251
`
`PAR PHARMACEUTICAL, INC.
`EX. 1021
`(Part 3 of 6)
`
`

`
`W0 200‘);"087-I74
`
`PCT;"lB2U08.='0(|37ti9
`
`-52-
`
`wherein
`
`R‘ represents a carboxyl group, phospate, phosphonate or sulfonate group or
`
`pharmaceutically acceptable salt thereof, cooR5, CONH2, CONR5R°, or an aldehyde,
`
`imine or aoetal protected derivative of said compounds, or a triglyceride moiety
`
`COOCH2(00CR5)CH2(O0CR“) or diglyceride moiety C00CH2(O0C_R5)CH2OH, or an
`
`amino acid group CONHCR"COOH or a salt thereof,
`
`R2“ represents hydrogen, hydroxyl, carbonyl, or a linear or branched substituted or
`
`nonsubstituted saturated or nonsaturated alkyl group with 1 to 10 carbon atoms or
`
`substituted or nonsubstituted aryl group,
`
`R3“ represents hydrogen, hydroxyl, carbonyl. or a linear or branched substituted or
`
`nonsubstituted saturated or nonsaturated alkyl group with 1 to 10 carbon atoms or
`
`substituted or nonsubstituted aryl group, except when R‘ is oarboxyl or a salt thereof R3‘
`
`is not hydrogen,
`
`R‘ represents hydrogen, or a linear or branched substituted or nonsubstituted
`
`saturated or nonsaturated alkyl group with ‘l to '10 carbon atoms or substituted or
`
`nonsubstituted aryl group,
`
`x represents a single, double or triple bond,
`or x-R3‘R“ together represent hydrogen in which case R‘ is COOR5, CONH2,
`
`C0NR5RB, or a triglyceride moiety COOCH2(OOCR5)CH2(OOCRa) or diglyceride moiety
`
`COOCH2(00CR5)CH2OH,
`
`R5 represents a linear or branched substituted or nonsubstituted saturated or
`
`nonsaturated alkyl group with 1 to 10 carbon atoms or substituted or nonsubstituted aryl
`
`group,
`
`R3 represents hydrogen, a linear or branched substituted or nonsubstituted
`
`saturated or nonsaturated alkyl group with 1 to 10 carbon atoms or substituted or
`
`nonsubstituted aryl group, and
`
`R7 represents CH;CHzSCH3, CH;-CH2CH2NHR“, CH;CH2CH2CH2NHR“,
`
`CH2CH2CH2CNHC(=NH)NHR", where R“ is hydrogen or a linear or branched acyl group
`
`10
`
`15
`
`20
`
`25
`
`30
`
`with three to five carbon atoms.
`
`3.
`
`A compound of formula I for use as a medicament for treating, counteracting or
`
`preventing microbial infections in an animal, including humans. by stimulating the innate
`
`antimicrobial peptide defense system
`
`252
`
`252
`
`

