WO 2007/144081
`
`PCT/EP2007/004937
`
`23
`
`zugt in weniger als 30 s nach Applikation im Mundraum zer-
`
`fallt.
`
`19. Arzneimittelzubereitung nach einem der vorhergehenden
`
`Anspriiche, dadurch gekennzeichnet, daB das hydrophile Poly-
`mer schnell
`im Mundraum zerfdllt, der Wirkstoff aber an
`
`einen Ionentauscher gebunden bleibt, der den Wirkstoff erst
`
`im Gastrointestinaltrakt freisetzt.
`
`10
`
`20. Arzneimittelzubereitung nach einem der vorhergehenden
`
`da& die Wirkstoffe in
`Anspriiche, dadurch gekennzeichnet,
`diskreten Schichten enthalten sind, die radumlich voneinan—
`
`der getrennt sind und sich in ihrem Aufbau voneinander un-
`
`terscheiden.
`
`15
`
`20
`
`25
`
`30
`
`21. Arzneimittelzubereitung nach einem der vorhergehenden
`Anspriiche, dadurch gekennzeichnet, daB die Zubereitung als
`Schaum vorliegt und mindestens einer der Wirkstoffe in
`
`flissiger Form in den Hohlraumen des Schaums vorliegt.
`
`22. Arzneimittelzubereitung nach einem der vorangehenden
`
`Anspriiche, dadurch gekennzeichnet, da sie eine Kombination
`
`aus einem nikotinergen Wirkstoff und einem Antidepressivum
`
`enthalt.
`
`23. Verwendung einer Darreichungsform nach einem oder meh-
`
`reren der Anspritiche 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
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0801
`
`page 0801
`
`

`

`WO 2007/144081
`
`PCT/EP2007/004937
`
`24
`
`Darreichungsform nach einem der vorhergehenden Anspriche
`
`zur Raucherentwohnung.
`
`25. Verwendung einer Wirkstoffkombination aus nikotinergem
`
`Wirkstoff und Antidepressivum zur Herstellung einer oralen
`
`Darreichungsform nach einem der vorhergehenden Anspriche
`
`zur Raucherentwéhnung.
`
`26. Verwendung nach einem oder mehreren der Anspriiche 23 -
`
`10
`
`26, dadurch gekennzeichnet, da& das Arzneimittel als Wafer
`
`formuliert wird.
`
`27. Verfahren zur therapeutischen Behandlung einer unter
`
`Entzugserscheinungen der Raucherentwéhnung leidenden Per-
`
`“15
`
`son, dGadurch gekennzeichnet,
`
`dafS§ die Verabreichung der
`
`Wirkstoffkombination aus nikotinergem Wirkstoff und Psycho-
`
`pharmakon mittels einer oral applizierbaren Darreichungs-
`
`form mit transmukosaler Resorption erfolgt.
`
`20
`
`28. Verfahren zur Herstellung einer fladchenfé6rmigen Darrei-
`
`chungsform nach einem der Anspritiche 1 bis 22, gekennzeich-
`
`net durch das
`
`- Herstellen einer Lésung, die zumindest ein Polymer und
`
`mindestens zwei Wirkstoffe enthalt, von denen einer
`
`25
`
`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
`
`30
`
`- Verfestigen der ausgestrichenen Lésung durch Trocknen
`
`und Entzug des Lésemittels.
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0802
`
`page 0802
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/US2009/038696
`
`A.
`
`CLASSIFICATION OF SUBJECT MATTER
`
`AGIK 31/3$13(2000.01}i, AGIK 31/355(2006.01)i, AGIK 9/16(2006.01)i, AGLK 47/10(2006.01)i, A6LP 25/22(2006.0Di
`
`According lo International Patent Classification (IPC) or to beth nationalclassification and IPC
`FIELDS SEARCHED
`
`Minimum documentation searched (classification system followed by classification symbols}
`IPC8 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
`
`Cc. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Citation ofdocument, with indication, where appropriate, afthe relevant passages
`
`Relevant to claim No.
`
`WO 2007043057 AZ CIOULTOU, ELKA et. al.) 19 April 2007
`See claims 18 and 35, p. 6 (line 1-3), 8 (line 3-11}
`
`WO 2005117830 Al (CAMURUS AB, SWED) 15 December 20015
`See whole document
`
`WO 2006075123 Al (CAMURUS AB, SWED) 20 July 2006
`See whole document
`
`WO 2007144081 A2 (LTS LOHMANN THERAPIE-SYSTEM A.-G.) 21 December 2007
`See whole document
`mewsnuneeryqeeeeeneeee cence [famenneeaneneevaneccceane ceeecneceeenas saeaaneennnmannnnennnenennndenenanee mens rae
`
`82-42-48 1-8164 Facsimile No. $2-42-472-7140
`
`x See patent family annex.
`later document published afler the international filing date or priority
`date and not in conflict with the application but cited to understand
`the principle or theory underlying the invention
`decument of particular relevance; the claimed invention cannot be
`considered novel or cannot be considered to involve an inventive
`step when the document is taken afone
`document of particular relevance; the claimed invention cannot be
`considered to involve an inventive step when the document is
`combined with one o¢ more other such documents,such combination
`being obvious Lo a person skilled in the art
`"&" document member of the same patent family
`
`[| Further documents are Listed in the continuation ofBox C.
`Spocial calegorica of cited documents:
`document defining the general state of the art which is not considered
`to be ofparticular relevance
`earlier application or patent bul published on or alter the international
`filing date
`dgcument which may throw doubts on priority clain(s) or which is
`ciled1o establish the publication date of citation or other
`special reason (as specified)
`document referring to an oral disclosure, use, exhibilion or other
`means
`
`document published pricr to the intemationalfiling date but later
`than the priority date claimed
`
`Date of the actual completion of the intemational search
`
`28 SEPTEMBER 2009 (28.09.2009)
`
`Name and mailing address of the ISA/KR
`Koarcan Inteflectual Property Office
`Government Complex-Daejeon, 139 Seonsa-ro, S¢o-
`gu, Daejeon 302-701, Republic of Korea
`
`Form PCT/ISA/210 (second sheet) (July 2008)
`
`*T”
`
`ex"
`
`Date of mailing of the international search report
`28 SEPTEMBER2009 (28.09.2009)
`Authorized afficer
`
`KIM, YONG
`
`Telephone Ne.
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0803
`
`page 0803
`
`

