`
`AMENDMENT AFTER FINAL
`EXPEDITED PROCESSING
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`PATENT
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`Customer No. 6449
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`Application No. 14/308,279
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In re Application of:
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`Roberto VILLA et a].
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`Application No.: 14/308,279
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`Filed:
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`June 18. 2014
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`For:
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`CONTROLLED RELEASE AND
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`TASTE MASKING ORAL
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`PHARMACEUTICAL
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`COMPOSITIONS
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`Group Art Unit: 1615
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`Examiner: Susan T. Tran
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`Confirmation No.: 9778
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`Vvvvvvvvvv
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`Mail Stop AF
`Commissioner for Patents
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`PO. Box 1450
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`Alexandria. VA 22313-1450
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`Sir or Madam:
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`This paper is being submitted as a response to the Office Action dated 11 December 2015.
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`This Response is timely submitted before the 11 March 2016 due date. Although the Applicants
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`do not believe any additional fees are required. the Commissioner is authorized to charge any
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`additional fees. including extension fees or other relief. which may be required, or credit any
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`overpayment to Deposit Account No. 02-2135.
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`Amendments to the Claims begin on page 2.
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`Remarks begin on page 7.
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`Application No. 14/308279
`Amendment dated 17 February 2016
`Reply to Office Action dated 1 1 December 2015
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`W
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`This listing of claims will replace all prior versions and listings of claims in the
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`application.
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`Listing of Claims
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`l.
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`(Currently Amended) A controlled release oral pharmaceutical composition comprising:
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`(i) budesonide in an amount effective to treat intestinal inflammatory disease;
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`(ii) a macroscopically homogenous structure comprising:
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`(a) at least one lipophilic compound and
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`(b) at least one hydrophilic compound.
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`wherein the macroscopically homogenous structure controls the release of
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`the budcsonide; and
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`(iii)
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`a gastro-resistant coating on the macroscopically homogenous structure that
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`prevents release of budesonide in the stomachA
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`wherein the macroscopically homogenous structure is a tablet.
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`(Canceled)
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`'u)
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`(Original) The controlled release oral pharmaceutical composition according to claim 1.
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`wherein the gastro-resistant coating is at
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`least one compound selected from the group
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`consisting of methacrylic acid polymers and cellulose derivatives.
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`(Original) The controlled release oral pharmaceutical composition according to claim 1,
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`wherein the at least one hydrophilic compound is selected from the group consisting of an
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`acrylic or methacrylic acid polymer or copolymer. an alkylvinyl polymer, a hydroxyalkyl
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`cellulose. a carboxyalkyl cellulose. a polysaccharide, dextrin. pectin. starch, a natural or
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`synthetic gum, and alginic acid.
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`Application No. 14/308279
`Amendment dated 17 February 2016
`Reply to Office Action dated 1 1 December 2015
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`(Original) The controlled release oral pharmaceutical composition according to claim 1,
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`wherein the at
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`least one hydrophilic compound is a hydroxyalkyl cellulose or a
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`carboxyalkyl cellulose.
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`(Previously Presented) The controlled release oral pharmaceutical composition according to
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`claim 3. wherein the at least one hydrophilic compound is a hydroxyalkyl cellulose.
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`(Original) The controlled release oral pharmaceutical composition according to claim 1.
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`further comprising at least one amphiphilic compound.
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`(Currently amended) The controlled release oral pharmaceutical composition according to
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`claim 7. wherein the at least one [[amphiliphilcj] amphiphilic compound is selected from
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`the group consisting of lecithin. phosphatidylcholinc. phosphatidylethanolaminc. ceramide.
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`and a glycol alkyl ether.
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`(Original) The controlled release oral pharmaceutical composition according to claim 7,
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`wherein the at least one amphiphilic compound is lecithin.
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`10.
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`(Original) The controlled release oral pharmaceutical composition according to claim 1.
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`wherein the at least one lipophilic compound is selected from the group consisting of an
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`unsaturated or hydrogenated alcohol or fatty acid. salt, ester. or amide thereof, a fatty acids
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`mono-. di- or triglyceride. or a polycthoxylated derivative thereof. a wax, ceramide. and a
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`cholesterol derivative.
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`11.
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`12.
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`(Original) The controlled release oral pharmaceutical composition according to claim 1,
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`wherein the at least one lipophilic compound is stearic acid.
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`(Original) The controlled release oral pharmaceutical composition according to claim 1.
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`further comprising at least one compound selected from the group consisting of a chitosan,
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`a polyacrylamide, a natural or synthetic gum. and an acrylic acid polymer.
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`Application No. 14/308.279
`Amendment dated 17 February 2016
`Reply to Office Action dated 1 1 December 2015
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`(Currently Amended) A controlled release oral pharmaceutical composition comprising:
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`(i) budesonide in an amount effective to treat intestinal inflammatory disease;
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`(ii) a macroscopically homogcnous structure comprising:
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`(a) at least one amphiphilic compound and
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`(b) at least one hydrophilic compound.
