IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Appl, No.
`Applicant
`Filed
`TCIA‘U.
`Examiner
`
`Docket No‘
`Customer No.
`Confirmation Ne.
`
`:3850-125
`: 06449
`: 781 1
`
`AMENDMENT AND RESPONSE TO ADVISORY AQTION
`
`MAIL STOP AF
`Commissioner for Patents
`P‘O‘ Box 1450
`
`Alexandria. Virginia 22313-1450
`
`Dear Sir:
`
`1131611138
`: Robeno VILLA at at'.
`: 14 September 2012
`: 1615
`: Susan T‘ Tran
`
`
`
`in further response to the Final Office Action dated 22 August 2013 and in response to
`
`the Advisory Action dated 18 October 2013, please further amend this application as follows.
`
`Amendments to the Claims begin on page 2 of this paper. The amendments to the
`
`claims include those made in the Amendment and Response filed on 26 September 2013.
`
`Remarks begin on page 4 ofthis paper immediately after the Amendments to the Claims.
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`Application No: l3z’617,l38
`Attorney Docket No. 3850-125
`
`AMENDMENTS TO THE CLAIMS
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`This listing of claims will replace all prior versions and listings of claims in the
`
`application.
`
`Lisling of Claims
`
`1. (Currently Amended)
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`A controlled release oral pharmaceutical composition consisting
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`essentially of:
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`{1) a tablet core comprising consisting essentially of:
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`a} budesonide in an amount effective to treat intestinal inflammatory disease; and
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`b) a macroscopically homogeneous composition comprising at least one
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`lipophilic excipient, at least one amphiphilic excipient, and at least one hydrogel-formin g
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`hydrophilic excipient other than a gum. wherein said budesonide is dispersed in said
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`macroscopically homogeneous composition; and
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`{2) a coating on said tablet core, said coating eemprisifi-g consisting essentially of a
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`gastro-resistant film.
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`2. (Canceled)
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`3. (Previously Presented) A controlled release oral pharmaceutical composition according to
`
`
`
`claim 1. wherein said at least one hydrogel-forming hydrophilic excipient comprises at least one
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`hydroxyalkyl cellulose
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`4. (Canceled)
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`5. (Currently Amended) A controlled release oral pharmaceutical composition according to
`
`claim 1. wherein said gastro-resistant film oemprises C0n§i§t§ essentially of at least one
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`methaerylie acid polymer.
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`Application No: l3!617,l38
`Attorney Docket No. 3850-125
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`6. (Previously Presented) A controlled release oral pharmaceutical composition according to
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`claim 5. wherein said at least one hydrogel-fonning hydrophilic excipient comprises at least one
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`hydroxyalkyl cellulose.
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`7-8. (Canceled)
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`9. (Previously Presented) A controlled release oral pharmaceutical composition according to
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`claim l, wherein said at least one lipophilic cxcipient comprises stearic acid or magnesium
`stearate.
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`10. (Previously Presented) A controlled release oral pharmaceutical composition according to
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`claim 9, wherein said at least one hydrogel—f'onning hydrophilic excipient comprises at least one
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`hydroxyalkyl cellulose.
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`I 1. {Previously Presented) A controlled release oral pharmaceutical compasition according to
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`claim 1. wherein said at least one amphiphilic exeipient comprises lecithin.
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`12. (Previously Presented} A controlled release oral pharmaceutical composition according to
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`claim 11, wherein said at least one hydrogel-forming hydrophilic cxcipient comprises at least one
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`hydroxyalkyl cellulose.
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`13. (Previously Presented) A controlled release oral pharmaceutical composition according to
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`claim 1 1, wherein said at least one lipophilic cxcipient comprises stearic acid or magnesium
`SIC aratc.
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`Application No: 13l617,i38
`Attorney Docket No. 3850-125
`
`REMARKS
`
`Status of Claims
`
`Claims 1, 3. 5, 6. and 9-l3, as amended, are currently pending and under examination.
`
`Claims 2, 4, 7 and 8 were previously canceled. Claims 1 and 5 are currently amended. Support
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`for the amendments can be found throughout the Specification, for example, at paragraphs
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`[0047], [0051], [0052]. [0080], and [0082] in the substitute Specification. Applicants note that
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`the amendment to claim 5 and the amendment to the tablet core language in claim 1 are newly
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`made in the paper. Applicants submit that these amendments do not constitute new matter, raise
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`new issues. or require further searching. Thus, their entry and allowance are requested.
