501
`
` LUPIN
`EX. 1021
`(Part 5 of 6)
`
`

`
`Substitute for Iorm 1449iPTO
`
`ALTERNATIVE TO PTOISBIOBA.-‘B
`(Based on PTO 08-08 version)
`
`Complete if Known
`
`Application Number
`
`1 2/3501 1 1
`
`January Ta 2009
`Bruce SCHAFISCHMIDT
`1651
`T_ Gough
`Examiner Name
`Attomey Docket Number 6439820001 00
`
`PISCITELLI. S.C. et al. (1995). "Disposition of Phenylbutyrate and its Metabolites,
`Phenylacetete and Phenylacetylglutamine,” J. Ciin. Pharmacoi. 35:368-373.
`PROPST, A. et al. {August 1995]. "Prognosis and Life Expectancy in Chronic Liver Disease,"
`Dig Dis Sci 40(8}:1805-1815. (Abstract Only}.
`RILEY, T.Fl. et al. (November 15, 2001). "Preventive Strategies in Chronic Liver Disease: Part
`II. Cirrhosos,” Am. Fam. Physician 64(10}:1735—1740. [Abstract Only).
`SHIPLE, G.J. et al. (1922). "Synthesis of Amino Acids in Animal Organisms. I. Synthesis oi
`Glycocoll and Glutamine in the Human Organism,“ J. Am. Chem. Soc. 44:618-624.
`SUMMAFI, lvl.L. et al. (October 2008, e—pub. July 17, 2008). "Diagnosis, Symptoms, Frequency
`and Mortality of 260 Patients with Urea Cycle Disorders From a 21 —Year, lvlulticentre Study of
`Acute H - rammonaemic Eisodes,“ Acre Paediatr. 9721420-1425.
`SUMMAR, M. et al. (2007). "Description and Outcomes of 316 Urea Cycle Patients From a 21-
`Year, lvlulticenter Study of Acute Hyperarnmonemic Episodes,“ Abstract, presented at Annuai
`Symposium CCH — Congress Centre Hamburg, September 4-7, 2007, GSSIEM 2007, two
`
`SWEDISH ORPHAN INTERNATIONAL. [January 12, 2007). “Urea Cycle Disorders an
`International Perspective," Poster, Symposium Swedish Orphan International, Barcelona,
`Sain, Januar
`12, 2007, one
`.
`TUCHMAN, M. et al. (2003, e—pub. June 17, 2008). "Cross-Sectional lvlulticenter Study of
`Patients With Urea Cycle Disorders in the United States," Moiec. Genetics Metab. 942397-402
`WATERLOW. J.C. (March 1963}. “The Partition of Nitrogen in the Urine oi Malnourished
`Jamaican Infants," Am. J. of Ciin. Nutrition 12:235-240.
`ZEITLIN, P.L. et al. (July 2002}. "Evidence of CFTFl Function in Cystic Fibrosis After System
`Administration of4—Phen Ibu
`rate," Moi. There
`6 1 2119-126
`
`Examiner
`Signature
`
`Date
`Considered
`
`‘EXAMINER. lnilial ii reielence considered, whether DI not citation is in conformance with MF'EF' B09. Draw line through ciiation if not in conformance and not
`considered.
`Include copy of this form with next communication to applicanl.
`
`'App|icant's unique citation Eignalion number [optional]. ‘Applicant is to place a check mark here it English language Translalion is attached.
`
`pa-1452119
`
`502
`
`502
`
`

