WO 2007/144081
`
`PCT/EP2007/004937
`
`23
`
`zugt in weniger als 30 s nach Applikation in Mundraum zer-
`
`fillt.
`
`19. Arzneimittelzubereitung nach einem der vorhergehenden
`
`Ansprfiche, dadurch gekennzeichnet, daB das hydrophile Poly-
`
`mer schnell
`
`im Mundraum zerfallt, der Wirkstoff aber an
`
`einen Ionentauscher gebunden bleibt, der den Wirkstoff erst
`
`im Gastrointestinaltrakt freisetzt.
`
`20. Arzneimittelzubereitung nach einem der vorhergehenden
`
`Ansprfiche, dadurch gekennzeichnet,
`
`daB die Wirkstoffe in
`
`diskreten Schichten enthalten sind, die réumlich voneinan—
`
`der getrennt sind und sich in ihrem Aufbau voneinander un—
`
`terscheiden .
`
`21. Arzneimittelzubereitung nach einem der vorhergehenden
`
`Anspriiche, dadurch gekennzeichnet, daB die Zubereitung als
`
`Schaum vorliegt
`
`und. mindestens einer der Wirkstoffe in
`
`flfissiger Form in den Hohlréiumen des Schéums vorliegt.
`
`22. Arzneimittelzubereitung nach einem der vorangehenden
`
`Ansprfiche, dadurch gekennzeichnet, dais sie eine Kombination
`
`aus einem nikotinergen Wirkstoff und einem Antidepressivum
`
`enthalt.
`
`23. Verwendung einer Darreichungsfonn nach einem oder meh-
`
`reren der Ansprfiche 1 bis 22 zur rektalen, vaginalen oder
`
`intranasalen Verabreichung von pharmazeutischen Wirkstoffen
`
`an Menschen oder Tiere.
`
`24. Verwendung einer Wirkstoffkombination aus nikotinergem
`
`Wirkstoff und Psychopharmakon zur Herstellung einer oralen
`
`10
`
`15
`
`20
`
`25
`
`30
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0801
`
`page 0801
`
`

`

`WO 2007/144081
`
`PCT/EP2007/004937
`
`24
`
`Darreichungsform nach einem der vorhergehenden Ansprfiche
`
`zur Raucherentwohnung.
`
`25. Verwendung einer Wirkstoffkombination aus nikotinergem
`
`Wirkstoff und Antidepressivum zur Herstellung einer oralen
`
`Darreichungsform nach einem der vorhergehenden Ansprfiche
`
`zur Raucherentwéhnung.
`
`26. Verwendung nach einem oder mehreren der Ansprfiche 23 -
`
`26, dadurch gekennzeichnet, dag das Arzneimittel als Wafer
`
`formuliert wird.
`
`27. Verfahren zur therapeutischen Behandlung einer unter
`
`Entzugserscheinungen der Raucherentwéhnung leidenden Per—
`
`son, dadurch gekennzeichnet, dafi die Verabreichung der
`
`Wirkstoffkombination aus nikotinergem Wirkstoff und Psycho—
`
`pharmakon mittels einer oral applizierbaren Darreichungs—
`
`form mit transmukosaler Resorption erfolgt.
`
`28. Verfahren zur Herstellung einer flachenférmigen Darrei-
`
`chungsform nach einem der Ansprfiche 1 bis 22, gekennzeich-
`
`net durch das
`
`— Herstellen einer Lésung, die zumindest ein Polymer und
`
`mindestens zwei Wirkstoffe enthalt, von denen einer
`
`Nikotin, ein Nikotinsalz, ein Nikotinderivat oder eine
`
`nikotinerg wirkende Substanz und der andere ein Psy—
`
`chopharmakon ist;
`
`- Ausstreichen der Lésung auf eine Beschichtungsunterla-
`
`ge und
`
`— Verfestigen der ausgestrichenen Losung durch Trocknen
`
`und Entzug des Lasemittels.
`
`10
`
`’15
`
`20
`
`25
`
`30
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0802
`
`page 0802
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCTJ‘US2009KO38696
`
`A.
`
`CLASSIFICATION OF SUBJECT MATTER
`
`A61K 31/5513f2006.01}t', A611? 31/355f2006.01)i, A61K 9/16(2006.0I)i, AtflK 47/10f2006.01}i, A61P25/22f2006.01)i
`
`According lo International Patent Classification (PC) or to bolh national classification and IPC
`FIELDS SEARCHED
`
`Minimum documentation searched (classification system followed by classification symbols}
`IPCS as above
`
`Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched
`
`Electronic data base consulted during the international search (name of data base and, where practicable, search terms used)
`cKOMPASS, Google scholar
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category“
`
`Citation of document, with indication, where appropriate, of the relevant passages
`
`Relevant to claim No.
`
`W0 2007043057 A2 (’J'OUI‘I‘OU, ELKA et. a1.) 19 April 2007
`See claims 18 and 35, p. 6 {line 1-3), 8 (line 3-11}
`
`WC) 2005] l?830 Al (CAMURUS AB, SWED) IS December 2005
`See whole document
`
`WO 2006075123 Al (CAMURUS AB, SWED) 20 July 2006
`See whole document
`
`WO 2007144031 A2 (LTS LOI-IMANN HERAPIE-SYSTEM A,«G.) 21 December 2007
`See whole document
`.......................... ;;._._--.............------.__.__.--____.................__..__._____...-..........__
`
`*
`"A"
`
`"E"
`
`I:l Further documents are listed in the continuation och-x C.
`Special categori- of cited documents:
`document defining the general state of the artwhich is not considered
`to be of particular relevance
`earlier application or patent but published on or alter the international
`filing date
`document which may throw doubts on priority claim(s) or which is
`cited to establish the publication date of citation or other
`special reason (as specified)
`documenl referring to an oral disclosure, use, exhibilion or other
`means
`
`
`
`“‘1"
`
`nxlr
`
`E Sec patent family annex.
`later document published aflerthe intemationa] filing date or priority
`date anan in conflict with the application but cited to understand
`the principle or theory underlyingthe invention
`document of particular relevance; the claimed invention cannot be
`considemd novel or cannot beconsideredto involvean inventive
`step when the document istaken alone
`document of particular relevance; the claimed invention cannot be
`ccnsideredto involve an inventive step when the document is
`combined with one or more other such documentasuch combination
`being obvious to a person skilled in the m1
`”8:" document member of the same patent family
`
`document published prior to the international tiling date but later
`than the priority date claimed
`
`Date of the actual completion of the international search
`
`Date of mailing of the international search report
`
`28 SEPTENUBER 2009 (28.09.2009)
`
`Name and mailing address of the [SAFKR
`Korean Intellectual Property Office
`Government Complex-Daejeon, 139 Seonsa-ro, Seo-
`gui Daejeon 302-70] , Republic of Korea
`Facsimile No. 82—42-472-7140
`
`Form PCTflSAtZlO (second sheet) (July 2008)
`
`28 SEPTEMBER 2009 (28.09.2009)
`Authorized otficer
`
`KW, YONG
`
`Telephone No
`
`8242-4181-8164
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0803
`
`page 0803
`
`

