UNITED STA 1ES p A 1ENT AND TRADEMARK OFFICE
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`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
`
`06/29/2016
`7590
`6980
`TROUTMANSANDERSLLP
`600 Peachtree Street
`Suite 5200
`Atlanta, GA 30308
`
`EXAMINER
`
`AKHOON, KAUSER M
`
`ART UNIT
`
`1642
`
`PAPER NUMBER
`
`DATE MAILED: 06/29/2016
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`06/03/2015
`14/729,660
`TITLE OF INVENTION: TAMPER RESISTANT DOSAGE FORMS
`
`William H, McKenna
`
`241957,000596
`
`2426
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
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`TOTAL FEE(S) DUE
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`nonprovisiona1
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`UNDISCOUNTED
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`$960
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`$0
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`09/29/2016
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`Pagel of3
`
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`

`

`PART B- FEE(S) TRANSMITTAL
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
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`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`06/03/2015
`14/729,660
`TITLE OF INVENTION: TAMPER RESISTANT DOSAGE FORMS
`
`William H. McKenna
`
`241957.000596
`
`2426
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
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`TOTAL FEE(S) DUE
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`nonprovisional
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`UNDISCOUNTED
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`$960
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`$0
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`$960
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`DATE DUE
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`09/29/2016
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`AKHOON, KAUSER M
`
`1642
`
`424-468000
`
`l. Change of correspondence address or indication of "Fee Address" (37
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`PTOL-85 Part B (10-13) Approved for use through 10/3112013.
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`OMB 0651-0033
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`Page 2 of3
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`UNITED STA 1ES p A 1ENT AND TRADEMARK OFFICE
`
`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
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/729,660
`
`06/03/2015
`
`William H. McKenna
`
`241957.000596
`
`2426
`
`06/29/2016
`7590
`6980
`TROUTMANSANDERSLLP
`600 Peachtree Street
`Suite 5200
`Atlanta, GA 30308
`
`EXAMINER
`
`AKHOON, KAUSER M
`
`ART UNIT
`
`1642
`
`PAPER NUMBER
`
`DATE MAILED: 06/29/2016
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
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`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
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`Section 1(h)(2) of the AlA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i) to eliminate the
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`PTOL-85 (Rev. 02/11)
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`Notice of Allowability
`
`Application No.
`14/729,660
`Examiner
`KAUSER AKHOON
`
`Applicant(s)
`MCKENNA ET AL.
`AlA (First Inventor to File)
`Art Unit
`Status
`1642
`No
`
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application. If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOW ABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`1. [8] This communication is responsive to 06/03/2016.
`D A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on ___ .
`2. D 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.
`
`3. [8] The allowed claim(s) is/are 170-199. As a result of the allowed claim(s), 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
`httg://www.usoto.govi.Qatents/init events/P.Qh/indexjso or send an inquiry to PPHfeedback@usgto.gov .
`4. D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`*c) D None of the:
`a) D All
`b) D Some
`1. D Certified copies of the priority documents have been received.
`2. D Certified copies of the priority documents have been received in Application No. __ .
`3. D 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)).
`* Certified copies not received: __ .
`
`Applicant has THREE MONTHS FROM THE "MAILING DATE" of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`5. D CORRECTED DRAWINGS (as "replacement sheets") must be submitted.
`D including changes required by the attached Examiner's Amendment I Comment or in the Office action of
`Paper No./Mail Date __ .
`Identifying indicia such as the application number {see 37 CFR 1.84{c)) should be written on the drawings in the front {not the back) of
`each sheet. Replacement sheet{s) should be labeled as such in the header according to 37 CFR 1.121{d).
`6. 0 DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. [8] Notice of References Cited (PT0-892)
`2. D Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date __
`3. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. D Interview Summary (PT0-413),
`Paper No./Mail Date __ .
`/K. A./
`Examiner, Art Unit 1642
`
`5. D Examiner's Amendment/Comment
`6. [8] Examiner's Statement of Reasons for Allowance
`7. D Other __ .
`
`/MISOOK YU/
`Supervisory Patent Examiner, Art Unit 1642
`
`U.S. Patent and Trademark Off1ce
`PTOL-37 (Rev. 08-13)
`20160610
`
`Notice of Allowability
`
`Part of Paper No./Mail Date
`
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`Application/Control Number: 14/729,660
`Art Unit: 1642
`
`Page 2
`
`The present application is being examined under the pre-AlA first to invent provisions.
`
`DETAILED ACTION
`
`Claims 170-199 are pending and under examination in the instant application.
`
`Withdrawn rejections
`
`Applicants' amendments and arguments filed June 3, 2016 are acknowledged and have
`
`been fully considered. The Examiner has re-weighed all the evidence of record. The
`
`amendments to the claims have overcome the rejections based on 35 §USC 103 (a). These
`
`rejections are withdrawn.