`
`PTOr'SBr1}' [10-D8)
`Approved for use Ihrough 09r30r2010. OMB 0651-0032
`U.S. Patenl and Trademark Office; U.S. DEPARTMENT OF COMMEFICE
`Under the P erwork Reduction Act of 1995. no erson are r u uired to re a u nd to a colleclion of information unless il dis la 5 a valid OMB control number
`
`Efledmmmwmm
`awumuo«mcomormmawwmmmmmamar.
`FEE -rnANsM|1-rA|_
`F0’ FY 2009
`I Applicant claims small entity status. See 3? CFFI 1 .2?
`01
`$1-917-00
`
`METHOD OF PAYMENT (check all that apply)
`
`Com lele rfKnown
`
`mough
`1551
`040002000‘ 00
`
`Artur-er Docket Nu
`
`lj Money ()rr‘Ier lj None El (}Iher (please identify J:
`I: (‘heck El Credit (‘ard
`Morrison 8. Foerster LLP
`l
`3: Deposit Account
`Depogfl ,qm,L.mNL.mi,5.;
`03-1952
`gems-.1 mmunluame;
`For the aboveidentilied deposit account, the Director is hereby authorized to: (check all that apply)
`El Charge feels] indicated below
`El Charge Ie-e(s.) indicated below. except for the filing fee
`El Charge any additional lee(s} or underpayments of El credit any overpayments
`tee-(S) under 3? CFFI1.16 and 1.1?
`FEE CALCULATION
`
`1. BASIC FILING, SEARCH, AND EXAMINATION FEES
`FILING FEES
`Small Entity
`are
`I65
`I 10
`I If]
`165
`I If]
`
`A
`Utility
`l)csi_gn
`Plant
`Reissue
`Provisional
`
`Fifi!
`3.'ilJ'
`220
`220
`330
`220
`
`SEAFICH FEES
`Small Entity
`Film
`270
`St]
`I65
`270
`[I
`
`Filil
`540
`I00
`fifill
`540
`[I
`
`2. EXCESS CLAIM FEES
`ee Desc '
`ion
`Each claim over 20 (including Reissues)
`liach independent claim over 3 (including Reissues)
`Multiple dependent claims
`
`Fee ($1
`Extra Claims
`Total Claims
`x 52.00
`0
`'?0°'”F’
`24
`HP = highest number of total claims paid for. if greater than 20.
`
`=
`
`Fee ($)_
`Extra Claims
`lndep. Claims
`=
`x 220.00
`0
`"1091 Hi’
`3
`HP = highest number of independent claims paid for. it greater than 3.
`3. APPLICATION SIZE FEE
`
`Fee Paid §$l
`0.00
`
`Fee Paid (E5)
`0.00
`
`EXAMINATION FEES
`Small Entig
`Filfil :
`I10
`Tit}
`85
`325
`0
`
`Fifi!
`220
`I40
`I70
`650
`fl
`
`Small Entity;
`Fifi)
`26
`I I0
`195
`
`:i-EFEE
`52
`220
`390
`
`Multigle Degndent Claims
`Fee r§1
`Fee Paid rs)
`390_(_)()
`(100
`
`If l.l1e specification and drawings exceed I00 sheets of paper (excluding electronically filed sequence or computer
`listings under 3'1’ (Il"R l.53(e)). the application size fee due is !527() ($135 for small entity) for each additional St]
`sheets or fraction thereof. See 35 U.S.(?. 4l(a)(l)((.i) and 3'? (TIFR I. l6(s).
`Tolal Sheets
`Extra Sheers
`Number of each additional 50 or fraclion lhereol
`(round up to a whole number} x
`
`Fee {$1
`
`Fee Paid [fit
`
`I50 =
`
`— IDCI :
`4. OTHEFI FEE{S)
`Non—| inglish Specification. SI 3t} fee (no small entity discount)
`Deficient Fees Owed ($3,668.00 minus $1 .751.00
`Other (e.g.. [are filing surcharge):
`Previously Paid}:
`
`Fees Paid [$1
`
`$1,917.00
`
`fMade|ine I. Johnston!
`Madeline I. Johnston
`
`tf‘;§g'f;‘a}e';‘,‘;
`
`35,174
`
`Telephone
`Dale
`
`(550) 313-5040
`May 12 2011
`
`pa—1 454795
`
`503
`
`503
`
`

`
`Docket No.: 643982000100
`
`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`Bruce SCHARSCHMIDT
`
`Application No.: 123350,] I l
`
`Confirmation No.: 6290
`
`Filed: January 7, 2009
`
`Art Unit: 1651
`
`For: METHODS OF TREATMENT USING
`AMMON lA—SCA\/ENGING DRUGS
`
`Examiner: T. Gough
`
`NOTIFICATION OF LOSS OF ENTITLEMENT TO SMALL ENTITY STATUS AND
`
`PAYMENT OF DEFICIENCY FEES OWED UNDER 37 CFR 1.2810;
`
`MS Amendment
`
`Commissioner for Patents
`
`P.O. Box 1450
`
`Alexandria, VA 223 13-1450
`
`Dear Sir:
`
`It has come to our attention that a good faith error appears to have been made regarding
`
`the entity status of the above—referenced application and that fee payments were made in error
`
`claiming the small entity discount.
`
`As required unde1' 3? CFR. §l.28(c), to correct these oversights and in order for the
`
`error in payments to be excused, we hereby submit an itemization of all erroneous small entity
`
`payments and the differential fees, together with the deficiency payment.
`
`pa-1454763
`
`504
`
`504
`
`

`
`Application No.: 127350,] 1 1
`
`Docket No.: 643982000100
`
`itemization of all erroneous small entity payments and the differential fees:
`
`Type of Fee
`
`Date Paid
`
`Amount Paid
`
`Current Fee
`
`Based on Small
`
`Entit Status
`
`Based on Large
`Enti t
`
`Deficiency
`Amount Owed
`
`Utility Filing Fee
`
`January 7, 2009
`
`$82.00
`
`Utility Search Fee
`
`January 7, 2009
`
`$270.00
`
`Utility
`
`January 7, 2009
`
`$110.00
`
`$330.00
`
`$540.00
`
`$220.00
`
`$248.00
`
`$270.00
`
`$110.00
`
`Examination Fee
`
`Claims in Excess
`
`January 7, 2009
`
`$234.00
`
`$468.00
`
`$234.00
`
`of 20 (9)
`
`Independent
`
`Januaiy 7, 2009
`
`$990.00
`
`$1 ,980.00
`
`$990.00
`
`Claims in Excess
`
`of 3 (9)
`
`Late Oath or
`
`February 24, 2009
`
`$65.00
`
`$130.00
`
`$65.00
`
`Declaration Fee
`
`Total of Fees
`
`$1,751.00
`
`$3,668.00
`
`$1,917.00
`
`Based upon the above, Applicants believe the total deficiency amount owed to be $1,917.00.
`
`Enclosed herewith is a Fee Transmittal for the purpose of charging the deficiency amount to our
`
`deposit account in the total amount of $1,917.00.
`
`pa-1454763
`
`505
`
`505
`
`

