Attorney Docket No. SYPA-009/X01US 321994-2142
`Application No. 13/421,769
`Page 2
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`Pursuant to §609
`Enclosed is a copy of a non-English publication(s)
`of the M.P.E.P., Applicant submits the attached foreign search or
`examination report, which cites such non-English language publication(s).
`Enclosed is a copy of a non-English publication(s)
`English
`language publication
`(copy enclosed) claims priority from this non-
`English publication.
`Enclosed is an explanation of non-English publication(s)
`an English translation is not available.
`Enclosed is an English translation of non-English publication(s)
`cited in the attached Form PTO/SB/08.
`Enclosed is a copy of pending patent Application Serial No.
`
`for which
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`This Information Disclosure Statement is filed within any one of the following
`time periods:
`
`C]
`
`C]
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`C]
`Xx
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`within three months from the filing date of this national application
`other than a CPA under 37 C.F.R. § 1.53(d);
`within three months from the date of entry of the national stage as
`set forth in 37 C.F.R. §1.491 in this international application;
`before the mailing date of a first office action on the merits; or
`before the mailing of a first office action after the filing of a
`request for continued examination under 37 C.F.R. § 1.114.
`
`It
`
`is
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`respectfully requested that
`
`the Examiner consider
`
`the above-noted
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`information and return an initialed copy of the attached Form PTO/SB/08 to the
`
`undersigned.
`
`Dated: December30, 2015
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue NW,Suite 700
`Washington, DC 20004
`
`Tel:
`(202) 728-7030
`Fax: (202) 842-7899
`
`Respectfully submitted,
`COOLEY LLP
`
`By:
`
`/Anne E. Fleckenstein/
`Anne E. Fleckenstein
`Reg. No. 62951
`
`125824598 v1
`
`MYLAN- EXHIBIT 1022 Part 14 of 16
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`MYLAN - EXHIBIT 1022 Part 14 of 16
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www .uspto.gov
`
`APPLICATION NO.
`
`
`
`
` FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATIONNO.
`
`13/421,769
`
`03/15/2012
`
`Stephen Comiskey
`
`SYPA-009X01US
`321994-2142
`
`3135
`
`01/04/2016
`
`7590
`
`58249
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue, NW
`Suite 700
`Washington, DC 20004
`
`LEE,JIA-HAI
`
`PAPER NUMBER
`
`1676
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`01/04/2016
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`zpatdcdocketing @ cooley.com
`
`PTOL-90A (Rev. 04/07)
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`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, may a reply be timely filed
`
`-
`-
`
` Attachment(s)
`
`
`Application No.
`Applicant(s)
`13/421,769
`COMISKEYET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor toFile)
`JIA-HAI LEE
`1676
`No
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address--
`Period for Reply
`
`Office Action Summary
`
`Status
`1) Responsive to communication(s) filed on 11/20/2015.
`L] A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filedon___
`2a)L] This action is FINAL.
`2b)X] This action is non-final.
`3)L] An election was made bythe applicant in responseto a restriction requirementset forth during the interview on
`
`; the restriction requirement and election have been incorporated into this action.
`4)L] Sincethis application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordancewith the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)K] Claim(s) 1-44 is/are pending in the application.
`5a) Of the above claim(s) 7,72,13,17-19 and 26-42 is/are withdrawn from consideration.
`6)L] Claim(s)___is/are allowed.
`
`7)K] Claim(s) 2-11, 14-16, 20-25, and 43-44 is/are rejected.
`8)L] Claim(s)___ is/are objectedto.
`
`9)L] Claim(s)
`are subjectto restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
` nite://www.usoto.dov/patenis/init events/oph/index.isp
`
`or send an inquiry to PPHieedback@uspte.dov.
`
`Application Papers
`10) The specification is objected to by the Examiner.
`
`11) The drawing(s) filed on
`is/are: a)[_] accepted or b)[_] objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)L] Acknowledgment is made ofa claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)LJ All
`b)[] Some** c)L] None ofthe:
`1.) Certified copies of the priority documents have been received.