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`wherein the macroscopically homogenous structure controls the release of
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`the budesonide; and
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`(iii)
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`a gastro-resistant coating on the macroscopically homogenous structure that
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`prevents release of budesonide in the stomach:
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`wherein the macroscopically homogenous structure is a tablet.
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`(Canceled)
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`(Original) The controlled release oral pharmaceutical composition according to claim 13,
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`wherein the gastro-resistant coating is at
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`least one compound selected from the group
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`consisting of methacrylic acid polymers and cellulose derivatives.
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`(Original) The controlled release oral pharmaceutical composition according to claim 13,
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`wherein the at least one hydrophilic compound is selected from the group consisting of an
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`acrylic or methacrylic acid polymer or copolymcr, an alkylvinyl polymer, a hydroxyalkyl
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`cellulose. a carboxyalkyl cellulose. a polysaccharide, dextrin. pectin, starch, a natural or
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`synthetic gum. and alginic acid.
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`(Original) The controlled release oral pharmaceutical composition according to claim 13,
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`wherein the at
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`least one hydrophilic compound is a hydroxyalkyl cellulose or a
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`carboxyalkyl cellulose.
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`(Previously Presented) The controlled release oral pharmaceutical composition according to
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`claim 13, wherein the at least one hydrophilic compound is a hydroxyalkyl cellulose.
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`14.
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`15.
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`16.
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`17.
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`18.
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`Application No. 14/308279
`Amendment dated 17 February 2016
`Reply to Office Action dated 1 1 December 2015
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`19.
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`20.
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`21.
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`22.
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`23.
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`24.
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`(Original) The controlled release oral pharmaceutical composition according to claim 13,
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`wherein the at least one amphiphilic compound is selected from the group consisting of
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`lecithin. phosphatidylcholine. phosphatidylcthanolamine. ceramidc, and a glycol alkyl
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`ether.
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`(Original) The controlled release oral pharmaceutical composition according to claim 13,
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`wherein the at least one amphiphilic compound is lecithin.
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`(Original) The controlled release oral pharmaceutical composition according to claim 13,
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`further comprising at least one lipophilic compound selected from the group consisting of
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`an unsaturated or hydrogenated alcohol or fatty acid, salt. ester, or amide thereof. a fatty
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`acids mono-, di- or triglyceride, or a polyethoxylated derivative thereof, a wax, ceramide,
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`and a cholesterol derivative.
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`(Original) The controlled release oral pharmaceutical composition according to claim 21,
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`wherein the at least one lipophilic compound is stearic acid.
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`(Original) The controlled release oral pharmaceutical composition according to claim 13,
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`further comprising at least one compound selected from the group consisting of a chitosan,
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`a polyacrylamide, a natural or synthetic gum. and an acrylic acid polymer.
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`(Currently Amended) A controlled release oral pharmaceutical composition comprising:
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`(i) budesonide in an amount effective to treat intestinal inflammatory disease;
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`(ii) a macroscopically homogenous structure comprising:
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`(a) budesonide;
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`(b) at least one amphiphilic compound;
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`(c) at least one lipophilic compound; and
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`(d) at least one hydrophilic compound.
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`wherein the macroscopically homogenous structure controls the release of
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`the budesonide; and
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`Application No. 14/308279
`Amendment dated 17 February 2016
`Reply to Office Action dated 1 1 December 2015
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`(iii)
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`a gastro-resistant coating on the macroscopically homogenous structure that
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`prevents release of budesonide in the stomacha
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`wherein the macroscopically homogenous structure is a tablet.
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`25.
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`(Canceled)
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`26.
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`(Canceled)
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`27.
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`28.
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`29.
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`30.
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`(Original) The controlled release oral pharmaceutical composition according to claim 24,
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`further comprising at least one compound selected from the group consisting of a chitosan,
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`a polyacrylamide. a natural or synthetic gum. and an acrylic acid polymer.
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`(Original) The controlled release oral pharmaceutical composition according to claim 1.
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`wherein the macroscopically homogenous structure comprises microcrystalline cellulose.
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`(Original) The controlled release oral pharmaceutical composition according to claim 13,
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`wherein the macroscopically homogenous structure comprises microcrystalline cellulose.
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`(Original) The controlled release oral pharmaceutical composition according to claim 24.
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`wherein the macroscopically homogenous structure comprises microcrystalline cellulose.
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`(Original) A method for treating intestinal inflammatory disease comprising administering
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`to a patient the controlled release oral pharmaceutical composition according to claim 1.
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`32.
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`(Original) A method for treating intestinal inflammatory disease comprising administering
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`to a patient the controlled release oral pharmaceutical composition according to claim 13.
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`(Original) A method for treating intestinal inflammatory disease comprising administering
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`to a patient the controlled release oral pharmaceutical composition according to claim 24.
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`Application No. 14/308279
`Amendment dated 17 February 2016
`Reply to Office Action dated 1 1 December 2015
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`W221:
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`REMARKS
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`Claims 1—33 are currently pending and under examination.
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`Claim 1 has been amended by incorporating the limitation of claim 2.
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`Claim 13 has been amended by incorporating the limitation of claim 14.
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`Claim 24 has been amended by incorporating the limitation of claim 25.
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`Claims 2, 14. 25 and 26 have been canceled.