`
`Application No.: l2:"350,l 1 l
`
`3
`
`Docket No.: 643982000100
`
`In the unlikely event that the transmittal letter is separated from this document and the
`
`Patent Office determines that an extension andfor other relief is required, applicant petitions for any
`
`required relief including extensions oftime and authorizes the Commissioner to charge the cost of
`
`such petitions andfor other fees due in connection with the filing of this document to figit
`
`Account No. 03-1952 referencing docket no. 643982000100.
`
`Dated: May 12, 2011
`
`Respectfully submitted,
`
`Electronic signature: J'Madeline I. Johnstoni
`Madeline I. Johnston
`
`Registration No.: 36,174
`MORRISON & FOERSTER LLP
`
`755 Page Mill Road
`Palo Alto, California 94304-1018
`
`(650) 813-5840
`
`pa-1454763
`
`506
`
`506
`
`

`
`Docket No.: 643982000100
`
`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`Bruce SCHARSCHMIDT
`
`Application No.: 123350,] I l
`
`Confirmation No.: 6290
`
`Filed: January 7, 2009
`
`Art Unit: 1651
`
`For: METHODS OF TREATMENT USING
`AMMON lA—SCA\/ENGING DRUGS
`
`Examiner: T. Gough
`
`PETITION TO MAKE SPECIAL
`
`UNDER 37 CFR l.l02(C[§'l} - APPLICANT'S AGE
`
`MS Amendment
`
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`Submitted herewith is a Petition to Make Special the above-identified patent application
`
`on account of Applicant’s age. Applicant is over 65 years of age.
`
`Accordingly, Applicant requests that this Petition to Make Special be granted and the
`
`application undergo accelerated examination.
`
`pa-1459560
`
`507
`
`507
`
`

`
`Application No.: l2:"350,l 1 l
`
`2
`
`Docket No.: 643982000100
`
`It is Applicants’ understanding that the above—referenced application for patent has not
`
`yet been examined by an Examiner at the United States Patent and Trademark Office (USPTO).
`
`Accordingly, Applicant submits this Petition to Make Special under MPEP § 703.02 IV. No Fee is
`
`due, see 37 CFR §l.102(G).
`
`However, if it is determined that fees are due, the Director is hereby authorized to charge
`
`any deficiency in the fees filed, asserted to be filed or which should have been filed herewith (or
`
`with any paper hereafter filed in this application by this firm) to our Deposit Account No. 03-1952
`
`under Attomey Docket No. 643982000100.
`
`Dated: May 12, 201 l
`
`Respectfully submitted,
`
`:"Madeline I. Johnston!
`E—Signature:
`Madeline I. Johnston
`
`Registration No.: 36,174
`MORRISON & FOERSTER LLP
`
`755 Page Mill Road
`Palo Alto, California 94304-1018
`
`(650) 813-5840
`
`pa-1459560
`
`508
`
`508
`
`

`
`Doc code : PET.OP.AGE
`
`PTOIS BII130 (O?-D9}
`Approved ,0, use mmugh .m31,2m2_ OMB c,.55,_ 0031
`Description : Petition to ma ke special based on AgeI'Health
`U5. Patenl and Trademark Office‘. U.5. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required Io tespond to a collection cI1'inlom1alion unless it contains a valid OMB control number
`
`PETITION To MAKE SPECIAL BASED oN AGE FOR ADVANCEMENT or EXAMINATION
`
`UNDER 37 CFR 1.1 o2(c)(1)
`
`Application Information
`
`Application
`Number
`
`12350111
`
`Confirmation
`Number
`
`Filing
`Date
`
`2009411-07
`
`Attorney Docket
`Number (optional)
`
`First Named
`Inventor
`
`643932000100
`
`A|1 Unit
`
`Examiner
`
`T GOUQI1
`
`Bruce SCHARSCHMIDT
`
`Title of Invention
`
`METHODS OF TREATMENT USING AMMON|A—SCAVENG|NG DRUGS
`
`Attention: OI‘-fice of Petitions
`
`An application may be made special for advancement of examination upon filing of a petition showing that the applicant is 6
`years of age, or more. No fee is required with such a petition. See 37 CFR 1.102§cI11 1 and MPEP 708.02 (IV).
`
`APPLICANT HEREBY PETITIONS TO MAKE SPECIAL FOR ADVANCEMENT OF EXAMINATION IN THIS APPLICATION
`
`UNDER 37 CFR 1.102(c)(1) and MPEP 708.02 (IV) ON THE BASIS OF THE APPLICANTS AGE.
`
`A grantable petition requires one of the following items:
`(1) Statement by one named inventor in the application that heI‘she is 65 years of age, or more; or
`(2) Certification by a registered attorneyfagent having evidence such as a birth certificate. passport, driver's license, etc.
`showing one named inventor in the application is 65 years of age, or more.
`
`Name of Inventor who is 65 years of age, or older
`
`A signature of the applicant or representative is required in accordance with 37 CFR 1.33 and 10.18.
`Please see 37 CFR 1.4(d) for the format of the signature.
`
`Select (1) or (2) :
`
`O (1) I am an inventor in this application and I am 65 years of age, or more.
`
`© (2) I am an attorney or agent registered to practice before the Patent and Trademark Office, and I certify that I am in possession of
`evidence, and will retain such in the application file record, showing that the inventor listed above is 65 years of age, or more.
`
`3'
`I
`Igna we
`
`Name
`
`(Madeline I. Johnston!
`
`D I
`(YaY:Y_MM_DD)
`
`2011'05'12
`
`Madeline I. Johnston
`
`Registration
`Number
`
`EFSWeh 1.0.18
`
`509
`
`509
`
`

