Electronic AcknowledgementReceipt
`
`Title of Invention:
`
`Formulations of Guanylate Cyclase C Agonists and Methods of Use
`
`First Named Inventor/Applicant Name:
`
`Stephen Comiskey
`
`Customer Number:
`
`58249
`
`Anne Elizabeth Fleckenstein
`
`Utility under 35 USC 111)
`
`Filer Authorized By:
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`Attorney Docket Number:
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`40737-509001US
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`Receipt Date:
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`
`19-FEB-2015
`
`15-MAR-2012
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`19:11:03
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKETNO.
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`CONFIRMATIONNO.
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`13/421,769
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`03/15/2012
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`Stephen Comiskey
`
`SYPA-009X01US
`321994-2142
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`3135
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`05/20/2015
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`7590
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`58249
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`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 receivedin 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) X Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`
`Paper No(s)/Mail Date 02/19/2015. ther
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20150427
`
`4137
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`4137
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`

`

`Application/Control Number: 13/421 ,769
`Art Unit: 1676
`
`Page 2
`
`DETAILED ACTION
`
`The present application is being examined underthe pre-AlA first to invent
`
`provisions.
`
`Priority
`
`This application is a CIP of PCT/US201 1/051805 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
`
`09/29/2010, and claims benefit of 61/892, 186 filed on 10/12/2010.
`
`Information Disclosure Statement
`
`The information disclosure statement (IDS) submitted on 02/19/2015 is in
`
`compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure
`
`statement has been considered by the examiner.
`
`Claim Status
`
`Claims 1-44 are pending.
`
`Claims 1, 12-13, 17-19, and 26-41 were withdrawnas being directed to a non-
`
`elected invention and species, the election having been made on 02/19/2015.
`
`Claims 2-11, 14-16, 20-25, and 42-44 have been examined.
`
`Any objections and/or rejections madein the office action dated 08/19/2014 and
`
`not specifically discussed belowin its original or modified form here are considered
`
`withdrawn.
`
`4138
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`4138
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
`
`Page 3
`
`Affidavit/ Declaration under 37 CFR 1.132
`
`The affidavit/declaration under 37 CFR 1.132 filed 07/16/2014 has beenfully
`
`considered, butit is insufficient to overcome the new ground of rejection. Mihranyan et
`
`al. (Int JU Pharm. 2004 Jan 28;269(2):433-42.) teach microcrystalline cellulose (MCC)is
`
`the most commonly used drug excipients but moisture in microcrystalline cellulose may
`
`cause stability problems for moisture sensitive drugs (Abstract; p433, col 1). Mihranyan
`
`et al. suggest the use of low moisture grades of commercial MCC product (1.5%, w/w,
`
`moisture in Avicel PH 112 and 3%, w/w, moisture in Avicel PH 103, FMC Corp.) for
`
`moisture sensitive drugs (p433, col 2). Avicel PH productinstruction from FMC (2005)
`
`showsthe advantagesof using Avicel PH products as a drug excipient of inert lower
`
`moisture carrier (Table in page 2 and 6) andfurther suggests the decrease of moisture
`
`content can increase stability of moisture-sensitive drugs and flow in making a capsule
`
`and tablet at page 12. The stability of peptide drugs was knownto be sensitive to
`
`temperature, moisture and excipients taught by Lai et al. in the Abstract (J Pharm Sci.
`
`1999 May:88(5):489-500. Review.).
`
`New groundsof rejections
`
`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 ordinary skill in the art to which
`
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`4139
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
`
`Page 4
`
`said subject matter pertains. Patentability shall not be negatived by the manner in which the
`invention was made.
`
`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:
`
`1. Determining the scope and contentsof the prior art.
`
`2. Ascertaining the differences betweenthe prior art and the claims at issue.
`
`3. Resolving the level of ordinary skill in the pertinentart.
`
`4. Considering objective evidence presentin the application indicating
`
`obviousness or nonobviousness.
`
`Claims 2-11, 16, 20-21, 23-24, and 42-44 are rejected under 35 U.S.C. 103(a) as
`
`being unpatentable over Shailubhai et al. (WO 02/078683 A1) in view of Currie et al.
`
`(WO 2005/016244) in view of Mihranyanetal. (Int J Pharm. 2004 Jan 28;269(2):433-
`
`42.) and in view of Avicel PH productinstruction (FMC 2005).
`
`This instant claim 2 is drawn to an oral dosage formulation comprising a
`
`guanylate cyclase C agonist peptide of SEQ ID NO: 1 at unit dose 0.01-10 mg with
`
`purity greater than 91% and aninert low moisture carrier.
`
`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. show the unit
`
`dosage of the GCC agonist peptide (p27, claim 22) is between 100 ug - 3 g (p4, line 20-
`
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`4140
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
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`Page 5
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`24) or 1 ug -10 mg (p/,line 14) and the purity of the GCC agonist peptide is >95%(p21,
`
`line 6), reading on claims 1 and 42-43.
`
`With respectto claim 3, Shailubhai et al. show the purity of the GCC agonist
`
`peptide is >95%(p21, line 6) in compliance with cGMP level (p21, Table 4).