`2.L] Certified copies of the priority documents have been received in Application No.
`3.L] Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`““ See the attached detailed Office action for a list of the certified copies not received.
`
`3) TC Interview Summary (PTO-413)
`1) X Notice of References Cited (PTO-892)
`Paper No(s)/Mail Date.
`;
`,
`O Oth
`2) CT] Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`
`Paper No(s)/Mail Date ther
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20151228
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
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`Page 2
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`DETAILED ACTION
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`The present application is being examined underthe pre-AlA first to invent
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`provisions.
`
`Continued Examination Under 37 CFR 1.114
`
`A requestfor continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), wasfiled in this application after final rejection. Since this
`
`application is eligible for continued examination under 37 CFR 1.114, and the fee set
`
`forth in 37 CFR 1.17(e) has beentimely paid, the finality of the previous Office action
`
`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on
`
`11/20/2015 has been entered.
`
`Claim Status
`
`Claims 1-44 are pending.
`
`Claims 1, 12-13, 17-19, and 26-42 were withdrawnas being directed to a non-
`
`elected invention and species, the election according the claim status identifier having
`
`been made on 11/20/2015.
`
`Claims 2-11, 14-16, 20-25, and 43-44 have been examined.
`
`Priority
`
`This application is a CIP of PCT/US2011/051805 filed on 09/15/2011, which
`
`claims benefit of 61/383, 156 filed on 09/15/2010, claims benefit of 61/387,636 filed on
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
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`Page 3
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`09/29/2010, and claims benefit of 61/892, 186 filed on 10/12/2010.
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`Claim Rejections - 35 USC § 112
`
`The following is a quotation of 35 U.S.C. 112(d):
`
`(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent
`form shall contain a reference to a claim previously set forth and then specify a further
`limitation of the subject matter claimed. A claim in dependent form shall be construed to
`incorporate by referenceall the limitations of the claim to whichit refers.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), fourth paragraph:
`
`Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AlA)], a claim in dependent form shall
`contain a referenceto a claim previously set forth and then specify a further limitation of the
`subject matter claimed. A claim in dependent form shall be construed to incorporate by
`referenceall the limitations of the claim to which it refers.
`
`New groundofrejection.
`
`Claims 4 and 9-11 are rejected under 35 U.S.C. 112(d) or pre-AlIA 35 U.S.C. 112,
`
`Ath paragraph, as being of improper dependentform for failing to further limit the subject
`
`matter of the claim upon which it depends, or for failing to include all the limitations of
`
`the claim upon which it depends.
`
`Claim 4 is drawn to the total impurity of the GCC agonist peptide hasatotal
`
`impurity content of no greater than 9%, which has the same meaning of the GCC
`
`agonist peptide has a chromatographic purity no less than 91%. Thus, claim 4 failed to
`
`furtherlimit the subject matter of claim 2.
`
`Claims 9-11 drawn to the one or more pharmaceutically acceptable excipients
`
`comprise an inert carrier, which broadens the inert low moisture carrier in claim 2. Thus,
`
`claims 9-11 failed to furtherlimit the subject matter of claim 2.
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
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`Page 4
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`Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in
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`proper dependentform, rewrite the claim(s) in independentform, or present a sufficient
`
`showing that the dependent claim(s) complies with the statutory requirements.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
`
`for all obviousnessrejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described
`as set forth in section 102 of thistitle, if the differences between the subject matter sought to
`be patented and the prior art are such that the subject matter as a whole would have been
`obvious at the time the invention was made to a person having ordinaryskill in the art to which
`said subject matter pertains. Patentability shall not be negatived by the manner in which the
`invention was made.
`
`This application currently namesjoint inventors. In considering patentability of the
`
`claims under pre-AlA 35 U.S.C. 103(a), the examiner presumes that the subject matter
`
`of the various claims was commonly ownedatthe time any inventions covered therein
`
`were made absent any evidenceto the contrary. Applicant is advised of the obligation
`
`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
`
`not commonly ownedatthe time a later invention was madein orderfor the examinerto
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`considerthe applicability of pre-AlA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C.
