MAIL STOP AF
`AMENDMENTAFTER FINAL
`EXPEDITED PROCESSING
`
`PATENT
`
`Customer No. 6449
`Application No. 14/308,279
`
`IN THE UNITED STATES PATENT AND TRADEMARKOFFICE
`
`In re Application of:
`
`Roberto VILLAefal.
`
`Application No.: 14/308,279
`
`Filed:
`
`June 18, 2014
`
`For:
`
`CONTROLLED RELEASE AND
`TASTE MASKING ORAL
`
`PHARMACEUTICAL
`COMPOSITIONS
`
`~—_—_—ii
`
`Group Art Unit: 1615
`
`Examiner: Susan T. Tran
`
`Confirmation No.: 9778
`
`Mail Stop AF
`Commissionerfor Patents
`
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir or Madam:
`
`This paper is being submitted as a response to the Office Action dated 11 December 2015.
`
`This Responseis timely submitted before the 11 March 2016 due date. Although the Applicants
`
`do not believe any additional fees are required, the Commissioner is authorized to charge any
`
`additional fees, including extension fees or other relief, which may be required, or credit any
`
`overpayment to Deposit Account No. 02-2135.
`
`Amendments to the Claims begin on page 2.
`
`Remarksbegin on page 7.
`
`Cosmo Ex. 2013-p. 1
`Argentum v Cosmo
`IPR2018-00080
`
`Cosmo Ex. 2013-p. 1
`Argentum v Cosmo
`IPR2018-00080
`
`

`

`Application No. 14/308,279
`Amendment dated 17 February 2016
`Reply to Office Action dated 11 December 2015
`
`
`
`AMENDMENTSTOTHECLAIMS
`
`This listing of claims will replace all prior versions andlistings of claims in the
`
`application.
`
`Listing of Claims
`
`I.
`
`(Currently Amended) A controlled release oral pharmaceutical composition comprising:
`
`(i) budesonide in an amounteffective to treat intestinal inflammatory disease;
`
`(ii) a macroscopically homogenousstructure comprising:
`
`(a) at least one lipophilic compoundand
`
`(b) at least one hydrophilic compound,
`
`wherein the macroscopically homogenous structure controls the release of
`
`the budesonide; and
`
`(iii)
`
`a gastro-resistant coating on the macroscopically homogenous structure that
`
`prevents release of budesonide in the stomach,
`
`wherein the macroscopically homogenousstructure is a tablet.
`
`‘2:
`
`3.
`
`(Canceled)
`
`(Original) The controlled release oral pharmaceutical composition according to claim 1,
`
`wherein the gastro-resistant coating is at
`
`least one compound selected from the group
`
`consisting of methacrylic acid polymers and cellulose derivatives.
`
`4.
`
`(Original) The controlled release oral pharmaceutical composition according to claim 1,
`
`wherein the at least one hydrophilic compoundis selected from the group consisting of an
`
`acrylic or methacrylic acid polymer or copolymer, an alkylvinyl polymer, a hydroxyalkyl
`
`cellulose, a carboxyalkyl cellulose, a polysaccharide, dextrin, pectin, starch, a natural or
`
`synthetic gum,and alginic acid.
`
`Cosmo Ex. 2013-p. 2
`Argentum v Cosmo
`IPR2018-00080
`
`Cosmo Ex. 2013-p. 2
`Argentum v Cosmo
`IPR2018-00080
`
`

`

`Application No. 14/308,279
`Amendment dated 17 February 2016
`Reply to Office Action dated 11 December 2015
`
`(Original) The controlled release oral pharmaceutical composition according to claim 1,
`
`wherein the at
`
`least one hydrophilic compound is a hydroxyalkyl cellulose or a
`
`carboxyalkyl] cellulose.
`
`(Previously Presented) The controlled release oral pharmaceutical composition according to
`
`claim 3, wherein the at least one hydrophilic compoundis a hydroxyalkyl cellulose.
`
`(Original) The controlled release oral pharmaceutical composition according to claim 1,
`
`further comprising at least one amphiphilic compound.
`
`(Currently amended) The controlled release oral pharmaceutical composition according to
`
`claim 7, wherein the at least one [[amphiliphilc]] amphiphilic compound is selected from
`
`the group consisting of lecithin, phosphatidylcholine, phosphatidylethanolamine, ceramide,
`
`and a glycol alkyl ether.
`
`(Original) The controlled release oral pharmaceutical composition according to claim 7,
`
`wherein the at least one amphiphilic compoundis lecithin.
`
`10.
`
`(Original) The controlled release oral pharmaceutical composition according to claim 1,
`
`wherein the at least one lipophilic compoundis selected from the group consisting of an
`
`unsaturated or hydrogenated alcoholor fatty acid, salt, ester, or amide thereof, a fatty acids
`
`mono-, di- or triglyceride, or a polyethoxylated derivative thereof, a wax, ceramide, and a
`
`cholesterol derivative.
`
`11.
`
`(Original) The controlled release oral pharmaceutical composition according to claim 1,
`
`wherein the at least one lipophilic compoundis stearic acid.
`
`12.
`
`(Original) The controlled release oral pharmaceutical composition according to claim 1,
`
`further comprising at least one compoundselected from the group consisting of a chitosan,
`
`a polyacrylamide, a natural or synthetic gum, and an acrylic acid polymer.
`
`Cosmo Ex. 2013-p. 3
`Argentum v Cosmo
`IPR2018-00080
`
`Cosmo Ex. 2013-p. 3
`Argentum v Cosmo
`IPR2018-00080
`
`