`
`W0 2009i'08747-I
`
`PCTi’lB2008i"l)037lJ9
`
`-53-
`
`wherein
`
`R‘ represents a carboxyl group, phospate, phosphonate or sulfonate group or
`
`pharrnaceutically acceptable salt thereof. COOR5, CONHz, C0NR5R°, or an aldehyde,
`
`imine or acetai protected derivative of said compounds, or a triglyceride moiety
`
`CO0CH2(00CR5)CH2(OOCR°) or diglyceride moiety COOCH2(O0CR5)CH2OH, or an
`
`amino acid group CONHCR7COOH or a salt thereof,
`
`R2“ represents hydrogen, hydroxyl, carbonyl, or a linear or branched substituted or
`
`nonsubstituted saturated or nonsaturated atkyl group with 1 to 10 carbon atoms or
`
`substituted or nonsubstituted aryi group,
`
`R3‘ represents hydrogen, hydroxylkcarbonyl, or a linear or branched substituted or
`
`nonsubstituted saturated or nonsaturated alkyl group with 1 to 10 carbon atoms or
`
`substituted or nonsubstituted aryl group, except when R‘ is carboxyl or a salt thereof R3’
`
`is not hydrogen,
`
`R‘ represents hydrogen, or a linear or branched substituted or nonsubstituted
`
`saturated or nonsaturated alkyl group with 1 to 10 carbon atoms or substituted or
`
`nonsubstituted aryl group,
`
`x represents a single, double or triple bond.
`
`or x—R“"‘R“ together represent hydrogen in which case R‘ is COOR5, CONH2,
`
`CONR5R°, or a triglyceride moiety COOCH-2(OOCR"’)CH2(0OCR‘) or diglyceride moiety
`
`COOCHz(OOCR5)CH2OH,
`
`R5 represents a linear or branched substituted or nonsubstituted saturated or
`
`nonsaturated alkyl group with 1 to 10 carbon atoms or substituted or nonsubstituted aryl
`
`QFOUP.
`
`R“ represents hydrogen. a linear or branched substituted or nonsubstituted
`
`saturated or nonsaturated alkyi group with 1 to 10 carbon atoms or substituted or
`
`nonsubstituted aryl group, and
`
`R? represents CH2CH2SCH3, CH2CH2CH2NHRB, CH;CH2CH2CH2NHRB,
`
`CH2CH2C_H2CNHC(=NH)NHR“, where R“ is hydrogen or a linear or branched acyi group
`with three to five carbon atoms.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`253
`
`253
`
`

`
`W0 200‘);"087-I74
`
`PCT;"lB2U08.='0(l3709
`
`4.
`
`The compound of any one of claims 2 to 3 wherein R‘ represents a carboxyl group
`
`or a pharmaceutically acceptable salt thereof.
`
`-54-
`
`The compound of any one of claims 2 to 4 wherein R‘_ represents an ester group
`5.
`of formula COOR5.
`
`6.
`
`The compound of any one of claims 2 to 5 wherein R2“ and R‘ represent
`
`hydrogen.
`
`10
`
`15
`
`20
`
`7.
`
`The compound of claim 6, wherein R3‘ represents a substituted or nonsubstituted
`
`aryl group.
`
`B.
`
`The compound of any of the aforementioned claims wherein R5 and R‘
`
`independently represent a linear or branched acyl chain with three to five carbon atoms.
`
`9-
`
`The compound of claim 1 wherein at least one of m and n is 1, R‘ represents a
`
`carboxyl group or a phannaceutically acceptable salt thereof and at least one of R”, R“.
`
`R”, R2”. R33, R3” and R‘ is a substituent other than hydrogen, or R‘ is a carboxylic acid
`
`derivative selected from: ester, amide.
`
`10.
`
`The compound of claim 9 wherein R‘ is an ester selected from a triglyceride ester
`
`moiety or diglyceride ester moiety.
`
`11.
`
`The compound of claim 9 wherein R‘ is an amide of an amino acid group such
`
`25
`
`that the compound has the general fonnula (llle):
`
`R33 R3b
`
`1b
`
`1
`
`R a R
`
`was
`
`3
`
`:I
`
`--1:
`
`(lie)
`
`30
`
`or a salt thereof, in which R7 is a naturally occuring amino acid side chain.
`
`254
`
`254
`
`