`

`
`
`
`
` C. DOCUMENTS CONSIDERED TO BE RELEVANT
`Caisson!"
`Citation of document, with indication, where appropriate, ofthe relevant passages
`
`x
`
`
`
`us 2009mm A1 (Care at al.} 15 October 2009 (15.10.2009) para [0010140021]. [0024]—
`[0030]. [coast-[0039]. 10047]. [0133]. [01421—10143], {0147]. [01311-10152]. [0180}[0181]. [0193}-
`{0204]
`
`us 2009110130216 A1 (Care at al.) 21 May 2000 (21.05.2009) entire comment
`
`us 2003:0279734 A1 (Cartl et at.) 13 November 2001: (13.11.20013) eottte document
`
`1.62
`
`
`
`INTERNATIONAL SEARCH REPORT
`
`
`International application No.
`PCTIUS 121'4231 1
`
`
`CLASSIFICATION OF SUBJECT MATTER
` A.
`IPC(8) — AOlN 431'62: A61K 3155 (2012.01)
`
`
`USPC - 5141'220-221
`
`
`According to International Patent Classification (IPC) or to both national classification and IPC
`B.
`FIELDS SEARCHED
`
`
`Minimum documentation searched (classification system followed by classification symbols)
`U3PO-5141220-221
`
`
`
`Documemation searched odierdcanminimtnn dourmeniationto the extent that such doctnnents are included in the fields searched
`
`USPO-4-24t'400. 434 (see search lemte below)
`
`Electronic data base consulted during the international search (name of data base and. where practicable, search terms used)
`PUBWEST, Gouge Scholar. Google. Intranaaal. nasal. Inhalation, mucosal, drug. delivery. denaodazeplne. diazepam. tocopnerol.
`toootn'enol, Vitamin E. alcohol, ethanol. benzyl alcohol. alkyl glycodide
`
`US 2009111304301 A1 {liversldge et al.) 10 December 2009 (10.12.2009) entire document
`
`
`
`"T"
`
`
`
`
`El Further documents are listed in the confirmation ofBox C.
`
`“
`Speeial categories of cited documents:
`‘01-in
`later document published after the international filing date or
`
`
`erstmd
`date and not in conflict With the a
`icnnon but cited to
`“A" document defining the general state crate an which is not considered
`
`
`the principle or theory underlying
`invention
`to be of particular relevance
`“E"
`earlier application or Palm! “3911““th 011 or W the Mom! “X" dwtment of particular relevance; the claimed invention cannot be
`
`
`filing date
`considered novel or camiot be considered to involve an inventive
`
`
`“L" twentneehcmdecmmmewet
`“W “WW“‘WM’
`'
`or
`to
`-
`-
`-
`la
`cation
`0
`or
`or
`let
`
`
`.
`“Y" document of motile: relevance; the claimed invention cannot be
`
`
`Wm reason (as ”We
`considered tominvolve an inventive step when the document is
`
`
`"0" document referring to an oral disclosure, use, exhibition or other
`combinedwithcneormorcothersuch docmnenmsuchcontbinaflon
`
`
`means
`being obviom to a person skilled in the art
`“
`
`“P" dter to the international filing detebttt later than «fig- clement member of the same patient family
`
`
`
`Date of mailing ofthe international search report
`Date of the actual completion of the imemational search
`
`
`
` 10 August 2012 (10.03.2012)
`
`Authorized officer:
`
`
`Name and mailing address of the ISAJ'US
`
`Mail Stop PCT. Aitn: lSAlUS. Commissioner liar Patents
`
`
`P.O. Box 1450, Alexandrla. Virginia 22313-1450
`PUT Helpdafik: 571-272-430]
`
`
`PCT use. 51-52-20“
`
`Facsimile N0.
`571.273-3201
`
`
`
`Form PCTflSAt'ZlO (second sheet) (July 2009)
`
`33 AUG 2012
`
`
`Lee W. Young
`
`"n...".,.,....,....,._......,_..-..,..__. r _.. “a-.. .-,...J ye... ,,_... ...- "we...“
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0804
`
`page 0804
`
`:va-'_i.':'_'J-_‘ea-:.-.'::Ilr‘h..'_'.'--.1-...._..__.._.._....,_____.....
`
`
`
`"-1:51.-.....
`
`

