PATENT
`Customer No. 6449
`Application No. 13/617,138
`Attorney Docket No. 3850-125
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Appl. No. (cid:9)
`Applicant (cid:9)
`Filed (cid:9)
`TC/A.U. (cid:9)
`Examiner (cid:9)
`
`: 13/617,138
`: Roberto VILLA et al.
`: 14 September 2012
`: 1615
`: Susan T. Tran
`
`Docket No. (cid:9)
`Customer No. (cid:9)
`Confirmation No. (cid:9)
`
`: 3850-125
`: 06449
`: 7811
`
`AMENDMENT
`
`MAIL STOP AMENDMENT
`Director of the United States Patent
`and Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`Dear Sir:
`
`In response to the Office Action dated 16 November 2012, please amend this
`
`application as follows:
`
`Amendments to the Claims begin on page 2.
`
`Remarks begin on page 5.
`
`Exhibit 1052
`ARGENTUM
`IPR2018-00080
`
`000001
`
`
`Customer No. 6449
`Application No. 13/617,138
`Attorney Docket No. 3850-125
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Appl. No. (cid:9)
`Applicant (cid:9)
`Filed (cid:9)
`TC/A.U. (cid:9)
`Examiner (cid:9)
`
`: 13/617,138
`: Roberto VILLA et al.
`: 14 September 2012
`: 1615
`: Susan T. Tran
`
`Docket No. (cid:9)
`Customer No. (cid:9)
`Confirmation No. (cid:9)
`
`: 3850-125
`: 06449
`: 7811
`
`AMENDMENT
`
`MAIL STOP AMENDMENT
`Director of the United States Patent
`and Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`Dear Sir:
`
`In response to the Office Action dated 16 November 2012, please amend this
`
`application as follows:
`
`Amendments to the Claims begin on page 2.
`
`Remarks begin on page 5.
`
`Exhibit 1052
`ARGENTUM
`IPR2018-00080
`
`000001
`
`
`
`Application No.: 13/617,138
`Attorney Docket No. 3850-125
`
`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) (cid:9)
`
`A controlled release oral pharmaceutical composition comprising:
`
`(1) a tablet core comprising:
`
`a) budesonide in an amount effective for treatment of inflammatory bowel
`
`disease in the gastrointestinal tract,
`
`b) a lipophilic excipient;
`
`c) an amphiphilic excipient;
`
`d) a hydrogel-forming hydrophilic excipient other than a gum; and
`
`(2) a coating on said tablet core, said coating comprising a gastro-resistant film.
`
`2. (Currently Amended) (cid:9)
`
`The composition of A controlled release oral pharmaceutical
`
`composition according to claim 1, comprising wherein said controlled release oral
`
`pharmaceutical composition comprises 9 mg of budesonide.
`
`3. (New) (cid:9)
`
`A controlled release oral pharmaceutical composition according to claim 1,
`
`wherein said hydrogel-forming hydrophilic excipient comprises hydroxypropyl cellulose.
`
`2
`
`000002
`
`
`
`Application No.: 13/617,138
`Attorney Docket No. 3850-125
`
`4. (New) (cid:9)
`
`A controlled release oral pharmaceutical composition according to claim 2,
`
`wherein said hydrogel-forming hydrophilic excipient comprises hydroxypropyl cellulose.
`
`5. (New) (cid:9)
`
`A controlled release oral pharmaceutical composition according to claim 1,
`
`wherein said gastro-resistant film comprises at least one methacrylic acid polymer or copolymer.
`
`6. (New) (cid:9)
`
`A controlled release oral pharmaceutical composition according to claim 5,
`
`wherein said hydrogel-forming hydrophilic excipient comprises hydroxypropyl cellulose.
`
`7. (New) (cid:9)
`
`A controlled release oral pharmaceutical composition according to claim 1,
`
`wherein said lipophilic excipient and said amphiphilic excipient are present in said controlled
`
`release oral pharmaceutical composition in a ratio of about 1 to 1 by weight.
`
`8. (New) (cid:9)
`
`A controlled release oral pharmaceutical composition according to claim 7,
`
`wherein said hydrogel-forming hydrophilic excipient comprises hydroxypropyl cellulose.
`
`9. (New) (cid:9)
`
`A controlled release oral pharmaceutical composition according to claim 1,
`
`wherein said lipophilic excipient comprises stearic acid.
