
`Patent-Appeals-a nd-Interference:
`
`Po st-Allowa nce-and-Po st-lss uance:
`
`Extension-of-Time:
`
`Extension — 2 months with $0 paid
`
`640
`
`

`
`Miscellaneous:
`
`Requestfor continued examination
`
`1
`
`|
`
`M S"3'3375'
`
`Total in USD (S)
`
`465
`
`|
`
`641
`
`641
`
`

`
`Document code: WFEE
`
`United States Patent and Trademark Office
`Sales Receipt for Accounting Date: 04/13i2012
`
`FPATTEHS
`
`SALE #D0000004 Mailroom Dt:
`01
`FC :2203
`
`04a’11»'2012
`225.00 DA
`
`502586
`
`12350111
`
`642
`
`642
`
`

`
`Docket No.: 79532.8001.USO1
`
`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of: Bruce SCHARSCHMIDT
`
`Confirmation No.: 6290
`
`Application No.: 12f350,111
`
`Art Unit: 1651
`
`Filed: January 7, 2009
`
`Examiner: Tiffany Maureen
`GOUGH
`
`For: METHODS OF TREATMENT USING
`
`AMMONIA-SCAVENGING DRUGS
`
`ASSEHTION OF SMALL ENTITY STATUS 37 C.F.Fl. § 1.27[C)j1[
`
`Commissioner for Patents
`
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`The above-identified patent application was filed as a large entity. Following a
`
`determination under 37 C.F.R §§ 1.27(a) and (f), the undersigned attorney of record
`
`states that the application is now entitled to small entity status due to the assignment of
`
`the application from Ucyclyd Pharma,
`
`Inc.
`
`to Hyperion Therapeutics,
`
`Inc.
`
`The
`
`assignment was recorded on April 9, 2012, at reel 028014, frame 0894.
`
`Respectfully submitted,
`
`Perkins Coie LLP
`
`/Patrick D. Morris/
`Patrick D. Morris, Ph.D.
`
`Registration No. 53,351
`
`Dated: April 11, 2012
`
`Correspondence Address:
`Customer No. 34055
`
`Perkins Coie LLP
`
`Patent — LA
`
`P.O. Box 1208
`
`Seattle, WA 98111-1208
`Telephone: (310) 788-9900
`Facsimile: (206) 332-7198
`
`79532-800] .USflli'L]_".GAL2322l573.l
`
`643
`
`643
`
`

`
`PTOISEIISDEFS (0510?)
`Approved for use through 11i3DI2007. OMB 0651-D031
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`REQUEST FOR CONTINUED EXAMINATION(RCE)TRANSMlTTAL
`(Submitted Only via EFS-Web)
`
`Ap'°"°a“°"
`Number
`
`12/350,111
`
`Fmng
`Date
`
`2009-01-07
`
`E.)°°ket .N”””be'
`(If applicable)
`
`79532.8001.USO1
`
`Art.
`Unit
`
`1651
`
`First Named Bruce Scharschmidt
`Inventor
`
`Examiner
`Name
`
`Tiffany Maureen Gough
`
`This is a Request for Continued Examination (RCE) under 37 CFR 1.1 14 of the above-identified application.
`Request for Continued Examination (RCE) practice under 37 CFR 1.114 does not apply to any utility or plant application filed prior to June 8,
`1995, or to any design application. The Instruction Sheet for this form is located at WWW.USPTO.GOV
`
`SUBMISSION REQUIRED UNDER 37 CFR1.114
`
`Note: If the RCE is proper, any previously filed unentered amendments and amendments enclosed with the RCE will be entered in the order
`in which they were filed unless applicant instructs otherwise. If applicant does not wish to have any previously filed unentered amendment(s)
`entered, applicant must request non—entry of such amendment(s).
`
`Previously submitted. If a final Office action is outstanding, any amendments filed after the final Office action may be considered as a
`submission even if this box is not checked.
`
`I: Consider the arguments in the Appeal Brief or Reply Brief previously filed on
`
`'2 other
`
`Amendment and Response to Final Office Action and Declaration of Bruce Scharschmidt filed February 21, 2011
`
`|:| Enclosed
`
`|: AmendmentlRep|y
`
`|: Information Disclosure Statement (IDS)
`
`|: Affidavit(s)/ Dec|aration(s)
`
`|: Other
`
`El Suspension of action on the above-identified application is requested under 37 CFR 1.103(0) for a period of months
`(Period of suspension shall not exceed 3 months; Fee under 37 CFR 1.17(i) required)
`
`MISCELLANEOUS
`
`|:| Other
`
`The RCE fee under 37 CFR 1.1T(e) is required by 37 CFR 1.114 when the RCE is filed.
`The Director is hereby authorized to charge any underpayment of fees, or credit any overpayments, to
`Deposit Account No
`502585
`
`SIGNATURE OF APPLICANT, ATTORNEY, OR AGENT REQUIRED
`
`FEES
`
`Patent Practitioner Sig nature
`
`|:| Applicant Signature
`
`EFS — Web 2.0.2
`
`644
`
`644
`
`

`
`PTOISEIISDEFS (0510?)
`Approved for use through 11i30i2007. OMB 0651 -0031
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
` /Patrick D. Morris]
`Date (YYYY-MM-DD) 2012-04-11
`
`Name
`
`Patrick D. Morris
`
`Registration Number
`
`53351
`
`Signature of Registered U.S. Patent Practitioner
`
`This collection of information is required by 37 CFR 1.114. 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 1.11 and 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 andior suggestions for
`reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, U.S. Department