`
`Docket No.: 643982000100
`
`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`Bruce SCHARSCHMIDT
`
`Application No.: 123350,] I l
`
`Confirmation No.: 6290
`
`Filed: January 7, 2009
`
`Art Unit: 1651
`
`For: METHODS OF TREATMENT USING
`AMMON lA—SCA\/ENGING DRUGS
`
`Examiner: T. Gough
`
`FIRST PRELIMINARY AMENDMENT UNDER 37 C.F.R. 1.115
`
`MS Amendment
`
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`Prior to examination on the merits, Applicant respectfully requests entry of this
`
`Preliminary Amendment for the above-captioned patent application.
`
`Amendments to the Claims a1'e1'eflected in the listing of claims which begins on page 2
`
`of this paper.
`
`Remarksmrguments begin on page 6 of this paper.
`
`pa-1459526
`
`510
`
`510
`
`

`
`Docket No. 643982000100
`
`Patent
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`Bruce SCHARSCHMIDT
`
`Application No.: 12J'350,l1l
`
`Filing Date: January 7, 2009
`
`For: METHODS OF TREATMENT USING
`
`AMMONIA—SCAVENING DRUGS
`
`Examiner: T. Gough
`
`Group Art Unit: 1651
`
`Confirmation No.2 6290
`
`SUPPLEMENTAL INFORMATION DISCLOSURE
`
`STATEMENT UNDER 37 C.F.R. § 1.97 & § 1.98
`
`MS Amendment
`Commissioner for Patents
`
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`Pursuant to 37 C.F.R. §l.97 and § 1.93, Applicant submits for consideration in the
`
`above—identified application the documents listed on the attached Form PTO/SB:"03afb. Copies of
`
`foreign documents and non—patent literature are submitted herewith. The Examiner is requested to
`
`make these documents of record.
`
`This Supplemental Information Disclosure Statement is submitted:
`
`El
`
`El
`
`With the application; accordingly, no fee or separate requirements are required.
`
`Before the mailing of a first Office Action after the filing of a Request for Continued
`
`Examination unde1' 37 C.F.R. § 1.114. However, if applicable, a certification under 37
`
`CFR. § L97 (e)(l) has been provided.
`
`pa-1462999
`
`511
`
`511
`
`

`
`Application No. 123350,] 1 1
`
`Patent
`Docket No. 643982000100
`
`IE
`
`Within three months of the application filing date or before mailing of a first Office Action
`
`on the merits; accordingly, no fee or separate requirements are required.
`
`
`
`D After receipt of a first Office Action on the merits but before mailing of a final Office Action
`
`or Notice of Allowance.
`
`E]
`
`A fee is required. Accordingly, a Fee Transmittal Form (PTOISB/17) is attached to
`
`this submission.
`
`E]
`
`A Certification under 37 C.F.R. § l.97('e) is provided above; accordingly; no fee is
`
`believed to be due.
`
`D After mailing ofa final Office Action or Notice of Allowance, but before payment of the
`
`Issue Fee.
`
`I:]
`
`A Certification under 37 CFR. § l.97(e) is provided above and a Fee Transmittal
`
`Form ("PTO/SBII7’) is attached to this submission.
`
`Applicant would appreciate the Examiner initialing and returning the Form
`
`PTO:’SB;’08aJ'b, indicating that the information has been considered and made of record herein.
`
`The information contained in this Supplemental Info1'mation Disclosure Statement under
`
`37 C.F.R. § 1.9’? and § 1.98 is not to be construed as a representation that:
`
`(i) a complete search has
`
`been made; (ii) additional information material to the examination of this application does not exist;
`
`(iii) the information, protocols, results and the like reported by third parties are accurate or enabling;
`
`or (iv) the above information constitutes prior art to the subject invention.
`
`In the unlikely event that the transmittal form is separated from this document and the
`
`Patent and Trademark Office determines that an extension andfor other relief (such as payment of a
`
`fee under 37 C.F.R. § 1.17 (p)) is required, Applicant petitions for‘ any required relief including
`
`extensions of time and authorizes the Commissioner to charge the cost of such petition andfor other
`
`pa-1462999
`
`2
`
`512
`
`512
`
`