`
`With respectto claim 4, Shailubhai et al. show the impurity of the GCC agonist
`
`peptide is < 5%, calculated as purity between 95%-100%(p21, line 6) in compliance
`
`with cGMP level (p21, Table 4).
`
`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. show the GCC agonist peptide has the
`
`dosage of once-a-day unit dose between 10 ug - 2 mg (p20, line 1-8).
`
`With respectto claim 8, Shailubhai et al. show the solid formulation of GCC
`
`agonist peptide in a unit dose is powders, tablets, and capsules (p17, line 44-49).
`
`With respectto claims 9, Shailubhai et al. show the pharmaceutically acceptable
`
`excipients comprise a pharmaceutical carrier of cellulose (p18, line 11-19).
`
`With respectto claim 21, Shailubhai et al. show the oral dosage formulation of
`
`GCC agonist peptideis in the form of a capsule or tablet (p17, line 44-49).
`
`Shailubhai et al. 1) do not specify the cellulose used is an inert carrier of
`
`microcrystalline cellulose and 2) do not specify the cellulose usedis an inert low
`
`moisture carrier.
`
`Currie et al. teach the use of the peptide of SEQ ID NO: 1 consisting of Asn Asp
`
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
`
`Page 6
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`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 administeredin a liposomal formulation or a capsule comprising a suspension in an
`
`aqueous liquid (p46, line 12-17), reading on claims 2, 16, and 23-24.
`
`Mihranyan et al. (Int J Pharm. 2004 Jan 28;269(2):433-42.) teach microcrystalline
`
`cellulose (MCC) is the most commonly used drug excipients as taught by Currie etal.
`
`(p48, line 22), but moisture in microcrystalline cellulose may cause stability problems for
`
`moisture sensitive drugs (Abstract; p433, col 1), reading on peptide drugs. Mihranyan et
`
`al. suggestthe use of 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), reading on claims 2, 9-10, and 16. With respect
`
`to claims 20 and 44, it is noted the same peptide composition having the same
`
`components must have the same properties. These properties are presumed to be
`
`present in any composition that meets the structural requirements of the claim, absent
`
`evidence to the contrary.
`
`If this is not the case, then applicant is either missing
`
`essential subject matter from the claims, not enabled for the full scope of the claims, or
`
`both. 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, 2.13), reading on claim 5. The inherent property of particle size is
`
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
`
`Page 7
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`50 uM for Avicel PH 103 and 100 uM for Avicel PH 112, reading on claim 11 evidenced
`
`in Avicel PH productinstruction (Table in page 6).
`
`Avicel PH productinstruction shows the advantages andinherent properties of
`
`particle size in using Avicel PH products as a drug excipient (Table in page 2 and 6)
`
`including the decrease of moisture content can increase stability of moisture-sensitive
`
`drugs (e€.g., GCC agonist peptide ) as well as increase flow in making a capsule and
`
`tablet (page 12). Thus, one of ordinary would use a commercial product of an inert low
`
`moisture microcrystalline cellulose (e.g., PH 112) according to the FMC’s manufacturer
`
`recommendation.
`
`It would have been obvious to one of ordinary skill in the art at the time the
`
`and Currie et al. teach the use of a
`
`invention was made to combine
`
`Shailubhai’s a guanylate cyclase C
`
`agonist peptide SEQ ID NO: 1 with
`
`Currie’s teaching of pharmaceutically
`
`acceptable inert carriers because
`
`Shailubhai’s peptide of SEQ ID NO: 1 is
`
`identical to Currie’s peptide (p27, line 17)
`
`commercial pharmaceutically acceptable
`
`inert carrier of microcrystalline cellulose (e.g., PH 103) purchased from FMC corporation
`
`(p48, line 22-23) to insure the stability of the peptide formulation (p48, line 1-5; 12-15;
`
`line 22). It would be further obvious to combine the teachings (Shailubhai in view of
`
`4143
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`4143
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`

`

`Application/Control Number: 13/421 ,769
`Art Unit: 1676
`
`Page 8
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`Currie) with Mihranyan’s low moisture grades of microcrystalline cellulose (1.5%, w/w,
`
`moisture in Avicel PH 112 and 3%, w/w, moisture in Avicel PH 103) sold by FMC Corp
`
`(p433, col 2). because Shailubhai in view of Currie teach a guanylate cyclase C agonist
`
`peptide (SEQ ID NO: 1) formulated with an inert carrier of microcrystalline cellulose
`
`from in an oral dosage composition and Mihranyanet al. teach moisture in
`
`microcrystalline cellulose may causestability problems for moisture sensitive drugs
`
`(e.g., peptide drug) and suggest the use low moisture grades of microcrystalline
`
`cellulose (1.5%, w/w, moisture in Avicel PH 112 and 3%, w/w, moisture in Avicel PH
`
`103) sold by FMC Corp consistent with Currie’s teaching (p48, line 22-23). Avicel PH
`
`productinstruction from FMC would demonstrate the common knowledgeof an inert low
`
`moisture grades of microcrystalline cellulose excipient and inherent properties of Avicel
`
`PH products used in drug manufacturing. The teaching/suggestion/motivation to
`
`combine the references is described above to establish a prima facie case of
`
`obviousness met the requirement described in MPEP 2143 and the combination would
`
`have yielded nothing more than predictable successto one of ordinary skill in the art at
`
`the time of the invention.