`

`Electronic Acknowledgement Receipt
`
`International Application Number: —
`
`Title of Invention:
`
`ADMINISTRATION OF BENZODIAZEPINE COMPOSITIONS
`
`First Named Inventor/Applicant Name:
`
`
`
`Application Type:
`
`Utillty under 35 USC111(a)
`
`Payment information:
`
`a_e 0805
`
`.
`
`.
`
`File Size(Bytes)/
`
`Multi
`
`Pages
`
`Transmittal Letter
`
`35401 -71 6-201_IDS_Transmitta
`|_11-16-2012.pdf
`
`439c472740d4cadb9a814d441410eba37fe
`76dd7
`
`A O UESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0805
`
`File Listing:
`
`Document
`
`Informatiom
`
`

`

`Information Disclosure Statement (IDS)
`Form (SBOS)
`
`35401-716-201_IDS_11-16-201
`2.pdf
`
`6d414c0363cab7292d0f46f36b4f5b04073 ‘
`dbbe
`
`Information.
`
`This is not an USPTO supplied IDS fiIIabIe form
`
`Foreign Reference
`
`W02005-117830.pdf
`
`6218647
`
`4150cebea90f7f7df4a044b5617b2760326d
`040f
`
`5620634
`
`315663aef55ccda96637a402b7393b6b5b0
`3f3ef
`
`4736531
`
`058fb2520a116d3c5c07180232c60268022
`a8156
`
`1836909
`
`49827b9fb26659e7ae1302d3187142a5328
`da65d
`
`Foreign Reference
`
`W02006-O75123.pdf
`
`Foreign Reference
`
`W02007-O43057.pdf
`
`Foreign Reference
`
`W02007-144081.pdf
`
`4d109
`
`Information:
`
`Information:
`
`Information:
`
`Information:
`
`Information:
`
`Non Patent Literature
`
`PCT-USO9—038696-ISR.pdf
`
`548174406b3b2c5b8d0943ac71626cc8f7d
`2565d
`
`Non Patent Literature
`
`PCT-U51 2-4231 1-ISR.pdf
`
`7a99b9ea862f5c3947435e677508e64fd0d
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0806
`
`page 0806
`
`