`
`W0 200‘);"087-I74
`
`PCT;"lB2U08.='0(l3709
`
`-55-
`
`12.
`
`The compound of any one of claims 9 to 11 wherein one of R“, R1”. R2“. R2”. R3‘,
`
`R3” and R‘ is an aryl group and the others are selected from hydrogen or an alkyl group.
`
`13.
`
`The compound of claim 12 wherein one of R2”, R2”, R3“, R3” and R‘ is an aryl
`
`5
`
`group and the others are selected from hydrogen or an alkyl group.
`
`14.
`
`The compound of any one of claims 9 to 13 wherein at least one of R” and R” is
`
`hydrogen.
`
`10
`
`15
`
`The compound of any of claims 1 to 14 wherein R5 and R“, if present, are
`
`independently represent propanoyl, n-butanoyl, or iso-butanoyl.
`
`16
`
`The compound of any of claims 1 to 15 wherein R“, if present, represents
`
`propanoyl, n—butanoyl, or iso-butanoyl.
`
`15
`
`17
`
`The compound of any of claims 1 to 16 whereinselected from the group consisting
`
`of: 4-phenylbutyric acid, 3—phenylbutyn'c acid, 2-phenylbutyric acid, 3-phenylpropionic
`
`acid, 2-phenylpropionic acid, 2-methyl-3-phenylpropionic acid [S77], 2-methyl—4-
`
`phenylbutyric acid, or a pharmaceutically acceptable salt of any of said compounds,
`
`20
`
`methyl 4-phenylbutyrate, ethyl 4-phenylbutyrate, methyl 3-phenylbutyrate, ethyl 3-
`
`phenylbutyrate. methyl 2-phenylbutyrate. ethyl 2—phenylbutyrate, methyl 3-
`
`phenylpropionate, ethyl 3-phenylpropionate, methyl 2-phenylpropionate, ethyl 2-
`
`phenylpropionate, methyl 2-methyl—3-phenylpropionate, ethyl 2-methy|-3-
`
`phenylpropionate, methyl 2-methyl-4-phenylbutyrate. and ethyl 2-methyl—4-
`
`25
`
`phenylbutyrate.
`
`18
`
`The compound of any of claims 1 to 17, wherein said microbial infection is
`
`selected from the group consisting of bacterial, viral, protozoa! and fungal infections.
`
`19
`
`The compound of claim 18, wherein said microbial infection is caused by a
`
`30
`
`microbial species selected from: Yersenia enterocolitica. Salmonella, Shigella.
`
`Carnpylobacter, Clostridium and E. Coli.
`
`20
`
`The compound of any one of claims 1 to 19, wherein said microbial infections
`
`results in gastrointestinal disorders selected from the list consisting of: traveller's
`
`diarrhoea, endemic diarrhoea, dysentery, viral gastroenteritis, parasitic enteritis, Crohn‘s
`
`35
`
`disease, ulcerative colitis, irritable bowel syndrome, precancerous states of the
`
`255
`
`255
`
`

`
`W0 200‘);"087-I74
`
`PCT;"lB2U08.='0(|3709
`
`-56-
`
`gastrointestinal tract, cancer of the gastrointestinal tract, diverticulitis, post-antibiotic
`
`diarrhoea. Clostridium difficile colitis, lactose intolerance, flatulence. gastritis, esophagltis,
`
`heartburn, gastric ulcer, ulcers associated with Helicobacter pylori, duodenal ulcer, short
`
`bowel syndrome, dumping syndrome, gluten enteropathy and food intolerance; eye
`
`infections optionally selected fromconjunctivitis, stye, blepharitis, cellulitis, keratitis,
`
`corneal ulcer, trachoma, uveitis, canaliculitis and dacryocystitis; urinary tract and genital
`
`infections optionally selected from pyelonephritis, cystitis, gonorrhoea and urethritis;
`
`infections of the respiratory system optionally selected from bronchitis, pneumonia,
`
`rhinosinusitis, sinusitis, pharyngitisitonsillitis, laryngitis and influenza; skin infections
`
`optionally selected from boils, carbuncles, furuncles, cellulitis, abscesses, impetigo, and
`
`erysipelas; infections caused by bacterial strains resistant to classical antibiotic treatment.
`
`21.
`
`The compound of any of claims 1 to 20 wherein the microbial infection in the
`
`animal has lead to down-regulation of the innate antimicrobial peptide defense system,
`
`and whereby stimulation of the innate antimicrobial peptide defense system upto or above
`
`basal levels leads to secretion of the relevant peptide onto an epithelial surface which is
`
`optionally in the gastrointestinal tract such as to enhance the antimicrobial activity thereof.
`
`22.
`
`The compound of any of claims 1 to 21 for use in a combination treatment for
`
`treating, counteracting or preventing microbial infection in an animal, wherein the
`
`compound is used in combination with any one or more of: an antibiotic; an aminosterol—
`
`type compound; isoleucine or active isomers or analogs thereof; a vitamin D type
`
`compound.
`
`10
`
`15
`
`20
`
`25
`
`23.
`
`' A pharmaceutical composition for treating, preventing or counteracting a microbial
`
`infection comprising as an active ingredient at least one compound of any one of claims 1
`
`to 21 and at least one pharmaceutically acceptable excipient.
`
`24
`
`The pharmaceutical composition of claim 23, formulated as an oral dosage form.
`
`30
`
`25
`
`The pharmaceutical composition of claim 24, wherein said oral dosage form is
`
`selected from a tablet, a capsule, a solution, a suspension, a powder, a paste, an elixir, a
`
`syrup.
`
`256
`
`256
`
`

