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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address; COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`15/998,868
`
`08/17/2018
`
`Alexander Oksche
`
`1861.2700007/JMC/MSB
`
`7842
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 NEW YORK AVENUE NW
`WASHINGTON,DC 20005
`
`RICCI, CRAIG D
`
`PAPER NUMBER
`
`ART UNIT
`
`1611
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`04/16/2020
`
`ELECTRONIC
`
`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.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`e-office @ sternekessler.com
`
`jcovert @ sternekessler.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-14 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) ___ is/are withdrawn from consideration.
`CC) Claim(s)
`is/are allowed.
`Claim(s) 1-14 is/are rejected.
`S)
`) O Claim(s)___is/are objected to.
`C) Claim(s
`are subjectto restriction and/or election requirement
`)
`S)
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http://www.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) )
`
`Application Papers
`10) The specification is objected to by the Examiner.
`11)0) The drawing(s) filedon__ is/are: a)) 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).
`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) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`c)X None ofthe:
`b)L) Some**
`a) All
`1... Certified copies of the priority documents have been received.
`2.¥} Certified copies of the priority documents have beenreceived in Application No. 12/439,410.
`3.4) Copies of the certified copies of the priority documents have been receivedin 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 (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date 10/23/2018.
`U.S. Patent and Trademark Office
`
`3) (J Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`4)
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20200413
`
`Application No.
`Applicant(s)
`15/998 868
`Oksche etal.
`
`Office Action Summary Art Unit|AIA (FITF) StatusExaminer
`CRAIG D RICCI
`1611
`No
`
`
`
`-- The MAILING DATEofthis communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom 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) MONTHSfrom 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, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1) Responsive to communication(s) filed on 3/24/2020.
`LC} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)(J This action is FINAL. 2b))This action is non-final.
`3) An election was madeby 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\(Z 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 Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`

`

`Application/Control Number: 15/998,868
`Art Unit: 1611
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`Page 2
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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 species in the reply filed on 3/24/2020 is
`
`also acknowledged.
`
`2.
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`3.
`
`The elected species read upon claims 1-14.
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`ALLOWABLE SUBJECT MATTER
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`Instant claim 1 is drawn to a transmucosal (and mucoadhesive (claim 4)) film dosage
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`form comprising:
`
`(a)
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`buprenorphine in an amount sufficient
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`to provide an average Cmax of less than
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`about 7 ng/ml and an average AUCO-48 of less than 40 (hrs*ng)/ml
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`(more
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`specifically, 2 mg, 4 mg, 8 mg or 16 mg (claims 8-9));
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`naloxone; and
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`at
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`least one non-gelatin polymeric
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`film-forming material
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`(more specifically,
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`(b)
`
`(c)
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`
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`carboxymethylcellulose (claims 5-7)) in which the buprenorphine and_the
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`naloxone are dissolved or homogenously dispered;
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`wherein the buprenorphine and naloxone are presentin the film dosage form in a weight
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`ratio of from 1:1 to 10:1 (more specifically, from 2:1 to 8:1 (claim 10)); and
`
`wherein the film dosage form releases substantially all of the buprenorphine
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`and
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`approximately substantially all of the naloxone into contact with a mucosal surface of the
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`oral cavity within less than 5 minutes after contacting the mucosal surface.
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`4,
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`Claim Interpretation: As defined by the Specification,
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`“[t]he term ‘substantially all’
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`means that approximately 95% of the drug will be have been released” and “[t]he term
`
`