`

`New Applications Under 35 U.S.C. 111
`lfa new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International Application under 35 U.S.C. 371
`lfa timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/EO/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO ofthe indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`the application.
`
`New International Application Filed with the USPTO as a Receiving Office
`lfa new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and ofthe International Filing Date (Form PCT/RO/105) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0807
`
`page 0807
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Attorney Docket No. 35401—716201
`PATENT
`
`Inventor:
`
`Steve CARTT, et al.
`
`Group Art Unit:
`
`1612
`
`Serial Number:
`
`12f4l3,439
`
`Examiner:
`
`MILLIGAN, ADAM C.
`
`Filing Date: March 27, 2009
`
`CONFIRMATION NO:
`
`9049
`
`Title: ADMINISTRATION OF
`BENZODIAZEPINE COMPOSITIONS
`
`
`
`FILED ELECTRONICALLY 0N: November '2, 2012
`
`Commissioner for Patents
`PO. Box 1450
`Alexandria VA 22313-1450
`
`INFORMATION DISCLOSURE STATEMENT
`
`UNDER 37 CFR §1.97
`
`Sir:
`
`An Information Disclosure Statement along with attached PTOISBIOS is hereby submitted. A
`
`copy of each listed publication is submitted, if required, pursuant to 37 CFR §§l.9?-l.98, as indicated
`
`below.
`
`The Examiner is requested to review the information provided and to make the information of
`
`record in the above-identified application. The Examiner is further requested to initial and return the
`
`attached PTOISBI'OS in accordance with MPEP §609.
`
`The right to establish the patentability of the claimed invention over any of the information
`
`provided herewith, andfor to prove that this information may not be prior art, andfor to prOve that this
`
`information may not be enabling for the teachings purportedly offered, is hereby reserved.
`
`This statement is not intended to represent that a search has been made or that the information
`
`cited in the statement is, or is considered to be, prior art or material to patentability as defined in §1.56.
`
`Attorney Docket No. 35401-21620]
`
`- l -
`
`S2360?3_l .DOC
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0808
`
`page 0808
`
`

`

`A.
`
`37 CFR §1.97(b). This Information Disclosure Statement should be considered by the Office
`because:
`
`I]
`
`(1)
`
`It is being filed within 3 months of the filing date of a national application and is
`other than a continued prosecution application under §l.53(d);
`
`-- OR __
`
`El
`
`(2)
`
`It is being filed within 3 months of entry of the national stage as set forth in
`§1.491 in an international application;
`
`-- OR -_
`
`I:I
`
`(3)
`
`It is being filed before the mailing of a first Office action on the merits;
`
`-- OR --
`
`E
`
`(4)
`
`It is being filed before the mailing of a first Office action after the filing of a
`request for continued examination under §1.114.
`
`B. El 37 CFR §I.97(c). Although this Information Disclosure Statement is being filed after the period
`specified in 37 CFR §1.97(b), above, it is filed before the mailing date of the earlier of (I) a final
`office action under §1.l 13, (2) a notice of allowance under §l.311, or (3) an action that otherwise
`closes prosecution on the merits, this Information Disclosure Statement should be considered because
`it is accompanied by one of:
`
`El
`
`3 statement as specified in §l.97(e) provided concurrently herewith;
`
`-- OR __
`
`D
`
`a fee of $180.00 as set forth in §1.17(p) authorized below, enclosed, or included with the
`payment of other papers filed together with this statement.
`
`C. D 37 CFR §1.97(d). Although this Information Disclosure Statement is being filed after the mailing
`date of the earlier of (1) a final office action under §1.1 13 or (2) a notice of allowance under §1.311,
`it is being filed before payment of the issue fee and should be considered because it is accompanied
`by:
`
`i.
`
`a statement as specified in §1.9?(e);
`
`—- AND --
`
`ii. a fee of $180.00 as set forth in §1.l't'(p) is authorized below, enclosed, or included
`with the payment of other papers filed together with this Statement.
`
`D.
`
`[:1 37 CFR §I.97(e). Statement.
`
`I:I
`
`A statement is provided herewith to satisfy the requirement under 3? CFR §§ l .97(c);
`
`-- ANDt'OR --
`
`I:I
`
`D
`
`A statement is provided herewith to satisfy the requirement under 37 CFR §§l .9?(d);
`-- AN DIOR ~-
`
`A copy of a dated communication from a foreign patent office clearly showing that the
`information disclosure statement is being submitted within 3 months of the filing date on
`the communication is provided in lieu of a statement under 3? CFR. § l.9‘t'(e)(1) as
`provided for under MPEP 609.04(b) V.
`
`E. El Statement Under 37 CFR. §I.704(d). Each item of information contained in the information
`discIOSure statement was first cited in a communication from a foreign patent office in a counterpart
`application that was received by an individual designated in § 1.56(c) not more than thir_ty 130) days
`prior to the filing of this information disclosure statement. This statement is made pursuant to the
`
`Attorney Docket NO. 35401-7l6201
`
`- 2 -
`
`5236073_l .DOC
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0809
`
`page 0809
`
`

