UNITED STA TES p A TENT 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.
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`15/015,722
`
`02/04/2016
`
`Curtis Wright
`
`21076-548
`
`9971
`
`04/08/2016
`
`7590
`118262
`Patent Docket Administrator
`Lowenstein Sandler LLP
`65 Livingston A venue
`Roseland, NJ 07068
`
`EXAMINER
`
`SINGH, RANDEEP
`
`ART UNIT
`
`PAPER NUMBER
`
`1615
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`MAIL DATE
`
`DELIVERY MODE
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`04/08/2016
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
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`PCLG00246786
`
`Purdue 2004
`Collegium v. Purdue, PGR2018-00048
`
`

`

`Application No.
`15/015,722
`
`Applicant(s)
`WRIGHT ET AL.
`
`Office Action Summary
`
`AIA (First Inventor to File)
`Status
`No
`I
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`Examiner
`RANDEEP SINGH
`
`Art Unit
`1615
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`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.
`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
`1 )~ Responsive to communication(s) filed on 02/04/2016.
`0 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`2a)0 This action is FINAL.
`2b)~ This 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*
`5)~ Claim(s) 41-60 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)~ Claim(s) 41-60 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`* 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
`http:i/www.usoto.gov/patents/init events/pphiindex.isp or send an inquiry to PPHfeedback(wuspto.aov.
`
`Application Papers
`10)0 The specification is objected to by the Examiner.
`11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected 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).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)O All
`b)O Some** c)O None of the:
`Certified copies of the priority documents have been received.
`1.0
`Certified copies of the priority documents have been received in Application No. __ .
`2.0
`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.
`
`Attachment{s)
`1) ~ Notice of References Cited (PT0-892)
`
`2) ~ Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date 02/04/2016.
`
`3) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20160402
`
`PCLG00246787
`
`Purdue 2004
`Collegium v. Purdue, PGR2018-00048
`
`

`

`Application/Control Number: 15/015,722
`Art Unit: 1615
`
`Page 2
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`DETAILED ACTION
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`Priority
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`Applicants' priority claim to U.S. Application No. 14/638685, filed 03/04/2015,
`
`which claims priority to U.S. Application No. 13/946418 (issued as U.S. Patent No.
`
`8999961 ), filed 07/19/2013, which claims priority to U.S. Application No. 13/890874,
`
`filed 05/09/2013, which claims priority to U.S. Application No. 13/765368 (issued as
`
`U.S. Patent No. 9040084), filed 02/12/2013, which claims priority to U.S. Patent No.
`
`8389007, filed 10/30/2008, which claims priority to U.S. Application No. 10/214412, filed
`
`08/06/2002, which claims priority to U.S. Provisional Application No. 60/310534, filed
`
`08/06/2001, is acknowledged.
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`Information Disclosure Statement
`
`The information disclosure statement (IDS) submitted on 02/04/2016 is in
`
`compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure
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`statement has been considered by the examiner. Please see attached initialed PT0-
`
`1449 forms.
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`Status of the Application
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`Applicants' Preliminary Amendment dated 02/04/2016 is acknowledged and has
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`been entered. Claims 41-60 are currently pending and have been examined in this
`
`action.
`
`PCLG00246788
`
`Purdue 2004
`Collegium v. Purdue, PGR2018-00048
`
`

`

`Application/Control Number: 15/015,722
`Art Unit: 1615
`
`Page 3
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
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`for all obviousness rejections set forth in this Office action:
`
`(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.
`
`Claims 41-60 are rejected under 35 U.S.C. 103(a) as being unpatentable
`
`over Kaiko et al. (cited in Applicants' IDS dated 02/04/2016) in view of Murari et al.
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`Kaiko et al. teach abuse resistant dosage forms designed to control Hie abuse
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`potential associated with opioid analgesics.
`
`Regarding claims 41-48 and 50-60, Kaiko et al. teach an abuse resistant dosage
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`form comprising oxycodone, salts or bases thereof (see claims of Kaiko et al. and
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`column 8, line 43). Kaiko et al. teach the production of dosage forms comprising
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`sustained release beads which may be included in capsules (see column 24). Kaiko et
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`al. further teach the inclusion of fatty acids or stearic acid as hydrophobic matrix
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`materials and/or solubilizing agent/wetting agent in their dosage forms (see column 17,
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`lines 4-5 and column 27, line 17). Kaiko et al. also teach the inclusion of waxes such as
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`beeswax and carnauba wax as suitable hydrophobic materials in their dosage forms
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`(see column 27, line 40). The dosage forms of Kaiko et al. can further comprise a
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`sustained released carrier that causes their opioid to be released over a time period of
`
`PCLG00246789
`
`Purdue 2004
`Collegium v. Purdue, PGR2018-00048
`
`

`

`Application/Control Number: 15/015,722
`Art Unit: 1615
`
`Page 4
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`about 8 to about 24 hours when orally administered to a human patient (see claim 11 of
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`Kaiko et al.).
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`Regarding the specific limitations of claim 49, Kaiko et al. teach U1e preparation
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`of a melt-extruded matrices obtained through melting at least one hydrophobic material
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`and preferably an additional hydrophobic material to obtain a homogeneous mixture,
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`and incorporating an opioid therein (see column 29).
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`Regarding the specific limitations of claims 41 and 60, Kaiko et al. do not
`
`explicitly recite the inclusion of polyglycolized glycerides in their compositions.
`
`Murari et al. teach solid pharmaceutical dosage forms comprising hydrophobic
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`drugs such as opioids (see Abstract and paragraph [0069]). Murari et aL teach
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`polyglycolyzed glycerides as commonly used surfactants in pharmaceuticals (see
`
`paragraph [007 4]).
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`Based on the teachings of Kaiko et al. and Murari et al., it would have been well
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`obvious to one of ordinary level of skill in the art at the time of the invention to prepare
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`an abuse deterrent controlled release dosage form comprising combining oxycodone or
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`oxycodone base, a surfactant such as a polyglycolyzed glyceride, hydrophobic
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`materials such as stearic acid and beeswax and/or carnauba wax to form a
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`combination, preparing beads/particles from the combination, and containing the
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`particles in a capsule, such that the abuse deterrent dosage form providing a
`
`PCLG00246790
`
`Purdue 2004
`Collegium v. Purdue, PGR2018-00048
`
`

`

`Application/Control Number: 15/015,722
`Art Unit: 1615
`
`Page 5
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`therapeutic effect for about 12 hours or longer when orally administered to a patient.
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`Because Kaiko et al. suggest that their dosage forms are abuse deterrent to those
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`intending to extract opioid from a dosage form (see background of Kaiko et al.), and
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`contain the same materials as claimed, a skilled artisan would have had a reasonable
`
`expectation that the abuse deterrent property of their dosage forms, such as suitable
`
`viscosity, would be present when their dosage forms are subject to tampering
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`comprising heating at a temperature greater than about 45 degrees C.
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`Conclusion
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`No claims are allowed.
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`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to RANDEEP SINGH whose telephone number is
`
`(571 )270-3881. The examiner can normally be reached on Monday-Friday 10:00-6:30
`
`PM.
`
`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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`PCLG00246791
`
`Purdue 2004
`Collegium v. Purdue, PGR2018-00048
`
`

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`Application/Control Number: 15/015,722
`Art Unit: 1615
`
`Page 6
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`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
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`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Randeep Singh/
`Examiner, Art Unit 1615
`
`/Robert A. Wax/
`Supervisory Patent Examiner
`Art Unit 1615
`
`PCLG00246792
`
`Purdue 2004
`Collegium v. Purdue, PGR2018-00048
`
`