`
`Examiner Interview
`
`The undersigned thanks the Examiner for the courtesies shown during the telephone
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`interview held on IS October 2013. During the interview, the undersigned discussed the
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`possibility of amending claim 5 to change the language to “consisting essentially of“ in order to
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`overcome the continued rejection of the claims. The Examiner indicated that this amendment
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`
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`might overcome the rejection as made with respect to die coating. but she would need to review
`the references. The Examiner then raised a further issue with the claims in the context of the
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`outstanding rejections. This issue concerned the language “comprising” as used with respect to
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`the tablet core. The Examiner said that she believes that this language does not exclude a
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`coating. As a basis for this belief, the Examiner explained that there are many types ol‘tablet
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`cores including those made by coating a particle. such as with a drug layer and with further
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`layers. Thus, she believes that this comprising language for the tablet core allows other layers.
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`such as a coating layer of Lemer.
`
`Rejection under 35 U.S.C.§ 102(a) over Lerner
`
`The Examiner has rejected claims 1. 5 and 6, as allegedly anticipated by US. Patent No.
`
`5,840,332 to Lemeret al, (“Lerner”). Final Office Action at 2—3.
`
`Claim l as amended is patentable over Lerner. Claim 1 specifies a controlled release oral
`
`pharmaceutical composition that consists essentially of a table core and a coating. The table core
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`Application No: l3i617,138
`Attorney Docket No. 3850-125
`
`consists essentially of budcsonide and a macroscopically homogeneous composition. This
`
`macroscopically homogeneous composition comprises (i) at least one lipophilic excipient, (ii) at
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`least one amphiphilic excipient and (iii) at least one hydrogcl-forming hydrophilic excipient
`
`other than a gum. The budcsonide is dispersed in the macroscopically homogeneous
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`composition.
`
`According to the Examiner,
`
`Lerner teaches a gastrointestinal drug delivery system comprising an active
`core surround by a coating. See abstract. Core in a form of a matrix tablet
`comprises drug and combinations of pectin, calcium pectinate,
`hydroxypropylmcthyl cellulose, microcrystalline cellulose, lactose, starch,
`calcium phosphate, and polyvinylpyrrolidone (column 6, lines 9-10; and
`column 8, lines 35—64). Coating comprises methacrylic acid. See column 9,
`lines 28-65. Drug includes budesonidc suitable for irritable bowel syndrome
`and the like {column 6,1incs 44-57; and column 12,1inc 43).
`Final Office Action at 3.
`
`
`
`Applicant submits that Lerner does not teach a tablet core that consists essentially of a
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`macroscopically homogeneous composition comprising “(i} at least one lipophilic excipient,
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`(ii) at least one amphiphilie excipient and {iii} at least one hydroch—f‘om'ting hydrophilic
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`excipient other than a gum." Thus. Lerner does not describe all of the elements of the
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`macroscopically homogeneous composition and hence does not describe all of the elements of
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`the tablet core. Therefore, Lerner does not anticipate the subject matter of amended claim 1. For
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`these reasons alone. the rejection under 35 U.S.C. § 102(a) in view of Lerner should be
`withdrawn.
`
`Furthermore, Applicants have amended claim 1 to recite the transitional phrase
`
`"consisting essentially of" in part (2) with respect to the coating. That is, pan (2) now recites “a
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`coating on said tablet core. said coating consisting essentially of a gastro-resistant film." In
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`addition. Applicants have amended claim 5 to recite the transitional phrase “consisting
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`essentially of" with respect to the gastro-resistant film in order to make the language consistent
`
`It will not be in dispute that “consisting essentially of“ is
`with the language ofamended claim 1.
`used to exclude from the claim that which affects the basic and novel characteristics of' the
`
`claimed invention. See MPEP 2]63(II)(A)(1). The amendment to claim 5 makes it clear that the
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`Application No; 13:611138
`Attorney Docket No. 3850- l 25
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`By reciting “consisting essentially of” for the coating, Applicants wish to clarify that a
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`basic and novel characteristic of amended claim I is a coating consisting essentially of a gastric
`
`resistant film, in which the coating is on a tablet core. See, e.g., substitute Specification.
`
`paragraph [0053].