`

`
`
`
` A.
`CLASSIFICATION OF SUBJECT MATTER.
`IPC(8} - AOQ1N 43/62; AG1K 31/55 (2012.01)
`
`
`USPC - 514/220-221
`
`
`According to Intemational Patent Classification (IPC) or to both national classification and IPC
`
`B.
`FIELDS SEARCHED
`Minimum documentation searched (classification system followed by classification symbols)
`USPC-514/220-221
`
`
`
` Documentation searched other than minimum documentation to the extent that such documents are included in the ficlds searched
`USPC-424/400, 434 (see search terms below)
`
`
`Electronic data base consulted during the international search (name of data base and, where practicable, search terms used)
`
`PUBWEST, Googie Scholar, Google,Intranasal, nasal, inhalation, mucosal, drug, delivery, denzodazepine, diazepam, tocopheral,
`
`tocatriano!, Vitamin E,alcohol, ethanal, benzyl alcohal, alkyl glycoside
`
`INTERNATIONAL SEARCH REPORT
`
`Intemational application No.
`PCTAJS 12/42311
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`
`
`
`
`Categary*
`
`
`
`
`
`
`
`DeRIESERTeeTeeeteetee
`
`“ee.
`
`Citetion of document, with indication, where appropriate, ofthe relevant passages
`
`
`
`US 2009/0268865 A1 (Cartt et al.) 15 October 2009 (15.10.2009) para [0010}{0021), [0024}-
`
`fo0sdh (6035}-{OOSOl, {0047], [0438], 0142}{0143}, (0147), [0161}-(01624, (0480]{0181], (0196}-
`
`US 2009/0130216 Af (Cart et al.) 21 May 2009 (21.05.2009) entire document
`
`US 20080279784 A1 (Carit et al.} 13 Novamber 2008 (13.11.2008) entire document
`
`Relevant to claim No.
`
`4-62
`
`
`
`
`US 2009/0304801 A1 (Liverskige et al.} 10 Decamber 2009 (10.12.2009) entire document
`
`
`
`
`
`
`rj Further documentsare listed in the continuation ofBox C. |
`
`ority
`priori
`*
`Specialcategories of cited documents:
`“T"
`laterdocument publishedaftertheinternational filing date or
`
`
`
`understand
`“4” document defining the generalstate ofthe art which is not considered
`date and not in conflict with the application but cited to
`to be ofparticular relevancetheinvention, the principle or theory underlying
`
`
`
`
` carlier application or patent butpublished on or after the intemational
`“Xx” document of particular relevance; the claimed invention cannot be
`“B"
`
`
`filing date
`considered novel or cannot be considered to invelve an inventive
`
`
`“L” document which may throw doubts on priority claim{e)or which is
`step when the document is taken alone
`
`
`siete cotablih, the
`blication date of another citation or other wy» document ofparticular relevance; the claimed invention cannot be
`a
`reason
`(as
`spec
`,
`considered to involve an inventive step when the document is
`
`
`“Q"
`document referring to an oral disclosure, use, exhibition or other
`combined with oneormore other such documents, such combination
`Means
`being obvious to person skilled in the art
`“
`
`
`“Pp documentpublishedpriortotheinternationalfilingdatebut laterthan «9 document memberofthe same patent family
`
`
`
` Date ofthe actual completion ofthe intemational search
`Date ofmailing ofthe international search report
`
`31 AUG 2017
`
`10 August 2012 (40.08.2012)
`
`
`Authorized officer:
`Name and mailing address of the ISA/US
`
`
`Mail Stop PCT, Attn: ISA/US, Commissioner for Patents
`
`
`P.O, Box 1450, Alexandra, Virginia 22313-1450
`POT Helpdesk: 574-272-4200
`
`
`
`POT CSP; 571-272-7774
`Facsimile No.
`374.273-3201
`
`
`
`
`Form PCT/ISA/210 (second sheet) (July 2009)
`AQUESTIVE EXHIBIT 1007 page 0804
`
`cnnnTE EE tO EEN dtp od td at tn mpae re amend
`
`AQUESTIVE EXHIBIT 1007
`
`page 0804
`
`Lee W. Young
`
`

