IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`MAIL STOP AFTER FINAL
`
`EXPEDITED PROCESSING
`
`Appl.N0.
`Applicant
`Filed
`TCIAU.
`
`Examiner
`
`: 13f617,138
`: Roberto VILLA er .51}.
`: 14 September 2012
`: l6l5
`
`: Susan T. Tran
`
`Docket No.
`
`Customer No.
`
`Confirmation No.
`
`: 3850-]25
`
`: 06449
`
`: 7811
`
`AMENDMENT AND RESPONSE TO OFFICE ACTION
`
`MAIL STOP AF
`
`Commissioner for Patents
`PO. Box 1450
`
`Alexandria, Virginia 22313-1450
`
`Dear Sir:
`
`In response to the Office Action' dated May 16 2013, please further amend this
`
`application as follows. No additional fee is believed to be due. In the event that a fee is required
`
`in connection with the filing of this Amendment and Response, the Commissioner for Patents is
`
`authorized to charge the amount of such fee to Rothwcll, Figg, Ernst and Manbeck PC Deposit
`
`Account No. 02-2I3S.
`
`Amendments to the Claims begin on page 2 of this paper.
`
`Remarks begin on page 4 of this paper immediately after the Amendments to the Claims.
`
`
`
`I During the interview with the Examiner on May 29, 2013. the Examiner indicated that the outstanding Office
`Action should he a final ()fiice Action, and the non-Final ()ffice Action shown in the Official communication
`resulted from clerical error.
`
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`Application No.: 136] 'x', 138
`Attorney Docket No. 3850-125
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`AMENDMENTS TO THE CLAIMS
`
`This listing of claims will replace all prior versions and listings of claims in the
`
`application.
`
`Listing of Claims
`
`1. (Currently Amended)
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`A controlled release oral pharmaceutical composition
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`consisting essentially of:
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`(1) a tablet core comprising:
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`a) budesonide in an amount effective to treat intestinal inflammatory diseaseflJ];
`
`w
`
`b) a macroscopically homogeneous composition comprising at least one
`
`lipophilic eacipient[[;]]A
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`[[c)]] at least one amphiphilic excipicnt[[;]],a_nd
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`[[d)]] at least one hydrogel-forming hydrophilic excipient other than a gum:
`
`wherein said budesonide is dis ersed in said macrosco icall homo eneous corn osition; and
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`(2) a coating on said tablet core, said coating comprising a 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
`
`hydroxyalkyl cellulose.
`
`4. (Canceled)
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`5. (Previously presented) A controlled release oral pharmaceutical composition according to
`
`claim 1, wherein said gastro-resistant film comprises at least one methacrylic acid polymer.
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`Application No.: 132’6 l 7', l 38
`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 hydrogcl-forming 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 1, wherein said at least one lipophilic excipicnt comprises stearic acid or magnesium
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`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-forming hydrophilic excipient comprises at least one
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`hydroxyalkyl cellulose.
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`l 1. (Previously Presented) A controlled release oral pharmaceutical composition according to
`
`claim 1, wherein said at least one amphiphilic excipicnt comprises lecithin.
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`l2. (Previously Presented) A controlled release oral pharmaceutical composition according to
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`claim 1 I, wherein said at least one hydrogel-forming hydrophilic excipient 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 11, wherein said at least one lipophilic excipient comprises stearic acid or magnesium
`
`stearate.
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`Cosmo Ex 2011-p. 3
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`IPR2017-01035
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`Application No.: 13K6l?,l38
`Attorney Docket No. 3850-125
`
`REMARKS
`
`Applicants thank Examiner Tran and Supervisory Primary Examiner Wax for the many
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`courtesies shown during the personal interview with Applicants” representatives on May 29,
`
`2013, and greatly appreciate the Office’s effort to agree on allowable subject matter. 3 Applicants
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`respectfully disagree with the Office‘s summary of the interview. Hence, Applicants respectfully
`
`do not adopt the Examiner‘s Statements as Applicants’ substance of the interview. Applicants
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`will provide immediately hereafter their view of the interview.3
`
`Interview Summary
`
`The Office issued an Interview Summary on June 3, 2013, stating:
`
`Applicants pointed out that the Savastano reference teaches
`tablet core containing active agent coated with layers of matrix
`materials, while the present invention is directed to tablet core
`composes of active agent homogeneously dispersed in the multi-
`matrix system. During the interview, the Faour et al. reference was
`also discussed. Applicants proposed to amend the claims to: 1)
`include budesonidc homogeneously dispersed, in the matrix system
`to overcome the Savastano reference; and 2), recite the transitional
`phrase “consisting of” to preclude the coating layers taught in
`Faour. The proposed Amendment appears to place the application
`in condition for allowance, hence, the Examiner suggested that the
`Amendment will be reviewed, and the patentability will be
`determined.
`
`Interview Summary.