`
`10. (New) (cid:9)
`
`A controlled release oral pharmaceutical composition according to claim 9,
`
`wherein said hydrogel-forming hydrophilic excipient comprises hydroxypropyl cellulose.
`
`3
`
`000003
`
`
`
`Application No.: 13/617,138
`Attorney Docket No. 3850-125
`
`11. (New) (cid:9)
`
`A controlled release oral pharmaceutical composition according to claim 1,
`
`wherein said amphiphilic excipient comprises lecithin.
`
`12. (New) (cid:9)
`
`A controlled release oral pharmaceutical composition according to claim 11,
`
`wherein said hydrogel-forming hydrophilic excipient comprises hydroxypropyl cellulose.
`
`4
`
`000004
`
`
`
`Application No.: 13/617,138
`Attorney Docket No. 3850-125
`
`Amendments
`
`REMARKS
`
`Claim 1 has been amended to specify that the hydrogel-forming hydrophilic excipient is
`
`not a gum. The as-filed specification discloses at paragraph 36 that the hydrophilic excipient can
`
`comprise hydrogel compounds, including natural or synthetic gums. As such, there is written
`
`description support for amending claim 1 to recite that the hydrogel-forming hydrophilic
`
`excipient comprising the presently claimed controlled release oral pharmaceutical compositions
`
`is other than a gum. In re Johnson, 558 F.2d 1008 (C.C.P.A. 1977).
`
`New claims 3, 4, 6, 8, 10 and 12 have been added to specify that the hydrogel-forming
`
`hydrophilic excipient comprises hydroxypropyl cellulose. Support for these claims can be found
`
`in the as-filed specification at least in Example 1 (paragraphs [0047] to [0051]) and Example 2
`
`(paragraphs [0052] to [0055]).
`
`New claim 5 has been added to specify that the gastro resistant film comprises at least
`
`one methacrylic acid polymer or copolymer. Support for this claim can be found in the as-filed
`
`specification at least in Example 1 (paragraphs [0047] to [0051]) and Example 2 (paragraphs
`
`[0052] to [0055]).
`
`New claim 7 has been added to specify that the lipophilic excipient and amphiphilic
`
`excipient are in a 1:1 ratio. Support for this claim can be found in the as-filed specification at
`
`least in Example 1 (paragraphs [0047] to [0051]) and Example 2 (paragraphs [0052] to [0055]).
`
`New claim 9 has been added to specify that the lipophilic excipient is stearic acid.
`
`Support for this claim can be found in the as-filed specification at least in Example 1 (paragraphs
`
`[0047] to [0051]) and Example 2 (paragraphs [0052] to [0055]).
`
`5
`
`000005
`
`
`
`Application No.: 13/617,138
`Attorney Docket No. 3850-125
`
`New claim 11 has been added to specify that the amphiphilic excipient is lecithin.
`
`Support for this claim can be found at least in paragraph [0033] in the as-filed specification.
`
`Applicants submit that these amendments do not constitute new matter, and their entry is
`
`requested.
`
`Rejections for obviousness-type double patenting
`
`The Examiner has provisionally rejected claims 1-2 for obviousness-type double
`
`patenting over claims 1-15 of copending application Serial No. 13/249,389.
`
`The Examiner has provisionally rejected claims 1-2 for obviousness-type double
`
`patenting over claims 1-3 of copending application Serial No. 13/462,409, which Applicants note
`
`is now U.S. Patent No. 8,293,273.
`
`The Examiner has rejected claims 1-2 for obviousness-type double patenting over claims
`
`1-11 of U.S. Patent No. 7,410,651.
`
`The Examiner has rejected claims 1-2 for obviousness-type double patenting over claims
`
`1-11 of U.S. Patent No. 7,431,943.
`
`The Examiner has rejected claims 1-2 for obviousness-type double patenting over claims
`
`1-11 of U.S. Patent No. 8,029,823 which Applicants note is now RE43799.
`
`There is no basis for this rejection. However, solely to expedite prosecution, Applicants
`
`submit herewith a Terminal Disclaimer which obviates these rejections. Withdrawal of these
`
`rejections is requested.