`
`Application No. 123350,] 1 1
`
`Patent
`Docket No. 643982000100
`
`fees due in connection with the filing of this document to Degosit Account No. 03-1952
`
`referencing 643982000100.
`
`Dated: May 12, 2011
`
`Respectfully submitted,
`
`Electronic Signature: r'Madeline I. Johnstom’
`Madeline I. Johnston
`
`Registration No.: 36,174
`MORRISON & FOERSTER LLP
`
`755 Page Mill Road
`Palo Alto, California 94304-1018
`
`(650) 813-5840
`
`pa-1462999
`
`3
`
`513
`
`513
`
`

`
`PTOISBIQI (0?-09)
`Approved lor use through 0?i‘3l.'2012. OMB 0651-0031
`US. Patent and Trademark Otlice: US. DEPARTMENT OF COMMERCE
`Underlhe P n - rwork Reduction Act ot1£-395. no I rsons are - n uired to res end to a collection of information unless it dis la a valid OMB control number.
`
`TRANSMITTAL
`FORM
`
`(to be used for all correspondence afterrnitral fling}
`
`Art Unit
`Examiner Name
`
`1651
`
`T. Gough
`
`Total Number ol Pages in This Submission
`
`Attorney Docket Number
`
`643982000100
`
`ENC LOSU RES (Check all that apply)
`
`Fee Transmittal Form (1 page)
`
`El Drawinglsl
`
`|:| Fee Attached
`
`|:| |Jcensing—re|ated Papers
`
`AmendmenURep|y (Preliminary,
`6 pages]
`
`Petition (Petition to Make Special
`Under 37 CFR 1_1o2(c)(1)-
`X Applicants Age and Form
`PTOISB-l130__ 3 pages)
`
`;:fl1‘_i(':A"°wa"C9 Communication
`
`Appeal Communication to Board
`ol Appeals and lnterterences
`
`Appeal c'°'i1m”ni.Cafi°n to T9
`i"”“""' ”°"“’* 3"“ "9"" “"9”
`
`El After Final
`
`Pemi_°_" to C°'""""_9" t_° 3
`Provisional Application
`
`|:| Proprietary lnlormation
`
`|:| Allidavitsi'dec|aration(s) mess |:| Status Letter
`
`|:| Extension ol Time Request
`
`|:| Terminal Disclaimer
`
`|:| Express Abandonment Request
`Inlormation Disclosure Statement
`(Supplemental. 3 pages)
`
`lj Request lor Relund
`
`l:l CD’ Number 0' CUE’)
`
`‘|:$:1‘tii'fyEt:"‘;:i':‘:;':'9lSl (please
`
`Phase 53° “Remarks” secuon‘
`
`Certilied Copy or Priority
`Documentlsj
`
`Reply to Missing Parts)’
`Incomplete Application
`
`Reply 10 Missing pans unde,
`37 CFR 152 or1_53
`
`:| Landscape Table on CD
`
`| H
`
`k
`emar 5
`
`|
`
`‘Notification of Loss of Entitlement to Small Entity Status and Payment of Deliciency
`Fees Owed Under 3? CFR 128(0) (3 pages)
`‘Supplemental Application Data Sheet (3 pages)
`‘Form PTOISBIOBAIB [4 pages}
`‘Fifty nine (59) relerences
`
`SIGNATURE OF APPLICANT, ATTORNEY, OR AGENT
`
`F""‘ “am
`Signature
`
`MORRISON 81 FOERSTER LLP (Customer No. 25226)
`
`{Madeline I. Johnston!
`
`Printed name Madeline I. Johnston
`
`MW-2°“
`
`SW
`
`pa—1 454793
`
`5 14
`
`514
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Commissioner for Patents
`United States Patent and Trademark Office
`PO. Box 1450
`Alexandria. VA 22313-1450
`M-vw.uapfo.gov
`
`MORRISON & FOERSTER LLP
`1253] HIGH BLUFF DRIVE
`SUITE 100
`SAN DIEGO CA 92130-2040
`
`In re Application of
`
`SCI-IARSCHMIDT, Bruce
`Application No.
`l2i'350,l I
`Filed: January 0?, 2009
`Attorney Docket No. 643982000100
`
`I
`
`MAY 2 4 2011
`OFFICE OF PETITIONS
`
`I
`
`:
`:
`:
`:
`
`DECISION ON PETITION
`TO MAKE SPECIAL UNDER
`3? CFR l.l02(c)(l)
`
`This is a decision on the petition under Ti" CFR l.l02(c)(l), filed May 12, 2011, to make the above-_
`identified application special based on applicant’s age as set forth in M.P.E.P. § 708.02, Section IV.
`
`The petition is GRANTED.
`
`A grantable petition to make an application special under 37 CFR l .l02(c)( 1) and MPEP § 'i'08.02,
`Section IV: Applicant’s Age rnustbe accompanied by evidence showing that at least one of the applicants
`is 65 years of age, or more, such as a birth certificate or a statement by applicant. No fee is required
`
`The instant petition includes a statement by Bruce Scharschmidt attesting to his age. Accordingly, the
`above-identified application will be accorded “special" status.
`
`Telephone inquiries concerning this decision should be directed to Tredelle Jackson at 571-272-2?83.
`
`All other inquiries concerning either the examination or status of the application should be directed to the
`Technology Center.
`
`The application is being forwarded to the Technology Center Art Unit I651 for action on the
`merits commensurate ‘with this decision.
`'
`
`!Tredellc D. Jackson!
`
`Paralegal Specialist
`Office of Petitions
`
`515
`
`515
`
`

