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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`
`
`
`
`14/500,409
`
`09/29/2014
`
`Alexander OKSCHE
`
`1861.2700001/JMC/MSB
`
`1091
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 NEW YORK AVENUE, N.W.
`WASHINGTON, DC 20005
`
`RICCL CRAIGD
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`PAPER
`
`ART UNIT
`
`1628
`
`MAIL DATE
`
`03/24/2015
`
`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)
`
`

`

`
`
`Applicant(s)
`Application No.
` 14/500,409 OKSCHE ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`1628CRAIG RICCI its“
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1. 136( a).
`after SIX () 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).
`
`In no event, however, may a reply be timely filed
`
`Status
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`1)IZI Responsive to communication(s) filed on 11/20/2014.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)|ZI This action is non-final.
`2a)|:l This action is FINAL.
`3)|:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`; the restriction requirement and election have been incorporated into this action.
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`4)|:| Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5)IZI Claim(s) 1-24 is/are pending in the application.
`5a) Of the above claim(s) 10-20 and 22 is/are withdrawn from consideration.
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`6)|:I Claim(s)
`is/are allowed.
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`7)|Z| Claim(s) 1 -9 21 23 and 24 is/are rejected.
`8)|:I Claim(s)_ is/are objected to.
`
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`are subject to restriction and/or election requirement.
`9)|:I 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
`hit z/thvvvtlsnto. ovI’ atentS/init events/
`
`
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`h/index.‘s or send an inquiry to PPI-iieedback{®usgtc.00v.
`
`Application Papers
`
`10)I:l The specification is objected to by the Examiner.
`11)I:l The drawing(s) filed on
`is/are: a)I:I accepted or b)|:l 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).
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`Priority under 35 U.S.C. § 119
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`12)IXI Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)IZl All
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`b)|:l Some” c)I:l None of the:
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`1.I:I Certified copies of the priority documents have been received.
`2.IZI Certified copies of the priority documents have been received in Application No. 12/439,410.
`3.|:| Copies of the certified copies of the priority documents have been received in this National Stage
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`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)
`
`
`
`3) D Interview Summary (PTO-413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`4) I:I Other'
`2) E InformatIon DIsclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date See Continuation Sheet.
`US. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20150322
`
`

`

`Continuation Sheet (PTOL-326)
`
`Application No. 14/500,409
`
`Continuation of Attachment(s) 2). Information Disclosure Statement(s) (PTO/SB/OS), Paper No(s)/Mai| Date :11/20/2014; 11/20/2014;
`1/21/2015;1/21/2015;2/20/2015.
`
`

`

`Application/Control Number: 14/500,409
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`Page 2
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`Art Unit: 1628
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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 Group I in the reply filed on 11/20/2014 is
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`acknowledged. The requirement is still deemed proper and is therefore made FINAL.
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`2.
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`Claims 10—20 and 22 are withdrawn from further consideration pursuant to 37 CFR
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`1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking
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`claim.
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`3.
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`Applicant’s election Without specifying traverse of a single species in the reply filed on
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`11/20/2014 is also acknowledged.
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`4.
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`The elected species read upon claims 1-9, 21 and 23-24.
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`Claim Rejections - 35 USC § 103
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`5.
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`The following is a quotation of 35 USC. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(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.
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`6.
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`This application currently names joint inventors.
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`In considering patentability of the
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`claims under 35 USC. 103(a), the examiner presumes that the subject matter of the various
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`claims was commonly owned at the time any inventions covered therein were made absent any
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`evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out
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`the inventor and invention dates of each claim that was not commonly owned at the time a later
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`invention was made in order for the examiner to consider the applicability of 35 USC. 103(c)
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`and potential 35 USC. 102(e), (f) or (g) prior art under 35 USC. 103(a).
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`

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`Application/Control Number: 14/500,409
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`Page 3
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`Art Unit: 1628
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`7.
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`Claims 1-9, 21 and 23-24 are rejected under 35 U.S.C. 103(a) as being unpatentable
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`over the SUBOXONE Package Insert (available online at WWW.naabt.org as of at least
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`7/27/2006 as evidenced by the attached Internet Archive Report) in view of Finn et al (US
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`2007/0148097 — having priority to 12/13/2005).
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`8.
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`Instant claim 1 is drawn to sublingual dosage form (in the form of a film) comprising:
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`(a)
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`a non-gelatin polymeric film-forming material (wherein Applicant has elected
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`HPMC (claims 2-5));
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`(b)
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`an amount (more specifically, about 0.1 mg to about 16 mg (claim 6), even more
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`specifically 2 mg, 4 mg, 8 mg or 16 mg (claim 7)) of buprenorphine or salt
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`thereof (wherein Applicant has elected buprenorphine HCl (claim 21)); and
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`(c)
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`an amount of naloxone or a salt thereof;
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`wherein:
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`(i)
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`the weight ratio of buprenorphine to naloxone is from 1:1 to 10:1 (more
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`specifically, 2:1 to 8:1 (claim 8), even more specifically 4:1 (claim 9));
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`(ii)
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`the dosage form releases substantially all of the buprenorphine within less than 5
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`minutes after sublingual administration of the dosage form; and
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`(iii)
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`the amount of buprenorphine delivered by the sublingual dosage form results in a
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`buprenorphine Cmax of less than about 7 ng/ml and an AUC0_48 of less than 40
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`(hrs*ng)/ml:
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`9.
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`As thus summarized, the invention reads on claims 1-9 and 21, as well as claim 24,
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`drafted in independent format.
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`