`

`requirements of 37 CPR. §l .?04(d) to avoid reduction of the period of adjustment of the patent term
`for Applicant(s) delay.
`
`F.
`
`37 CFR §1.98(a) (2). The content of the Information Disclosure Statement is as follows:
`
`I]
`
`E
`
`IE
`
`I:I
`
`Copies of each of the references listed on the attached Form PTOISBIOS are enclosed
`herewith.
`
`-- 0R __
`
`Copies of U.S. Patent Documents (issued patents and patent publications) listed on the
`attached Form PTOISBIOS are NOT enclosed.
`
`-- ANDE'OR --
`
`Copies of Foreign Patent Documents andfor Non Patent Literature Documents listed on
`the attached Form PTOISBIOS are enclosed in accordance with 37 CFR §1.98 (a)(2).
`
`-- ANDI'OR --
`
`Copies of pending unpublished US. patent applications are enclosed in accordance with
`3? CFR §l.98(a)(2)(iii).
`
`G. [I 37 CFR §1.98(a)(3). The Information Disclosme Statement includes non-English patents andz’or
`references.
`
`I:I
`
`Pursuant to 3? CFR §1.98(a)(3)(i), a concise explanation of the relevance of each patent,
`publication or other information provided that is not in English is provided herewith.
`
`I:I
`
`D
`
`Pursuant to MPEP 609(3), an English language copy of a foreign search report is
`submitted herewith to satisfy the requirement for a concise explanation where
`non-English language information is cited in the search report.
`
`-- OR --
`
`A concise explanation of the relevance of each patent, publication or other
`information provided that is not in English is as follows:
`
`El
`
`Pursuant to 37 CFR §l.98(a)(3)(ii), a copy of a translation, or a portion thereof, of the
`non-English language reference(s) is provided herewith.
`
`H. I] 37 CFR §1.98(d). Copies of patents, publications and pending US. patent applications, or other
`information specified in 3'? C.F.R. § 1.93(a) are not provided herewith because:
`
`CI
`
`to 3? CFR §l.98(d)(l) the information was previously submitted in an
`Pursuant
`Information Disclosure Statement, or cited by examiner, for another application under
`which this application claims priority for an earlier effective filing date under 35 U.S.C.
`120.
`
`Application in which the information was submitted:
`
`Information Disclosure Statement(s) filed on:
`
`AND
`
`D
`
`The information disclosure statement submitted in the earlier application complied with
`paragraphs (a) through (c) of 3'? CFR §1 .98.
`
`Attorney Docket No. 354Dl-7l6.201
`
`- 3 -
`
`52360'8‘1 .DOC
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0810
`
`page 0810
`
`

`

`1.
`
`IE Fee Authorization. The Commissioner is hereby authorized to charge the above-referenced fees
`of $0.00 and charge any additional
`fees or credit any overpayment associated with this
`communication to Deposit Account No. 23-2415 {Docket No. 35401-716201 1.
`
`Respectfully submitted,
`
`WILSON SONSINI GOODRICH & ROSATI
`
`By: mdfi'
`
`a
`
`.
`
`Matthew V. Grumbling
`Reg. No. 44,427
`
`Dated:
`
`”Z {@Z ad“;
`
`650 Page Mill Road
`Palo Alto, CA 94304—1050
`
`(650) 493-9300
`Customer No. 0219?1
`
`Attorney Docket No. 3540l-?16.201
`
`- 4 -
`
`52360T3_l .DOC
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0811
`
`page 0811
`
`