`
`2 Due to unavoidable circumstances, Examiner Tran was unable to arrive at the USPTO at the hour appointed for the
`interview. Until she came. Applicants’ representatives were graciously received by Supervisory Primary Examiner
`Wax and informal discussion ensued. But the undersigned understands that the informal discussion with Supervisory
`Examiner Wax was subsumed in and superseded by the interview with Examiner Tran reported herein. Hence. no
`Separate summary of the discussion with Mr. Wax is deemed necessary.
`
`3 Of course. no transcript is generated during an interview and Applicants interviewed another five applications at
`the same time. No doubt. then, that reasonable people can differ in their recollection of this particular interview.
`
`4
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`Application No.: 132’6 l 7', l 38
`Attorney Docket No. 3850-125
`
`Substance of Interview
`
`MPEP § 713.04 provides eight items (A-H) that should be addressed in Applicants’
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`submission of the substance of the interview. Applicants make the following submissions
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`regarding each of those items:
`
`(A)
`
`The following draft claim formed at least part of the basis for the discussion:
`
`1. (Currently amended)
`
`A controlled release oral pharmaceutical composition comprising:
`
`(1) a tablet core comprising:
`
`a) budesonide in an amount effective to treat intestinal inflammatory diseasc,a_nd
`
`b) a matrix comprising:
`
`i) at least one lipophilic excipient;
`
`[[c]]@ at least one amphiphilic excipient;
`
`[[d]]m) at least one hydrogel-forming hydrophilic excipient other than a
`
`gum; and
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`(2) further wherein said controlled release harmaceutical com osition com rises a
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`coating on said tablet core, said coating comprising a gastro—resistant film.
`
`In addition, the following illustrations were shown at the interview:
`
`Tablet core containing the
`active substance (reservoir)
`
`\\\\\
`
`______________
`
`Semi-permeable membrane
`
`Delay jacket
`
`Figure 1. Structure of Savastano’s drug delivery device.
`
`Optional cnteric coating
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`Application No.: 136] 'x', 138
`Attorney Docket No. 3850-125
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`Tablet core containing the
`active substance homogeneously
`dispersed
`
`Gastro-resistant film coating
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`Figure 2. Budesonide matrix structure of the invention.
`
`(B)
`
`Claim I proposed to be amended as shown in (A) was discussed with the Examiner but
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`further discussions ensued during the Interview. Thereafter, Applicants decided to present the
`
`amended claim 1 as set forth in the Amendment to the Claims in this Amendment and Response.
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`Hence amended claim 1 should be entered and allowed. Although Applicants discussed adding
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`“consisting essentially of’ to the claim, Applicants have no recollection of proposing to add
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`“consisting of” in any claim. And on fithher consideration, Applicants have chosen to recite in
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`claim 1, as amended: “a macroscopically homogeneous composition comprising at least one
`
`. ." and “wherein said budcsonidc is dispersed in said macroscopically
`lipophilic cxcipient .
`
`homogeneous composition.“
`
`(C)
`
`The prior art of record, Savastano, and the obviousness—type double patenting (OTDP)
`
`rejections were discussed. The Office also for the first time raised the Faour reference (US
`
`6,004,582) at the interview. Apparently, the Examiner had performed an additional search to
`
`find Faour. Applicants respectfully assert that amended claim 1 requires no additional searching
`
`because it is narrower regarding the budesonide being dispersed in the macroscopically
`
`homogenous tablet core.
`
`(D)
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`Amendments of a substantive nature were discussed.
`
`(E)
`
`Applicants traversed all the rejections issued in the Office Action. Applicants, however,
`
`agreed to file a terminal disclaimer to overcome the OTDP rejections over the ‘86? and “430
`
`applications, as explained below. Agreement was not reached as to all points.
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`Application No.: 132’6l 7', 138
`Attorney Docket No. 3850-125
`
`(F)
`
`Applicants discussed why there is patentable subject matter in view of Savastano and also
`
`in view of Faour, which was newly raised at the interview but has not yet been applied against
`
`the claims in an Official Action. This Amendment requires no extensive consideration.
`
`(G)
`
`See item (B) and the Applicant-Initiated Interview Summary mailed June 3, 2013
`
`establishing that no agreement was reached. And as noted in the footnote above, Applicants
`
`understand from the interview that the present rejection is a Final Rejection.
`
`(H)
`
`This interview Was personally conducted between Examiner Tran and Mr. Huntington,
`
`Mr. Ihnen, Dr. Tidwell, and Mr. Irving, not via electronic mail, so this item does not apply.
`
`Status of Claims
`
`Claims 1, 3, 5, 6, and 9-13, as amended, are currently pending and under examination.
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`Claims 2, 4, 3’ and 8 were previously canceled. Claim 1 is currently amended. Support for the
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`amendments can be found throughout the spec ifteation, for example, at paragraphs [004?],
`
`[0051], [0052], [0080], and [0082] in the substitute Specification. Applicants submit that these
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`amendments do not constitute new matter, raise new issues, or require further searching. Thus,
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`their entry and allowance are requested.