`
`6
`
`000006
`
`
`
`Application No.: 13/617,138
`Attorney Docket No. 3850-125
`
`Rejection under 35 U.S.C. § 102(e)
`
`The Examiner has rejected claims 1-2 under 35 U.S.C. § 102(e) as being anticipated by
`
`Hallgren et al. (US 6,239,120). The Examiner contends that Hallgren teaches a tablet
`
`composition comprising budesonide and pharmaceutically acceptable carriers which may include
`
`a hydrogel excipient (e.g., mannitol cellulose derivatives), an amphiphilic excipient (e.g.,
`
`polyethylene glycol) and a lipophilic excipient (e.g., waxes). The Examiner also contends that
`
`Hallgren discloses that the tablet may be coated with an enteric coating. The Examiner further
`
`contends that Hallgren discloses a dosage of active ingredient of 0.5-20 mg and the use of 9 mg
`
`budesonide in the Examples. Applicants traverse this rejection.
`
`Hallgren discloses the use of glucocorticoids, including budesonide, for treating
`
`glomerulonephritis, a renal disease. Hallgren does not disclose the use of glucocorticoids for
`
`treating inflammatory bowel disease or intestinal diseases. Thus, there is no disclosure in
`
`Hallgren of the use of 9 mg budesonide for treating inflammatory bowel disease as required by
`
`claim 2.
`
`Applicant notes that Hallgren discloses using 9 mg of budesonide for treating IgA
`
`nephrology. The total of 9 mg of budesonide was administered via the use of Entocort®
`
`budesonide capsules. According to the Entocort® EC budesonide prescribing information (copy
`
`attached for the convenience of the Examiner), Entocort® budesonide is in the form of a capsule
`
`comprising small pellets, each of which comprises micronized budesonide and a controlled-
`
`release coating. Each capsule contains enough of the small pellets that the total dose of
`
`budesonide in each capsule is 3 mg. Thus, the 9 mg dose of budesonide disclosed in the
`
`Examples of Hallgren is arrived at by the administration of three capsules, each comprising
`
`coated pellets, and not in a single tablet, comprising a tablet core and a gastro-resistant coating
`
`7
`
`000007
`
`
`
`Application No.: 13/617,138
`Attorney Docket No. 3850-125
`
`on the tablet core. One of ordinary skill in the art would appreciate that the capsules used in
`
`Hallgren are not the same as, and so do not anticipate, the presently claimed controlled release
`
`oral dosage form that comprises a tablet core. Applicants submit that Hallgren does not disclose
`
`all of the elements of claims 1 and 2 and thus cannot anticipate these claims.
`
`In addition, Hallgren does not teach a tablet in which the hydrogel-forming hydrophilic
`
`excipient is hydroxypropyl cellulose (claims 3, 4, 6, 8, 10 and 12). Hallgren does not teach a
`
`tablet in which the lipophilic excipient and amphiphilic excipient are present in a 1:1 ratio (claim
`
`7). Hallgren also does not disclose a tablet that includes stearic acid as the lipophilic excipient
`
`(claim 9). In addition, Hallgren does not disclose a tablet that includes lecithin as the
`
`amphiphilic excipient (claim 11). Because Hallgren does not disclose all of the elements of the
`
`claimed subject matter as amended, Applicants submit that Hallgren cannot anticipate the claims.
`
`In view of the above remarks, Applicants submit that the claimed subject matter is not
`
`anticipated by Hallgren et al. Withdrawal of this rejection is requested.
`
`Rejection under 35 U.S.C. § 102(b)
`
`The Examiner has rejected claim 1 under 35 U.S.C. § 102(b) as being anticipated by
`
`Friend et al. (US 5,811,388). The Examiner contends that Friend teaches a drug delivery system
`
`such as a tablet that comprises a hydrogel gum, a drug such as budesonide, a penetration
`
`enhancer (an amphiphilic excipient) and cellulosic excipients (lipophilic excipients). The
`
`Examiner also contends that Friend discloses that the tablet may be coated with an enteric
`
`coating. Applicants traverse this rejection.