`
`W0 200‘);"087-I74
`
`PCT;"lB2U08.='0(l3709
`
`-57-
`
`26
`
`The pharmaceutical composition of any one of claims 23 to 25. wherein a unit
`
`dose of said composition comprises in the range of about 10-1000 mg of said active
`
`ingredient.
`
`5
`
`27
`
`The pharmaceutical composition of any one of claims 23 to claim 26 further
`
`comprising any one or more of: an antibiotic; an aminosterol—type compound; isoleucine
`
`or active isomers or analogs thereof; a vitamin D type compound.
`
`28
`
`A functional food'or feed product comprising an amount of at least one compound
`
`10
`
`of any one of claims 1 to 21, which amount is effective for treating, counteracting or
`
`preventing bacterial infections in an animal being fed with said food or feed.
`
`29
`
`The functional food or feed product of claim 28, comprising in the range of about
`
`0.1 to 20 mg of the active ingredient per g of food product.
`
`15
`
`30
`
`A method for treating, preventing or counteracting microbial infection in an animal,
`
`wherein the effects of the microbial infection are diminished or reduced by upregulation of
`
`the innate antimicrobial peptide system. said method comprising administration of a
`
`medicament comprising a secretagogue-effective amount of at least one compound of
`
`20
`
`formula I as defined in any one of claims 1 to 22.
`
`31
`
`The method of claim 30, comprising administration of said medicament in an oral
`
`dosage form.
`
`25
`
`32
`
`The method of claim 31, wherein the daily dosage is between 250 pg to about 25
`
`g which is optionally split into doses given ‘I, 2 or 3 times daily.
`
`33
`
`A compound, composition, food, or method as claimed in any one of the
`
`preceding claims wherein the animal is a human.
`
`257
`
`257
`
`

`
`W0 2l}(I9fU87-I7-I
`
`PCTr'lB2(l(|8)'0l)370.9
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`2D
`
`18
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`16
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`
`
`
`
`
`
`Foldinductionrelativetocontrol
`
`
`
`
`
`Figure 1.
`
`1:9
`
`258
`
`258
`
`

`
`W0 2009;’087-I74
`
`PCT![B2008;'003709
`
`A '
`
`-
`
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`
`0
`
`Butyrate (BA)
`
`0- Nn+
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`
`83
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`
`29
`
`259
`
`259
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`PCTJ'IB2(lU8.r’003709
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`
`Figure 4
`
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`
`260
`
`260
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`

`
`W0 2009;'0874‘}'4
`
`PCT!IB20U8!003709
`
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`Figure 5
`
`4:9
`
`261
`
`261
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`FoldinductionofCAMP
`
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`
`25.0
`
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`
`5:9
`
`262
`
`262
`
`

`
`WO 2009/087474
`
`PCT.-’I.B2008i'003709
`
`Figure 7
`
`619
`
`263
`
`263
`
`

`
`W0 20U9.n’l}87-17-I.
`
`PCT!lB2(|08;"003709
`
`350
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`264
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`
`

`
`W0 2(l()9l’087-I-74
`
`PCTi'IB2(lU8i’0037l}9
`
`
`
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`
`Foldinductionovercontrol
`
`3
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`
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`Figure 10
`
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`FoldinductionofmRNAlevelovercontrol
`
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`
`hBD-1
`
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`
`265
`
`265
`
`