`

`PTO/SB/OSa (07-09)
`.
`Approved for use through 07/31/2012. OMB 0651-0031
`US. Patent and Trademark Office; US. DEPARTMENT OF COMNLERCE
`Under the Pa-erwork Reduction Act of 1995, no nersons reuired to res-0nd to a collection of information unless it contains a valid 0m control number.
`Complete ifKnown
`.
`.
`
`
`
`
`
`Substitute for form 1449/PTO
`
`
`
`
`
`
`
`
`
`STATEMENT BY APPLICANT
`
`
`
`(Use as many sheets as necessary)
`
`
`
`Adam Mag...
`»
`
`35401—71620 1
`Attorney Docket Number
`
`
`INFORMATION DISCLOSURE
`
`
`U.s. PATENT DOCUMENTS
`
`Examiner
`Cite
`.
`Publication Date
`‘
`Name of Patentee or
`Pages; Columns, Lines, Where
`Initials* .
`No.I
`Relevant Passages or Relevant .
`Fi ,ures A- user
`
`
`
`08/21/2008
`.
`6.
`US—2008-0200418
`
`10/09/2008——
`7
`US-2008—0248 123
`12/04/2008 _—
`8.
`Us—2008-0299079
`—_—
`10-
`US-2009-0297619
`12/03/2009—_
`11.
`US—2010-0068209
`93/18/2010—_
`12.
`US-2011—0172211
`07/14/2011
`Back et a1.
`13.
`US—2011-025-7096
`10/20/2011 Maggie
`
`.
`
`14.
`15.
`16.
`17.
`- 18.
`- 19.
`20.
`21.
`22.
`
`.
`
`US-2012—0196941
`US-2013—0065886
`US—4,973,465
`US-5,457,100
`US-5,661,130
`Us-5,861,510
`US~5,863,949
`US-6,143,211
`US—6,193,985
`
`.
`
`23.
`24;
`
`25.
`
`‘ US-6,235,224
`US-6,428,814
`
`US-6,610,271
`
`-
`
`.
`
`.
`
`.
`
`.
`
`08/02/2012 Maggio
`03/14/2013
`Cartt
`11/27/1990 Baurain et a1.
`10/10/1995 Daniel
`08/26/1997 Meezan et a1.
`01/19/1999
`Piscipio et a1.
`01/26/1999 Robinson et a1.
`11/07/2000 Mathiowitz et a1.
`02/27/2001
`Sonne ‘
`
`-
`
`'
`
`‘
`
`05/22/2001 Mathiowitz et a1.
`
`08/06/2002 Bosch et a1.
`08/26/2003 Wermeling
`
`'
`
`.
`
`US—6,616,914
`26.
`27.
`US-6,627,211
`
`
`09/09/2003 Ward et a1.
`09/30/2003
`01101 et a1.
`
`51:21::
`*EXAMINER: Initial ifreference considered, whether or not citation is in conformance with MPEP 609. Draw [incl/trough citation ifnot in conformance and not considered Include copy
`ofthis form with next communication to applicant;
`'Applicant’s unique citation designation number (optional). 2See Kinds Codes ofUSPTO Patent Documents at www.csptogov or WEP
`901.04. 3Enter Office that issued the document, by the two-letter code (WIPO Standard ST.3). “For Japanese patent documents, the indication ofthe year ofthe reign of the Emperor must
`precede the serial number ofthe patent document. 5Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST. 16 ifpossible. 6Applicant is to place a
`check mark here ifEnglish language Translation is attached.
`.
`g
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain abenefit by the public which is to file (and by the USPTO to process) an
`application. Confidentiality is go'vemed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete, including gathering, preparing, and submitting the
`completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount oftime you require to complete this form and/or suggestions for'
`reducing this burden, should be sent to the Chicflnformation Officer, US. Patent and Trademark Office, PO. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES 0R COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.0. Box 1450, Alexandria, VA 223134450.
`[fyou needassislance in completing lheform, call l-800-PTO—9199 (1800-7815-9199) andselect option 2.
`
`Attomey Docket No. 35401-716201
`
`.
`
`- 1—
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0812
`
`page 0812
`
`Number-Kind Code (Ifknown)
`US~2001—0042932
`
`11/22/2001
`
`.
`
`US-2003—003 1719
`US-2006-0198896
`
`02/13/2003
`09/07/2006
`
`1.
`
`2 3 4
`
`5.
`
`
`
`
`
`
`
`
`
`
`