`

`Application No. 14/308,279
`Amendment dated 17 February 2016
`Reply to Office Action dated 11 December 2015
`
`(Currently Amended) A controlled release oral pharmaceutical composition comprising:
`
`(i) budesonide in an amounteffective to treat intestinal inflammatory disease;
`
`(ii) a macroscopically homogenousstructure comprising:
`
`(a) at least one amphiphilic compound and
`
`(b) at least one hydrophilic compound,
`
`wherein the macroscopically homogenous structure controls the release of
`
`the budesonide; and
`
`(iii)
`
`a gastro-resistant coating on the macroscopically homogenous structure that
`
`prevents release of budesonide in the stomach,
`
`wherein the macroscopically homogenousstructure is a tablet.
`
`14.
`
`(Canceled)
`
`IS:
`
`(Original) The controlled release oral pharmaceutical composition according to claim 13,
`
`wherein the gastro-resistant coating is at
`
`least one compound sclected from the group
`
`consisting of methacrylic acid polymers and cellulose derivatives.
`
`16.
`
`(Original) The controlled release oral pharmaceutical composition according to claim 13,
`
`wherein the at least one hydrophilic compound is selected from the group consisting of an
`
`acrylic or methacrylic acid polymer or copolymer, an alkylvinyl polymer, a hydroxyalkyl
`
`cellulose, a carboxyalkyl cellulose, a polysaccharide, dextrin, pectin, starch, a natural or
`
`synthetic gum, and alginic acid.
`
`17:
`
`(Original) The controlled release oral pharmaceutical composition according to claim 13,
`
`wherein the at
`
`least one hydrophilic compound is a hydroxyalkyl cellulose or a
`
`carboxyalkyl cellulose.
`
`18.
`
`(Previously Presented) The controlled release oral pharmaceutical composition according to
`
`claim 13, wherein the at least one hydrophilic compoundis a hydroxyalkyl cellulose.
`
`Cosmo Ex. 2013-p. 4
`Argentum v Cosmo
`IPR2018-00080
`
`Cosmo Ex. 2013-p. 4
`Argentum v Cosmo
`IPR2018-00080
`
`

`

`Application No. 14/308,279
`Amendment dated 17 February 2016
`Reply to Office Action dated 11 December 2015
`
`19;
`
`(Original) The controlled release oral pharmaceutical composition according to claim 13,
`
`wherein the at least one amphiphilic compound is selected from the group consisting of
`
`lecithin, phosphatidylcholine, phosphatidylethanolamine, ceramide, and a glycol alkyl
`
`ether.
`
`20.
`
`(Original) The controlled release oral pharmaceutical composition according to claim 13,
`
`wherein the at least one amphiphilic compoundis lecithin.
`
`21.
`
`(Original) The controlled release oral pharmaceutical composition according to claim 13,
`
`further comprising at least one lipophilic compoundselected from the group consisting of
`
`an unsaturated or hydrogenated alcohol or fatty acid, salt, ester, or amide thereof, a fatty
`
`acids mono-, di- or triglyceride, or a polyethoxylated derivative thereof, a wax, ceramide,
`
`and a cholesterol derivative.
`
`ne
`
`(Original) The controlled release oral pharmaceutical composition according to claim 21,
`
`wherein the at least one lipophilic compoundis stearic acid.
`
`23.
`
`(Original) The controlled release oral pharmaceutical composition according to claim 13,
`
`further comprising at least one compoundselected from the group consisting of a chitosan,
`
`a polyacrylamide, a natural or synthetic gum, and an acrylic acid polymer.
`
`24.
`
`(Currently Amended) A controlled release oral pharmaceutical composition comprising:
`
`(i) budesonide in an amounteffective to treat intestinal inflammatory disease;
`
`(ii) a macroscopically homogenousstructure comprising:
`
`(a) budesonide;
`
`(b) at least one amphiphilic compound;
`
`(c) at least one lipophilic compound; and
`
`(d) at least one hydrophilic compound,
`
`wherein the macroscopically homogenous structure controls the release of
`
`the budesonide; and
`
`Cosmo Ex. 2013-p. 5
`Argentum v Cosmo
`IPR2018-00080
`
`Cosmo Ex. 2013-p. 5
`Argentum v Cosmo
`IPR2018-00080
`
`

