`
`UNITED STATES PATENT 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
`wwwuSplo.gov
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATION NO.
`
`15/015,722
`
`FILING DATE
`
`02/04/2016
`
` APPLICATION NO.
`
`Curtis Wright
`
`21076-548
`
`9971
`
`Patent Docket Administrator
`Lowenstein Sandler LLP
`65 Livingston Avenue
`Roscland, NF 07068
`
`SINGH, RANDLEP
`
`1615
`
`11/02/2016
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period forreply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`PCLG00246846
`
`Purdue 2005
`Collegium v. Purdue, PGR2018-00048
`
`Purdue 2005
`Collegium v. Purdue, PGR2018-00048
`
`

`

`
`
`
`Application No.
`Applicant(s)
`15/015,722
`WRIGHTETAL.
`
`Examiner
`Art Unit
`AIA (First Inventorto File)
`
`RANDEEP SINGH
`1615
`Ne
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address--
`Period for Reply
`
`Office Action Summary
`
`
`
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`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).
`Anyreply 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).
`
`In no event, however, may a reply be timelyfiled
`
`Status
`1) Responsive to communication(s) filed on 07/08/2016.
`C1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiledon_
`2a)C] This action is FINAL.
`2b) This action is non-final.
`3) Anelection was made by the applicant in responseto a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
`4)L] Since this application is in condition for allowance exceptfor formal matters, prosecution as to the merits is
`closed in accordancewith the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`
`5) Claim(s) 41-62 is/are pending in the application.
`
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6) Claim(s)__is/are allowed.
`7) Claim(s) 41-62 is/are rejected.
`8) Claim(s)___is/are objectedto.
`
`9)L] Claim(s)
`are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may beeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`
`
`
`hito/www, uspto.dov/patents/init events/poh/index.isp or send an inquiry to PPHfeedback@usxte doy.
`
`Application Papers
`
`10) The specification is objected to by the Examiner.
`
`
`11) The drawing(s)filed on
`is/are: a)L] accepted or b)(] 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).
`Replacementdrawing 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)_] Acknowledgmentis made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a) All bj) Some** c)L] Noneofthe:
`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.
`3.0] Copiesof the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 1 7.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`
`
`Attachment(s)
`3) CL] Interview Summary (PTO-413)
`1)
`Notice of References Cited (PTO-892)
`Paper No(s)/Mail Date.
`.
`:
`4) oO Other:
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`
`Paper No(s)/Mail Date 4/6/16, 7/6/16, 7/21/16.
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`7
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20161031
`
`PCLG00246847
`
`Purdue 2005
`Collegium v. Purdue, PGR2018-00048
`
`Purdue 2005
`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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`Information Disclosure Statement
`
`The information disclosure statements submitted on 04/05/2016, 07/06/2016, and
`
`07/21/2016 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the
`
`information disclosure statements have been considered by the examiner. Please see
`
`attachedinitialed PTO-1449 forms.
`
`Status of the Application
`
`Applicants’ Amendment/Response dated 07/08/2016 has been entered and
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`carefully considered.
`
`In the Amendment/Response, claims 41, 53, and 60 were
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`amended, and claims 61 and 62 were newly added. Claims 41-62 are currently pending
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`and have been examinedin this action. Claims 41-62 are rejected.
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`Rejections not reiterated from previous actions are hereby withdrawn. The
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`following rejections are either reiterated or newly applied and constitute the complete
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`set of rejections currently being applied to the instant application.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of pre-AlA 35 U.S.C. 103(a) which forms the basis
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`for all obviousnessrejections 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 thistitle, 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.
`
`PCLG00246848
`
`Purdue 2005
`Collegium v. Purdue, PGR2018-00048
`
`Purdue 2005
`Collegium v. Purdue, PGR2018-00048
`
`