`

`
`
`
`Under the Pa-erwork Reduction Act of 1995, no ersons re-uired to res
`
`
`PTO/SB/OSa (07-09)
`Approved for use through 07/31/2012. OMB 0651-0031
`U.S. Patent and Trademark Office; U.S. DEPAR'IWNT OF COMMERCE
`mud to a collection of information unless it'contains a valid OMB control number.
`
`Complete ifKnown
`
`
`
`12/413,439
`Application Number
`
`
`03/27/2009
`
`
`
`Filing Date
`. Steve Cartt
`First Named Inventor
`
`
`
`
`(Use as many sheets as necessary)
`
`Examiner Name
`
`
` Adam Milligan
`
`35401-716201
`2
`i of l
`3
`l Attorney Docket Number
`
`
`
`Substitute for form l449/PTO
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`'
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Flares Appear
`
`,
`
`U.S. PATENT DOCUMENTS
`Publication Date
`Name of Patentee or
`»
`
`
`
`Applicant of Cited Document
`Document Number
`Number-Kind Code (ifknown)
`
`— 28.
`Cooper et'al.
`06/21/2005
`US-6,908,626
`
`Choi etal.
`11/07/2006
`'
`US-7,132,112
`
`
`30.
`US—7,434,579
`10/ 14/2008. Young et a1.
`
`
`
`Examiner
`Initials“
`
`Cite
`No.1
`
`U.S. PROVISIONAL PATENT DOCUMENTS
`
`Examiner
`Initials“
`
`I Cite
`No.1
`
`,
`Document Number
`‘—’—‘—."—-f—.—‘—‘
`11
`N mber—Kmd Code (if/mown)
`
`Filing Date
`W-DD-YYYY
`
`Name of Applicant of Cited
`Document
`«
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`‘ ures A . ear
`F1
`
`31.
`
`U.S. Prov. Appl. No.
`60/148,464
`'
`
`.
`
`.
`08/12/ 1999
`
`
`
`
`
`
`
` Examiner
`
`
`
`
`
`JP 2003~505403 (w/
`
`
`Corresponding English
`euivalent WO-OlO6987)
`
`
`4/7/2005 '
`JP 2005—5023939 (w/
`
`I
`Corresponding English
`
`
`equivalent WO~03 030872)
`
`
`
`4/26/2007
`Elan Pharma
`40.
`JP 2007-510722 (w/
`
`
`
`International Ltd.
`Corresponding English
`
`
`equivalent WO-2005-
`
`
`
`044234)
`
`
`
`
`wo-1990-05719
`5/31/1990
`British Bio-
`-
`
`.
`Date
`Considered
`I___Signature
`*EXAMNER: Initial ifreferenca considered, wheiher or not citation is in caigfomiance with MPEP 609. Draw line through citation ifnot in cary‘ormance and not considered Include copy
`ofthis form with next communication to applicant. 1Applicant’s unique citation designation number (optional). 2See Kinds Codes ofUSPTO Patent Documents at wwwusptogov or MPEP
`901.04. 3Enter Office that issued the document, by the two-letter code (WH’O Standard 5T3), 4For Japanese patent documents, the indication ofthe year ofthe reign ofthe Emperor must
`precede the serial number ofthe patent document. sKind of document by the appropriate symbols as indicated on the document under WIPO Standard ST. 16 if possible. ‘Applicant is to place a
`check mark here ifEnglish language Translation is attached.
`This collection of information is required by 37 CPR 1.97 and 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO to process) an
`application. Confidentiality is governed by 35 U.S.C, 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete, including gathering, preparing; and submitting the
`completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you require to complete this form and/or suggestions for
`reducing this burden, should be sent to the ChiefInformation Officer, U.S. Patent and Trademark Office, PO. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissioner for Parents, I'.O. Box 1450, Alexandria, VA 22313-1450.
`Ifyou need assistance in completing the/arm, call 1-800-PTO-9199 (1~800-786-9199) amt/select option 2.
`. 2 _
`
`
`
` FOREIGN PATENT DOCUMENTS
`Examiner
`Cite
`Foreign Patent Document
`Publication Date—I‘— Name ofPatentee or
`Pages, Columns,m
`
`Applicant of Cited Document
`Where Relevant Passages
`Initials*
`No.1
`MM-DD-YYYY
`
`of Relevant Figures Appear
`CouWNuWTKind Code (ifknown)
`EP-007803 86
`EP-0818442
`EP~0945485
`EP-1004578
`
`’
`
`6/25/1997
`1/14/1998
`9/29/1999
`5/31/2000
`
`Hoffman-La Roche AG
`Pfizer Inc.
`Morton Int'l., Inc.
`Pfizer Products Inc.
`
`"“-
`—
`_
`
`EP—606046
`EP-931788
`
`,
`
`7/13/1994
`7/28/1999
`
`.
`
`CIBA-GEIGY AG
`Pfizer Limited
`
`.
`
`33.
`34.
`35.
`
`36.
`37.
`
`
`
`
`2/12/2003
`
`,
`
`SK Corpororation
`(US)
`
`'
`Cooper, Eugene R.
`’
`
`,
`
`X
`
`_
`X
`
`,
`
`X
`
`41;
`
`Attemey Docket No. 35401-716201
`
`AQUESTIVE EXHIBIT 1007 page 0813
`
`AQUESTIVE EXHIBIT 1007
`
`page 0813
`
`