`

`14255341
`
`12413439
`
`Application Number:
`
`International Application Number:
`
`Confirmation Number:
`
`Title of Invention:
`
`ADMINISTRATION OF BENZODIAZEPINE COMPOSITIONS
`
`Electronic AcknowledgementReceipt
`
`Utility under 35 USC 111)
`
`First Named Inventor/Applicant Name:
`
`Steve Cartt
`
`Customer Number:
`
`21971
`
`Matthew Virgil Grumbling/Lori Holslin
`
`Filer Authorized By:
`
`Matthew Virgil Grumbling
`
`Attorney Docket Number:
`
`35401-716.201
`
`Receipt Date:
`
`Filing Date:
`
`16-NOV-2012
`
`27-MAR-2009
`
`Time Stamp:
`
`18:29:15
`
`Application Type:
`
`Paymentinformation:
`
`Submitted with Payment
`
`File Listing:
`
`3 °
`
`Pages
`Multi
`File Size(Bytes)/
`DocumentDescription
`Document
`
`
`
`Number Message Digest|Part/.zip|P (if appl.)
`
`Transmittal Letter
`
`35401-716-201_IDS_Transmitta
`|_11-16-2012.pdf
`
`439c472740d4cadb9a814d44141 0eba37fe
`
`~aSaaN Information:
`
`AQUESTIVE EXHIBIT 1007 page 0805
`AQUESTIVE EXHIBIT 1007
`page 0805
`
`

`

`Information Disclosure Statement (IDS)|}35401-716-201_IDS_11-16-201
`6d414<0363cab7292.d0f46f36b45b040739
`Form (SB08)
`2.pdf
`dbbe
`
`Information:
`
`This is not an USPTO supplied IDS fillable form
`
`Foreign Reference
`
`W02005-117830.pdf
`
`6218647
`
`4150cebea90f7f7df4.a044b561 7b2760326d]
`o4of
`
`Information:
`
`Information:
`
`Information:
`
`Information:
`
`4d 109
`
`Foreign Reference
`
`W02006-075123.pdf
`
`Foreign Reference
`
`W02007-043057.pdf
`
`Foreign Reference
`
`WO02007-144081.pdf
`
`5620634
`
`315663aef55ccda966a7a402b7a93b6b5b0
`3f3ef
`
`4736531
`
`058fb2520a1 16d3c5c07180232c60268022|
`a8156
`
`1836909
`
`49827b9fb26659e7ae130203 187142a5a28}
`da65d
`
`Non Patent Literature
`
`PCT-US09-038696-ISR. pdf
`
`548174406b3b2c5b8d0943ac71626cc8f7d
`2565d
`
`Non Patent Literature
`
`PCT-US12-42311-ISR.pdf
`
`7a99b9ea862f5c3947435e677508e64fddd
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0806
`
`page 0806
`
`