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`Application/Control Number: 14/500,409
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`Page 4
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`Art Unit: 1628
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`10.
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`As taught by the S UBOXONE Package Insert, “SUBOXONE sublingual tablets contain
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`buprenorphine HCl and naloxone HCl dihydrate at a ratio of 4:1 buprenorphinemaloxone” which
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`is “available in two dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, and 8 mg
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`buprenorphine with 2 mg naloxone” (Description). As fiarther taught by the S UBOXONE
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`Package Insert, the AUC0_48 is 12.52 (hrs*ng)/ml at 4 mg buprenorphine, 20.22 (hrs*ng)/ml at 8
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`mg buprenorphine, and 34.89 (hrs*ng)/ml at 16 mg buprenorphine; and the CmX is 1.84 ng/ml at
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`4 mg buprenorphine, 3.0 ng/ml at 8 mg, and 5.95 ng/ml at 16 mg (Table 1) (Table 1).
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`11.
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`As such, the SUBOXONE sublingual tablets taught by the S UBOXONE Package Insert
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`differ from the instantly claimed sublingual pharmaceutical dosage form in that the SUBOXONE
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`sublingual tablets are n_ot in the form of a mucoadhesive film (comprising at least one non-
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`gelatin polymeric film-forming material (e. g., HPMC)) wherein the film releases substantially
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`all of the buprenorphine within less than 5 minutes after sublingual administration of the dosage
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`form.
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`12.
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`Finn et al teach a “pharmaceutical dosage form for abusable drug delivery with reduced
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`illicit abuse potential”, in particular “as a bioerodable transmucosal delivery device... in the form
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`of a layered film” (Abstract; see also claim 33), more specifically wherein the delivery device
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`can be “a sublingual delivery device” (Paragraph 0012) “in the form of... a film” (Paragraph
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`0013) comprising a mucoadhesive layer “comprised of water—soluble polymers which include...
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`hydroxypropylmethylcellulose" and so on (Paragraph 0053), wherein said devices “generally
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`include a drug and its antagonist” (Paragraph 0008) wherein “[t]he abusable drug... include...
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`buprenorphine” (Paragraph 0058) and "[t]he antagonist
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`to the abusable drug can be...
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`naloxone” (Paragraph 0062).
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`

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`Application/Control Number: 14/500,409
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`Page 5
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`Art Unit: 1628
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`13.
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`Accordingly, in further view of Finn et al, it would have been prima facie obvious to
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`modify the SUBOXONE sublingual tablets taught by S UBOXONE Package Insert such that the
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`tablets were, instead, formulated in the form of a mucoahesive film as instantly claimed, with a
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`reasonable expectation of success. The skilled artisan would have recognized that the various
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`delivery forms are alternatively useable, rendering the instant claims prima facie obvious.
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`Moreover,
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`the skilled artisan would have been particularly motivated to formulate the
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`SUBOXONE sublingual
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`tablets taught by S UBOXONE Package Insert
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`in the form of a
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`mucoahesive film considering that it is well known in the art that some patients have difficulty
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`swallowing tablets and capsules and, thus, the skilled artisan would have found it prima facie
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`obvious to formulate the tablets of SUBOXONE Package Insert as a mucoahesive film to
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`overcome such problems and to provide treatment
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`to patients wherein administration via
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`tablet/capsule is infeasible.
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`14.
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`Furthermore, it is asserted, absent evidence to the contrary, that the prima facie obvious
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`mucoadhesive film based on S UBOXONE Package Insert in view of Finn et al would necessarily
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`provide the outcomes (i.e., release of substantially all of the buprenorphine within less than 5
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`minutes; average buprenorphine AUC0_48; Cmax) recited by the claims. Although it is recognized
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`that “[i]nherency may not be established by probabilities or possibilities” (In re Robertson, 169
`
`F.3d 743 (Fed. Cir. 1999)), Applicant is also reminded that the US. Patent Office is not equipped
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`with analytical instruments to test prior art compositions for the infinite number of ways that a
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`subsequent Applicant may present previously unmeasured characteristics. When, as here, the
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`prior art appears to contain the exact same elements as those instantly claimed, the burden is
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`properly shifted to Applicant to show otherwise. As stated in In re Best, Bolton, and Shaw,
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`

