IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`MAIL STOP AFTER FINAL
`EXPEDITED PROCESSING
`
`Appl. No.
`Applicant
`Filed
`TC/A.U.
`Examiner
`
`: 13/617,138
`: Roberto VILLA etal.
`: 14 September 2012
`“A615
`: Susan T. Tran
`
`Docket No.
`Customer No.
`Confirmation No.
`
`: 3850-125
`: 06449
`: 7811
`
`AMENDMENT AND RESPONSE TO OFFICE ACTION
`
`MAIL STOP AF
`Commissionerfor Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`DearSir:
`
`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 Rothwell, Figg, Ernst and Manbeck PC Deposit
`
`Account No. 02-2135.
`
`Amendments to the Claims begin on page 2 ofthis paper.
`
`Remarksbegin on page 4 of this paper immediately after the Amendments to the Claims.
`
`
`
`' During the interview with the Examiner on May 29, 2013, the Examinerindicated that the outstanding Office
`Action should be a final Office Action, and the non-Final Office Action shownin the Official communication
`resulted from clerical error.
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`Application No.: 13/617,138
`Attorney Docket No. 3850-125
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`AMENDMENTS TO THE CLAIMS
`
`Thislisting of claims will replaceall prior versionsandlistings of claims in the
`
`application.
`
`Listing of Claims
`
`1. (Currently Amended)
`
`A controlled release oral pharmaceutical composition cemprising
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`consisting essentially of:
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`(1) a tablet core comprising:
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`a) budesonide in an amounteffective to treat intestinal inflammatory disease[[,]]:
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`and
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`b) amacroscopically homogencous composition comprising at least one
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`lipophilic excipient[[;]].
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`[[c)]] at least one amphiphilic excipient[[;]],and
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`[[d)]] at least one hydrogel-forming hydrophilic excipient other than a gum,
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`wherein said budesonide is dispersed in said macroscopically homogeneous composition; 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
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`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.: 13/617,138
`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-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 excipient 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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`11. (Previously Presented) A controlled release oral pharmaceutical composition according to
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`claim 1, wherein said at least one amphiphilic excipient compriseslecithin.
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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 excipient comprisesat 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
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`stearate.
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`Application No.: 13/617,138
`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. * Applicants
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`respectfully disagree with the Office’s summary of the interview. Hence, Applicants respectfully
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`do not adopt the Examiner’s Statements as Applicants’ substance of the interview. Applicants
`will provide immediately hereafter their view ofthe interview.”
`
`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
`composesof active agent homogeneously dispersed in the multi-
`matrix system. During the interview, the Faouret al. reference was
`also discussed. Applicants proposed to amendthe claimsto: 1)
`include budesonide homogeneously dispersed, in the matrix system
`to overcomethe Savastano reference; and 2), recite the transitional
`phrase “consisting of” to preclude the coating layers taught in
`Faour. The proposed Amendmentappearsto place the application
`in condition for allowance, hence, the Examiner suggested that the
`Amendmentwill be reviewed, and the patentability will be
`determined.
`
`Interview Summary.
`
`? Due to unavoidable circumstances, Examiner Tran was unable to arrive at the USPTO at the hour appointedfor the
`interview. Until she came, Applicants’ representatives were graciously received by Supervisory Primary Examiner
`Waxand informal discussion ensued. But the undersigned understandsthat the informal discussion with Supervisory
`Examiner Wax was subsumed in and superseded by the interview with Examiner Tran reported herein. Hence, no
`separate summary ofthe discussion with Mr. Wax is deemed necessary.
`
`* Of course, no transcript is generated during an interview and Applicants interviewed anotherfive applicationsat
`the same time. No doubt, then, that reasonable people can differ in their recollection ofthis particular interview.
`
`4
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`Application No.: 13/617,138
`Attorney Docket No. 3850-125
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`Substance of Interview
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`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:
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`(A)_The following draft claim formed at least part of the basis for the discussion:
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`1. (Currently amended)
`
`A controlled release oral pharmaceutical composition comprising:
`
`(1) a tablet core comprising:
`
`a) budesonide in an amounteffective to treat intestinal inflammatory disease,and
`
`b) a matrix comprising:
`
`i) at least one lipophilic excipient;
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`[[c]]ii) at least one amphiphilic excipient;
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`[[d]]iii) at least one hydrogel-forming hydrophilic excipient other than a
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`gum; and
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`(2) further wherein said controlled release pharmaceutical composition comprises a
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`coating on said tablet core, said coating comprising a gastro-resistant film.
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`In addition, the followingillustrations were shownatthe interview:
`Tablet core containing the
`active substance (reservoir)
`
`Semi-permeable membrane
`
`Delay jacket
`
`Optional enteric coating
`
`Figure 1. Structure of Savastano’s drug delivery device.
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`Application No.: 13/617,138
`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 | proposed to be amended as shownin (A) wasdiscussed with the Examiner but
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`further discussions ensued during the Interview. Thereafter, Applicants decided to present the
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`amendedclaim | as set forth in the Amendmentto the Claims in this Amendment and Response.
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`Hence amended claim | 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 further consideration, Applicants have chosen to recite in
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`claim 1, as amended: “a macroscopically homogeneous composition comprising at least one
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`lipophilic excipient...” and “wherein said budesonide is dispersed in said macroscopically
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`homogeneous composition.”