`

`Application No. 14/308,279
`Amendment dated 17 February 2016
`Reply to Office Action dated 11 December 2015
`
`(iii)
`
`a gastro-resistant coating on the macroscopically homogenousstructure that
`
`prevents release of budesonide in the stomach,
`
`wherein the macroscopically homogenousstructureis a tablet.
`
`ons
`
`(Canceled)
`
`26.
`
`(Canceled)
`
`2h.
`
`(Original) The controlled release oral pharmaceutical composition according to claim 24,
`
`further comprising at least one compoundselected from the group consisting of a chitosan,
`
`a polyacrylamide, a natural or synthetic gum,and an acrylic acid polymer.
`
`28.
`
`(Original) The controlled release oral pharmaceutical composition according to claim 1,
`
`wherein the macroscopically homogenousstructure comprises microcrystalline cellulose.
`
`29.
`
`(Original) The controlled release oral pharmaceutical composition according to claim 13,
`
`wherein the macroscopically homogenousstructure comprises microcrystalline cellulose.
`
`30.
`
`(Original) The controlled release oral pharmaceutical composition according to claim 24,
`
`wherein the macroscopically homogenousstructure comprises microcrystalline cellulose.
`
`(Original) A method for treating intestinal inflammatory disease comprising administering
`
`to a patient the controlled release oral pharmaceutical composition according to claim 1.
`
`De.
`
`(Original) A method for treating intestinal inflammatory disease comprising administering
`
`to a patient the controlled release oral pharmaceutical composition according to claim 13.
`
`33;
`
`(Original) A method for treating intestinal inflammatory disease comprising administering
`
`to a patient the controlled release oral pharmaceutical composition according to claim 24.
`
`CosmoEx. 2013-p. 6
`Argentum v Cosmo
`IPR2018-00080
`
`Cosmo Ex. 2013-p. 6
`Argentum v Cosmo
`IPR2018-00080
`
`

`

`Application No. 14/308,279
`Amendment dated 17 February 2016
`Reply to Office Action dated 11 December 2015
`
`REMARKS
`
`StatusoftheClaims
`
`Claims 1-33 are currently pending and under examination.
`
`Claim 1 has been amendedbyincorporating the limitation of claim 2.
`
`Claim 13 has been amendedby incorporating the limitation of claim 14.
`
`Claim 24 has been amendedby incorporating the limitation of claim 25.
`
`Claims 2, 14, 25 and 26 have been canceled.
`
`All amendments here are made without prejudice. Applicants reserve the right
`
`to
`
`reintroduce the combinations of features claimed in the original claims or to add additional claims
`
`either later during the prosecution of the present application or in applications related to the present
`
`one,like continuation, divisional, and continuation-in-part applications.
`
`Applicants submit that no new matter has been added, and entry of these amendments is
`
`requested
`
`Allowable Claims
`
`Applicant acknowlege the Examiner’s indication that claims 2-12, 14-23, 25 and 27-33
`
`would be allowable.
`
`jections under
`
`5102
`
`Claims 1, 13, 24, and 26 are rejected under pre-AIA 35 U.SC. § 102(e) as being anticipated
`
`by Hallgren et al. (U.S. Patent No. 6,239,120). Without acquiescing in the propriety of this
`
`rejection, Applicant has amended claims 1, 13 and 24 to include the limitations of allowable claims
`
`2, 14, and 25, respectively, and has canceled claim 26.
`
`In view of these amendments, Applicant
`
`submits that this rejection has been obviated, and its withdrawal is requested.
`
`Claims 1, 13, 24, and 26 are rejected under pre-AJA 35 U.SC. 102(b) as being anticipated
`
`by Friend etal. (U.S. Patent No. 5,811,388). Without acquiescing in the propriety ofthis rejection,
`
`Applicant has amended claims 1, 13 and 24 to include the limitations of allowable claims 2, 14,
`
`and 25, respectively, and has canceled claim 26.
`
`In view of these amendments, Applicant submits
`
`that this rejection has been obviated, and its withdrawal is requested.
`
`7
`
`Cosmo Ex. 2013-p. 7
`Argentum v Cosmo
`IPR2018-00080
`
`Cosmo Ex. 2013-p. 7
`Argentum v Cosmo
`IPR2018-00080
`
`