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`All amendments here are made without prejudice. Applicants reserve the right
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`to
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`reintroduce the combinations of features claimed in the original claims or to add additional claims
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`either later during the prosecution of the present application or in applications related to the present
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`one. like continuation. divisional. and continuation-impart applications.
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`Applicants submit that no new matter has been added. and entry of these amendments is
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`requested
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`Allowable Claims
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`Applicant acknowlege the Examiner’s indication that claims 2-12, 14-23, 25 and 27-33
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`would be allowable.
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`'
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`ti n an r
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`'1 2
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`Claims 1. 13. 24. and 26 are rejected under pre-AIA 35 U.SC. § 102(e) as being anticipated
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`by Hallgren et al. (US. Patent No. 6.239.120). Without acquiescing in the propriety of this
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`rejection. Applicant has amended claims 1, 13 and 24 to include the limitations of allowable claims
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`2, 14, and 25. respectively. and has canceled claim 26.
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`In view of these amendments, Applicant
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`submits that this rejection has been obviated, and its withdrawal is requested.
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`Claims 1. 13. 24. and 26 are rejected under pre-AIA 35 U.SC. 102(b) as being anticipated
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`by Friend et al. (US. Patent No. 5.811.388). Without acquiescing in the propriety of this rejection.
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`Applicant has amended claims 1. l3 and 24 to include the limitations of allowable claims 2. 14,
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`and 25. respectively. and has canceled claim 26.
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`In view of these amendments. Applicant submits
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`that this rejection has been obviated. and its withdrawal is requested.
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`7
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`Application No. 14/308279
`Amendment dated 17 February 2016
`Reply to Office Action dated 1 1 December 2015
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`' u n
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`u l
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`ntin
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`'
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`' I
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`Applicant notes that the Examiner had made several obviousness-type double patenting
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`(ODP) rejections in the Office Action dated 8 July 2015.
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`In response to the ODP rejections over
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`(a) copending Application No. 13/462409 (now Patent No. 8,293,723), (b) Patent No. 7,410,651.
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`(c) Patent No. 7,431,943, ((1) Patent No. 8,029,823 (now RE43799) and (e) Patent No. 8.787.888
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`(which properly should be 8,784,888 as noted by Applicant in the response filed 8 October 2015),
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`Applicant filed a Terminal Disclaimer on 8 October 2015.
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`In the instant Office Action.
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`the
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`Examiner noted that the Terminal Disclaimer has been recorded and as a result the ODP rejections
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`were withdrawn.
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`Applicant has learned on PAIR that the Terminal Disclaimer was disqualified after the
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`mailing date of the instant Office Action because the signor of the Power of Attorney of record
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`failed to state that he/she is authorized to act on behalf of Applicant.
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`In order to remedy this
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`disqualification, Applicant submits herewith a new Power of Attorney which includes the
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`necessary statement. A new Terminal Disclaimer is also being filed in view of this new Power of
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`Attorney.
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`For the sake of completeness, Applicant notes that in the Office Action dated 8 July 2015,
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`the Examiner also rejected claims 1-33 are rejected on the ground of nonstatutory obviousness-type
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`double patenting (GDP) as being unpatentable over claims 1-12 of U.S. Patent No. 8,895,064 in
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`view of U.S. publication No. 2014/0302143 (the ‘143 publication).
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`In the response dated 8
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`October 2015. Applicant noted that
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`the ‘143 publication corresponds to U.S. Application No.
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`14/308,305, which was filed on 18 June 2014 and which claims priority to PCT/EP00/05356, filed
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`9 June 2000. By comparison. the present application was filed on 18 June 2014 and claims priority
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`to PCT/EP00/05356 filed on 9 June 2000. Hence, the ‘143 publication does not constitute a prior
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`art reference against the instant application. and consequently this ODP rejection is improper.
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`Based on the Examiner’s comments in the instant Office Action, it appears that this ODP rejection
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`was withdrawn on the basis of these remarks.
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`In view of the concurrently filed Power of Attorney, the currently filed Terminal Disclaimer
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`and the above remarks (incorporated from the response dated 8 October 2015), Applicant submits
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`8
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`Application No. 14/308279
`Amendment dated 17 February 2016
`Reply to Office Action dated 1 1 December 2015
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`that the obviousness-type double patenting rejections have been overcome. Withdrawal of these
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`rejections is requested.
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`mm
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`In view of the above amendments and remarks, it is submitted that the claims pending in
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`this application satisfy the requirements of the patent statutes and are patentable over the prior an
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`of record. Reconsideration of this application and a notice of allowance are requested. The
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`Examiner is invited to telephone the undersigned if it will assist in expediting the prosecution and
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`allowance of the instant application.
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`Respectfully submitted,
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`ROTHWELL. FIGG. ERNST & MANBECK, p.c.
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`By
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`/Jeffrey L. Ihnen/
`Jeffrey L. Ihncn
`Registration No. 28.957
`Attorney for Applicants
`607 14th Street. N.W., Suite 800
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`Washington, DC. 20005
`Phone: 202—783—6040
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`Fax:
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`202-783-6031
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