`
`W0 2009:'08747-‘f-
`
`PCT.-"E2008I003709
`
`Figure 12
`
`9x9
`
`266
`
`266
`
`

`
`ALTERNATIVE TO FTOISEJOSA.-‘B
`(Based on PTO 06-08 version)
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`
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`Study of Glyceryl Tri (4—Pheny|butyrate)(GT4P} to Treat Urea Cycle Disorders" [accessed 5
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`COMTE et al., Journal of Mass Spectrometry (2002) 37{6):5B1-590
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`Pemm
`
`Pellllorl to C°"“"_9rl l_° 3
`Provisional Application
`
`0
`fiflggnllowanm Communication
`
`Appeal Communication To Board
`of Appeals and interferences
`Appeal Communication to TC
`{Appeal Notice, Brief, Reply Brien
`
`Proprietary Information
`
`El Attidavitsi'dec|aration(s]
`
`gfigfigggfigzzcggbgrfgsfigiilddress
`
`Status Letter
`
`Extension of Time Request
`
`Express Abandonment Request
`.
`.
`Information Disclosure Statement
`.
`(Supplemental In 3 pages)
`
`Terminal Disclaimer
`
`Request tor Refund
`
`CD, N
`
`t CD
`be
`Um r 0
`
`ls)
`
`Certified Copy of Priority
`Documentisi
`Reply to Missing Parts!
`Incomplete Application
`
`E Landscape Tame on CD
`
`Reply to Missing Parts under
`37 CFR 1.52 or 1.53
`
`CUSTOMER NO‘: 25225
`
`|C;lel;1‘:'fyEt?;:J‘:u5;-:'r9(5) lPl"=‘3'-‘W’-'
`
`PTO F077" 5B*'l03a-''lb (1 Pagel
`6 References
`
`SIGNATURE OF APPLICANT, ATTORNEY, OR AGENT
`
`F'"“ ”“'"‘*
`Signature
`
`Printed name
`
`MORRISON 3. FOERSTER LLP
`
`!l\i1ichae| G. Smith‘
`
`Michael G. Smith
`
`Date
`
`February 2, 2010
`
`sd—505888
`
`268
`
`268
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`

`
`Docket No. 643982000100
`
`Patent
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`Bruce SCI-IARSCHMIDT
`
`Application No.: 12!350,1l1
`
`Filing Date: January 7, 2009
`
`For: METHODS OF TREATMENT USING
`
`AMMON1A—SCA\/ENGING DRUGS
`
`Examiner: Not Yet Assigned
`
`Group Art Unit: 1614
`
`Confirmation No.: 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. § 1.97 and § 1.98, Applicant submits for consideration in the
`
`above—identified application the documents listed on the attached Form PTOr'SB:"08afb. Copies of
`
`the documents are also submitted herewith. The Examiner is requested to make these documents of
`
`record.
`
`The documents listed on the attached Foim PTO;’SB.=’08a.!'b were cited in a Sea1'ch and
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`Examination Report dated on October 8, 2009, directed to a counterpart international or foreign
`
`application and have not been previously cited.
`
`269
`
`269
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`