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`102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
`
`USPQ 459 (1966), that are applied for establishing a background for determining
`
`obviousness under pre-AlA 35 U.S.C. 103(a) are summarized as follows:
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`Application/Control Number: 13/421 ,769
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`Page 5
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`1. Determining the scope and contentsof the prior art.
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`2. Ascertaining the differences betweenthe prior art and the claims at issue.
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`3. Resolving the level of ordinary skill in the pertinent art.
`
`4. Considering objective evidence presentin the application indicating
`
`obviousness or nonobviousness.
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`New groundofrejection.
`
`Claims 2-11, 14-16, 20-23, 25, and 43-44 rejected under pre-AlA 35 U.S.C.
`
`103(a) as being unpatentable over Shailubhai et al. (WO 02/078683 A1, cited in the
`
`prior action) in view of Mihranyanetal. (Int J Pharm. 2004 Jan 28;269(2):433-42, cited
`
`in the prior action) and Fretzenet al. (US 2010/0048489 A1).
`
`Shailubhai et al. teach a pharmaceutical composition comprising a guanylate
`
`cyclase C (GCC) agonist peptide having the sequence of Asn Asp Glu Cys Glu Leu Cys
`
`Val Asn Val Ala Cys Thr Gly Cys Leu with 100% homology to SEQ ID NO: 1 ofthis
`
`instant application (p6, line 32) and formulated with pharmaceutically acceptable
`
`excipients for oral administration (p17, line 45-49). Shailubhai et al. showsthe unit
`
`dosage of the GCC agonist peptide (p27, claim 22) is optimized between 100 ug - 3g
`
`(p4, line 20-24) or 1 ug -10 mg (p7, line 14) and the purity of the GCC agonist peptideis
`
`>95%(p21, line 6).
`
`Shailubhai et al. does not specify the cellulose carrier (p18, line 17-18) for the
`
`peptide drug formulation is an inert low moisture carrier of cellulose.
`
`Mihranyanet al. (Int J Pharm. 2004 Jan 28;269(2):433-42.) teach microcrystalline
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`cellulose (MCC) is the most commonly used drug excipients, but moisture in
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`microcrystalline cellulose may causestability problems for moisture sensitive drugs,
`
`e.g., peptide drugs, (Abstract; p433, col 1). Mihranyan et al. suggests the useofinert
`
`low moisture grades of commercial MCC knownin the art (1.5%, w/w, moisture in Avicel
`
`PH 112 and 3%, w/w, moisture in Avicel PH 103, FMC Corp. knownin the art) for
`
`moisture sensitive drugs (Abstract, p433, col 2), reading on an inert low moisture carrier
`
`in claim 2.
`
`Shailubhai et al. in view of Mihranyan et al. do not show peptide purity no less
`
`than 91%after storage for at least three months.
`
`Fretzen et al. teaches stable solid formulation of a guanylate cyclase-C (GCC)
`
`receptor agonist polypeptide suitable for oral administration [Abstract, Example 1-9].
`
`Fretzen et al. teaches the peptide formulation has chromatographic purity of a GCC
`
`agonist peptide drug (e.g., linaclotide) decreases by less than 9%, 8%, 7%, 6%, 5%, 4%
`
`or 2% after 18 months or 24 months of storage at the sealed container containing a
`
`desiccant at 25°C. at 60%relative humidity [0009], reading on a chromatographic purity
`
`of no less than 91 %after storage for at least three months in claim 2.
`
`With respectto claims 3-4, Fretzen et al. teaches the peptide formulation has
`
`chromatographic purity of a GCC agonist peptide drug (e.g., linaclotide) decreases by
`
`less than 9%, 8%, 7%, 6%, 5%, 4% or 2% after 18 months or 24 months of storage in
`
`the sealed container containing a desiccant at 25° C. at 60%relative humidity [0009].
`
`MPEP 2144.05 states “In the case wherethe claimed ranges “overlap or lie inside
`
`ranges disclosed by the prior art” a prima facie case of obviousnessexists. /n re
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
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`Page 7
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`Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,
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`16 USPQ2d 1934 (Fed. Cir. 1990).”