`
`Claims 2, 14-16, 20-22, 25, and 44 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over Shailubhai et al. (WO 02/078683 A1) in view of Currie et al. (WO
`
`2005/016244) in view of Mihranyan etal. (Int J Pharm. 2004 Jan 28;269(2):433-42.) and
`
`in view of Avicel PH productinstruction (FMC 2005) as applied to claims 2-11, 16, 21,
`
`23-24, and 42-43 andfurtherin view of Fretzen et al. (WO 2010/027404 A2).
`
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
`
`Page 9
`
`This instant claim 2 is drawn to an oral dosage formulation comprising a
`
`guanylate cyclase C agonist peptide of SEQ ID NO: 1 at unit dose 0.01-10 mg with
`
`purity greater than 91% and aninert low moisture carrier.
`
`Shailubhai in view of Currie in view of Mihranyan andin view of Avicel PH
`
`productinstruction teach an oral dosage formulation comprising a guanylate cyclase C
`
`agonist peptide of SEQ ID NO: 1 at unit dose 0.01-10 mg with purity greater than 91%
`
`and an inert low moisture carrier (e.g., Avicel PH 112) described above.
`
`Shailubhai in view of Currie in view of Mihranyan andin view of Avicel PH
`
`productinstruction do not specify the ratio for an excipient of an amino acid to a
`
`therapeutic peptide in the therapeutic composition.
`
`Fretzen et al. teach a peptide formulation for oral administration comprises (a) an
`
`aqueous coating solution, a therapeutic peptide, a sterically hindered primary amine
`
`(e.g., amino acid of leucine) and (b) a pharmaceutically acceptable/SATYANARAYANA
`
`R GUDIBANDE/
`
`Primary Examiner, Art Unit 1676 carrieroffiller (06, line 10-18) to form the tablets
`
`or to be placed into capsules (p6, line 24-25). Fretzen et al. suggest the lubricant of the
`
`peptide composition can be the amino acid leucine (p9, line 8).
`
`With respectto claims 14-15, Fretzen et al. suggest the molar ratio of an amino
`
`acid of leucine (comprising a primary amine) to the therapeutic peptide is ranged from
`
`5:1 to 50:1 (p7, line 32-34 bridging to p8, line 1-5).
`
`With respectto claim 16, Fretzen et al. suggest a formulation consists of a
`
`therapeutic peptide, an inert carrier of a microcrystalline cellulose (p9, line 1-6) anda
`
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
`
`lubricant of an amino acid leucine (p9, line 8).
`
`Page 10
`
`With respectto claims 20 and 44, Fretzenetal. further suggest the formulated
`
`peptide is stabilized against degradation, less than 2% degradation, after 18-24 months
`
`of storage at 25°C and 60%relative humidity (p2, line 15-21).
`
`With respectto claim 21, Fretzen et al. suggestfinal pharmaceutical composition
`
`is in the form of tablets or to be placed into capsules (p6, line 24-25).
`
`With respectto claim 22, Fretzen et al. suggest the use of a blister pack with
`
`individual dosesof a tablet for pressing out of the pack according to a therapeutic
`
`schedule (p16, line 2-3).
`
`With respectto claim 25, Fretzen et al. suggest the use of special oil, e.g.,
`
`mineral oil or vegetable oil, as a lubricant and/or glidant in the oral dosage composition
`
`(p9, line 9).
`
`It would have been obvious to one of ordinary skill in the art at the time the
`
`invention was madeto combine the teachings (Shailubhai et al. in view of Currie etal. in
`
`view of Mihranyan etal. and in view of Avicel PH productinstruction) with Fretzen
`
`teaching of leucine in a peptide formulation because Shailubhaiet al. in view of Currie
`
`et al. in view of Mihranyanet al. and in view of Avicel PH productinstruction teach an
`
`oral dosage formulation comprising the peptide of SEQ ID NO: 1 and an inert low
`
`moisture carrier of microcrystalline cellulose excipient and Fretzenet al. teach
`
`microcrystalline cellulose can be used asa filler together with a glidant/lubricant of
`
`leucine and the ratio of leucine to a therapeutic peptide in a composition (p9, line 19-
`
`21). The teaching/suggestion/motivation to combine the referencesis described above
`
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`Application/Control Number: 13/421 ,769
`Art Unit: 1676
`
`Page 11
`
`to establish a prima facie case of obviousness met the requirement described in MPEP
`
`2143 and the combination would have yielded nothing morethan predictable success to
`
`one of ordinary skill in the art at the time of the invention.
`
`DP
`
`Conclusion
`
`No claim is allowed.
`
`Applicant's amendmentnecessitated the new ground(s)of rejection presentedin
`
`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
`
`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
`
`CFR 1.136(a).
`
`A shortened statutory period for reply to this fina