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`This Information Disclosure Statement is submitted:
`
`CID
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`With the application; accordingly, no fee or separate requirements are required.
`
`Before the mailing of a first Office Action after the filing ofa Request for Continued
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`Examination under 37 C.F.R. § 1.] 14. However, if applicable, a certification under 37
`
`C.F.R. § 1.97 (e)(l ) has been provided.
`
`E Within three months of the application filing date or before mailing of a first Office Action
`
`on the merits; accordingly, no fee 01' separate requirements are required. However, if
`
`applicable, a certification under 37 C.F.R. § 1.97 (e)( 1) has been provided.
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`D After receipt of a first Office Action on the merits but before mailing of a final Office Action
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`or Notice of Allowance.
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`El
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`A fee is required. Accordingly, a Fee Transmittal Form (PTO/SB! 17) is attached to
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`this submission.
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`El
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`A Certification under 37 C.F.R. § 1.97(e) is provided above; accordingly; no fee is
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`believed to be due.
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`El
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`After mailing ofa final Office Action or Notice of Allowance, but before payment of the
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`Issue Fee.
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`D A Certification under 37 CPR. § 1.97(e) is provided above and a Fee Transmittal
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`Form (PTOISB/17) is attached to this submission.)
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`Applicants would appreciate the Examiner initialing and retuming the Fo1'm
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`PTOISB/U33/b, indicating that the information has been considered and made of record herein.
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`The information contained in this Information Disclosure Statement under
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`37 C.F.R. § 1.97 and § 1.98 is not to be construed as a representation that: (i) a complete search has
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`been made; (ii) additional information material to the examination of this application does not exist;
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`(iii) the information, protocols, results and the like reported by third pa1'ties are accurate 01' enabling;
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`01' (iv) the above information constitutes prior art to the subject invention.
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`sd-505675
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`l
`Serial No. 121350,] 1
`Docket No. 6439820(){) 1 U0
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`270
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`270
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`In the unlikely event that the transmittal fo1'm is separated from this document and the
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`Patent and Trademark Office determines that an extension andfor other relief (such as payment of a
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`fee under 37'' CPR. § 1.17 (p)) is required, Applicant petitions for any required relief including
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`extensions of time and authorizes the Commissioner to charge the cost of such petition andfor other
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`fees due in connection with the filing of this document to Deposit Account N0. 03-1952
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`referencing 643982000100.
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`Dated: February 2, 2010
`
`Respectfully submitted,
`
`Electronic signature:
`Michael G. Smith
`
`./Michael G. Smith!’
`
`Registration No.: 44,422
`MORRISON & FOERSTER LLP
`
`l2531 High Bluff Drive, Suite 100
`San Diego, California 92130-2040
`(858) 720-5113
`
`sd-505675
`
`l
`Serial No. l2J"350,l l
`Docket No. 643982000 1 00
`
`271
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`271
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`