`
`Applicants submit that Friend does not disclose all of the elements of the claims as
`
`amended. Specifically, Friend discloses the use of a hydrogel gum. Claim 1 as amended
`
`8
`
`000008
`
`
`
`Application No.: 13/617,138
`Attorney Docket No. 3850-125
`
`excludes a gum as the hydrogel excipient. Since Friend does not disclose other hydrophilic
`
`excipients, it does not disclose this element of claim 1 as amended. In addition, Friend does not
`
`teach a tablet in which the hydrogel-forming hydrophilic excipient is hydroxypropyl cellulose
`
`(claims 3, 4, 6, 8, 10 and 12). Friend does not disclose a tablet containing 9 mg of budesonide
`
`(claim 2). Friend does not teach a tablet in which the lipophilic excipient and amphiphilic
`
`excipient are present in a 1:1 ratio (claim 7). Friend also does not disclose a tablet that includes
`
`stearic acid as the lipophilic excipient (claim 9). In addition, Friend does not disclose a tablet
`
`that includes lecithin as the amphiphilic excipient (claim 11). Because Friend does not disclose
`
`all of the elements of the claimed subject matter as amended, Applicants submit that Friend
`
`cannot anticipate the claims as amended.
`
`In view of the above remarks, Applicants submit that the claimed subject matter is not
`
`anticipated by Friend et al. Withdrawal of this rejection is requested.
`
`Rejection under 35 U.S.C. § 103(a)
`
`The Examiner has rejected claims 1-2 under 35 U.S.C. § 103(a) as being unpatentable
`
`over Friend et al. (US 5,811,388) in view of Hallgren et al. (US 6,239,120). The Examiner notes
`
`that Friend does not teach the amount of budesonide and cites Hallgren for teaching a tablet
`
`dosage of budesonide from 0.5-20 mg and the use of 9 mg budesonide in the Examples. The
`
`Examiner then contends that it would have been obvious to modify the dosage form of Friend to
`
`include budesonide in 9 mg per tablet. Applicants traverse this rejection.
`
`As described above, Friend does not disclose hydrophilic excipients other than gums; it
`
`does not disclose this element of claim 1 as amended. In addition, Friend does not teach a tablet
`
`in which the hydrogel-forming hydrophilic excipient is hydroxypropyl cellulose (claims 3, 4, 6,
`
`9
`
`000009
`
`
`
`Application No.: 13/617,138
`Attorney Docket No. 3850-125
`
`8, 10 and 12). Friend does not disclose a tablet containing 9 mg of budesonide (claim 2). Friend
`
`does not teach a tablet in which the lipophilic excipient and amphiphilic excipient are present in
`
`a 1:1 ratio (claim 7). Friend also does not disclose a tablet that includes stearic acid as the
`
`lipophilic excipient (claim 9). In addition, Friend does not disclose a tablet that includes lecithin
`
`as the amphiphilic excipient (claim 11). Hallgren does not cure these deficiencies of Friend.
`
`Thus, the combination of Hallgren with Friend does not result in a controlled release oral
`
`pharmaceutical composition which has all of the elements set forth in the claims as amended.
`
`Accordingly, the combination of Friend and Hallgren does not render obvious the claims as
`
`amended.
`
`In addition, Friend teaches the use of a hydrocolloid gum to act as delayed release tool
`
`inside of a composition aimed to deliver the active ingredients in the colon. Friend also teaches
`
`the use of an enzymatic activation of the release mechanism once the tablet is transiting through
`
`the colon. Since these mechanisms are important for the compositions of Friend to deliver the
`
`active ingredients, Applicant submits that one of ordinary skill in the art would not look to
`
`modify Friend by the elements of Hallgren which would change the basic function of the
`
`composition of Friend. For this reason, Applicant submits that the combination of Friend and
`
`Hallgren is improper and does not render obvious the claimed subject matter.
`
`In view of the above remarks, Applicants submit that the claimed subject matter is not
`
`rendered obvious by the combination of Friend et al. and Hallgren et al. Withdrawal of this
`
`rejection is requested.
`
`10
`
`000010
`
`
`
`Application No.: 13/617,138
`Attorney Docket No. 3850-125
`
`Conclusion
`
`In view of the above amendments and remarks, it is submitted that the claims satisfy the
`
`requirements of the patent statutes and are patentable over the prior art of record.
`
`Reconsideration of this application and early notice of allowance is requested. The Examiner is
`
`invited to telephone the undersigned if it will assist in expediting the prosecution and allowance
`
`of the instant application.
`
`Respectfully submitted,
`
`Dated: 15 January 2013
`
`By (cid:9)
`
`/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
`
`Attachment: ENTOCORT® EC (budesonide) Capsules, Prescribing Information
`
`11
`
`000011
`
`(cid:9)
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