`
`Page 1 of 1
`
`UNITF.I) STAT!-"S DFIP.-\RTM'ENT OF COM’.-“ERCE
`United States Patent and 'I'radc-Inark 0fi'|cr:
`Addnsssz (.‘()MMISSI()NliR I-"OR 1:5-’\'I'|iN'|'S
`P.0. B
`[-150
`Alexa:
`'0, \-‘it;-:.ini:1 22311‘-I-I50
`www.ii:ipIn.gm'
`
`CONFIRMATION NO. 6290
`
`NO.
`643982000100
`
`
`
`UNl'l‘l:‘D S'l‘A'l‘l:‘S P/\'l‘];'N'I‘ AND TRADEMARK Ol~'l~‘1C]:'
`
`BIB DATA SHEET
`
`SERIAL NUMBER
`
`12850.11 1
`
`FILING or 371(9)
`DATE
`01 r07r2009
`
`RULE
`
`APPLICANTS
`Bruce SCHARSCHMIDT, South San Francisco, CA;
`
`iddltttiflililililiiiitieieieieiliit
`
`This appln claims benefit of 613093234 08!29f2008
`and claims benefit of 61i’048,830 04i’29i'2008
`
`Iiiiitttttiiiiitttttiiiii
`
`it
`
`it
`
`“‘ IF REQUIRED, FOREIGN FILING LICENSE GRANTED ** ” SMALL ENTITY ”
`01 I21 E2009
`
`Allowance
`D Metafier
`
`COUNTRY
`
`DRAWINGS
`
`nilials
`
`CA
`
`‘I5
`
`CLAIMS
`
`12
`
`D Yes END
`Foreign Priority claimed
`35 USC 119(a—d‘1 conditions met D Yes D No
`Verified and
`‘TIFFANY MAUREEN
`BOUGHJII
`Examiners Signafure
`
`Ac|mow|edged
`ADDRESS
`
`MORRISON 8: FOERSTER LLP
`12531 HIGH BLUFF DRIVE
`SUITE 100
`
`SAN DIEGO, CA 92130-2040
`UNITED STATES
`
`TITLE
`
`METHODS OF TREATMENT USING AMMONIA-SCAVENGING DRUGS
`
`ID All Fees
`I
`FILING FEE FEES: Authority has been given in Paper |1'16 Fees (Filing)
`RECEIVED NO.
`to chargefcredit DEPOSIT ACCOUNT
`ID 1'17 Fees (Processing Ext‘ 01 time) I
`.
`for following:
`ID 1.18 Fees (Issue)
`I
`ID Other
`I
`ID Credit
`I
`
`EIIB (Rev. 05:07]
`
`516
`
`516
`
`

`
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`
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`
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`
`EAST Search History (Interference)
`
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`
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`
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`
`518
`
`518
`
`

`
`Substitute for form 1 «MQEPTO
`
`Complete if Known
`
`12350111 - C3/3iU:1651
`
`ALTERNATIVE TO PTOISEJBSA.-‘B
`(Based on PTO 06-08 version)
`
`Application Number
`
`12,I'35O,1 1 1
`January 7. 2009
`Bruce SCHAFISCHIVIIDT
`
`Not Yet Assigned
`Examiner Name
`Attomey Docket Number 643982000100
`
`U.S. PATENT DOCUMENTS
`.
`.
`Pubhcamn Dale
`MM-DD-Y‘I'YY
`
`Name °t Patentee 9'
`Applicant of Cited Document
`
`Pages, Columns. Lines, Where
`Relevant Passages or Relevant
`Fig was Appear
`
`
`
`FOREIGN PATENT DOCUMENTS
`Publication
`'
`Dene
`Fomlgn Patent Document
`Country Code’-Number‘-Kind Codei’ rrrrcnoum) MM.D[p,«wy
`
`Name of Patentee or
`Applicant 01 Cited Dofiumenl
`
`Examiner
`Initials‘
`
`No.‘
`
`,
`L
`, C I
`P
`wh§:5Re|:V:TnnE',‘a5:1:;’es
`Or Relevant Figures Appear
`
`Examiner
`Si I nature
`
`Date
`Considered
`
`‘EXAMINER: Initial if information considered, whether or not citation is in conformance with MPEP 609. Draw line through citation ll not in conformance and i1o1
`considered.
`Include copy of this form with next communication to applicant.
`' Applicants unique citation designation number [optional].
`2' See Kinds Codes of
`USPTO Patent Documents at v\ru\rw.usmo.gov or MPEP 901.04.
`3 Enter Office that issued the document. by the two-letter code IWIPO Standard ST.3l.
`4 For
`Japanese patent documents the indication of the year of the reign of the Emperor must precede the serial number of the patent document. “ Kind of document by
`the appropriate symbols as indicated on the document under WIPO Standard ST. 16 if possible. afitpplicant is to place a check mark here if English language
`Translation is attached.
`
`NON PATENT LHEFIATUFIE DOCUMENTS
`
`Include name of the author [in CAPITAL LETTERS]. title oi the article [when appropriate}. title of
`the item (book. magazine, journal. serial, symposium. catalog. etc.}. date. page(s). volurne—issue
`nun'iber(§}, publisher, city andfor country where published.
`MACARTHUFI et al. (2004). Molecular Genetics and Metabolism 81 (1 12867-873
`SIMMELL et at. 1936 . Pediatric Research 20 11 :1117-1121
`TANNER et al. 2007 . Journal of Inherited Metabolic Disease 30 5 2716-721
`
`International Search Report and Written Opinion for PCTfUS2009l055256, mailed 30
`
`December 2009, 13 an es ianvG0=-=9hr‘
`
`email
`‘EXAMINER. Initial it reference considered, whether or not citation is in i::onfon1'iance with MPEP 609. Draw line through citalion it not in conformance and not
`considered.
`Include copy of this form with next communication to applicant.
`
`’Applicant's unique citation designation number {optional}. 7App|icanl is to place a check marl: here it English language Translation is attached.
`
`sd-511516
`519
`ALL REFERENCES CONStDEEtE} EXCEPT WHERE UNED TH ROUGH.
`
`/TGr"
`
`