`
`In addition, by reciting “consisting essentially of” for the tablet core, Applicants wish to
`
`clarify that a basic and novel characteristic of amended claim I is a tablet core consisting
`
`essentially of budesonide and a macroscopically homogeneous composition comprising at least
`
`one lipophilie cxeipient, at least one amphiphilic excipient and at least one hydrogel—forming
`
`hydrophilic exeipient other than a gum in which the budesonide is dispersed in the
`
`macroscOpically homogeneous composition. See, e.g., substitute Specification, paragraph
`
`“consisting essentially of” language used in part [2) is used to exclude from the claim that which
`affects the basic and novel characteristics ofthe claimed invention.
`
`
`
`[0052].
`
`Lerner is directed to a gastrointestinal delivery system in which a core is “surrounded by
`
`a water-insoluble or relatively water-insoluble coating material in which a particulate water-
`
`insoluble material is embedded.” Lerner, Abstract, 11. 1-4; see also col. 6, II. 11-16; col 10,112—
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`1 i and 63-67. In the gastrointestinal tract, that particulate matter “takes up liquid, thus forming
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`channels interconnecting the drug containing core with the outside of the delivery device."
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`Lerner, Abstract, 11. 5-8; see also col. 6, 11. 11-25. More specifically, the particulates embedded
`
`in the coating swell, thereby creating channels through which fluid can pass into the core and
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`dissolve the active ingredient contained in the core. The solubilized active ingredient then passes
`
`through the channels, thereby controlling the release of the active ingredient. See eg, Lerner at
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`col. 6, II. 11-14; col. 8, II. 66-67; col. 6, [1, 11-14. Therefore, the Lerner coating is not a coating
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`that is meant to dissolve in the gastrointestinal tract, but instead remains intact to control the
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`release of the active ingredient in the core. Lerner, col. 10, ll. 6-} 1.
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`In contrast, the claimed controlled release oral pharmaceutical compositions consist
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`essentially of a tablet core and a coating on the tablet core, the coating consisting essentially of a
`
`gastro—resistant film. See, e.g., substitute Specification, paragraph [0053] and Example 1 at
`
`paragraphs [0078}[0079]. One of ordinary skill in the art reading the specification would
`
`understand that a gastro—resistant coating is designed to prevent early release of the drug in the
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`Application No; 13K6l7,l38
`Attorney Docket No. 3850» 125
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`stomach but dissolves when the dosage form reaches the desired target region of the
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`gastrointestinal tract, such as the colon. As such, one ofordinary skill in the art would
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`understand that the dosage forms disclosed in Lerner are very different than the presently
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`claimed controlled release oral pharmaceutical compositions in which a core is coated with a
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`gastro-rcsistant film that is designed to dissolve when the dosage form reaches the target region
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`of the gastrointestinal tract. Therefore, Lerner does not anticipate the subject matter of amended
`
`claim 1. For these additional reasons, the rejection under 35 U.S.C. § 102{a) in view ofLerner
`should be withdrawn.
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`In the Advisory Action, the Examiner argued that the language “comprising” in claim 5
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`which depends from claim 1 requires the interpretation of claim 1 to include other components
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`that which affect the basic and novel characteristics of the claimed invention. Applicants submit
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`that the amendment of claim 5 to use the language “consisting essentially of” does not support
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`such an interpretation of claim 1. That is. it is now that the language of claim 1 excludes the
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`presence of particulates in the coating as taught and required by Lerner. Therefore, Lerner does
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`not anticipate the subject matter of amended claim 1. For these additional reasons, the rejection
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`under 35 U.S.C. § 102(21) in view of Lerner should be withdrawal.
`
`In addition. one of ordinary skill in the art reading the specification would also
`
`understand that the tablet core is designed to be a macroscopically homogeneous composition of
`
`the recited cxcipicnts in which the budesonidc is di5pcrsed. See, e.g., substitute Specification,
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`paragraph [0052]. This macroscopically homogeneous composition is different than a core made
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`oflayers or that includes a layer. Therefore, Lerner does not anticipate the subject matter of'
`
`
`
`amended claim 1. For these additional reasons, the rejection under 35 U.S.C. § 102{a) in view of
`Lerner should be withdrawn.
`
`Rejection under 35 U.S.C. § 103(a) over Lerner in view of Savastano
`
`The Examiner has rejected claims 1,3, 5, 6, and 9-13 as aliegedly unpatentablc over U.S.
`
`Patent No. 5,840,332 to Lerner et a1. (“Lerner”) in view ofU.S. Patent No. 5,68] ,584 to
`
`Savastano {“Savastano"). Final Office Action at 3-4.