`

`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary componentsfora 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 shownonthis
`AcknowledgementReceiptwill establish thefiling date of the application.
`
`National Stage of an International Application under 35 U.S.C. 371
`If a 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/903indicating acceptanceof 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 AcknowledgementReceipt evidences receipt on the noted date by the USPTOofthe 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
`If a 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 of the International Filing Date (Form PCT/RO/105)will be issued in due course, subject to prescriptions concerning
`national security, and the date shownon this AcknowledgementReceiptwill 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. 35401-716.201
`PATENT
`
`Inventor:
`
`Steve CARTT,et al.
`
`Group Art Unit:
`
`1612
`
`Serial Number:
`
`12/413,439
`
`Examiner:
`
`MILLIGAN, ADAM C,
`
`
`
`Filing Date: March 27, 2009 CONFIRMATION NO:=9049
`
`Title: ADMINISTRATION OF
`BENZODIAZEPINE COMPOSITIONS
`
`
`FILED ELECTRONICALLY ON: November lb, 2012
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria VA 22313-1450
`
`INFORMATION DISCLOSURE STATEMENT
`UNDER37 CFR §1.97
`
`Sir:
`
`An Information Disclosure Statement along with attached PTO/SB/08 is hereby submitted. A
`copy of eachlisted publication is submitted, if required, pursuant to 37 CFR §§1.97-1.98, 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 Examineris further requested to initial and return the
`attached PTO/SB/08 in accordance with MPEP §609.
`The right to establish the patentability of the claimed invention over any of the information
`provided herewith, and/or to prove that this information may not be prior art, and/or 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 madeor that the information
`cited in the statementis, or is considered to be, prior art or material to patentability as defined in §1.56.
`
`Attorney Docket No. 35401-716.201
`
`-l-
`
`§236073_1.D0C
`
`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:
`
`LI
`
`(1)
`
`It is being filed within 3 monthsofthe filing date of a national application andis
`other than a continued prosecution application under §1.53(d);
`
`-- OR -
`
`OO
`
`(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 --
`
`CJ
`
`G3)
`
`It is being filed before the mailing ofa first Office action on the merits;
`
`-- OR --
`
`Xl
`
`(4)
`
`It is being filed before the mailing of a first Office action after the filmg of a
`request for continued examination under §1.114.
`B. LJ 37 CFR §1.97(c). Although this Information Disclosure Statementis being filed after the period
`specified in 37 CFR §1.97(b), above, it is filed before the mailing date of the earlier of (1) a final
`office action under §1.113, (2) a notice of allowance under §1.311, or (3) an action that otherwise
`closes prosecution on the merits, this Information Disclosure Statement should be considered because
`it is accompanied by oneof;
`LC]
`a statement as specified in §1.97(e) provided concurrently herewith;
`
`- OR --
`
`Cc.
`
`CJ
`
`a fee of $180.00 as set forth in §1.17(p) authorized below, enclosed, or included with the
`paymentof other papers filed together with this statement.
`[1] 37 CFR §1.97(d}. Although this Information Disclosure Statementis being filed after the mailing
`date of the earlier of (1) a final office action under §1.113 or (2) a notice of allowance under §1.311,
`it is being filed before paymentof the issue fee and should be considered because it is accompanied
`by:
`
`i. astatement as specified in §1.97(e);
`
`-- AND --
`
`ii. a fee of $180.00 as set forth in §1.17(p) is authorized below, enclosed, or included
`with the paymentofother papers filed together with this Statement.
`[-] 37 CFR §1.97(e). Statement.
`[]
`A statementis provided herewith to satisfy the requirement under 37 CFR §§1.97(c);
`
`D.
`
`-- AND/OR --
`
`|
`
`A statement is provided herewith to satisfy the requirement under 37 CFR §§1.97(d);
`-- AND/OR --
`
`CO
`
`A copy of a dated communication from a foreign patent office clearly showing that the
`information disclosure statement is being submitted within 3 monthsofthe filing date on
`the communication is provided in lieu of a statement under 37 C.F.R. § 1.97(e)(1) as
`provided for under MPEP 609.04(b)V.
`([] Statement Under 37 C.F.R. §1.704(d). Each item of information contained in the information
`disclosure 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 thirty (30) days
`prior to the filing of this information disclosure statement. This statement is made pursuant to the
`
`E.
`
`Attomey Docket No. 35401-716.201
`
`-2-
`
`$236073_1.DOC
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0809
`
`page 0809
`
`

