UNITED STA (cid:9)IES PA (cid:9) PENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
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`APPLICATION NO. (cid:9)
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO. (cid:9)
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`CONFIRMATION NO.
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`13/617,138
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`09/14/2012
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`Roberto VILLA
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`3850-125
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`7811
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`7590 (cid:9)
`03/06/2013
`6449 (cid:9)
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`607 14th Street, N.W.
`SUIIE 800
`WASHINGTON, DC 20005
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`EXAMINER
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`TRAN, SUSAN T
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`ART UNIT
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`PAPER NUMBER
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`1615
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`NOTIFICATION DATE
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`DELIVERY MODE
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`03/06/2013
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`PTO-PAT-Email@rfem.com
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`PTOL-90A (Rev. 04/07)
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`MYLAN Ex 1057, Page 1
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`Office Action Summary
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`Application No.
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`13/617,138
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`Examiner
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`Applicant(s)
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`VILLA ET AL.
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`Art Unit
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`SUSAN TRAN
`1615
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`- (cid:9) Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`- (cid:9) Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`Status
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`1)Z Responsive to communication(s) filed on 15 January 2013.
`2a)Z This action is FINAL. (cid:9)
`2b)EIThis action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
`4)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`Disposition of Claims
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`5)E1 Claim(s) 1-12 is/are pending in the application.
`5a) Of the above claim(s) (cid:9)
`is/are withdrawn from consideration.
`6)0 Claim(s) (cid:9)
`is/are allowed.
`7)Z Claim(s) 1-12 is/are rejected.
`8)0 Claim(s) (cid:9)
`is/are objected to.
`9)0 Claim(s) (cid:9)
`are subject to restriction and/or election requirement.
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`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway
`program at a participating intellectual property office for the corresponding application. For more information, please see
`htto://www.uspto.aowbatentslinit eventsloph/index.isp or send an inquiry to PPFIfeedback(auspto.gov.
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`Application Papers
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`10)0 The specification is objected to by the Examiner.
`11)0 The drawing(s) filed on (cid:9)
`is/are: a)E accepted or bElobjected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
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`Priority under 35 U.S.C. § 119
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`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`b)E1Some * c)EINone of:
`1.0 Certified copies of the priority documents have been received.
`.
`2.0 Certified copies of the priority documents have been received in Application No. (cid:9)
`3.0 Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`* See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1) Z Notice of References Cited (PTO-892)
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`2) Z Information Disclosure Statement(s) (PTO/SIB/08)
`Paper No(s)/Mail Date 11/30/12.
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`3) q Interview Summary (PTO-413)
`Paper No(s)/Mail Date.
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`4) q Other: (cid:9)
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`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 09-12)
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`Office Action Summary (cid:9)
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`Part of Paper No./Mail Date 20130227
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`MYLAN Ex 1057, Page 2
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`(cid:9)
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`Application/Control Number: 13/617,138 (cid:9)
`Art Unit: 1615
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`Page 2
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`DETAILED ACTION
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`Priority
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`The later-filed application must be an application for a patent for an invention
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`which is also disclosed in the prior application (the parent or original nonprovisional
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`application or provisional application). The disclosure of the invention in the parent
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`application and in the later-filed application must be sufficient to comply with the
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`requirements of 35 U.S.C. 112(a) or the first paragraph of 35 U.S.C. 112 (pre-AIA). See
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`Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077
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`(Fed. Cir. 1994).
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`The disclosure of the prior-filed applications fail to provide adequate support or
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`enablement in the manner provided by 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA),
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`first paragraph for one or more claims of this application. (cid:9)
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`None of the prior-filed
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`applications appear to provide support for the limitation "hydrogel-forming hydrophilic
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`excipient other than a gum" recites in the present claims. As such, the present
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`application does not have priority date of the earlier filed applications.
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`Terminal Disclaimer
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`The terminal disclaimer filed on 01/15/13 disclaiming the terminal portion of any
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`patent granted on this application which would extend beyond the expiration date of
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`USPN 8,293,273; 8,029,823; 7,410,651; 7,431,943; and copending applications
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`13/249,389 and 13/462,409 has been reviewed and is accepted. The terminal
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`disclaimer has been recorded.
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`MYLAN Ex 1057, Page 3
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`Application/Control Number: 13/617,138 (cid:9)
`Art Unit: 1615
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`Page 3
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`Claim Rejections - 35 USC § 102
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
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`form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
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`(b) the invention was patented or described in a printed publication in this or a foreign country or in
`public use or on sale in this country, more than one year prior to the date of application for patent in
`the United States.
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`Claims 1 and 2 are rejected under 35 U.S.C. 102(e) as being anticipated by
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`Hallgren et al. US 6,239,120.
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`Claim 1 is rejected under 35 U.S.C. 102(b) as being anticipated by Friend et al.
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`US 5,811,388.
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`These rejections have been withdrawn in view of Applicant's Amendment filed
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`01/15/13.
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`Claims 1-12 are rejected under 35 U.S.C. 102(b) as being anticipated by Villa et
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`al. US 2006/0134208 Al .
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`Villa teaches a controlled release and taste masking oral tablet comprising
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`budesonide, and an inert matrix comprising of one or more hydrophilic water-swellable
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`excipients, an amphiphilic compound, and a lipophilic excipient. Amphiphilic compound
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`includes lecithin. Lipophilic includes compound having melting point between 40°C to
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`90°C. Hydrophilic includes compound capable of molecular relaxation. See abstract;
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`and paragraphs 0028-0031. The tablet is coated with a gastro-resistant film. (ID).
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`MYLAN Ex 1057, Page 4
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`Application/Control Number: 13/617,138 (cid:9)
`Art Unit: 1615
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`Page 4
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`Example 2 shows a tablet having: 1) a core comprising of 9.0 mg of budesonide, stearic
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`acid, lecithin, and cellulosic excipients; and 2) a gastro-resistant coating.
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
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`Claims 1 and 2 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Friend et al. US 5,811,388 in view of HaIlgren et al. US 6,239,120.
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`This rejection has been withdrawn in view of Applicant's Amendment filed
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`01/15/13.
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`Response to Arguments
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`Applicant's arguments have been considered but are moot because the
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`arguments do not apply to any of the references being used in the current rejection.
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`Conclusion
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`Applicant's amendment necessitated the new ground(s) of rejection presented in
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`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
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`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
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`CFR 1.136(a).
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`MYLAN Ex 1057, Page 5
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`Application/Control Number: 13/617,138 (cid:9)
`Art Unit: 1615
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`Page 5
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action. In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action. In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the date of this final action.
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`Correspondence
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to SUSAN TRAN whose telephone number is (571)272-
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`0606. The examiner can normally be reached on M-F 8:30 am to 5:30 pm.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number
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`for the organization where this application or proceeding is assigned is 571-273-8300.
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`MYLAN Ex 1057, Page 6
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`Application/Control Number: 13/617,138 (cid:9)
`Art Unit: 1615
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`Page 6
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. (cid:9)
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`Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`/S. TRAN/
`Primary Examiner, Art Unit 1615
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`MYLAN Ex 1057, Page 7
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