`
`12350111 - C3/3iU:1651
`
`ALTERNATIVE TO PTOISEJBSA.-‘B
`(Based on PTO 06-08 version)
`
`Substitute for form 1 «MQEPTO
`
`Complete if Known
`
`Application Number
`
`12,I'35O,1 1 1
`
`INFORMATION DISCLOSURE
`STATEMENT BY App|_|cAN'r—
`
`(Use as many sheets as necessary)
`
`Not Yet Assigned
`Examine, Name
`Attomey Docket Number 643982000100
`
`U.S. PATENT DOCUMENTS
`
`Publicafion Dale
`DOCUn1ent Number
`Number.Ki.1d cgde’ frrgnmm) MM-DD-Y‘I'YY
`
`Name °l Palentee 9'
`Applicant of Cited Document
`
`Pages. Columns. Lines, Where
`Relevant Passa
`or Relevant
`Figums?-fspear
`
`FOREIGN PATENT DOCUMENTS
`
`Examiner
`
`'
`
`Fore‘ n Patent Document
`C m Cody.”
`be ‘.K' dead "(,3
`0” 7}’
`krl;'o'':m)'
`'"
`9
`WO—2005i'053607
`WO—2009i'0874'/'4
`
`Publication
`Date
`MM_DD_YYYY
`06i'2005
`07i'2009
`
`Name of Patemee Gr
`—
`.
`Applicant oi Cited Document
`
`Pages. Columns. Unes.
`Where Flelevant Passages
`ornekwam Flgwesfippear
`
`T..-
`
`Examiner
`Si I nature
`
`Date
`Considered
`
`‘EXAMINER: Initial if information considered. whelher or not citalion is in conformance with MPEP 609. Draw line through citalion if not in conformance and not
`considered.
`Include copy of Ihis form with nexl communication to applicant.
`' Applicant's unique cilation designalion number [optional].
`2' See Kinds Codes of
`USPTO Patent Documents at winni\r.usg!o.gov or MPEP 901.04.
`5 Enter Office Ihal Issued the do-i:ument, by Ihe lwo-letter code EWIPO Standard ST.'.3].
`4 For
`Japanese patent documents, the indication of Ihe year of the reign of lhe Emperor must precede Ihe serial number of the patent document. 1' Kind of do-cumenl by
`Ihe appropriate symbols as indicaled on the document under WIPO Slandard ST. 16 if possible. “Applicant is to place a check mark here if English language
`Translation is atlached.
`
`NON PATENT LITERATURE DOCUMENTS
`
`Examiner
`
`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. pageisl. volumeissue
`number(§}, publisher. city andfor country where published.
`Clinica|Tria|s.Gow‘Archi\re View of NCTOD551200 on 200'/_12_11 "Dose—Esca|ation Safety
`Study of Glyceryl Tri (4—Pheny|butyrate){GT4P} to Treat Urea Cycle Disorders" [accessed 5
`October 2009 , 4
`
`COMTE et al.. Journal of Mass Spectrometry (2002) 37{6):581-590
`LEE et al., Journal of Inherited Metabolic Disease (2008) 31(1):91
`Search and Examination Report for British Patent Application No. GB 091554513, dated 8
`
`October 2009, 5 pages E
`
`_,
`-.._
`.=
`'
`om4.-*2o11
`-"T‘i'¢~“‘:"5’~°“9"-’
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`‘EXAMINER: lnilial if reference considered, whether or not citation is in i::onfon1'Iance wilh MPEP 609. Draw line through citalion if not in conformance and not
`considered.
`Include copy of this form with next communication to applicanl.
`
`Dat
`
`'AppIicant's unique cilation designation number {optional}. 2.-fiipplicanl is Io place a check mark here if English language Translation is at1ached.
`
`sd-505679
`520
`ALL REFERENCES COl\iSiDE EXCEPT WHERE Lii\lED TH ROUGH.
`
`/TGI‘
`
`