`

`F.
`
`requirements of 37 C.F.R. §1.704(d) to avoid reduction of the period of adjustment of the patent term
`for Applicant(s) delay.
`37 CFR $1.98(a)(2). The contentof the Information Disclosure Statementis as follows:
`CJ
`Copies of each of the references listed on the attached Form PTO/SB/08 are enclosed
`herewith.
`
`i
`
`XxX
`
`-- OR --
`
`Copies of U.S. Patent Documents (issued patents and patent publications) listed on the
`attached Form PTO/SB/08 are NOTenclosed.
`
`-- AND/OR--
`
`Copies of Foreign Patent Documents and/or Non Patent Literature Documents listed on
`the attached Form PTO/SB/08are enclosed in accordance with 37 CFR §1.98 (a}(2).
`
`-- AND/OR--
`
`Copies of pending unpublished U.S. patent applications are enclosed in accordance with
`37 CFR §1.98(a)(2)iii).
`G. 1] 37 CFR $1.98(a)(3). The Information Disclosure Statement includes non-English patents and/or
`references.
`
`C]
`
`Pursuant to 37 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.
`L]
`Pursuant to MPEP 609(B), 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 --
`
`CJ
`
`CJ
`
`A concise explanation of the relevance of each patent, publication or other
`information provided that is not in English is as follows:
`Pursuant to 37 CFR §1,98(a)(3\ii), a copy of a translation, or a portion thereof, of the
`non-English language reference(s) is provided herewith.
`H. (1 37 CFR §1.98(d). Copies of patents, publications and pending U.S. patent applications, or other
`information specified in 37 C.F.R. § 1.98(a) are not provided herewith because:
`
`{| Pursuant to 37 CFR §1.98(d)(1) the information was previously submitted in an
`
`
`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
`
`Cc
`
`The information disclosure statement submitted in the earlier application complied with
`paragraphs(a) through (c) of 37 CFR §1.98.
`
`Attorney Docket No. 35401-716.201
`
`-3-
`
`5236073_1.BO0C
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0810
`
`page 0810
`
`

`

`1.
`
`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. 35401-716.201).
`
`Respectfully submitted,
`
`WILSON SONSINI GOODRICH & ROSATI
`
`By: MeetsV-{ 2
`
`Matthew V. Grumbling
`Reg. No. 44,427
`
`.
`
`Dated:
`
`UN 7 Adz
`
`650 Page Mill Road
`Palo Alto, CA 94304-1050
`(650) 493-9300
`Customer No. 021971
`
`Attorney Docket No, 35401-716.201
`
`-4-
`
`5236073_1.D0C
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 0811
`
`page 0811
`
`