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`Rejections for Obviousness—type Double Patenting
`
`The Office has rejected claims 1, 3, 5, 6, and 9-]3 on the grounds of nonstatutory
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`obviousness—type double patenting over claims 1, 4, 5, 7, 8, 11, 12, 14, 15, and 17-27 ofU.S.
`
`Application No. 13,859,867 (86?), claim 1 of US. Application No. 13f462,430 C430), claims
`
`142-165 of US. Application No. 13f226,758 C758), and claims 1-30 ofU.S. Application No.
`
`l3f585,190 (‘190). Office Action at 2-5. As agreed at the interview, a terminal disclaimer over
`
`the ‘86? and ‘430 applications is submitted herewith, thereby obviating the double patenting
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`rejection. However, the Office should withdraw the provisional rejection over the co-pcnding
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`claims of the ‘ 190 and ‘758 applications, which do not claim the benefit of prior applications,
`
`and thus must be patentable over the substitute application. As such, the patcntability of the
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`claims of the ‘ 190 and ‘758 applications should not affect the allowance of the present claims.
`
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`Application No.: 132’6l 7', 138
`Attorney Docket No. 3850-125
`
`Rejection under 35 U.S.C. § 102(b) over Savastano
`
`The Examiner has rejected claims I, 3, S, 6, and 9-l3 as allegedly anticipated by US.
`
`Patent No. 5,681,584 to Savastano (“Savastano”). Office Action at 5.
`
`Claim 1 as amended is patentable over Savastano. Applicants have amended claim 1 to
`
`recite “wherein said budesonide is dispersed in said macroscopically homogeneous
`
`composition.” This feature is not taught in Savastano. Claim 1 has also been amended to recite
`
`the transitional phrase “consisting CSSentially of.” It will not be in dispute that “consisting
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`essentially of” is used to exclude from the claim that which affects the basic and novel
`
`characteristics ofthe claimed invention. See MPEP 2163(ll)(A)(l).
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`By reciting “consisting essentially of,” Applicants wish to clarify that the basic and novel
`
`characteristic of amended claim 1 is a tablet core comprising budesonide dispersed in a
`
`macroscopically homogeneous composition. See, e.g., substitute Specification, paragraphs
`
`[0014]-[0020], [0023], [0041], [0051], [0052], [0080], and [0082].
`
`In sharp contrast, the compositions taught by Savastano completely depart from such
`
`novel and basic characteristics. In particular, the dosage forms taught by Savastano require both
`
`a delay jacket and a semi-permeable membrane surrounding the tablet core to control the release
`
`of the active ingredient. See 8.3., Savastano, abstract, and col. 5, lines 3l-42.
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`Hence, the “consisting essontially of” language used in amended claim 1, coupled with
`
`the other feature highlighted above, completely distinguishes over the very different teachings of
`
`Savastano. Therefore, Savastano does not anticipate and would not have rendered obvious the
`
`subject matter of amended claim 1. For those reasons, the rejections under 35 U.S.C.
`
`102(b)
`
`and 103 in view of Savastano should be withdrawn.
`
`Nor is Faour any better as prior art. Specifically, Faour requires, among other features,
`
`that a first active agent-containing core (5) be surrounded by a semipermeable membrane (4).
`
`Faour, abstract, Fig. 2, and col. 4, line 53 to col. 5, line 13. Faour teaches that the semipermeable
`
`membrane is critical in controlling the release of the active agent from the described dosage
`
`forms through the development of an osmotic pressure gradient in the core of the tablet. 163., col.
`
`5, lines 14-20. In contrast, and as explained earlier, the presently claimed controlled release oral
`
`pharmaceutical compositions do not contain such a semipermeable membrane.
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`Application No.: 136] 'x', 138
`Attorney Docket No. 3850-125
`
`As such, the Faour reference fails to teach the invention recited in amended claim 1 and
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`also would not have rendered it obvious. Therefore, the instant claims are patentable over Faour.
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`Conclusion
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`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 ifit will assist in expediting the
`
`prosecution and allowance of the instant application.
`
`No fee is believed to be due. In the event that a fee is required in connection with the
`
`filing of this Amendment and Response, the Commissioner for Patents is authorized to charge
`
`the amount of such fee to Rothwell, Figg, Ernst and Manbeck PC Deposit Account No. 02-2135.
`
`Respectfully submitted,
`
`Dated:
`
`1 July 20l3
`
`By
`
`fJeffrey L. lhnen/
`Jeffrey L. Ihnen
`Registration No. 28,95?
`Attorney for Applicants
`607 14th Street, N.W., Suite 800
`
`Washington, DC. 20005
`Phone: 202-783-6040
`
`Fax:
`
`202-783-6031
`
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