`
`With respectto claim 5, Mihranyanet al. suggest inorganic acid (HCL)
`
`hydrolyzes cellulose materials; thus, one of ordinary skill in the art would make drug
`
`cellulose composition free of inorganic acid (p434, 2.1.3).
`
`With respectto claim 6, Shailubhai et al. show the GCC agonist peptide having
`
`the sequence of Asn Asp Glu Cys Glu Leu Cys Val Asn Val Ala Cys Thr Gly Cys Leu
`
`with 100% homology to SEQ ID NO: 1 of this instant application (p6, line 32).
`
`With respectto claim 7, Shailubhai et al. shows the unit dosage of the GCC
`
`agonist peptide (p27, claim 22) is optimized between 100 yg - 3 g (p4, line 20-24) or 1
`
`Ug -10 mg (p7, line 14).
`
`With respectto claim 8, Shailubhai et al. show the solid formulation of GCC
`
`agonist peptide in a unit doseis tablets or capsules (p17, line 44-49). Similarly, Fretzen
`
`et al. teaches the GCC agonist peptide for oral administration can be used to create unit
`
`dosagesforms, e.g., tablets, capsules, sachets, pellets, or blister packs [0061, 0072].
`
`With respectto claim 9, Shailubhai et al. show the pharmaceutically acceptable
`
`excipients comprise a pharmaceutical carrier of cellulose (p18, line 11-19). Mihranyanet
`
`al. further suggests the use of inert low moisture grades of commercial MCC (1.5%,
`
`w/w, moisture in Avicel PH 112 and 3%, w/w, moisture in Avicel PH 103, FMC Corp.) for
`
`moisture sensitive drugs (Abstract, p433, col 2).
`
`With respectto claim 10, Fretzen et al. teaches the inert carrier is a
`
`microcrystalline cellulose [0063-0064]. Mihranyan et al. suggests the use of inert low
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`Application/Control Number: 13/421 ,769
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`Page 8
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`moisture grades of commercial microcrystalline cellulose knownin the art (1.5%, w/w,
`
`moisture in Avicel PH 112 and 3%, w/w, moisture in Avicel PH 103, FMC Corp.) for
`
`moisture sensitive drugs (Abstract, p433, col 2).
`
`With respect to claim 11, Fretzen et al. suggests a pharmaceutically acceptable
`
`carrier comprising particles having an average diameter between 50 um and 1000 um
`
`[0037]. Furthermore, the intrinsic particle size of an inert low moisture carrier is 50 uM
`
`for Avicel PH 103 and 100 uM for Avicel PH 112, shownin Avicel PH productinstruction
`
`(Table in page 6, cited in the prior action).
`
`With respectto claim 14, Fretzen et al. teaches the molarratio of the amino acid
`
`leucine to the GCC agonist peptide can be optimized from 5:1 to 50:1 [0028].
`
`With respect to claim 15, Fretzen et al. teaches the amino acid is leucine [0028]
`
`With respectto claim 16, Shailubhai et al. teach a pharmaceutical composition
`
`comprising a guanylate cyclase C (GCC) agonist peptide having the sequence of Asn
`
`Asp Glu Cys Glu Leu Cys Val Asn Val Ala Cys Thr Gly Cys Leu with 100% homology to
`
`SEQ ID NO: 1 of this instant application (p6, line 32) and formulated with
`
`pharmaceutically acceptable excipients for oral administration (p17, line 45-49).
`
`Mihranyanet al. suggests the useof inert low moisture grades of commercial MCC
`
`(1.5%, w/w, moisture in Avicel PH 112 and 3%, w/w, moisture in Avicel PH 103, FMC
`
`Corp.) for moisture sensitive drugs (Abstract, p433, col 2). Fretzen et al. teaches the
`
`use of leucine as a GCC agonist peptide stabilizer [p4, 0024] and a lubricant [0037].