`

`PTO/SB/08a (07-09)
`.
`Approvedfor use through 07/31/2012. OMB 0651-0031
`U.S.Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons required to respondto a collection of information unless it contains a valid OMB control number.
`
`
`Complete ifKnown
`_
`
`
`
`
`12/413,439.
`
`Substitute for form 1449/PTO
`03/27/2009
`
`
`INFORMATION DISCLOSURE
`
`
`
`STATEMENT BY APPLICANT
`
`
`
`(Use as many sheets as necessary)
`
`
`Adan lig
`
`Attorney Docket Number|35401-716.201
`
`
`
`
`
`Application Number
`Filing Date.
`First Named Inventor
`
`1612
`
`
`
`
`
`
`U.S. PATENT DOCUMENTS
`Pages, Columns, Lines, Where
`Publication Date
`|/
`Name ofPatentee or
`.
`Cite
`Examiner
`No.
`
`
`
`
`Initials* - MM-DD-YYYY|Applicant of Cited Document0 . Document Number| Relevant Passages or Relevant _
`
`Number-Kind Code* (known)
`Figures Appear
`|1.|US-2001-0042932 11/22/2001
`
`1.
`2
`US-2002-0127278
`09/12/2012
`3.
`4,|US-2003-0031719 02/13/2003
`
`5
`US-2006-0198896
`09/07/2006
`
`6
`US-2008-0200418
`08/21/2008
`
`7.|US-2008-0248123 10/09/2008|Swansonetal.|sd
`
`8.|US-2008-0299079 12/04/2008 |Meezanetal.=|sd
`f9.[|US-2009-0163447|06/25/2009|Maggio|
`
`10.|US-2009-0297619 12/03/2009 |Swansonetal..[|sd
`
`11.|US-2010-0068209 03/18/2010|Maggio[|tst—<CSsSSCOY
`
`
`12.|US-2011-0172211 07/14/2011|Back et al. |
`
`13.|US-2011-0257096 10/20/2011|Maggio
`
`14.|US-2012-0196941 08/02/2012|Maggio
`
`15.|US-2013-0065886 03/14/2013|Cartt
`
`16.|US-4,973,465 -|11/27/1990|Baurain etal.
`
`17.|US-5,457,100 10/10/1995|Daniel
`
`|sf 18.|US-5,661,130 08/26/1997|Meezan et al.
`
`}«|19.|US-5,861,510 01/19/1999_|Piscipioet al.
`
`20.|US-5,863,949 _|01/26/1999|Robinsonet al.
`
`21.|US-6,143,211 11/07/2000|Mathiowitz et al.
`
`22.|US-6,193,985 02/27/2001|Sonne —
`23. 05/22/2001|Mathiowitz et al.| US-6,235,224
`
`
`
`24: 08/06/2002|Boschet al.US-6,428,814
`
`
`
`25.|US-6,610,271 08/26/2003|Wermeling
`
`26.|US-6,616,914 09/09/2003|Wardet al.
`
`27.|US-6,627,211 09/30/2003|Choiet al.
`
`
`
`
`
`
`
`
`
`Sa
`
`*EXAMINER: Initial ifreference considered, whether or not citation is in conformance with MPEP 609. Draw linethroughcitation ifnot in conformance and not considered. Include copy
`ofthis form with next communication to applicant:
`'Applicant’s uniquecitation designation number(optional). 2See Kinds Codes ofUSPTO Patent Documents at www.uspto.gov or MPEP
`901.04, 7Enter 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 numberofthe patent document. 5Kind ofdocumentby the appropriate symbols as indicated on the document under WIPO Standard ST. 16 ifpossible. SApplicantis to place a
`check mark here ifEnglish language Translation is attached,
`.
`.
`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 whichis 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 uponthe individual case. Any comments on the amount oftime you require to complete this form and/or suggestions for”
`reducing this burden, should be sentto the ChiefInformation Officer, U.S. Patent and Trademark Office, P.O, Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450,
`:
`Ifyou needassistance in completing theform, call 1-800-PTO-9199 (1-800-786-9199) andselectoption 2.
`-l-
`
`Attorney Docket No. 35401-716.201
`
`AQUESTIVE EXHIBIT 1007 page 0812
`AQUESTIVE EXHIBIT 1007
`page 0812
`
`
`
`
`

