MAIL STOP AF
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`AMENDMENT AFTER FINAL
`EXPEDITED PROCESSING
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`PATENT
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`Customer No. 6449
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`Application No. 143308279
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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 at (£1.
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`Application No.: 14808279
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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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`COM POSITIONS
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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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`vva—Ix—IVVM—Ix—dv
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`Mail Stop AF
`Commissioner for Patents
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`P.O. 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. 14808279
`
`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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`1.
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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 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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`DJ
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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 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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`Application No. 14808279
`
`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 [[amphiliphilc]] amphiphilic compound is selected from
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`the group consisting of lecithin. phosphatidylcholine. phosphatidylethanolamine. 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 polyethoxylated 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 slearic 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. 14808279
`
`Amendment dated 17 February 2016
`Reply to Office Action dated 1 1 December 2015
`
`(Currently Amended) A controlled release oral pharmaceutical composition comprising:
`
`(i) budesonide in an amount effective to treat intestinal inflammatory disease;
`
`(ii) a macroscopically homogenous structure comprising:
`
`(a) at least one amphiphilic compound and
`
`(b) at least one hydrophilic compound,
`
`wherein the macroscopically homogcnous 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 stomacha
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`wherein the macroscopically homogenous structure is a tablet.
`
`(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 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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`(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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`1'7.
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`18.
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`Application No. 14808279
`
`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. phosphatidylethanolamine. 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 polyethoxylatcd 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;
`
`(ii) a macroscopically homogenous structure comprising:
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`(a) budesonide;
`
`(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 homogcnous structure controls the release of
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`the budesonide; and
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`Application No. 14808279
`
`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 stomach:
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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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`27.
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`28.
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`29.
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`30.
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`31.
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`(Canceled)
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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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`(Original) A method [or 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. 14f308,279
`
`Amendment dated 17 February 2016
`Reply to Office Action dated 1 1 December 2015
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`REMARKS
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`W C
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`laims 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—in—part 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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`R'tinundr
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`.
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`'12
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`Claims 1, 13. 24, and 26 are rejected under pre-AIA 35 U.SC. § 102(c) as being anticipated
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`by Hallgren et a1. (U.S. 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 a1. (U.S. Patent No. 5,811,388). Without acquiescing in the propriety of this rejection,
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`Applicant has amended claims l, 13 and 24 to include the limitations of allowable claims 2, l4,
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`and 25, respectively, and has canceled claim 26. 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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`3’
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`Application No. 14808279
`
`Amendment dated 17 February 2016
`Reply to Office Action dated 1 1 December 2015
`
`Qfigigusngfl Dguflg Pgtgnting Rmtigng
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`Applicant notes that the Examiner had made several obviousness—typc 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. 13f462409 (now Patent No. 8,293,723). (b) Patent No. 7,410,651.
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`(c) Patent No. 7,431,943, (d) Patent No. 8,029,823 (now RE43799) and (e) Patent No. 8,782,888
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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 hcfshc 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 (ODP) 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. 2014f0302l43 (the ‘143 publication).
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`In the response dated 8
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`October 2015, Applicant noted that the “143 publication corresponds to U.S. Application No.
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`14808305, which was filed on 18 June 2014 and which claims priority to PCTIEP00f05356, 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 PCTIEP00r’05356 filed on 9 June 2000. Hence, the ‘143 publication does not constitute a prior
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`art reference against
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`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. 14808279
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`Amendment dated 1? 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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`W I
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`n 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 art
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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 & MAN BECK. p.c.
`
`By
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`{Jeffrey L. Ihnem’
`
`Jeffrey L. Hinen
`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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