`
`PATENT COOPERATION TREATY
`
`--
`
`S
`SAN. Dig-gg <3 F
`
`12531 High Bluff Drive, Suite 100
`San Diego CA 92130-2040
`ET}-‘tTS—-UNIS D*AMERIQU'E
`
`_.
`From the INTERNATIONAL SEARCHING AUTHORITY
`_
`I
`To:
`
` NOTIFICATION OF TRANSMITTAL OF
`
`
`MORRISON & FOERSTER LLP
`THE INTERNATIONAL SEARCH REPORT AND
`THE WRITTEN OPINION OF THE INTERNATIONAL
`Attn. Smith,
`I/lichael G.
`SEARCHING AUTHORITY, OR THE DECLARATION
`
`
`
`
`
`(PCT-Rule 44.1)
`Date of mailing
`(day/month/year)
`
`
`
`3 O /1 2 /2 0 0 9
`
`
`
`DOCKETED:'§
`REMlNDER:
`INAI. DUEDATE:__3
`
`
`
`Appli
`=
`nt's or agent's file reference
`
`
`643982000141
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`lntemational application No.
`
`PCT/US2009/055256
`
`Applicant
`
`Hyperion Therapeutics
`
`
`
`as
`
`.
`
`1. Ea The applicant is hereby notified that the international search report and the written opinion of the International Searching
`Authority have been established and are transmitted herewith.
`
`_
`Filing of amendments and statement under Article 19:
`The applicant is entitled, if he so wishes, to amend the claims of the International Application {see Flute 46):
`when? The time limit for filing such amendments is normally two months from the date of transmittal of the
`lntemational Search Report.
`
`Where? Directly to the lntemational Bureau of WIPO, 34 ohernin des Colombettes
`" 1211 Geneva 20, Switzerland, Fascimiile No.2 (41-22) 338132.70
`For more detailed instructions, see the notes on the accompanying sheet.
`
`2. D The applicant is hereby notified that no intemationat ‘search report will-be established and that the declaration under
`' Article 17{2)(a) to that effect and the written opinion of the lntemational Searching Authority are transmitted herewith.
`3. D with regard to any protest against payment of (an) additional fee{s) under Rule 40.2. the applicant is notified that:
`
`the protest together with the decision thereon has l:Ieen‘transmitted to the lntemational _Bureau together with the
`applicant's request to forward the texts of both the protest and the decision thereon to the designated -Offices.
`]:| no decision has been made yet on the protest; the applicant will be notified as soon as a decision is made.
`4. Reminders
`
`
`
`
`
`
`
`
`Shortiy after the expiration of 18 months from the priority date. the international application will be published by the
`lntemational Bureau. if the applicant wishes to avoid or postpone publication. a notice of withdrawai of the international
`application, or of the priority claim, must reach the lntemational Bureau as provided in Rules 90bis.1 and 90bis.3, respectively.
`before the completion of the technical preparations for lntemational publication.
`The applicant may submit comments on an informal basis on the written opinion of the International Searching Authority to the
`International Bureau. ihe lntemational Elureauwillsend a copy of such commentsto all designated Offices unless an
`internafionat preliminary examination report has been or is to be established. These comments wouidalso be made available to
`the public but not before the expiration of 30 months from the priority date.
`Within 19 monthsirom the priority date, but only in respect of some designated Offices, a demand for international preliminary
`examination must be filed if the applicant wishes to postpone the entry into the national phase until 30 months from the priority
`date (in some Offices even later); otherwise. the applicant must, within 20 months from the priority date, perform the prescribed
`acts for entry into the national phase before those designated Oftices.
`
`in respect of other designated Offices. the time limit of 30 months {or later) will apply even if no demand is filed within 19
`months.
`"
`
`See the Annex to Form PCTilBl'301 and, for details about the applicable time limits, Office by Office. see the PCT Appl‘l'cant’s
`Guide, National Chapters.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`_
`
`Authorized officer
`
`Monika Lange rova
`
`Name and mailing address of the lntemational Searching Authority
`European Patent Office, PB. 5818 Patentiaan 2
`NL—22B0 HV Fliiswijk
`‘ 0 Tel. (+31—70) 340-2040, Tx. 31 651 epo nl,
`__j Fax; (+31—70) 340-3016 .
`'
`
`272
`
`Form PCTilSAi220 {July 2009)
`
`(See nofes on accompanying sheet)
`
`FOR FURTHER ACTION
`
`See paragraphs 1 and 4 below
`
`International filing date
`(day/monrhzyear)
`
`2 7 / 0 8 / 2 0 0 9
`
`

