UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Olflce
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.mptogov
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`15/708,991
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`09/ 19/2017
`
`Alexander OKSCHE
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`18612700006
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`7484
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 NEW YORK AVENUE NW
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`WASHINGTON, DISTRICT OF COLUMBIA 20005
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`MCCI' CRAIG D
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`PAPER NUMBER
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`DELIVERY MODE
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`PAPER
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`ART UNIT
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`1628
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`MAIL DATE
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`02/21/2018
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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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`PTOL-QOA (Rev. 04/07)
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`

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`017709 A0110” Summary
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`Application No.
`15/708,991
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`Examiner
`CRAIG D RICCI
`
`Applicant(s)
`OKSCHE et al.
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`Art Unit
`1628
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`AIA Status
`NO
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`- The MAILING DA TE ofthis communication appears on the cover sheet with the correspondence address -
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS 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). 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).
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`Status
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`1). Responsive to communication(s) filed on 11/21/2017
`.
`D A declaration(s)laffidavit(s) under 37 CFR 1.130(b) was/were filed on
`2a)[:| This action is FINAL.
`2b)
`This action is non-final.
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`3)|:| 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.
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`4)I:| 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 Exparfe Quay/e, 1935 CD. 11, 453 O.G. 213.
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`
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`Disposition of Claims"
`5)
`Claim(s)
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`1-14 is/are pending in the application.
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`5a) Of the above Claim(s)
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`is/are withdrawn from consideration.
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`6) El Claim(s)
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`is/are allowed.
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`7)
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`8)
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`Claim(s) 1-14 is/are rejected.
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`I] Claim(s)
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`is/are objected to.
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`are subject to restriction and/or election requirement
`9) El Claim(s)
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`http:llwww.uspto.govlpatents/init_events/pphlindex.jsp or send an inquiry to PPeredback@uspto.gov.
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`Application Papers
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`10)l:| The specification is objected to by the Examiner.
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`is/are: a)[:| accepted or b)|:| objected to by the Examiner.
`11)|:| The drawing(s) filed on
`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).
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`Priority under 35 U.S.C. § 119
`12)l:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or ( ).
`Certified copies:
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`a)I:I All
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`b)l:l Some**
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`c)I:I None of the:
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`1.[:|
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`Certified copies of the priority documents have been received.
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`2.l:|
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`Certified copies of the priority documents have been received in Application No.
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`3.|:| 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)).
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`** 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) [3 Notice of References Cited (PTO-892)
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`Information Disclosure Statement(s) (PTOISBIOSa andfor PTOISBIOBb)
`2)
`Paper No(s)lMail Date 9/19/2017.
`US. Patent and Trademark Office
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`3) |:| Interview Summary (PTO—413)
`Paper No(s)/Mail Date
`4) D Other'
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`PTOL-325 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper NoJMail Date 20180220
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`

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`App lication/Control Number : 1 5/70 8,991
`Art Unit21628
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`Page2
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`DETAILED ACTION
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`Election/Restrictions
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`1.
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`Applicant’s election without traverse of a single film dosage form in the reply filed on
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`11/21/2017 is acknowledged.
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`The requirement
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`is still deemed proper and is therefore made
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`FINAL.
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`2.
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`The elected species read upon claims 1-14.
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`Double Parenting
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`3.
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`The nonstatutory double patenting rejection is based on a judicially created doctrine
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`grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or
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`improper timewise extension of the “right to exclude” granted by a patent and to prevent possible
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`harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where
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`the conflicting claims are not
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`identical, but at least one examined application claim is not
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`patentably distinct from the reference claim(s) because the examined application claim is either
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`anticipated by, or would have been obvious over, the reference claim(s). See, e. g., In re Berg, 140
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`F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010
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`(Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed Cir. 1985); In re Van Ornum,
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`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA
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`1970); In re Th0rington,418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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`4.
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`A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may
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`be used to overcome an actual or provisional rejection based on nonstatutory double patenting
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`provided the reference application or patent either is shown to be commonly owned with the
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`examined application, or claims an invention made as a result of activities undertaken within the
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`scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination
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`

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`App lication/Control Number : 1 5/70 8,991
`Art Unit21628
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`Page3
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`under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§
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`706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to
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`file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR
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`1.321(b).
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`5.
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`The USPTO Internet website contains terminal disclaimer
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`forms which may be used.
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`Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the
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`form is filed determines what form (e.g., PTO/SB/ZS, PTO/SB/26, PTO/AIA/ZS, or PTO/AIA/26)
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`should be used. A web-based eTerminal Disclaimer may be filled out completely online using
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`web-screens. AneTerminal Disclaimer that meets all requirements is auto-processed and approved
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`immediately upon submission. For more information about eTerminal Disclaimers,
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`refer to
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`www.uspto. gov/patents/process/file/efs/guidance/eTD-inf0—I.jsp.
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`6.
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`Claims 1-14 are rejected on the ground of nonstatutory double patenting as being
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`unpate ntable over claims of U.S. Patent No. 9,101 ,625.
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`7.
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`Although the claims at issue are not identical,
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`they are not patentably distinct from each
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`other. The instant claims are drawn to film dosage forms for trans-mucosal administration
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`comprising buprenorphine and naloxone in a weight ratio of 1:1 to 10:10, and at least one non-
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`gelatin polymeric
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`film forming material
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`in which the buprenorphine
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`and naloxone
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`are
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`dissolved/homogenously
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`dispersed, wherein the film dosage releases substantially all
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`the
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`buprenorphine and naloxone into contact with the mucosal surface of the oral cavity within less
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`than 5 minutes after contact. The ‘625 patent is similarly drawn to film dosage forms for sublingual
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`administration comprising buprenorphine and naloxone in a weight ratio of 1:1 to 10:10, and at
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`least one non-gelatin polymeric film forming material in which the buprenorphine and naloxone
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`are dissolved/homogenously dispersed, wherein the film dosage releases substantially all the
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`

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`Application/Control Number:1 5/70 8,991
`Art Unit21628
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`Page4
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`buprenorphine and naloxone to be absorbed by the subligual mucosa within less than 5 minutes
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`after sublingual administration.
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the examiner
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`should be directed to CRAIGD RICCI whose telephone number is (571) 270-5864. The examiner
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`can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm
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`ET. Examiner interviews are available via telephone,
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`in—person, and video conferencing using a
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`USPTO supplied web-based collaboration tool To schedule an interview, applicant is encouraged
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`to use the USP T0 Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractic e .
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
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`Wu—Cheng Winston Shen can be reached on (571) 272-3157. The fax phone number for the
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`organization where this application or proceeding is assigned is 571-273-8300.
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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
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`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
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`applications is available through Private PAIR only. For more information about the PAIR system,
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`see htth/pair-directusptogov. Should you have questions on access to the Private PAIR system,
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`contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like
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`assistance from a USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA 0R CANADA) or 571-272-1000.
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`/CRAIG D RICCI/
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`Primary Examiner, Art Unit 1628
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`