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`Application/Control Number: 14/500,409
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`Page 6
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`Art Unit: 1628
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`“Where...
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`the claimed and prior art products are identical or substantially identical, or are
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`produced by identical or substantially identical processes, the PTO can require an applicant to
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`prove that the prior art products do not necessarily or inherently possess the characteristics of his
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`claimed product" 562 F2d 1252 (CCPA 1977).
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`In the instant case, the claimed and prior art
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`products are substantially identical. As such, absent evidence to the contrary, it is asserted that
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`the claimed outcomes would necessarily result. See also In re Fitzgerald 619 F2d 67 (CCPA
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`1980): the burden is shifted to the applicants to "prove that subject matter shown to be in the
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`prior art does not possess characteristic relied on.”
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`15.
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`Based on all of the foregoing, instant claims 1-9, 21 and 24 are rejected as prima facie
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`obvious.
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`16.
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`Instant claim 23 is drawn to the sublingual pharmaceutical dosage form of claim 21
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`wherein the buprenorphine is dissolved or homogenously dispersed within the non—gelatin film—
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`forrning material.
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`17.
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`Applicant is reminded that product—by—process claims are not limited to the manipulations
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`of the recited steps, only the structure implied by the steps (MPEP 2113). As stated by the court
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`in In re Thorpe (777 F.2d 695 (Fed. Cir. 1985), “even though product—by—process claims are
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`limited by and defined by the process, determination of patentability is based on the product
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`itself. The patentability of a product does not depend on its method of production. If the product
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`in the product—by—process claims is the same or obvious from a product of the prior art, the claim
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`is unpatentable even though the prior art product was made by a different process."
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`18.
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`Based on the foregoing, instant claim 23 is also rejected as primafacie obvious.
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`

`

`Application/Control Number: 14/500,409
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`Page 7
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`Art Unit: 1628
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`19.
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`In the alternative, however, it is further noted that Finn et al specifically teach that, “with
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`respect to the incorporation of [the] drug and/or [the] antagonist into the devices of the present
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`invention or any layer of the devices of the present invention...
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`the mixture, association or
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`combination need not be regular or homogenous" (Paragraph 0046).
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`20.
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`In view of the foregoing,
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`the skilled artisan would have clearly recognized that the
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`buprenorphine is preferably, albeit not necessarily, dissolved or homogenously dispersed within
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`the non—gelatin film—forming material.
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`21.
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`As such,
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`in the alternative, instant claim 23 is also rejected as prima facie obvious
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`because it would have been obvious to formulate the dosage form wherein the buprenorphine is
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`dissolved or homogenously dispersed within the non—gelatin film—forming material.
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`Double Patenting
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`22.
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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
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`where the claims at issue are not 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,
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`140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d
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`2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van
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`Ornnm, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
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`(CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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`

`

`Application/Control Number: 14/500,409
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`Page 8
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`Art Unit: 1628
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`23.
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`A timely filed terminal disclaimer in compliance with 37 CFR l.32l(c) or l.32l(d) may
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`be used to overcome an actual or provisional rejection based on a nonstatutory double patenting
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`ground provided the reference application or patent either is shown to be commonly owned with
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`this application, or claims an invention made as a result of activities undertaken within the scope
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`of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR
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`l.32l(b).
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`24.
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`The USPTO internet Web site contains terminal disclaimer forms which may be used.
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`Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what
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`form should be used. A web—based eTerminal Disclaimer may be filled out completely online
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`using web—screens. An eTerminal Disclaimer that meets all requirements is auto—processed and
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`approved immediately upon submission. For more information about eTerminal Disclaimers,
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`refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD—info—I.j sp.
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`25.
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`Claims 1-9, 21 and 23-24 are provisionally rejected on the ground of nonstatutory
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`double patenting as being unpatentable over claims 21-37 of copending Application No.
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`12/439,410.
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`26.
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`Although the claims at issue are not identical, they are not patentably distinct from each
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`other.
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`The “410 claims are similarly drawn to sublingual dosage forms comprising
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`buprenorphine and naloxone in the recited ratios, further comprising a non—gelatin polymeric
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`film—forming material.
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`27.
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`This is a provisional nonstatutory double patenting rejection because the patentably
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`indistinct claims have not in fact been patented.
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`Conclusion
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`

`

`Application/Control Number: 14/500,409
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`Page 9
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`Art Unit: 1628
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to CRAIG RICCI Whose telephone number is (571) 270—5864. The
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`examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30
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`am — 5:00 pm.
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`If attempts to reach the examiner by telephone are unsuccessfiJl,
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`the examiner’s
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`supervisor, Wu—Cheng Winston Shen can be reached on (571) 272—3157. 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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`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 you have questions on access to 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
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`information system, call 800—786—9199 (IN USA OR CANADA) or 571—272—1000.
`
`/CRAIG RICCI/
`
`Primary Examiner, Art Unit 1628
`
`