`

`
`
`
`Under the Paperwork Reduction Act of 1995, no persons required to res;
`
`
`PTO/SB/08a (07-09)
`Approvedfor use through 07/31/2012. OMB 0651-0031
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`pond to a collection of information unless it contains a valid OMB control number.
`
`
`Complete ifKnown
`
`
`Application Number
`Substitute for form 1449/PTO
`12/413,439
`
`
`
`
`
`03/27/2009
`INFORMATION DISCLOSURE
`Filing Date
`
`- Steve Cartt
`
`First Named Inventor
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`
`-|Examiner Name
`
` Adam Milligan
`2
`| of |
`3
`| Attorney Docket Number
`L
`|
`
`
`-35401-716.201
`Sheet
`
`
`
`
` Examiner
`
`
`
`
`
`
`
`
`
`
`
`U.S. PATENT DOCUMENTS
`
`
`
`
`Pages, Columns, Lines, Where
`Publication Date
`Nameof Patentee or
`.
`Cite
`Examiner
`Initials*
`
`
`
`No.! MM-DD-YYYY|Applicant of Cited DocumentDocument Number Relevant Passages or Relevant
`
`Number-Kind Code* (ifknown)
`Figures Appear
`.
`
`
`
`US-6,908,626 06/21/2005|Cooperetal:
`
`
`US-7, 132,112 11/07/2006|Choietal.
`
`
`
`30, 10/14/2008.|Young etal.US-7,434,579
`
`
`
`U.S. PROVISIONAL PATENT DOCUMENTS
`
`
`Pages, Columns, Lines, Where
`
`
`Cite
`:
`Filing Date
`Name of Applicantof Cited
`Examiner
`Relevant Passages or Relevant
`
`
`
`Initials* |_____DocumentNumber_|No! MM-DD-YYYY Document
`
`
`
`Figures Appear
`
`Number-Kind Code’* (ifknown)
`
`
`U.S. Prov. Appl. No.
`31.
`08/12/1999
`60/148,464
`
`
`
`
`
`
`
`FOREIGN PATENT DOCUMENTS
`
`
`
`
` PublicationDateTo ‘NameofPatentee or Pages, Columns,Examiner Cite|Foreign Patent DocumentLines,|T°|Initials*
`
`No.!
`MM-DD-YYYY
`Applicant of Cited Document
`Where Relevant Passages
`
`
`. CountryCode’-Number"~Kind Code’ (flown) | Or Relevant Figures Appear
`
`
`EP-00780386 6/25/1997|Hoffman-La Roche AG r|
`
`
`
`33,|EP-0818442 1/14/1998|Pfizer Inc. [|
`
`
`
`34, 9/29/1999|Morton Int'l, Inc.EP-0945485 ri
`35.
`EP-1004578
`5/31/2000
`Pfizer Products Inc.
`
`36. 7/13/1994|CIBA-GEIGY AGEP-606046
`
`
`37. .|7/28/1999.|Pfizer LimitedEP-931788
`
`
`JP 2003-505403 (w/
`2/12/2003
`SK Corpororation
`x
`Corresponding English
`(US)
`
`||
`.
`equivalent WO-0106987)
`
`
`
`
`
`JP 2005-508939 (w/ 4/7/2005 -|Cooper,EugeneR. X
`
`Corresponding English
`,
`
`
`equivalent WO-03030872)
`
`
`
`
`
`
`
`
`
`
`Corresponding English
`International Ltd.
`
`equivalent WO-2005-
`
`
`
`044234)
`
`
`
`
`41:|WO-1990-05719 5/31/1990|British Bio-||
`
`.
`Date
`Considered
`|_Signature
`*EXAMINER:Initial ifreference considered, whether or not citationis in conformance wiih MPEP 609, Draw line throughcitation ifnotin conformance and not considered. Include copy
`ofthis form with next communication to applicant,
`'Applicant’s uniquecitation designation number(optional). 2See Kinds Codes ofUSPTO Patent Documents at www.uspto.gov or MPEP
`901.04, 7Enter Office that issued the document, by the two-letter cade (WIPO Standard ST.3). 4For Japanese patent documents,the indication ofthe yearofthe reign ofthe Emperor must
`precedethe serial numberofthe patent document, 5Kind ofdocumentby the appropriate symbols as indicated on the document under WIPO Standard ST.16 ifpossible. SApplicantis to place a
`check mark here ifEnglish language Translation is attached.
`This collection of information is required by 37 CFR 1.97 and 1.98, The information is required to obtain or retain a benefit by the public whichistofile (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 uponthe individual case, Any comments on the amountoftime you require to complete this form and/or suggestions for
`reducingthis burden, should be sent to the ChiefInformation Officer, U.S. Patent and Trademark Office, P.O, Box 1450, Alexandria, VA 22313-1450, DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450,
`°
`.
`Ifyou need assistance in completing theform, call 1-800-PTO-9199 (1-800-786-9199) andselect option 2.
`-2-
`
`40. 4/26/2007|Elan PharmaJP 2007-510722 (w/ Xx
`
`Attorney Docket No. 35401-716.201
`
`AQUESTIVE EXHIBIT 1007 page 0813
`AQUESTIVE EXHIBIT 1007
`page 0813
`
`