`
`Examiner's Amendment
`
`An examiner's amendment to the record appears below. Should the changes and/or
`
`additions be unacceptable to applicant, an amendment may be filed as provided by 37 CPR
`
`1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the
`
`payment of the issue fee.
`
`Please replace paragraph [001] on page 1 of the specification with the following replacement
`
`paragraph [001]:
`
`[001] The present application is a continuation of U.S. Application Serial No. 14/515,924, filed
`
`October 16, 2014, issued as US Patent No.: 9,084,816, which is a continuation of U.S.
`
`Application Serial No. 13/803,132, filed March 14, 2013, now abandoned, which is a divisional
`
`application of U.S. Application Serial No. 11/844,872, filed August 24, 2007, issued as US
`
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`Application/Control Number: 14/729,660
`Art Unit: 1642
`
`Page 3
`
`Patent No.: 8, 894,987, which claims priority from U.S. Provisional Application Serial No.
`
`60/840,244, filed August 25, 2006. The entire contents of those applications are incorporated
`
`herein by reference.
`
`Terminal Disclaimer
`
`The terminal disclaimers filed on 06/02/2016 and 06/16/2016 disclaiming the terminal
`
`portion of any patent granted on this application have been reviewed and are accepted. The
`
`terminal disclaimers have been recorded.
`
`Reasons for Allowance
`
`The following is an examiner's statement of reasons for allowance. The present
`
`invention is directed to a method of treating pain by administering a pharmaceutical tablet
`
`comprising polyethylene oxide and oxycodone or pharmaceutically acceptable salt thereof,
`
`wherein the polyethylene oxide has a molecular weight of approximately 4,000,000, 7,000,000
`
`or combination thereof and is at least 79% by weight of the composition and prepared by
`
`compression shaping then followed by air curing without compression. The closest prior art of
`
`record is Bartholomaus et al. ("Bartholomaus", US 2005/0031546, of record), which does not
`
`teach the particular embodiment instantly recited. Bartholomaus does not teach with sufficient
`
`specificity the instantly recited claimed polyethylene oxide with a molecular weight of
`
`approximately 4,000,000, 7,000,000 or combination thereof in an amount of at least 79%. The
`
`instant claims as amended require a polyethylene oxide with a molecular weight of
`
`approximately 4,000,000, 7,000,000 or combination thereof and is at least 79% by weight of the
`
`composition which were shown to have unexpected results as supported by the data in the instant
`
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`Application/Control Number: 14/729,660
`Art Unit: 1642
`
`Page 4
`
`specification in Examples 13 and 22, a non-obvious improvement over the prior art and showing
`
`a density decrease compared to uncured tablets.
`
`Not only does the prior art not teach with sufficient specificity this combination of
`
`components but also Applicant has demonstrated unexpected results concerning density
`
`decreasing changes that are a result of the curing process that has been addressed in the Affidavit
`
`filed on 12111/2015. As far as the Examiner can determine, there is an expectation in the art to
`
`increase the density of the polymer matrix upon heat curing. Mai et al. (Materiaux et
`
`Constructions 1982. 15(2); pp:99-106) teach that heat treatment of polypropylene increases the
`
`density of the polymer (Abstract); AlKhatib et al. (AAPS PharmSciTech, 2010. 11(1); pp:253-
`
`266) teach that the density of neat polymeric compacts increased upon exposure to heat
`
`(Abstract); and Mpofu et al. (Journal of Colloid and Interface Science. 2004, 271; pp:l45-156)
`
`teach the absorbed polymer density of PEO and PAM showed significant increase with
`
`increasing temperature (Abstract). In contrast, Applicant has surprisingly demonstrated a
`
`decrease in density which does not appear to be a predictable or expected result. As a
`
`consequence of the amendment to specific ingredients and amounts as well as a showing of
`
`unexpected results, the instant claims are deemed allowable.
`
`Any comments considered necessary by applicant must be submitted no later than the
`
`payment of the issue fee and, to avoid processing delays, should preferably accompany the issue
`
`fee. Such submissions should be clearly labeled "Comments on Statement of Reasons for
`
`Allowance."
`
`Telephone Inquiry
`
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`Application/Control Number: 14/729,660
`Art Unit: 1642
`
`Page 5
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to KAUSER M. AKHOON whose telephone number is (571) 270-
`
`1026. The examiner can normally be reached on M-F 8:00AM-5:00PM.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Misook Yu can be reached on (571) 272-0839. The fax phone number for the
`
`organization where this application or proceeding is assigned is 571-273-8300.
`
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`/K. A./
`Examiner, Art Unit 1642
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`/MISOOK YU/
`Supervisory Patent Examiner, Art Unit 1642
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`KASHIV1040
`IPR of Patent No. 9,492,393
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`