`
`With respectto claim 20, Fretzen et al. teaches the GCC agonist peptide
`
`formulation has chromatographic purity of a GCC agonist peptide drug (e.g., linaclotide)
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
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`Page 9
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`decreasesby less than 9%, 8%, 7%, 6%, 5%, 4% or 2% after 18 months or 24 months
`
`of storage of the sealed container containing a desiccant at 25°C, at 60%relative
`
`humidity [0009].
`
`With respectto claim 21, Shailubhai et al. show the solid formulation of GCC
`
`agonist peptide in a unit doseis tablets or capsules (p17, line 44-49). Similarly, Fretzen
`
`et al. teaches the GCC agonist peptide for oral administration can be used to create unit
`
`dosagesforms, e.g., tablets, capsules, sachets, pellets, or blister packs [0061, 0072].
`
`With respectto claim 22, Fretzen et al. teaches the GCC agonist peptide for oral
`
`administration can be used to create unit dosagesforms, e.g., tablets, capsules, or
`
`blister packs [0061, 0072].
`
`With respectto claim 23, Shailubhai et al. teaches the GCC agonist peptide can
`
`be formulated in unit dose form of a solution (p4, line 20-22). Similarly, Fretzen etal.
`
`teaches the GCC agonist peptide for oral administration can be used to create unit
`
`dosages form suspension in mineraloil or vegetable oil (lipophilic liquid) [0065].
`
`With respectto claim 25, Fretzen et al. suggests the GCC agonist peptide can be
`
`formulatedin a liquid of mineral oil or vegetable oil as a lubricant [0037, 0065].
`
`With respectto claim 43, Shailubhai et al. shows the unit dosage of the GCC
`
`agonist peptide (p27, claim 22) is optimized between 100 yg - 3 g (p4, line 20-24) or 1
`
`Ug -10 mg (p7, line 14).
`
`With respectto claim 44, Fretzen et al. teaches the GCC agonist peptide
`
`formulation has chromatographic purity of a GCC agonist peptide drug (e.g., linaclotide)
`
`decreasesby less than 9%, 8%, 7%, 6%, 5%, 4% or 2% after 18 months or 24 months
`
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
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`Page 10
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`of storage of the sealed container containing a desiccant at 25° C, at 60%relative
`
`humidity [0009].
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`It would have been obvious to one of ordinary skill in the art at the time the
`
`invention was made to combine Shailubhai’s GCC agonist peptide with Mihranyan’s
`
`inert low moisture grades of commercial microcrystalline cellulose (1.5%, w/w, moisture
`
`in Avicel PH 112 and 3%, w/w, moisture in Avicel PH 103, FMC Corp.) because
`
`Shailubhai’s GCC agonist peptide stability is moisture sensitive and Mihranyanetal.
`
`suggests the useof inert low moisture grades of commercial MCC (1.5%, w/w, moisture
`
`in Avicel PH 112 and 3%, w/w, moisture in Avicel PH 103, FMC Corp.) for moisture
`
`sensitive drugs (Abstract, p433, col 2). It would have been further obvious to combine
`
`the teachings (Shailubhai et al. in view of Mihranyanetal.) with Fretzen’s method and
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`composition for peptide storage because Fretzen et al. demonstrates the addition of
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`leucine to a GCC agonist peptide formulation and storage of the GCC agonist peptidein
`
`the sealed container containing a desiccant at 25° C. at 60%relative humidity, resulting
`
`in chromatographic purity of a GCC agonist peptide drug (e.g., linaclotide) decreases by
`
`less than 9%, 8%, 7%, 6%, 5%, 4% or 2% after 18 months or 24 months [0009,
`
`Example 1-9]. The combination would have predictable success for a GCC agonist
`
`peptide having a chromatographic purity of no less than 91 %after storage for at least
`
`three months.
`
`Responseto Arguments
`
`Applicant's argumentsfiled 11/20/2015 have been fully considered but they are
`
`not persuasive. Applicant argues 1) the combined references do not teach the GCC
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
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`Page 11
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`agonist peptide has a chromatographic purity of no less than 91 %after storage for at
`
`least three months, and 2) Mihranyan teaches away from using low moisture gradesof
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`MCC.