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`Claim 1 as amended is patentable over Lerner in view of Savastano. As discussed in
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`detail above. Applicants have amended claim 1 to recite the transitional phrase “consisting
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`Application No: 1311111138
`Attorney Docket No. 3850-125
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`essentially of" in part (2) with respect to the coating. That is, part (2) new recites “a coating on
`
`said tablet core, said coating consisting essentially of a gastro-resistant film.“ The presently
`
`claimed controlled release oral dosage forms are very different than those disclosed in the Lerner
`and Savastano references.
`
`As discussed earlier, Lerner is directed to a gastrointcsfinal delivery system in which a
`
`core is “surrounded by a water-insoluble or relatively water-insoluble coating material in which a
`
`particulate water-insoluble material is embedded.” Lerner, Abstract, ll. l—4; see also col. 6, ll.
`
`1 1-16, col IO, 1]. 2-11 and 63-67.
`
`in the gastrointestinal tract, that paniculate matter “takes up
`
`liquid, thus forming channels interconnecting the drug containing core with the outside of the
`
`delivery device.“ Lerner, Abstract, ll. 5—8, see also col. 6, ll.
`
`1 1-25. More specifically. the
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`particulates embedded in the coating Swell, thereby creating channels through which fluid can
`
`pass into the core and dissolve the active ingredient contained in the core. The solubilized active
`
`ingredient then passes through the channels, thereby controlling the release of the active
`
`ingredient. See e.g., Lerner at col. 6. ll. 11-14; col. 8, ll. 66-67; col. 6, ll. 11-14. Therefore. the
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`Lerner coating is not a coating meant to dissolve in the gastrointestinal tract, but instead remains
`
`intact to control the release of the active ingredient in the core. Lerner, col. 10, ll. 6-] 1.
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`Therefore, one of ordinary skill in the art would not seek to modify the teachings of the Lerner
`
`reference in order to arrive at the presently claimed controlled release oral pharmaceutical
`
`compositions.
`
`
`
`amended claim I. For these reasons, the rejection under 35 U.S.C. § 103(a) over Lerner in view
`of Savastano should be withdrawn.
`
`Further, the addition of the Savastano reference does not cure the deficiencies of Lerner.
`
`In particular. the dosage forms taught by Savastano require both a delay jacket and a semi-
`
`permeable membranc surrounding the tablet core to control the release of the active ingredient
`
`and so are very different than the presently claimed controlled release oral pharmaceutical
`
`compositions. See e.g.. Savastano, abstract, and col. 5, lines 31-42.
`
`Hence, the “consisting essentially of” language used in amended claim 1 and in claim 5,
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`completely distinguishes over the very different teachings of Lerner and Savastano. Therefore.
`
`the combination of Lerner and Savastano would not have rendered obvious the subject matter of
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`Application No.: l3f617,l38
`Attorney Docket No. 3850—125
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`In addition, one ofordinary skill in the art reading the specification would also
`
`understand that the tablet core is designed to be a macrOSCOpically homogeneous composition of
`
`the recited excipients in which the budesonide is dispersed. See. e.g., substitute Specification.
`
`paragraph [0052]. This macroscopically homogeneous composition is different than a core made
`
`of layers or that includes a layer. Therefore, the combination of Lerner and Savastano would not
`
`have rendered obvious the subject matter of amended claim ] . For these additional reasons. the
`
`rejection under 35 U.S.C. § 1030:) over Lerner in view of Savastano should be withdrawn.
`
`Conclusion
`
`
`
`filef‘frey L. Ihnenl
`Jeffrey L. lhnen
`Registration No. 28.957
`Attorney for Applicants
`607 14th Street, N.W., Suite 800
`Washington, D.C. 20005
`Phone: 202-783-6040
`Fax:
`202-?83-6031
`
`Although principally directed to amended claim 1, the remarks above apply with equal
`
`force to all the dependent Claims. Consequently‘ in view of the above amendments and remarks,
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`it is submitted that the claims satisfy the requirements of the patent statutes and are patentable
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`over the prior art of record. Reconsideration of this application and early notice of allowance is
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`requested. The Examiner is invited to telephone the undersigned if it will assist in expediting the
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`prosecution and allowance of the instant application.
`
`In the event that any additional fee is required in connection with the filing of this
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`Amendment and Response. the Commissioner for Patents is authorized to charge the amount of
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`such fee to Rothwell, Figg, Ernst and Manbeck P.C. Deposit Account No. 02-2135.
`
`Dated: 21 F ebruagy 2014
`
`By
`
`Respectfully submitted,
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