`

`Sheet
`
`Examiner
`Initials“
`
`
`
`42,
`
`Country Code -Number — Kind Code fiflmown}
`
`WO-1996—27583
`
`
`
`FOREIGN PATENT DOCUMENTS
`
`
`Name of Patentee or
`Publication Date
`Pages, Columns, Lines,
`
`MM-DD-YYYY
`Applicant of Cited Document
`Where Relevant Passages
`
`
`
`
`'
`Or Relevant Figures Appear
`
`Technology Ltd.
`9/12/1996 '
`Pfizer Inc.
`
`10/24/ 1996
`Pfizer Inc.
`1/29/1998
`Pfizer Inc.
`
`‘
`
`
`
`PTO/SB/OSar (07-09)
`‘
`Approved for use through 07/31/2012. OMB 0651-0031
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Under the Pacrwork Reduction Act of 1995, no nersons re uired to res-0nd to a collection of information unless it contains a valid OMB control number.
`
`Substitute for form 1449/PTO
`
`,
`
`-
`
`Complete ifKnown
`
`12/413,439
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`03/27/2009
`Steve Cartt,
`
`1612 '
`
`Adam Mag...
`
`Attorne Docket Number
`
`35401—716201
`
`
`
`
`
`
`
`
`
`43.
`44.
`
`WO—l 996—33 172
`W0— 1 998-035 16 '
`
`WO—l998-07697
`45.
`'
`_‘i“‘“‘46. wow-30566
`47.
`WO—1998-33768
`
`2/26/1998
`
`Pfizer Inc.
`
`
`8/6/1998
`Pfizer Products Inc.
`
`8/13/1998
`
`Pfizer Inc.
`
`‘ 2/18/1999
`
`Pfizer Products Inc.
`
`—
`
`48.
`
`49.
`
`WO-l998—34915
`
`wows-34918
`
`'
`
`50.
`
`51.
`
`WO—l999—007675
`wows-29667
`
`»
`
`52.
`
`53.
`54.
`
`55.
`
`56.
`
`WO—l999-52889
`
`WO-1999-5291O
`WO—2000-74681
`
`10/21/1999
`
`Pfizer Inc.
`
`‘
`
`10/21/1999, Pfizer Products Inc.
`12/14/2000
`Pfizer Limited
`
`WO-2006-055603 ‘
`.
`
`9/29/2005
`
`5/26/2006
`
`Univ. of Kentucky
`
`Research Found.
`Elan Pharma
`International Ltd.
`
`'
`
`4
`
`'
`
`~
`
`.
`
`‘—
`.
`
`, -
`
`57.
`
`-
`
`' WG-2006-088894
`
`} 8/24/2006
`
`’ Elan Pharma
`
`
`International Ltd.
`
`
`
`
`NON PATENT LITERATURE DOCUMENTS
`
`
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the
`
`
`Examiner
`item (book, magazine, journal, serial, symposium, catalog, etc), date, page(s), volume-issue number(s),
`
`
`Initials*
`publisher, city and/or country where ublished. .
`
`
`9
`Date
`Examiner
`Considered
`Si nature
`*EXAMINER: Initial ifrqfcrance considered whether or no! citation is in conformance with WEP 609. Draw line through citation final in conformance and not considered. Include copy
`ofthis form with next communication to applicant.
`lApplicant’s unique citation designation number (optional). zSee Kinds Codes ofUSPTO Patent Documents at www.uspto.gov or MPEP
`901.04. 3Enter Office that issued the document, by the two-letter code (WIPO Standard 8T3). “For Japanese patent documents, the indication ofthe year of the reign ofthe Emperor must
`precede the serial number ofthe patent document. ‘Kind ofdocument by the appropriate symbols as indicated on the document under WIPO Standard STAG ifpossible. ‘Applicant is to place a
`check mark here ifEnglish language Translation is attached.
`This collection of information is required by 37 CFR 197 and 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO to process) an
`application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete, including gathering, preparing, and submitting the
`completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you require to complete this form and/or suggestions for
`reducing this burden, should be sent to the ChiefInformation Officer, US. Patent and Trademark Office, PO. Box 1450, Alexandria, VA 223134450. DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, 13.0. Box 1450, Alexandria, VA 22313-1450.
`‘
`[fyou need assistance in completing theform, call 1-800—PTO~9199 {14300-786-9199) andselect option 2.
`
`Attorney Docket No. 35401-716201
`
`- 3 _
`
`AQUESTIVE EXHIBIT 1007 page 0814
`
`AQUESTIVE EXHIBIT 1007
`
`page 0814 -
`
`

`

`Europaisches Patentamt
`
`(19)
`
`0’
`
`European Patent Office
`
`Office européen des brevets
`
`(11)
`
`EP 0 780 386 A1
`
`(12)
`
`EUROPEAN PATENT APPLICATION
`
`(43) Date of publication:
`25.06.1997 Bulletin 1997/26
`
`(21) Application number: 96119780.3
`
`(22) Date of filing: 10.12.1996
`
`(51) Int. CI.6: CO7D 309/08,
`C07D 213/64,
`
`CO7D 211/54,
`
`C07D 401/06,
`
`C07D 407/12,
`
`C07D 413/12,
`
`C07D 405/12,
`A61 K 31 /445
`
`A61 K 31/35,
`
`(84) Designated Contracting States:
`AT BE CH DE DK ES FI FR GB GR IE IT LI LU MC
`NL PT SE
`
`(30) Priority: 20.12.1995 US 8939
`07.08.1996 US 22439
`04.12.1996 US 32096
`
`(71) Applicants:
`- F. HOFFMANN-LA ROCHE AG
`
`4070 Basel (CH)
`- AGOURON PHARMACEUTICALS, INC.
`La Jolla, CA 93057 (US)
`
`(72) Inventors:
`- Bender, Steven Lee
`CA 92054 (US)
`
`
`
`- Broka, Chris Allen
`CA 94404 (US)
`- Campbell, Jeffrey Allen
`Fremont, CA 94555 (US)
`- Castelhano, Arlindo Lucas
`NY 10956 (US)
`- Fisher, Lawrence Emerson
`CA 94040 (US)
`- Hendricks, Robert Than
`Palo Alto, CA 94306 (US)
`- Sarma, Keshab
`CA 94087 (US)
`