`
`With respect to the argument 1, Applicant’s argument is based on Shailubhaiet
`
`al. in view of Currie et al. in view of Mihranyan et al. and in view of Avicel PH product
`
`instruction (FMC 2005); whereas, this current rejection is based on the combination of
`
`Shailubhai et al. in view of Mihranyan etal. and Fretzen et al. In summary, Shailubhai et
`
`al. teach a pharmaceutical composition comprising a guanylate cyclase C (GCC)
`
`agonist peptide having the sequence of Asn Asp Glu Cys Glu Leu Cys Val Asn Val Ala
`
`Cys Thr Gly Cys Leu with 100% homology to SEQ ID NO: 1 of this instant application
`
`(p6, line 32) and formulated with pharmaceutically acceptable excipients for oral
`
`administration (p17, line 45-49). Shailubhai et al. shows the unit dosage of the GCC
`
`agonist peptide (p27, claim 22) is optimized between 100 ug - 3 g (p4, line 20-24) or 1
`
`ug -10 mg (p/,line 14) and the purity of the GCC agonist peptide is >95% (p21, line 6).
`
`Mihranyanet al. (Int J Pharm. 2004 Jan 28;269(2):433-42.) teach microcrystalline
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`cellulose (MCC) is the most commonly used drug excipients, but moisture in
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`microcrystalline cellulose may causestability problems for moisture sensitive drugs,
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`€.g., peptide drugs, (Abstract; p433, col 1). Mihranyan et al. suggests the useofinert
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`low moisture grades of commercial MCC knownin the art (1.5%, w/w, moisture in Avicel
`
`PH 112 and 3%, w/w, moisture in Avicel PH 103, FMC Corp.) for moisture sensitive
`
`drugs (Abstract, p433, col 2). Fretzen et al. teaches a GCC agonist peptide formulation
`
`comprising an inert carrier a microcrystalline cellulose [0063-0064] with a ratio of
`
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
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`Page 12
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`leucine to the GCC agonist peptide from 5:1 to 50:1 [0028]. When Fretzen’s GCC
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`agonist peptide formulation is stored at a sealed container containing a desiccant at 25°
`
`C, at 60%relative humidity, the chromatographic purity of a GCC agonist peptide drug
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`(e.g., linaclotide) would be predictable to be decreased by less than 9%, 8%, 7%, 6%,
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`5%, 4% or 2% after 18 months or 24 months [0009], reading on the limitation of claim 2
`
`and its rejected dependent claims.
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`With respect to the argument 2, Mihranyanet al. does not teach awayfrom using
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`low moisture grades of MCC; Mihranyan et al. concludesthe structure of cellulose
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`should be thoroughly considered when manufacturing low moisture grades of MCC
`
`(p441, col 1, 5. Conclusion). MEPE 2123 states “Disclosed examples and preferred
`
`embodiments do not constitute a teaching away from a broader disclosure or
`
`nonpreferred embodiments. in re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971}."
`
`Furthermore, one of ordinary skil in the art would study Avicel PH productinstruction
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`(FMC 2005, cited in the prior action) as suggested by Mihranyan's teaching. Avicel PH
`
`productinstruction shows the advantagesin using Avicel PH products as a drug
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`excipient (Table in page 2 and 6) including the decrease of moisture content to increase
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`stability of moisture-sensitive drugs (e.g., GCC agonist peptide ) as well as increase
`
`flow in making a capsule andtablet (page 12). Thus, one of ordinary would be more
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`likely than not to use a commercial product of an inert low moisture microcrystalline
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`cellulose (e.g., PH 112) according to the FMC’s manufacturer recommendation. Thus,
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`the prior rejection is maintained.
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
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`Page 13
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`Claims 2 and 24 rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable
`
`over Shailubhai et al. in view of Mihranyanet al. and Fretzen et al. as applied to claims
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`2-11, 14-16, 20-23, 25, and 43-44 and further in view of Currie et al. (WO 2005/016244,
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`cited in the prior action).
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`Claim 24 is drawn to the unit dosageform is a liquid-filled capsule.