`

`
`
`
`
`
`
`
`
`48, 8/13/1998|Pfizer Inc.WO-1998-34915
`
`
`9.|WO-1998-34918
`
`
`50.|WO-1999-007675 | 2/18/1999|Pfizer Products Inc. ;
`51,_|
`W0-1999-29667
`_
`
`52. 10/21/1999|PfizerInc.WO-1999-52889
`
`
`
`53.|WO-1999-52910 10/21/1999 | Pfizer Products Inc.||
`
`
`
`54, 12/14/2000|Pfizer LimitedWO-2000-74681 .
`
`
`55. 9/29/2005|Univ. of Kentucky |
`
`:
`—
`Research Found.
`56. 5/26/2006|Elan PharmaWO-2006-055603 -
`International Ltd.
`
`
`
`
`
`57,
`
`| WO-2006-088894
`
`| 8/24/2006
`
`| Elan Pharma
`
`International Ltd.
`
`
`
`
`
`NON PATENT LITERATURE DOCUMENTS
`
`
`
`Include nameofthe author (in CAPITAL LETTERS),title of the article (when appropriate),title of the
`Exarniner
`item (book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`
`Initials*
`publisher, city and/or country where published.
`.
`
`
`
`
`
`Date
`Examiner
`Considered
`Signature
`*EXAMINER:Initialifreference considered, whether or notcitation is in conformance with MPEP 609. Draw line through citationifnot in conformance and not considered, Include copy.
`ofthis form with next communication to applicant.
`'Applicant’s unique citation designation number(optional), ?See Kinds Codes ofUSPTO Patent Documents at www.uspto.gov or MPEP
`901.04. 7Enter Office that issued the document, by the two-letter code (WIPO Standard ST.3). “For Japanese patent documents,the indication ofthe yearofthe 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 ST,16 ifpossible. *Applicant is to place a
`check mark here ifEnglish language Translation is attached.
`This collection of information is required by 37 CFR 1.97 and 1.98, The information is required to obtain or retain a benefit by the public which is to filé (and by the USPTO to process) an
`application. Confidentiality is governed by 33 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 amountof 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, P.O. Box 1450, Alexandria, VA 22313-1450, DO NOT SEND FEES OR COMPLETED
`FORMSTO THIS ADDRESS. SEND TO: Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-24450,
`‘Ifyau need assistance in completing theform, call 1-800-PTO-9199 (1-800-786-9199) andselect option 2.
`
`: A
`
`AQUESTIVE EXHIBIT 1007 page 0814
`QUESTIVE EXHIBIT 1007
`page 0814
`
`Attorney Docket No. 35401-716.201
`
`-3-
`
`PTO/SB/08a(07-09)
`Approved for use through 07/31/2012. OMB 0651-0031
`US. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons required to respond to a collection of information unless it contains a valid OMB control number.
`.Complete ifKnown
`12/413,439
`Application Number
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE_|Filing Date _ 03/27/2009
`STATEMENT BY APPLICANT
`First Named Inventor
`Steve Cartt.
`(Use as many sheets as necessary)
`1612
`Adan Miliga
`
`
`
`Sheet Attorney Docket Number|35401-716.201
`
`
`
`
`
`FOREIGN PATENT DOCUMENTS
`
`
`
`
`
`
`
`
`|Examiner|Cite Foreign Patent Document Publication Date NameofPatentee or Pages, Columns, Lines,
`
`
`Where Relevant Passages
`MM-DD-YYYY
`Applicant of Cited Document
`Initials*
`No.!
`
`
`
`
`
`
`Country Code’ — Number — Kind Code’ (ifknown)
`,
`Or Relevant Figures Appear
`.
`
`
`
`Technology Ltd.
`42, 9/12/1996|Pfizer Inc.WO-1996-27583
`
`43, 10/24/1996|Pfizer Inc.WO-1996-33172
`
`
`44,
`WO-1998-03516 ~
`1/29/1998
`Pfizer Inc.
`
`~145, 2/26/1998||Pfizer Inc.WO-1998-07697
`
`|__|46._|
`WO-1998-30566
`47.
`WO-1998-33768
`
`
`8/6/1998
`Pfizer Products Inc.
`
`
`
`

`

`(19) 9d
`
`(12)
`
`Europaisches Patentamt
`
`European PatentOffice
`
`Office européen des brevets
`
`(11)
`
`EP 0 780 386 A1
`
`EUROPEA