`

`Application No. 14/308,279
`Amendment dated 17 February 2016
`Reply to Office Action dated 11 December 2015
`
`iousn
`
`ubl.
`
`ntin
`
`fection
`
`Applicant notes that the Examiner had made several obviousness-type double patenting
`
`(ODP) rejections in the Office Action dated 8 July 2015.
`
`In response to the ODPrejections over
`
`(a) copending Application No. 13/462409 (now Patent No. 8,293,723), (b) Patent No. 7,410,651,
`
`(c) Patent No. 7,431,943, (d) Patent No. 8,029,823 (now RE43799) and (e) Patent No. 8,787,888
`
`(which properly should be 8,784,888 as noted by Applicant in the response filed 8 October 2015),
`
`Applicant filed a Terminal Disclaimer on 8 October 2015.
`
`In the instant Office Action,
`
`the
`
`Examiner noted that the Terminal Disclaimer has been recorded and asa result the ODPrejections
`
`were withdrawn.
`
`Applicant has learned on PAIR that the Terminal Disclaimer was disqualified after the
`
`mailing date of the instant Office Action because the signor of the Power of Attorney of record
`
`failed to state that he/she is authorized to act on behalf of Applicant.
`
`In order to remedythis
`
`disqualification, Applicant submits herewith a new Power of Attorney which includes the
`
`necessary statement. A new Terminal Disclaimeris also being filed in view of this new Power of
`
`Attorney.
`
`For the sake of completeness, Applicant notes that in the Office Action dated 8 July 2015,
`
`the Examineralso rejected claims 1-33 are rejected on the ground of nonstatutory obviousness-type
`
`double patenting (ODP) as being unpatentable over claims 1-12 of U.S. Patent No. 8,895,064 in
`
`view of U.S. publication No. 2014/0302143 (the ‘143 publication).
`
`In the response dated 8
`
`October 2015, Applicant noted that
`
`the ‘143 publication corresponds to U.S. Application No.
`
`14/308,305, which was filed on 18 June 2014 and which claims priority to PCT/EP00/05356,filed
`
`9 June 2000. By comparison,the present application wasfiled on 18 June 2014 and claimspriority
`
`to PCT/EP00/05356 filed on 9 June 2000. Hence, the “143 publication does not constitute a prior
`
`art reference against the instant application, and consequently this ODP rejection is improper.
`
`Based on the Examiner’s comments in the instant Office Action, it appears that this ODP rejection
`
`was withdrawn on the basis of these remarks.
`
`In view of the concurrently filed Power of Attorney, the currently filed Terminal Disclaimer
`
`and the above remarks (incorporated from the response dated 8 October 2015), Applicant submits
`8
`Cosmo Ex. 2013-p. 8
`Argentum v Cosmo
`IPR2018-00080
`
`Cosmo Ex. 2013-p. 8
`Argentum v Cosmo
`IPR2018-00080
`
`

`

`Application No. 14/308,279
`Amendment dated 17 February 2016
`Reply to Office Action dated 11 December 2015
`
`that the obviousness-type double patenting rejections have been overcome. Withdrawal of these
`
`rejections is requested.
`
`Conclusion
`
`In view of the above amendments and remarks, it is submitted that the claims pending in
`
`this application satisfy the requirements of the patent statutes and are patentable overthe priorart
`
`of record. Reconsideration of this application and a notice of allowance are requested. The
`
`Examineris invited to telephone the undersignedif it will assist in expediting the prosecution and
`
`allowanceofthe instant application.
`
`Respectfully submitted,
`
`ROTHWELL, FIGG, ERNST & MANBECK,p.c.
`
`By
`
`/Jeffrey L. Ihnen/
`Jeffrey L. Ihnen
`Registration No. 28,957
`Attorney for Applicants
`607 14th Street, N.W., Suite 800
`Washington, D.C. 20005
`Phone: 202-783-6040
`Fax:
`202-783-6031
`
`CosmoEx. 2013-p. 9
`Argentum v Cosmo
`IPR2018-00080
`
`Cosmo Ex. 2013-p. 9
`Argentum v Cosmo
`IPR2018-00080
`
`