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`Shailubhaiet al. in view of Mihranyan et al. and Fretzen et al. teach an oral
`
`dosage formulation comprising a GCC agonist peptide (e.g., SEQ ID NO: 1) from 0.01
`
`mg to 10 mg, has a chromatographic purity of no less than 91 %after storagefor at
`
`least three months and the formulation comprises an inert low moisture carrier as
`
`applied to claims 2-11, 14-16, 20-23, 25, and 43-44 described above.
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`Shailubhai et al. in view of Mihranyan et al. and Fretzen et al. teach the unit
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`dosage form can bein a capsule (e.g., Fretzen et al. 0072), but
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`they do not show the
`
`unit dosage formis a liquid-filled capsule.
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`Currie et al. teach the use of the peptide of SEQ ID NO: 1 consisting of Asn Asp
`
`Glu Cys Glu Leu Cys Val Asn Val Ala Cys Thr Gly Cys Leu (p27, line 17) for the
`
`treatment of gastrointestinal disorders (Abstract). Currie et al. teach the use of
`
`pharmaceutically acceptable inert carriers such as microcrystalline cellulose purchased
`
`from FMC corporation (p48, line 22-23) and lubricants to insure the stability of the
`
`peptide formulation (p48, line 1-5; 12-15). Currie et al. teach the oral peptide formulation
`
`is administered in a liposomal formulation or a capsule comprising a solution or a
`
`suspension in an aqueous liquid or a non-aqueous liquid (p46, line 12-17), reading on
`
`the limitation of claim 24.
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`4457
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
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`Page 14
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`It would have been obvious to one of ordinary skill in the art at the time the
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`invention was madeto combine the teachings (Shailubhai et al. in view of Mihranyan et
`
`al. and Fretzen et al.) with Currie’s formulation of a GCC analog peptide because Currie
`
`et al. teaches a GCC agonist peptide formulatedin a liquid-filled capsule is suitable for
`
`oral administration (p46, line 11-16).
`
`Responseto Arguments
`
`Applicant's argumentsfiled 11/20/2015 have been fully considered but they are
`
`not persuasive. See response to argument described above.
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`Conclusion
`
`No claim is allowed.
`
`Anyinquiry concerning this communication or earlier communications from the
`
`examiner should be directed to JIA-HAI LEE whosetelephone number is (571)270-
`
`1691. The examiner can normally be reached on Mon-Fri.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Karlheinz R. Skowronek can be reached on 571-272-9047. The fax phone
`
`numberfor the organization where this application or proceeding is assignedis 571 -
`
`273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`4458
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
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`Page 15
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`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on accessto the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automatedinformation
`
`system, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/J. LA/
`Examiner, Art Unit 1676
`
`29-December-2015
`
`/KARLHEINZ R SKOWRONEK/
`Supervisory Patent Examiner, Art
`Unit 1676
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`.
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`.
`
`Application/Control No.
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`13/421 ,769
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`JIA-HAI LEE
`U.S. PATENT DOCUMENTS
`
`Fretzen; Angelika|asika/ie11|K9/1611 pratt1
`
`Notice of References Cited Examiner
`
`Applicant(s)/Patent Under
`Reexamination
`
`COMISKEY ET AL.
`Art Unit
`1676
`
`Page 1 of |
`
`Ge
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`|US-2010/0048489AI|2010/0048489 A1 02-2010|2010
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`*A copyof this reference is not being furnished with this Office action. (See MPEP § 707.05(a).)
`Dates in MM-YYYYformat are publication dates. Classifications may be US or foreign.
`U.S. Patent and Trademark Office
`
`PTO-892 (Rev. 01-2001)
`20151228
`
`Notice of References Cited
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`Part of Paper No.
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`4460
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`4460
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`

`

`
`Application/Control No.
`Applicant(s)/Patent Under
`Reexamination
`COMISKEYETAL.
`
`Search Notes
`
`13421769
`
`
`
`Art Unit
`|| “
`ll
`Hi
`
`JIA-HAI LEE
`
`1676
`
`Examiner.Art Unit 1676
`
`poCSymbot|SCiate|Examiner
`
`(A61K2300/00 OR A61K38/10 OR A61K31/215 OR A61K8/731 OR|12/29/2015 JL
`C07D213/81 OR C07D213/56).CPC.