`
`(C)
`
`Theprior art of record, Savastano, and the obviousness-type double patenting (OTDP)
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`rejections were discussed. The Office also for the first time raised the Faour reference (US
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`6,004,582) at the interview. Apparently, the Examiner had performed an additional search to
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`find Faour. Applicants respectfully assert that amended claim | requires no additional searching
`
`becauseit is narrower regarding the budesonide being dispersed in the macroscopically
`
`homogenoustablet core.
`
`(D)
`
`(E)
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`Amendments of a substantive nature were discussed.
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`Applicants traversed all the rejections issued in the Office Action. Applicants, however,
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`agreedto file a terminal disclaimer to overcome the OTDPrejections over the “867 and ‘430
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`applications, as explained below. Agreement wasnotreachedastoall points.
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`Application No.: 13/617,138
`Attorney Docket No. 3850-125
`
`(F)
`
`Applicants discussed whythere is patentable subject matter in view of Savastano andalso
`
`in view of Faour, which was newlyraised at the interview but has not yet been applied against
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`the claims in an Official Action. This Amendment requires no extensive consideration.
`
`(G)
`
`See item (E) and the Applicant-Initiated Interview Summary mailed June 3, 2013
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`establishing that no agreement was reached. And as noted in the footnote above, Applicants
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`understand from the interview that the present rejection is a Final Rejection.
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`(H)—This interview was personally conducted between Examiner Tran and Mr. Huntington,
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`Mr.Ihnen, Dr. Tidwell, and Mr.Irving, not via electronic mail, so this item does not apply.
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`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, 7 and 8 were previously canceled. Claim | is currently amended. Support for the
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`amendments can be found throughout the specification, for example, at paragraphs [0047],
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`[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 9-13 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 of U.S.
`
`Application No. 13/359,867 (°867), claim 1 of U.S. Application No. 13/462,430 (‘430), claims
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`142-165 of U.S. Application No. 13/226,758 (‘758), and claims 1-30 of U.S. Application No.
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`13/585,190 (190). Office Action at 2-5. As agreed at the interview, a terminal disclaimer over
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`the ‘867 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-pending
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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 patentability of the
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`claims of the ‘190 and ‘758 applications should not affect the allowance ofthe present claims.
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`Application No.: 13/617,138
`Attorney Docket No. 3850-125
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`Rejection under 35 U.S.C. § 102(b) over Savastano
`
`The Examinerhasrejected claims 1, 3, 5, 6, and 9-13 as allegedly anticipated by U.S.
`
`Patent No. 5,681,584 to Savastano (“Savastano”’). Office Action at5.
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`Claim | as amended is patentable over Savastano. Applicants have amended claim | to
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`recite “wherein said budesonideis dispersed in said macroscopically homogeneous
`
`composition.” This feature is not taught in Savastano. Claim | has also been amendedto recite
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`the transitional phrase “consisting essentially 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
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`characteristics of the claimed invention. See MPEP 2163(II)(A)(1).
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`Byreciting “consisting essentially of,’ Applicants wish to clarify that the basic and novel
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`characteristic of amended claim | is a tablet core comprising budesonide dispersed in a
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`macroscopically homogeneous composition. See, e.g., substitute Specification, paragraphs
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`[0014]-[0020], [0023], [0041], [0051], [0052], [0080], and [0082].
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`In sharp contrast, the compositions taught by Savastano completely depart from such
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`novel and basic characteristics. In particular, the dosage forms taught by Savastano require both
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`a delay jacket and a semi-permeable membrane surroundingthe tablet core to control the release
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`of the active ingredient. See e.g., Savastano, abstract, and col. 5, lines 31-42.
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`Hence,the “consisting essentially of’ language used in amended claim 1, coupled with
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`the other feature highlighted above, completely distinguishes over the very different teachings of
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`Savastano. Therefore, Savastano does not anticipate and would not have rendered obviousthe
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`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.
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`Noris Faouranybetter as prior art. Specifically, Faour requires, among otherfeatures,
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`that a first active agent-containing core (5) be surrounded by a semipermeable membrane(4).
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`Faour, abstract, Fig. 2, and col. 4, line 53 to col. 5, line 13. Faour teaches that the semipermeable
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`membraneis critical in controlling the release of the active agent from the described dosage
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`forms through the development of an osmotic pressure gradient in the core of the tablet.
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`/d., col.
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`5, lines 14-20. In contrast, and as explained earlier, the presently claimed controlled release oral
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`pharmaceutical compositions do not contain such a semipermeable membrane.
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`Application No.: 13/617,138
`Attorney Docket No. 3850-125
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`As such, the Faourreference fails to teach the invention recited in amended claim | 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
`
`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 claimssatisfy the requirements of the patent statutes and are patentable
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`overthe prior art of record. Reconsideration of this application and early notice of allowance is
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`requested. The Examineris invited to telephone the undersignedif it will assist in expediting the
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`prosecution and allowanceofthe instant application.
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`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
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`the amount of such fee to Rothwell, Figg, Ernst and Manbeck PC Deposit Account No. 02-2135.
`
`Respectfully submitted,
`
`Dated:
`
`_1 July 2013
`
`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
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