`
`NOTES TO FORM PCT!lSAi'220
`
`These Notes are intended to give the basic instructions. conceming the tiling of amendments under article 19. The
`Notes are based on the requirements of the Patent Cooperation Treaty. the Fiegulations and the Administrative Instructions
`under that Treaty. In se of discrepancy between these Notes and those requirements. the latter are applicable. For more
`detailed information, see also the PCTAppl'r'canl"s Guide.
`
`In these Notes, "Articte". "Flute". and “Section” refer to the provisions of the PCT, the PCT Regulations and the PCT
`Administrative Instructions, respectively.
`
`INSTRUCTIONS CONCERNING AMENDMENTS UNDER ARTICLE 19
`
`The applicant has, after having received the international search report and the written opinion of the International
`Searching Authority, one opportunity to amend the claims of the intemationat application. It should however be emphasized
`that, since all parts of the international application (claims,description and drawings) may be amended during the
`international preliminary examination procedure, there is usually no need to tile amendments of the claims under Article 19
`except where, e.g. the applicant wants the latter to be published for the purposes of provisional protection or has another
`reason for amending the claims before international publication. Furthermore, it should be emphasized that provisional
`protection is availabte in some States only {see PCT Applicant's Guide, Annex B).
`
`The attention of the applicant is drawn to the tact that amendments to the claims under Article 19 are not allowed where
`the International Searching Authority has declared. under Article 17(2), that no intemational search report would be
`established (see PCTApplr‘cant's Guide. lntemational Phase. paragraph 296).
`
`What parts of the international application may be amended?
`
`Under Article ‘I9, only the claims may be amended.
`
`During the international phase. the claims may also be amended (or further amended) under Article 34 belore the
`International Preliminary Examining Authority. The description and drawings may only be amended under
`Article 34 belore the lntemational Examining Authority.
`
`Upon entry into the nationai phase, all parts of the international application may be amended under Article 28 or,
`where applicable, Article 41.
`
`Within 2 months from the date ot transmittal of the intemational search report or 16 months from the priority date,
`whichever time limit expires later. It should be noted, however. that the amendments will be considered as having
`been received on time if they are received by the International Bureau after the expiration oi the applicable time
`limit but belore the completion of the technical preparations for intemational publication {Flute 46.1).
`
`"
`
`Where not to tile the amendments?
`
`The amendments may only be ‘filed with the International Bureau and not with the receiving Office or the
`lntemational Searching Authority" (Flute 5i6.2).
`
`Where a demand for international preliminary examination has beenfis tiled, see below.
`
`Either by cancelling one or more entire claims, by adding one or more new claims or by amending the text of one
`or more of the claims as filed.
`'
`
`A replacement sheet or sheets containing a complete set of claims in replacement of all the claims previously filed
`must be submitted.
`
`Where a_ claim is carlcelied, no renumberlng of the other claims is required. In all cases where claims are
`. renumbered, they must be renumbered con_secuti_v_ely in Arabic numerals (Section 205(a)].
`
`The amendments must be made in the -language in which the international application is to be published.
`
`What difcurrients mustlmay accompany the amendments?
`
`Letter (Section 2G5(b}):
`
`The amendments must be submitted with a letter.
`
`The letter will not be published with the intemational application and the amended claims. It should not be
`confused with the “Statement under Article 19(1)‘ {see beiow, under “Statement under Article 19(1)“).
`
`The letter must be in English or French, at the choice of the applicant. However, it the language of the
`international application is English, the letter must be in English; it the language oi the international application
`is French, the letter must be in French.
`
`Notes to Form PCTilSAi'220 (tirst sheet) (July 2009)
`
`273
`
`

`
`NOTES TO FORM PCTi'lSAl220 _
`
`These Notes are intended to give the basic instructions conceming the filing of amendments under article 19. The
`Notes are based on the requirements of the Patent Cooperation Treaty, the Flegulations and the Administrative lnstmctions
`under that Treaty. In case of discrepancy between these Notes and those requirements, the latter are applicable. For more
`detailed inion'nation. see also the PCT Appir'cant's Guide.
`
`In these Notes. ‘Article’. 'Flule", and "Section" refer to the provisions of the PCT, the PCT Regulations and the PCT
`Administrative lnstmctions. respectively.
`
`INSTRUCTIONS CONCERNING AMENDMENTS UNDER ARTICLE 19
`
`The applicant has, after having received the international search report and the written opinion of the International
`Searching Authority. one opportunity to amend the claims of the international application. It should however be emphasized
`that. since all parts of the lntemational application (ciaims.description and drawings} may be amended during the
`international preliminary examination procedure. there is usually no need to fife amendments ot the claims under Article 19
`except where, e.g. the applicant wants the latter to be published for the purposes of provisional protection or has another
`reason for amending the claims before international publication. Furthermore. it should be emphasized that provisional
`protection is available in some States only {see PCTAppir'cani"s Guide, Annex B).
`
`The attention of the applicant is drawn to the fact that amendments to the claims under Article 19 are not allowed where
`the lntemational Searching Authority has declared. under Article 17(2). that no international search report would be
`established (see PCTAppl'icanf’s Guide. lntemational Phase. paragraph 296).
`
`What parts of the lntemational application may be amended?
`Under Article 19. only the claims may be amended.
`
`_
`
`During the international phase. the claims may also be amended (or further amended} under Article 34 before the
`lntemational Preliminary Examining Authority. The description and drawings may only be amended under
`Article 34 before the lntemational Examining Authority.
`
`Upon entry into the national phase. all pans ot the lntemational applic