`
`CPC- SEARCHED
`
`CPC COMBINATION SETS - SEARCHED
`
`US CLASSIFICATION SEARCHED
`
`SEARCH NOTES
`
`Search Notes
`EAST, Database: USPATFUL, USPGPUB, EPO, JPO, DERWENT,
`Search history enclosed
`STN, Databases: Biosis, Embase, Medline, Caplus, Search history
`enclosed
`PALM Inventor Search
`STIC search, results available on SCORE
`
`12/29/2015
`
`JL
`
`12/29/2015
`
`12/29/2015
`05/29/2014
`
`JL
`
`JL
`
`INTERFERENCE SEARCH
`
`US Class/
`CPC Symbol
`
`US Subclass / CPC Group
`
`PF
`
`MJ.L/
`
`U.S. Patent and Trademark Office
`
`Part of Paper No.
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`: 20151228
`
`4461
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`4461
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`

`

`EAST Search History
`
`EAST Search History
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`
`
`EAST Search History (Prior Art)
`‘Default
`
`iSearch Query
`Sanneened Reneetenet heeeeeeeens! bacterineeeenna ficeeensetend haceneeeennetal bennettnetted
`
`
`
`(guanylate near cyclase near C) or US-PGPUB; USPAT;
`i GCC
`| USOCR; FPRS;
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`
`i EPO; JPO;
`DERWENT;
`
`% 1BM_TDB
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`
`
`
`4US-PGPUB; USPAT; ;
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`| USOCR: FPRS;
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`DERWENT;
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`
`4L46 and @py<"2011"
`4US-PGPUB; USPAT; :
`4 USOCR; FPRS;
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`4 EPO; JPO;
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`3 DERWENT;
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`Seanenenceeed Recentented MeeeeeeeeeeEEEEEEeeeened beneeenSreeeeeeeneenenetenented hanceeneenenerented heenenceennabeeeneeeeneee
`1
`|BM_TDB
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`
`
`
`
`4US-PGPUB; USPAT; |
`4GCC agonist peptide
`4 USOCR; FPRS;
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`EPO; JPO;
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`4} DERWENT:
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`4 1BM_TDB
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`
`
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`4US-PGPUB; USPAT; ;
`4GCC agonist peptide
`| USOCR:; FPRS;
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`EPO; JPO;
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`DERWENT;
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`
`
` %US-PGPUB; USPAT;
`L49 and tablet and process
` USOCR; FPRS;
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`4} EPO; JPO;
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`DERWENT;
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`*1BMTDB
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`
`
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`u(blister pack) with liquid
`4US-PGPUB; USPAT; |
`4 USOCR; FPRS;
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`EPO; JPO;
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`4 DERWENT;
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`4 1BM_TDB
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`
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`NUS-PGPUB; USPAT;}
`#L51 with capsule
`4 USOCR; FPRS;
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`EPO; JPO;
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`DERWENT;
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`4L52 same peptide
`4US-PGPUB; USPAT;
`4} USOCR; FPRS;
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`4} EPO; JPO;
`DERWENT;
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` %L52 and peptide
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`%US-PGPUB; USPAT; ;
`4 USOCR; FPRS;
`:
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`EPO; JPO;
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`DERWENT;
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`4 1BM_TDB
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`EASTSearchHistory.13421769_AccessibleVersion.htm[12/29/2015 9:59:41 AM]
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`EAST Search History
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`4US-PGPUB; USPAT; |
`4} USOCR; FPRS;
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`4 EPO; JPO;
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`4 DERWENT;
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`henceceented MeeeeeceeeeEEEeenesd benececereenacteneenteted haseeneeneneenented haereenecenennabeeenecient
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`4L55 and cyclase
`4US-PGPUB; USPAT;:
`4 USOCR; FPRS;
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`EPO; JPO;
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`4) DERWENT;
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`4 1BM_TDB
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