`
`12350111 - C3/3tU:1651
`
`ALTERNATIVE TO Prorssroamre
`(Based on PTO 08-08 version)
`
`Substitute [or Iorm 1449fF-‘TO
`
`INFORMATION DISCLOSURE
`STATEMENT By App|_|cANT
`
`(Use as many sheets as necessary)
`
`Complete if Known
`
`Application Number
`
`1 2,r"350"I 1 1
`
`F*'r-wire
`
`January I 2009
`
`1614
`Examine, Name
`Not Yet Assigned
`Attorney Docket Number
`
`U.S. PATENT DOCUMENTS
`
`Examiner
`
`Publication Date
`Nu.-nber.Kind code’ rjrrmown) MM-DD-YWY
`U84‘-I,284,6«'-I7
`08I’1981
`
`Name °' Patemee °"
`Applicant of Cited Document
`Brusilow et al.
`
`F’ages,Co|umns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`I
`Examlner
`
`‘
`
`Examiner
`Si a nature
`
`FOREIGN PATENT DOCUMENTS
`
`Name ol Patentee or
`Applicant of Cited Document
`
`Pages, Columns. Lines.
`where Relevam Passages
`or Relevam figures Appear Tr.
`
`Date
`Considered
`
`‘EXAMINER: Initial if information considered. whether or not citation is in conformance with MPEP 609. Draw line through citation it not in coniormance and not
`considered.
`Include copy of this form with next communication to applicant.
`‘ Applicants unique citation designation number (optional). ’See Kinds Codes of
`USPTO Patent Documents at www.uspto.go\r or MPEP 901.04.
`3 Enter Otlice that issued the document, by the two-letter code {WIPO Standard STJ3).
`4 For
`Japanese patent documents. the indication ot the year oi the reign of the Emperor must precede the serial number oi the patent document. ” Kind oi document by
`the appropriate synbols as indicated on the document under WIPO Standard ST. 15 it possible.
`5 Applicant is to place a check mark here it English language
`Translation is attached.
`
`NON PATENT LITERATURE DOCUMENTS
`
`Examiner
`
`Include name of the author (in CAPITAL LEITERS}, title of the article (when appropriate], title of
`
`the item (book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), uolume—issue
`numbertsj, publisher, city andfor country where published.
`International Search Report and Written Opinion for PCTr’US09l30362. mailed 2 March 2009.
`8 on es
`
`T
`
`
`
`Examiner
`
`-
`-
`miiany Gought
`
`Date
`
`:_
`_
`0?? H2011
`
`‘EXAMINER: Initial it reterence considered. whether or not citation is in conformance with MPEF’ 609. Draw line through citation ii not in ooniormanoe and not
`considered.
`Include copy of this ton11 with next communication to applicant.
`
`'AppIicant's unique citation designation number {optional}. “Applicant is to place a check mark here it English language Translation is attached.
`
`d—475082
`ALL REFERENCES COI\IStDE%D EXCEPT WHERE UNED TH ROUGH.
`521
`
`5
`
`/TG_r"
`
`

`
`12350111 - C3/3iU:1651
`
`ALTERNATIVE TO PTOrSBr’0aArB
`(Based on PTO 08-08 version)
`
`Substitute [or term 1449fF-‘TO
`
`Complete if Known
`
`Application Number
`
`1 2,I"350’1 1 1
`
`INFORMATION DISCLOSURE Date
`STATEMENT BY APPLICANT
`
`January 7. 2009
`Bruce S0“AF*SC“M'DT
`
`(Use as many sheets as necessary)
`
`Examine, Name
`Attorney Docket Number
`
`Not Yet Assigned
`
`Examiner
`
`‘
`
`US—5,968,979
`US-208-4l0229948
`
`2 US-2006i0135612
`
`Us-2ooaro119554
`
`4.
`
`U.S- PATENT DOCUMENTS
`
`PUb”C3ii0" Date
`MM'DD'YWY
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`10i1999
`1 12004
`
`06r'2006
`
`05/2003
`
`Brusilow
`Summar et al.
`
`Ferrante
`
`Jalan etal.
`
`FOREIGN PATENT DOCUMENTS
`
`Emminer
`Initials’
`
`Cite
`No.‘
`
`Publication
`(3
`p
`'
`F
`Date
`mag” men‘ ocumem
`Country Code’-Numbei"—Kind code‘ frfknown) MM.o[).yw~r
`
`Name °' Pa“3""3‘3 °’
`*"PP"C3”‘ 0* Wed D°C""‘e”'
`
`.
`. L'
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`wh1‘i§5ne.e.Z.“L‘."F»a5'."§§es
`Or Relevant l-_Igures Appear T‘
`
`21—"I|
`
`Examiner
`Si a nature
`
`Date
`Considered
`
`‘EXAMINER: Initial it inlormation considered. whether or not citation is in conformance with MPEP 6'09. Draw line through citation it not in conformance and not
`considered.
`Include copy of this torm with next communication to applicant.
`‘Applicant's unique citation designation number (optional).
`2 See Ki