`

`Application/Control Number: 15/015,722
`Art Unit: 1615
`
`Page 3
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`Claims 41-62 are rejected under 35 U.S.C. 103(a) as being unpatentable
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`over Kaikoetal. (cited previously) in view of Pateletal.
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`Kaiko et al. teach abuse resistant dosage forms designed to contra! the abuse
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`potential associated with opioid analgesics.
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`Regarding claims 41-48 and 50-62, Kaiko et al. teach an abuseresistant 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 beincluded in capsules (see column 24). Kaiko et
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`al. teach capsules comprising homagenous multiparticulates with particles of diameter
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`0.1 mm to 12 mm (see column 29, lines 39-64 and column 30, lines 21-23). Kaiko etal.
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`further teach the inclusion of fatty acids or stearic acid as hydrophobic matrix materials
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`and/or solubilizing agent/wetting agentin their dosage forms (see column 17, lines 4-5
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`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 overa time period of
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`about 8 to about 24 hours whenorally administered to a human patient (see claim 11 of
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`Kaiko et al.).
`
`Regarding the specific limitations of clair 49, Kaiko et al. teach the preparation
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`of a meit-exiruded matrices obtained through meiting at least one hydrophobic material
`
`PCLG00246849
`
`Purdue 2005
`Collegium v. Purdue, PGR2018-00048
`
`Purdue 2005
`Collegium v. Purdue, PGR2018-00048
`
`

`

`Application/Control Number: 15/015,722
`Art Unit: 1615
`
`Page 4
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`and preferably an acelitional 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 47 and 60, Kaike et al. do not
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`explicitly recite the inclusion of palyglycalized glycerides in their compositions.
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`Patel st al. tsach solid pharmaceutical dosage forms comprising hydrophobic
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`drugs such as opioids (see ciaim 9 of Patel et al}. Patel et al. teach dosage forms
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`comprising particles having a hamogenous distribution of active ingredient, surfactant,
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`triglyceride and/or additives (see colurrin 53, lines 55-67). Patel et al. further teach
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`polyglycolized glycerides as commonly used surfactants in pharmaceuticals (see
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`column 35}.
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`Based onthe teachings of Kaiko et al. and Patelet al., it would have been well
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`obvious to one of ordinary levelof skill in the art at the time of the invention to prepare
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`an abusedeterrent 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 forma
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`homogenous mixture, preparing beads/particles from the combination, and containing
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`the particles in a capsule, such that the abuse deterrent dosage form providing a
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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
`
`PCLG00246850
`
`Purdue 2005
`Collegium v. Purdue, PGR2018-00048
`
`Purdue 2005
`Collegium v. Purdue, PGR2018-00048
`
`

`

`Application/Control Number: 15/015,722
`Art Unit: 1615
`
`Page 5
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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
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`expectation that the abuse deterrent property of their dosage forms, such as suitable
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`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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`Response to Arguments
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`e Claim Rejections under 35 U.S.C. 103
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`Applicants argue that Murari, like Kaiko, fails to disclose or suggest preparing an
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`abuse deterrent dosage form comprising particles prepared from a homogenous mixture
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`of polyglycolyzed glycerides with oxycodone orsalt thereof together with the other
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`componentsrecited in claims 41 and 60 (see page 10 of Response). Applicants go on
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`to state that Murari teaches away from a homogenous mixture comprising
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`polyglycolyzed glycerides with oxycodone or salt thereof as recited in the present
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`claims.
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`Applicants’ arguments directed towards Murari were found to be persuasive, and the
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`rejections in view of Murari have been withdrawn. The Examiner notes, however,that
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`the rejections of the claims under 35 U.S.C. 103 have been maintained in view of
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`previously cited Kaiko and newly cited Patel et al.
`
`PCLG00246851
`
`Purdue 2005
`Collegium v. Purdue, PGR2018-00048
`
`Purdue 2005
`Collegium v. Purdue, PGR2018-00048
`
`

`

`Application/Control Number: 15/015,722
`Art Unit: 1615
`
`Page 6
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`No claims are allowed.
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to RANDEEP SINGH whosetelephone numberis
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`(571)270-3881. The examiner can normally be reached on Monday-Friday 10:00-6:30
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`PM.
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`If attempts to reach the examinerby 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.
`
`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-cirect.uspto.gov. Should
`
`you have questions on accessto the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`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
`
`PCLG00246852
`
`Purdue 2005
`Collegium v. Purdue, PGR2018-00048
`
`Purdue 2005
`Collegium v. Purdue, PGR2018-00048
`
`