`

`Application/Control Number: 15/998,868
`Art Unit: 1611
`
`Page 3
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`‘approximately’ in the context of the present invention describes a deviation from the indicated
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`value of 10%” (Page8).
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`5.
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`Assuch, the claim requires that the film dosage form releases 85% the buprenorphine (ie.,
`
`approximately 95%) and 75% (i.e., approximately approximately 95%) of the naloxone within less
`
`than 5 minutes after contacting the mucosal surface.
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`6.
`
`Reasons for Allowance: The closest prior art is considered to be Sherman et al (US
`
`2003/0191147) and Finn etal (US 2007/0148097).
`
`7.
`
`Sherman etal teach “novel dosage forms... comprising an opioid antagonist and another
`
`active ingredient,
`
`such as an opioid agonist... that provide concurrent release of an opioid
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`antagonist and another active ingredient” (Abstract) which “may be administered to the human
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`subject by... sublingual...
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`transmucosal... modes of administration”
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`(Paragraph 0173) and
`
`wherein “[o]pioid antagonists include... naloxone” (Paragraph 0003) which may be “present in
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`an amount of about 0.0001 to about 1.0 mg” (Paragraph 0071), and “[a]gonists
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`include...
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`buprenorphine” (Paragraph 0068) which may be “present in an amount of about 0.1 t0 about 300
`
`mg” (Paragraph 0071). As further taught by Sherman etal, the composition may further comprise
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`“non-toxic,
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`pharmaceutically
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`acceptable excipients,
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`carriers, diluents
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`or other adjuvants”
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`(Paragraph 0104) such as “carboxymethyl cellulose” (Paragraph 0105) wherein “the opioid
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`antagonist...
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`in combination with an opioid agonist,
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`is mixed with a pharmaceutical carrier or
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`excipient...
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`to form a solid preformulation composition containing a homogenous mixture”
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`(Paragraph 0142).
`
`8.
`
`Although Sherman etal do not teachfilms as instantly claimed, it would have been obvious
`
`for formulate the solid dosage forms of Sherman et al as a mucoadhesive film in view of Finn et
`
`al which teachrelated compositions in the form ofa film.
`
`

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`Application/Control Number: 15/998,868
`Art Unit: 1611
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`Page 4
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`9.
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`Despite the foregoing, neither Sherman et al nor Finn et al teach that 85% of the
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`buprenorphine and 75% of the naloxone is released within less than 5 minutes after contacting the
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`mucosal surface and it does not appear that it would have been obvious to provide said release
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`based on the prior art.
`
`Indeed, as taught by Sherman et al, each pharmaceutical
`
`ingredient
`
`is
`
`
`
`releasedasfollows: —_———_—_——§— (Paragraph 0150).
`
`10.
`
`As such, claims 1-14 are considered to be free of the art and non-obvious. Furthermore,
`
`claims 1-14 contain written support and are considered to be enabled.
`
`Double Patenting
`
`11.
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine
`
`grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or
`
`improper timewise extension of the “right to exclude” granted by a patent and to prevent possible
`
`harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where
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`the conflicting claims are not
`
`identical, but at least one examined application claim is not
`
`patentably distinct from the reference claim(s) because the examined application claim is either
`
`anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140
`
`F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010
`
`(Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
`
`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA
`
`1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`

`

`Application/Control Number: 15/998,868
`Art Unit: 1611
`
`Page 5
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`12.
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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 asa 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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`underthe first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §$§
`
`706.02(1)(1)
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`- 706.02(1)(3) for applications not subject to examination underthe first inventor to
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`file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR
`
`1.321(b).
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`13.
`
`The USPTO Internet website contains terminal disclaimer
`
`forms which may be used.
`
`Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the
`
`form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26)
`
`should be used. A web-based eTerminal Disclaimer may befilled out completely online using
`
`web-screens. AneTerminal Disclaimer that meets all requirements is auto-processed and approved
`
`immediately upon submission. For more information about eTerminal Disclaimers,
`
`refer to
`
`www.uspto.gov/patents/process/file/efs/guidance/eTD-info-L jsp.
`
`14.
`
`Claims 1-14 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-14 of U.S. Patent No. 9,101,625.
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`15.
`
`Although the claims at issue are not identical,
`
`they are not patentably distinct from each
`
`other. The ‘625 patent is similarly drawn toa sublingual dosage form comprising buprenorphine
`
`and naloxone in a 1:1 to 10:1 ration which are dissolve/homogenously dispersed in at least one
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`non-gelatin polymeric film formmg-material and whichrelease said agents as claimed.
`
`

`

`Application/Control Number: 15/998,868
`Art Unit: 1611
`
`Page 6
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`Conclusion
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`Anyinquiry concerning this communication or earlier communications from the examiner
`
`should be directed to CRAIG D RICCI whosetelephone numberis (571) 270-5864. The examiner
`
`can normally be reached on Mondaythrough Thursday, and every other Friday, 7:30 am - 5:00 pm
`
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`to use the USPTO Automated Interview Request (AIR)at http://www.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
`
`Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization
`
`where this application or proceeding is assigned is 571-273-8300.
`
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`
`/CRAIG D RICCI/
`Primary Examiner, Art Unit 1611
`
`